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States cracking down harder on docs who sexually abuse patients
It’s the latest example of states taking doctor sexual misconduct more seriously after longstanding criticism that medical boards have been too lenient.
The law, which takes effect in January 2023, requires the state’s medical board to permanently revoke these doctors’ licenses instead of allowing them to petition the board for reinstatement after 3 years.
“Physician licenses should not be reinstated after egregious sexual misconduct with patients. The doctor-patient relationship has to remain sacrosanct and trusted,” said Peter Yellowlees, MD, a professor of psychiatry at the University of California, Davis.
Although the vast majority of the nation’s estimated 1 million doctors don’t sexually abuse patients, the problem is a national one.
The Federation of State Medical Boards defines sexual misconduct as the exploitation of the physician-patient relationship in a sexual way. The exploitation may be verbal or physical and can occur in person or virtually.
The FSMB conducted a 2-year review of how medical boards handled cases of sexual misconduct, issuing a report in 2020 that contained 38 recommended actions.
Four states in addition to California have enacted laws that incorporate some FSMB recommendations. These include revoking doctors’ licenses after a single egregious act of sexual misconduct (including sexual assault), regardless of whether the physician was charged or convicted; increased reporting by hospitals and doctors of sexual misconduct; and training of physicians to recognize and report sexual misconduct.
The four state laws are:
- Georgia’s HB 458. It was signed into law in May 2021, and it authorizes the medical board to revoke or suspend a license if a physician is found guilty of sexually assaulting a patient in a criminal case. Doctors are required to report other doctors who have sexually abused patients and to take continuing medical education (CME) units on sexual misconduct.
- Florida’s SB 1934. This legislation was signed into law in June 2021, and it bars physicians charged with serious crimes such as sexual assault, sexual misconduct against patients, or possession of child pornography from seeing patients until those charges are resolved by the legal system.
- West Virginia’s SB 603. Signed into law in March 2022 it prohibits the medical board from issuing a license to a physician who engaged in sexual activity or misconduct with a patient whose license was revoked in another state or was involved in other violations.
- Tennessee HB 1045. It was signed into law in May 2021, and authorizes the medical board, upon learning of an indictment against a physician for a controlled substance violation or sexual offense, to immediately suspend the doctor’s ability to prescribe controlled substances until the doctor’s case is resolved.
A published study identified a total of 1,721 reports of physician sexual misconduct that were submitted to the National Practitioner Data Bank between 2000 and 2019. The annual incidence of sexual misconduct reports averaged 10.8 per 100,000 U.S. physician licensees, said the researchers.
In a groundbreaking 2016 investigation, the Atlanta Journal-Constitution reviewed thousands of documents and found more than 2,400 doctors whose sexual misconduct cases clearly involved patients since 1999.
Physician sexual misconduct is likely underreported
The actual incidence of physician-patient sexual misconduct is likely higher as a result of underreporting, according to the researchers.
Because a substantial power differential exists between patients and their physicians, the researchers noted, it follows that patient victims, like other sexual assault victims, may be unwilling or unable to report the incident in question.
Many violations involving physician sexual misconduct of patients never came to the attention of state regulators, according to the Journal-Constitution investigation. Reporting showed that hospitals, clinics, and fellow doctors fail to report sexual misconduct to regulators, despite laws in most states requiring them to do so.
Media investigations highlight medical board shortcomings
Public pressure on the California Medical Board increased after the Los Angeles Times investigated what happened to doctors who surrendered or had their licenses revoked after being reported for sexual abuse with patients. The Times revealed in 2021 that the board reinstated 10 of 17 doctors who petitioned for reinstatement.
They include Esmail Nadjmabadi, MD, of Bakersfield, Calif., who had sexually abused six female patients, including one in her mid-teens. The Times reported that, in 2009, he pleaded no contest to a criminal charge that he sexually exploited two or more women and surrendered his medical license the following year.
Five years later, Dr. Nadjmabadi petitioned the medical board to be reinstated and the board approved his request.
The California board has also reinstated several doctors who underwent sex offender rehabilitation. Board members rely heavily on a doctor’s evidence of rehabilitation, usually with the testimony of therapists hired by the doctor, and no input from the patients who were harmed, according to the Times’ investigation.
High-profile sexual misconduct or abuse cases involving Larry Nassar, MD, and Robert Anderson, MD, in Michigan; Richard Strauss, MD, in Ohio; and Ricardo Cruciani, MD, in New York, added to the mounting criticism that medical boards were too lenient in their handling of complaints of sexual misconduct.
Another state tackles sexual misconduct
Ohio’s medical board created an administrative rule stating that licensed physicians have a legal and ethical duty to report colleagues for sexual misconduct with patients and to complete a 1-hour CME training. Failure to report sexual misconduct complaints can lead to a doctor being permanently stripped of his license.
This happened to Robert S. Geiger, MD, in 2016 after not reporting his colleague James Bressi, MD, to the medical board after receiving complaints that Dr. Bressi was sexually abusing female patients at their pain clinic.
Dr. Bressi was convicted of sexual misconduct with a patient, stripped of his medical license, and sentenced to 59 days in prison.
“I think all of these reforms are a step in the right direction and will help to deter doctors from committing sexual misconduct to some extent,” said California activist Marian Hollingsworth, cofounder of the Patient Safety League.
But there’s room for improvement, she said, since “most states fall short in not requiring medical boards to notify law enforcement when they get a complaint of doctor sexual misconduct so the public can be aware of it.”
A version of this article first appeared on Medscape.com.
It’s the latest example of states taking doctor sexual misconduct more seriously after longstanding criticism that medical boards have been too lenient.
The law, which takes effect in January 2023, requires the state’s medical board to permanently revoke these doctors’ licenses instead of allowing them to petition the board for reinstatement after 3 years.
“Physician licenses should not be reinstated after egregious sexual misconduct with patients. The doctor-patient relationship has to remain sacrosanct and trusted,” said Peter Yellowlees, MD, a professor of psychiatry at the University of California, Davis.
Although the vast majority of the nation’s estimated 1 million doctors don’t sexually abuse patients, the problem is a national one.
The Federation of State Medical Boards defines sexual misconduct as the exploitation of the physician-patient relationship in a sexual way. The exploitation may be verbal or physical and can occur in person or virtually.
The FSMB conducted a 2-year review of how medical boards handled cases of sexual misconduct, issuing a report in 2020 that contained 38 recommended actions.
Four states in addition to California have enacted laws that incorporate some FSMB recommendations. These include revoking doctors’ licenses after a single egregious act of sexual misconduct (including sexual assault), regardless of whether the physician was charged or convicted; increased reporting by hospitals and doctors of sexual misconduct; and training of physicians to recognize and report sexual misconduct.
The four state laws are:
- Georgia’s HB 458. It was signed into law in May 2021, and it authorizes the medical board to revoke or suspend a license if a physician is found guilty of sexually assaulting a patient in a criminal case. Doctors are required to report other doctors who have sexually abused patients and to take continuing medical education (CME) units on sexual misconduct.
- Florida’s SB 1934. This legislation was signed into law in June 2021, and it bars physicians charged with serious crimes such as sexual assault, sexual misconduct against patients, or possession of child pornography from seeing patients until those charges are resolved by the legal system.
- West Virginia’s SB 603. Signed into law in March 2022 it prohibits the medical board from issuing a license to a physician who engaged in sexual activity or misconduct with a patient whose license was revoked in another state or was involved in other violations.
- Tennessee HB 1045. It was signed into law in May 2021, and authorizes the medical board, upon learning of an indictment against a physician for a controlled substance violation or sexual offense, to immediately suspend the doctor’s ability to prescribe controlled substances until the doctor’s case is resolved.
A published study identified a total of 1,721 reports of physician sexual misconduct that were submitted to the National Practitioner Data Bank between 2000 and 2019. The annual incidence of sexual misconduct reports averaged 10.8 per 100,000 U.S. physician licensees, said the researchers.
In a groundbreaking 2016 investigation, the Atlanta Journal-Constitution reviewed thousands of documents and found more than 2,400 doctors whose sexual misconduct cases clearly involved patients since 1999.
Physician sexual misconduct is likely underreported
The actual incidence of physician-patient sexual misconduct is likely higher as a result of underreporting, according to the researchers.
Because a substantial power differential exists between patients and their physicians, the researchers noted, it follows that patient victims, like other sexual assault victims, may be unwilling or unable to report the incident in question.
Many violations involving physician sexual misconduct of patients never came to the attention of state regulators, according to the Journal-Constitution investigation. Reporting showed that hospitals, clinics, and fellow doctors fail to report sexual misconduct to regulators, despite laws in most states requiring them to do so.
Media investigations highlight medical board shortcomings
Public pressure on the California Medical Board increased after the Los Angeles Times investigated what happened to doctors who surrendered or had their licenses revoked after being reported for sexual abuse with patients. The Times revealed in 2021 that the board reinstated 10 of 17 doctors who petitioned for reinstatement.
They include Esmail Nadjmabadi, MD, of Bakersfield, Calif., who had sexually abused six female patients, including one in her mid-teens. The Times reported that, in 2009, he pleaded no contest to a criminal charge that he sexually exploited two or more women and surrendered his medical license the following year.
Five years later, Dr. Nadjmabadi petitioned the medical board to be reinstated and the board approved his request.
The California board has also reinstated several doctors who underwent sex offender rehabilitation. Board members rely heavily on a doctor’s evidence of rehabilitation, usually with the testimony of therapists hired by the doctor, and no input from the patients who were harmed, according to the Times’ investigation.
High-profile sexual misconduct or abuse cases involving Larry Nassar, MD, and Robert Anderson, MD, in Michigan; Richard Strauss, MD, in Ohio; and Ricardo Cruciani, MD, in New York, added to the mounting criticism that medical boards were too lenient in their handling of complaints of sexual misconduct.
Another state tackles sexual misconduct
Ohio’s medical board created an administrative rule stating that licensed physicians have a legal and ethical duty to report colleagues for sexual misconduct with patients and to complete a 1-hour CME training. Failure to report sexual misconduct complaints can lead to a doctor being permanently stripped of his license.
This happened to Robert S. Geiger, MD, in 2016 after not reporting his colleague James Bressi, MD, to the medical board after receiving complaints that Dr. Bressi was sexually abusing female patients at their pain clinic.
Dr. Bressi was convicted of sexual misconduct with a patient, stripped of his medical license, and sentenced to 59 days in prison.
“I think all of these reforms are a step in the right direction and will help to deter doctors from committing sexual misconduct to some extent,” said California activist Marian Hollingsworth, cofounder of the Patient Safety League.
But there’s room for improvement, she said, since “most states fall short in not requiring medical boards to notify law enforcement when they get a complaint of doctor sexual misconduct so the public can be aware of it.”
A version of this article first appeared on Medscape.com.
It’s the latest example of states taking doctor sexual misconduct more seriously after longstanding criticism that medical boards have been too lenient.
The law, which takes effect in January 2023, requires the state’s medical board to permanently revoke these doctors’ licenses instead of allowing them to petition the board for reinstatement after 3 years.
“Physician licenses should not be reinstated after egregious sexual misconduct with patients. The doctor-patient relationship has to remain sacrosanct and trusted,” said Peter Yellowlees, MD, a professor of psychiatry at the University of California, Davis.
Although the vast majority of the nation’s estimated 1 million doctors don’t sexually abuse patients, the problem is a national one.
The Federation of State Medical Boards defines sexual misconduct as the exploitation of the physician-patient relationship in a sexual way. The exploitation may be verbal or physical and can occur in person or virtually.
The FSMB conducted a 2-year review of how medical boards handled cases of sexual misconduct, issuing a report in 2020 that contained 38 recommended actions.
Four states in addition to California have enacted laws that incorporate some FSMB recommendations. These include revoking doctors’ licenses after a single egregious act of sexual misconduct (including sexual assault), regardless of whether the physician was charged or convicted; increased reporting by hospitals and doctors of sexual misconduct; and training of physicians to recognize and report sexual misconduct.
The four state laws are:
- Georgia’s HB 458. It was signed into law in May 2021, and it authorizes the medical board to revoke or suspend a license if a physician is found guilty of sexually assaulting a patient in a criminal case. Doctors are required to report other doctors who have sexually abused patients and to take continuing medical education (CME) units on sexual misconduct.
- Florida’s SB 1934. This legislation was signed into law in June 2021, and it bars physicians charged with serious crimes such as sexual assault, sexual misconduct against patients, or possession of child pornography from seeing patients until those charges are resolved by the legal system.
- West Virginia’s SB 603. Signed into law in March 2022 it prohibits the medical board from issuing a license to a physician who engaged in sexual activity or misconduct with a patient whose license was revoked in another state or was involved in other violations.
- Tennessee HB 1045. It was signed into law in May 2021, and authorizes the medical board, upon learning of an indictment against a physician for a controlled substance violation or sexual offense, to immediately suspend the doctor’s ability to prescribe controlled substances until the doctor’s case is resolved.
A published study identified a total of 1,721 reports of physician sexual misconduct that were submitted to the National Practitioner Data Bank between 2000 and 2019. The annual incidence of sexual misconduct reports averaged 10.8 per 100,000 U.S. physician licensees, said the researchers.
In a groundbreaking 2016 investigation, the Atlanta Journal-Constitution reviewed thousands of documents and found more than 2,400 doctors whose sexual misconduct cases clearly involved patients since 1999.
Physician sexual misconduct is likely underreported
The actual incidence of physician-patient sexual misconduct is likely higher as a result of underreporting, according to the researchers.
Because a substantial power differential exists between patients and their physicians, the researchers noted, it follows that patient victims, like other sexual assault victims, may be unwilling or unable to report the incident in question.
Many violations involving physician sexual misconduct of patients never came to the attention of state regulators, according to the Journal-Constitution investigation. Reporting showed that hospitals, clinics, and fellow doctors fail to report sexual misconduct to regulators, despite laws in most states requiring them to do so.
Media investigations highlight medical board shortcomings
Public pressure on the California Medical Board increased after the Los Angeles Times investigated what happened to doctors who surrendered or had their licenses revoked after being reported for sexual abuse with patients. The Times revealed in 2021 that the board reinstated 10 of 17 doctors who petitioned for reinstatement.
They include Esmail Nadjmabadi, MD, of Bakersfield, Calif., who had sexually abused six female patients, including one in her mid-teens. The Times reported that, in 2009, he pleaded no contest to a criminal charge that he sexually exploited two or more women and surrendered his medical license the following year.
Five years later, Dr. Nadjmabadi petitioned the medical board to be reinstated and the board approved his request.
The California board has also reinstated several doctors who underwent sex offender rehabilitation. Board members rely heavily on a doctor’s evidence of rehabilitation, usually with the testimony of therapists hired by the doctor, and no input from the patients who were harmed, according to the Times’ investigation.
High-profile sexual misconduct or abuse cases involving Larry Nassar, MD, and Robert Anderson, MD, in Michigan; Richard Strauss, MD, in Ohio; and Ricardo Cruciani, MD, in New York, added to the mounting criticism that medical boards were too lenient in their handling of complaints of sexual misconduct.
Another state tackles sexual misconduct
Ohio’s medical board created an administrative rule stating that licensed physicians have a legal and ethical duty to report colleagues for sexual misconduct with patients and to complete a 1-hour CME training. Failure to report sexual misconduct complaints can lead to a doctor being permanently stripped of his license.
This happened to Robert S. Geiger, MD, in 2016 after not reporting his colleague James Bressi, MD, to the medical board after receiving complaints that Dr. Bressi was sexually abusing female patients at their pain clinic.
Dr. Bressi was convicted of sexual misconduct with a patient, stripped of his medical license, and sentenced to 59 days in prison.
“I think all of these reforms are a step in the right direction and will help to deter doctors from committing sexual misconduct to some extent,” said California activist Marian Hollingsworth, cofounder of the Patient Safety League.
But there’s room for improvement, she said, since “most states fall short in not requiring medical boards to notify law enforcement when they get a complaint of doctor sexual misconduct so the public can be aware of it.”
A version of this article first appeared on Medscape.com.
How a cheap liver drug may be the key to preventing COVID
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.
As soon as the pandemic started, the search was on for a medication that could stave off infection, or at least the worst consequences of infection.
One that would be cheap to make, safe, easy to distribute, and, ideally, was already available. The search had a quest-like quality, like something from a fairy tale. Society, poisoned by COVID, would find the antidote out there, somewhere, if we looked hard enough.
You know the story. There were some pretty dramatic failures: hydroxychloroquine, ivermectin. There were some successes, like dexamethasone.
I’m not here today to tell you that the antidote has been found – no, it takes large randomized trials to figure that out. But
How do you make a case that an existing drug – UDCA, in this case – might be useful to prevent or treat COVID? In contrast to prior basic-science studies, like the original ivermectin study, which essentially took a bunch of cells and virus in a tube filled with varying concentrations of the antiparasitic agent, the authors of this paper appearing in Nature give us multiple, complementary lines of evidence. Let me walk you through it.
All good science starts with a biologically plausible hypothesis. In this case, the authors recognized that SARS-CoV-2, in all its variants, requires the presence of the ACE2 receptor on the surface of cells to bind.
That is the doorway to infection. Vaccines and antibodies block the key to this door, the spike protein and its receptor binding domain. But what if you could get rid of the doors altogether?
The authors first showed that ACE2 expression is controlled by a certain transcription factor known as the farnesoid X receptor, or FXR. Reducing the binding of FXR should therefore reduce ACE2 expression.
As luck would have it, UDCA – Actigall – reduces the levels of FXR and thus the expression of ACE2 in cells.
Okay. So we have a drug that can reduce ACE2, and we know that ACE2 is necessary for the virus to infect cells. Would UDCA prevent viral infection?
They started with test tubes, showing that cells were less likely to be infected by SARS-CoV-2 in the presence of UDCA at concentrations similar to what humans achieve in their blood after standard dosing. The red staining here is spike protein; you can see that it is markedly lower in the cells exposed to UDCA.
So far, so good. But test tubes aren’t people. So they moved up to mice and Syrian golden hamsters. These cute fellows are quite susceptible to human COVID and have been a model organism in countless studies
Mice and hamsters treated with UDCA in the presence of littermates with COVID infections were less likely to become infected themselves compared with mice not so treated. They also showed that mice and hamsters treated with UDCA had lower levels of ACE2 in their nasal passages.
Of course, mice aren’t humans either. So the researchers didn’t stop there.
To determine the effects of UDCA on human tissue, they utilized perfused human lungs that had been declined for transplantation. The lungs were perfused with a special fluid to keep them viable, and were mechanically ventilated. One lung was exposed to UDCA and the other served as a control. The authors were able to show that ACE2 levels went down in the exposed lung. And, importantly, when samples of tissue from both lungs were exposed to SARS-CoV-2, the lung tissue exposed to UDCA had lower levels of viral infection.
They didn’t stop there.
Eight human volunteers were recruited to take UDCA for 5 days. ACE2 levels in the nasal passages went down over the course of treatment. They confirmed those results from a proteomics dataset with several hundred people who had received UDCA for clinical reasons. Treated individuals had lower ACE2 levels.
Finally, they looked at the epidemiologic effect. They examined a dataset that contained information on over 1,000 patients with liver disease who had contracted COVID-19, 31 of whom had been receiving UDCA. Even after adjustment for baseline differences, those receiving UDCA were less likely to be hospitalized, require an ICU, or die.
Okay, we’ll stop there. Reading this study, all I could think was, Yes! This is how you generate evidence that you have a drug that might work – step by careful step.
But let’s be careful as well. Does this study show that taking Actigall will prevent COVID? Of course not. It doesn’t show that it will treat COVID either. But I bring it up because the rigor of this study stands in contrast to those that generated huge enthusiasm earlier in the pandemic only to let us down in randomized trials. If there has been a drug out there this whole time which will prevent or treat COVID, this is how we’ll find it. The next step? Test it in a randomized trial.
For Medscape, I’m Perry Wilson.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He disclosed no relevant financial relationships.
A version of this video transcript first appeared on Medscape.com.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.
As soon as the pandemic started, the search was on for a medication that could stave off infection, or at least the worst consequences of infection.
One that would be cheap to make, safe, easy to distribute, and, ideally, was already available. The search had a quest-like quality, like something from a fairy tale. Society, poisoned by COVID, would find the antidote out there, somewhere, if we looked hard enough.
You know the story. There were some pretty dramatic failures: hydroxychloroquine, ivermectin. There were some successes, like dexamethasone.
I’m not here today to tell you that the antidote has been found – no, it takes large randomized trials to figure that out. But
How do you make a case that an existing drug – UDCA, in this case – might be useful to prevent or treat COVID? In contrast to prior basic-science studies, like the original ivermectin study, which essentially took a bunch of cells and virus in a tube filled with varying concentrations of the antiparasitic agent, the authors of this paper appearing in Nature give us multiple, complementary lines of evidence. Let me walk you through it.
All good science starts with a biologically plausible hypothesis. In this case, the authors recognized that SARS-CoV-2, in all its variants, requires the presence of the ACE2 receptor on the surface of cells to bind.
That is the doorway to infection. Vaccines and antibodies block the key to this door, the spike protein and its receptor binding domain. But what if you could get rid of the doors altogether?
The authors first showed that ACE2 expression is controlled by a certain transcription factor known as the farnesoid X receptor, or FXR. Reducing the binding of FXR should therefore reduce ACE2 expression.
As luck would have it, UDCA – Actigall – reduces the levels of FXR and thus the expression of ACE2 in cells.
Okay. So we have a drug that can reduce ACE2, and we know that ACE2 is necessary for the virus to infect cells. Would UDCA prevent viral infection?
They started with test tubes, showing that cells were less likely to be infected by SARS-CoV-2 in the presence of UDCA at concentrations similar to what humans achieve in their blood after standard dosing. The red staining here is spike protein; you can see that it is markedly lower in the cells exposed to UDCA.
So far, so good. But test tubes aren’t people. So they moved up to mice and Syrian golden hamsters. These cute fellows are quite susceptible to human COVID and have been a model organism in countless studies
Mice and hamsters treated with UDCA in the presence of littermates with COVID infections were less likely to become infected themselves compared with mice not so treated. They also showed that mice and hamsters treated with UDCA had lower levels of ACE2 in their nasal passages.
Of course, mice aren’t humans either. So the researchers didn’t stop there.
To determine the effects of UDCA on human tissue, they utilized perfused human lungs that had been declined for transplantation. The lungs were perfused with a special fluid to keep them viable, and were mechanically ventilated. One lung was exposed to UDCA and the other served as a control. The authors were able to show that ACE2 levels went down in the exposed lung. And, importantly, when samples of tissue from both lungs were exposed to SARS-CoV-2, the lung tissue exposed to UDCA had lower levels of viral infection.
They didn’t stop there.
Eight human volunteers were recruited to take UDCA for 5 days. ACE2 levels in the nasal passages went down over the course of treatment. They confirmed those results from a proteomics dataset with several hundred people who had received UDCA for clinical reasons. Treated individuals had lower ACE2 levels.
Finally, they looked at the epidemiologic effect. They examined a dataset that contained information on over 1,000 patients with liver disease who had contracted COVID-19, 31 of whom had been receiving UDCA. Even after adjustment for baseline differences, those receiving UDCA were less likely to be hospitalized, require an ICU, or die.
Okay, we’ll stop there. Reading this study, all I could think was, Yes! This is how you generate evidence that you have a drug that might work – step by careful step.
But let’s be careful as well. Does this study show that taking Actigall will prevent COVID? Of course not. It doesn’t show that it will treat COVID either. But I bring it up because the rigor of this study stands in contrast to those that generated huge enthusiasm earlier in the pandemic only to let us down in randomized trials. If there has been a drug out there this whole time which will prevent or treat COVID, this is how we’ll find it. The next step? Test it in a randomized trial.
For Medscape, I’m Perry Wilson.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He disclosed no relevant financial relationships.
A version of this video transcript first appeared on Medscape.com.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.
As soon as the pandemic started, the search was on for a medication that could stave off infection, or at least the worst consequences of infection.
One that would be cheap to make, safe, easy to distribute, and, ideally, was already available. The search had a quest-like quality, like something from a fairy tale. Society, poisoned by COVID, would find the antidote out there, somewhere, if we looked hard enough.
You know the story. There were some pretty dramatic failures: hydroxychloroquine, ivermectin. There were some successes, like dexamethasone.
I’m not here today to tell you that the antidote has been found – no, it takes large randomized trials to figure that out. But
How do you make a case that an existing drug – UDCA, in this case – might be useful to prevent or treat COVID? In contrast to prior basic-science studies, like the original ivermectin study, which essentially took a bunch of cells and virus in a tube filled with varying concentrations of the antiparasitic agent, the authors of this paper appearing in Nature give us multiple, complementary lines of evidence. Let me walk you through it.
All good science starts with a biologically plausible hypothesis. In this case, the authors recognized that SARS-CoV-2, in all its variants, requires the presence of the ACE2 receptor on the surface of cells to bind.
That is the doorway to infection. Vaccines and antibodies block the key to this door, the spike protein and its receptor binding domain. But what if you could get rid of the doors altogether?
The authors first showed that ACE2 expression is controlled by a certain transcription factor known as the farnesoid X receptor, or FXR. Reducing the binding of FXR should therefore reduce ACE2 expression.
As luck would have it, UDCA – Actigall – reduces the levels of FXR and thus the expression of ACE2 in cells.
Okay. So we have a drug that can reduce ACE2, and we know that ACE2 is necessary for the virus to infect cells. Would UDCA prevent viral infection?
They started with test tubes, showing that cells were less likely to be infected by SARS-CoV-2 in the presence of UDCA at concentrations similar to what humans achieve in their blood after standard dosing. The red staining here is spike protein; you can see that it is markedly lower in the cells exposed to UDCA.
So far, so good. But test tubes aren’t people. So they moved up to mice and Syrian golden hamsters. These cute fellows are quite susceptible to human COVID and have been a model organism in countless studies
Mice and hamsters treated with UDCA in the presence of littermates with COVID infections were less likely to become infected themselves compared with mice not so treated. They also showed that mice and hamsters treated with UDCA had lower levels of ACE2 in their nasal passages.
Of course, mice aren’t humans either. So the researchers didn’t stop there.
To determine the effects of UDCA on human tissue, they utilized perfused human lungs that had been declined for transplantation. The lungs were perfused with a special fluid to keep them viable, and were mechanically ventilated. One lung was exposed to UDCA and the other served as a control. The authors were able to show that ACE2 levels went down in the exposed lung. And, importantly, when samples of tissue from both lungs were exposed to SARS-CoV-2, the lung tissue exposed to UDCA had lower levels of viral infection.
They didn’t stop there.
Eight human volunteers were recruited to take UDCA for 5 days. ACE2 levels in the nasal passages went down over the course of treatment. They confirmed those results from a proteomics dataset with several hundred people who had received UDCA for clinical reasons. Treated individuals had lower ACE2 levels.
Finally, they looked at the epidemiologic effect. They examined a dataset that contained information on over 1,000 patients with liver disease who had contracted COVID-19, 31 of whom had been receiving UDCA. Even after adjustment for baseline differences, those receiving UDCA were less likely to be hospitalized, require an ICU, or die.
Okay, we’ll stop there. Reading this study, all I could think was, Yes! This is how you generate evidence that you have a drug that might work – step by careful step.
But let’s be careful as well. Does this study show that taking Actigall will prevent COVID? Of course not. It doesn’t show that it will treat COVID either. But I bring it up because the rigor of this study stands in contrast to those that generated huge enthusiasm earlier in the pandemic only to let us down in randomized trials. If there has been a drug out there this whole time which will prevent or treat COVID, this is how we’ll find it. The next step? Test it in a randomized trial.
For Medscape, I’m Perry Wilson.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He disclosed no relevant financial relationships.
A version of this video transcript first appeared on Medscape.com.
Paxlovid has been free so far. Next year, sticker shock awaits
Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID.
And that means fewer people will get the potentially lifesaving treatments, experts said.
“I think the numbers will go way down,” said Jill Rosenthal, director of public health policy at the Center for American Progress, a left-leaning think tank. A bill for several hundred dollars or more would lead many people to decide the medication isn’t worth the price, she said.
In response to the unprecedented public health crisis caused by COVID, the federal government spent billions of dollars on developing new vaccines and treatments, to swift success: Less than a year after the pandemic was declared, medical workers got their first vaccines. But as many people have refused the shots and stopped wearing masks, the virus still rages and mutates. In 2022 alone, 250,000 Americans have died from COVID, more than from strokes or diabetes.
But soon the Department of Health & Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.
The U.S. government has so far purchased 20 million courses of Paxlovid, priced at about $530 each, a discount for buying in bulk that Pfizer CEO Albert Bourla called “really very attractive” to the federal government in a July earnings call. The drug will cost far more on the private market, although in a statement to Kaiser Health News, Pfizer declined to share the planned price. The government will also stop paying for the company’s COVID vaccine next year – those shots will quadruple in price, from the discount rate the government pays of $30 to about $120.
Mr. Bourla told investors in November that he expects the move will make Paxlovid and its COVID vaccine “a multibillion-dollars franchise.”
Nearly 9 in 10 people dying from the virus now are 65 or older. Yet federal law restricts Medicare Part D – the prescription drug program that covers nearly 50 million seniors – from covering the COVID treatment pills. The medications are meant for those most at risk of serious illness, including seniors.
Paxlovid and the other treatments are currently available under an emergency use authorization from the FDA, a fast-track review used in extraordinary situations. Although Pfizer applied for full approval in June, the process can take anywhere from several months to years. And Medicare Part D can’t cover any medications without that full stamp of approval.
Paying out-of-pocket would be “a substantial barrier” for seniors on Medicare – the very people who would benefit most from the drug, wrote federal health experts.
“From a public health perspective, and even from a health care capacity and cost perspective, it would just defy reason to not continue to make these drugs readily available,” said Dr. Larry Madoff, medical director of Massachusetts’s Bureau of Infectious Disease and Laboratory Sciences. He’s hopeful that the federal health agency will find a way to set aside unused doses for seniors and people without insurance.
In mid-November, the White House requested that Congress approve an additional $2.5 billion for COVID therapeutics and vaccines to make sure people can afford the medications when they’re no longer free. But there’s little hope it will be approved – the Senate voted that same day to end the public health emergency and denied similar requests in recent months.
Many Americans have already faced hurdles just getting a prescription for COVID treatment. Although the federal government doesn’t track who’s gotten the drug, a Centers for Disease Control and Prevention study using data from 30 medical centers found that Black and Hispanic patients with COVID were much less likely to receive Paxlovid than White patients. (Hispanic people can be of any race or combination of races.) And when the government is no longer picking up the tab, experts predict that these gaps by race, income, and geography will widen.
People in Northeastern states used the drug far more often than those in the rest of the country, according to a KHN analysis of Paxlovid use in September and October. But it wasn’t because people in the region were getting sick from COVID at much higher rates – instead, many of those states offered better access to health care to begin with and created special programs to get Paxlovid to their residents.
About 10 mostly Democratic states and several large counties in the Northeast and elsewhere created free “test-to-treat” programs that allow their residents to get an immediate doctor visit and prescription for treatment after testing positive for COVID. In Massachusetts, more than 20,000 residents have used the state’s video and phone hotline, which is available 7 days a week in 13 languages. Massachusetts, which has the highest insurance rate in the country and relatively low travel times to pharmacies, had the second-highest Paxlovid usage rate among states this fall.
States with higher COVID death rates, like Florida and Kentucky, where residents must travel farther for health care and are more likely to be uninsured, used the drug less often. Without no-cost test-to-treat options, residents have struggled to get prescriptions even though the drug itself is still free.
“If you look at access to medications for people who are uninsured, I think that there’s no question that will widen those disparities,” Ms. Rosenthal said.
People who get insurance through their jobs could face high copays at the register, too, just as they do for insulin and other expensive or brand-name drugs.
Most private insurance companies will end up covering COVID therapeutics to some extent, said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. After all, the pills are cheaper than a hospital stay. But for most people who get insurance through their jobs, there are “really no rules at all,” she said. Some insurers could take months to add the drugs to their plans or decide not to pay for them.
And the additional cost means many people will go without the medication. “We know from lots of research that when people face cost sharing for these drugs that they need to take, they will often forgo or cut back,” Ms. Corlette said.
One group doesn’t need to worry about sticker shock. Medicaid, the public insurance program for low-income adults and children, will cover the treatments in full until at least early 2024.
HHS officials could set aside any leftover taxpayer-funded medication for people who can’t afford to pay the full cost, but they haven’t shared any concrete plans to do so. The government purchased 20 million courses of Paxlovid and 3 million of Lagevrio. Fewer than a third have been used, and usage has fallen in recent months, according to KHN’s analysis of the data from HHS.
Sixty percent of the government’s supply of Evusheld is also still available, although the COVID prevention therapy is less effective against new strains of the virus. The health department in one state, New Mexico, has recommended against using it.
HHS did not make officials available for an interview or answer written questions about the commercialization plans.
The government created a potential workaround when they moved bebtelovimab, another COVID treatment, to the private market this summer. It now retails for $2,100 per patient. The agency set aside the remaining 60,000 government-purchased doses that hospitals could use to treat uninsured patients in a convoluted dose-replacement process. But it’s hard to tell how well that setup would work for Paxlovid: Bebtelovimab was already much less popular, and the FDA halted its use on Nov. 30 because it’s less effective against current strains of the virus.
Federal officials and insurance companies would have good reason to make sure patients can continue to afford COVID drugs: They’re far cheaper than if patients land in the emergency room.
“The medications are so worthwhile,” said Dr. Madoff, the Massachusetts health official. “They’re not expensive in the grand scheme of health care costs.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID.
And that means fewer people will get the potentially lifesaving treatments, experts said.
“I think the numbers will go way down,” said Jill Rosenthal, director of public health policy at the Center for American Progress, a left-leaning think tank. A bill for several hundred dollars or more would lead many people to decide the medication isn’t worth the price, she said.
In response to the unprecedented public health crisis caused by COVID, the federal government spent billions of dollars on developing new vaccines and treatments, to swift success: Less than a year after the pandemic was declared, medical workers got their first vaccines. But as many people have refused the shots and stopped wearing masks, the virus still rages and mutates. In 2022 alone, 250,000 Americans have died from COVID, more than from strokes or diabetes.
But soon the Department of Health & Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.
The U.S. government has so far purchased 20 million courses of Paxlovid, priced at about $530 each, a discount for buying in bulk that Pfizer CEO Albert Bourla called “really very attractive” to the federal government in a July earnings call. The drug will cost far more on the private market, although in a statement to Kaiser Health News, Pfizer declined to share the planned price. The government will also stop paying for the company’s COVID vaccine next year – those shots will quadruple in price, from the discount rate the government pays of $30 to about $120.
Mr. Bourla told investors in November that he expects the move will make Paxlovid and its COVID vaccine “a multibillion-dollars franchise.”
Nearly 9 in 10 people dying from the virus now are 65 or older. Yet federal law restricts Medicare Part D – the prescription drug program that covers nearly 50 million seniors – from covering the COVID treatment pills. The medications are meant for those most at risk of serious illness, including seniors.
Paxlovid and the other treatments are currently available under an emergency use authorization from the FDA, a fast-track review used in extraordinary situations. Although Pfizer applied for full approval in June, the process can take anywhere from several months to years. And Medicare Part D can’t cover any medications without that full stamp of approval.
Paying out-of-pocket would be “a substantial barrier” for seniors on Medicare – the very people who would benefit most from the drug, wrote federal health experts.
“From a public health perspective, and even from a health care capacity and cost perspective, it would just defy reason to not continue to make these drugs readily available,” said Dr. Larry Madoff, medical director of Massachusetts’s Bureau of Infectious Disease and Laboratory Sciences. He’s hopeful that the federal health agency will find a way to set aside unused doses for seniors and people without insurance.
In mid-November, the White House requested that Congress approve an additional $2.5 billion for COVID therapeutics and vaccines to make sure people can afford the medications when they’re no longer free. But there’s little hope it will be approved – the Senate voted that same day to end the public health emergency and denied similar requests in recent months.
Many Americans have already faced hurdles just getting a prescription for COVID treatment. Although the federal government doesn’t track who’s gotten the drug, a Centers for Disease Control and Prevention study using data from 30 medical centers found that Black and Hispanic patients with COVID were much less likely to receive Paxlovid than White patients. (Hispanic people can be of any race or combination of races.) And when the government is no longer picking up the tab, experts predict that these gaps by race, income, and geography will widen.
People in Northeastern states used the drug far more often than those in the rest of the country, according to a KHN analysis of Paxlovid use in September and October. But it wasn’t because people in the region were getting sick from COVID at much higher rates – instead, many of those states offered better access to health care to begin with and created special programs to get Paxlovid to their residents.
About 10 mostly Democratic states and several large counties in the Northeast and elsewhere created free “test-to-treat” programs that allow their residents to get an immediate doctor visit and prescription for treatment after testing positive for COVID. In Massachusetts, more than 20,000 residents have used the state’s video and phone hotline, which is available 7 days a week in 13 languages. Massachusetts, which has the highest insurance rate in the country and relatively low travel times to pharmacies, had the second-highest Paxlovid usage rate among states this fall.
States with higher COVID death rates, like Florida and Kentucky, where residents must travel farther for health care and are more likely to be uninsured, used the drug less often. Without no-cost test-to-treat options, residents have struggled to get prescriptions even though the drug itself is still free.
“If you look at access to medications for people who are uninsured, I think that there’s no question that will widen those disparities,” Ms. Rosenthal said.
People who get insurance through their jobs could face high copays at the register, too, just as they do for insulin and other expensive or brand-name drugs.
Most private insurance companies will end up covering COVID therapeutics to some extent, said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. After all, the pills are cheaper than a hospital stay. But for most people who get insurance through their jobs, there are “really no rules at all,” she said. Some insurers could take months to add the drugs to their plans or decide not to pay for them.
And the additional cost means many people will go without the medication. “We know from lots of research that when people face cost sharing for these drugs that they need to take, they will often forgo or cut back,” Ms. Corlette said.
One group doesn’t need to worry about sticker shock. Medicaid, the public insurance program for low-income adults and children, will cover the treatments in full until at least early 2024.
HHS officials could set aside any leftover taxpayer-funded medication for people who can’t afford to pay the full cost, but they haven’t shared any concrete plans to do so. The government purchased 20 million courses of Paxlovid and 3 million of Lagevrio. Fewer than a third have been used, and usage has fallen in recent months, according to KHN’s analysis of the data from HHS.
Sixty percent of the government’s supply of Evusheld is also still available, although the COVID prevention therapy is less effective against new strains of the virus. The health department in one state, New Mexico, has recommended against using it.
HHS did not make officials available for an interview or answer written questions about the commercialization plans.
The government created a potential workaround when they moved bebtelovimab, another COVID treatment, to the private market this summer. It now retails for $2,100 per patient. The agency set aside the remaining 60,000 government-purchased doses that hospitals could use to treat uninsured patients in a convoluted dose-replacement process. But it’s hard to tell how well that setup would work for Paxlovid: Bebtelovimab was already much less popular, and the FDA halted its use on Nov. 30 because it’s less effective against current strains of the virus.
Federal officials and insurance companies would have good reason to make sure patients can continue to afford COVID drugs: They’re far cheaper than if patients land in the emergency room.
“The medications are so worthwhile,” said Dr. Madoff, the Massachusetts health official. “They’re not expensive in the grand scheme of health care costs.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID.
And that means fewer people will get the potentially lifesaving treatments, experts said.
“I think the numbers will go way down,” said Jill Rosenthal, director of public health policy at the Center for American Progress, a left-leaning think tank. A bill for several hundred dollars or more would lead many people to decide the medication isn’t worth the price, she said.
In response to the unprecedented public health crisis caused by COVID, the federal government spent billions of dollars on developing new vaccines and treatments, to swift success: Less than a year after the pandemic was declared, medical workers got their first vaccines. But as many people have refused the shots and stopped wearing masks, the virus still rages and mutates. In 2022 alone, 250,000 Americans have died from COVID, more than from strokes or diabetes.
But soon the Department of Health & Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.
The U.S. government has so far purchased 20 million courses of Paxlovid, priced at about $530 each, a discount for buying in bulk that Pfizer CEO Albert Bourla called “really very attractive” to the federal government in a July earnings call. The drug will cost far more on the private market, although in a statement to Kaiser Health News, Pfizer declined to share the planned price. The government will also stop paying for the company’s COVID vaccine next year – those shots will quadruple in price, from the discount rate the government pays of $30 to about $120.
Mr. Bourla told investors in November that he expects the move will make Paxlovid and its COVID vaccine “a multibillion-dollars franchise.”
Nearly 9 in 10 people dying from the virus now are 65 or older. Yet federal law restricts Medicare Part D – the prescription drug program that covers nearly 50 million seniors – from covering the COVID treatment pills. The medications are meant for those most at risk of serious illness, including seniors.
Paxlovid and the other treatments are currently available under an emergency use authorization from the FDA, a fast-track review used in extraordinary situations. Although Pfizer applied for full approval in June, the process can take anywhere from several months to years. And Medicare Part D can’t cover any medications without that full stamp of approval.
Paying out-of-pocket would be “a substantial barrier” for seniors on Medicare – the very people who would benefit most from the drug, wrote federal health experts.
“From a public health perspective, and even from a health care capacity and cost perspective, it would just defy reason to not continue to make these drugs readily available,” said Dr. Larry Madoff, medical director of Massachusetts’s Bureau of Infectious Disease and Laboratory Sciences. He’s hopeful that the federal health agency will find a way to set aside unused doses for seniors and people without insurance.
In mid-November, the White House requested that Congress approve an additional $2.5 billion for COVID therapeutics and vaccines to make sure people can afford the medications when they’re no longer free. But there’s little hope it will be approved – the Senate voted that same day to end the public health emergency and denied similar requests in recent months.
Many Americans have already faced hurdles just getting a prescription for COVID treatment. Although the federal government doesn’t track who’s gotten the drug, a Centers for Disease Control and Prevention study using data from 30 medical centers found that Black and Hispanic patients with COVID were much less likely to receive Paxlovid than White patients. (Hispanic people can be of any race or combination of races.) And when the government is no longer picking up the tab, experts predict that these gaps by race, income, and geography will widen.
People in Northeastern states used the drug far more often than those in the rest of the country, according to a KHN analysis of Paxlovid use in September and October. But it wasn’t because people in the region were getting sick from COVID at much higher rates – instead, many of those states offered better access to health care to begin with and created special programs to get Paxlovid to their residents.
About 10 mostly Democratic states and several large counties in the Northeast and elsewhere created free “test-to-treat” programs that allow their residents to get an immediate doctor visit and prescription for treatment after testing positive for COVID. In Massachusetts, more than 20,000 residents have used the state’s video and phone hotline, which is available 7 days a week in 13 languages. Massachusetts, which has the highest insurance rate in the country and relatively low travel times to pharmacies, had the second-highest Paxlovid usage rate among states this fall.
States with higher COVID death rates, like Florida and Kentucky, where residents must travel farther for health care and are more likely to be uninsured, used the drug less often. Without no-cost test-to-treat options, residents have struggled to get prescriptions even though the drug itself is still free.
“If you look at access to medications for people who are uninsured, I think that there’s no question that will widen those disparities,” Ms. Rosenthal said.
People who get insurance through their jobs could face high copays at the register, too, just as they do for insulin and other expensive or brand-name drugs.
Most private insurance companies will end up covering COVID therapeutics to some extent, said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. After all, the pills are cheaper than a hospital stay. But for most people who get insurance through their jobs, there are “really no rules at all,” she said. Some insurers could take months to add the drugs to their plans or decide not to pay for them.
And the additional cost means many people will go without the medication. “We know from lots of research that when people face cost sharing for these drugs that they need to take, they will often forgo or cut back,” Ms. Corlette said.
One group doesn’t need to worry about sticker shock. Medicaid, the public insurance program for low-income adults and children, will cover the treatments in full until at least early 2024.
HHS officials could set aside any leftover taxpayer-funded medication for people who can’t afford to pay the full cost, but they haven’t shared any concrete plans to do so. The government purchased 20 million courses of Paxlovid and 3 million of Lagevrio. Fewer than a third have been used, and usage has fallen in recent months, according to KHN’s analysis of the data from HHS.
Sixty percent of the government’s supply of Evusheld is also still available, although the COVID prevention therapy is less effective against new strains of the virus. The health department in one state, New Mexico, has recommended against using it.
HHS did not make officials available for an interview or answer written questions about the commercialization plans.
The government created a potential workaround when they moved bebtelovimab, another COVID treatment, to the private market this summer. It now retails for $2,100 per patient. The agency set aside the remaining 60,000 government-purchased doses that hospitals could use to treat uninsured patients in a convoluted dose-replacement process. But it’s hard to tell how well that setup would work for Paxlovid: Bebtelovimab was already much less popular, and the FDA halted its use on Nov. 30 because it’s less effective against current strains of the virus.
Federal officials and insurance companies would have good reason to make sure patients can continue to afford COVID drugs: They’re far cheaper than if patients land in the emergency room.
“The medications are so worthwhile,” said Dr. Madoff, the Massachusetts health official. “They’re not expensive in the grand scheme of health care costs.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Advanced practice providers – an evolving role in pulmonary medicine
The integration of advanced practice providers (APPs) into pulmonology practice is in flux and deepening across numerous settings, from outpatient clinics to intensive care and inpatient pulmonary consult services – and as it evolves, so are issues of training.
Some institutions are developing pulmonary fellowship programs for APPs. This is a good indication that team-based pulmonology may be moving toward a time in the future when nurse practitioners (NPs) and physician assistants (PAs) join pulmonologists in practice after having undergone formal education in the subspecialty, rather than learning solely on the job from dedicated mentors.
Neither NPs nor PAs, who comprise almost all of the APP workforce in pulmonology, currently have a pulmonary tract for training. “Weight falls on the employer’s shoulders to train and educate their APPs,” said Corinne R. Young, MSN, FNP-C, FCCP, director of APP and clinical services at Colorado Springs Pulmonary Consultants and founder and president of the Association of Pulmonary Advanced Practice Providers, which launched in 2018.
The role that an APP plays and their scope of practice is determined not only by state policies and regulations – and by their prior experience, knowledge and motivation – but by “how much work a practice puts into [education and training],” she said.
An estimated 3,000-8,000 APPs are working in pulmonology, according to an analysis done by a marketing agency that has worked for the American College of Chest Physicians, Ms. Young said.
A 2021 APAPP survey of its several hundred members at the time showed them working in hospital systems (41%), private practice (28%), university systems (10%), and other health care systems (21%). They indicated practicing in pulmonary medicine, sleep medicine, or critical care – or some combination of these areas – and the vast majority (82%) indicated they were seeing both new and established patients in their roles.
“Nobody knows exactly how many of us are out there,” Ms. Young said. “But CHEST and APAPP are making great efforts to be beacons to APPs working in this realm and to bring them together to have a voice.”
The APAPP also wants to “close the education gap” and to “eventually develop a certification program to vet our knowledge in this area,” she said. “Right now, the closest we can get to vetting our knowledge is to become an FCCP through CHEST.”
Earning trust, seeking training
Omar Hussain, DO, has been practicing with an NP for over a decade in his role as an intensivist and knows what it’s like to train, supervise, and grow together. He and his private practice colleagues have a contract with Advocate Condell Hospital in Libertyville, Ill., to cover its ICU, and they hired their NP primarily to help care for shorter-stay, non–critically ill patients in the ICU (for example, patients receiving postoperative monitoring).
The NP has been invaluable. “We literally sit next to each other and in the mornings we make a game plan of which patients she will tackle first and which ones I’ll see first,” Dr. Hussain said. “When we’re called by the nurse for an ICU evaluation [on the floor], we’ll decide in real time who goes.”
The NP ensures that all guidelines and quality measures are followed in the ICU and, with a Monday-Friday schedule, she provides valuable continuity when there are handoffs from one intensivist to another, said Dr. Hussain, who serves as cochair of the joint CHEST/American Thoracic Society clinical practice committee, which deals with issues of physician-APP collaboration.
After working collaboratively for some time, Dr. Hussain and his partners decided to teach the NP how to intubate. It was a thoughtful and deliberate process, and “we used the same kind of mindset we’d used when we’ve supervised residents at other institutions,” he said.
Dr. Hussain and his partners have been fortunate in having such a long-term relationship with an APP. Their NP had worked as a nurse in the ICU before training as an adult gerontology–acute care NP and joining Dr. Hussain’s practice, so she was also “well known to us,” he added.
Rachel Adney, CPNP-PC, a certified pediatric NP in the division of pediatric pulmonology at Stanford (Calif.) Medicine Children’s Health, is an APP who actively sought advanced training. She joined Stanford in 2011 to provide ambulatory care, primarily, and having years of prior experience in asthma management and education, she fast became known as “the asthma person.”
After a physician colleague one day objected to her caring for a patient without asthma, Ms. Adney, the first APP in the division, approached John D. Mark, MD, program director of the pediatric fellowship program at Stanford, and inquired about training “so I could have more breadth and depth across the whole pulmonary milieu.”
Together they designed a “mini pediatric pulmonary fellowship” for Ms. Adney, incorporating elements of the first year of Stanford’s pediatric fellowship program as well as training materials from the University of Arizona’s Pediatric Pulmonary Center, Tucson, one of six federally funded PCCs that train various health care providers to care for pediatric patients with chronic pulmonary conditions. (Dr. Mark had previously been an educator at the center while serving on the University of Arizona faculty.)
Her curriculum consisted of 1,000 total hours of training, including 125 hours of didactic learning and 400 hours of both inpatient and outpatient clinical training in areas such as cystic fibrosis, sleep medicine, bronchopulmonary dysplasia (BPD), neuromuscular disorders, and general pulmonary medicine. “Rachel rotated through clinics, first as an observer, then as a trainee ... and she attended lectures that my fellows attended,” said Dr. Mark, who has long been a preceptor for APPs. “She became like a 1-year fellow in my division.”
Today, Ms. Adney sees patients independently in four outreach clinics along California’s central coast. “She sees very complicated pediatric pulmonary patients now” overall, and has become integral to Stanford’s interdisciplinary CRIB program (cardiac and respiratory care for infants with BPD), Dr. Mark said. “She follows these patients at Stanford along with the whole CRIB group, then sees them on her own for follow-up.”
As a result of her training, Ms. Adney said, “knowing that I have the knowledge and experience to take on more complex patients, my colleagues now trust me and are confident in my skills. They feel comfortable sending [patients] to me much earlier. ... And they know that if there’s something I need help with I will go to them instantly.”
Pulmonology “really spoke to my heart,” she said, recalling her pre-Stanford journey as an in-hospital medical-surgical nurse, and then, after her NP training, as a outpatient primary care PNP. “For the most part, it’s like putting a puzzle together, and being able to really impact the quality of life these patients have,” said Ms. Adney, who serves on the APAPP’s pediatric subcommittee.
It’s clear, Dr. Mark said, that “things are changing around the country” with increasing institutional interest in developing formal APP specialty training programs. “There’s no way [for an APP] to walk into a specialty and play an active role without additional training,” and institutions are frustrated with turnover and the loss of APPs who decide after 6-9 months of on-the-job training that they’re not interested in the field.
Stanford Medicine Children’s Health, in fact, has launched an internal Pediatric APP Fellowship Program that is training its first cohort of six newly graduated NPs and PAs in two clinical tracks, including a medical/surgical track that incorporates rotations in pulmonary medicine, said Raji Koppolu, CPNP-PC/AC, manager of advanced practice professional development for Stanford Medicine Children’s Health.
APP fellowship programs have been in existence since 2007 in a variety of clinical settings, she said, but more institutions are developing them as a way of recruiting and retaining APPs in areas of high need and of equipping them for successful transitions to their APP roles. Various national bodies accredit APP fellowship programs.
Most pulmonary fellowship programs, Ms. Young said, are also internal programs providing postgraduate education to their own newly hired APPs or recent NP/PA graduates. This limits their reach, but “it’s a step in the right direction toward standardizing education for pulmonary APPs.”
Defining APP competencies
In interventional pulmonology, training may soon be guided by newly defined “core clinical competencies” for APPs. The soon-to-be published and distributed competencies – the first such national APP competencies in pulmonology – were developed by an APP Leadership Council within the American Association of Bronchology and Interventional Pulmonology and cover the most common disease processes and practices in IP, from COPD and bronchoscopic lung volume reduction to pleural effusion and lung cancer screening.
Rebecca Priebe, ACNP-BC, who cochairs the AABIP’s APP chapter, organized the effort several years ago, bringing together a group of APPs and physician experts in advanced bronchoscopy and IP (some but not all of whom have worked with APPs), after fielding questions from pulmonologists at AABIP meetings about what to look for in an AAP and how to train them.
Physicians and institutions who are hiring and training APPs for IP can use any or all of the 11 core competencies to personalize and evaluate the training process for each APP’s needs, she said. “Someone looking to hire an APP for pleural disease, for instance, can pull up the content on plural effusion.”
APP interest in interventional pulmonology is growing rapidly, Ms. Priebe said, noting growth in the AABIP’s APP chapter from about 7-8 APPs 5 years ago to at least 60 currently.
Ms. Priebe was hired by Henry Ford Health in Detroit about 5 years ago to help establish and run an inpatient IP consult service, and more recently, she helped establish their inpatient pleural disease service and a bronchoscopic lung volume reduction program.
For the inpatient IP service, after several months of side-by-side training with an IP fellow and attending physicians, she began independently evaluating new patients, writing notes, and making recommendations.
For patients with pleural disease, she performs ultrasound examinations, chest tube insertions, and bedside thoracentesis independently. And for the bronchoscopic lung volume reduction program, she evaluates patients for candidate status, participates in valve placement, and sees patients independently through a year of follow-up.
“Physician colleagues often aren’t sure what an APP’s education and scope of practice is,” said Ms. Priebe, who was an ICU nurse before training as an acute care NP and then worked first with a private practice inpatient service and then with the University of Michigan, Ann Arbor, where she established and grew an APP-run program managing lung transplant patients and a step-down ICU unit.
“It’s a matter of knowing [your state’s policies], treating them like a fellow you would train, and then using them to the fullest extent of their education and training. If they’re given an opportunity to learn a subspecialty skill set, they can be an asset to any pulmonary program.”
‘We’re here to support,’ not replace
In her own practice, Ms. Young is one of seven APPs who work with nine physicians on a full range of inpatient care, outpatient care, critical care, sleep medicine, and procedures. Many new patients are seen first by the APP, who does the workup and orders tests, and by the physician on a follow-up visit. Most patients needing routine management of asthma and COPD are seen by the physician every third or fourth visit, she said.
Ms. Young also directs a 24-hour in-house APP service recently established by the practice, and she participates in research. In a practice across town, she noted, APPs see mainly established patients and do not practice as autonomously as the state permits. “Part of that difference may [stem from] the lack of a standard of education and variable amounts of work the practice puts into their APPs.”
The American Medical Association’s #StopScopeCreep social media messaging feels divisive and “sheds a negative light on APPs working in any area,” Ms. Young said. “One of the biggest things we want to convey [at APAPP] is that we’re not here for [physicians’] jobs.”
“We’re here to support those who are practicing, to support underserved populations, and to help bridge gaps” created by an aging pulmonologist workforce and real and projected physician shortages, Ms. Young said, referring to a 2016 report from the Health Resources and Services Administration and a 2017 report from Merritt Hawkins indicating that 73% of U.S. pulmonologists (the largest percentage of all subspecialties) were at least 55 years old.
Dr. Hussain said he has “seen scope creep” first-hand in his hospitals, in the form of noncollaborative practices and tasks performed by APPs without adequate training – most likely often stemming from poor decisions and oversight by physicians. But when constructed thoughtfully, APP-physician teams are “serving great needs” in many types of care, he said, from follow-up care and management of chronic conditions to inpatient rounding. “My [colleagues] are having great success,” he said.
He is watching with interest – and some concern – pending reimbursement changes from the Centers for Medicare & Medicaid Services that will make time the only defining feature of the “substantive” portion of a split/shared visit involving physicians and APPs in a facility setting. Medical decision-making will no longer be applicable.
For time-based services like critical care, time alone is currently the metric. (And in the nonfacility setting, physician-APP teams may still apply “incident to” billing practices). But in the facility setting, said Amy M. Ahasic, MD, MPH, a pulmonologist in Norwalk, Conn., who coauthored a 2022 commentary on the issue, the change (now planned for 2024) could be problematic for employed physicians whose contracts are based on productivity, and could create tension and possibly lead to reduced use of APPs rather than supporting collaborative care.
“The team model has been evolving so well over the past 10-15 years,” said Dr. Ahasic, who serves on the CHEST Health Policy and Advocacy Reimbursement Workgroup and cochairs the CHEST/American Thoracic Society clinical practice committee with Dr. Hussain. “It’s good for patient safety to have more [providers] involved ... and because APP salaries are lower health systems could do it and be able to have better care and better coverage.”
The pulmonology culture, said Dr. Hussain, has been increasingly embracing APPs and “it’s collegial.” Pulmonologists are “coming to CHEST meetings with their APPs. They’re learning the same things we’re learning, to manage the same patients we manage.”
The article sources reported that they had no relevant financial conflicts of interest to disclose.
The integration of advanced practice providers (APPs) into pulmonology practice is in flux and deepening across numerous settings, from outpatient clinics to intensive care and inpatient pulmonary consult services – and as it evolves, so are issues of training.
Some institutions are developing pulmonary fellowship programs for APPs. This is a good indication that team-based pulmonology may be moving toward a time in the future when nurse practitioners (NPs) and physician assistants (PAs) join pulmonologists in practice after having undergone formal education in the subspecialty, rather than learning solely on the job from dedicated mentors.
Neither NPs nor PAs, who comprise almost all of the APP workforce in pulmonology, currently have a pulmonary tract for training. “Weight falls on the employer’s shoulders to train and educate their APPs,” said Corinne R. Young, MSN, FNP-C, FCCP, director of APP and clinical services at Colorado Springs Pulmonary Consultants and founder and president of the Association of Pulmonary Advanced Practice Providers, which launched in 2018.
The role that an APP plays and their scope of practice is determined not only by state policies and regulations – and by their prior experience, knowledge and motivation – but by “how much work a practice puts into [education and training],” she said.
An estimated 3,000-8,000 APPs are working in pulmonology, according to an analysis done by a marketing agency that has worked for the American College of Chest Physicians, Ms. Young said.
A 2021 APAPP survey of its several hundred members at the time showed them working in hospital systems (41%), private practice (28%), university systems (10%), and other health care systems (21%). They indicated practicing in pulmonary medicine, sleep medicine, or critical care – or some combination of these areas – and the vast majority (82%) indicated they were seeing both new and established patients in their roles.
“Nobody knows exactly how many of us are out there,” Ms. Young said. “But CHEST and APAPP are making great efforts to be beacons to APPs working in this realm and to bring them together to have a voice.”
The APAPP also wants to “close the education gap” and to “eventually develop a certification program to vet our knowledge in this area,” she said. “Right now, the closest we can get to vetting our knowledge is to become an FCCP through CHEST.”
Earning trust, seeking training
Omar Hussain, DO, has been practicing with an NP for over a decade in his role as an intensivist and knows what it’s like to train, supervise, and grow together. He and his private practice colleagues have a contract with Advocate Condell Hospital in Libertyville, Ill., to cover its ICU, and they hired their NP primarily to help care for shorter-stay, non–critically ill patients in the ICU (for example, patients receiving postoperative monitoring).
The NP has been invaluable. “We literally sit next to each other and in the mornings we make a game plan of which patients she will tackle first and which ones I’ll see first,” Dr. Hussain said. “When we’re called by the nurse for an ICU evaluation [on the floor], we’ll decide in real time who goes.”
The NP ensures that all guidelines and quality measures are followed in the ICU and, with a Monday-Friday schedule, she provides valuable continuity when there are handoffs from one intensivist to another, said Dr. Hussain, who serves as cochair of the joint CHEST/American Thoracic Society clinical practice committee, which deals with issues of physician-APP collaboration.
After working collaboratively for some time, Dr. Hussain and his partners decided to teach the NP how to intubate. It was a thoughtful and deliberate process, and “we used the same kind of mindset we’d used when we’ve supervised residents at other institutions,” he said.
Dr. Hussain and his partners have been fortunate in having such a long-term relationship with an APP. Their NP had worked as a nurse in the ICU before training as an adult gerontology–acute care NP and joining Dr. Hussain’s practice, so she was also “well known to us,” he added.
Rachel Adney, CPNP-PC, a certified pediatric NP in the division of pediatric pulmonology at Stanford (Calif.) Medicine Children’s Health, is an APP who actively sought advanced training. She joined Stanford in 2011 to provide ambulatory care, primarily, and having years of prior experience in asthma management and education, she fast became known as “the asthma person.”
After a physician colleague one day objected to her caring for a patient without asthma, Ms. Adney, the first APP in the division, approached John D. Mark, MD, program director of the pediatric fellowship program at Stanford, and inquired about training “so I could have more breadth and depth across the whole pulmonary milieu.”
Together they designed a “mini pediatric pulmonary fellowship” for Ms. Adney, incorporating elements of the first year of Stanford’s pediatric fellowship program as well as training materials from the University of Arizona’s Pediatric Pulmonary Center, Tucson, one of six federally funded PCCs that train various health care providers to care for pediatric patients with chronic pulmonary conditions. (Dr. Mark had previously been an educator at the center while serving on the University of Arizona faculty.)
Her curriculum consisted of 1,000 total hours of training, including 125 hours of didactic learning and 400 hours of both inpatient and outpatient clinical training in areas such as cystic fibrosis, sleep medicine, bronchopulmonary dysplasia (BPD), neuromuscular disorders, and general pulmonary medicine. “Rachel rotated through clinics, first as an observer, then as a trainee ... and she attended lectures that my fellows attended,” said Dr. Mark, who has long been a preceptor for APPs. “She became like a 1-year fellow in my division.”
Today, Ms. Adney sees patients independently in four outreach clinics along California’s central coast. “She sees very complicated pediatric pulmonary patients now” overall, and has become integral to Stanford’s interdisciplinary CRIB program (cardiac and respiratory care for infants with BPD), Dr. Mark said. “She follows these patients at Stanford along with the whole CRIB group, then sees them on her own for follow-up.”
As a result of her training, Ms. Adney said, “knowing that I have the knowledge and experience to take on more complex patients, my colleagues now trust me and are confident in my skills. They feel comfortable sending [patients] to me much earlier. ... And they know that if there’s something I need help with I will go to them instantly.”
Pulmonology “really spoke to my heart,” she said, recalling her pre-Stanford journey as an in-hospital medical-surgical nurse, and then, after her NP training, as a outpatient primary care PNP. “For the most part, it’s like putting a puzzle together, and being able to really impact the quality of life these patients have,” said Ms. Adney, who serves on the APAPP’s pediatric subcommittee.
It’s clear, Dr. Mark said, that “things are changing around the country” with increasing institutional interest in developing formal APP specialty training programs. “There’s no way [for an APP] to walk into a specialty and play an active role without additional training,” and institutions are frustrated with turnover and the loss of APPs who decide after 6-9 months of on-the-job training that they’re not interested in the field.
Stanford Medicine Children’s Health, in fact, has launched an internal Pediatric APP Fellowship Program that is training its first cohort of six newly graduated NPs and PAs in two clinical tracks, including a medical/surgical track that incorporates rotations in pulmonary medicine, said Raji Koppolu, CPNP-PC/AC, manager of advanced practice professional development for Stanford Medicine Children’s Health.
APP fellowship programs have been in existence since 2007 in a variety of clinical settings, she said, but more institutions are developing them as a way of recruiting and retaining APPs in areas of high need and of equipping them for successful transitions to their APP roles. Various national bodies accredit APP fellowship programs.
Most pulmonary fellowship programs, Ms. Young said, are also internal programs providing postgraduate education to their own newly hired APPs or recent NP/PA graduates. This limits their reach, but “it’s a step in the right direction toward standardizing education for pulmonary APPs.”
Defining APP competencies
In interventional pulmonology, training may soon be guided by newly defined “core clinical competencies” for APPs. The soon-to-be published and distributed competencies – the first such national APP competencies in pulmonology – were developed by an APP Leadership Council within the American Association of Bronchology and Interventional Pulmonology and cover the most common disease processes and practices in IP, from COPD and bronchoscopic lung volume reduction to pleural effusion and lung cancer screening.
Rebecca Priebe, ACNP-BC, who cochairs the AABIP’s APP chapter, organized the effort several years ago, bringing together a group of APPs and physician experts in advanced bronchoscopy and IP (some but not all of whom have worked with APPs), after fielding questions from pulmonologists at AABIP meetings about what to look for in an AAP and how to train them.
Physicians and institutions who are hiring and training APPs for IP can use any or all of the 11 core competencies to personalize and evaluate the training process for each APP’s needs, she said. “Someone looking to hire an APP for pleural disease, for instance, can pull up the content on plural effusion.”
APP interest in interventional pulmonology is growing rapidly, Ms. Priebe said, noting growth in the AABIP’s APP chapter from about 7-8 APPs 5 years ago to at least 60 currently.
Ms. Priebe was hired by Henry Ford Health in Detroit about 5 years ago to help establish and run an inpatient IP consult service, and more recently, she helped establish their inpatient pleural disease service and a bronchoscopic lung volume reduction program.
For the inpatient IP service, after several months of side-by-side training with an IP fellow and attending physicians, she began independently evaluating new patients, writing notes, and making recommendations.
For patients with pleural disease, she performs ultrasound examinations, chest tube insertions, and bedside thoracentesis independently. And for the bronchoscopic lung volume reduction program, she evaluates patients for candidate status, participates in valve placement, and sees patients independently through a year of follow-up.
“Physician colleagues often aren’t sure what an APP’s education and scope of practice is,” said Ms. Priebe, who was an ICU nurse before training as an acute care NP and then worked first with a private practice inpatient service and then with the University of Michigan, Ann Arbor, where she established and grew an APP-run program managing lung transplant patients and a step-down ICU unit.
“It’s a matter of knowing [your state’s policies], treating them like a fellow you would train, and then using them to the fullest extent of their education and training. If they’re given an opportunity to learn a subspecialty skill set, they can be an asset to any pulmonary program.”
‘We’re here to support,’ not replace
In her own practice, Ms. Young is one of seven APPs who work with nine physicians on a full range of inpatient care, outpatient care, critical care, sleep medicine, and procedures. Many new patients are seen first by the APP, who does the workup and orders tests, and by the physician on a follow-up visit. Most patients needing routine management of asthma and COPD are seen by the physician every third or fourth visit, she said.
Ms. Young also directs a 24-hour in-house APP service recently established by the practice, and she participates in research. In a practice across town, she noted, APPs see mainly established patients and do not practice as autonomously as the state permits. “Part of that difference may [stem from] the lack of a standard of education and variable amounts of work the practice puts into their APPs.”
The American Medical Association’s #StopScopeCreep social media messaging feels divisive and “sheds a negative light on APPs working in any area,” Ms. Young said. “One of the biggest things we want to convey [at APAPP] is that we’re not here for [physicians’] jobs.”
“We’re here to support those who are practicing, to support underserved populations, and to help bridge gaps” created by an aging pulmonologist workforce and real and projected physician shortages, Ms. Young said, referring to a 2016 report from the Health Resources and Services Administration and a 2017 report from Merritt Hawkins indicating that 73% of U.S. pulmonologists (the largest percentage of all subspecialties) were at least 55 years old.
Dr. Hussain said he has “seen scope creep” first-hand in his hospitals, in the form of noncollaborative practices and tasks performed by APPs without adequate training – most likely often stemming from poor decisions and oversight by physicians. But when constructed thoughtfully, APP-physician teams are “serving great needs” in many types of care, he said, from follow-up care and management of chronic conditions to inpatient rounding. “My [colleagues] are having great success,” he said.
He is watching with interest – and some concern – pending reimbursement changes from the Centers for Medicare & Medicaid Services that will make time the only defining feature of the “substantive” portion of a split/shared visit involving physicians and APPs in a facility setting. Medical decision-making will no longer be applicable.
For time-based services like critical care, time alone is currently the metric. (And in the nonfacility setting, physician-APP teams may still apply “incident to” billing practices). But in the facility setting, said Amy M. Ahasic, MD, MPH, a pulmonologist in Norwalk, Conn., who coauthored a 2022 commentary on the issue, the change (now planned for 2024) could be problematic for employed physicians whose contracts are based on productivity, and could create tension and possibly lead to reduced use of APPs rather than supporting collaborative care.
“The team model has been evolving so well over the past 10-15 years,” said Dr. Ahasic, who serves on the CHEST Health Policy and Advocacy Reimbursement Workgroup and cochairs the CHEST/American Thoracic Society clinical practice committee with Dr. Hussain. “It’s good for patient safety to have more [providers] involved ... and because APP salaries are lower health systems could do it and be able to have better care and better coverage.”
The pulmonology culture, said Dr. Hussain, has been increasingly embracing APPs and “it’s collegial.” Pulmonologists are “coming to CHEST meetings with their APPs. They’re learning the same things we’re learning, to manage the same patients we manage.”
The article sources reported that they had no relevant financial conflicts of interest to disclose.
The integration of advanced practice providers (APPs) into pulmonology practice is in flux and deepening across numerous settings, from outpatient clinics to intensive care and inpatient pulmonary consult services – and as it evolves, so are issues of training.
Some institutions are developing pulmonary fellowship programs for APPs. This is a good indication that team-based pulmonology may be moving toward a time in the future when nurse practitioners (NPs) and physician assistants (PAs) join pulmonologists in practice after having undergone formal education in the subspecialty, rather than learning solely on the job from dedicated mentors.
Neither NPs nor PAs, who comprise almost all of the APP workforce in pulmonology, currently have a pulmonary tract for training. “Weight falls on the employer’s shoulders to train and educate their APPs,” said Corinne R. Young, MSN, FNP-C, FCCP, director of APP and clinical services at Colorado Springs Pulmonary Consultants and founder and president of the Association of Pulmonary Advanced Practice Providers, which launched in 2018.
The role that an APP plays and their scope of practice is determined not only by state policies and regulations – and by their prior experience, knowledge and motivation – but by “how much work a practice puts into [education and training],” she said.
An estimated 3,000-8,000 APPs are working in pulmonology, according to an analysis done by a marketing agency that has worked for the American College of Chest Physicians, Ms. Young said.
A 2021 APAPP survey of its several hundred members at the time showed them working in hospital systems (41%), private practice (28%), university systems (10%), and other health care systems (21%). They indicated practicing in pulmonary medicine, sleep medicine, or critical care – or some combination of these areas – and the vast majority (82%) indicated they were seeing both new and established patients in their roles.
“Nobody knows exactly how many of us are out there,” Ms. Young said. “But CHEST and APAPP are making great efforts to be beacons to APPs working in this realm and to bring them together to have a voice.”
The APAPP also wants to “close the education gap” and to “eventually develop a certification program to vet our knowledge in this area,” she said. “Right now, the closest we can get to vetting our knowledge is to become an FCCP through CHEST.”
Earning trust, seeking training
Omar Hussain, DO, has been practicing with an NP for over a decade in his role as an intensivist and knows what it’s like to train, supervise, and grow together. He and his private practice colleagues have a contract with Advocate Condell Hospital in Libertyville, Ill., to cover its ICU, and they hired their NP primarily to help care for shorter-stay, non–critically ill patients in the ICU (for example, patients receiving postoperative monitoring).
The NP has been invaluable. “We literally sit next to each other and in the mornings we make a game plan of which patients she will tackle first and which ones I’ll see first,” Dr. Hussain said. “When we’re called by the nurse for an ICU evaluation [on the floor], we’ll decide in real time who goes.”
The NP ensures that all guidelines and quality measures are followed in the ICU and, with a Monday-Friday schedule, she provides valuable continuity when there are handoffs from one intensivist to another, said Dr. Hussain, who serves as cochair of the joint CHEST/American Thoracic Society clinical practice committee, which deals with issues of physician-APP collaboration.
After working collaboratively for some time, Dr. Hussain and his partners decided to teach the NP how to intubate. It was a thoughtful and deliberate process, and “we used the same kind of mindset we’d used when we’ve supervised residents at other institutions,” he said.
Dr. Hussain and his partners have been fortunate in having such a long-term relationship with an APP. Their NP had worked as a nurse in the ICU before training as an adult gerontology–acute care NP and joining Dr. Hussain’s practice, so she was also “well known to us,” he added.
Rachel Adney, CPNP-PC, a certified pediatric NP in the division of pediatric pulmonology at Stanford (Calif.) Medicine Children’s Health, is an APP who actively sought advanced training. She joined Stanford in 2011 to provide ambulatory care, primarily, and having years of prior experience in asthma management and education, she fast became known as “the asthma person.”
After a physician colleague one day objected to her caring for a patient without asthma, Ms. Adney, the first APP in the division, approached John D. Mark, MD, program director of the pediatric fellowship program at Stanford, and inquired about training “so I could have more breadth and depth across the whole pulmonary milieu.”
Together they designed a “mini pediatric pulmonary fellowship” for Ms. Adney, incorporating elements of the first year of Stanford’s pediatric fellowship program as well as training materials from the University of Arizona’s Pediatric Pulmonary Center, Tucson, one of six federally funded PCCs that train various health care providers to care for pediatric patients with chronic pulmonary conditions. (Dr. Mark had previously been an educator at the center while serving on the University of Arizona faculty.)
Her curriculum consisted of 1,000 total hours of training, including 125 hours of didactic learning and 400 hours of both inpatient and outpatient clinical training in areas such as cystic fibrosis, sleep medicine, bronchopulmonary dysplasia (BPD), neuromuscular disorders, and general pulmonary medicine. “Rachel rotated through clinics, first as an observer, then as a trainee ... and she attended lectures that my fellows attended,” said Dr. Mark, who has long been a preceptor for APPs. “She became like a 1-year fellow in my division.”
Today, Ms. Adney sees patients independently in four outreach clinics along California’s central coast. “She sees very complicated pediatric pulmonary patients now” overall, and has become integral to Stanford’s interdisciplinary CRIB program (cardiac and respiratory care for infants with BPD), Dr. Mark said. “She follows these patients at Stanford along with the whole CRIB group, then sees them on her own for follow-up.”
As a result of her training, Ms. Adney said, “knowing that I have the knowledge and experience to take on more complex patients, my colleagues now trust me and are confident in my skills. They feel comfortable sending [patients] to me much earlier. ... And they know that if there’s something I need help with I will go to them instantly.”
Pulmonology “really spoke to my heart,” she said, recalling her pre-Stanford journey as an in-hospital medical-surgical nurse, and then, after her NP training, as a outpatient primary care PNP. “For the most part, it’s like putting a puzzle together, and being able to really impact the quality of life these patients have,” said Ms. Adney, who serves on the APAPP’s pediatric subcommittee.
It’s clear, Dr. Mark said, that “things are changing around the country” with increasing institutional interest in developing formal APP specialty training programs. “There’s no way [for an APP] to walk into a specialty and play an active role without additional training,” and institutions are frustrated with turnover and the loss of APPs who decide after 6-9 months of on-the-job training that they’re not interested in the field.
Stanford Medicine Children’s Health, in fact, has launched an internal Pediatric APP Fellowship Program that is training its first cohort of six newly graduated NPs and PAs in two clinical tracks, including a medical/surgical track that incorporates rotations in pulmonary medicine, said Raji Koppolu, CPNP-PC/AC, manager of advanced practice professional development for Stanford Medicine Children’s Health.
APP fellowship programs have been in existence since 2007 in a variety of clinical settings, she said, but more institutions are developing them as a way of recruiting and retaining APPs in areas of high need and of equipping them for successful transitions to their APP roles. Various national bodies accredit APP fellowship programs.
Most pulmonary fellowship programs, Ms. Young said, are also internal programs providing postgraduate education to their own newly hired APPs or recent NP/PA graduates. This limits their reach, but “it’s a step in the right direction toward standardizing education for pulmonary APPs.”
Defining APP competencies
In interventional pulmonology, training may soon be guided by newly defined “core clinical competencies” for APPs. The soon-to-be published and distributed competencies – the first such national APP competencies in pulmonology – were developed by an APP Leadership Council within the American Association of Bronchology and Interventional Pulmonology and cover the most common disease processes and practices in IP, from COPD and bronchoscopic lung volume reduction to pleural effusion and lung cancer screening.
Rebecca Priebe, ACNP-BC, who cochairs the AABIP’s APP chapter, organized the effort several years ago, bringing together a group of APPs and physician experts in advanced bronchoscopy and IP (some but not all of whom have worked with APPs), after fielding questions from pulmonologists at AABIP meetings about what to look for in an AAP and how to train them.
Physicians and institutions who are hiring and training APPs for IP can use any or all of the 11 core competencies to personalize and evaluate the training process for each APP’s needs, she said. “Someone looking to hire an APP for pleural disease, for instance, can pull up the content on plural effusion.”
APP interest in interventional pulmonology is growing rapidly, Ms. Priebe said, noting growth in the AABIP’s APP chapter from about 7-8 APPs 5 years ago to at least 60 currently.
Ms. Priebe was hired by Henry Ford Health in Detroit about 5 years ago to help establish and run an inpatient IP consult service, and more recently, she helped establish their inpatient pleural disease service and a bronchoscopic lung volume reduction program.
For the inpatient IP service, after several months of side-by-side training with an IP fellow and attending physicians, she began independently evaluating new patients, writing notes, and making recommendations.
For patients with pleural disease, she performs ultrasound examinations, chest tube insertions, and bedside thoracentesis independently. And for the bronchoscopic lung volume reduction program, she evaluates patients for candidate status, participates in valve placement, and sees patients independently through a year of follow-up.
“Physician colleagues often aren’t sure what an APP’s education and scope of practice is,” said Ms. Priebe, who was an ICU nurse before training as an acute care NP and then worked first with a private practice inpatient service and then with the University of Michigan, Ann Arbor, where she established and grew an APP-run program managing lung transplant patients and a step-down ICU unit.
“It’s a matter of knowing [your state’s policies], treating them like a fellow you would train, and then using them to the fullest extent of their education and training. If they’re given an opportunity to learn a subspecialty skill set, they can be an asset to any pulmonary program.”
‘We’re here to support,’ not replace
In her own practice, Ms. Young is one of seven APPs who work with nine physicians on a full range of inpatient care, outpatient care, critical care, sleep medicine, and procedures. Many new patients are seen first by the APP, who does the workup and orders tests, and by the physician on a follow-up visit. Most patients needing routine management of asthma and COPD are seen by the physician every third or fourth visit, she said.
Ms. Young also directs a 24-hour in-house APP service recently established by the practice, and she participates in research. In a practice across town, she noted, APPs see mainly established patients and do not practice as autonomously as the state permits. “Part of that difference may [stem from] the lack of a standard of education and variable amounts of work the practice puts into their APPs.”
The American Medical Association’s #StopScopeCreep social media messaging feels divisive and “sheds a negative light on APPs working in any area,” Ms. Young said. “One of the biggest things we want to convey [at APAPP] is that we’re not here for [physicians’] jobs.”
“We’re here to support those who are practicing, to support underserved populations, and to help bridge gaps” created by an aging pulmonologist workforce and real and projected physician shortages, Ms. Young said, referring to a 2016 report from the Health Resources and Services Administration and a 2017 report from Merritt Hawkins indicating that 73% of U.S. pulmonologists (the largest percentage of all subspecialties) were at least 55 years old.
Dr. Hussain said he has “seen scope creep” first-hand in his hospitals, in the form of noncollaborative practices and tasks performed by APPs without adequate training – most likely often stemming from poor decisions and oversight by physicians. But when constructed thoughtfully, APP-physician teams are “serving great needs” in many types of care, he said, from follow-up care and management of chronic conditions to inpatient rounding. “My [colleagues] are having great success,” he said.
He is watching with interest – and some concern – pending reimbursement changes from the Centers for Medicare & Medicaid Services that will make time the only defining feature of the “substantive” portion of a split/shared visit involving physicians and APPs in a facility setting. Medical decision-making will no longer be applicable.
For time-based services like critical care, time alone is currently the metric. (And in the nonfacility setting, physician-APP teams may still apply “incident to” billing practices). But in the facility setting, said Amy M. Ahasic, MD, MPH, a pulmonologist in Norwalk, Conn., who coauthored a 2022 commentary on the issue, the change (now planned for 2024) could be problematic for employed physicians whose contracts are based on productivity, and could create tension and possibly lead to reduced use of APPs rather than supporting collaborative care.
“The team model has been evolving so well over the past 10-15 years,” said Dr. Ahasic, who serves on the CHEST Health Policy and Advocacy Reimbursement Workgroup and cochairs the CHEST/American Thoracic Society clinical practice committee with Dr. Hussain. “It’s good for patient safety to have more [providers] involved ... and because APP salaries are lower health systems could do it and be able to have better care and better coverage.”
The pulmonology culture, said Dr. Hussain, has been increasingly embracing APPs and “it’s collegial.” Pulmonologists are “coming to CHEST meetings with their APPs. They’re learning the same things we’re learning, to manage the same patients we manage.”
The article sources reported that they had no relevant financial conflicts of interest to disclose.
Advocacy Update: Ringing in 2023
New Year, New Codes: A Win-Win for Digital Pathology
In July 2022, the American Medical Association CPT (Current Procedural Terminology) Editorial Panel released 13 new digital pathology add-on Category III codes for 2023 that the College of American Pathologists successfully advocated for inclusion.1 These codes are for reporting additional clinical staff work and service requirements associated with digitizing glass microscope slides for primary diagnosis (Table). They go into effect on January 1, 2023.
Although there is no additional compensation with the new Category III codes, dermatopathology laboratories will be able to report when they have made a diagnosis using digital pathology. The new CPT codes will provide payers with data they need to directly understand the utilization and increased value of digital pathology, which will bring dermatopathology laboratories one step closer to receiving additional reimbursement for digital interpretation.
The adoption of digital pathology has been accelerating in the United States but still lags behind many European countries where reimbursement for digital pathology has been established for many years. Many of the barriers to digital pathology have improved—cloud storage is more affordable, scanners have a higher throughput, digital pathology platforms have improved, and the US Food and Drug Administration has granted approvals for digital pathology. Digital pathology allows for more efficient workflow, which results in increased productivity and a reduction in turnaround times. It also allows for a wide spectrum of clinical applications and more innovation as well as research and educational applications.
The new Category III codes cannot be reported solely for archival purposes (eg, after the Category I service has already been performed and reported), solely for educational purposes (eg, when services are not used for individual patient reporting), solely for developing a database for training or validation of artificial intelligence algorithms, and solely for clinical conference presentations (eg, tumor board interdisciplinary conferences).
The new codes are a major victory for the adoption and future compensation for digital pathology.
New Year, New Cuts: Proposed 2023 Medicare Policy and Payment Changes for Dermatologists
The United States Spent $3.8 Trillion on Health Care in 2019: Where Did It Go?—In 2019, approximately $3.8 trillion was spent on health care in the United States (Figure 1). Physician services accounted for approximately 15% of total health care spending.2
Medicare Payments for Physician Services—Medicare payments for physician services are determined by a relative value unit (RVU) multiplied by a conversion factor (CF). Relative value units were set up in 1992 by what is now the Centers for Medicare & Medicaid Services, and they calculated the time it took a physician to complete a task or RVU and multiplied it by $32.00 (CF).3
Thirty years later—in 2022—the CF is $34.61. If the CF had increased with inflation, it would be $59.00. If the Proposed Rule is adopted, the 2023 fee schedule payment formula would decrease by 4.4% (to $33.08) relative to that of the 2022 fee schedule ($34.61), which is a decrease of 8.2% since 2019 ($36.04). This decrease is due to expiration of the 3% increase to Medicare fee schedule payments for 2022 required by the Protecting Medicare and American Farmers from Sequester Cuts Act and the required budget neutrality adjustment required by changes in RVUs. Medicare physician payment has declined 22% from 2001 to 2022 (Figure 2).4,5
The adjustments to the CF typically are made based on 3 factors: (1) the Medicare Economic Index; (2) expenditure target “performance adjustment”; and (3) miscellaneous adjustments, including those for “budget neutrality” required by law.
Medicare Physician Payments Compared With Other Provider Types and Inflation—The proposed Medicare physician payment policy is unsustainable for outpatient dermatologists. Practice overhead has increased markedly since 1992. Other service providers, such as those in skilled nursing facilities and hospitals (Figure 3), have received favorable payment increases compared with practice cost inflation and the Consumer Price Index.3-6 Flat reimbursement affects all physicians who accept insurance, as even private insurers base their reimbursement on Medicare.
In addition, there are other issues resulting in decreased physician payments when evaluation and management services are reported with same-day procedures using modifier −25 as well as preserving or finding alternative strategies for 10- and 90-day global period payments for medical procedures. When Medicare cuts physician payments, dermatologists find it difficult to own and operate their own practices, resulting in health market consolidation, limited competition, increased health care costs, limited patient access to care, and decreased quality of health care.
Medicare Payment Reform—Medicare payment reform is necessary to stop annual payment cuts and create a stable predictable payment system that ensures patient access to quality, value-based care. Medicare physician payment reform needs to happen at a national level. The American Academy of Dermatology Association (AADA) is working with the House of Medicine and the medical specialty community to develop specific proposals, such as “Characteristics of a Rational Medicare Physician Payment System,” to reform Medicare’s payment system.7 Advocacy groups, including the AADA, have been working to mitigate the proposed 2023 cuts by engaging with Congress and urging them to act before these changes go into effect on January 1, 2023.
Make Advocacy Your New Year’s Resolution: AADA’s Top Advocacy Priorities
The AADA’s top priority is Medicare payment policies.3 In addition, the AADA is working on drug access and cost by cutting the bureaucratic red tape caused by prior authorization (PA) and step therapy policies. The AADA collaborates with manufacturers, the health care community, policymakers, private payers, pharmacists, pharmacy benefit managers, and patients to minimize and/or eliminate barriers that patients face in accessing needed medications. Specifically, the AADA advocates for legislation that limits obstacles associated with health insurance step therapy requirements, streamlines PA, and prohibits mid-year formulary changes.8
Step therapy requires that patients first try a medication specified by the insurance company; the therapy must fail before the patient is placed on the medication originally prescribed by the provider. Regarding PA, the AADA tries to ensure that determinations are standardized, requires the speed of determinations to be quantified and minimized, and ensures that PA and appeals policies do not unduly burden physicians or patients in accessing optimal drug therapy.8
Another advocacy priority is telehealth. The AADA is advocating for legislation on expansion of telehealth in underserved areas and modifications to state licensure requirements, liability issues, and reimbursement for store-and-forward technology. The AADA is involved in protecting scope of practice, truth in advertising, and access to specialty care, as well as monitoring legislation and regulation concerning the potential environmental impact of sunscreen ingredients, indoor tanning restrictions, and skin cancer prevention.8
Advocacy Matters and Makes a Difference—It is important to learn about and support advocacy priorities and efforts and join forces to protect your practice. The AADA advocacy priorities are to protect the value of dermatology services, mobilize dermatologists for political action, ensure dermatologists can participate in new payment models, and strengthen the profession.9 Physician advocacy is no longer an elective pursuit. We need to be involved and engaged through our medical societies to help patients, communities, and ourselves. All of us are in it together, and a collaborative collective voice can make a difference. Take action, join the AADA, and contact Congress today to stop Medicare payment cuts (https://takeaction.aad.org/).
- Kaplan KJ. AMA announces new add-on digital pathology codes—no reimbursement (yet). July 18, 2022. Accessed October 19, 2022. https://tissuepathology.com/2022/07/18/ama-announces-new-add-on-digital-pathology-codes-no-reimbursement-yet/
- Centers for Medicare & Medicaid Services. National Health Expenditure Data: NHE fact sheet. Published April 2020. Accessed November 21, 2022. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NHE-Fact-Sheet
- Houghton V. Ask the expert (Dr. Mark Kaufmann): fighting for fair Medicare reimbursement. Dermatology World. October 2022. Accessed November 21, 2022. https://digitaleditions.walsworth.com/article/Advocacy+News/4355162/763056/article.html
- Federal Register, Medicare Trustees’ Reports and U.S. Bureau of Labor Statistics, AMA, Economic and Health Policy Research. September 2022. Accessed November 21, 2022. https://www.ama-assn.org/system/files/key-measures-medicare-economic-index-chart.pdf
- American Medical Association. Current Medicare payment system on unsustainable path: contact Congress. September 30, 2022. Accessed November 21, 2022. https://www.ama-assn.org/practice-management/medicare-medicaid/current-medicare-payment-system-unsustainable-path-contact
- U.S. Bureau of Labor Statistics, American Medical Association, Economic and Health Policy Research, February 2022. Accessed November 21, 2022. https://www.ama-assn.org/system/files/key-measures-medicare-economic-index-chart.pdf
- American Medical Association. Characteristics of a rational Medicare payment system. Accessed November 22, 2022. https://www.ama-assn.org/system/files/characteristics-rational-medicare-payment-principles-signatories.pdf
- Ensuring patient access to effective and affordable treatments remains a top priority for the AAD. Dermatology Practice Management. June 2020. Accessed November 21, 2022. https://dermatologypracticemanagement.com/issues/2020/june-2020-vol-1-no-1/11-supporting-access-to-treatment-exceptional-customer-experience-innovation-and-growth-a-conversation-with-sumner-madden
- Marteja L. Advocacy: when, where, and how for dermatologists. The Dermatologist. September 2021. Accessed November 21, 2022. https://www.hmpgloballearningnetwork.com/site/thederm/cover-story/advocacy-when-where-and-how-dermatologists
New Year, New Codes: A Win-Win for Digital Pathology
In July 2022, the American Medical Association CPT (Current Procedural Terminology) Editorial Panel released 13 new digital pathology add-on Category III codes for 2023 that the College of American Pathologists successfully advocated for inclusion.1 These codes are for reporting additional clinical staff work and service requirements associated with digitizing glass microscope slides for primary diagnosis (Table). They go into effect on January 1, 2023.
Although there is no additional compensation with the new Category III codes, dermatopathology laboratories will be able to report when they have made a diagnosis using digital pathology. The new CPT codes will provide payers with data they need to directly understand the utilization and increased value of digital pathology, which will bring dermatopathology laboratories one step closer to receiving additional reimbursement for digital interpretation.
The adoption of digital pathology has been accelerating in the United States but still lags behind many European countries where reimbursement for digital pathology has been established for many years. Many of the barriers to digital pathology have improved—cloud storage is more affordable, scanners have a higher throughput, digital pathology platforms have improved, and the US Food and Drug Administration has granted approvals for digital pathology. Digital pathology allows for more efficient workflow, which results in increased productivity and a reduction in turnaround times. It also allows for a wide spectrum of clinical applications and more innovation as well as research and educational applications.
The new Category III codes cannot be reported solely for archival purposes (eg, after the Category I service has already been performed and reported), solely for educational purposes (eg, when services are not used for individual patient reporting), solely for developing a database for training or validation of artificial intelligence algorithms, and solely for clinical conference presentations (eg, tumor board interdisciplinary conferences).
The new codes are a major victory for the adoption and future compensation for digital pathology.
New Year, New Cuts: Proposed 2023 Medicare Policy and Payment Changes for Dermatologists
The United States Spent $3.8 Trillion on Health Care in 2019: Where Did It Go?—In 2019, approximately $3.8 trillion was spent on health care in the United States (Figure 1). Physician services accounted for approximately 15% of total health care spending.2
Medicare Payments for Physician Services—Medicare payments for physician services are determined by a relative value unit (RVU) multiplied by a conversion factor (CF). Relative value units were set up in 1992 by what is now the Centers for Medicare & Medicaid Services, and they calculated the time it took a physician to complete a task or RVU and multiplied it by $32.00 (CF).3
Thirty years later—in 2022—the CF is $34.61. If the CF had increased with inflation, it would be $59.00. If the Proposed Rule is adopted, the 2023 fee schedule payment formula would decrease by 4.4% (to $33.08) relative to that of the 2022 fee schedule ($34.61), which is a decrease of 8.2% since 2019 ($36.04). This decrease is due to expiration of the 3% increase to Medicare fee schedule payments for 2022 required by the Protecting Medicare and American Farmers from Sequester Cuts Act and the required budget neutrality adjustment required by changes in RVUs. Medicare physician payment has declined 22% from 2001 to 2022 (Figure 2).4,5
The adjustments to the CF typically are made based on 3 factors: (1) the Medicare Economic Index; (2) expenditure target “performance adjustment”; and (3) miscellaneous adjustments, including those for “budget neutrality” required by law.
Medicare Physician Payments Compared With Other Provider Types and Inflation—The proposed Medicare physician payment policy is unsustainable for outpatient dermatologists. Practice overhead has increased markedly since 1992. Other service providers, such as those in skilled nursing facilities and hospitals (Figure 3), have received favorable payment increases compared with practice cost inflation and the Consumer Price Index.3-6 Flat reimbursement affects all physicians who accept insurance, as even private insurers base their reimbursement on Medicare.
In addition, there are other issues resulting in decreased physician payments when evaluation and management services are reported with same-day procedures using modifier −25 as well as preserving or finding alternative strategies for 10- and 90-day global period payments for medical procedures. When Medicare cuts physician payments, dermatologists find it difficult to own and operate their own practices, resulting in health market consolidation, limited competition, increased health care costs, limited patient access to care, and decreased quality of health care.
Medicare Payment Reform—Medicare payment reform is necessary to stop annual payment cuts and create a stable predictable payment system that ensures patient access to quality, value-based care. Medicare physician payment reform needs to happen at a national level. The American Academy of Dermatology Association (AADA) is working with the House of Medicine and the medical specialty community to develop specific proposals, such as “Characteristics of a Rational Medicare Physician Payment System,” to reform Medicare’s payment system.7 Advocacy groups, including the AADA, have been working to mitigate the proposed 2023 cuts by engaging with Congress and urging them to act before these changes go into effect on January 1, 2023.
Make Advocacy Your New Year’s Resolution: AADA’s Top Advocacy Priorities
The AADA’s top priority is Medicare payment policies.3 In addition, the AADA is working on drug access and cost by cutting the bureaucratic red tape caused by prior authorization (PA) and step therapy policies. The AADA collaborates with manufacturers, the health care community, policymakers, private payers, pharmacists, pharmacy benefit managers, and patients to minimize and/or eliminate barriers that patients face in accessing needed medications. Specifically, the AADA advocates for legislation that limits obstacles associated with health insurance step therapy requirements, streamlines PA, and prohibits mid-year formulary changes.8
Step therapy requires that patients first try a medication specified by the insurance company; the therapy must fail before the patient is placed on the medication originally prescribed by the provider. Regarding PA, the AADA tries to ensure that determinations are standardized, requires the speed of determinations to be quantified and minimized, and ensures that PA and appeals policies do not unduly burden physicians or patients in accessing optimal drug therapy.8
Another advocacy priority is telehealth. The AADA is advocating for legislation on expansion of telehealth in underserved areas and modifications to state licensure requirements, liability issues, and reimbursement for store-and-forward technology. The AADA is involved in protecting scope of practice, truth in advertising, and access to specialty care, as well as monitoring legislation and regulation concerning the potential environmental impact of sunscreen ingredients, indoor tanning restrictions, and skin cancer prevention.8
Advocacy Matters and Makes a Difference—It is important to learn about and support advocacy priorities and efforts and join forces to protect your practice. The AADA advocacy priorities are to protect the value of dermatology services, mobilize dermatologists for political action, ensure dermatologists can participate in new payment models, and strengthen the profession.9 Physician advocacy is no longer an elective pursuit. We need to be involved and engaged through our medical societies to help patients, communities, and ourselves. All of us are in it together, and a collaborative collective voice can make a difference. Take action, join the AADA, and contact Congress today to stop Medicare payment cuts (https://takeaction.aad.org/).
New Year, New Codes: A Win-Win for Digital Pathology
In July 2022, the American Medical Association CPT (Current Procedural Terminology) Editorial Panel released 13 new digital pathology add-on Category III codes for 2023 that the College of American Pathologists successfully advocated for inclusion.1 These codes are for reporting additional clinical staff work and service requirements associated with digitizing glass microscope slides for primary diagnosis (Table). They go into effect on January 1, 2023.
Although there is no additional compensation with the new Category III codes, dermatopathology laboratories will be able to report when they have made a diagnosis using digital pathology. The new CPT codes will provide payers with data they need to directly understand the utilization and increased value of digital pathology, which will bring dermatopathology laboratories one step closer to receiving additional reimbursement for digital interpretation.
The adoption of digital pathology has been accelerating in the United States but still lags behind many European countries where reimbursement for digital pathology has been established for many years. Many of the barriers to digital pathology have improved—cloud storage is more affordable, scanners have a higher throughput, digital pathology platforms have improved, and the US Food and Drug Administration has granted approvals for digital pathology. Digital pathology allows for more efficient workflow, which results in increased productivity and a reduction in turnaround times. It also allows for a wide spectrum of clinical applications and more innovation as well as research and educational applications.
The new Category III codes cannot be reported solely for archival purposes (eg, after the Category I service has already been performed and reported), solely for educational purposes (eg, when services are not used for individual patient reporting), solely for developing a database for training or validation of artificial intelligence algorithms, and solely for clinical conference presentations (eg, tumor board interdisciplinary conferences).
The new codes are a major victory for the adoption and future compensation for digital pathology.
New Year, New Cuts: Proposed 2023 Medicare Policy and Payment Changes for Dermatologists
The United States Spent $3.8 Trillion on Health Care in 2019: Where Did It Go?—In 2019, approximately $3.8 trillion was spent on health care in the United States (Figure 1). Physician services accounted for approximately 15% of total health care spending.2
Medicare Payments for Physician Services—Medicare payments for physician services are determined by a relative value unit (RVU) multiplied by a conversion factor (CF). Relative value units were set up in 1992 by what is now the Centers for Medicare & Medicaid Services, and they calculated the time it took a physician to complete a task or RVU and multiplied it by $32.00 (CF).3
Thirty years later—in 2022—the CF is $34.61. If the CF had increased with inflation, it would be $59.00. If the Proposed Rule is adopted, the 2023 fee schedule payment formula would decrease by 4.4% (to $33.08) relative to that of the 2022 fee schedule ($34.61), which is a decrease of 8.2% since 2019 ($36.04). This decrease is due to expiration of the 3% increase to Medicare fee schedule payments for 2022 required by the Protecting Medicare and American Farmers from Sequester Cuts Act and the required budget neutrality adjustment required by changes in RVUs. Medicare physician payment has declined 22% from 2001 to 2022 (Figure 2).4,5
The adjustments to the CF typically are made based on 3 factors: (1) the Medicare Economic Index; (2) expenditure target “performance adjustment”; and (3) miscellaneous adjustments, including those for “budget neutrality” required by law.
Medicare Physician Payments Compared With Other Provider Types and Inflation—The proposed Medicare physician payment policy is unsustainable for outpatient dermatologists. Practice overhead has increased markedly since 1992. Other service providers, such as those in skilled nursing facilities and hospitals (Figure 3), have received favorable payment increases compared with practice cost inflation and the Consumer Price Index.3-6 Flat reimbursement affects all physicians who accept insurance, as even private insurers base their reimbursement on Medicare.
In addition, there are other issues resulting in decreased physician payments when evaluation and management services are reported with same-day procedures using modifier −25 as well as preserving or finding alternative strategies for 10- and 90-day global period payments for medical procedures. When Medicare cuts physician payments, dermatologists find it difficult to own and operate their own practices, resulting in health market consolidation, limited competition, increased health care costs, limited patient access to care, and decreased quality of health care.
Medicare Payment Reform—Medicare payment reform is necessary to stop annual payment cuts and create a stable predictable payment system that ensures patient access to quality, value-based care. Medicare physician payment reform needs to happen at a national level. The American Academy of Dermatology Association (AADA) is working with the House of Medicine and the medical specialty community to develop specific proposals, such as “Characteristics of a Rational Medicare Physician Payment System,” to reform Medicare’s payment system.7 Advocacy groups, including the AADA, have been working to mitigate the proposed 2023 cuts by engaging with Congress and urging them to act before these changes go into effect on January 1, 2023.
Make Advocacy Your New Year’s Resolution: AADA’s Top Advocacy Priorities
The AADA’s top priority is Medicare payment policies.3 In addition, the AADA is working on drug access and cost by cutting the bureaucratic red tape caused by prior authorization (PA) and step therapy policies. The AADA collaborates with manufacturers, the health care community, policymakers, private payers, pharmacists, pharmacy benefit managers, and patients to minimize and/or eliminate barriers that patients face in accessing needed medications. Specifically, the AADA advocates for legislation that limits obstacles associated with health insurance step therapy requirements, streamlines PA, and prohibits mid-year formulary changes.8
Step therapy requires that patients first try a medication specified by the insurance company; the therapy must fail before the patient is placed on the medication originally prescribed by the provider. Regarding PA, the AADA tries to ensure that determinations are standardized, requires the speed of determinations to be quantified and minimized, and ensures that PA and appeals policies do not unduly burden physicians or patients in accessing optimal drug therapy.8
Another advocacy priority is telehealth. The AADA is advocating for legislation on expansion of telehealth in underserved areas and modifications to state licensure requirements, liability issues, and reimbursement for store-and-forward technology. The AADA is involved in protecting scope of practice, truth in advertising, and access to specialty care, as well as monitoring legislation and regulation concerning the potential environmental impact of sunscreen ingredients, indoor tanning restrictions, and skin cancer prevention.8
Advocacy Matters and Makes a Difference—It is important to learn about and support advocacy priorities and efforts and join forces to protect your practice. The AADA advocacy priorities are to protect the value of dermatology services, mobilize dermatologists for political action, ensure dermatologists can participate in new payment models, and strengthen the profession.9 Physician advocacy is no longer an elective pursuit. We need to be involved and engaged through our medical societies to help patients, communities, and ourselves. All of us are in it together, and a collaborative collective voice can make a difference. Take action, join the AADA, and contact Congress today to stop Medicare payment cuts (https://takeaction.aad.org/).
- Kaplan KJ. AMA announces new add-on digital pathology codes—no reimbursement (yet). July 18, 2022. Accessed October 19, 2022. https://tissuepathology.com/2022/07/18/ama-announces-new-add-on-digital-pathology-codes-no-reimbursement-yet/
- Centers for Medicare & Medicaid Services. National Health Expenditure Data: NHE fact sheet. Published April 2020. Accessed November 21, 2022. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NHE-Fact-Sheet
- Houghton V. Ask the expert (Dr. Mark Kaufmann): fighting for fair Medicare reimbursement. Dermatology World. October 2022. Accessed November 21, 2022. https://digitaleditions.walsworth.com/article/Advocacy+News/4355162/763056/article.html
- Federal Register, Medicare Trustees’ Reports and U.S. Bureau of Labor Statistics, AMA, Economic and Health Policy Research. September 2022. Accessed November 21, 2022. https://www.ama-assn.org/system/files/key-measures-medicare-economic-index-chart.pdf
- American Medical Association. Current Medicare payment system on unsustainable path: contact Congress. September 30, 2022. Accessed November 21, 2022. https://www.ama-assn.org/practice-management/medicare-medicaid/current-medicare-payment-system-unsustainable-path-contact
- U.S. Bureau of Labor Statistics, American Medical Association, Economic and Health Policy Research, February 2022. Accessed November 21, 2022. https://www.ama-assn.org/system/files/key-measures-medicare-economic-index-chart.pdf
- American Medical Association. Characteristics of a rational Medicare payment system. Accessed November 22, 2022. https://www.ama-assn.org/system/files/characteristics-rational-medicare-payment-principles-signatories.pdf
- Ensuring patient access to effective and affordable treatments remains a top priority for the AAD. Dermatology Practice Management. June 2020. Accessed November 21, 2022. https://dermatologypracticemanagement.com/issues/2020/june-2020-vol-1-no-1/11-supporting-access-to-treatment-exceptional-customer-experience-innovation-and-growth-a-conversation-with-sumner-madden
- Marteja L. Advocacy: when, where, and how for dermatologists. The Dermatologist. September 2021. Accessed November 21, 2022. https://www.hmpgloballearningnetwork.com/site/thederm/cover-story/advocacy-when-where-and-how-dermatologists
- Kaplan KJ. AMA announces new add-on digital pathology codes—no reimbursement (yet). July 18, 2022. Accessed October 19, 2022. https://tissuepathology.com/2022/07/18/ama-announces-new-add-on-digital-pathology-codes-no-reimbursement-yet/
- Centers for Medicare & Medicaid Services. National Health Expenditure Data: NHE fact sheet. Published April 2020. Accessed November 21, 2022. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NHE-Fact-Sheet
- Houghton V. Ask the expert (Dr. Mark Kaufmann): fighting for fair Medicare reimbursement. Dermatology World. October 2022. Accessed November 21, 2022. https://digitaleditions.walsworth.com/article/Advocacy+News/4355162/763056/article.html
- Federal Register, Medicare Trustees’ Reports and U.S. Bureau of Labor Statistics, AMA, Economic and Health Policy Research. September 2022. Accessed November 21, 2022. https://www.ama-assn.org/system/files/key-measures-medicare-economic-index-chart.pdf
- American Medical Association. Current Medicare payment system on unsustainable path: contact Congress. September 30, 2022. Accessed November 21, 2022. https://www.ama-assn.org/practice-management/medicare-medicaid/current-medicare-payment-system-unsustainable-path-contact
- U.S. Bureau of Labor Statistics, American Medical Association, Economic and Health Policy Research, February 2022. Accessed November 21, 2022. https://www.ama-assn.org/system/files/key-measures-medicare-economic-index-chart.pdf
- American Medical Association. Characteristics of a rational Medicare payment system. Accessed November 22, 2022. https://www.ama-assn.org/system/files/characteristics-rational-medicare-payment-principles-signatories.pdf
- Ensuring patient access to effective and affordable treatments remains a top priority for the AAD. Dermatology Practice Management. June 2020. Accessed November 21, 2022. https://dermatologypracticemanagement.com/issues/2020/june-2020-vol-1-no-1/11-supporting-access-to-treatment-exceptional-customer-experience-innovation-and-growth-a-conversation-with-sumner-madden
- Marteja L. Advocacy: when, where, and how for dermatologists. The Dermatologist. September 2021. Accessed November 21, 2022. https://www.hmpgloballearningnetwork.com/site/thederm/cover-story/advocacy-when-where-and-how-dermatologists
Practice Points
- New digital pathology codes proposed by the American Medical Association can be used starting January 1, 2023.
- A proposed 2023 fee schedule negatively impacting dermatology practices was published by the Centers for Medicare & Medicaid Services in July 2022.
- Advocacy involvement provides a collaborative collective voice for our specialty to help our patients improve their care.
Diagnosed too late
It had only been 3 weeks since I first met this patient. She presented with an advanced case of colon cancer, but instead of treatment,
Within the course of 2 weeks I saw another new patient, but this time with pancreatic cancer that metastasized to the liver. “When can we start treatment?” he asked. Like my female patient with colon cancer, he was diagnosed too late as he was already in an incurable stage. He was shocked to learn that his condition was in stage 4, that achieving remission would be difficult and a cure, not likely. Certainly, standard of care treatments and clinical trials offered him hope, but they were unlikely to change the outcome.
We take a course in this – that is, in giving bad news, but every doctor has his or her own approach. Some are so uncomfortable with the talk, they choose avoidance and adopt the “look like you gotta go approach.” Or, the doctor may schedule another treatment or another test with the intention of avoiding end-of-life discussions. Other doctors opt for straight talk: “I think you should get your affairs in order. You’ve got 3 months to live.” These are extreme behaviors I wouldn’t recommend.
In my practice, I sit with my patients and explain the diagnosis. After discussing all options and the advanced stage and diagnosis, it ultimately comes down to “Win or lose, I will be here to take care of you.” Sometimes there is therapy that may help, but either way, the patient understands that death is a real possibility.
I find that people just want to know if there is hope. A different treatment regimen or a clinical trial may (or may not) extend their life. And while we cannot predict outcomes, we can give them hope. You can’t shut down hope. True for some people the cup is always half empty, but most people want to live and are optimistic no matter how small the chances are.
These conversations are very difficult. I don’t like them, but then I don’t avoid them either. Fortunately, patients don’t usually come to my office for the first visit presenting with advanced disease. In the cases I described above, one patient had been experiencing unexplained weight loss, but didn’t share it with a physician. And, for the patient with pancreatic cancer, other than some discomfort in the last couple of weeks, the disease was not associated with other symptoms. But the absence of symptoms should not in any way rule out a malignant disease. A diagnosis should be based on a complete evaluation of signs and symptoms followed by testing.
We’ve got to be able to take the time to listen to our patients during these encounters. We may not spend as much time as we should because we’re so busy now and we’re slaves to EMRs. It helps if we take more time to probe symptoms a little longer, especially in the primary care setting.
It is possible for a patient with cancer to be asymptomatic up until the later stages of the disease. A study published in ESMO Open in 2020 found that fewer than half of patients with stage 4 non–small cell lung cancer have only one or two symptoms at diagnosis regardless of whether the patient was a smoker. In this study only 33% of patients reported having a cough and 25% had chest pain.
A study presented in October at the United European Gastroenterology Week found that of 600 pancreatic cancer cases, 46 of these were not detected by CT or MRI conducted 3-18 months prior to diagnosis. Of the 46 cases, 26% were not picked up by the radiologist and the rest were largely as a result of imaging changes over time. Radiology techniques are good, but they cannot pick up lesions that are too small. And some lesions, particularly in pancreatic cancer, can grow and metastasize rather quickly.
When a patient is diagnosed with advanced disease, it is most often simply because of the nature of the disease. But sometimes patients put off scheduling a doctor visit because of fear of the potential for bad news or fear of the doctor belittling their symptoms. Some tell me they were “just hoping the symptoms would disappear.” Waiting too long to see a doctor is never a good idea because timing is crucial. In many cases, there is a small window of opportunity to treat disease if remission is to be achieved.
Dr. Henry is a practicing clinical oncologist with PennMedicine in Philadelphia where he also serves as Vice Chair of the Department of Medicine at Pennsylvania Hospital.
This article was updated 12/7/22.
It had only been 3 weeks since I first met this patient. She presented with an advanced case of colon cancer, but instead of treatment,
Within the course of 2 weeks I saw another new patient, but this time with pancreatic cancer that metastasized to the liver. “When can we start treatment?” he asked. Like my female patient with colon cancer, he was diagnosed too late as he was already in an incurable stage. He was shocked to learn that his condition was in stage 4, that achieving remission would be difficult and a cure, not likely. Certainly, standard of care treatments and clinical trials offered him hope, but they were unlikely to change the outcome.
We take a course in this – that is, in giving bad news, but every doctor has his or her own approach. Some are so uncomfortable with the talk, they choose avoidance and adopt the “look like you gotta go approach.” Or, the doctor may schedule another treatment or another test with the intention of avoiding end-of-life discussions. Other doctors opt for straight talk: “I think you should get your affairs in order. You’ve got 3 months to live.” These are extreme behaviors I wouldn’t recommend.
In my practice, I sit with my patients and explain the diagnosis. After discussing all options and the advanced stage and diagnosis, it ultimately comes down to “Win or lose, I will be here to take care of you.” Sometimes there is therapy that may help, but either way, the patient understands that death is a real possibility.
I find that people just want to know if there is hope. A different treatment regimen or a clinical trial may (or may not) extend their life. And while we cannot predict outcomes, we can give them hope. You can’t shut down hope. True for some people the cup is always half empty, but most people want to live and are optimistic no matter how small the chances are.
These conversations are very difficult. I don’t like them, but then I don’t avoid them either. Fortunately, patients don’t usually come to my office for the first visit presenting with advanced disease. In the cases I described above, one patient had been experiencing unexplained weight loss, but didn’t share it with a physician. And, for the patient with pancreatic cancer, other than some discomfort in the last couple of weeks, the disease was not associated with other symptoms. But the absence of symptoms should not in any way rule out a malignant disease. A diagnosis should be based on a complete evaluation of signs and symptoms followed by testing.
We’ve got to be able to take the time to listen to our patients during these encounters. We may not spend as much time as we should because we’re so busy now and we’re slaves to EMRs. It helps if we take more time to probe symptoms a little longer, especially in the primary care setting.
It is possible for a patient with cancer to be asymptomatic up until the later stages of the disease. A study published in ESMO Open in 2020 found that fewer than half of patients with stage 4 non–small cell lung cancer have only one or two symptoms at diagnosis regardless of whether the patient was a smoker. In this study only 33% of patients reported having a cough and 25% had chest pain.
A study presented in October at the United European Gastroenterology Week found that of 600 pancreatic cancer cases, 46 of these were not detected by CT or MRI conducted 3-18 months prior to diagnosis. Of the 46 cases, 26% were not picked up by the radiologist and the rest were largely as a result of imaging changes over time. Radiology techniques are good, but they cannot pick up lesions that are too small. And some lesions, particularly in pancreatic cancer, can grow and metastasize rather quickly.
When a patient is diagnosed with advanced disease, it is most often simply because of the nature of the disease. But sometimes patients put off scheduling a doctor visit because of fear of the potential for bad news or fear of the doctor belittling their symptoms. Some tell me they were “just hoping the symptoms would disappear.” Waiting too long to see a doctor is never a good idea because timing is crucial. In many cases, there is a small window of opportunity to treat disease if remission is to be achieved.
Dr. Henry is a practicing clinical oncologist with PennMedicine in Philadelphia where he also serves as Vice Chair of the Department of Medicine at Pennsylvania Hospital.
This article was updated 12/7/22.
It had only been 3 weeks since I first met this patient. She presented with an advanced case of colon cancer, but instead of treatment,
Within the course of 2 weeks I saw another new patient, but this time with pancreatic cancer that metastasized to the liver. “When can we start treatment?” he asked. Like my female patient with colon cancer, he was diagnosed too late as he was already in an incurable stage. He was shocked to learn that his condition was in stage 4, that achieving remission would be difficult and a cure, not likely. Certainly, standard of care treatments and clinical trials offered him hope, but they were unlikely to change the outcome.
We take a course in this – that is, in giving bad news, but every doctor has his or her own approach. Some are so uncomfortable with the talk, they choose avoidance and adopt the “look like you gotta go approach.” Or, the doctor may schedule another treatment or another test with the intention of avoiding end-of-life discussions. Other doctors opt for straight talk: “I think you should get your affairs in order. You’ve got 3 months to live.” These are extreme behaviors I wouldn’t recommend.
In my practice, I sit with my patients and explain the diagnosis. After discussing all options and the advanced stage and diagnosis, it ultimately comes down to “Win or lose, I will be here to take care of you.” Sometimes there is therapy that may help, but either way, the patient understands that death is a real possibility.
I find that people just want to know if there is hope. A different treatment regimen or a clinical trial may (or may not) extend their life. And while we cannot predict outcomes, we can give them hope. You can’t shut down hope. True for some people the cup is always half empty, but most people want to live and are optimistic no matter how small the chances are.
These conversations are very difficult. I don’t like them, but then I don’t avoid them either. Fortunately, patients don’t usually come to my office for the first visit presenting with advanced disease. In the cases I described above, one patient had been experiencing unexplained weight loss, but didn’t share it with a physician. And, for the patient with pancreatic cancer, other than some discomfort in the last couple of weeks, the disease was not associated with other symptoms. But the absence of symptoms should not in any way rule out a malignant disease. A diagnosis should be based on a complete evaluation of signs and symptoms followed by testing.
We’ve got to be able to take the time to listen to our patients during these encounters. We may not spend as much time as we should because we’re so busy now and we’re slaves to EMRs. It helps if we take more time to probe symptoms a little longer, especially in the primary care setting.
It is possible for a patient with cancer to be asymptomatic up until the later stages of the disease. A study published in ESMO Open in 2020 found that fewer than half of patients with stage 4 non–small cell lung cancer have only one or two symptoms at diagnosis regardless of whether the patient was a smoker. In this study only 33% of patients reported having a cough and 25% had chest pain.
A study presented in October at the United European Gastroenterology Week found that of 600 pancreatic cancer cases, 46 of these were not detected by CT or MRI conducted 3-18 months prior to diagnosis. Of the 46 cases, 26% were not picked up by the radiologist and the rest were largely as a result of imaging changes over time. Radiology techniques are good, but they cannot pick up lesions that are too small. And some lesions, particularly in pancreatic cancer, can grow and metastasize rather quickly.
When a patient is diagnosed with advanced disease, it is most often simply because of the nature of the disease. But sometimes patients put off scheduling a doctor visit because of fear of the potential for bad news or fear of the doctor belittling their symptoms. Some tell me they were “just hoping the symptoms would disappear.” Waiting too long to see a doctor is never a good idea because timing is crucial. In many cases, there is a small window of opportunity to treat disease if remission is to be achieved.
Dr. Henry is a practicing clinical oncologist with PennMedicine in Philadelphia where he also serves as Vice Chair of the Department of Medicine at Pennsylvania Hospital.
This article was updated 12/7/22.
Employers use patient assistance programs to offset their own costs
Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”
The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.
“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.
Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.
Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.
Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.
It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.
Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.
Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.
Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.
In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.
The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.
In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.
“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.
The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.
Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.
“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.
Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.
Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.
Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.
If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.
How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.
“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.
J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”
Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.
None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.
In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”
Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.
In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”
In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.
For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.
So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.
Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”
The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.
“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.
Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.
Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.
Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.
It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.
Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.
Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.
Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.
In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.
The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.
In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.
“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.
The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.
Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.
“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.
Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.
Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.
Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.
If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.
How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.
“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.
J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”
Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.
None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.
In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”
Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.
In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”
In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.
For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.
So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.
Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”
The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.
“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.
Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.
Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.
Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.
It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.
Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.
Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.
Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.
In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.
The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.
In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.
“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.
The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.
Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.
“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.
Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.
Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.
Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.
If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.
How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.
“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.
J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”
Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.
None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.
In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”
Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.
In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”
In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.
For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.
So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.
Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Study comparing surgical and N95 masks sparks concern
The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.
Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”
The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.
This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.
A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.
In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”
Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”
“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”
“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”
“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.
“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”
The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.
A version of this article first appeared on Medscape.com.
The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.
Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”
The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.
This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.
A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.
In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”
Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”
“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”
“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”
“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.
“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”
The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.
A version of this article first appeared on Medscape.com.
The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.
Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”
The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.
This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.
A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.
In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”
Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”
“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”
“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”
“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.
“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”
The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
Florida doc dies by suicide after allegedly drugging and raping patients
according to a police statement.
A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.
Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.
Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.
Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.
The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.
At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.
“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”
Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.
Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”
A version of this article first appeared on Medscape.com.
according to a police statement.
A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.
Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.
Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.
Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.
The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.
At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.
“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”
Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.
Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”
A version of this article first appeared on Medscape.com.
according to a police statement.
A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.
Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.
Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.
Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.
The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.
At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.
“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”
Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.
Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”
A version of this article first appeared on Medscape.com.
Pediatric emergencies associated with unnecessary testing: AAP
Children seen for these conditions in emergency settings and even in primary care offices could experience avoidable pain, exposure to harmful radiation, and other harms, according to the group.
“The emergency department has the ability to rapidly perform myriad diagnostic tests and receive results quickly,” said Paul Mullan, MD, MPH, chair of the AAP’s Section of Emergency Medicine’s Choosing Wisely task force. “However, this comes with the danger of diagnostic overtesting.”
The five recommendations are as follows:
- Radiographs should not be obtained for children with bronchiolitis, croup, asthma, or first-time wheezing.
- Laboratory tests for screening should not be undertaken in the medical clearance process of children who require inpatient psychiatric admission unless clinically indicated.
- Laboratory testing or a CT scan of the head should not be ordered for a child with an unprovoked, generalized seizure or a simple febrile seizure whose mental status has returned to baseline.
- Abdominal radiographs should not be obtained for suspected constipation.
- Comprehensive viral panel testing should not be undertaken for children who are suspected of having respiratory viral illnesses.
The AAP task force partnered with Choosing Wisely Canada to create the recommendations. The list is the first of its kind to be published jointly by two countries, according to the release.
“We hope this Choosing Wisely list will encourage clinicians to rely on their clinical skills and avoid unnecessary tests,” said Dr. Mullan, who is also a physician at Children’s Hospital of the King’s Daughters and professor of pediatrics at Eastern Virginia Medical School, Norfolk.
A version of this article first appeared on Medscape.com.
Children seen for these conditions in emergency settings and even in primary care offices could experience avoidable pain, exposure to harmful radiation, and other harms, according to the group.
“The emergency department has the ability to rapidly perform myriad diagnostic tests and receive results quickly,” said Paul Mullan, MD, MPH, chair of the AAP’s Section of Emergency Medicine’s Choosing Wisely task force. “However, this comes with the danger of diagnostic overtesting.”
The five recommendations are as follows:
- Radiographs should not be obtained for children with bronchiolitis, croup, asthma, or first-time wheezing.
- Laboratory tests for screening should not be undertaken in the medical clearance process of children who require inpatient psychiatric admission unless clinically indicated.
- Laboratory testing or a CT scan of the head should not be ordered for a child with an unprovoked, generalized seizure or a simple febrile seizure whose mental status has returned to baseline.
- Abdominal radiographs should not be obtained for suspected constipation.
- Comprehensive viral panel testing should not be undertaken for children who are suspected of having respiratory viral illnesses.
The AAP task force partnered with Choosing Wisely Canada to create the recommendations. The list is the first of its kind to be published jointly by two countries, according to the release.
“We hope this Choosing Wisely list will encourage clinicians to rely on their clinical skills and avoid unnecessary tests,” said Dr. Mullan, who is also a physician at Children’s Hospital of the King’s Daughters and professor of pediatrics at Eastern Virginia Medical School, Norfolk.
A version of this article first appeared on Medscape.com.
Children seen for these conditions in emergency settings and even in primary care offices could experience avoidable pain, exposure to harmful radiation, and other harms, according to the group.
“The emergency department has the ability to rapidly perform myriad diagnostic tests and receive results quickly,” said Paul Mullan, MD, MPH, chair of the AAP’s Section of Emergency Medicine’s Choosing Wisely task force. “However, this comes with the danger of diagnostic overtesting.”
The five recommendations are as follows:
- Radiographs should not be obtained for children with bronchiolitis, croup, asthma, or first-time wheezing.
- Laboratory tests for screening should not be undertaken in the medical clearance process of children who require inpatient psychiatric admission unless clinically indicated.
- Laboratory testing or a CT scan of the head should not be ordered for a child with an unprovoked, generalized seizure or a simple febrile seizure whose mental status has returned to baseline.
- Abdominal radiographs should not be obtained for suspected constipation.
- Comprehensive viral panel testing should not be undertaken for children who are suspected of having respiratory viral illnesses.
The AAP task force partnered with Choosing Wisely Canada to create the recommendations. The list is the first of its kind to be published jointly by two countries, according to the release.
“We hope this Choosing Wisely list will encourage clinicians to rely on their clinical skills and avoid unnecessary tests,” said Dr. Mullan, who is also a physician at Children’s Hospital of the King’s Daughters and professor of pediatrics at Eastern Virginia Medical School, Norfolk.
A version of this article first appeared on Medscape.com.