Practice Management

Before reading this editorial and concluding that the author (me) has lost his grip on reality, I would ask that you consider the facts I provide below and the ramifications incurred by your patients and practices, due to the misbehaviors adopted by the health insurance industry.

• Two of the most common issues discussed in today’s health care environment are revenue generation and provider/staff burnout.

While these issues are impacted by several factors, one of the most common denominators is increasing administrative workloads driven by non–revenue-generating activities. Consider this:

• A recent American Medical Association survey pointed out that during the course of the average workweek, a physician completes an average of 37 prior authorization requests. Physicians and their staff spend an average of 16.4 hours per week completing prior authorization requirements for patient medicines, procedures, and medical services that they may need.¹
• While physicians report that about 65% of prior authorizations take only 1 day, they report that 26% take 3 or more days.²

The potential significance of the generated delays

While this may not seem like a long time (other than the impact it has on staff workload), consider the impact this can have on the patient if the medication being requested is: PrEP, the morning after pill, or other contraceptives? The consequences of the delay or denial could be a lifetime living with HIV, or an unintended pregnancy. This is to say nothing on the larger impact to family, partners, and the potential social stigma faced by all.

Beyond the personal costs and costs within your practice associated with the additional workload, consider the financial costs. The average cost to complete a prior authorization remains the single highest cost for the health care industry at $13.40 per manual transaction, and $7.19 per partially electronic web portal transaction,³ meaning that if I did only one prescription per week, I probably would not mind, but at $13.40 per prior authorization, this burden amounts to millions, actually $767 million by recent estimates.³ Additionally, if you factor in the number of denials and potential follow-ups, this creates a significant amount of waste and spending.

Ultimately, in my experience, I have found that most prior authorizations are simply unnecessary. Here, I’ve picked key examples from just my own recent experiences:

1. My patient was denied access to a particular birth control pill she had been on successfully before, and my office was told she needed to try and fail on 5 different generic pills before she could be approved. However, the Affordable Care Act’s (ACA; aka Obamacare) Contraceptive Mandate requires coverage of all contraceptives determined to be most appropriate between a patient and their provider (see below).
2. A menopausal patient was denied coverage twice (electronically) for generic micronized progesterone, and I was asked to write a letter of appeal because the insurance company wanted me to use medroxyprogesterone acetate instead. Polling my nearby retail independent pharmacy, the total cost difference per year was $19.96 savings/year ($47.01 ‒ $27.05 = $19.96). My pharmacist did note it could have been a different amount at a large chain pharmacy. Really? I had to write a letter, following two denials, to save less than $20, for a full year!
3. A 78-year-old patient using Prolia for severe osteoporosis and preexisting fractures was delayed in getting her next Prolia injection due to a prior authorization snafu. She ended up with multiple additional fractures, a well-described effect of the increase in bone turnover when stopping or delaying this medication. She is now disabled.
4. A 94-year-old patient was sent an email reminder to get the medical practice to authorize a refill of ileostomy bags. The email went to spam, and the patient ran out of bags prior to a holiday weekend. I got them in 2 days on Amazon Prime. But who emails a 94-year-old? And ileostomy bags! When does anyone stop needing ileostomy bags?
5. I requested a prior authorization for Orilissa (clearly off label) because a severely progestogen-sensitive patient (augmented depression) with severe premenstrual dysphoric disorder requiring hospitalization was thought by her psychiatrist to be better off without menstrual periods. I completed the proper paperwork, two electronic appeals, and a letter of explanation including available references on the use of gonadotropin-releasing hormone analogues for such patients. I was then told I would need to have a peer-to-peer discussion, so I filled out that paperwork, which clearly noted that I am a board-certified reproductive endocrinologist. I got a phone call a few days later by a pleasant, young-sounding pediatric rheumatologist. Our interaction did not go well for him. This was not peer-to-peer!

Let us be clear, prior authorizations have nothing to do with patient care. In fact, they are solely about the money. We in ObGyn have mostly inexpensive and generic products, but even that fact has not lowered the excessive burden of the prior authorization process. In the case of contraception, whether you like the ACA or not it is the law, and it contains specific provisions regarding contraception. With the goals of providing broad access to patients and incentives to developers for new and novel contraceptive methods, these provisions require insurers to cover, without cost-sharing, women’s preventive services including the full range of FDA-approved contraceptives (currently 18 different method categories), and additional methods identified by the FDA as they become available. Further, providers must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider (or other individuals acting as a patient’s authorized representative).

And while I can regale you with chapter and verse and citations of the legal precedent and language, it boils down to this:

• The AMA reported that medical practices spend an average of 2 business days a week per physician to comply with health plans’ inefficient and overused prior-authorization protocols.⁴ To keep up with the administrative burden, 2 out of 5 physicians (40%) employ staff members who work exclusively on tasks associated with prior authorization.⁴
• About 86% of practices reported an increased burden of prior authorizations in the last 5 years.⁵

Continue to: What is to be done?

I do have suggested solutions. Given the insurance industry’s complete lack of progress in voluntarily reducing the burdens of prior authorizations agreed to in their consensus statement with the AMA, American Hospital Association, America’s Health Insurance Plans, American Pharmacists Association, Blue Cross Blue Shield Association, and the Medical Group Management Association, I say, why not fine them? The AMA is calling on Congress to pass legislation that would codify much of the agreement, in which the above parties had already agreed that reforms were needed to reduce prior authorization burdens and enhance patient-centered care.⁶

A good model for enforcement via fines could be based on the old “incident to” rules of Medicare. These state that a physician needs to be “in the space” when advanced practice nurses or physician assistants see Medicare recipients. If they are not actually “in the space” they are subject to a fine. As a completely theoretical example, let’s say the claim was for $100. The practitioner would have to pay it back plus triple that amount in damages, or $400. They can also be fined up to $11,000 per claim and kick you out of Medicare and Medicaid. Take my example of Prolia from above…a single shot of Prolia is about $1,000. The insurer would theoretically have to pay $14,000/claim (the claim + triple damages + $11,000) if it was determined that the prior authorization was unnecessary. Seems about right to me. Or we could just sit the health insurance CEOs and their proxies in the corner on 2-foot-tall plastic Little Tikes® chairs for a “timeout” (dunce cap optional), like the outset of the article says.

Until the detrimental prior authorization process is challenged at all levels, we will continue to see and feel the effects of the harm it causes. Being able to drive change through advocacy and education is the best way we as clinicians can impact not just the future of health care but provide for the daily care of our patients who depend on and trust us to provide for their medical needs. We must be the impactors of change for ourselves, colleagues, staff, and profession if we are to really make advancements into the future.

Oh…and health insurance CEOs and their proxies, to get out of their “time-out” would still be entitled to one phone call to beg forgiveness from their mommies/daddies, priest/ rabbi/pastor, psychologist/psychiatrist/mystic healer, etc., but alas, the average wait time is an hour, and if anyone answers the phone, they have a grade school education used in following an irrelevant algorithm. ●

Before reading this editorial and concluding that the author (me) has lost his grip on reality, I would ask that you consider the facts I provide below and the ramifications incurred by your patients and practices, due to the misbehaviors adopted by the health insurance industry.

• Two of the most common issues discussed in today’s health care environment are revenue generation and provider/staff burnout.

While these issues are impacted by several factors, one of the most common denominators is increasing administrative workloads driven by non–revenue-generating activities. Consider this:

• A recent American Medical Association survey pointed out that during the course of the average workweek, a physician completes an average of 37 prior authorization requests. Physicians and their staff spend an average of 16.4 hours per week completing prior authorization requirements for patient medicines, procedures, and medical services that they may need.¹
• While physicians report that about 65% of prior authorizations take only 1 day, they report that 26% take 3 or more days.²

The potential significance of the generated delays

While this may not seem like a long time (other than the impact it has on staff workload), consider the impact this can have on the patient if the medication being requested is: PrEP, the morning after pill, or other contraceptives? The consequences of the delay or denial could be a lifetime living with HIV, or an unintended pregnancy. This is to say nothing on the larger impact to family, partners, and the potential social stigma faced by all.

Beyond the personal costs and costs within your practice associated with the additional workload, consider the financial costs. The average cost to complete a prior authorization remains the single highest cost for the health care industry at $13.40 per manual transaction, and $7.19 per partially electronic web portal transaction,³ meaning that if I did only one prescription per week, I probably would not mind, but at $13.40 per prior authorization, this burden amounts to millions, actually $767 million by recent estimates.³ Additionally, if you factor in the number of denials and potential follow-ups, this creates a significant amount of waste and spending.

Ultimately, in my experience, I have found that most prior authorizations are simply unnecessary. Here, I’ve picked key examples from just my own recent experiences:

1. My patient was denied access to a particular birth control pill she had been on successfully before, and my office was told she needed to try and fail on 5 different generic pills before she could be approved. However, the Affordable Care Act’s (ACA; aka Obamacare) Contraceptive Mandate requires coverage of all contraceptives determined to be most appropriate between a patient and their provider (see below).
2. A menopausal patient was denied coverage twice (electronically) for generic micronized progesterone, and I was asked to write a letter of appeal because the insurance company wanted me to use medroxyprogesterone acetate instead. Polling my nearby retail independent pharmacy, the total cost difference per year was $19.96 savings/year ($47.01 ‒ $27.05 = $19.96). My pharmacist did note it could have been a different amount at a large chain pharmacy. Really? I had to write a letter, following two denials, to save less than $20, for a full year!
3. A 78-year-old patient using Prolia for severe osteoporosis and preexisting fractures was delayed in getting her next Prolia injection due to a prior authorization snafu. She ended up with multiple additional fractures, a well-described effect of the increase in bone turnover when stopping or delaying this medication. She is now disabled.
4. A 94-year-old patient was sent an email reminder to get the medical practice to authorize a refill of ileostomy bags. The email went to spam, and the patient ran out of bags prior to a holiday weekend. I got them in 2 days on Amazon Prime. But who emails a 94-year-old? And ileostomy bags! When does anyone stop needing ileostomy bags?
5. I requested a prior authorization for Orilissa (clearly off label) because a severely progestogen-sensitive patient (augmented depression) with severe premenstrual dysphoric disorder requiring hospitalization was thought by her psychiatrist to be better off without menstrual periods. I completed the proper paperwork, two electronic appeals, and a letter of explanation including available references on the use of gonadotropin-releasing hormone analogues for such patients. I was then told I would need to have a peer-to-peer discussion, so I filled out that paperwork, which clearly noted that I am a board-certified reproductive endocrinologist. I got a phone call a few days later by a pleasant, young-sounding pediatric rheumatologist. Our interaction did not go well for him. This was not peer-to-peer!

Let us be clear, prior authorizations have nothing to do with patient care. In fact, they are solely about the money. We in ObGyn have mostly inexpensive and generic products, but even that fact has not lowered the excessive burden of the prior authorization process. In the case of contraception, whether you like the ACA or not it is the law, and it contains specific provisions regarding contraception. With the goals of providing broad access to patients and incentives to developers for new and novel contraceptive methods, these provisions require insurers to cover, without cost-sharing, women’s preventive services including the full range of FDA-approved contraceptives (currently 18 different method categories), and additional methods identified by the FDA as they become available. Further, providers must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider (or other individuals acting as a patient’s authorized representative).

And while I can regale you with chapter and verse and citations of the legal precedent and language, it boils down to this:

• The AMA reported that medical practices spend an average of 2 business days a week per physician to comply with health plans’ inefficient and overused prior-authorization protocols.⁴ To keep up with the administrative burden, 2 out of 5 physicians (40%) employ staff members who work exclusively on tasks associated with prior authorization.⁴
• About 86% of practices reported an increased burden of prior authorizations in the last 5 years.⁵

Continue to: What is to be done?

I do have suggested solutions. Given the insurance industry’s complete lack of progress in voluntarily reducing the burdens of prior authorizations agreed to in their consensus statement with the AMA, American Hospital Association, America’s Health Insurance Plans, American Pharmacists Association, Blue Cross Blue Shield Association, and the Medical Group Management Association, I say, why not fine them? The AMA is calling on Congress to pass legislation that would codify much of the agreement, in which the above parties had already agreed that reforms were needed to reduce prior authorization burdens and enhance patient-centered care.⁶

A good model for enforcement via fines could be based on the old “incident to” rules of Medicare. These state that a physician needs to be “in the space” when advanced practice nurses or physician assistants see Medicare recipients. If they are not actually “in the space” they are subject to a fine. As a completely theoretical example, let’s say the claim was for $100. The practitioner would have to pay it back plus triple that amount in damages, or $400. They can also be fined up to $11,000 per claim and kick you out of Medicare and Medicaid. Take my example of Prolia from above…a single shot of Prolia is about $1,000. The insurer would theoretically have to pay $14,000/claim (the claim + triple damages + $11,000) if it was determined that the prior authorization was unnecessary. Seems about right to me. Or we could just sit the health insurance CEOs and their proxies in the corner on 2-foot-tall plastic Little Tikes® chairs for a “timeout” (dunce cap optional), like the outset of the article says.

Until the detrimental prior authorization process is challenged at all levels, we will continue to see and feel the effects of the harm it causes. Being able to drive change through advocacy and education is the best way we as clinicians can impact not just the future of health care but provide for the daily care of our patients who depend on and trust us to provide for their medical needs. We must be the impactors of change for ourselves, colleagues, staff, and profession if we are to really make advancements into the future.

Oh…and health insurance CEOs and their proxies, to get out of their “time-out” would still be entitled to one phone call to beg forgiveness from their mommies/daddies, priest/ rabbi/pastor, psychologist/psychiatrist/mystic healer, etc., but alas, the average wait time is an hour, and if anyone answers the phone, they have a grade school education used in following an irrelevant algorithm. ●

Before reading this editorial and concluding that the author (me) has lost his grip on reality, I would ask that you consider the facts I provide below and the ramifications incurred by your patients and practices, due to the misbehaviors adopted by the health insurance industry.

• Two of the most common issues discussed in today’s health care environment are revenue generation and provider/staff burnout.

While these issues are impacted by several factors, one of the most common denominators is increasing administrative workloads driven by non–revenue-generating activities. Consider this:

• A recent American Medical Association survey pointed out that during the course of the average workweek, a physician completes an average of 37 prior authorization requests. Physicians and their staff spend an average of 16.4 hours per week completing prior authorization requirements for patient medicines, procedures, and medical services that they may need.¹
• While physicians report that about 65% of prior authorizations take only 1 day, they report that 26% take 3 or more days.²

The potential significance of the generated delays

While this may not seem like a long time (other than the impact it has on staff workload), consider the impact this can have on the patient if the medication being requested is: PrEP, the morning after pill, or other contraceptives? The consequences of the delay or denial could be a lifetime living with HIV, or an unintended pregnancy. This is to say nothing on the larger impact to family, partners, and the potential social stigma faced by all.

Beyond the personal costs and costs within your practice associated with the additional workload, consider the financial costs. The average cost to complete a prior authorization remains the single highest cost for the health care industry at $13.40 per manual transaction, and $7.19 per partially electronic web portal transaction,³ meaning that if I did only one prescription per week, I probably would not mind, but at $13.40 per prior authorization, this burden amounts to millions, actually $767 million by recent estimates.³ Additionally, if you factor in the number of denials and potential follow-ups, this creates a significant amount of waste and spending.

Ultimately, in my experience, I have found that most prior authorizations are simply unnecessary. Here, I’ve picked key examples from just my own recent experiences:

1. My patient was denied access to a particular birth control pill she had been on successfully before, and my office was told she needed to try and fail on 5 different generic pills before she could be approved. However, the Affordable Care Act’s (ACA; aka Obamacare) Contraceptive Mandate requires coverage of all contraceptives determined to be most appropriate between a patient and their provider (see below).
2. A menopausal patient was denied coverage twice (electronically) for generic micronized progesterone, and I was asked to write a letter of appeal because the insurance company wanted me to use medroxyprogesterone acetate instead. Polling my nearby retail independent pharmacy, the total cost difference per year was $19.96 savings/year ($47.01 ‒ $27.05 = $19.96). My pharmacist did note it could have been a different amount at a large chain pharmacy. Really? I had to write a letter, following two denials, to save less than $20, for a full year!
3. A 78-year-old patient using Prolia for severe osteoporosis and preexisting fractures was delayed in getting her next Prolia injection due to a prior authorization snafu. She ended up with multiple additional fractures, a well-described effect of the increase in bone turnover when stopping or delaying this medication. She is now disabled.
4. A 94-year-old patient was sent an email reminder to get the medical practice to authorize a refill of ileostomy bags. The email went to spam, and the patient ran out of bags prior to a holiday weekend. I got them in 2 days on Amazon Prime. But who emails a 94-year-old? And ileostomy bags! When does anyone stop needing ileostomy bags?
5. I requested a prior authorization for Orilissa (clearly off label) because a severely progestogen-sensitive patient (augmented depression) with severe premenstrual dysphoric disorder requiring hospitalization was thought by her psychiatrist to be better off without menstrual periods. I completed the proper paperwork, two electronic appeals, and a letter of explanation including available references on the use of gonadotropin-releasing hormone analogues for such patients. I was then told I would need to have a peer-to-peer discussion, so I filled out that paperwork, which clearly noted that I am a board-certified reproductive endocrinologist. I got a phone call a few days later by a pleasant, young-sounding pediatric rheumatologist. Our interaction did not go well for him. This was not peer-to-peer!

Let us be clear, prior authorizations have nothing to do with patient care. In fact, they are solely about the money. We in ObGyn have mostly inexpensive and generic products, but even that fact has not lowered the excessive burden of the prior authorization process. In the case of contraception, whether you like the ACA or not it is the law, and it contains specific provisions regarding contraception. With the goals of providing broad access to patients and incentives to developers for new and novel contraceptive methods, these provisions require insurers to cover, without cost-sharing, women’s preventive services including the full range of FDA-approved contraceptives (currently 18 different method categories), and additional methods identified by the FDA as they become available. Further, providers must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider (or other individuals acting as a patient’s authorized representative).

And while I can regale you with chapter and verse and citations of the legal precedent and language, it boils down to this:

• The AMA reported that medical practices spend an average of 2 business days a week per physician to comply with health plans’ inefficient and overused prior-authorization protocols.⁴ To keep up with the administrative burden, 2 out of 5 physicians (40%) employ staff members who work exclusively on tasks associated with prior authorization.⁴
• About 86% of practices reported an increased burden of prior authorizations in the last 5 years.⁵

Continue to: What is to be done?

I do have suggested solutions. Given the insurance industry’s complete lack of progress in voluntarily reducing the burdens of prior authorizations agreed to in their consensus statement with the AMA, American Hospital Association, America’s Health Insurance Plans, American Pharmacists Association, Blue Cross Blue Shield Association, and the Medical Group Management Association, I say, why not fine them? The AMA is calling on Congress to pass legislation that would codify much of the agreement, in which the above parties had already agreed that reforms were needed to reduce prior authorization burdens and enhance patient-centered care.⁶

A good model for enforcement via fines could be based on the old “incident to” rules of Medicare. These state that a physician needs to be “in the space” when advanced practice nurses or physician assistants see Medicare recipients. If they are not actually “in the space” they are subject to a fine. As a completely theoretical example, let’s say the claim was for $100. The practitioner would have to pay it back plus triple that amount in damages, or $400. They can also be fined up to $11,000 per claim and kick you out of Medicare and Medicaid. Take my example of Prolia from above…a single shot of Prolia is about $1,000. The insurer would theoretically have to pay $14,000/claim (the claim + triple damages + $11,000) if it was determined that the prior authorization was unnecessary. Seems about right to me. Or we could just sit the health insurance CEOs and their proxies in the corner on 2-foot-tall plastic Little Tikes® chairs for a “timeout” (dunce cap optional), like the outset of the article says.

Until the detrimental prior authorization process is challenged at all levels, we will continue to see and feel the effects of the harm it causes. Being able to drive change through advocacy and education is the best way we as clinicians can impact not just the future of health care but provide for the daily care of our patients who depend on and trust us to provide for their medical needs. We must be the impactors of change for ourselves, colleagues, staff, and profession if we are to really make advancements into the future.

Oh…and health insurance CEOs and their proxies, to get out of their “time-out” would still be entitled to one phone call to beg forgiveness from their mommies/daddies, priest/ rabbi/pastor, psychologist/psychiatrist/mystic healer, etc., but alas, the average wait time is an hour, and if anyone answers the phone, they have a grade school education used in following an irrelevant algorithm. ●

Doctors providing “fraudulent” COVID-19 information became a hot-button issue for physicians responding to Medscape’s recent article, "Shouldn’t Doctors Who Spread False COVID-19 Information Lose Their Licenses?”

COVID-19 safety recommendations are set by mainstream medical organizations as new information becomes available, but some doctors consistently oppose advice from the Centers for Disease Control and Prevention and other medical authorities. These physicians often promote off-label, unapproved use of medications for COVID-19 and/or contradict mainstream safety guidelines such as vaccines, masks, and social distancing.

Some medical organizations are concerned that these doctors are hampering efforts to control the highly contagious coronavirus and are, at worst, placing lives in danger with their contrarian views that can spread like wildfire on social media sites. Their words are often used by those who refuse to be vaccinated or wear masks.

State licensing boards have mostly refused to discipline these doctors for making false and/or misleading claims, but as the virus spreads, there are calls to take action against them. However, others worry that such actions would violate free speech and critical thought.

Medscape recently took on the question of whether doctors should lose their licenses for spreading misinformation and disinformation about COVID-19, which spurred a strong response from clinician readers.
 

Yes, those doctors are doing wrong

Several physicians took a strong stand against their fellow doctors who are spreading misinformation about COVID-19.

One doctor endorsed the idea of removing licenses for spreading misinformation and called for criminal prosecution: “It should certainly be grounds for cancellation of all licensing (after appropriate examination to rule out acute psychotic episodes, dementia, tumor, etc.) and very likely [include] a charge of manslaughter.”

Another health care provider said, “A person who does not accept science should not, of course, be allowed to practice medicine. One who argues publicly that vaccines and masks don’t work should be prosecuted for crimes ranging from reckless endangerment to attempted murder.”

One reader framed COVID-19 misinformers in stark terms: “These men and women are medical prostitutes. Their medical and surgical colleges [should] have a panel to track in-court testimony and the disinformation they spread ...”

“This is malpractice of the worst kind,” said a clinician. “Public health officials and science are quite clear on [the] best practices for safety during a pandemic, which is killing millions. This is a standard of care.”

“Medical Boards should suspend licenses and give the physician a chance to testify [about] the scientific basis for his comments,” added a health care provider. “Boards involve themselves in all kinds of perceived disciplinary infractions. We are in the midst of a lethal pandemic. I would think that would take precedence over many other issues?”

“I do believe that physicians have the responsibility to speak the truth and have scientifically displayed minds,” said a reader. “Not [to] promulgate misleading, false, and/or unverified information.”

“Any physician, who holds a license, should abide [by] government and state regulation,” asserted a doctor. “He should be disciplined by the board for spreading medical/public misinformation since he is creating potential harm to the population.”

One specialist insisted that “state boards do not do enough to restrict/limit the practice of physicians touting questionable therapies.”

“Any doctor who spreads false information about Covid is hurting our country, our individuals, and our economy and leading to needless deaths,” asserted a physician. “However, there are uncertainties, and where those exist, physicians [should] simply say ‘it is unknown.’”
 

No, those physicians have a right to speak their beliefs

However, many physicians worried that science and controversial thought were being muzzled.

“Absolutely no,” a doctor stated. “Who judges what is misinformation in this age where debate is canceled? Science advances with challenge, and it’s not about an authority dictating the allowable opinion.”

Another clinician claimed the “truth is very difficult to discern from less-than-truth in a country running on a profit-oriented economic ideology.”

One specialist warned that if disinformation doctors are held responsible, then “that means a lot of doctors” will be “gone” because “almost anything that is written or said about COVID can be contested.”

Another physician warned his colleagues about suppressing new ideas: “To condemn what we didn’t try, or purposefully ignore a different approach because [it] doesn’t agree with our opinion is suppression of information.”

Some doctors insisted the issue extended beyond medicine and into Constitutional freedoms. They also expressed their mistrust in the government to regulate physicians.

“There is a First Amendment in this country,” said one reader. “What you think is false may not be so. The people can listen to whoever they want to and make their own medical decisions. We do not need one iota more of politicizing medicine. Having an MD or DO does not mean you relinquish your First Amendment rights.”

“One of the fundamental problems with a system that allows government to ‘license’ physicians, or any other profession, is that politics inevitably turn to cronyism, and big businesses and wealthy people start controlling the government,” argued a doctor.

One clinician suggested enforcement against health food, drug company commercials, and talk shows: “What about all the [misinformation] at the health food stores and the like. Doctors of natural-whatever? Those info-commercials on tv. How many faxes do I get to ‘approve’ because ‘patients request’ braces and pain-treating expensive compounds advertised on TV? We tolerate those ... What about Dr. Oz and the docs on talk shows claiming BS?”
 

And the debate goes even further

Some physicians questioned the very notion of claiming “truth.”

“Nobody should be certain that they have the ‘absolute truth,’” said one reader. “In fact, the best clinical insights exceed so-called knowledge by at least one step.”

“Who can determine exactly what is truth?” asked another clinician. “For sure, the ‘Federal Government,’ who ‘is here to help you,’ is not qualified to make such determinations, and who are you to make such a suggestion as to remove someone’s license because they disagree with you? Give me a break!”

Another physician echoed that sentiment: “What’s true and false is often and certainly currently debatable. There are well-qualified physicians (with credentials such as the development of mRNA technology), virologists, and biostatisticians that have valid thoughts on this but do not necessarily agree with the drug company-sponsored journals and news channels (most of them). Their voices should be heard, and they should not lose their licenses. They are doing their work in good conscience.”

One reader commented that he wanted his “freedom of speech,” and offered this defiant advice: “You can take this license and shove it.”

Finally, a physician noted that the political climate has influenced medical directives: “If someone in a leadership role knowingly, and with intent, spread false information, that is wrong. However, during this global pandemic the active and the politics have combined. Red state no mandate, blue state mandate – what does that tell you about American leadership?”

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

Doctors providing “fraudulent” COVID-19 information became a hot-button issue for physicians responding to Medscape’s recent article, "Shouldn’t Doctors Who Spread False COVID-19 Information Lose Their Licenses?”

COVID-19 safety recommendations are set by mainstream medical organizations as new information becomes available, but some doctors consistently oppose advice from the Centers for Disease Control and Prevention and other medical authorities. These physicians often promote off-label, unapproved use of medications for COVID-19 and/or contradict mainstream safety guidelines such as vaccines, masks, and social distancing.

Some medical organizations are concerned that these doctors are hampering efforts to control the highly contagious coronavirus and are, at worst, placing lives in danger with their contrarian views that can spread like wildfire on social media sites. Their words are often used by those who refuse to be vaccinated or wear masks.

State licensing boards have mostly refused to discipline these doctors for making false and/or misleading claims, but as the virus spreads, there are calls to take action against them. However, others worry that such actions would violate free speech and critical thought.

Medscape recently took on the question of whether doctors should lose their licenses for spreading misinformation and disinformation about COVID-19, which spurred a strong response from clinician readers.
 

Yes, those doctors are doing wrong

Several physicians took a strong stand against their fellow doctors who are spreading misinformation about COVID-19.

One doctor endorsed the idea of removing licenses for spreading misinformation and called for criminal prosecution: “It should certainly be grounds for cancellation of all licensing (after appropriate examination to rule out acute psychotic episodes, dementia, tumor, etc.) and very likely [include] a charge of manslaughter.”

Another health care provider said, “A person who does not accept science should not, of course, be allowed to practice medicine. One who argues publicly that vaccines and masks don’t work should be prosecuted for crimes ranging from reckless endangerment to attempted murder.”

One reader framed COVID-19 misinformers in stark terms: “These men and women are medical prostitutes. Their medical and surgical colleges [should] have a panel to track in-court testimony and the disinformation they spread ...”

“This is malpractice of the worst kind,” said a clinician. “Public health officials and science are quite clear on [the] best practices for safety during a pandemic, which is killing millions. This is a standard of care.”

“Medical Boards should suspend licenses and give the physician a chance to testify [about] the scientific basis for his comments,” added a health care provider. “Boards involve themselves in all kinds of perceived disciplinary infractions. We are in the midst of a lethal pandemic. I would think that would take precedence over many other issues?”

“I do believe that physicians have the responsibility to speak the truth and have scientifically displayed minds,” said a reader. “Not [to] promulgate misleading, false, and/or unverified information.”

“Any physician, who holds a license, should abide [by] government and state regulation,” asserted a doctor. “He should be disciplined by the board for spreading medical/public misinformation since he is creating potential harm to the population.”

One specialist insisted that “state boards do not do enough to restrict/limit the practice of physicians touting questionable therapies.”

“Any doctor who spreads false information about Covid is hurting our country, our individuals, and our economy and leading to needless deaths,” asserted a physician. “However, there are uncertainties, and where those exist, physicians [should] simply say ‘it is unknown.’”
 

No, those physicians have a right to speak their beliefs

However, many physicians worried that science and controversial thought were being muzzled.

“Absolutely no,” a doctor stated. “Who judges what is misinformation in this age where debate is canceled? Science advances with challenge, and it’s not about an authority dictating the allowable opinion.”

Another clinician claimed the “truth is very difficult to discern from less-than-truth in a country running on a profit-oriented economic ideology.”

One specialist warned that if disinformation doctors are held responsible, then “that means a lot of doctors” will be “gone” because “almost anything that is written or said about COVID can be contested.”

Another physician warned his colleagues about suppressing new ideas: “To condemn what we didn’t try, or purposefully ignore a different approach because [it] doesn’t agree with our opinion is suppression of information.”

Some doctors insisted the issue extended beyond medicine and into Constitutional freedoms. They also expressed their mistrust in the government to regulate physicians.

“There is a First Amendment in this country,” said one reader. “What you think is false may not be so. The people can listen to whoever they want to and make their own medical decisions. We do not need one iota more of politicizing medicine. Having an MD or DO does not mean you relinquish your First Amendment rights.”

“One of the fundamental problems with a system that allows government to ‘license’ physicians, or any other profession, is that politics inevitably turn to cronyism, and big businesses and wealthy people start controlling the government,” argued a doctor.

One clinician suggested enforcement against health food, drug company commercials, and talk shows: “What about all the [misinformation] at the health food stores and the like. Doctors of natural-whatever? Those info-commercials on tv. How many faxes do I get to ‘approve’ because ‘patients request’ braces and pain-treating expensive compounds advertised on TV? We tolerate those ... What about Dr. Oz and the docs on talk shows claiming BS?”
 

And the debate goes even further

Some physicians questioned the very notion of claiming “truth.”

“Nobody should be certain that they have the ‘absolute truth,’” said one reader. “In fact, the best clinical insights exceed so-called knowledge by at least one step.”

“Who can determine exactly what is truth?” asked another clinician. “For sure, the ‘Federal Government,’ who ‘is here to help you,’ is not qualified to make such determinations, and who are you to make such a suggestion as to remove someone’s license because they disagree with you? Give me a break!”

Another physician echoed that sentiment: “What’s true and false is often and certainly currently debatable. There are well-qualified physicians (with credentials such as the development of mRNA technology), virologists, and biostatisticians that have valid thoughts on this but do not necessarily agree with the drug company-sponsored journals and news channels (most of them). Their voices should be heard, and they should not lose their licenses. They are doing their work in good conscience.”

One reader commented that he wanted his “freedom of speech,” and offered this defiant advice: “You can take this license and shove it.”

Finally, a physician noted that the political climate has influenced medical directives: “If someone in a leadership role knowingly, and with intent, spread false information, that is wrong. However, during this global pandemic the active and the politics have combined. Red state no mandate, blue state mandate – what does that tell you about American leadership?”

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

Doctors providing “fraudulent” COVID-19 information became a hot-button issue for physicians responding to Medscape’s recent article, "Shouldn’t Doctors Who Spread False COVID-19 Information Lose Their Licenses?”

COVID-19 safety recommendations are set by mainstream medical organizations as new information becomes available, but some doctors consistently oppose advice from the Centers for Disease Control and Prevention and other medical authorities. These physicians often promote off-label, unapproved use of medications for COVID-19 and/or contradict mainstream safety guidelines such as vaccines, masks, and social distancing.

Some medical organizations are concerned that these doctors are hampering efforts to control the highly contagious coronavirus and are, at worst, placing lives in danger with their contrarian views that can spread like wildfire on social media sites. Their words are often used by those who refuse to be vaccinated or wear masks.

State licensing boards have mostly refused to discipline these doctors for making false and/or misleading claims, but as the virus spreads, there are calls to take action against them. However, others worry that such actions would violate free speech and critical thought.

Medscape recently took on the question of whether doctors should lose their licenses for spreading misinformation and disinformation about COVID-19, which spurred a strong response from clinician readers.
 

Yes, those doctors are doing wrong

Several physicians took a strong stand against their fellow doctors who are spreading misinformation about COVID-19.

One doctor endorsed the idea of removing licenses for spreading misinformation and called for criminal prosecution: “It should certainly be grounds for cancellation of all licensing (after appropriate examination to rule out acute psychotic episodes, dementia, tumor, etc.) and very likely [include] a charge of manslaughter.”

Another health care provider said, “A person who does not accept science should not, of course, be allowed to practice medicine. One who argues publicly that vaccines and masks don’t work should be prosecuted for crimes ranging from reckless endangerment to attempted murder.”

One reader framed COVID-19 misinformers in stark terms: “These men and women are medical prostitutes. Their medical and surgical colleges [should] have a panel to track in-court testimony and the disinformation they spread ...”

“This is malpractice of the worst kind,” said a clinician. “Public health officials and science are quite clear on [the] best practices for safety during a pandemic, which is killing millions. This is a standard of care.”

“Medical Boards should suspend licenses and give the physician a chance to testify [about] the scientific basis for his comments,” added a health care provider. “Boards involve themselves in all kinds of perceived disciplinary infractions. We are in the midst of a lethal pandemic. I would think that would take precedence over many other issues?”

“I do believe that physicians have the responsibility to speak the truth and have scientifically displayed minds,” said a reader. “Not [to] promulgate misleading, false, and/or unverified information.”

“Any physician, who holds a license, should abide [by] government and state regulation,” asserted a doctor. “He should be disciplined by the board for spreading medical/public misinformation since he is creating potential harm to the population.”

One specialist insisted that “state boards do not do enough to restrict/limit the practice of physicians touting questionable therapies.”

“Any doctor who spreads false information about Covid is hurting our country, our individuals, and our economy and leading to needless deaths,” asserted a physician. “However, there are uncertainties, and where those exist, physicians [should] simply say ‘it is unknown.’”
 

No, those physicians have a right to speak their beliefs

However, many physicians worried that science and controversial thought were being muzzled.

“Absolutely no,” a doctor stated. “Who judges what is misinformation in this age where debate is canceled? Science advances with challenge, and it’s not about an authority dictating the allowable opinion.”

Another clinician claimed the “truth is very difficult to discern from less-than-truth in a country running on a profit-oriented economic ideology.”

One specialist warned that if disinformation doctors are held responsible, then “that means a lot of doctors” will be “gone” because “almost anything that is written or said about COVID can be contested.”

Another physician warned his colleagues about suppressing new ideas: “To condemn what we didn’t try, or purposefully ignore a different approach because [it] doesn’t agree with our opinion is suppression of information.”

Some doctors insisted the issue extended beyond medicine and into Constitutional freedoms. They also expressed their mistrust in the government to regulate physicians.

“There is a First Amendment in this country,” said one reader. “What you think is false may not be so. The people can listen to whoever they want to and make their own medical decisions. We do not need one iota more of politicizing medicine. Having an MD or DO does not mean you relinquish your First Amendment rights.”

“One of the fundamental problems with a system that allows government to ‘license’ physicians, or any other profession, is that politics inevitably turn to cronyism, and big businesses and wealthy people start controlling the government,” argued a doctor.

One clinician suggested enforcement against health food, drug company commercials, and talk shows: “What about all the [misinformation] at the health food stores and the like. Doctors of natural-whatever? Those info-commercials on tv. How many faxes do I get to ‘approve’ because ‘patients request’ braces and pain-treating expensive compounds advertised on TV? We tolerate those ... What about Dr. Oz and the docs on talk shows claiming BS?”
 

And the debate goes even further

Some physicians questioned the very notion of claiming “truth.”

“Nobody should be certain that they have the ‘absolute truth,’” said one reader. “In fact, the best clinical insights exceed so-called knowledge by at least one step.”

“Who can determine exactly what is truth?” asked another clinician. “For sure, the ‘Federal Government,’ who ‘is here to help you,’ is not qualified to make such determinations, and who are you to make such a suggestion as to remove someone’s license because they disagree with you? Give me a break!”

Another physician echoed that sentiment: “What’s true and false is often and certainly currently debatable. There are well-qualified physicians (with credentials such as the development of mRNA technology), virologists, and biostatisticians that have valid thoughts on this but do not necessarily agree with the drug company-sponsored journals and news channels (most of them). Their voices should be heard, and they should not lose their licenses. They are doing their work in good conscience.”

One reader commented that he wanted his “freedom of speech,” and offered this defiant advice: “You can take this license and shove it.”

Finally, a physician noted that the political climate has influenced medical directives: “If someone in a leadership role knowingly, and with intent, spread false information, that is wrong. However, during this global pandemic the active and the politics have combined. Red state no mandate, blue state mandate – what does that tell you about American leadership?”

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

From the Department of Medicine (Drs. Meisenberg, Muganlinskaya, Sharma, Amjadi, Arnold, Barnes, Clance, Khalil, Miller, Mooradian, O’Connell, Patel, Press, Samaras, Shanmugam, Tavadze, and Thompson), Department of Pharmacy (Drs. Jiang, Jarawan, Sheth, and Trinh), Department of Nursing (Dr. Ohnmacht), and Department of Women and Children’s Services (Dr. Raji), Luminis Health, Annapolis, MD, and Lanham, MD.

Objective: The COVID-19 pandemic has been a challenge for hospital medical staffs worldwide due to high volumes of patients acutely ill with novel syndromes and prevailing uncertainty regarding optimum supportive and therapeutic interventions. Additionally, the response to this crisis was driven by a plethora of nontraditional information sources, such as email chains, websites, non–peer-reviewed preprints, and press releases. Care patterns became idiosyncratic and often incorporated unproven interventions driven by these nontraditional information sources. This report evaluates the efforts of a health system to create and empower a multidisciplinary committee to develop, implement, and monitor evidence-based, standardized protocols for patients with COVID-19.

Methods: This report describes the composition of the committee, its scope, and its important interactions with the health system pharmacy and therapeutics committee, research teams, and other work groups planning other aspects of COVID-19 management. It illustrates how the committee was used to demonstrate for trainees the process and value of critically examining evidence, even in a chaotic environment.

Results: Data show successful interventions in reducing excessive ordering of certain laboratory tests, reduction of nonrecommended therapies, and rapid uptake of evidence-based or guidelines-supported interventions.

Conclusions: A multidisciplinary committee dedicated solely to planning, implementing, and monitoring standard approaches that eventually became evidence-based decision-making led to an improved focus on treatment options and outcomes for COVID-19 patients. Data presented illustrate the attainable success that is both adaptable and suitable for similar emergencies in the future.

Keywords: COVID-19; clinical management; pharmacy and therapeutics; treatment; therapy.

The COVID-19 pandemic has spread to nearly all countries, carrying with it high morbidity, mortality, and severe impacts on both well-developed and less-well-developed health systems. Media reports of chaos within overwhelmed hospitals have been prominent.^1,2 As of January 5, 2022, SARS-CoV-2 has infected more than 295 million people globally and directly caused the death of more than 5.4 million,³ though this number is likely an undercount even in countries with well-developed mortality tracking.⁴

Throughout the COVID-19 pandemic, hospital-based medical teams have been confronted with a flood of severely ill patients with novel syndromes. Initially, there were no standards for therapy or supportive care except for treatments borrowed from similar syndromes. In the setting of high volumes, high acuity, and public dismay, it is unsurprising that the usual deliberative methods for weighing evidence and initiating interventions were often pushed aside in favor of the solace of active intervention.⁵ In this milieu of limited evidence, there was a lamentable, if understandable, tendency to seek guidance from “nontraditional” sources,⁶ including email chains from colleagues, hospital websites, non–peer-reviewed manuscripts, advanced publication by medical journals,⁷ and nonscientific media presentations. In many localities, practitioners responded in idiosyncratic ways. For example, findings of high cytokine levels in COVID-19,⁸ along with reports of in-vitro antiviral activity with drugs like hydroxychloroquine against both SARS⁹ and SARS-CoV-2,¹⁰ drove laboratory test ordering and therapeutic interventions, respectively, carving shortcuts into the traditional clinical trial–dependent standards. Clinical trial results eventually emerged.¹¹COVID-19 created a clinical dilemma for hospital medical staffs in terms of how to organize, standardize, and rapidly adapt to a flood of new information. In this report, we describe how 1 health system responded to these challenges by forming a COVID-19 Clinical Management Committee (CCMC) and empowering this interdisciplinary team to review evidence, create and adjust order sets, educate practitioners, oversee care, and collaborate across teams addressing other aspects of the COVID-19 response.

Program Overview

Health System Description

Luminis Health is a health system with 2 acute care hospitals that was formed in 2019 just before the start of the pandemic. Anne Arundel Medical Center (hospital A) is a 385-bed teaching hospital in Annapolis, MD. It has more than 23 000 discharges annually. Patients with COVID-19 were cared for by either an internal medicine teaching service or nonteaching hospitalist services on cohorted nursing units. Doctor’s Community Medical Center, in Lanham, MD (hospital B), is a 206-bed acute care hospital with more than 10 350 annual discharges. COVID-19 patients were cared for by hospitalist groups, initially in noncohorted units with transition to cohorted nursing units after a few months. The medical staffs are generally distinct, with different leadership structures, though the Luminis Health Department of Medicine has oversight responsibilities at both hospitals. More than 47 physicians attended COVID-19 patients at hospital A (with medical residents) and 30 individual physicians at hospital B, respectively, including intensivists. The nursing and pharmacy staffs are distinct, but there is a shared oversight Pharmacy and Therapeutics (P&T) Committee.

The 2 hospitals had distinct electronic medical records (EMR) until January 2021, when hospital B adopted the same EMR as hospital A (Epic).

Mission and Formation of CCMC

In order to coordinate the therapeutic approach across the health system, it was important for the CCMC to be designated by the health system P&T committee as an official subcommittee so that decisions on restrictions of medications and/or new or revised order sets could be rapidly initiated across the system without waiting for the subsequent P&T meetings. The full committee retained oversight of the CCMC. Some P&T members were also on the CCMC.

The committee reviewed new reports in medical journals and prepublication servers and consulted recommendations of professional societies, such as the National Institutes of Health (NIH) COVID-19 guidelines, Infectious Diseases Society of America, Society of Critical Care Medicine, and US Food and Drug Administration (FDA) Emergency Use Authorizations (EUA), among other sources.

Composition of the CCMC

Physician leaders from both hospitals in the following specialties were solicited for participation: critical care, epidemiology, hospital medicine (internal medicine), emergency medicine, infectious diseases, nephrology, women and children’s services, and medical informatics. Specialists in other areas, such as hematology, were invited for topic-specific discussions. Hospital pharmacists with different specialties and nursing leadership were essential contributors. The committee members were expected to use various communication channels to inform frontline clinicians of new care standards and the existence of new order sets, which were embedded in the EMR.

Clinical Research

An important connection for the CCMC was with theCOVID-19 clinical research team. Three members of the research team were also members of the CCMC. All new study proposals for therapeutics were discussed with the CCMC as they were being considered by the research team. In this way, feedback on the feasibility and acceptance of new study opportunities could be discussed with the CCMC. Occasionally, CCMC decisions impacted clinical research accrual strategies. For example, new data from randomized trials about tocilizumab^1,2 demonstrated benefits in some subsets of patients and resulted in a recommendation for use by the NIH guideline committee in these populations.¹ The CCMC quickly adopted this recommendation, which required a reprioritization of clinical research enrollment for studies testing other immune-modulating agents. This important dialogue was mediated within the CCMC.

Guideline Distribution, Reinforcement, and Platform for Feedback

New guidelines were disseminated to clinicians via daily brief patient huddles held on COVID units, with participation by nursing and pharmacy, and by weekly meetings with hospitalist leaders and frontline hospital physicians. Order sets and guidelines were maintained on the intranet. Adherence was reinforced by unit-based and central pharmacists. Order sets, including admission order sets, could be created only by designated informatics personnel, thus enforcing standardization. Feedback on the utility of the order sets was obtained during the weekly meetings or huddles, as described above. To ensure a sense of transparency, physicians who had interest in commenting on a particular therapy, or who wished to discuss a particular manuscript, news article, or website, were invited to attend CCMC meetings.

Scope of CCMC

In order to be effective and timely, we limited the scope of our work to the report to the inpatient therapeutic environment, allowing other committees to work on other aspects of the pandemic response. In addition to issuing guidance and creating order sets to direct clinical practice, the CCMC also monitored COVID-19 therapeutic shortages^15,16 and advised on prioritization of such treatments as convalescent plasma, remdesivir (prioritization and duration of therapy, 5 vs 10 days), baricitinib, and tocilizumab, depending upon the location of the patient (critical care or not). The CCMC was not involved in the management of non–COVID-19 shortages brought about by supply chain deficiencies.

Table 1 shows some aspects of the health system pandemic-response planning and the committee workforce that undertook that work. Though many items were out of scope for the CCMC, members of the CCMC did participate in the planning work of these other committees and therefore stayed connected to this complementary work.

A Teaching Opportunity About Making Thoughtful Choices

Another important feature of the CCMC was the contributions of residents from both pharmacy and internal medicine. The purpose and operations of the committee were recognized as an opportunity to involve learners in a curriculum based on Kern’s 6-step approach.¹⁷ Though the problem identification and general needs assessment were easily defined, the targeted needs assessment, extracted from individual and group interviews with learners and the committee members, pointed at the need to learn how to assess and analyze a rapidly growing body of literature on several relevant clinical aspects of SARS-CoV-2 and COVID-19. To achieve goals and objectives, residents were assigned to present current literature on a particular intervention during a committee meeting, specifically commenting on the merit or deficiencies of the study design, the strength of the data, and applicability to the local context with a recommendation. Prior to the presentations, the residents worked with faculty to identify the best studies or systematic analyses with potential to alter current practices. We thus used the CCMC process as a teaching tool about evidence-based medicine and the dilemma of clinical equipoise. This was imperative, since trainees thrust into the COVID-19 response have often keenly observed a movement away from deliberative decision-making.¹⁸ Indeed, including residents in the process of deliberative responses to COVID-19 addresses a recent call to adjust medical education during COVID-19 to “adapt curriculum to current issues in real time.”¹⁹

Interventions and Therapies Considered

Table 2 shows the topics reviewed by the CCMC. By the time of the first meeting, nonstandardization of care was already a source of concern for clinicians. Dialogue often continued outside of the formal meetings. Many topics were considered more than once as new guidance developed, changes to EUAs occurred, and new data or new publicity arose.

Methods

The Human Protections Administrator determined that this work constituted “quality improvement, and not research” and was therefore exempt from institutional review board review.

Quantitative Analysis

All admitted patients from March 10, 2020, through April 20, 2021, were considered in the quantitative aspects of this report except as noted. Patients diagnosed with COVID-19 were identified by searching our internal data base using diagnostic codes. Patient admissions with the following diagnostic codes were included (prior to April 1, 2020): J12.89, J20.8, J40, J22, J98.8, J80, each with the additional code of B97.29. After April 1, 2020, the guideline for coding COVID-19 was U07.1.

Descriptive statistics were used to measure utilization rates of certain medications and laboratory tests of interest over time. These data were adjusted for number of unique admissions. In a few cases, not all data elements were available from both hospitals due to differences in the EMR.

Case fatality rate was calculated based upon whether the patient died or was admitted to inpatient hospice as a result of COVID-19. Four patients transferred out of hospital A and 18 transferred out of hospital B were censored from case-fatality-rate determination.

Figure 1 shows the number of admissions for each acute care hospital in the health system and the combined COVID-19 case-fatality rate over time.

Results

A total of 5955 consecutive COVID-19 patients admitted from March 10, 2020, through April 30, 2021, were analyzed. Patients with International Statistical Classification of Diseases, Tenth Revision codes J12.89. J20.8, J40, J22, J98.8, J80, each with the additional code of B97.29 (or the code UO7.1 after April 1, 2020), were included in the analysis. The median age of admitted patients was 65 years (range 19-91 years). Using the NIH classification system for severity,²⁰ the distribution of severity during the first 24 hours after the time of hospital admission was as follows: asymptomatic/presymptomatic, 0.5%; mild illness, 5.3%; moderate illness, 37.1%; severe illness, 55.5%; and critical illness, 1.1%.

The impact of the CCMC can be estimated by looking at care patterns over time. Since the work of the CCMC was aimed at influencing and standardizing physician ordering and therapy choices through order set creation and other forms of oversight, we measured the use of the CCMC-approved order sets at both hospitals and the use of certain laboratory tests and therapies that the CCMC sought either to limit or increase. These counts were adjusted for number of unique COVID-19 admissions. But the limits of the case collection tool meant it also collected cases that were not eligible for some of the interventions. For example, COVID-19 admissions without hypoxemia would not have been eligible for remdesivir or glucocorticoids. When admitted, some patients were already on steroids for other medical indications and did not receive the prescribed dexamethasone dose that we measured in pharmacy databases. Similarly, a few patients were hospitalized for indications unrelated to COVID-19, such as surgery or childbirth, and were found to be SARS-CoV-2-positive on routine screening.

Figure 2 shows the utilization of CCMC-approved standard COVID-19 admission order sets as a proportion of all COVID-19 admissions over time. The trend reveals a modest increase in usage (R² = 0.34), but these data do not reflect the progressive build of content into order sets over time. One of the goals of the order sets was to standardize and reduce the ordering of certain biomarkers: C-reactive protein, serum ferritin, and D-dimer, which were ordered frequently in many early patients. Orders for these 3 laboratory tests are combined and expressed as an average number of labs per COVID-19 admission in Figure 2. A downward trend, with an R² value of 0.65, is suggestive of impact from the order sets, though other explanations are possible.

Medication guidance was also a goal of the CCMC, simultaneously discouraging poorly supported interventions and driving uptake of the recommended evidence-based interventions in appropriate patients. Figure 3 shows the utilization pattern for some drugs of interest over the course of the pandemic, specifically the proportion of patients receiving at least 1 dose of medication among all COVID-19 admissions by month. (Data for hospital B was excluded from this analysis because it did not include all admitted patients.)

Hydroxychloroquine, which enjoyed a wave of popularity early on during the pandemic, was a target of successful order stewardship through the CCMC. Use of hydroxychloroquine as a COVID-19 therapeutic option after the first 2 months of the pandemic stopped, and subsequent use at low levels likely represented continuation therapy for outpatients who took hydroxychloroquine for rheumatologic indications.

Dexamethasone, as used in the RECOVERY trial,²¹ had a swift uptake among physicians after it was incorporated into order sets and its use encouraged. Similarly, uptake was immediate for remdesivir when, in May 2020, preliminary reports showed at least some benefits, confirmed by later analysis,²² and it received an FDA EUA.

Our data also show successful stewardship of the interleukin-6 antagonist toclilizumab, which was discouraged early on by the CCMC due to lack of data or negative results. But in March 2021, with new studies releasing data^12,13 and new recommendations¹⁴ for its use in some subsets of patients with COVID-19, this drug was encouraged in appropriate subsets. A new order set with qualifying indications was prepared by the CCMC and new educational efforts made to encourage its use in appropriate patients.

Ivermectin was nonformulary at the start of the pandemic. This drug enjoyed much publicity from media sources and was promoted by certain physicians and on websites,²³ based on in-vitro activity against coronaviruses. Eventually, the World Health Organization²⁴ and the FDA²⁵ found it necessary to issue advisory statements to the public against its use outside of clinical trials. The CCMC had requests from physicians to incorporate ivermectin but declined to add it to the formulary and recommended not approving nonformulary requests due to lack of data. As a result, ivermectin was not used at either hospital.

Discussion

COVID-19 represents many challenges to health systems all over the world. For Luminis Health, the high volume of acutely ill patients with novel syndromes was a particular challenge for the hospital-based care teams. A flood of information from preprints, press releases, preliminary reports, and many other nontraditional sources made deliberative management decisions difficult for individual physicians. Much commentary has appeared around the phenomenon but with less practical advice about how to make day-to-day care decisions at a time of scientific uncertainty and intense pressure to intervene.^26,27 The CCMC was designed to overcome the information management dilemma. The need to coordinate, standardize, and oversee care was necessary given the large number of physicians who cared for COVID-19 patients on inpatient services.

It should be noted that creating order sets and issuing guidance is necessary, but not sufficient, to achieve our goals of being updated and consistent. This is especially true with large cadres of health care workers attending COVID-19 patients. Guidelines and recommendations were reinforced by unit-based oversight and stewardship from pharmacy and other leaders who constituted the CCMC.

The reduction in COVID-19 mortality over time experienced in this health care system was not unique and cannot necessarily be attributed to standardization of care. Similar improvements in mortality have been reported at many US hospitals in aggregate.²⁸ Many other factors, including changes in patient characteristics, may be responsible for reduction in mortality over time.

Throughout this report we have relied upon an implicit assumption that standardization of medical therapeutics is desirable and leads to better outcomes as compared with allowing unlimited empiricism by individual physicians, either consultants or hospitalists. Our program represents a single health system with 2 acute care hospitals located 25 miles apart and which thus were similarly impacted by the different phases of the pandemic. Generalizability to health systems either smaller or larger, or in different geographical areas, has not been established. Data limitations have already been discussed.

We did not measure user satisfaction with the program either from physicians or nurses. However, the high rate of compliance suggests general agreement with the content and process.

We cannot definitively ascribe reduction in utilization of some nonrecommended treatments and increased utilization of the recommended therapies to the work of the CCMC. Individual physicians may have made these adjustments on their own or under the influence of other sources.

Finally, it should be noted that the mission to rapidly respond to data from well-conducted trials might be thwarted by too rigid a process or a committee’s lack of a sense of urgency. Organizing a committee and then empowering it to act is no guarantee of success; commitment to the mission is.

Conclusion

COVID-19 represented a challenge to medical staffs everywhere, inundating them with high volumes of acutely ill patients presenting with unfamiliar syndromes. Initial responses were characterized by idiosyncratic management approaches based on nontraditional sources of opinion and influences.

This report describes how a complex medical system brought order and standardization through a deliberative, but urgent, multidisciplinary committee with responsibility for planning, implementing, and monitoring standard approaches that eventually became evidence based. The composition of the committee and its scope of influence, limited to inpatient management, were important elements of success, allowing for better focus on the many treatment decisions. The important connection between the management committee and the system P&T committee, the clinical research effort, and teaching programs in both medicine and pharmacy are offered as exemplars of coordination. The data presented show success in achieving standardized, guideline-directed care. The approach is adoptable and suitable for similar emergencies in the future.

Acknowledgments: The authors thank Gary Scabis, Kip Waite, John Moxley, Angela Clubb, and David Woodley for their assistance in gathering data. We express appreciation and admiration for all our colleagues at the bedside.

Corresponding author: Barry R. Meisenberg, MD, Department of Medicine, Luminis Health, 2001 Medical Pkwy, Annapolis, MD 21401; [email protected].

Financial disclosures: None.

From the Department of Medicine (Drs. Meisenberg, Muganlinskaya, Sharma, Amjadi, Arnold, Barnes, Clance, Khalil, Miller, Mooradian, O’Connell, Patel, Press, Samaras, Shanmugam, Tavadze, and Thompson), Department of Pharmacy (Drs. Jiang, Jarawan, Sheth, and Trinh), Department of Nursing (Dr. Ohnmacht), and Department of Women and Children’s Services (Dr. Raji), Luminis Health, Annapolis, MD, and Lanham, MD.

Objective: The COVID-19 pandemic has been a challenge for hospital medical staffs worldwide due to high volumes of patients acutely ill with novel syndromes and prevailing uncertainty regarding optimum supportive and therapeutic interventions. Additionally, the response to this crisis was driven by a plethora of nontraditional information sources, such as email chains, websites, non–peer-reviewed preprints, and press releases. Care patterns became idiosyncratic and often incorporated unproven interventions driven by these nontraditional information sources. This report evaluates the efforts of a health system to create and empower a multidisciplinary committee to develop, implement, and monitor evidence-based, standardized protocols for patients with COVID-19.

Methods: This report describes the composition of the committee, its scope, and its important interactions with the health system pharmacy and therapeutics committee, research teams, and other work groups planning other aspects of COVID-19 management. It illustrates how the committee was used to demonstrate for trainees the process and value of critically examining evidence, even in a chaotic environment.

Results: Data show successful interventions in reducing excessive ordering of certain laboratory tests, reduction of nonrecommended therapies, and rapid uptake of evidence-based or guidelines-supported interventions.

Conclusions: A multidisciplinary committee dedicated solely to planning, implementing, and monitoring standard approaches that eventually became evidence-based decision-making led to an improved focus on treatment options and outcomes for COVID-19 patients. Data presented illustrate the attainable success that is both adaptable and suitable for similar emergencies in the future.

Keywords: COVID-19; clinical management; pharmacy and therapeutics; treatment; therapy.

The COVID-19 pandemic has spread to nearly all countries, carrying with it high morbidity, mortality, and severe impacts on both well-developed and less-well-developed health systems. Media reports of chaos within overwhelmed hospitals have been prominent.^1,2 As of January 5, 2022, SARS-CoV-2 has infected more than 295 million people globally and directly caused the death of more than 5.4 million,³ though this number is likely an undercount even in countries with well-developed mortality tracking.⁴

Throughout the COVID-19 pandemic, hospital-based medical teams have been confronted with a flood of severely ill patients with novel syndromes. Initially, there were no standards for therapy or supportive care except for treatments borrowed from similar syndromes. In the setting of high volumes, high acuity, and public dismay, it is unsurprising that the usual deliberative methods for weighing evidence and initiating interventions were often pushed aside in favor of the solace of active intervention.⁵ In this milieu of limited evidence, there was a lamentable, if understandable, tendency to seek guidance from “nontraditional” sources,⁶ including email chains from colleagues, hospital websites, non–peer-reviewed manuscripts, advanced publication by medical journals,⁷ and nonscientific media presentations. In many localities, practitioners responded in idiosyncratic ways. For example, findings of high cytokine levels in COVID-19,⁸ along with reports of in-vitro antiviral activity with drugs like hydroxychloroquine against both SARS⁹ and SARS-CoV-2,¹⁰ drove laboratory test ordering and therapeutic interventions, respectively, carving shortcuts into the traditional clinical trial–dependent standards. Clinical trial results eventually emerged.¹¹COVID-19 created a clinical dilemma for hospital medical staffs in terms of how to organize, standardize, and rapidly adapt to a flood of new information. In this report, we describe how 1 health system responded to these challenges by forming a COVID-19 Clinical Management Committee (CCMC) and empowering this interdisciplinary team to review evidence, create and adjust order sets, educate practitioners, oversee care, and collaborate across teams addressing other aspects of the COVID-19 response.

Program Overview

Health System Description

Luminis Health is a health system with 2 acute care hospitals that was formed in 2019 just before the start of the pandemic. Anne Arundel Medical Center (hospital A) is a 385-bed teaching hospital in Annapolis, MD. It has more than 23 000 discharges annually. Patients with COVID-19 were cared for by either an internal medicine teaching service or nonteaching hospitalist services on cohorted nursing units. Doctor’s Community Medical Center, in Lanham, MD (hospital B), is a 206-bed acute care hospital with more than 10 350 annual discharges. COVID-19 patients were cared for by hospitalist groups, initially in noncohorted units with transition to cohorted nursing units after a few months. The medical staffs are generally distinct, with different leadership structures, though the Luminis Health Department of Medicine has oversight responsibilities at both hospitals. More than 47 physicians attended COVID-19 patients at hospital A (with medical residents) and 30 individual physicians at hospital B, respectively, including intensivists. The nursing and pharmacy staffs are distinct, but there is a shared oversight Pharmacy and Therapeutics (P&T) Committee.

The 2 hospitals had distinct electronic medical records (EMR) until January 2021, when hospital B adopted the same EMR as hospital A (Epic).

Mission and Formation of CCMC

In order to coordinate the therapeutic approach across the health system, it was important for the CCMC to be designated by the health system P&T committee as an official subcommittee so that decisions on restrictions of medications and/or new or revised order sets could be rapidly initiated across the system without waiting for the subsequent P&T meetings. The full committee retained oversight of the CCMC. Some P&T members were also on the CCMC.

The committee reviewed new reports in medical journals and prepublication servers and consulted recommendations of professional societies, such as the National Institutes of Health (NIH) COVID-19 guidelines, Infectious Diseases Society of America, Society of Critical Care Medicine, and US Food and Drug Administration (FDA) Emergency Use Authorizations (EUA), among other sources.

Composition of the CCMC

Physician leaders from both hospitals in the following specialties were solicited for participation: critical care, epidemiology, hospital medicine (internal medicine), emergency medicine, infectious diseases, nephrology, women and children’s services, and medical informatics. Specialists in other areas, such as hematology, were invited for topic-specific discussions. Hospital pharmacists with different specialties and nursing leadership were essential contributors. The committee members were expected to use various communication channels to inform frontline clinicians of new care standards and the existence of new order sets, which were embedded in the EMR.

Clinical Research

An important connection for the CCMC was with theCOVID-19 clinical research team. Three members of the research team were also members of the CCMC. All new study proposals for therapeutics were discussed with the CCMC as they were being considered by the research team. In this way, feedback on the feasibility and acceptance of new study opportunities could be discussed with the CCMC. Occasionally, CCMC decisions impacted clinical research accrual strategies. For example, new data from randomized trials about tocilizumab^1,2 demonstrated benefits in some subsets of patients and resulted in a recommendation for use by the NIH guideline committee in these populations.¹ The CCMC quickly adopted this recommendation, which required a reprioritization of clinical research enrollment for studies testing other immune-modulating agents. This important dialogue was mediated within the CCMC.

Guideline Distribution, Reinforcement, and Platform for Feedback

New guidelines were disseminated to clinicians via daily brief patient huddles held on COVID units, with participation by nursing and pharmacy, and by weekly meetings with hospitalist leaders and frontline hospital physicians. Order sets and guidelines were maintained on the intranet. Adherence was reinforced by unit-based and central pharmacists. Order sets, including admission order sets, could be created only by designated informatics personnel, thus enforcing standardization. Feedback on the utility of the order sets was obtained during the weekly meetings or huddles, as described above. To ensure a sense of transparency, physicians who had interest in commenting on a particular therapy, or who wished to discuss a particular manuscript, news article, or website, were invited to attend CCMC meetings.

Scope of CCMC

In order to be effective and timely, we limited the scope of our work to the report to the inpatient therapeutic environment, allowing other committees to work on other aspects of the pandemic response. In addition to issuing guidance and creating order sets to direct clinical practice, the CCMC also monitored COVID-19 therapeutic shortages^15,16 and advised on prioritization of such treatments as convalescent plasma, remdesivir (prioritization and duration of therapy, 5 vs 10 days), baricitinib, and tocilizumab, depending upon the location of the patient (critical care or not). The CCMC was not involved in the management of non–COVID-19 shortages brought about by supply chain deficiencies.

Table 1 shows some aspects of the health system pandemic-response planning and the committee workforce that undertook that work. Though many items were out of scope for the CCMC, members of the CCMC did participate in the planning work of these other committees and therefore stayed connected to this complementary work.

A Teaching Opportunity About Making Thoughtful Choices

Another important feature of the CCMC was the contributions of residents from both pharmacy and internal medicine. The purpose and operations of the committee were recognized as an opportunity to involve learners in a curriculum based on Kern’s 6-step approach.¹⁷ Though the problem identification and general needs assessment were easily defined, the targeted needs assessment, extracted from individual and group interviews with learners and the committee members, pointed at the need to learn how to assess and analyze a rapidly growing body of literature on several relevant clinical aspects of SARS-CoV-2 and COVID-19. To achieve goals and objectives, residents were assigned to present current literature on a particular intervention during a committee meeting, specifically commenting on the merit or deficiencies of the study design, the strength of the data, and applicability to the local context with a recommendation. Prior to the presentations, the residents worked with faculty to identify the best studies or systematic analyses with potential to alter current practices. We thus used the CCMC process as a teaching tool about evidence-based medicine and the dilemma of clinical equipoise. This was imperative, since trainees thrust into the COVID-19 response have often keenly observed a movement away from deliberative decision-making.¹⁸ Indeed, including residents in the process of deliberative responses to COVID-19 addresses a recent call to adjust medical education during COVID-19 to “adapt curriculum to current issues in real time.”¹⁹

Interventions and Therapies Considered

Table 2 shows the topics reviewed by the CCMC. By the time of the first meeting, nonstandardization of care was already a source of concern for clinicians. Dialogue often continued outside of the formal meetings. Many topics were considered more than once as new guidance developed, changes to EUAs occurred, and new data or new publicity arose.

Methods

The Human Protections Administrator determined that this work constituted “quality improvement, and not research” and was therefore exempt from institutional review board review.

Quantitative Analysis

All admitted patients from March 10, 2020, through April 20, 2021, were considered in the quantitative aspects of this report except as noted. Patients diagnosed with COVID-19 were identified by searching our internal data base using diagnostic codes. Patient admissions with the following diagnostic codes were included (prior to April 1, 2020): J12.89, J20.8, J40, J22, J98.8, J80, each with the additional code of B97.29. After April 1, 2020, the guideline for coding COVID-19 was U07.1.

Descriptive statistics were used to measure utilization rates of certain medications and laboratory tests of interest over time. These data were adjusted for number of unique admissions. In a few cases, not all data elements were available from both hospitals due to differences in the EMR.

Case fatality rate was calculated based upon whether the patient died or was admitted to inpatient hospice as a result of COVID-19. Four patients transferred out of hospital A and 18 transferred out of hospital B were censored from case-fatality-rate determination.

Figure 1 shows the number of admissions for each acute care hospital in the health system and the combined COVID-19 case-fatality rate over time.

Results

A total of 5955 consecutive COVID-19 patients admitted from March 10, 2020, through April 30, 2021, were analyzed. Patients with International Statistical Classification of Diseases, Tenth Revision codes J12.89. J20.8, J40, J22, J98.8, J80, each with the additional code of B97.29 (or the code UO7.1 after April 1, 2020), were included in the analysis. The median age of admitted patients was 65 years (range 19-91 years). Using the NIH classification system for severity,²⁰ the distribution of severity during the first 24 hours after the time of hospital admission was as follows: asymptomatic/presymptomatic, 0.5%; mild illness, 5.3%; moderate illness, 37.1%; severe illness, 55.5%; and critical illness, 1.1%.

The impact of the CCMC can be estimated by looking at care patterns over time. Since the work of the CCMC was aimed at influencing and standardizing physician ordering and therapy choices through order set creation and other forms of oversight, we measured the use of the CCMC-approved order sets at both hospitals and the use of certain laboratory tests and therapies that the CCMC sought either to limit or increase. These counts were adjusted for number of unique COVID-19 admissions. But the limits of the case collection tool meant it also collected cases that were not eligible for some of the interventions. For example, COVID-19 admissions without hypoxemia would not have been eligible for remdesivir or glucocorticoids. When admitted, some patients were already on steroids for other medical indications and did not receive the prescribed dexamethasone dose that we measured in pharmacy databases. Similarly, a few patients were hospitalized for indications unrelated to COVID-19, such as surgery or childbirth, and were found to be SARS-CoV-2-positive on routine screening.

Figure 2 shows the utilization of CCMC-approved standard COVID-19 admission order sets as a proportion of all COVID-19 admissions over time. The trend reveals a modest increase in usage (R² = 0.34), but these data do not reflect the progressive build of content into order sets over time. One of the goals of the order sets was to standardize and reduce the ordering of certain biomarkers: C-reactive protein, serum ferritin, and D-dimer, which were ordered frequently in many early patients. Orders for these 3 laboratory tests are combined and expressed as an average number of labs per COVID-19 admission in Figure 2. A downward trend, with an R² value of 0.65, is suggestive of impact from the order sets, though other explanations are possible.

Medication guidance was also a goal of the CCMC, simultaneously discouraging poorly supported interventions and driving uptake of the recommended evidence-based interventions in appropriate patients. Figure 3 shows the utilization pattern for some drugs of interest over the course of the pandemic, specifically the proportion of patients receiving at least 1 dose of medication among all COVID-19 admissions by month. (Data for hospital B was excluded from this analysis because it did not include all admitted patients.)

Hydroxychloroquine, which enjoyed a wave of popularity early on during the pandemic, was a target of successful order stewardship through the CCMC. Use of hydroxychloroquine as a COVID-19 therapeutic option after the first 2 months of the pandemic stopped, and subsequent use at low levels likely represented continuation therapy for outpatients who took hydroxychloroquine for rheumatologic indications.

Dexamethasone, as used in the RECOVERY trial,²¹ had a swift uptake among physicians after it was incorporated into order sets and its use encouraged. Similarly, uptake was immediate for remdesivir when, in May 2020, preliminary reports showed at least some benefits, confirmed by later analysis,²² and it received an FDA EUA.

Our data also show successful stewardship of the interleukin-6 antagonist toclilizumab, which was discouraged early on by the CCMC due to lack of data or negative results. But in March 2021, with new studies releasing data^12,13 and new recommendations¹⁴ for its use in some subsets of patients with COVID-19, this drug was encouraged in appropriate subsets. A new order set with qualifying indications was prepared by the CCMC and new educational efforts made to encourage its use in appropriate patients.

Ivermectin was nonformulary at the start of the pandemic. This drug enjoyed much publicity from media sources and was promoted by certain physicians and on websites,²³ based on in-vitro activity against coronaviruses. Eventually, the World Health Organization²⁴ and the FDA²⁵ found it necessary to issue advisory statements to the public against its use outside of clinical trials. The CCMC had requests from physicians to incorporate ivermectin but declined to add it to the formulary and recommended not approving nonformulary requests due to lack of data. As a result, ivermectin was not used at either hospital.

Discussion

COVID-19 represents many challenges to health systems all over the world. For Luminis Health, the high volume of acutely ill patients with novel syndromes was a particular challenge for the hospital-based care teams. A flood of information from preprints, press releases, preliminary reports, and many other nontraditional sources made deliberative management decisions difficult for individual physicians. Much commentary has appeared around the phenomenon but with less practical advice about how to make day-to-day care decisions at a time of scientific uncertainty and intense pressure to intervene.^26,27 The CCMC was designed to overcome the information management dilemma. The need to coordinate, standardize, and oversee care was necessary given the large number of physicians who cared for COVID-19 patients on inpatient services.

It should be noted that creating order sets and issuing guidance is necessary, but not sufficient, to achieve our goals of being updated and consistent. This is especially true with large cadres of health care workers attending COVID-19 patients. Guidelines and recommendations were reinforced by unit-based oversight and stewardship from pharmacy and other leaders who constituted the CCMC.

The reduction in COVID-19 mortality over time experienced in this health care system was not unique and cannot necessarily be attributed to standardization of care. Similar improvements in mortality have been reported at many US hospitals in aggregate.²⁸ Many other factors, including changes in patient characteristics, may be responsible for reduction in mortality over time.

Throughout this report we have relied upon an implicit assumption that standardization of medical therapeutics is desirable and leads to better outcomes as compared with allowing unlimited empiricism by individual physicians, either consultants or hospitalists. Our program represents a single health system with 2 acute care hospitals located 25 miles apart and which thus were similarly impacted by the different phases of the pandemic. Generalizability to health systems either smaller or larger, or in different geographical areas, has not been established. Data limitations have already been discussed.

We did not measure user satisfaction with the program either from physicians or nurses. However, the high rate of compliance suggests general agreement with the content and process.

We cannot definitively ascribe reduction in utilization of some nonrecommended treatments and increased utilization of the recommended therapies to the work of the CCMC. Individual physicians may have made these adjustments on their own or under the influence of other sources.

Finally, it should be noted that the mission to rapidly respond to data from well-conducted trials might be thwarted by too rigid a process or a committee’s lack of a sense of urgency. Organizing a committee and then empowering it to act is no guarantee of success; commitment to the mission is.

Conclusion

COVID-19 represented a challenge to medical staffs everywhere, inundating them with high volumes of acutely ill patients presenting with unfamiliar syndromes. Initial responses were characterized by idiosyncratic management approaches based on nontraditional sources of opinion and influences.

This report describes how a complex medical system brought order and standardization through a deliberative, but urgent, multidisciplinary committee with responsibility for planning, implementing, and monitoring standard approaches that eventually became evidence based. The composition of the committee and its scope of influence, limited to inpatient management, were important elements of success, allowing for better focus on the many treatment decisions. The important connection between the management committee and the system P&T committee, the clinical research effort, and teaching programs in both medicine and pharmacy are offered as exemplars of coordination. The data presented show success in achieving standardized, guideline-directed care. The approach is adoptable and suitable for similar emergencies in the future.

Acknowledgments: The authors thank Gary Scabis, Kip Waite, John Moxley, Angela Clubb, and David Woodley for their assistance in gathering data. We express appreciation and admiration for all our colleagues at the bedside.

Corresponding author: Barry R. Meisenberg, MD, Department of Medicine, Luminis Health, 2001 Medical Pkwy, Annapolis, MD 21401; [email protected].

Financial disclosures: None.

From the Department of Medicine (Drs. Meisenberg, Muganlinskaya, Sharma, Amjadi, Arnold, Barnes, Clance, Khalil, Miller, Mooradian, O’Connell, Patel, Press, Samaras, Shanmugam, Tavadze, and Thompson), Department of Pharmacy (Drs. Jiang, Jarawan, Sheth, and Trinh), Department of Nursing (Dr. Ohnmacht), and Department of Women and Children’s Services (Dr. Raji), Luminis Health, Annapolis, MD, and Lanham, MD.

Objective: The COVID-19 pandemic has been a challenge for hospital medical staffs worldwide due to high volumes of patients acutely ill with novel syndromes and prevailing uncertainty regarding optimum supportive and therapeutic interventions. Additionally, the response to this crisis was driven by a plethora of nontraditional information sources, such as email chains, websites, non–peer-reviewed preprints, and press releases. Care patterns became idiosyncratic and often incorporated unproven interventions driven by these nontraditional information sources. This report evaluates the efforts of a health system to create and empower a multidisciplinary committee to develop, implement, and monitor evidence-based, standardized protocols for patients with COVID-19.

Methods: This report describes the composition of the committee, its scope, and its important interactions with the health system pharmacy and therapeutics committee, research teams, and other work groups planning other aspects of COVID-19 management. It illustrates how the committee was used to demonstrate for trainees the process and value of critically examining evidence, even in a chaotic environment.

Results: Data show successful interventions in reducing excessive ordering of certain laboratory tests, reduction of nonrecommended therapies, and rapid uptake of evidence-based or guidelines-supported interventions.

Conclusions: A multidisciplinary committee dedicated solely to planning, implementing, and monitoring standard approaches that eventually became evidence-based decision-making led to an improved focus on treatment options and outcomes for COVID-19 patients. Data presented illustrate the attainable success that is both adaptable and suitable for similar emergencies in the future.

Keywords: COVID-19; clinical management; pharmacy and therapeutics; treatment; therapy.

The COVID-19 pandemic has spread to nearly all countries, carrying with it high morbidity, mortality, and severe impacts on both well-developed and less-well-developed health systems. Media reports of chaos within overwhelmed hospitals have been prominent.^1,2 As of January 5, 2022, SARS-CoV-2 has infected more than 295 million people globally and directly caused the death of more than 5.4 million,³ though this number is likely an undercount even in countries with well-developed mortality tracking.⁴

Throughout the COVID-19 pandemic, hospital-based medical teams have been confronted with a flood of severely ill patients with novel syndromes. Initially, there were no standards for therapy or supportive care except for treatments borrowed from similar syndromes. In the setting of high volumes, high acuity, and public dismay, it is unsurprising that the usual deliberative methods for weighing evidence and initiating interventions were often pushed aside in favor of the solace of active intervention.⁵ In this milieu of limited evidence, there was a lamentable, if understandable, tendency to seek guidance from “nontraditional” sources,⁶ including email chains from colleagues, hospital websites, non–peer-reviewed manuscripts, advanced publication by medical journals,⁷ and nonscientific media presentations. In many localities, practitioners responded in idiosyncratic ways. For example, findings of high cytokine levels in COVID-19,⁸ along with reports of in-vitro antiviral activity with drugs like hydroxychloroquine against both SARS⁹ and SARS-CoV-2,¹⁰ drove laboratory test ordering and therapeutic interventions, respectively, carving shortcuts into the traditional clinical trial–dependent standards. Clinical trial results eventually emerged.¹¹COVID-19 created a clinical dilemma for hospital medical staffs in terms of how to organize, standardize, and rapidly adapt to a flood of new information. In this report, we describe how 1 health system responded to these challenges by forming a COVID-19 Clinical Management Committee (CCMC) and empowering this interdisciplinary team to review evidence, create and adjust order sets, educate practitioners, oversee care, and collaborate across teams addressing other aspects of the COVID-19 response.

Program Overview

Health System Description

Luminis Health is a health system with 2 acute care hospitals that was formed in 2019 just before the start of the pandemic. Anne Arundel Medical Center (hospital A) is a 385-bed teaching hospital in Annapolis, MD. It has more than 23 000 discharges annually. Patients with COVID-19 were cared for by either an internal medicine teaching service or nonteaching hospitalist services on cohorted nursing units. Doctor’s Community Medical Center, in Lanham, MD (hospital B), is a 206-bed acute care hospital with more than 10 350 annual discharges. COVID-19 patients were cared for by hospitalist groups, initially in noncohorted units with transition to cohorted nursing units after a few months. The medical staffs are generally distinct, with different leadership structures, though the Luminis Health Department of Medicine has oversight responsibilities at both hospitals. More than 47 physicians attended COVID-19 patients at hospital A (with medical residents) and 30 individual physicians at hospital B, respectively, including intensivists. The nursing and pharmacy staffs are distinct, but there is a shared oversight Pharmacy and Therapeutics (P&T) Committee.

The 2 hospitals had distinct electronic medical records (EMR) until January 2021, when hospital B adopted the same EMR as hospital A (Epic).

Mission and Formation of CCMC

In order to coordinate the therapeutic approach across the health system, it was important for the CCMC to be designated by the health system P&T committee as an official subcommittee so that decisions on restrictions of medications and/or new or revised order sets could be rapidly initiated across the system without waiting for the subsequent P&T meetings. The full committee retained oversight of the CCMC. Some P&T members were also on the CCMC.

The committee reviewed new reports in medical journals and prepublication servers and consulted recommendations of professional societies, such as the National Institutes of Health (NIH) COVID-19 guidelines, Infectious Diseases Society of America, Society of Critical Care Medicine, and US Food and Drug Administration (FDA) Emergency Use Authorizations (EUA), among other sources.

Composition of the CCMC

Physician leaders from both hospitals in the following specialties were solicited for participation: critical care, epidemiology, hospital medicine (internal medicine), emergency medicine, infectious diseases, nephrology, women and children’s services, and medical informatics. Specialists in other areas, such as hematology, were invited for topic-specific discussions. Hospital pharmacists with different specialties and nursing leadership were essential contributors. The committee members were expected to use various communication channels to inform frontline clinicians of new care standards and the existence of new order sets, which were embedded in the EMR.

Clinical Research

An important connection for the CCMC was with theCOVID-19 clinical research team. Three members of the research team were also members of the CCMC. All new study proposals for therapeutics were discussed with the CCMC as they were being considered by the research team. In this way, feedback on the feasibility and acceptance of new study opportunities could be discussed with the CCMC. Occasionally, CCMC decisions impacted clinical research accrual strategies. For example, new data from randomized trials about tocilizumab^1,2 demonstrated benefits in some subsets of patients and resulted in a recommendation for use by the NIH guideline committee in these populations.¹ The CCMC quickly adopted this recommendation, which required a reprioritization of clinical research enrollment for studies testing other immune-modulating agents. This important dialogue was mediated within the CCMC.

Guideline Distribution, Reinforcement, and Platform for Feedback

New guidelines were disseminated to clinicians via daily brief patient huddles held on COVID units, with participation by nursing and pharmacy, and by weekly meetings with hospitalist leaders and frontline hospital physicians. Order sets and guidelines were maintained on the intranet. Adherence was reinforced by unit-based and central pharmacists. Order sets, including admission order sets, could be created only by designated informatics personnel, thus enforcing standardization. Feedback on the utility of the order sets was obtained during the weekly meetings or huddles, as described above. To ensure a sense of transparency, physicians who had interest in commenting on a particular therapy, or who wished to discuss a particular manuscript, news article, or website, were invited to attend CCMC meetings.

Scope of CCMC

In order to be effective and timely, we limited the scope of our work to the report to the inpatient therapeutic environment, allowing other committees to work on other aspects of the pandemic response. In addition to issuing guidance and creating order sets to direct clinical practice, the CCMC also monitored COVID-19 therapeutic shortages^15,16 and advised on prioritization of such treatments as convalescent plasma, remdesivir (prioritization and duration of therapy, 5 vs 10 days), baricitinib, and tocilizumab, depending upon the location of the patient (critical care or not). The CCMC was not involved in the management of non–COVID-19 shortages brought about by supply chain deficiencies.

Table 1 shows some aspects of the health system pandemic-response planning and the committee workforce that undertook that work. Though many items were out of scope for the CCMC, members of the CCMC did participate in the planning work of these other committees and therefore stayed connected to this complementary work.

A Teaching Opportunity About Making Thoughtful Choices

Another important feature of the CCMC was the contributions of residents from both pharmacy and internal medicine. The purpose and operations of the committee were recognized as an opportunity to involve learners in a curriculum based on Kern’s 6-step approach.¹⁷ Though the problem identification and general needs assessment were easily defined, the targeted needs assessment, extracted from individual and group interviews with learners and the committee members, pointed at the need to learn how to assess and analyze a rapidly growing body of literature on several relevant clinical aspects of SARS-CoV-2 and COVID-19. To achieve goals and objectives, residents were assigned to present current literature on a particular intervention during a committee meeting, specifically commenting on the merit or deficiencies of the study design, the strength of the data, and applicability to the local context with a recommendation. Prior to the presentations, the residents worked with faculty to identify the best studies or systematic analyses with potential to alter current practices. We thus used the CCMC process as a teaching tool about evidence-based medicine and the dilemma of clinical equipoise. This was imperative, since trainees thrust into the COVID-19 response have often keenly observed a movement away from deliberative decision-making.¹⁸ Indeed, including residents in the process of deliberative responses to COVID-19 addresses a recent call to adjust medical education during COVID-19 to “adapt curriculum to current issues in real time.”¹⁹

Interventions and Therapies Considered

Table 2 shows the topics reviewed by the CCMC. By the time of the first meeting, nonstandardization of care was already a source of concern for clinicians. Dialogue often continued outside of the formal meetings. Many topics were considered more than once as new guidance developed, changes to EUAs occurred, and new data or new publicity arose.

Methods

The Human Protections Administrator determined that this work constituted “quality improvement, and not research” and was therefore exempt from institutional review board review.

Quantitative Analysis

All admitted patients from March 10, 2020, through April 20, 2021, were considered in the quantitative aspects of this report except as noted. Patients diagnosed with COVID-19 were identified by searching our internal data base using diagnostic codes. Patient admissions with the following diagnostic codes were included (prior to April 1, 2020): J12.89, J20.8, J40, J22, J98.8, J80, each with the additional code of B97.29. After April 1, 2020, the guideline for coding COVID-19 was U07.1.

Descriptive statistics were used to measure utilization rates of certain medications and laboratory tests of interest over time. These data were adjusted for number of unique admissions. In a few cases, not all data elements were available from both hospitals due to differences in the EMR.

Case fatality rate was calculated based upon whether the patient died or was admitted to inpatient hospice as a result of COVID-19. Four patients transferred out of hospital A and 18 transferred out of hospital B were censored from case-fatality-rate determination.

Figure 1 shows the number of admissions for each acute care hospital in the health system and the combined COVID-19 case-fatality rate over time.

Results

A total of 5955 consecutive COVID-19 patients admitted from March 10, 2020, through April 30, 2021, were analyzed. Patients with International Statistical Classification of Diseases, Tenth Revision codes J12.89. J20.8, J40, J22, J98.8, J80, each with the additional code of B97.29 (or the code UO7.1 after April 1, 2020), were included in the analysis. The median age of admitted patients was 65 years (range 19-91 years). Using the NIH classification system for severity,²⁰ the distribution of severity during the first 24 hours after the time of hospital admission was as follows: asymptomatic/presymptomatic, 0.5%; mild illness, 5.3%; moderate illness, 37.1%; severe illness, 55.5%; and critical illness, 1.1%.

The impact of the CCMC can be estimated by looking at care patterns over time. Since the work of the CCMC was aimed at influencing and standardizing physician ordering and therapy choices through order set creation and other forms of oversight, we measured the use of the CCMC-approved order sets at both hospitals and the use of certain laboratory tests and therapies that the CCMC sought either to limit or increase. These counts were adjusted for number of unique COVID-19 admissions. But the limits of the case collection tool meant it also collected cases that were not eligible for some of the interventions. For example, COVID-19 admissions without hypoxemia would not have been eligible for remdesivir or glucocorticoids. When admitted, some patients were already on steroids for other medical indications and did not receive the prescribed dexamethasone dose that we measured in pharmacy databases. Similarly, a few patients were hospitalized for indications unrelated to COVID-19, such as surgery or childbirth, and were found to be SARS-CoV-2-positive on routine screening.

Figure 2 shows the utilization of CCMC-approved standard COVID-19 admission order sets as a proportion of all COVID-19 admissions over time. The trend reveals a modest increase in usage (R² = 0.34), but these data do not reflect the progressive build of content into order sets over time. One of the goals of the order sets was to standardize and reduce the ordering of certain biomarkers: C-reactive protein, serum ferritin, and D-dimer, which were ordered frequently in many early patients. Orders for these 3 laboratory tests are combined and expressed as an average number of labs per COVID-19 admission in Figure 2. A downward trend, with an R² value of 0.65, is suggestive of impact from the order sets, though other explanations are possible.

Medication guidance was also a goal of the CCMC, simultaneously discouraging poorly supported interventions and driving uptake of the recommended evidence-based interventions in appropriate patients. Figure 3 shows the utilization pattern for some drugs of interest over the course of the pandemic, specifically the proportion of patients receiving at least 1 dose of medication among all COVID-19 admissions by month. (Data for hospital B was excluded from this analysis because it did not include all admitted patients.)

Hydroxychloroquine, which enjoyed a wave of popularity early on during the pandemic, was a target of successful order stewardship through the CCMC. Use of hydroxychloroquine as a COVID-19 therapeutic option after the first 2 months of the pandemic stopped, and subsequent use at low levels likely represented continuation therapy for outpatients who took hydroxychloroquine for rheumatologic indications.

Dexamethasone, as used in the RECOVERY trial,²¹ had a swift uptake among physicians after it was incorporated into order sets and its use encouraged. Similarly, uptake was immediate for remdesivir when, in May 2020, preliminary reports showed at least some benefits, confirmed by later analysis,²² and it received an FDA EUA.

Our data also show successful stewardship of the interleukin-6 antagonist toclilizumab, which was discouraged early on by the CCMC due to lack of data or negative results. But in March 2021, with new studies releasing data^12,13 and new recommendations¹⁴ for its use in some subsets of patients with COVID-19, this drug was encouraged in appropriate subsets. A new order set with qualifying indications was prepared by the CCMC and new educational efforts made to encourage its use in appropriate patients.

Ivermectin was nonformulary at the start of the pandemic. This drug enjoyed much publicity from media sources and was promoted by certain physicians and on websites,²³ based on in-vitro activity against coronaviruses. Eventually, the World Health Organization²⁴ and the FDA²⁵ found it necessary to issue advisory statements to the public against its use outside of clinical trials. The CCMC had requests from physicians to incorporate ivermectin but declined to add it to the formulary and recommended not approving nonformulary requests due to lack of data. As a result, ivermectin was not used at either hospital.

Discussion

COVID-19 represents many challenges to health systems all over the world. For Luminis Health, the high volume of acutely ill patients with novel syndromes was a particular challenge for the hospital-based care teams. A flood of information from preprints, press releases, preliminary reports, and many other nontraditional sources made deliberative management decisions difficult for individual physicians. Much commentary has appeared around the phenomenon but with less practical advice about how to make day-to-day care decisions at a time of scientific uncertainty and intense pressure to intervene.^26,27 The CCMC was designed to overcome the information management dilemma. The need to coordinate, standardize, and oversee care was necessary given the large number of physicians who cared for COVID-19 patients on inpatient services.

It should be noted that creating order sets and issuing guidance is necessary, but not sufficient, to achieve our goals of being updated and consistent. This is especially true with large cadres of health care workers attending COVID-19 patients. Guidelines and recommendations were reinforced by unit-based oversight and stewardship from pharmacy and other leaders who constituted the CCMC.

The reduction in COVID-19 mortality over time experienced in this health care system was not unique and cannot necessarily be attributed to standardization of care. Similar improvements in mortality have been reported at many US hospitals in aggregate.²⁸ Many other factors, including changes in patient characteristics, may be responsible for reduction in mortality over time.

Throughout this report we have relied upon an implicit assumption that standardization of medical therapeutics is desirable and leads to better outcomes as compared with allowing unlimited empiricism by individual physicians, either consultants or hospitalists. Our program represents a single health system with 2 acute care hospitals located 25 miles apart and which thus were similarly impacted by the different phases of the pandemic. Generalizability to health systems either smaller or larger, or in different geographical areas, has not been established. Data limitations have already been discussed.

We did not measure user satisfaction with the program either from physicians or nurses. However, the high rate of compliance suggests general agreement with the content and process.

We cannot definitively ascribe reduction in utilization of some nonrecommended treatments and increased utilization of the recommended therapies to the work of the CCMC. Individual physicians may have made these adjustments on their own or under the influence of other sources.

Finally, it should be noted that the mission to rapidly respond to data from well-conducted trials might be thwarted by too rigid a process or a committee’s lack of a sense of urgency. Organizing a committee and then empowering it to act is no guarantee of success; commitment to the mission is.

Conclusion

COVID-19 represented a challenge to medical staffs everywhere, inundating them with high volumes of acutely ill patients presenting with unfamiliar syndromes. Initial responses were characterized by idiosyncratic management approaches based on nontraditional sources of opinion and influences.

This report describes how a complex medical system brought order and standardization through a deliberative, but urgent, multidisciplinary committee with responsibility for planning, implementing, and monitoring standard approaches that eventually became evidence based. The composition of the committee and its scope of influence, limited to inpatient management, were important elements of success, allowing for better focus on the many treatment decisions. The important connection between the management committee and the system P&T committee, the clinical research effort, and teaching programs in both medicine and pharmacy are offered as exemplars of coordination. The data presented show success in achieving standardized, guideline-directed care. The approach is adoptable and suitable for similar emergencies in the future.

Acknowledgments: The authors thank Gary Scabis, Kip Waite, John Moxley, Angela Clubb, and David Woodley for their assistance in gathering data. We express appreciation and admiration for all our colleagues at the bedside.

Corresponding author: Barry R. Meisenberg, MD, Department of Medicine, Luminis Health, 2001 Medical Pkwy, Annapolis, MD 21401; [email protected].

Financial disclosures: None.

Although teledermatology utilization in the United States traditionally has lagged behind other countries,^1,2 the COVID-19 pandemic upended this trend by creating the need for a massive teledermatology experiment. Recently reported survey results from a large representative sample of US dermatologists (5000 participants) on perceptions of teledermatology during COVID-19 indicated that only 14.1% of participants used teledermatology prior to the COVID-19 pandemic vs 54.1% of dermatologists in Europe.^2,3 Since the pandemic started, 97% of US dermatologists reported teledermatology use,³ demonstrating a huge shift in utilization. This trend is notable, as teledermatology has been shown to increase access to dermatology in underserved areas, reduce patient travel times, improve patient triage, and even reduce carbon footprints.^1,4 Thus, to sustain the momentum, insights from the recent teledermatology experience during the pandemic should inform future development.

Notably, the COVID-19 pandemic led to a rapid shift in focus from store-and-forward teledermatology to live video–based models.^1,2 Logistically, live video visits are challenging, require more time and resources, and often are diagnostically limited, with concerns regarding technology, connectivity, reimbursement, and appropriate use.³ Prior to COVID-19, formal Health Insurance Portability and Accountability Act–compliant teledermatology platforms often were costly to establish and maintain, largely relegating use to academic centers and Veterans Affairs hospitals. Thus, many fewer private practice dermatologists had used teledermatology compared to academic dermatologists in the United States (11.4% vs 27.6%).³ Government regulations—a key barrier to the adoption of teledermatology in private practice before COVID-19—were greatly relaxed during the pandemic. The Centers for Medicare and Medicaid Services removed restrictions on where patients could be seen, improved reimbursement for video visits, and allowed the use of platforms that are not Health Insurance Portability and Accountability Act compliant. Many states also relaxed medical licensing rules.

Overall, the general outlook on telehealth seems positive. Reimbursement has been found to be a primary factor in dermatologists’ willingness to use teledermatology.³ Thus, sustainable use of teledermatology likely will depend on continued reimbursement parity for live video as well as store-and-forward consultations, which have several advantages but currently are de-incentivized by low reimbursement. The survey also found that 70% of respondents felt that teledermatology use will continue after COVID-19, while 58% intended to continue use—nearly 5-fold more than before the pandemic.³ We suspect the discrepancy between participants’ predictions regarding future use of teledermatology and their personal intent to use it highlights perceived barriers and limitations of the long-term success of teledermatology. Aside from reimbursement, connectivity and functionality were common concerns, emphasizing the need for innovative technological solutions.³ Moving forward, we anticipate that dermatologists will need to establish consistent workflows to establish consistent triage for the most appropriate visit—in-person visits vs teledermatology, which may include augmented, intelligence-enhanced solutions. Similar to prior clinician perspectives about which types of visits are conducive to teledermatology,² most survey participants believed virtual visits were effective for acne, routine follow-ups, medication monitoring, and some inflammatory conditions.³

Importantly, we must be mindful of patients who may be left behind by the digital divide, such as those with lack of access to a smartphone or the internet, language barriers, or limited telehealth experience.⁵ Systems should be designed to provide these patients with technologic and health literacy aid or alternate modalities to access care. For example, structured methods could be introduced to provide training and instructions on how to access phone applications, computer-based programs, and more. Likewise, for those with hearing or vision deficits, it will be important to improve sound amplification and accessibility for headphones or hearing aid connectivity, as well as appropriate font size, button size, and application navigation. In remote areas, existing clinics may be used to help field specialty consultation teleconferences. Certainly, applications and platforms devised for teledermatology must be designed to serve diverse patient groups, with special consideration for the elderly, those who speak languages other than English, and those with disabilities that may make telehealth use more challenging.

Large-scale regulatory changes and reimbursement parity can have a substantial impact on future teledermatology use. Advocacy efforts continue to push for fair valuation of telemedicine, coverage of store-and-forward teledermatology codes, and coverage for all models of care. It is imperative for the dermatology community to continue discussions on implementation and methodology to best leverage this technology for the most patient benefit.

Although teledermatology utilization in the United States traditionally has lagged behind other countries,^1,2 the COVID-19 pandemic upended this trend by creating the need for a massive teledermatology experiment. Recently reported survey results from a large representative sample of US dermatologists (5000 participants) on perceptions of teledermatology during COVID-19 indicated that only 14.1% of participants used teledermatology prior to the COVID-19 pandemic vs 54.1% of dermatologists in Europe.^2,3 Since the pandemic started, 97% of US dermatologists reported teledermatology use,³ demonstrating a huge shift in utilization. This trend is notable, as teledermatology has been shown to increase access to dermatology in underserved areas, reduce patient travel times, improve patient triage, and even reduce carbon footprints.^1,4 Thus, to sustain the momentum, insights from the recent teledermatology experience during the pandemic should inform future development.

Notably, the COVID-19 pandemic led to a rapid shift in focus from store-and-forward teledermatology to live video–based models.^1,2 Logistically, live video visits are challenging, require more time and resources, and often are diagnostically limited, with concerns regarding technology, connectivity, reimbursement, and appropriate use.³ Prior to COVID-19, formal Health Insurance Portability and Accountability Act–compliant teledermatology platforms often were costly to establish and maintain, largely relegating use to academic centers and Veterans Affairs hospitals. Thus, many fewer private practice dermatologists had used teledermatology compared to academic dermatologists in the United States (11.4% vs 27.6%).³ Government regulations—a key barrier to the adoption of teledermatology in private practice before COVID-19—were greatly relaxed during the pandemic. The Centers for Medicare and Medicaid Services removed restrictions on where patients could be seen, improved reimbursement for video visits, and allowed the use of platforms that are not Health Insurance Portability and Accountability Act compliant. Many states also relaxed medical licensing rules.

Overall, the general outlook on telehealth seems positive. Reimbursement has been found to be a primary factor in dermatologists’ willingness to use teledermatology.³ Thus, sustainable use of teledermatology likely will depend on continued reimbursement parity for live video as well as store-and-forward consultations, which have several advantages but currently are de-incentivized by low reimbursement. The survey also found that 70% of respondents felt that teledermatology use will continue after COVID-19, while 58% intended to continue use—nearly 5-fold more than before the pandemic.³ We suspect the discrepancy between participants’ predictions regarding future use of teledermatology and their personal intent to use it highlights perceived barriers and limitations of the long-term success of teledermatology. Aside from reimbursement, connectivity and functionality were common concerns, emphasizing the need for innovative technological solutions.³ Moving forward, we anticipate that dermatologists will need to establish consistent workflows to establish consistent triage for the most appropriate visit—in-person visits vs teledermatology, which may include augmented, intelligence-enhanced solutions. Similar to prior clinician perspectives about which types of visits are conducive to teledermatology,² most survey participants believed virtual visits were effective for acne, routine follow-ups, medication monitoring, and some inflammatory conditions.³

Importantly, we must be mindful of patients who may be left behind by the digital divide, such as those with lack of access to a smartphone or the internet, language barriers, or limited telehealth experience.⁵ Systems should be designed to provide these patients with technologic and health literacy aid or alternate modalities to access care. For example, structured methods could be introduced to provide training and instructions on how to access phone applications, computer-based programs, and more. Likewise, for those with hearing or vision deficits, it will be important to improve sound amplification and accessibility for headphones or hearing aid connectivity, as well as appropriate font size, button size, and application navigation. In remote areas, existing clinics may be used to help field specialty consultation teleconferences. Certainly, applications and platforms devised for teledermatology must be designed to serve diverse patient groups, with special consideration for the elderly, those who speak languages other than English, and those with disabilities that may make telehealth use more challenging.

Large-scale regulatory changes and reimbursement parity can have a substantial impact on future teledermatology use. Advocacy efforts continue to push for fair valuation of telemedicine, coverage of store-and-forward teledermatology codes, and coverage for all models of care. It is imperative for the dermatology community to continue discussions on implementation and methodology to best leverage this technology for the most patient benefit.

Although teledermatology utilization in the United States traditionally has lagged behind other countries,^1,2 the COVID-19 pandemic upended this trend by creating the need for a massive teledermatology experiment. Recently reported survey results from a large representative sample of US dermatologists (5000 participants) on perceptions of teledermatology during COVID-19 indicated that only 14.1% of participants used teledermatology prior to the COVID-19 pandemic vs 54.1% of dermatologists in Europe.^2,3 Since the pandemic started, 97% of US dermatologists reported teledermatology use,³ demonstrating a huge shift in utilization. This trend is notable, as teledermatology has been shown to increase access to dermatology in underserved areas, reduce patient travel times, improve patient triage, and even reduce carbon footprints.^1,4 Thus, to sustain the momentum, insights from the recent teledermatology experience during the pandemic should inform future development.

Notably, the COVID-19 pandemic led to a rapid shift in focus from store-and-forward teledermatology to live video–based models.^1,2 Logistically, live video visits are challenging, require more time and resources, and often are diagnostically limited, with concerns regarding technology, connectivity, reimbursement, and appropriate use.³ Prior to COVID-19, formal Health Insurance Portability and Accountability Act–compliant teledermatology platforms often were costly to establish and maintain, largely relegating use to academic centers and Veterans Affairs hospitals. Thus, many fewer private practice dermatologists had used teledermatology compared to academic dermatologists in the United States (11.4% vs 27.6%).³ Government regulations—a key barrier to the adoption of teledermatology in private practice before COVID-19—were greatly relaxed during the pandemic. The Centers for Medicare and Medicaid Services removed restrictions on where patients could be seen, improved reimbursement for video visits, and allowed the use of platforms that are not Health Insurance Portability and Accountability Act compliant. Many states also relaxed medical licensing rules.

Overall, the general outlook on telehealth seems positive. Reimbursement has been found to be a primary factor in dermatologists’ willingness to use teledermatology.³ Thus, sustainable use of teledermatology likely will depend on continued reimbursement parity for live video as well as store-and-forward consultations, which have several advantages but currently are de-incentivized by low reimbursement. The survey also found that 70% of respondents felt that teledermatology use will continue after COVID-19, while 58% intended to continue use—nearly 5-fold more than before the pandemic.³ We suspect the discrepancy between participants’ predictions regarding future use of teledermatology and their personal intent to use it highlights perceived barriers and limitations of the long-term success of teledermatology. Aside from reimbursement, connectivity and functionality were common concerns, emphasizing the need for innovative technological solutions.³ Moving forward, we anticipate that dermatologists will need to establish consistent workflows to establish consistent triage for the most appropriate visit—in-person visits vs teledermatology, which may include augmented, intelligence-enhanced solutions. Similar to prior clinician perspectives about which types of visits are conducive to teledermatology,² most survey participants believed virtual visits were effective for acne, routine follow-ups, medication monitoring, and some inflammatory conditions.³

Importantly, we must be mindful of patients who may be left behind by the digital divide, such as those with lack of access to a smartphone or the internet, language barriers, or limited telehealth experience.⁵ Systems should be designed to provide these patients with technologic and health literacy aid or alternate modalities to access care. For example, structured methods could be introduced to provide training and instructions on how to access phone applications, computer-based programs, and more. Likewise, for those with hearing or vision deficits, it will be important to improve sound amplification and accessibility for headphones or hearing aid connectivity, as well as appropriate font size, button size, and application navigation. In remote areas, existing clinics may be used to help field specialty consultation teleconferences. Certainly, applications and platforms devised for teledermatology must be designed to serve diverse patient groups, with special consideration for the elderly, those who speak languages other than English, and those with disabilities that may make telehealth use more challenging.

Large-scale regulatory changes and reimbursement parity can have a substantial impact on future teledermatology use. Advocacy efforts continue to push for fair valuation of telemedicine, coverage of store-and-forward teledermatology codes, and coverage for all models of care. It is imperative for the dermatology community to continue discussions on implementation and methodology to best leverage this technology for the most patient benefit.

Practice Gap

In accordance with World Health Organization guidelines on social distancing to limit transmission of SARS-CoV-2, dermatologists have relied on teledermatology (TD) to develop novel adaptations of traditional workflows, optimize patient care, and limit in-person appointments during the COVID-19 pandemic. Pandemic-induced physical and emotional stress were anticipated to increase the incidence of dermatologic diseases with psychologic triggers. 

The connection between hair loss and emotional stress is well documented for telogen effluvium and alopecia areata.^1,2 As anticipated, dermatology visits increased during the COVID-19 pandemic for the diagnosis of alopecia^1-4; a survey performed during the pandemic found that alopecia was one of the most common diagnoses dermatologists made through telehealth platforms.⁵

This article provides a practical guide for dermatology practitioners to efficiently and accurately assess alopecia by TD in all patients, with added considerations for skin of color patients.

Diagnostic Tools

The intersection of TD, as an effective mechanism for the diagnosis and treatment of dermatologic disorders, and the increase in alopecia observed during the COVID-19 pandemic prompted us to develop a workflow for conducting virtual scalp examinations. Seven dermatologists (A.M., A.A., O.A., N.E., V.C., C.M.B., S.C.T.) who are experts in hair disorders contributed to developing workflows to optimize the assessment of alopecia through a virtual scalp examination, with an emphasis on patients of color. These experts completed a 7-question survey (Table) detailing their approach to the virtual scalp examination. One author (B.N.W.) served as an independent reviewer and collated responses into the following workflows.

Telemedicine Previsit Workflow

Components of the previsit workflow include:

• Instruct patients to provide all laboratory values and biopsy reports before the appointment.

• Test for a stable Wi-Fi connection using a speed test (available at https://www.speedtest.net/). A speed of 10 megabits/second or more is required for high-quality video via TD.⁶

• Provide a handout illustrating the required photographs of the anterior hairline; the mid scalp, including vertex, bilateral parietal, and occipital scalp; and posterior hairline. Photographs should be uploaded 2 hours before the visit. Figures 1 and 2 are examples of photographs that should be requested.

• Request images with 2 or 3 different angles of the area of the scalp with the greatest involvement to help appreciate primary and secondary characteristics.

• Encourage patients to present with clean, recently shampooed, dried, and detangled natural hair, unless they have an itchy or flaky scalp.

• For concerns of scalp, hairline, eyebrow, or facial flaking and scaling, instruct the patient to avoid applying a moisturizer before the visit.

• Instruct the patient to remove false eyelashes, eyelash extensions, eyebrow pencil, hair camouflage, hair accessories, braids, extensions, weaves, twists, and other hairstyles so that the hair can be maneuvered to expose the scalp surface.

• Instruct the patient to have a comb, pic, or brush, or more than one of these implements, available during the visit.

Telemedicine Visit Workflow

Components of the visit workflow include:

• If a stable Wi-Fi connection cannot be established, switch to an audio-only visit to collect a pertinent history. Advise the patient that in-person follow-up must be scheduled.

• Confirm that (1) the patient is in a private setting where the scalp can be viewed and (2) lighting is positioned in front of the patient.

• Ensure that the patient’s hairline, full face, eyebrows, and eyelashes and, upon request, the vertex and posterior scalp, are completely visible.

• Initiate the virtual scalp examination by instructing the patient how to perform a hair pull test. Then, examine the pattern and distribution of hair loss alongside supplemental photographs.

• Instruct the patient to apply pressure with the fingertips throughout the scalp to help localize tenderness, which, in combination with the pattern of hair loss observed, might inform the diagnosis.

• Instruct the patient to scan the scalp with the fingertips for “bumps” to locate papules, pustules, and keloidal scars.

Diagnostic Pearls

Distribution of Alopecia—The experts noted that the pattern, distribution, and location of hair loss determined from the telemedicine alopecia assessment provided important clues to distinguish the type of alopecia.

Diagnostic clues for diffuse or generalized alopecia include:

• Either of these findings might be indicative of telogen effluvium or acquired trichorrhexis nodosa. Results of the hair pull test can help distinguish between these diagnoses.

• Recent stressful life events along with the presence of telogen hairs extracted during a hair pull test support the diagnosis of telogen effluvium.

• A history of external stress on the hair—thermal, traction, or chemical—along with broken hair shafts following the hair pull test support the diagnosis of acquired trichorrhexis nodosa.

Diagnostic clues for focal or patchy alopecia include:

• Alopecia areata generally presents as focal hair loss in an annular distribution; pruritus, erythema, and scale are absent.

• Seborrheic dermatitis can present as pruritic erythematous patches with scale distributed on the scalp and, in some cases, in the eyebrows, nasolabial folds, or paranasal skin.⁷ Some skin of color patients present with petaloid seborrheic dermatitis—pink or hypopigmented polycyclic coalescing rings with minimal scale.^7,8

• Discoid lupus erythematosus, similar to seborrheic dermatitis, might present as pruritic, scaly, hypopigmented patches. However, in the experience of the experts, a more common presentation is tender erythematous patches of hair loss with central hypopigmentation and surrounding hyperpigmentation.

Diagnostic clues for vertex and mid scalp alopecia include:

• Androgenetic alopecia typically presents as a reduction of terminal hair density in the vertex and mid scalp regions (with widening through the midline part) and fine hair along the anterior hairline.⁹ Signs of concomitant hyperandrogenism, including facial hirsutism, acne, and obesity, might be observed.¹⁰

• Central centrifugal cicatricial alopecia typically affects the vertex and mid scalp with a shiny scalp appearance and follicular dropout.

Diagnostic clues for frontotemporal alopecia include:

• Frontal fibrosing alopecia (FFA) often presents with spared single terminal hairs (lonely hair sign).

• Traction alopecia commonly presents with the fringe hair sign.

Scalp Symptoms—The experts noted that the presence of symptoms (eg, pain, tenderness, pruritus) in conjunction with the pattern of hair loss might support the diagnosis of an inflammatory scarring alopecia.

When do symptoms raise suspicion of central centrifugal cicatricial alopecia?

• Suspected in the setting of vertex alopecia associated with tenderness, pain, or itching.

When do symptoms raise suspicion of FFA?

• Suspected when patients experience frontotemporal tenderness, pain, or burning associated with alopecia.

• The skin hue of the affected area might be lighter in color than, and contrast with, the darker hue of the photoaged upper forehead.¹¹

• The lonely hair sign can aid in diagnosing FFA and distinguish it from the fringe sign of traction alopecia.

• Concurrent madarosis, flesh-colored papules on the cheeks, or lichen planus pigmentosus identified by visual inspection of the face confirms the diagnosis.^9,12 Madarosis of the eyebrow was frequently cited by the experts as an associated symptom of FFA.

When do symptoms raise suspicion of lichen planopilaris?

• Suspected in the presence of pruritus, burning, tenderness, or pain associated with perifollicular erythema and scale in the setting of vertex and parietal alopecia.¹³

• Anagen hair release is observed during the hair pull test.^11,14• The experts cited flesh-colored papules and lichen planus pigmentosus as frequently associated symptoms of lichen planopilaris.

Practice Implications

There are limitations to a virtual scalp examination—the inability to perform a scalp biopsy or administer certain treatments—but the consensus of the expert panel is that an initial alopecia assessment can be completed successfully utilizing TD. Although TD is not a replacement for an in-person dermatology visit, this technology has allowed for the diagnosis, treatment, and continuing care of many common dermatologic conditions without the patient needing to travel to the office.⁵

With the increased frequency of hair loss concerns documented over the last year and more patients seeking TD, it is imperative that dermatologists feel confident performing a virtual hair and scalp examination on all patients.^1,3,4

Practice Gap

In accordance with World Health Organization guidelines on social distancing to limit transmission of SARS-CoV-2, dermatologists have relied on teledermatology (TD) to develop novel adaptations of traditional workflows, optimize patient care, and limit in-person appointments during the COVID-19 pandemic. Pandemic-induced physical and emotional stress were anticipated to increase the incidence of dermatologic diseases with psychologic triggers. 

The connection between hair loss and emotional stress is well documented for telogen effluvium and alopecia areata.^1,2 As anticipated, dermatology visits increased during the COVID-19 pandemic for the diagnosis of alopecia^1-4; a survey performed during the pandemic found that alopecia was one of the most common diagnoses dermatologists made through telehealth platforms.⁵

This article provides a practical guide for dermatology practitioners to efficiently and accurately assess alopecia by TD in all patients, with added considerations for skin of color patients.

Diagnostic Tools

The intersection of TD, as an effective mechanism for the diagnosis and treatment of dermatologic disorders, and the increase in alopecia observed during the COVID-19 pandemic prompted us to develop a workflow for conducting virtual scalp examinations. Seven dermatologists (A.M., A.A., O.A., N.E., V.C., C.M.B., S.C.T.) who are experts in hair disorders contributed to developing workflows to optimize the assessment of alopecia through a virtual scalp examination, with an emphasis on patients of color. These experts completed a 7-question survey (Table) detailing their approach to the virtual scalp examination. One author (B.N.W.) served as an independent reviewer and collated responses into the following workflows.

Telemedicine Previsit Workflow

Components of the previsit workflow include:

• Instruct patients to provide all laboratory values and biopsy reports before the appointment.

• Test for a stable Wi-Fi connection using a speed test (available at https://www.speedtest.net/). A speed of 10 megabits/second or more is required for high-quality video via TD.⁶

• Provide a handout illustrating the required photographs of the anterior hairline; the mid scalp, including vertex, bilateral parietal, and occipital scalp; and posterior hairline. Photographs should be uploaded 2 hours before the visit. Figures 1 and 2 are examples of photographs that should be requested.

• Request images with 2 or 3 different angles of the area of the scalp with the greatest involvement to help appreciate primary and secondary characteristics.

• Encourage patients to present with clean, recently shampooed, dried, and detangled natural hair, unless they have an itchy or flaky scalp.

• For concerns of scalp, hairline, eyebrow, or facial flaking and scaling, instruct the patient to avoid applying a moisturizer before the visit.

• Instruct the patient to remove false eyelashes, eyelash extensions, eyebrow pencil, hair camouflage, hair accessories, braids, extensions, weaves, twists, and other hairstyles so that the hair can be maneuvered to expose the scalp surface.

• Instruct the patient to have a comb, pic, or brush, or more than one of these implements, available during the visit.

Telemedicine Visit Workflow

Components of the visit workflow include:

• If a stable Wi-Fi connection cannot be established, switch to an audio-only visit to collect a pertinent history. Advise the patient that in-person follow-up must be scheduled.

• Confirm that (1) the patient is in a private setting where the scalp can be viewed and (2) lighting is positioned in front of the patient.

• Ensure that the patient’s hairline, full face, eyebrows, and eyelashes and, upon request, the vertex and posterior scalp, are completely visible.

• Initiate the virtual scalp examination by instructing the patient how to perform a hair pull test. Then, examine the pattern and distribution of hair loss alongside supplemental photographs.

• Instruct the patient to apply pressure with the fingertips throughout the scalp to help localize tenderness, which, in combination with the pattern of hair loss observed, might inform the diagnosis.

• Instruct the patient to scan the scalp with the fingertips for “bumps” to locate papules, pustules, and keloidal scars.

Diagnostic Pearls

Distribution of Alopecia—The experts noted that the pattern, distribution, and location of hair loss determined from the telemedicine alopecia assessment provided important clues to distinguish the type of alopecia.

Diagnostic clues for diffuse or generalized alopecia include:

• Either of these findings might be indicative of telogen effluvium or acquired trichorrhexis nodosa. Results of the hair pull test can help distinguish between these diagnoses.

• Recent stressful life events along with the presence of telogen hairs extracted during a hair pull test support the diagnosis of telogen effluvium.

• A history of external stress on the hair—thermal, traction, or chemical—along with broken hair shafts following the hair pull test support the diagnosis of acquired trichorrhexis nodosa.

Diagnostic clues for focal or patchy alopecia include:

• Alopecia areata generally presents as focal hair loss in an annular distribution; pruritus, erythema, and scale are absent.

• Seborrheic dermatitis can present as pruritic erythematous patches with scale distributed on the scalp and, in some cases, in the eyebrows, nasolabial folds, or paranasal skin.⁷ Some skin of color patients present with petaloid seborrheic dermatitis—pink or hypopigmented polycyclic coalescing rings with minimal scale.^7,8

• Discoid lupus erythematosus, similar to seborrheic dermatitis, might present as pruritic, scaly, hypopigmented patches. However, in the experience of the experts, a more common presentation is tender erythematous patches of hair loss with central hypopigmentation and surrounding hyperpigmentation.

Diagnostic clues for vertex and mid scalp alopecia include:

• Androgenetic alopecia typically presents as a reduction of terminal hair density in the vertex and mid scalp regions (with widening through the midline part) and fine hair along the anterior hairline.⁹ Signs of concomitant hyperandrogenism, including facial hirsutism, acne, and obesity, might be observed.¹⁰

• Central centrifugal cicatricial alopecia typically affects the vertex and mid scalp with a shiny scalp appearance and follicular dropout.

Diagnostic clues for frontotemporal alopecia include:

• Frontal fibrosing alopecia (FFA) often presents with spared single terminal hairs (lonely hair sign).

• Traction alopecia commonly presents with the fringe hair sign.

Scalp Symptoms—The experts noted that the presence of symptoms (eg, pain, tenderness, pruritus) in conjunction with the pattern of hair loss might support the diagnosis of an inflammatory scarring alopecia.

When do symptoms raise suspicion of central centrifugal cicatricial alopecia?

• Suspected in the setting of vertex alopecia associated with tenderness, pain, or itching.

When do symptoms raise suspicion of FFA?

• Suspected when patients experience frontotemporal tenderness, pain, or burning associated with alopecia.

• The skin hue of the affected area might be lighter in color than, and contrast with, the darker hue of the photoaged upper forehead.¹¹

• The lonely hair sign can aid in diagnosing FFA and distinguish it from the fringe sign of traction alopecia.

• Concurrent madarosis, flesh-colored papules on the cheeks, or lichen planus pigmentosus identified by visual inspection of the face confirms the diagnosis.^9,12 Madarosis of the eyebrow was frequently cited by the experts as an associated symptom of FFA.

When do symptoms raise suspicion of lichen planopilaris?

• Suspected in the presence of pruritus, burning, tenderness, or pain associated with perifollicular erythema and scale in the setting of vertex and parietal alopecia.¹³

• Anagen hair release is observed during the hair pull test.^11,14• The experts cited flesh-colored papules and lichen planus pigmentosus as frequently associated symptoms of lichen planopilaris.

Practice Implications

There are limitations to a virtual scalp examination—the inability to perform a scalp biopsy or administer certain treatments—but the consensus of the expert panel is that an initial alopecia assessment can be completed successfully utilizing TD. Although TD is not a replacement for an in-person dermatology visit, this technology has allowed for the diagnosis, treatment, and continuing care of many common dermatologic conditions without the patient needing to travel to the office.⁵

With the increased frequency of hair loss concerns documented over the last year and more patients seeking TD, it is imperative that dermatologists feel confident performing a virtual hair and scalp examination on all patients.^1,3,4

Practice Gap

In accordance with World Health Organization guidelines on social distancing to limit transmission of SARS-CoV-2, dermatologists have relied on teledermatology (TD) to develop novel adaptations of traditional workflows, optimize patient care, and limit in-person appointments during the COVID-19 pandemic. Pandemic-induced physical and emotional stress were anticipated to increase the incidence of dermatologic diseases with psychologic triggers. 

The connection between hair loss and emotional stress is well documented for telogen effluvium and alopecia areata.^1,2 As anticipated, dermatology visits increased during the COVID-19 pandemic for the diagnosis of alopecia^1-4; a survey performed during the pandemic found that alopecia was one of the most common diagnoses dermatologists made through telehealth platforms.⁵

This article provides a practical guide for dermatology practitioners to efficiently and accurately assess alopecia by TD in all patients, with added considerations for skin of color patients.

Diagnostic Tools

The intersection of TD, as an effective mechanism for the diagnosis and treatment of dermatologic disorders, and the increase in alopecia observed during the COVID-19 pandemic prompted us to develop a workflow for conducting virtual scalp examinations. Seven dermatologists (A.M., A.A., O.A., N.E., V.C., C.M.B., S.C.T.) who are experts in hair disorders contributed to developing workflows to optimize the assessment of alopecia through a virtual scalp examination, with an emphasis on patients of color. These experts completed a 7-question survey (Table) detailing their approach to the virtual scalp examination. One author (B.N.W.) served as an independent reviewer and collated responses into the following workflows.

Telemedicine Previsit Workflow

Components of the previsit workflow include:

• Instruct patients to provide all laboratory values and biopsy reports before the appointment.

• Test for a stable Wi-Fi connection using a speed test (available at https://www.speedtest.net/). A speed of 10 megabits/second or more is required for high-quality video via TD.⁶

• Provide a handout illustrating the required photographs of the anterior hairline; the mid scalp, including vertex, bilateral parietal, and occipital scalp; and posterior hairline. Photographs should be uploaded 2 hours before the visit. Figures 1 and 2 are examples of photographs that should be requested.

• Request images with 2 or 3 different angles of the area of the scalp with the greatest involvement to help appreciate primary and secondary characteristics.

• Encourage patients to present with clean, recently shampooed, dried, and detangled natural hair, unless they have an itchy or flaky scalp.

• For concerns of scalp, hairline, eyebrow, or facial flaking and scaling, instruct the patient to avoid applying a moisturizer before the visit.

• Instruct the patient to remove false eyelashes, eyelash extensions, eyebrow pencil, hair camouflage, hair accessories, braids, extensions, weaves, twists, and other hairstyles so that the hair can be maneuvered to expose the scalp surface.

• Instruct the patient to have a comb, pic, or brush, or more than one of these implements, available during the visit.

Telemedicine Visit Workflow

Components of the visit workflow include:

• If a stable Wi-Fi connection cannot be established, switch to an audio-only visit to collect a pertinent history. Advise the patient that in-person follow-up must be scheduled.

• Confirm that (1) the patient is in a private setting where the scalp can be viewed and (2) lighting is positioned in front of the patient.

• Ensure that the patient’s hairline, full face, eyebrows, and eyelashes and, upon request, the vertex and posterior scalp, are completely visible.

• Initiate the virtual scalp examination by instructing the patient how to perform a hair pull test. Then, examine the pattern and distribution of hair loss alongside supplemental photographs.

• Instruct the patient to apply pressure with the fingertips throughout the scalp to help localize tenderness, which, in combination with the pattern of hair loss observed, might inform the diagnosis.

• Instruct the patient to scan the scalp with the fingertips for “bumps” to locate papules, pustules, and keloidal scars.

Diagnostic Pearls

Distribution of Alopecia—The experts noted that the pattern, distribution, and location of hair loss determined from the telemedicine alopecia assessment provided important clues to distinguish the type of alopecia.

Diagnostic clues for diffuse or generalized alopecia include:

• Either of these findings might be indicative of telogen effluvium or acquired trichorrhexis nodosa. Results of the hair pull test can help distinguish between these diagnoses.

• Recent stressful life events along with the presence of telogen hairs extracted during a hair pull test support the diagnosis of telogen effluvium.

• A history of external stress on the hair—thermal, traction, or chemical—along with broken hair shafts following the hair pull test support the diagnosis of acquired trichorrhexis nodosa.

Diagnostic clues for focal or patchy alopecia include:

• Alopecia areata generally presents as focal hair loss in an annular distribution; pruritus, erythema, and scale are absent.

• Seborrheic dermatitis can present as pruritic erythematous patches with scale distributed on the scalp and, in some cases, in the eyebrows, nasolabial folds, or paranasal skin.⁷ Some skin of color patients present with petaloid seborrheic dermatitis—pink or hypopigmented polycyclic coalescing rings with minimal scale.^7,8

• Discoid lupus erythematosus, similar to seborrheic dermatitis, might present as pruritic, scaly, hypopigmented patches. However, in the experience of the experts, a more common presentation is tender erythematous patches of hair loss with central hypopigmentation and surrounding hyperpigmentation.

Diagnostic clues for vertex and mid scalp alopecia include:

• Androgenetic alopecia typically presents as a reduction of terminal hair density in the vertex and mid scalp regions (with widening through the midline part) and fine hair along the anterior hairline.⁹ Signs of concomitant hyperandrogenism, including facial hirsutism, acne, and obesity, might be observed.¹⁰

• Central centrifugal cicatricial alopecia typically affects the vertex and mid scalp with a shiny scalp appearance and follicular dropout.

Diagnostic clues for frontotemporal alopecia include:

• Frontal fibrosing alopecia (FFA) often presents with spared single terminal hairs (lonely hair sign).

• Traction alopecia commonly presents with the fringe hair sign.

Scalp Symptoms—The experts noted that the presence of symptoms (eg, pain, tenderness, pruritus) in conjunction with the pattern of hair loss might support the diagnosis of an inflammatory scarring alopecia.

When do symptoms raise suspicion of central centrifugal cicatricial alopecia?

• Suspected in the setting of vertex alopecia associated with tenderness, pain, or itching.

When do symptoms raise suspicion of FFA?

• Suspected when patients experience frontotemporal tenderness, pain, or burning associated with alopecia.

• The skin hue of the affected area might be lighter in color than, and contrast with, the darker hue of the photoaged upper forehead.¹¹

• The lonely hair sign can aid in diagnosing FFA and distinguish it from the fringe sign of traction alopecia.

• Concurrent madarosis, flesh-colored papules on the cheeks, or lichen planus pigmentosus identified by visual inspection of the face confirms the diagnosis.^9,12 Madarosis of the eyebrow was frequently cited by the experts as an associated symptom of FFA.

When do symptoms raise suspicion of lichen planopilaris?

• Suspected in the presence of pruritus, burning, tenderness, or pain associated with perifollicular erythema and scale in the setting of vertex and parietal alopecia.¹³

• Anagen hair release is observed during the hair pull test.^11,14• The experts cited flesh-colored papules and lichen planus pigmentosus as frequently associated symptoms of lichen planopilaris.

Practice Implications

There are limitations to a virtual scalp examination—the inability to perform a scalp biopsy or administer certain treatments—but the consensus of the expert panel is that an initial alopecia assessment can be completed successfully utilizing TD. Although TD is not a replacement for an in-person dermatology visit, this technology has allowed for the diagnosis, treatment, and continuing care of many common dermatologic conditions without the patient needing to travel to the office.⁵

With the increased frequency of hair loss concerns documented over the last year and more patients seeking TD, it is imperative that dermatologists feel confident performing a virtual hair and scalp examination on all patients.^1,3,4

A prominent Florida oncologist was arrested in December, and some members of the medical community are puzzled.

Michael Dattoli, MD, a radiation oncologist and physician-in-chief of the Dattoli Cancer Center in Sarasota, Fla., has been charged with prescription and insurance fraud, according to the Sarasota County Sheriff’s Office.

The charges include three counts of possessing a controlled substance by fraud, three counts of criminal use of personal identification information, and three counts of insurance fraud.

Dr. Dattoli was arrested on December 16.

According to investigators, a former employee of the Dattoli Cancer Center alleged that Dr. Dattoli filled prescriptions for diazepam (Valium) three times in his wife’s name using a different healthcare provider’s information.

Some experts find it bizarre for a physician of his stature to have possibly engaged in such a transgression — a relatively minor fraud that comes with serious consequences.

“This is a very well-respected physician who has done a lot of good in the community, and this makes no sense at all,” said Jay Wolfson, PhD, JD, Distinguished Service Professor of Public Health Medicine and Pharmacy and associate vice president for health law, policy, and safety at the University of South Florida, Tampa. “It’s low-level fraud, and not like he was laundering money or involved in pill mills, which has been problematic in Florida.”

According to recent accounts from local news agencies, in August 2021, the Sarasota police connected with investigators from the Sarasota County Sheriff’s Office’s Pharmaceutical Diversion Unit regarding prescription fraud dating back to 2019 and 2020 involving Dr. Dattoli and a “victim.”

The victim, a former employee of the Dattoli Cancer Center, had left his job at the end of 2020 after 5 years. His name and position at the cancer center were redacted in the arrest warrant, but the warrant mentions that he treated patients while he worked at the center.

The former employee told police that when checking the Florida prescription drug database for controlled substances in September 2021, he noticed that several fraudulent prescriptions for diazepam — a controlled substance — had been entered from 2020. The recipient was Dr. Dattoli’s wife, Rita Beatrice Dattoli, but the former employee stated he had never authorized these prescriptions and that Dr. Dattoli’s wife was never his patient.

In September 2021, the police obtained copies of multiple prescriptions from local pharmacies that were phoned in throughout 2020 by the Dattoli Cancer Center. The prescriptions were filled and picked up the same day by Dr. Dattoli himself, whose identity had been verified by his driver’s license.

Dr. Dattoli’s wife, who was interviewed by the police in October 2021, stated she had never been a patient at the center, that the prescription was not hers, and that she had never used the prescribed drug.

A month later, the Sarasota police subpoenaed bank records that matched accounts belonging to Dr. Dattoli, which showed the same dates, total purchase price, and stores where fraudulent prescriptions were filled, picked up, and purchased.

None of this really makes any sense, Dr. Wolfson told this news organizataion. “Any physician in need of Valium doesn’t have to forge a prescription, he can get it from any of his colleagues,” he noted. “And why put it in his wife’s name? He also submitted it to his insurance, which leaves more of a paper trail. And he didn’t need to have insurance pay for it — Valium is a very inexpensive drug.”

Plus, Dr. Wolfson added, “I know people who have been treated by Dr. Dattoli and they have nothing but good things to say about him — he’s an excellent doctor with a great bedside manner. His record is clean, he’s never been reprimanded, he’s built a successful practice, and then this thing just parachutes out of the sky.”

The investigation is ongoing, and detectives from the Sarasota police department have stated that they “believe there may be additional victims.”

Dr. Dattoli was released the day after his arrest on a $1,500 bond. His arraignment is scheduled for January 22. If convicted, he could face prison time, fines, or even lose his license to practice medicine.

Dr. Wolfson added that the arraignment is the first step in the process. “But even if it can be determined that he forged a signature, I don’t think it will rise to a level where his license will be revoked,” he said.

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

A prominent Florida oncologist was arrested in December, and some members of the medical community are puzzled.

Michael Dattoli, MD, a radiation oncologist and physician-in-chief of the Dattoli Cancer Center in Sarasota, Fla., has been charged with prescription and insurance fraud, according to the Sarasota County Sheriff’s Office.

The charges include three counts of possessing a controlled substance by fraud, three counts of criminal use of personal identification information, and three counts of insurance fraud.

Dr. Dattoli was arrested on December 16.

According to investigators, a former employee of the Dattoli Cancer Center alleged that Dr. Dattoli filled prescriptions for diazepam (Valium) three times in his wife’s name using a different healthcare provider’s information.

Some experts find it bizarre for a physician of his stature to have possibly engaged in such a transgression — a relatively minor fraud that comes with serious consequences.

“This is a very well-respected physician who has done a lot of good in the community, and this makes no sense at all,” said Jay Wolfson, PhD, JD, Distinguished Service Professor of Public Health Medicine and Pharmacy and associate vice president for health law, policy, and safety at the University of South Florida, Tampa. “It’s low-level fraud, and not like he was laundering money or involved in pill mills, which has been problematic in Florida.”

According to recent accounts from local news agencies, in August 2021, the Sarasota police connected with investigators from the Sarasota County Sheriff’s Office’s Pharmaceutical Diversion Unit regarding prescription fraud dating back to 2019 and 2020 involving Dr. Dattoli and a “victim.”

The victim, a former employee of the Dattoli Cancer Center, had left his job at the end of 2020 after 5 years. His name and position at the cancer center were redacted in the arrest warrant, but the warrant mentions that he treated patients while he worked at the center.

The former employee told police that when checking the Florida prescription drug database for controlled substances in September 2021, he noticed that several fraudulent prescriptions for diazepam — a controlled substance — had been entered from 2020. The recipient was Dr. Dattoli’s wife, Rita Beatrice Dattoli, but the former employee stated he had never authorized these prescriptions and that Dr. Dattoli’s wife was never his patient.

In September 2021, the police obtained copies of multiple prescriptions from local pharmacies that were phoned in throughout 2020 by the Dattoli Cancer Center. The prescriptions were filled and picked up the same day by Dr. Dattoli himself, whose identity had been verified by his driver’s license.

Dr. Dattoli’s wife, who was interviewed by the police in October 2021, stated she had never been a patient at the center, that the prescription was not hers, and that she had never used the prescribed drug.

A month later, the Sarasota police subpoenaed bank records that matched accounts belonging to Dr. Dattoli, which showed the same dates, total purchase price, and stores where fraudulent prescriptions were filled, picked up, and purchased.

None of this really makes any sense, Dr. Wolfson told this news organizataion. “Any physician in need of Valium doesn’t have to forge a prescription, he can get it from any of his colleagues,” he noted. “And why put it in his wife’s name? He also submitted it to his insurance, which leaves more of a paper trail. And he didn’t need to have insurance pay for it — Valium is a very inexpensive drug.”

Plus, Dr. Wolfson added, “I know people who have been treated by Dr. Dattoli and they have nothing but good things to say about him — he’s an excellent doctor with a great bedside manner. His record is clean, he’s never been reprimanded, he’s built a successful practice, and then this thing just parachutes out of the sky.”

The investigation is ongoing, and detectives from the Sarasota police department have stated that they “believe there may be additional victims.”

Dr. Dattoli was released the day after his arrest on a $1,500 bond. His arraignment is scheduled for January 22. If convicted, he could face prison time, fines, or even lose his license to practice medicine.

Dr. Wolfson added that the arraignment is the first step in the process. “But even if it can be determined that he forged a signature, I don’t think it will rise to a level where his license will be revoked,” he said.

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

A prominent Florida oncologist was arrested in December, and some members of the medical community are puzzled.

Michael Dattoli, MD, a radiation oncologist and physician-in-chief of the Dattoli Cancer Center in Sarasota, Fla., has been charged with prescription and insurance fraud, according to the Sarasota County Sheriff’s Office.

The charges include three counts of possessing a controlled substance by fraud, three counts of criminal use of personal identification information, and three counts of insurance fraud.

Dr. Dattoli was arrested on December 16.

According to investigators, a former employee of the Dattoli Cancer Center alleged that Dr. Dattoli filled prescriptions for diazepam (Valium) three times in his wife’s name using a different healthcare provider’s information.

Some experts find it bizarre for a physician of his stature to have possibly engaged in such a transgression — a relatively minor fraud that comes with serious consequences.

“This is a very well-respected physician who has done a lot of good in the community, and this makes no sense at all,” said Jay Wolfson, PhD, JD, Distinguished Service Professor of Public Health Medicine and Pharmacy and associate vice president for health law, policy, and safety at the University of South Florida, Tampa. “It’s low-level fraud, and not like he was laundering money or involved in pill mills, which has been problematic in Florida.”

According to recent accounts from local news agencies, in August 2021, the Sarasota police connected with investigators from the Sarasota County Sheriff’s Office’s Pharmaceutical Diversion Unit regarding prescription fraud dating back to 2019 and 2020 involving Dr. Dattoli and a “victim.”

The victim, a former employee of the Dattoli Cancer Center, had left his job at the end of 2020 after 5 years. His name and position at the cancer center were redacted in the arrest warrant, but the warrant mentions that he treated patients while he worked at the center.

The former employee told police that when checking the Florida prescription drug database for controlled substances in September 2021, he noticed that several fraudulent prescriptions for diazepam — a controlled substance — had been entered from 2020. The recipient was Dr. Dattoli’s wife, Rita Beatrice Dattoli, but the former employee stated he had never authorized these prescriptions and that Dr. Dattoli’s wife was never his patient.

In September 2021, the police obtained copies of multiple prescriptions from local pharmacies that were phoned in throughout 2020 by the Dattoli Cancer Center. The prescriptions were filled and picked up the same day by Dr. Dattoli himself, whose identity had been verified by his driver’s license.

Dr. Dattoli’s wife, who was interviewed by the police in October 2021, stated she had never been a patient at the center, that the prescription was not hers, and that she had never used the prescribed drug.

A month later, the Sarasota police subpoenaed bank records that matched accounts belonging to Dr. Dattoli, which showed the same dates, total purchase price, and stores where fraudulent prescriptions were filled, picked up, and purchased.

None of this really makes any sense, Dr. Wolfson told this news organizataion. “Any physician in need of Valium doesn’t have to forge a prescription, he can get it from any of his colleagues,” he noted. “And why put it in his wife’s name? He also submitted it to his insurance, which leaves more of a paper trail. And he didn’t need to have insurance pay for it — Valium is a very inexpensive drug.”

Plus, Dr. Wolfson added, “I know people who have been treated by Dr. Dattoli and they have nothing but good things to say about him — he’s an excellent doctor with a great bedside manner. His record is clean, he’s never been reprimanded, he’s built a successful practice, and then this thing just parachutes out of the sky.”

The investigation is ongoing, and detectives from the Sarasota police department have stated that they “believe there may be additional victims.”

Dr. Dattoli was released the day after his arrest on a $1,500 bond. His arraignment is scheduled for January 22. If convicted, he could face prison time, fines, or even lose his license to practice medicine.

Dr. Wolfson added that the arraignment is the first step in the process. “But even if it can be determined that he forged a signature, I don’t think it will rise to a level where his license will be revoked,” he said.

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

As of 2018, the mean dermatologist to population ratio in the United States was 1.10 per 100,000 people, highlighting a shortage of dermatologists that is only predicted to increase in coming years.^1-4 This undersupply is fueled by both an increasing burden of dermatologic disease and population growth.⁴ Without readily available access to dermatologic care, many patients are left waiting for weeks to see a dermatologist, depending on geographic region.^5-7 It is not simply patients who perceive wait times to be prolonged; approximately half of dermatologists surveyed by the American Academy of Dermatology (AAD) reported an undersupply of dermatologists in their communities, a finding that strongly correlated with patient wait times.² Ensuring the dermatologic workforce is sufficient to fulfill patient needs requires innovation of current practice models. To address this unmet demand, many practices have begun incorporating physician extenders, a term that encompasses physicians not board certified in dermatology, physician assistants, and nurse practitioners.⁷ The evolving landscape of the dermatologic workforce raises questions about future practice models and patient outcomes.

Scope of Practice for Physician Extenders

In practice, the role of physician extenders is highly variable. Legislation involving the scope of practice for physician extenders constantly is changing and varies by state. As of November 2021, 24 states and the District of Columbia permit nurse practitioners “full practice” authority to triage patients, interpret diagnostic tests, and prescribe treatments without physician oversight, including controlled substances.^8,9 Even in states with “reduced practice” and “restricted practice” paradigms, which necessitate physician oversight, there remains ambiguity. Across the country, state regulatory bodies differ in statues governing licensing requirements, accessibility of the supervising physician, and ultimately culpability in the case of patient harm. Lack of consensus guidelines that clearly define roles and responsibilities has kindled controversy regarding extent of autonomy and liability for adverse outcomes.^10,11

With respect to procedures, the AAD has explicitly recommended that “only active and properly licensed doctors of medicine and osteopathy shall engage in the practice of medicine” but that “under appropriate circumstances, a physician may delegate certain procedures and services to appropriately trained nonphysician office personnel.”¹² This statement does not refer to or explicitly list the procedures that are appropriate for delegation to nonphysician personnel, and there is wide variability in how this recommendation is applied in daily practice. As it was originally intended, the AAD’s “Ethics in Medical Practice” position statement indicated that dermatologists must directly oversee physician extenders, a responsibility that is defined as being “present on-site, immediately available and able to respond promptly” to issues arising during the provision of health care services.¹²

Adverse Events From Cosmetic Procedures

The American Society for Dermatologic Surgery has documented a steady growth in the demand for cosmetic, medical, and surgical services,¹³ a trend that has heralded an increase in the number of procedures performed by physician extenders.^14,15 One study contrasted the risk for adverse events following minimally invasive cosmetic procedures performed by physicians or nonphysicians. Of 2116 patients surveyed, 50 adverse events were documented.¹⁴ The cohort treated by nonphysicians experienced a higher incidence of laser burns and dyspigmentation, and the use of improper technique was the most frequently implicated cause of developing an adverse event. Approximately 24.6% of American Society for Dermatologic Surgery members reported treating 10 or more complications of cosmetic procedures performed by nonphysicians.¹⁴ Beyond laser burns and dyspigmentation, this wide range of complications included inappropriately placed filler product, facial drooping, and scarring. These studies highlight the need for further investigation into the outcomes of procedures performed by physician extenders.

Training of Physician Extenders

Even with medical management, emphasis on proper training of personnel is key and remains a legitimate concern. The training of physician extenders in dermatology differs greatly by location; while some physician extenders operate under meticulous guidance and thus can expand their skill set, other physician extenders shadow dermatologists for an arbitrary amount of time before being thrust into practice.¹⁰ It would be a disservice to both patients and nonphysician providers alike to conflate the latter regimen with the 4 years of medical school, 1 year of internship, and 3 years of rigorous specialized dermatologic training that physicians undergo.

This stark discrepancy between the training of physicians and physician extenders raises difficult questions about the patient’s right to make an informed decision regarding how they receive health care. Indeed, the casually regulated autonomous practice of some nonphysician providers has ignited public shock and ire.¹¹

Reducing Health Care Expenditures

As legislatures deliberate over expanding scope of practice, policies should be based on evidence that prioritizes patient safety. In the appropriate setting, physician extenders can be instrumental to mitigating health care disparities; the use of physician extenders can diminish wait times for patients with routine visits for stable dermatologic disease.¹⁶ Moreover, reducing health care expenditures often is cited as a major benefit of increased utilization of physician extenders.¹⁴ It stands to reason that compensation of nonphysician providers is less expensive for a practice compared with physicians. Physician extenders participating in the management of stable chronic conditions or mild acute conditions may be cost-efficient in these circumstances; however, evidence suggests that physician extenders may incur greater costs than physicians with respect to the utilization of diagnostic tests or prescribing medications. For example, several studies have documented a substantial difference in the number of biopsies needed per malignant neoplasm by physicians compared to physician extenders.^17-19 Particularly in patients younger than 65 years and in patients without history of skin cancer, physician extenders had to perform a greater number of biopsies to diagnose malignant neoplasms vs physicians.¹⁸ In addition to increased utilization of diagnostic tests, nonphysician providers more frequently prescribe medications of varying classes.^20-22 Whether in outpatient offices, emergency departments, or hospital clinics, physician extenders more frequently prescribe antibiotics, which has concerning implications for antibiotic stewardship.^20,21 In states with independent prescription authority, physician extenders are more than 20 times more likely to overprescribeopioids compared to physician extenders in states requiring physician supervision.²³ These findings warrant additional investigation into how prescription patterns vary by provider type and how these differences impact patient outcomes.

Final Thoughts

Improving patient care is inherently a team endeavor, and the contributions of all members of the health care team are critical to success. Engaging physician extenders may help mitigate disparities in dermatologic care, with respect to surveillance of stable chronic conditions or the diagnosis of mild acute diseases. However, the exact scope of practice of physician extenders remains ambiguous, and their training regimens can vary drastically. Therefore, in the interest of patient safety, new patients or medically complex patients (ie, cutaneous lymphomas, nonstable autoimmune connective tissue disease) should be examined and managed by physicians. In either scenario, the patient should be informed of which providers are available and should be integrated into the decision-making process for their care. Through mutual respect, close collaboration, and candid assessments of patient complexity, different parties within the medical team can unite behind the mission to improve patient outcomes and champion equitable access to health care.

As of 2018, the mean dermatologist to population ratio in the United States was 1.10 per 100,000 people, highlighting a shortage of dermatologists that is only predicted to increase in coming years.^1-4 This undersupply is fueled by both an increasing burden of dermatologic disease and population growth.⁴ Without readily available access to dermatologic care, many patients are left waiting for weeks to see a dermatologist, depending on geographic region.^5-7 It is not simply patients who perceive wait times to be prolonged; approximately half of dermatologists surveyed by the American Academy of Dermatology (AAD) reported an undersupply of dermatologists in their communities, a finding that strongly correlated with patient wait times.² Ensuring the dermatologic workforce is sufficient to fulfill patient needs requires innovation of current practice models. To address this unmet demand, many practices have begun incorporating physician extenders, a term that encompasses physicians not board certified in dermatology, physician assistants, and nurse practitioners.⁷ The evolving landscape of the dermatologic workforce raises questions about future practice models and patient outcomes.

Scope of Practice for Physician Extenders

In practice, the role of physician extenders is highly variable. Legislation involving the scope of practice for physician extenders constantly is changing and varies by state. As of November 2021, 24 states and the District of Columbia permit nurse practitioners “full practice” authority to triage patients, interpret diagnostic tests, and prescribe treatments without physician oversight, including controlled substances.^8,9 Even in states with “reduced practice” and “restricted practice” paradigms, which necessitate physician oversight, there remains ambiguity. Across the country, state regulatory bodies differ in statues governing licensing requirements, accessibility of the supervising physician, and ultimately culpability in the case of patient harm. Lack of consensus guidelines that clearly define roles and responsibilities has kindled controversy regarding extent of autonomy and liability for adverse outcomes.^10,11

With respect to procedures, the AAD has explicitly recommended that “only active and properly licensed doctors of medicine and osteopathy shall engage in the practice of medicine” but that “under appropriate circumstances, a physician may delegate certain procedures and services to appropriately trained nonphysician office personnel.”¹² This statement does not refer to or explicitly list the procedures that are appropriate for delegation to nonphysician personnel, and there is wide variability in how this recommendation is applied in daily practice. As it was originally intended, the AAD’s “Ethics in Medical Practice” position statement indicated that dermatologists must directly oversee physician extenders, a responsibility that is defined as being “present on-site, immediately available and able to respond promptly” to issues arising during the provision of health care services.¹²

Adverse Events From Cosmetic Procedures

The American Society for Dermatologic Surgery has documented a steady growth in the demand for cosmetic, medical, and surgical services,¹³ a trend that has heralded an increase in the number of procedures performed by physician extenders.^14,15 One study contrasted the risk for adverse events following minimally invasive cosmetic procedures performed by physicians or nonphysicians. Of 2116 patients surveyed, 50 adverse events were documented.¹⁴ The cohort treated by nonphysicians experienced a higher incidence of laser burns and dyspigmentation, and the use of improper technique was the most frequently implicated cause of developing an adverse event. Approximately 24.6% of American Society for Dermatologic Surgery members reported treating 10 or more complications of cosmetic procedures performed by nonphysicians.¹⁴ Beyond laser burns and dyspigmentation, this wide range of complications included inappropriately placed filler product, facial drooping, and scarring. These studies highlight the need for further investigation into the outcomes of procedures performed by physician extenders.

Training of Physician Extenders

Even with medical management, emphasis on proper training of personnel is key and remains a legitimate concern. The training of physician extenders in dermatology differs greatly by location; while some physician extenders operate under meticulous guidance and thus can expand their skill set, other physician extenders shadow dermatologists for an arbitrary amount of time before being thrust into practice.¹⁰ It would be a disservice to both patients and nonphysician providers alike to conflate the latter regimen with the 4 years of medical school, 1 year of internship, and 3 years of rigorous specialized dermatologic training that physicians undergo.

This stark discrepancy between the training of physicians and physician extenders raises difficult questions about the patient’s right to make an informed decision regarding how they receive health care. Indeed, the casually regulated autonomous practice of some nonphysician providers has ignited public shock and ire.¹¹

Reducing Health Care Expenditures

As legislatures deliberate over expanding scope of practice, policies should be based on evidence that prioritizes patient safety. In the appropriate setting, physician extenders can be instrumental to mitigating health care disparities; the use of physician extenders can diminish wait times for patients with routine visits for stable dermatologic disease.¹⁶ Moreover, reducing health care expenditures often is cited as a major benefit of increased utilization of physician extenders.¹⁴ It stands to reason that compensation of nonphysician providers is less expensive for a practice compared with physicians. Physician extenders participating in the management of stable chronic conditions or mild acute conditions may be cost-efficient in these circumstances; however, evidence suggests that physician extenders may incur greater costs than physicians with respect to the utilization of diagnostic tests or prescribing medications. For example, several studies have documented a substantial difference in the number of biopsies needed per malignant neoplasm by physicians compared to physician extenders.^17-19 Particularly in patients younger than 65 years and in patients without history of skin cancer, physician extenders had to perform a greater number of biopsies to diagnose malignant neoplasms vs physicians.¹⁸ In addition to increased utilization of diagnostic tests, nonphysician providers more frequently prescribe medications of varying classes.^20-22 Whether in outpatient offices, emergency departments, or hospital clinics, physician extenders more frequently prescribe antibiotics, which has concerning implications for antibiotic stewardship.^20,21 In states with independent prescription authority, physician extenders are more than 20 times more likely to overprescribeopioids compared to physician extenders in states requiring physician supervision.²³ These findings warrant additional investigation into how prescription patterns vary by provider type and how these differences impact patient outcomes.

Final Thoughts

Improving patient care is inherently a team endeavor, and the contributions of all members of the health care team are critical to success. Engaging physician extenders may help mitigate disparities in dermatologic care, with respect to surveillance of stable chronic conditions or the diagnosis of mild acute diseases. However, the exact scope of practice of physician extenders remains ambiguous, and their training regimens can vary drastically. Therefore, in the interest of patient safety, new patients or medically complex patients (ie, cutaneous lymphomas, nonstable autoimmune connective tissue disease) should be examined and managed by physicians. In either scenario, the patient should be informed of which providers are available and should be integrated into the decision-making process for their care. Through mutual respect, close collaboration, and candid assessments of patient complexity, different parties within the medical team can unite behind the mission to improve patient outcomes and champion equitable access to health care.

As of 2018, the mean dermatologist to population ratio in the United States was 1.10 per 100,000 people, highlighting a shortage of dermatologists that is only predicted to increase in coming years.^1-4 This undersupply is fueled by both an increasing burden of dermatologic disease and population growth.⁴ Without readily available access to dermatologic care, many patients are left waiting for weeks to see a dermatologist, depending on geographic region.^5-7 It is not simply patients who perceive wait times to be prolonged; approximately half of dermatologists surveyed by the American Academy of Dermatology (AAD) reported an undersupply of dermatologists in their communities, a finding that strongly correlated with patient wait times.² Ensuring the dermatologic workforce is sufficient to fulfill patient needs requires innovation of current practice models. To address this unmet demand, many practices have begun incorporating physician extenders, a term that encompasses physicians not board certified in dermatology, physician assistants, and nurse practitioners.⁷ The evolving landscape of the dermatologic workforce raises questions about future practice models and patient outcomes.

Scope of Practice for Physician Extenders

In practice, the role of physician extenders is highly variable. Legislation involving the scope of practice for physician extenders constantly is changing and varies by state. As of November 2021, 24 states and the District of Columbia permit nurse practitioners “full practice” authority to triage patients, interpret diagnostic tests, and prescribe treatments without physician oversight, including controlled substances.^8,9 Even in states with “reduced practice” and “restricted practice” paradigms, which necessitate physician oversight, there remains ambiguity. Across the country, state regulatory bodies differ in statues governing licensing requirements, accessibility of the supervising physician, and ultimately culpability in the case of patient harm. Lack of consensus guidelines that clearly define roles and responsibilities has kindled controversy regarding extent of autonomy and liability for adverse outcomes.^10,11

With respect to procedures, the AAD has explicitly recommended that “only active and properly licensed doctors of medicine and osteopathy shall engage in the practice of medicine” but that “under appropriate circumstances, a physician may delegate certain procedures and services to appropriately trained nonphysician office personnel.”¹² This statement does not refer to or explicitly list the procedures that are appropriate for delegation to nonphysician personnel, and there is wide variability in how this recommendation is applied in daily practice. As it was originally intended, the AAD’s “Ethics in Medical Practice” position statement indicated that dermatologists must directly oversee physician extenders, a responsibility that is defined as being “present on-site, immediately available and able to respond promptly” to issues arising during the provision of health care services.¹²

Adverse Events From Cosmetic Procedures

The American Society for Dermatologic Surgery has documented a steady growth in the demand for cosmetic, medical, and surgical services,¹³ a trend that has heralded an increase in the number of procedures performed by physician extenders.^14,15 One study contrasted the risk for adverse events following minimally invasive cosmetic procedures performed by physicians or nonphysicians. Of 2116 patients surveyed, 50 adverse events were documented.¹⁴ The cohort treated by nonphysicians experienced a higher incidence of laser burns and dyspigmentation, and the use of improper technique was the most frequently implicated cause of developing an adverse event. Approximately 24.6% of American Society for Dermatologic Surgery members reported treating 10 or more complications of cosmetic procedures performed by nonphysicians.¹⁴ Beyond laser burns and dyspigmentation, this wide range of complications included inappropriately placed filler product, facial drooping, and scarring. These studies highlight the need for further investigation into the outcomes of procedures performed by physician extenders.

Training of Physician Extenders

Even with medical management, emphasis on proper training of personnel is key and remains a legitimate concern. The training of physician extenders in dermatology differs greatly by location; while some physician extenders operate under meticulous guidance and thus can expand their skill set, other physician extenders shadow dermatologists for an arbitrary amount of time before being thrust into practice.¹⁰ It would be a disservice to both patients and nonphysician providers alike to conflate the latter regimen with the 4 years of medical school, 1 year of internship, and 3 years of rigorous specialized dermatologic training that physicians undergo.

This stark discrepancy between the training of physicians and physician extenders raises difficult questions about the patient’s right to make an informed decision regarding how they receive health care. Indeed, the casually regulated autonomous practice of some nonphysician providers has ignited public shock and ire.¹¹

Reducing Health Care Expenditures

As legislatures deliberate over expanding scope of practice, policies should be based on evidence that prioritizes patient safety. In the appropriate setting, physician extenders can be instrumental to mitigating health care disparities; the use of physician extenders can diminish wait times for patients with routine visits for stable dermatologic disease.¹⁶ Moreover, reducing health care expenditures often is cited as a major benefit of increased utilization of physician extenders.¹⁴ It stands to reason that compensation of nonphysician providers is less expensive for a practice compared with physicians. Physician extenders participating in the management of stable chronic conditions or mild acute conditions may be cost-efficient in these circumstances; however, evidence suggests that physician extenders may incur greater costs than physicians with respect to the utilization of diagnostic tests or prescribing medications. For example, several studies have documented a substantial difference in the number of biopsies needed per malignant neoplasm by physicians compared to physician extenders.^17-19 Particularly in patients younger than 65 years and in patients without history of skin cancer, physician extenders had to perform a greater number of biopsies to diagnose malignant neoplasms vs physicians.¹⁸ In addition to increased utilization of diagnostic tests, nonphysician providers more frequently prescribe medications of varying classes.^20-22 Whether in outpatient offices, emergency departments, or hospital clinics, physician extenders more frequently prescribe antibiotics, which has concerning implications for antibiotic stewardship.^20,21 In states with independent prescription authority, physician extenders are more than 20 times more likely to overprescribeopioids compared to physician extenders in states requiring physician supervision.²³ These findings warrant additional investigation into how prescription patterns vary by provider type and how these differences impact patient outcomes.

Final Thoughts

Improving patient care is inherently a team endeavor, and the contributions of all members of the health care team are critical to success. Engaging physician extenders may help mitigate disparities in dermatologic care, with respect to surveillance of stable chronic conditions or the diagnosis of mild acute diseases. However, the exact scope of practice of physician extenders remains ambiguous, and their training regimens can vary drastically. Therefore, in the interest of patient safety, new patients or medically complex patients (ie, cutaneous lymphomas, nonstable autoimmune connective tissue disease) should be examined and managed by physicians. In either scenario, the patient should be informed of which providers are available and should be integrated into the decision-making process for their care. Through mutual respect, close collaboration, and candid assessments of patient complexity, different parties within the medical team can unite behind the mission to improve patient outcomes and champion equitable access to health care.

Federal officials will allow some flexibility in meeting new requirements on covering the costs of clinical trials for people enrolled in Medicaid, seeking to accommodate states where legislatures will not meet in time to make needed changes in rules.

Congress in 2020 ordered U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology (ASCO) and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.

The mandate went into effect on Jan. 1, but the Centers for Medicare & Medicaid Services will allow accommodations in terms of implementation time for states that have not yet been able to make needed legislative changes, Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services, wrote in a Dec. 7 letter. Mr. Tsai’s letter doesn’t mention specific states. The CMS did not immediately respond to a request seeking information on the states expected to apply for waivers.

Medicaid has in recent years been a rare large U.S. insurance program that does not cover the costs of clinical trials. The Affordable Care Act of 2010 mandated this coverage for people in private insurance plans. The federal government in 2000 decided that Medicare would do so.

‘A hidden opportunity’

A perspective article last May in the New England Journal of Medicine referred to the new Medicaid mandate on clinical trials as a “hidden opportunity,” referring to its genesis as an add-on in a massive federal spending package enacted in December 2020.

In the article, Samuel U. Takvorian, MD, MSHP, of the University of Pennsylvania, Philadelphia, and coauthors noted that rates of participation in clinical trials remain low for racial and ethnic minority groups, due in part to the lack of Medicaid coverage.

“For example, non-Hispanic White patients are nearly twice as likely as Black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials – a gap that has widened over time,” Dr. Takvorian and coauthors wrote. “Inequities in enrollment have also manifested during the COVID-19 pandemic, which has disproportionately affected non-White patients, without their commensurate representation in trials of COVID-19 therapeutics.”

In October, researchers from the Arthur G. James Cancer Hospital and Ohio State University, Columbus, published results of a retrospective study of patients with stage I-IV pancreatic cancer that also found inequities in enrollment. Mariam F. Eskander, MD, MPH, and coauthors reported what they found by examining records for 1,127 patients (0.4%) enrolled in clinical trials and 301,340 (99.6%) who did not enroll. They found that enrollment in trials increased over the study period, but not for Black patients or patients on Medicaid.

In an interview, Dr. Eskander said the new Medicaid policy will remove a major obstacle to participation in clinical trials. An oncologist, Dr. Eskander said she is looking forward to being able to help more of her patients get access to experimental medicines and treatments.

But that may not be enough to draw more people with low incomes into these studies, said Dr. Eskander, who is now at Rutgers Cancer Institute of New Jersey in New Brunswick. She urges greater use of patient navigators to help people on Medicaid understand the resources available to them, as well as broad use of Medicaid’s nonemergency medical transportation (NEMT) benefit.

“Some patients will be offered clinical trial enrollment and some will accept, but I really worry about the challenges low-income people face with things like transportation and getting time off work,” she said.

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

Federal officials will allow some flexibility in meeting new requirements on covering the costs of clinical trials for people enrolled in Medicaid, seeking to accommodate states where legislatures will not meet in time to make needed changes in rules.

Congress in 2020 ordered U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology (ASCO) and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.

The mandate went into effect on Jan. 1, but the Centers for Medicare & Medicaid Services will allow accommodations in terms of implementation time for states that have not yet been able to make needed legislative changes, Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services, wrote in a Dec. 7 letter. Mr. Tsai’s letter doesn’t mention specific states. The CMS did not immediately respond to a request seeking information on the states expected to apply for waivers.

Medicaid has in recent years been a rare large U.S. insurance program that does not cover the costs of clinical trials. The Affordable Care Act of 2010 mandated this coverage for people in private insurance plans. The federal government in 2000 decided that Medicare would do so.

‘A hidden opportunity’

A perspective article last May in the New England Journal of Medicine referred to the new Medicaid mandate on clinical trials as a “hidden opportunity,” referring to its genesis as an add-on in a massive federal spending package enacted in December 2020.

In the article, Samuel U. Takvorian, MD, MSHP, of the University of Pennsylvania, Philadelphia, and coauthors noted that rates of participation in clinical trials remain low for racial and ethnic minority groups, due in part to the lack of Medicaid coverage.

“For example, non-Hispanic White patients are nearly twice as likely as Black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials – a gap that has widened over time,” Dr. Takvorian and coauthors wrote. “Inequities in enrollment have also manifested during the COVID-19 pandemic, which has disproportionately affected non-White patients, without their commensurate representation in trials of COVID-19 therapeutics.”

In October, researchers from the Arthur G. James Cancer Hospital and Ohio State University, Columbus, published results of a retrospective study of patients with stage I-IV pancreatic cancer that also found inequities in enrollment. Mariam F. Eskander, MD, MPH, and coauthors reported what they found by examining records for 1,127 patients (0.4%) enrolled in clinical trials and 301,340 (99.6%) who did not enroll. They found that enrollment in trials increased over the study period, but not for Black patients or patients on Medicaid.

In an interview, Dr. Eskander said the new Medicaid policy will remove a major obstacle to participation in clinical trials. An oncologist, Dr. Eskander said she is looking forward to being able to help more of her patients get access to experimental medicines and treatments.

But that may not be enough to draw more people with low incomes into these studies, said Dr. Eskander, who is now at Rutgers Cancer Institute of New Jersey in New Brunswick. She urges greater use of patient navigators to help people on Medicaid understand the resources available to them, as well as broad use of Medicaid’s nonemergency medical transportation (NEMT) benefit.

“Some patients will be offered clinical trial enrollment and some will accept, but I really worry about the challenges low-income people face with things like transportation and getting time off work,” she said.

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

Federal officials will allow some flexibility in meeting new requirements on covering the costs of clinical trials for people enrolled in Medicaid, seeking to accommodate states where legislatures will not meet in time to make needed changes in rules.

Congress in 2020 ordered U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology (ASCO) and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.

The mandate went into effect on Jan. 1, but the Centers for Medicare & Medicaid Services will allow accommodations in terms of implementation time for states that have not yet been able to make needed legislative changes, Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services, wrote in a Dec. 7 letter. Mr. Tsai’s letter doesn’t mention specific states. The CMS did not immediately respond to a request seeking information on the states expected to apply for waivers.

Medicaid has in recent years been a rare large U.S. insurance program that does not cover the costs of clinical trials. The Affordable Care Act of 2010 mandated this coverage for people in private insurance plans. The federal government in 2000 decided that Medicare would do so.

‘A hidden opportunity’

A perspective article last May in the New England Journal of Medicine referred to the new Medicaid mandate on clinical trials as a “hidden opportunity,” referring to its genesis as an add-on in a massive federal spending package enacted in December 2020.

In the article, Samuel U. Takvorian, MD, MSHP, of the University of Pennsylvania, Philadelphia, and coauthors noted that rates of participation in clinical trials remain low for racial and ethnic minority groups, due in part to the lack of Medicaid coverage.

“For example, non-Hispanic White patients are nearly twice as likely as Black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials – a gap that has widened over time,” Dr. Takvorian and coauthors wrote. “Inequities in enrollment have also manifested during the COVID-19 pandemic, which has disproportionately affected non-White patients, without their commensurate representation in trials of COVID-19 therapeutics.”

In October, researchers from the Arthur G. James Cancer Hospital and Ohio State University, Columbus, published results of a retrospective study of patients with stage I-IV pancreatic cancer that also found inequities in enrollment. Mariam F. Eskander, MD, MPH, and coauthors reported what they found by examining records for 1,127 patients (0.4%) enrolled in clinical trials and 301,340 (99.6%) who did not enroll. They found that enrollment in trials increased over the study period, but not for Black patients or patients on Medicaid.

In an interview, Dr. Eskander said the new Medicaid policy will remove a major obstacle to participation in clinical trials. An oncologist, Dr. Eskander said she is looking forward to being able to help more of her patients get access to experimental medicines and treatments.

But that may not be enough to draw more people with low incomes into these studies, said Dr. Eskander, who is now at Rutgers Cancer Institute of New Jersey in New Brunswick. She urges greater use of patient navigators to help people on Medicaid understand the resources available to them, as well as broad use of Medicaid’s nonemergency medical transportation (NEMT) benefit.

“Some patients will be offered clinical trial enrollment and some will accept, but I really worry about the challenges low-income people face with things like transportation and getting time off work,” she said.

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

Dear colleagues and friends,

After an excellent debate on the future of telemedicine in GI in our most recent Perspectives column, we continue to explore changes in the way we traditionally provide care. In this issue, we discuss the GI hospitalist service, a relatively new but growing model of providing inpatient care. Is this the new ideal, allowing for more efficient care? Or are traditional or alternative models more appropriate? As with most things, the answer often lies somewhere in the middle, driven by local needs and infrastructure. Dr. Tau and Dr. Mehendiratta explore the pros and cons of these different approaches to providing inpatient GI care. I look forward to hearing your thoughts and experiences on the AGA Community forum and by email ([email protected]).

Gyanprakash A. Ketwaroo, MD, MSc, is an assistant professor of medicine at Baylor College of Medicine, Houston. He is an associate editor for GI & Hepatology News.

The dedicated GI hospitalist: Taking ownership not ‘call’

By J. Andy Tau, MD

In my experience, a GI hospitalist provides mutual benefit to patients, employers, and consulting physicians. The patient benefits from more expedient consultations and expert endoscopic therapy, which translates to shorter hospitalizations and improved outcomes. The employer enjoys financial benefits as busy outpatient providers can stay busy without interruption. Consulting physicians enjoy having to only call a single phone number for trusted help from a familiar physician who does not rotate off service. Personally, the position provides the volume to develop valuable therapeutic endoscopy skills and techniques. With one stable physician at the helm, a sense of ownership can develop, rather than a sense of survival until “call” is over.

As a full-time GI hospitalist for a large single-specialty group, I provide inpatient GI and hepatology consultation from 7 a.m. to 5 p.m., Monday-Friday. I do not rotate off service. I cover three hospitals with a total of 1,000 beds with two advanced practice providers and one part-time physician. Except for endoscopic ultrasound, I perform all other endoscopic procedures. The census is usually 25-35 with an average of 10-15 new consults per day.

The most important benefit of a dedicated GI hospitalist is providing expedited consultation and expert endoscopy for patients. I can offer emergent (<6 hour) endoscopy for any patient. An esophageal food impaction is usually resolved within an hour of arrival to the ED during the day. I can help a surgeon intraoperatively on very short notice. As for acute GI bleeding cases, I oversee resuscitative efforts, while the endoscopy team prepares my preferred endoscopic equipment, eliminating surprises and delays before endoscopy. I have developed an expertise in hemostasis and managing esophageal perforations, along with a risk tolerance that cannot be matured in any setting other than daily emergency.

I have enacted evidence-based protocols for GI bleeding, iron-deficiency anemia, colonic pseudo-obstruction, pancreatitis, and liver decompensation, which internists have adopted over time, reducing phone calls and delays in prep or resuscitation.

While the day is unstructured and filled with interruptions, it is also very flexible. As opposed to the set time intervals of an outpatient clinic visit, I can spend an hour in a palliative care meeting or revisit high-risk patients multiple times a day to detect pending deterioration. Combined endoscopic and surgical cases are logistically easy to schedule given my flexibility. For example, patients with choledocholithiasis often can have a combined cholecystectomy and supine endoscopic retrograde cholangiopancreatography (ERCP) in the OR, shaving a day off admission.

My employer benefits financially as the outpatient doctors can stay busy without interruption from the hospital. With secure group messaging, we are able to make joint decisions and arrange close follow up. The relative value units earned from the hospital are high. Combined with proceeds from the professional service agreement with the hospital, they are more than enough to cover my compensation.

Any physician in need of a GI consult needs only to call one number for help. I make it as easy as possible to obtain a consult and never push back, as banal as any consult may seem. I stake my reputation on providing a service that is able, affable, and available. By teaching a consistent message to consulting physicians, I have now effected best evidence-based practices for GI conditions even without engaging me. The most notable examples include antibiotics for variceal bleeding, fluid resuscitation and early feeding for acute pancreatitis, risk stratification for choledocholithiasis, and last but not least, abandoning the inpatient fecal occult blood test.

I am on a first-name basis with every nurse in the hospital now. In exchange for my availability and cell phone number, they place orders for me and protect me from avoidable nuisances.

Many physician groups cover the inpatient service by rotating a week at a time. There can be at times a reluctance to take ownership over a difficult patient and instead a sense of “survival of the call”. However, in my job, “the buck stops with me” even if it is in the form of readmission. For example, I have to take some ownership of indigent patients who cannot easily follow up. Who will remove the stent I placed? How will they pay for Helicobacter pylori eradication or biologic therapy? Another example is diverticular bleeding. While 80% stop on their own, I take extraordinary efforts to endoscopically find and halt the bleeding in order to reduce the recurrence rate. I must find durable solutions because these high-risk patients are my responsibility again when they bounce back to me via the ED.

By way of volume alone, this position has allowed me to develop many therapeutic skills outside of a standard 3-year GI fellowship. While I did only 200 ERCPs in fellowship, I have become proficient in ERCP with around 400 cases per year (mostly native papilla) and have grown comfortable with the needle knife. I have learned endoscopic suturing, luminal stenting, and endoscopic vacuum-assisted therapy for perforation closure independently. Out of necessity, I developed a novel technique in optimizing the use of hemostatic powder by using a bone-wax plug. As endoscopy chief, I can purchase a wide variety of endoscopy equipment, compare brands, and understand the nuances of each.

In conclusion, the dedicated GI hospitalist indirectly improves the efficiency of an outpatient practice, while directly improving inpatient outcomes, collegiality, and even one’s own skills as an endoscopist. While it can be challenging and hectic, with the right mentality towards ownership of the service, it is also an incredibly rewarding position.

Dr. Tau practices with Austin Gastroenterology in Austin, Tex. He disclosed relationships with Cook Medical and Conmed.

Inpatient-only GI hospitalist: Not so fast

By Vaibhav Mehendiratta, MD

Over the past 2 decades, the medical hospitalist system has assumed care of hospitalized patients with the promise of reduced length of stay (LOS) and improved outcomes. Although data on LOS is promising, there have been conflicting results in terms of total medical costs and resource utilization. Inpatient care for patients with complex medical histories often requires regular communication with other subspecialties and outpatient providers to achieve better patient-centered outcomes.

Courtesy Connecticut GI, PC

Providing inpatient gastrointestinal care is complicated. Traditional models rely on physicians trying to balance outpatient obligations with inpatient rounding and procedures, which can result in delayed endoscopy and an inability to participate fully in multidisciplinary rounds and family meetings. The complexity of hospitalized patients often requires a multidisciplinary approach with coordination of care that is hard to accomplish in between seeing outpatients. GI groups, both private practice and academics, need to adopt a strategy for inpatient care that is tailored to the hospital system in which they operate.

As one of the largest private practice groups in New England, our experience can provide a framework for others to follow. We provide inpatient GI care at eight hospitals across northern Connecticut. Our inpatient service at the largest tertiary care hospital is composed of one general gastroenterologist, one advanced endoscopist, one transplant hepatologist, two advanced practitioners, and two fellows in training. Each practitioner provides coverage on a rotating basis, typically 1 week at a time every 4-8 weeks. This model also offers flexibility, such that we can typically accommodate urgent outpatient endoscopy for patients who may otherwise require inpatient care. Coverage at the other seven hospitals is tailored to local needs and ranges from half-day to whole-day coverage by general gastroenterologists and advanced practitioners. We believe that our model is financially viable and, based on our experience, inpatient relative value units generated are quite similar to a typical day in outpatient GI practice.

Inpatient GI care accounts for a substantial portion of overall inpatient care in the United States. Endoscopy delays have been the focus of many research articles looking at inpatient GI care. The delays are caused by many factors, including endoscopy unit/staff availability, anesthesia availability, and patient factors. While having a dedicated inpatient GI Hospitalist offers the potential to streamline access for hospital consultations and endoscopy, an exclusive inpatient GI hospitalist may be less familiar with a patient’s chronic GI illness and have different (and perhaps, conflicting) priorities regarding a patient’s care. Having incomplete access to outpatient records or less familiarity with the intricacies of outpatient care could also lead to duplication of work and increase the number of inpatient procedures that may have otherwise been deferred to the outpatient setting.

Additionally, with physician burnout on the rise and particularly in the inpatient setting, one must question the sustainability of an exclusively inpatient GI practice. That is, the hours and demands of inpatient care typically do not allow the quality of life that outpatient care provides. Our model provides time for dedicated inpatient care, while allowing each practitioner ample opportunity to build a robust outpatient practice.

Some health care organizations are adopting an extensivist model to provide comprehensive care to patients with multiple medical problems. Extensivists are outpatient primary care providers who take the time to coordinate with inpatient hospitalists to provide comprehensive care to their patients. Constant contact with outpatient providers during admission is expected to improve patient satisfaction, reduce hospital readmissions, and decrease inpatient resource utilization.

In conclusion, our experience highlights sustained benefits, and distinct advantages, of providing inpatient GI care without a GI hospitalist model. The pendulum in inpatient care keeps swinging and with progress arise new challenges and questions. Close collaboration between gastroenterologists and health systems to develop a program that fits local needs and allows optimal resource allocation will ensure delivery of high-quality inpatient GI care.

Dr. Mehendiratta is a gastroenterologist with Connecticut GI PC, Hartford, and assistant clinical professor in the department of medicine at the University of Connecticut, Farmington. He has no relevant conflicts of interest to disclose.

Dear colleagues and friends,

After an excellent debate on the future of telemedicine in GI in our most recent Perspectives column, we continue to explore changes in the way we traditionally provide care. In this issue, we discuss the GI hospitalist service, a relatively new but growing model of providing inpatient care. Is this the new ideal, allowing for more efficient care? Or are traditional or alternative models more appropriate? As with most things, the answer often lies somewhere in the middle, driven by local needs and infrastructure. Dr. Tau and Dr. Mehendiratta explore the pros and cons of these different approaches to providing inpatient GI care. I look forward to hearing your thoughts and experiences on the AGA Community forum and by email ([email protected]).

Gyanprakash A. Ketwaroo, MD, MSc, is an assistant professor of medicine at Baylor College of Medicine, Houston. He is an associate editor for GI & Hepatology News.

The dedicated GI hospitalist: Taking ownership not ‘call’

By J. Andy Tau, MD

In my experience, a GI hospitalist provides mutual benefit to patients, employers, and consulting physicians. The patient benefits from more expedient consultations and expert endoscopic therapy, which translates to shorter hospitalizations and improved outcomes. The employer enjoys financial benefits as busy outpatient providers can stay busy without interruption. Consulting physicians enjoy having to only call a single phone number for trusted help from a familiar physician who does not rotate off service. Personally, the position provides the volume to develop valuable therapeutic endoscopy skills and techniques. With one stable physician at the helm, a sense of ownership can develop, rather than a sense of survival until “call” is over.

As a full-time GI hospitalist for a large single-specialty group, I provide inpatient GI and hepatology consultation from 7 a.m. to 5 p.m., Monday-Friday. I do not rotate off service. I cover three hospitals with a total of 1,000 beds with two advanced practice providers and one part-time physician. Except for endoscopic ultrasound, I perform all other endoscopic procedures. The census is usually 25-35 with an average of 10-15 new consults per day.

The most important benefit of a dedicated GI hospitalist is providing expedited consultation and expert endoscopy for patients. I can offer emergent (<6 hour) endoscopy for any patient. An esophageal food impaction is usually resolved within an hour of arrival to the ED during the day. I can help a surgeon intraoperatively on very short notice. As for acute GI bleeding cases, I oversee resuscitative efforts, while the endoscopy team prepares my preferred endoscopic equipment, eliminating surprises and delays before endoscopy. I have developed an expertise in hemostasis and managing esophageal perforations, along with a risk tolerance that cannot be matured in any setting other than daily emergency.

I have enacted evidence-based protocols for GI bleeding, iron-deficiency anemia, colonic pseudo-obstruction, pancreatitis, and liver decompensation, which internists have adopted over time, reducing phone calls and delays in prep or resuscitation.

While the day is unstructured and filled with interruptions, it is also very flexible. As opposed to the set time intervals of an outpatient clinic visit, I can spend an hour in a palliative care meeting or revisit high-risk patients multiple times a day to detect pending deterioration. Combined endoscopic and surgical cases are logistically easy to schedule given my flexibility. For example, patients with choledocholithiasis often can have a combined cholecystectomy and supine endoscopic retrograde cholangiopancreatography (ERCP) in the OR, shaving a day off admission.

My employer benefits financially as the outpatient doctors can stay busy without interruption from the hospital. With secure group messaging, we are able to make joint decisions and arrange close follow up. The relative value units earned from the hospital are high. Combined with proceeds from the professional service agreement with the hospital, they are more than enough to cover my compensation.

Any physician in need of a GI consult needs only to call one number for help. I make it as easy as possible to obtain a consult and never push back, as banal as any consult may seem. I stake my reputation on providing a service that is able, affable, and available. By teaching a consistent message to consulting physicians, I have now effected best evidence-based practices for GI conditions even without engaging me. The most notable examples include antibiotics for variceal bleeding, fluid resuscitation and early feeding for acute pancreatitis, risk stratification for choledocholithiasis, and last but not least, abandoning the inpatient fecal occult blood test.

I am on a first-name basis with every nurse in the hospital now. In exchange for my availability and cell phone number, they place orders for me and protect me from avoidable nuisances.

Many physician groups cover the inpatient service by rotating a week at a time. There can be at times a reluctance to take ownership over a difficult patient and instead a sense of “survival of the call”. However, in my job, “the buck stops with me” even if it is in the form of readmission. For example, I have to take some ownership of indigent patients who cannot easily follow up. Who will remove the stent I placed? How will they pay for Helicobacter pylori eradication or biologic therapy? Another example is diverticular bleeding. While 80% stop on their own, I take extraordinary efforts to endoscopically find and halt the bleeding in order to reduce the recurrence rate. I must find durable solutions because these high-risk patients are my responsibility again when they bounce back to me via the ED.

By way of volume alone, this position has allowed me to develop many therapeutic skills outside of a standard 3-year GI fellowship. While I did only 200 ERCPs in fellowship, I have become proficient in ERCP with around 400 cases per year (mostly native papilla) and have grown comfortable with the needle knife. I have learned endoscopic suturing, luminal stenting, and endoscopic vacuum-assisted therapy for perforation closure independently. Out of necessity, I developed a novel technique in optimizing the use of hemostatic powder by using a bone-wax plug. As endoscopy chief, I can purchase a wide variety of endoscopy equipment, compare brands, and understand the nuances of each.

In conclusion, the dedicated GI hospitalist indirectly improves the efficiency of an outpatient practice, while directly improving inpatient outcomes, collegiality, and even one’s own skills as an endoscopist. While it can be challenging and hectic, with the right mentality towards ownership of the service, it is also an incredibly rewarding position.

Dr. Tau practices with Austin Gastroenterology in Austin, Tex. He disclosed relationships with Cook Medical and Conmed.

Inpatient-only GI hospitalist: Not so fast

By Vaibhav Mehendiratta, MD

Over the past 2 decades, the medical hospitalist system has assumed care of hospitalized patients with the promise of reduced length of stay (LOS) and improved outcomes. Although data on LOS is promising, there have been conflicting results in terms of total medical costs and resource utilization. Inpatient care for patients with complex medical histories often requires regular communication with other subspecialties and outpatient providers to achieve better patient-centered outcomes.

Courtesy Connecticut GI, PC

Providing inpatient gastrointestinal care is complicated. Traditional models rely on physicians trying to balance outpatient obligations with inpatient rounding and procedures, which can result in delayed endoscopy and an inability to participate fully in multidisciplinary rounds and family meetings. The complexity of hospitalized patients often requires a multidisciplinary approach with coordination of care that is hard to accomplish in between seeing outpatients. GI groups, both private practice and academics, need to adopt a strategy for inpatient care that is tailored to the hospital system in which they operate.

As one of the largest private practice groups in New England, our experience can provide a framework for others to follow. We provide inpatient GI care at eight hospitals across northern Connecticut. Our inpatient service at the largest tertiary care hospital is composed of one general gastroenterologist, one advanced endoscopist, one transplant hepatologist, two advanced practitioners, and two fellows in training. Each practitioner provides coverage on a rotating basis, typically 1 week at a time every 4-8 weeks. This model also offers flexibility, such that we can typically accommodate urgent outpatient endoscopy for patients who may otherwise require inpatient care. Coverage at the other seven hospitals is tailored to local needs and ranges from half-day to whole-day coverage by general gastroenterologists and advanced practitioners. We believe that our model is financially viable and, based on our experience, inpatient relative value units generated are quite similar to a typical day in outpatient GI practice.

Inpatient GI care accounts for a substantial portion of overall inpatient care in the United States. Endoscopy delays have been the focus of many research articles looking at inpatient GI care. The delays are caused by many factors, including endoscopy unit/staff availability, anesthesia availability, and patient factors. While having a dedicated inpatient GI Hospitalist offers the potential to streamline access for hospital consultations and endoscopy, an exclusive inpatient GI hospitalist may be less familiar with a patient’s chronic GI illness and have different (and perhaps, conflicting) priorities regarding a patient’s care. Having incomplete access to outpatient records or less familiarity with the intricacies of outpatient care could also lead to duplication of work and increase the number of inpatient procedures that may have otherwise been deferred to the outpatient setting.

Additionally, with physician burnout on the rise and particularly in the inpatient setting, one must question the sustainability of an exclusively inpatient GI practice. That is, the hours and demands of inpatient care typically do not allow the quality of life that outpatient care provides. Our model provides time for dedicated inpatient care, while allowing each practitioner ample opportunity to build a robust outpatient practice.

Some health care organizations are adopting an extensivist model to provide comprehensive care to patients with multiple medical problems. Extensivists are outpatient primary care providers who take the time to coordinate with inpatient hospitalists to provide comprehensive care to their patients. Constant contact with outpatient providers during admission is expected to improve patient satisfaction, reduce hospital readmissions, and decrease inpatient resource utilization.

In conclusion, our experience highlights sustained benefits, and distinct advantages, of providing inpatient GI care without a GI hospitalist model. The pendulum in inpatient care keeps swinging and with progress arise new challenges and questions. Close collaboration between gastroenterologists and health systems to develop a program that fits local needs and allows optimal resource allocation will ensure delivery of high-quality inpatient GI care.

Dr. Mehendiratta is a gastroenterologist with Connecticut GI PC, Hartford, and assistant clinical professor in the department of medicine at the University of Connecticut, Farmington. He has no relevant conflicts of interest to disclose.

Dear colleagues and friends,

After an excellent debate on the future of telemedicine in GI in our most recent Perspectives column, we continue to explore changes in the way we traditionally provide care. In this issue, we discuss the GI hospitalist service, a relatively new but growing model of providing inpatient care. Is this the new ideal, allowing for more efficient care? Or are traditional or alternative models more appropriate? As with most things, the answer often lies somewhere in the middle, driven by local needs and infrastructure. Dr. Tau and Dr. Mehendiratta explore the pros and cons of these different approaches to providing inpatient GI care. I look forward to hearing your thoughts and experiences on the AGA Community forum and by email ([email protected]).

Gyanprakash A. Ketwaroo, MD, MSc, is an assistant professor of medicine at Baylor College of Medicine, Houston. He is an associate editor for GI & Hepatology News.

The dedicated GI hospitalist: Taking ownership not ‘call’

By J. Andy Tau, MD

In my experience, a GI hospitalist provides mutual benefit to patients, employers, and consulting physicians. The patient benefits from more expedient consultations and expert endoscopic therapy, which translates to shorter hospitalizations and improved outcomes. The employer enjoys financial benefits as busy outpatient providers can stay busy without interruption. Consulting physicians enjoy having to only call a single phone number for trusted help from a familiar physician who does not rotate off service. Personally, the position provides the volume to develop valuable therapeutic endoscopy skills and techniques. With one stable physician at the helm, a sense of ownership can develop, rather than a sense of survival until “call” is over.

As a full-time GI hospitalist for a large single-specialty group, I provide inpatient GI and hepatology consultation from 7 a.m. to 5 p.m., Monday-Friday. I do not rotate off service. I cover three hospitals with a total of 1,000 beds with two advanced practice providers and one part-time physician. Except for endoscopic ultrasound, I perform all other endoscopic procedures. The census is usually 25-35 with an average of 10-15 new consults per day.

The most important benefit of a dedicated GI hospitalist is providing expedited consultation and expert endoscopy for patients. I can offer emergent (<6 hour) endoscopy for any patient. An esophageal food impaction is usually resolved within an hour of arrival to the ED during the day. I can help a surgeon intraoperatively on very short notice. As for acute GI bleeding cases, I oversee resuscitative efforts, while the endoscopy team prepares my preferred endoscopic equipment, eliminating surprises and delays before endoscopy. I have developed an expertise in hemostasis and managing esophageal perforations, along with a risk tolerance that cannot be matured in any setting other than daily emergency.

I have enacted evidence-based protocols for GI bleeding, iron-deficiency anemia, colonic pseudo-obstruction, pancreatitis, and liver decompensation, which internists have adopted over time, reducing phone calls and delays in prep or resuscitation.

While the day is unstructured and filled with interruptions, it is also very flexible. As opposed to the set time intervals of an outpatient clinic visit, I can spend an hour in a palliative care meeting or revisit high-risk patients multiple times a day to detect pending deterioration. Combined endoscopic and surgical cases are logistically easy to schedule given my flexibility. For example, patients with choledocholithiasis often can have a combined cholecystectomy and supine endoscopic retrograde cholangiopancreatography (ERCP) in the OR, shaving a day off admission.

My employer benefits financially as the outpatient doctors can stay busy without interruption from the hospital. With secure group messaging, we are able to make joint decisions and arrange close follow up. The relative value units earned from the hospital are high. Combined with proceeds from the professional service agreement with the hospital, they are more than enough to cover my compensation.

Any physician in need of a GI consult needs only to call one number for help. I make it as easy as possible to obtain a consult and never push back, as banal as any consult may seem. I stake my reputation on providing a service that is able, affable, and available. By teaching a consistent message to consulting physicians, I have now effected best evidence-based practices for GI conditions even without engaging me. The most notable examples include antibiotics for variceal bleeding, fluid resuscitation and early feeding for acute pancreatitis, risk stratification for choledocholithiasis, and last but not least, abandoning the inpatient fecal occult blood test.

I am on a first-name basis with every nurse in the hospital now. In exchange for my availability and cell phone number, they place orders for me and protect me from avoidable nuisances.

Many physician groups cover the inpatient service by rotating a week at a time. There can be at times a reluctance to take ownership over a difficult patient and instead a sense of “survival of the call”. However, in my job, “the buck stops with me” even if it is in the form of readmission. For example, I have to take some ownership of indigent patients who cannot easily follow up. Who will remove the stent I placed? How will they pay for Helicobacter pylori eradication or biologic therapy? Another example is diverticular bleeding. While 80% stop on their own, I take extraordinary efforts to endoscopically find and halt the bleeding in order to reduce the recurrence rate. I must find durable solutions because these high-risk patients are my responsibility again when they bounce back to me via the ED.

By way of volume alone, this position has allowed me to develop many therapeutic skills outside of a standard 3-year GI fellowship. While I did only 200 ERCPs in fellowship, I have become proficient in ERCP with around 400 cases per year (mostly native papilla) and have grown comfortable with the needle knife. I have learned endoscopic suturing, luminal stenting, and endoscopic vacuum-assisted therapy for perforation closure independently. Out of necessity, I developed a novel technique in optimizing the use of hemostatic powder by using a bone-wax plug. As endoscopy chief, I can purchase a wide variety of endoscopy equipment, compare brands, and understand the nuances of each.

In conclusion, the dedicated GI hospitalist indirectly improves the efficiency of an outpatient practice, while directly improving inpatient outcomes, collegiality, and even one’s own skills as an endoscopist. While it can be challenging and hectic, with the right mentality towards ownership of the service, it is also an incredibly rewarding position.

Dr. Tau practices with Austin Gastroenterology in Austin, Tex. He disclosed relationships with Cook Medical and Conmed.

Inpatient-only GI hospitalist: Not so fast

By Vaibhav Mehendiratta, MD

Over the past 2 decades, the medical hospitalist system has assumed care of hospitalized patients with the promise of reduced length of stay (LOS) and improved outcomes. Although data on LOS is promising, there have been conflicting results in terms of total medical costs and resource utilization. Inpatient care for patients with complex medical histories often requires regular communication with other subspecialties and outpatient providers to achieve better patient-centered outcomes.

Courtesy Connecticut GI, PC

Providing inpatient gastrointestinal care is complicated. Traditional models rely on physicians trying to balance outpatient obligations with inpatient rounding and procedures, which can result in delayed endoscopy and an inability to participate fully in multidisciplinary rounds and family meetings. The complexity of hospitalized patients often requires a multidisciplinary approach with coordination of care that is hard to accomplish in between seeing outpatients. GI groups, both private practice and academics, need to adopt a strategy for inpatient care that is tailored to the hospital system in which they operate.

As one of the largest private practice groups in New England, our experience can provide a framework for others to follow. We provide inpatient GI care at eight hospitals across northern Connecticut. Our inpatient service at the largest tertiary care hospital is composed of one general gastroenterologist, one advanced endoscopist, one transplant hepatologist, two advanced practitioners, and two fellows in training. Each practitioner provides coverage on a rotating basis, typically 1 week at a time every 4-8 weeks. This model also offers flexibility, such that we can typically accommodate urgent outpatient endoscopy for patients who may otherwise require inpatient care. Coverage at the other seven hospitals is tailored to local needs and ranges from half-day to whole-day coverage by general gastroenterologists and advanced practitioners. We believe that our model is financially viable and, based on our experience, inpatient relative value units generated are quite similar to a typical day in outpatient GI practice.

Inpatient GI care accounts for a substantial portion of overall inpatient care in the United States. Endoscopy delays have been the focus of many research articles looking at inpatient GI care. The delays are caused by many factors, including endoscopy unit/staff availability, anesthesia availability, and patient factors. While having a dedicated inpatient GI Hospitalist offers the potential to streamline access for hospital consultations and endoscopy, an exclusive inpatient GI hospitalist may be less familiar with a patient’s chronic GI illness and have different (and perhaps, conflicting) priorities regarding a patient’s care. Having incomplete access to outpatient records or less familiarity with the intricacies of outpatient care could also lead to duplication of work and increase the number of inpatient procedures that may have otherwise been deferred to the outpatient setting.

Additionally, with physician burnout on the rise and particularly in the inpatient setting, one must question the sustainability of an exclusively inpatient GI practice. That is, the hours and demands of inpatient care typically do not allow the quality of life that outpatient care provides. Our model provides time for dedicated inpatient care, while allowing each practitioner ample opportunity to build a robust outpatient practice.

Some health care organizations are adopting an extensivist model to provide comprehensive care to patients with multiple medical problems. Extensivists are outpatient primary care providers who take the time to coordinate with inpatient hospitalists to provide comprehensive care to their patients. Constant contact with outpatient providers during admission is expected to improve patient satisfaction, reduce hospital readmissions, and decrease inpatient resource utilization.

In conclusion, our experience highlights sustained benefits, and distinct advantages, of providing inpatient GI care without a GI hospitalist model. The pendulum in inpatient care keeps swinging and with progress arise new challenges and questions. Close collaboration between gastroenterologists and health systems to develop a program that fits local needs and allows optimal resource allocation will ensure delivery of high-quality inpatient GI care.

Dr. Mehendiratta is a gastroenterologist with Connecticut GI PC, Hartford, and assistant clinical professor in the department of medicine at the University of Connecticut, Farmington. He has no relevant conflicts of interest to disclose.

A Chicago-based medical oncologist has been charged with insider trading by the U.S. Securities and Exchange Commission, according to a Dec. 20 press release issued by the U.S. Department of Justice.

Daniel V.T. Catenacci, MD, PhD, a gastrointestinal medical oncologist and associate professor of medicine at the University of Chicago, is alleged to have used confidential information to purchase shares of California-based biotechnology company Five Prime Therapeutics before it publicly announced positive results from a clinical trial of bemarituzumab, an experimental cancer drug.

Dr. Catenacci served as the lead investigator of the clinical trial that evaluated bemarituzumab. The drug, which earned breakthrough therapy designation from the Food and Drug Administration earlier this year, is designed to target fibroblast growth factor receptor 2b (FGFR2b), overexpressed in about 30% of patients with HER2-negative gastric cancer and other solid tumors.

Bemarituzumab is being positioned as a potential frontline therapy for advanced gastric or gastroesophageal junction cancer. A recent phase 2 trial found that adding bemarituzumab to chemotherapy in this patient population improved survival over chemotherapy alone.

According to the criminal information, filed on Dec. 17 in U.S. District Court in Chicago, the charges state that, in November 2020, Dr. Catenacci “used material, non-public information about the trial results to make more than $134,000 in illegal profits from the purchase and sale of securities in the company.”

More specifically, the SEC’s complaint alleges that Dr. Catenacci received confidential information about the company and its positive clinical trial results through his position as principal investigator. Dr. Catenacci then purchased almost 8,800 shares of Five Prime Therapeutics before the company announced the positive results. Dr. Catenacci subsequently sold those shares shortly after the trial results were announced. In the interim, the shares tripled or quadrupled in value.

He has been charged with one count of securities fraud, punishable by up to 20 years in federal prison. Arraignment in federal court in Chicago has yet to be scheduled.

In addition, the federal complaint alleges that Dr. Catenacci violated the antifraud provisions of the federal securities laws. According to a press release, “Catenacci has agreed to be permanently enjoined from violations of these provisions, and to pay a civil penalty in an amount to be determined by the court later.”

Erin E. Schneider, regional director of the SEC’s San Francisco Regional Office, stated in the press release that clinical drug trials typically involve sensitive and valuable information about the viability of an experimental drug.

“As alleged in our complaint, Catenacci was required to safeguard the material nonpublic information he learned about Five Prime’s clinical trial, and not trade on it,” said Mr. Schneider.

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

A Chicago-based medical oncologist has been charged with insider trading by the U.S. Securities and Exchange Commission, according to a Dec. 20 press release issued by the U.S. Department of Justice.

Daniel V.T. Catenacci, MD, PhD, a gastrointestinal medical oncologist and associate professor of medicine at the University of Chicago, is alleged to have used confidential information to purchase shares of California-based biotechnology company Five Prime Therapeutics before it publicly announced positive results from a clinical trial of bemarituzumab, an experimental cancer drug.

Dr. Catenacci served as the lead investigator of the clinical trial that evaluated bemarituzumab. The drug, which earned breakthrough therapy designation from the Food and Drug Administration earlier this year, is designed to target fibroblast growth factor receptor 2b (FGFR2b), overexpressed in about 30% of patients with HER2-negative gastric cancer and other solid tumors.

Bemarituzumab is being positioned as a potential frontline therapy for advanced gastric or gastroesophageal junction cancer. A recent phase 2 trial found that adding bemarituzumab to chemotherapy in this patient population improved survival over chemotherapy alone.

According to the criminal information, filed on Dec. 17 in U.S. District Court in Chicago, the charges state that, in November 2020, Dr. Catenacci “used material, non-public information about the trial results to make more than $134,000 in illegal profits from the purchase and sale of securities in the company.”

More specifically, the SEC’s complaint alleges that Dr. Catenacci received confidential information about the company and its positive clinical trial results through his position as principal investigator. Dr. Catenacci then purchased almost 8,800 shares of Five Prime Therapeutics before the company announced the positive results. Dr. Catenacci subsequently sold those shares shortly after the trial results were announced. In the interim, the shares tripled or quadrupled in value.

He has been charged with one count of securities fraud, punishable by up to 20 years in federal prison. Arraignment in federal court in Chicago has yet to be scheduled.

In addition, the federal complaint alleges that Dr. Catenacci violated the antifraud provisions of the federal securities laws. According to a press release, “Catenacci has agreed to be permanently enjoined from violations of these provisions, and to pay a civil penalty in an amount to be determined by the court later.”

Erin E. Schneider, regional director of the SEC’s San Francisco Regional Office, stated in the press release that clinical drug trials typically involve sensitive and valuable information about the viability of an experimental drug.

“As alleged in our complaint, Catenacci was required to safeguard the material nonpublic information he learned about Five Prime’s clinical trial, and not trade on it,” said Mr. Schneider.

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

A Chicago-based medical oncologist has been charged with insider trading by the U.S. Securities and Exchange Commission, according to a Dec. 20 press release issued by the U.S. Department of Justice.

Daniel V.T. Catenacci, MD, PhD, a gastrointestinal medical oncologist and associate professor of medicine at the University of Chicago, is alleged to have used confidential information to purchase shares of California-based biotechnology company Five Prime Therapeutics before it publicly announced positive results from a clinical trial of bemarituzumab, an experimental cancer drug.

Dr. Catenacci served as the lead investigator of the clinical trial that evaluated bemarituzumab. The drug, which earned breakthrough therapy designation from the Food and Drug Administration earlier this year, is designed to target fibroblast growth factor receptor 2b (FGFR2b), overexpressed in about 30% of patients with HER2-negative gastric cancer and other solid tumors.

Bemarituzumab is being positioned as a potential frontline therapy for advanced gastric or gastroesophageal junction cancer. A recent phase 2 trial found that adding bemarituzumab to chemotherapy in this patient population improved survival over chemotherapy alone.

According to the criminal information, filed on Dec. 17 in U.S. District Court in Chicago, the charges state that, in November 2020, Dr. Catenacci “used material, non-public information about the trial results to make more than $134,000 in illegal profits from the purchase and sale of securities in the company.”

More specifically, the SEC’s complaint alleges that Dr. Catenacci received confidential information about the company and its positive clinical trial results through his position as principal investigator. Dr. Catenacci then purchased almost 8,800 shares of Five Prime Therapeutics before the company announced the positive results. Dr. Catenacci subsequently sold those shares shortly after the trial results were announced. In the interim, the shares tripled or quadrupled in value.

He has been charged with one count of securities fraud, punishable by up to 20 years in federal prison. Arraignment in federal court in Chicago has yet to be scheduled.

In addition, the federal complaint alleges that Dr. Catenacci violated the antifraud provisions of the federal securities laws. According to a press release, “Catenacci has agreed to be permanently enjoined from violations of these provisions, and to pay a civil penalty in an amount to be determined by the court later.”

Erin E. Schneider, regional director of the SEC’s San Francisco Regional Office, stated in the press release that clinical drug trials typically involve sensitive and valuable information about the viability of an experimental drug.

“As alleged in our complaint, Catenacci was required to safeguard the material nonpublic information he learned about Five Prime’s clinical trial, and not trade on it,” said Mr. Schneider.

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