Infectious Disease Practitioner

A U.S. Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.

No similar safety signal has been detected for the more recently approved 15-valent and 20-valent pneumococcal conjugate vaccines, explain the investigators, led by Brendan Day, MD, MPH, from the FDA’s Center for Biologics Evaluation and Research, in their report published online in JAMA Internal Medicine.

Reports of injection-site necrosis emerged after the vaccine (Pneumovax 23, Merck) had been approved by the FDA and was administered to a large, diverse, real-world population.

Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population.

Therefore, “postmarketing safety surveillance is critical to further characterize the safety profile of licensed vaccines,” the investigators point out.

The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System (VAERS), which relies on people who get the vaccines to report adverse events.
 

Real-world finding

After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.

They found that the reporting rate for injection-site necrosis was less than 0.2 cases per 1 million vaccine doses administered. The PubMed search yielded two cases of injection-site necrosis after the vaccine.

The 23-valent vaccine helps protect people from pneumococcus bacterial infection. The manufacturer reports that it is for people at least 50 years of age and for children who are at least 2 years of age with medical conditions that put them at elevated risk for infection.

The U.S. package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.

Of the 104 VAERS reports identified by the researchers, 48 met the case definition. Of those cases, most were for skin necrosis (n = 43), five of which also included fat necrosis. The remaining five cases of necrosis affected fascia (n = 2); fat and fascia (n = 1); fat, fascia, and muscle (n = 1); and muscle (n = 1).

In 23 of the 48 cases (47.9%), the reactions were serious and included one death (unrelated to vaccination).

Seventeen patients (35.4%) were hospitalized and 26 (54.2%) required surgery, most commonly debridement. Eight patients (16.7%) underwent multiple surgical procedures and three (6.3%) required a skin graft.

For patients with skin necrosis (n = 43), the median age was 67 years, and most patients were female (n = 36). Twelve patients were immunocompromised.

Concomitant vaccinations were reported in 10 patients, five of whom got the shot in the same arm as the 23-valent pneumococcal vaccine. A concurrent diagnosis of cellulitis was reported in 16 patients and an abscess was reported in three patients. There were too few cases of fat, fascia, or muscle necrosis to draw conclusions, the researchers report.

Often, skin necrosis was seen after a progression of symptoms, such as redness, pain, or swelling.

“These reports are consistent with published descriptions of injection-site necrosis, which has been reported as a rare complication for many vaccines and injectable drugs,” the investigators report.

Although the researchers couldn’t conclude from the VAERS reports alone that the vaccine injection caused the necrosis, “the timing and the location of reactions at the injection site suggest a possible causal association with the vaccine,” they explain. However, they add, patient comorbidities and poor injection technique may also be contributors.

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

A U.S. Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.

No similar safety signal has been detected for the more recently approved 15-valent and 20-valent pneumococcal conjugate vaccines, explain the investigators, led by Brendan Day, MD, MPH, from the FDA’s Center for Biologics Evaluation and Research, in their report published online in JAMA Internal Medicine.

Reports of injection-site necrosis emerged after the vaccine (Pneumovax 23, Merck) had been approved by the FDA and was administered to a large, diverse, real-world population.

Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population.

Therefore, “postmarketing safety surveillance is critical to further characterize the safety profile of licensed vaccines,” the investigators point out.

The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System (VAERS), which relies on people who get the vaccines to report adverse events.
 

Real-world finding

After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.

They found that the reporting rate for injection-site necrosis was less than 0.2 cases per 1 million vaccine doses administered. The PubMed search yielded two cases of injection-site necrosis after the vaccine.

The 23-valent vaccine helps protect people from pneumococcus bacterial infection. The manufacturer reports that it is for people at least 50 years of age and for children who are at least 2 years of age with medical conditions that put them at elevated risk for infection.

The U.S. package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.

Of the 104 VAERS reports identified by the researchers, 48 met the case definition. Of those cases, most were for skin necrosis (n = 43), five of which also included fat necrosis. The remaining five cases of necrosis affected fascia (n = 2); fat and fascia (n = 1); fat, fascia, and muscle (n = 1); and muscle (n = 1).

In 23 of the 48 cases (47.9%), the reactions were serious and included one death (unrelated to vaccination).

Seventeen patients (35.4%) were hospitalized and 26 (54.2%) required surgery, most commonly debridement. Eight patients (16.7%) underwent multiple surgical procedures and three (6.3%) required a skin graft.

For patients with skin necrosis (n = 43), the median age was 67 years, and most patients were female (n = 36). Twelve patients were immunocompromised.

Concomitant vaccinations were reported in 10 patients, five of whom got the shot in the same arm as the 23-valent pneumococcal vaccine. A concurrent diagnosis of cellulitis was reported in 16 patients and an abscess was reported in three patients. There were too few cases of fat, fascia, or muscle necrosis to draw conclusions, the researchers report.

Often, skin necrosis was seen after a progression of symptoms, such as redness, pain, or swelling.

“These reports are consistent with published descriptions of injection-site necrosis, which has been reported as a rare complication for many vaccines and injectable drugs,” the investigators report.

Although the researchers couldn’t conclude from the VAERS reports alone that the vaccine injection caused the necrosis, “the timing and the location of reactions at the injection site suggest a possible causal association with the vaccine,” they explain. However, they add, patient comorbidities and poor injection technique may also be contributors.

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

A U.S. Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.

No similar safety signal has been detected for the more recently approved 15-valent and 20-valent pneumococcal conjugate vaccines, explain the investigators, led by Brendan Day, MD, MPH, from the FDA’s Center for Biologics Evaluation and Research, in their report published online in JAMA Internal Medicine.

Reports of injection-site necrosis emerged after the vaccine (Pneumovax 23, Merck) had been approved by the FDA and was administered to a large, diverse, real-world population.

Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population.

Therefore, “postmarketing safety surveillance is critical to further characterize the safety profile of licensed vaccines,” the investigators point out.

The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System (VAERS), which relies on people who get the vaccines to report adverse events.
 

Real-world finding

After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.

They found that the reporting rate for injection-site necrosis was less than 0.2 cases per 1 million vaccine doses administered. The PubMed search yielded two cases of injection-site necrosis after the vaccine.

The 23-valent vaccine helps protect people from pneumococcus bacterial infection. The manufacturer reports that it is for people at least 50 years of age and for children who are at least 2 years of age with medical conditions that put them at elevated risk for infection.

The U.S. package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.

Of the 104 VAERS reports identified by the researchers, 48 met the case definition. Of those cases, most were for skin necrosis (n = 43), five of which also included fat necrosis. The remaining five cases of necrosis affected fascia (n = 2); fat and fascia (n = 1); fat, fascia, and muscle (n = 1); and muscle (n = 1).

In 23 of the 48 cases (47.9%), the reactions were serious and included one death (unrelated to vaccination).

Seventeen patients (35.4%) were hospitalized and 26 (54.2%) required surgery, most commonly debridement. Eight patients (16.7%) underwent multiple surgical procedures and three (6.3%) required a skin graft.

For patients with skin necrosis (n = 43), the median age was 67 years, and most patients were female (n = 36). Twelve patients were immunocompromised.

Concomitant vaccinations were reported in 10 patients, five of whom got the shot in the same arm as the 23-valent pneumococcal vaccine. A concurrent diagnosis of cellulitis was reported in 16 patients and an abscess was reported in three patients. There were too few cases of fat, fascia, or muscle necrosis to draw conclusions, the researchers report.

Often, skin necrosis was seen after a progression of symptoms, such as redness, pain, or swelling.

“These reports are consistent with published descriptions of injection-site necrosis, which has been reported as a rare complication for many vaccines and injectable drugs,” the investigators report.

Although the researchers couldn’t conclude from the VAERS reports alone that the vaccine injection caused the necrosis, “the timing and the location of reactions at the injection site suggest a possible causal association with the vaccine,” they explain. However, they add, patient comorbidities and poor injection technique may also be contributors.

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

Choosing the right partner to add to your practice takes planning and strategic decision-making. When the match is right, the benefits can be significant: more hands to share the load of running a medical practice, and increased revenue and expanded patient population. A partner can bring in new, complementary strengths and skills. Adding a partner is also a way to prepare for the future by setting your practice up for a smooth transition if you or another partner is looking toward retirement.

But a mismatched partnership can cost you time and money, not to mention endless amount of conflict, dysfunction, and liability. Mutual trust and a long-term commitment on both sides are critical.

“Just like with marriage, it can be very difficult, traumatic, and expensive to break up with a partner,” said Clifton Straughn, MD, partner at Direct Access MD, a concierge-service model family practice in Anderson, S.C. “So, do your due diligence and take your time.” Picking the right partner is essential.
 

The basics

Before you begin the process of partnership with a physician, be sure you know what you need, the skill sets you’re looking for to complement your practice, and the personality characteristics and values that are important to you so the person you choose can check all the boxes and not just add a name to the letterhead.

“A lot of times, doctors go into this with just a general idea that they need more doctors or that they would like to be bigger or have more clout,” said Tim Boden, a certified medical practice executive with over 40 years of experience. “But you have to understand that to a certain degree, if you’re bringing somebody in who has basically an identical clinical profile to yours, you’re going to be sacrificing a bit of your lunch for a while until that person builds a name for himself or herself. A new partner’s skill set should match the need that you’re trying to fill.”

Figure out and discuss with your current partners how much it will cost to bring in a partner between their compensation and additional practice expenses. How much revenue will you expect the partner to generate? Will your practice break even the first year or the second? And how will you cover any shortfall?

It’s also essential to understand how the day-to-day operation of your practice will change after you add another partner.

• Will the new partner’s percentage of ownership be the same as that of the other partners?
• Will their ownership include a percentage of the facility, equipment, supplies, and accounts receivable?
• How will you split call and work hours?
• How will decision-making work?
• How would buyout work if a partner were to leave the practice, and is there a minimum obligation, such as a 5-year commitment?

As a team, you may also want to discuss “soft skills,” or the way you’d hope a partner would represent your practice to patients and the community.

“These can be harder to quantify,” said Dr. Straughn. “Evaluating them can take artful questions and simple observation over time.”
 

It’s a slow process

Many practices offer paths to partnership rather than bringing in a partner straight away. With this process, an incoming physician works toward that goal. If you’re going this route, discuss this during the hiring process, so that both sides are clear about the process. Rule No. 1 is to make sure that new hires understand that partnership is possible, although it’s not a given. The typical partnership track is 2-3 years, but you can set the timeline that works best for your practice.

Mr. Boden recommends at least a year for this period so as to allow you the opportunity to evaluate the new member, how they work, and how they fit with your team. The partnership track method is typically for young or fairly new physicians.

“I would avoid ever promising an ownership position to a recruit,” said Mr. Boden. “I would only show them how it can happen and what it would look like if they qualify.”
 

Consider professional help

If you want to be sure you weigh all the pros and cons of your new partner, a medical practice consultant may be the way to go. A consultant can identify many situations that you might overlook.

Some services offer a medical practice assessment to help you see where you need the most help and what skills might be best to bring to the table. They might also be able to take over some of the administrative work of a new hire if you like, so you and the other partners can focus solely on interacting with and observing the clinical abilities of a potential partner.

A health care attorney can help you build a sound agreement regarding decision-making and how the fees/costs will be divided and can put legal protections in place for everyone involved.

You’ll need a buy-sell agreement (also called a partnership or shareholder agreement) that spells out the terms and conditions, including buying into and selling out of the practice. A fair agreement respects all parties, while a poor one that offers the new partner a minority share or lessor profit may favor the practice’s current partners but could breed resentment, undermining the practice’s culture and morale.
 

Takeaway

Ideally, you’ll select someone with excellent credentials and experience with similar goals for the practice who blends well with your staff. It’s best to find someone who fits well culturally with your office and who practices medicine with a similar patient philosophy.

To that end, Mr. Boden encourages out-of-the-box questions for interviews, such as what a potential partner wants to make sure they have room for in their life, or what their ideal work and family life looks like. The more you can assess components such as emotional intelligence, =the fuller picture you’ll get.

“You’re going to be spending major hours every week with this person, and your destiny is going to be tied up with theirs to some degree,” said Mr. Boden. You can teach somebody the job, but if you don’t genuinely like and respect them and want to work with them daily, it may not be the right fit.

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

Choosing the right partner to add to your practice takes planning and strategic decision-making. When the match is right, the benefits can be significant: more hands to share the load of running a medical practice, and increased revenue and expanded patient population. A partner can bring in new, complementary strengths and skills. Adding a partner is also a way to prepare for the future by setting your practice up for a smooth transition if you or another partner is looking toward retirement.

But a mismatched partnership can cost you time and money, not to mention endless amount of conflict, dysfunction, and liability. Mutual trust and a long-term commitment on both sides are critical.

“Just like with marriage, it can be very difficult, traumatic, and expensive to break up with a partner,” said Clifton Straughn, MD, partner at Direct Access MD, a concierge-service model family practice in Anderson, S.C. “So, do your due diligence and take your time.” Picking the right partner is essential.
 

The basics

Before you begin the process of partnership with a physician, be sure you know what you need, the skill sets you’re looking for to complement your practice, and the personality characteristics and values that are important to you so the person you choose can check all the boxes and not just add a name to the letterhead.

“A lot of times, doctors go into this with just a general idea that they need more doctors or that they would like to be bigger or have more clout,” said Tim Boden, a certified medical practice executive with over 40 years of experience. “But you have to understand that to a certain degree, if you’re bringing somebody in who has basically an identical clinical profile to yours, you’re going to be sacrificing a bit of your lunch for a while until that person builds a name for himself or herself. A new partner’s skill set should match the need that you’re trying to fill.”

Figure out and discuss with your current partners how much it will cost to bring in a partner between their compensation and additional practice expenses. How much revenue will you expect the partner to generate? Will your practice break even the first year or the second? And how will you cover any shortfall?

It’s also essential to understand how the day-to-day operation of your practice will change after you add another partner.

• Will the new partner’s percentage of ownership be the same as that of the other partners?
• Will their ownership include a percentage of the facility, equipment, supplies, and accounts receivable?
• How will you split call and work hours?
• How will decision-making work?
• How would buyout work if a partner were to leave the practice, and is there a minimum obligation, such as a 5-year commitment?

As a team, you may also want to discuss “soft skills,” or the way you’d hope a partner would represent your practice to patients and the community.

“These can be harder to quantify,” said Dr. Straughn. “Evaluating them can take artful questions and simple observation over time.”
 

It’s a slow process

Many practices offer paths to partnership rather than bringing in a partner straight away. With this process, an incoming physician works toward that goal. If you’re going this route, discuss this during the hiring process, so that both sides are clear about the process. Rule No. 1 is to make sure that new hires understand that partnership is possible, although it’s not a given. The typical partnership track is 2-3 years, but you can set the timeline that works best for your practice.

Mr. Boden recommends at least a year for this period so as to allow you the opportunity to evaluate the new member, how they work, and how they fit with your team. The partnership track method is typically for young or fairly new physicians.

“I would avoid ever promising an ownership position to a recruit,” said Mr. Boden. “I would only show them how it can happen and what it would look like if they qualify.”
 

Consider professional help

If you want to be sure you weigh all the pros and cons of your new partner, a medical practice consultant may be the way to go. A consultant can identify many situations that you might overlook.

Some services offer a medical practice assessment to help you see where you need the most help and what skills might be best to bring to the table. They might also be able to take over some of the administrative work of a new hire if you like, so you and the other partners can focus solely on interacting with and observing the clinical abilities of a potential partner.

A health care attorney can help you build a sound agreement regarding decision-making and how the fees/costs will be divided and can put legal protections in place for everyone involved.

You’ll need a buy-sell agreement (also called a partnership or shareholder agreement) that spells out the terms and conditions, including buying into and selling out of the practice. A fair agreement respects all parties, while a poor one that offers the new partner a minority share or lessor profit may favor the practice’s current partners but could breed resentment, undermining the practice’s culture and morale.
 

Takeaway

Ideally, you’ll select someone with excellent credentials and experience with similar goals for the practice who blends well with your staff. It’s best to find someone who fits well culturally with your office and who practices medicine with a similar patient philosophy.

To that end, Mr. Boden encourages out-of-the-box questions for interviews, such as what a potential partner wants to make sure they have room for in their life, or what their ideal work and family life looks like. The more you can assess components such as emotional intelligence, =the fuller picture you’ll get.

“You’re going to be spending major hours every week with this person, and your destiny is going to be tied up with theirs to some degree,” said Mr. Boden. You can teach somebody the job, but if you don’t genuinely like and respect them and want to work with them daily, it may not be the right fit.

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

Choosing the right partner to add to your practice takes planning and strategic decision-making. When the match is right, the benefits can be significant: more hands to share the load of running a medical practice, and increased revenue and expanded patient population. A partner can bring in new, complementary strengths and skills. Adding a partner is also a way to prepare for the future by setting your practice up for a smooth transition if you or another partner is looking toward retirement.

But a mismatched partnership can cost you time and money, not to mention endless amount of conflict, dysfunction, and liability. Mutual trust and a long-term commitment on both sides are critical.

“Just like with marriage, it can be very difficult, traumatic, and expensive to break up with a partner,” said Clifton Straughn, MD, partner at Direct Access MD, a concierge-service model family practice in Anderson, S.C. “So, do your due diligence and take your time.” Picking the right partner is essential.
 

The basics

Before you begin the process of partnership with a physician, be sure you know what you need, the skill sets you’re looking for to complement your practice, and the personality characteristics and values that are important to you so the person you choose can check all the boxes and not just add a name to the letterhead.

“A lot of times, doctors go into this with just a general idea that they need more doctors or that they would like to be bigger or have more clout,” said Tim Boden, a certified medical practice executive with over 40 years of experience. “But you have to understand that to a certain degree, if you’re bringing somebody in who has basically an identical clinical profile to yours, you’re going to be sacrificing a bit of your lunch for a while until that person builds a name for himself or herself. A new partner’s skill set should match the need that you’re trying to fill.”

Figure out and discuss with your current partners how much it will cost to bring in a partner between their compensation and additional practice expenses. How much revenue will you expect the partner to generate? Will your practice break even the first year or the second? And how will you cover any shortfall?

It’s also essential to understand how the day-to-day operation of your practice will change after you add another partner.

• Will the new partner’s percentage of ownership be the same as that of the other partners?
• Will their ownership include a percentage of the facility, equipment, supplies, and accounts receivable?
• How will you split call and work hours?
• How will decision-making work?
• How would buyout work if a partner were to leave the practice, and is there a minimum obligation, such as a 5-year commitment?

As a team, you may also want to discuss “soft skills,” or the way you’d hope a partner would represent your practice to patients and the community.

“These can be harder to quantify,” said Dr. Straughn. “Evaluating them can take artful questions and simple observation over time.”
 

It’s a slow process

Many practices offer paths to partnership rather than bringing in a partner straight away. With this process, an incoming physician works toward that goal. If you’re going this route, discuss this during the hiring process, so that both sides are clear about the process. Rule No. 1 is to make sure that new hires understand that partnership is possible, although it’s not a given. The typical partnership track is 2-3 years, but you can set the timeline that works best for your practice.

Mr. Boden recommends at least a year for this period so as to allow you the opportunity to evaluate the new member, how they work, and how they fit with your team. The partnership track method is typically for young or fairly new physicians.

“I would avoid ever promising an ownership position to a recruit,” said Mr. Boden. “I would only show them how it can happen and what it would look like if they qualify.”
 

Consider professional help

If you want to be sure you weigh all the pros and cons of your new partner, a medical practice consultant may be the way to go. A consultant can identify many situations that you might overlook.

Some services offer a medical practice assessment to help you see where you need the most help and what skills might be best to bring to the table. They might also be able to take over some of the administrative work of a new hire if you like, so you and the other partners can focus solely on interacting with and observing the clinical abilities of a potential partner.

A health care attorney can help you build a sound agreement regarding decision-making and how the fees/costs will be divided and can put legal protections in place for everyone involved.

You’ll need a buy-sell agreement (also called a partnership or shareholder agreement) that spells out the terms and conditions, including buying into and selling out of the practice. A fair agreement respects all parties, while a poor one that offers the new partner a minority share or lessor profit may favor the practice’s current partners but could breed resentment, undermining the practice’s culture and morale.
 

Takeaway

Ideally, you’ll select someone with excellent credentials and experience with similar goals for the practice who blends well with your staff. It’s best to find someone who fits well culturally with your office and who practices medicine with a similar patient philosophy.

To that end, Mr. Boden encourages out-of-the-box questions for interviews, such as what a potential partner wants to make sure they have room for in their life, or what their ideal work and family life looks like. The more you can assess components such as emotional intelligence, =the fuller picture you’ll get.

“You’re going to be spending major hours every week with this person, and your destiny is going to be tied up with theirs to some degree,” said Mr. Boden. You can teach somebody the job, but if you don’t genuinely like and respect them and want to work with them daily, it may not be the right fit.

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

In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.

David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However, he claims in a lawsuit filed July 5 in Allen County Superior Court that an Indiana law that took effect 4 days earlier nullifies the clause because he quit his job with cause. 

Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.

“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”

Lutheran Health’s media relations department did not respond to requests for comment.
 

Noncompete clauses ‘extremely common’

Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.

However, the tide has been turning against them.

About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.

For more about state-by-state restrictions on noncompete clauses, check this chart.

In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.

Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions. 

In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023. 

Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.

Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”

The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
 

Impact on patients

The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.  

State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.

However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.

The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”

For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
 

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

In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.

David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However, he claims in a lawsuit filed July 5 in Allen County Superior Court that an Indiana law that took effect 4 days earlier nullifies the clause because he quit his job with cause. 

Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.

“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”

Lutheran Health’s media relations department did not respond to requests for comment.
 

Noncompete clauses ‘extremely common’

Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.

However, the tide has been turning against them.

About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.

For more about state-by-state restrictions on noncompete clauses, check this chart.

In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.

Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions. 

In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023. 

Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.

Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”

The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
 

Impact on patients

The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.  

State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.

However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.

The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”

For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
 

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

In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.

David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However, he claims in a lawsuit filed July 5 in Allen County Superior Court that an Indiana law that took effect 4 days earlier nullifies the clause because he quit his job with cause. 

Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.

“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”

Lutheran Health’s media relations department did not respond to requests for comment.
 

Noncompete clauses ‘extremely common’

Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.

However, the tide has been turning against them.

About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.

For more about state-by-state restrictions on noncompete clauses, check this chart.

In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.

Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions. 

In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023. 

Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.

Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”

The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
 

Impact on patients

The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.  

State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.

However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.

The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”

For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
 

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

The U.S. Food and Drug Administration has approved an injectable monoclonal antibody to protect newborns and infants against respiratory syncytial virus (RSV).

The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.

As many as 80,000 children under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.

The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.

Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.

Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; P < .001).

The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.

“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”

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

The U.S. Food and Drug Administration has approved an injectable monoclonal antibody to protect newborns and infants against respiratory syncytial virus (RSV).

The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.

As many as 80,000 children under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.

The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.

Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.

Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; P < .001).

The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.

“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”

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

The U.S. Food and Drug Administration has approved an injectable monoclonal antibody to protect newborns and infants against respiratory syncytial virus (RSV).

The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.

As many as 80,000 children under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.

The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.

Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.

Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; P < .001).

The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.

“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”

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

The COVID-19 vaccines have been a game changer for millions of people worldwide in preventing death or disability from the virus. Research suggests that they offer significant protection against long COVID.

Studies have consistently found that these vaccines prevent the new onset of long COVID as well as flare-ups for people who already have the condition.

False and unfounded claims made by some antivaccine groups that the vaccines themselves may cause long COVID persist and serve as barriers to vaccination.

To help separate the facts from falsehoods, here’s a checklist for doctors on what scientific studies have determined about vaccination and long COVID.
 

What the research shows

Doctors who work in long COVID clinics have for years suspected that vaccination may help protect against the development of long COVID, noted Lawrence Purpura, MD, MPH, an infectious disease specialist at New York–Presbyterian/Columbia University Irving Medical Center, who treats patients with long COVID in his clinic.

Over the past year, several large, well-conducted studies have borne out that theory, including the following studies:

• In the RECOVER study, published in May in the journal Nature Communications, researchers examined the electronic health records of more than 5 million people who had been diagnosed with COVID and found that vaccination reduced the risk that they would develop long COVID. Although the researchers didn’t compare the effects of having boosters to being fully vaccinated without them, experts have suggested that having a full round of recommended shots may offer the most protection. “My thoughts are that more shots are better, and other work has shown compelling evidence that the protective effect of vaccination on COVID-19 wanes over time,” said study coauthor Daniel Brannock, MS, a research scientist at RTI International in Research Triangle Park, N.C. “It stands to reason that the same is true for long COVID.”
• A review published in February in BMJ Medicine concluded that 10 studies showed a significant reduction in the incidence of long COVID among vaccinated patients. Even one dose of a vaccine was protective.
• A meta-analysis of six studies published last December in Antimicrobial Stewardship and Healthcare Epidemiology found that one or more doses of a COVID-19 vaccine were 29% effective in preventing symptoms of long COVID.
• In a June meta-analysis published in JAMA Internal Medicine, researchers analyzed more than 40 studies that included 860,000 patients and found that two doses of a COVID-19 vaccine reduced the risk of long COVID by almost half.

The message? COVID vaccination is very effective in reducing the risk of long COVID.

“It’s important to emphasize that many of the risk factors [for long COVID] cannot be changed, or at least cannot be changed easily, but vaccination is a decision that can be taken by everyone,” said Vassilios Vassiliou, MBBS, PhD, clinical professor of cardiac medicine at Norwich Medical School in England, who coauthored the article in JAMA Internal Medicine.
 

Why vaccines may be protective

The COVID-19 vaccines work well to prevent serious illness from the virus, noted Aaron Friedberg, MD, clinical coleader of the Post COVID Recovery Program at the Ohio State University Wexner Medical Center. That may be a clue to why the vaccines help prevent long COVID symptoms.

“When you get COVID and you’ve been vaccinated, the virus may still attach in your nose and respiratory tract, but it’s less likely to spread throughout your body,” he explained. “It’s like a forest fire – if the ground is wet or it starts to rain, it’s less likely to create a great blaze. As a result, your body is less likely to experience inflammation and damage that makes it more likely that you’ll develop long COVID.”

Dr. Friedberg stressed that even for patients who have had COVID, it’s important to get vaccinated – a message he consistently delivers to his own patients.

“There is some protection that comes from having COVID before, but for some people, that’s not enough,” he said. “It’s true that after infection, your body creates antibodies that help protect you against the virus. But I explain to patients that these may be like old Velcro: They barely grab on enough to stay on for the moment, but they don’t last long term. You’re much more likely to get a reliable immune response from the vaccine.”

In addition, a second or third bout of COVID could be the one that gives patients long COVID, Dr. Friedberg adds.

“I have a number of patients in my clinic who were fine after their first bout of COVID but experienced debilitating long COVID symptoms after they developed COVID again,” he said. “Why leave it to chance?”
 

Vaccines and ‘long vax’

The COVID vaccines are considered very safe but have been linked to very rare side effects, such as blood clots and heart inflammation. There have also been anecdotal reports of symptoms that resemble long COVID – a syndrome that has come to be known as “long Vax” – an extremely rare condition that may or may not be tied to vaccination.

“I have seen people in my clinic who developed symptoms suggestive of long COVID that linger for months – brain fog, fatigue, heart palpitations – soon after they got the COVID-19 vaccine,” said Dr. Purpura. But no published studies have suggested a link, he cautions.

A study called LISTEN is being organized at Yale in an effort to better understand postvaccine adverse events and a potential link to long COVID.
 

Talking to patients

Discussions of vaccination with patients, including those with COVID or long COVID, are often fraught and challenging, said Dr. Purpura.

“There’s a lot of fear that they will have a worsening of their symptoms,” he explained. The conversation he has with his patients mirrors the conversation all physicians should have with their patients about COVID-19 vaccination, even if they don’t have long COVID. He stresses the importance of highlighting the following components:

• Show compassion and empathy. “A lot of people have strongly held opinions – it’s worth it to try to find out why they feel the way that they do,” said Dr. Friedberg.
• Walk them through side effects. “Many people are afraid of the side effects of the vaccine, especially if they already have long COVID,” explained Dr. Purpura. Such patients can be asked how they felt after their last vaccination, such a shingles or flu shot. Then explain that the COVID-19 vaccine is not much different and that they may experience temporary side effects such as fatigue, headache, or a mild fever for 24-48 hours.
• Explain the benefits. Eighty-five percent of people say their health care provider is a trusted source of information on COVID-19 vaccines, according to the Kaiser Family Foundation. That trust is conducive to talks about the vaccine’s benefits, including its ability to protect against long COVID.

Other ways to reduce risk of long COVID

Vaccines can lower the chances of a patient’s developing long COVID. So can the antiviral medication nirmatrelvir (Paxlovid). A March 2023 study published in JAMA Internal Medicine included more than 280,000 people with COVID. The researchers found that vaccination reduced the risk for developing the condition by about 25%.

“I mention that study to all of my long COVID patients who become reinfected with the virus,” said Dr. Purpura. “It not only appears protective against long COVID, but since it lowers levels of virus circulating in their body, it seems to help prevent a flare-up of symptoms.”

Another treatment that may help is the diabetes drug metformin, he added.

A June 2023 study published in The Lancet Infectious Diseases found that when metformin was given within 3 days of symptom onset, the incidence of long COVID was reduced by about 41%.

“We’re still trying to wrap our brains around this one, but the thought is it may help to lower inflammation, which plays a role in long COVID,” Dr. Purpura explained. More studies need to be conducted, though, before recommending its use.

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

The COVID-19 vaccines have been a game changer for millions of people worldwide in preventing death or disability from the virus. Research suggests that they offer significant protection against long COVID.

Studies have consistently found that these vaccines prevent the new onset of long COVID as well as flare-ups for people who already have the condition.

False and unfounded claims made by some antivaccine groups that the vaccines themselves may cause long COVID persist and serve as barriers to vaccination.

To help separate the facts from falsehoods, here’s a checklist for doctors on what scientific studies have determined about vaccination and long COVID.
 

What the research shows

Doctors who work in long COVID clinics have for years suspected that vaccination may help protect against the development of long COVID, noted Lawrence Purpura, MD, MPH, an infectious disease specialist at New York–Presbyterian/Columbia University Irving Medical Center, who treats patients with long COVID in his clinic.

Over the past year, several large, well-conducted studies have borne out that theory, including the following studies:

• In the RECOVER study, published in May in the journal Nature Communications, researchers examined the electronic health records of more than 5 million people who had been diagnosed with COVID and found that vaccination reduced the risk that they would develop long COVID. Although the researchers didn’t compare the effects of having boosters to being fully vaccinated without them, experts have suggested that having a full round of recommended shots may offer the most protection. “My thoughts are that more shots are better, and other work has shown compelling evidence that the protective effect of vaccination on COVID-19 wanes over time,” said study coauthor Daniel Brannock, MS, a research scientist at RTI International in Research Triangle Park, N.C. “It stands to reason that the same is true for long COVID.”
• A review published in February in BMJ Medicine concluded that 10 studies showed a significant reduction in the incidence of long COVID among vaccinated patients. Even one dose of a vaccine was protective.
• A meta-analysis of six studies published last December in Antimicrobial Stewardship and Healthcare Epidemiology found that one or more doses of a COVID-19 vaccine were 29% effective in preventing symptoms of long COVID.
• In a June meta-analysis published in JAMA Internal Medicine, researchers analyzed more than 40 studies that included 860,000 patients and found that two doses of a COVID-19 vaccine reduced the risk of long COVID by almost half.

The message? COVID vaccination is very effective in reducing the risk of long COVID.

“It’s important to emphasize that many of the risk factors [for long COVID] cannot be changed, or at least cannot be changed easily, but vaccination is a decision that can be taken by everyone,” said Vassilios Vassiliou, MBBS, PhD, clinical professor of cardiac medicine at Norwich Medical School in England, who coauthored the article in JAMA Internal Medicine.
 

Why vaccines may be protective

The COVID-19 vaccines work well to prevent serious illness from the virus, noted Aaron Friedberg, MD, clinical coleader of the Post COVID Recovery Program at the Ohio State University Wexner Medical Center. That may be a clue to why the vaccines help prevent long COVID symptoms.

“When you get COVID and you’ve been vaccinated, the virus may still attach in your nose and respiratory tract, but it’s less likely to spread throughout your body,” he explained. “It’s like a forest fire – if the ground is wet or it starts to rain, it’s less likely to create a great blaze. As a result, your body is less likely to experience inflammation and damage that makes it more likely that you’ll develop long COVID.”

Dr. Friedberg stressed that even for patients who have had COVID, it’s important to get vaccinated – a message he consistently delivers to his own patients.

“There is some protection that comes from having COVID before, but for some people, that’s not enough,” he said. “It’s true that after infection, your body creates antibodies that help protect you against the virus. But I explain to patients that these may be like old Velcro: They barely grab on enough to stay on for the moment, but they don’t last long term. You’re much more likely to get a reliable immune response from the vaccine.”

In addition, a second or third bout of COVID could be the one that gives patients long COVID, Dr. Friedberg adds.

“I have a number of patients in my clinic who were fine after their first bout of COVID but experienced debilitating long COVID symptoms after they developed COVID again,” he said. “Why leave it to chance?”
 

Vaccines and ‘long vax’

The COVID vaccines are considered very safe but have been linked to very rare side effects, such as blood clots and heart inflammation. There have also been anecdotal reports of symptoms that resemble long COVID – a syndrome that has come to be known as “long Vax” – an extremely rare condition that may or may not be tied to vaccination.

“I have seen people in my clinic who developed symptoms suggestive of long COVID that linger for months – brain fog, fatigue, heart palpitations – soon after they got the COVID-19 vaccine,” said Dr. Purpura. But no published studies have suggested a link, he cautions.

A study called LISTEN is being organized at Yale in an effort to better understand postvaccine adverse events and a potential link to long COVID.
 

Talking to patients

Discussions of vaccination with patients, including those with COVID or long COVID, are often fraught and challenging, said Dr. Purpura.

“There’s a lot of fear that they will have a worsening of their symptoms,” he explained. The conversation he has with his patients mirrors the conversation all physicians should have with their patients about COVID-19 vaccination, even if they don’t have long COVID. He stresses the importance of highlighting the following components:

• Show compassion and empathy. “A lot of people have strongly held opinions – it’s worth it to try to find out why they feel the way that they do,” said Dr. Friedberg.
• Walk them through side effects. “Many people are afraid of the side effects of the vaccine, especially if they already have long COVID,” explained Dr. Purpura. Such patients can be asked how they felt after their last vaccination, such a shingles or flu shot. Then explain that the COVID-19 vaccine is not much different and that they may experience temporary side effects such as fatigue, headache, or a mild fever for 24-48 hours.
• Explain the benefits. Eighty-five percent of people say their health care provider is a trusted source of information on COVID-19 vaccines, according to the Kaiser Family Foundation. That trust is conducive to talks about the vaccine’s benefits, including its ability to protect against long COVID.

Other ways to reduce risk of long COVID

Vaccines can lower the chances of a patient’s developing long COVID. So can the antiviral medication nirmatrelvir (Paxlovid). A March 2023 study published in JAMA Internal Medicine included more than 280,000 people with COVID. The researchers found that vaccination reduced the risk for developing the condition by about 25%.

“I mention that study to all of my long COVID patients who become reinfected with the virus,” said Dr. Purpura. “It not only appears protective against long COVID, but since it lowers levels of virus circulating in their body, it seems to help prevent a flare-up of symptoms.”

Another treatment that may help is the diabetes drug metformin, he added.

A June 2023 study published in The Lancet Infectious Diseases found that when metformin was given within 3 days of symptom onset, the incidence of long COVID was reduced by about 41%.

“We’re still trying to wrap our brains around this one, but the thought is it may help to lower inflammation, which plays a role in long COVID,” Dr. Purpura explained. More studies need to be conducted, though, before recommending its use.

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

The COVID-19 vaccines have been a game changer for millions of people worldwide in preventing death or disability from the virus. Research suggests that they offer significant protection against long COVID.

Studies have consistently found that these vaccines prevent the new onset of long COVID as well as flare-ups for people who already have the condition.

False and unfounded claims made by some antivaccine groups that the vaccines themselves may cause long COVID persist and serve as barriers to vaccination.

To help separate the facts from falsehoods, here’s a checklist for doctors on what scientific studies have determined about vaccination and long COVID.
 

What the research shows

Doctors who work in long COVID clinics have for years suspected that vaccination may help protect against the development of long COVID, noted Lawrence Purpura, MD, MPH, an infectious disease specialist at New York–Presbyterian/Columbia University Irving Medical Center, who treats patients with long COVID in his clinic.

Over the past year, several large, well-conducted studies have borne out that theory, including the following studies:

• In the RECOVER study, published in May in the journal Nature Communications, researchers examined the electronic health records of more than 5 million people who had been diagnosed with COVID and found that vaccination reduced the risk that they would develop long COVID. Although the researchers didn’t compare the effects of having boosters to being fully vaccinated without them, experts have suggested that having a full round of recommended shots may offer the most protection. “My thoughts are that more shots are better, and other work has shown compelling evidence that the protective effect of vaccination on COVID-19 wanes over time,” said study coauthor Daniel Brannock, MS, a research scientist at RTI International in Research Triangle Park, N.C. “It stands to reason that the same is true for long COVID.”
• A review published in February in BMJ Medicine concluded that 10 studies showed a significant reduction in the incidence of long COVID among vaccinated patients. Even one dose of a vaccine was protective.
• A meta-analysis of six studies published last December in Antimicrobial Stewardship and Healthcare Epidemiology found that one or more doses of a COVID-19 vaccine were 29% effective in preventing symptoms of long COVID.
• In a June meta-analysis published in JAMA Internal Medicine, researchers analyzed more than 40 studies that included 860,000 patients and found that two doses of a COVID-19 vaccine reduced the risk of long COVID by almost half.

The message? COVID vaccination is very effective in reducing the risk of long COVID.

“It’s important to emphasize that many of the risk factors [for long COVID] cannot be changed, or at least cannot be changed easily, but vaccination is a decision that can be taken by everyone,” said Vassilios Vassiliou, MBBS, PhD, clinical professor of cardiac medicine at Norwich Medical School in England, who coauthored the article in JAMA Internal Medicine.
 

Why vaccines may be protective

The COVID-19 vaccines work well to prevent serious illness from the virus, noted Aaron Friedberg, MD, clinical coleader of the Post COVID Recovery Program at the Ohio State University Wexner Medical Center. That may be a clue to why the vaccines help prevent long COVID symptoms.

“When you get COVID and you’ve been vaccinated, the virus may still attach in your nose and respiratory tract, but it’s less likely to spread throughout your body,” he explained. “It’s like a forest fire – if the ground is wet or it starts to rain, it’s less likely to create a great blaze. As a result, your body is less likely to experience inflammation and damage that makes it more likely that you’ll develop long COVID.”

Dr. Friedberg stressed that even for patients who have had COVID, it’s important to get vaccinated – a message he consistently delivers to his own patients.

“There is some protection that comes from having COVID before, but for some people, that’s not enough,” he said. “It’s true that after infection, your body creates antibodies that help protect you against the virus. But I explain to patients that these may be like old Velcro: They barely grab on enough to stay on for the moment, but they don’t last long term. You’re much more likely to get a reliable immune response from the vaccine.”

In addition, a second or third bout of COVID could be the one that gives patients long COVID, Dr. Friedberg adds.

“I have a number of patients in my clinic who were fine after their first bout of COVID but experienced debilitating long COVID symptoms after they developed COVID again,” he said. “Why leave it to chance?”
 

Vaccines and ‘long vax’

The COVID vaccines are considered very safe but have been linked to very rare side effects, such as blood clots and heart inflammation. There have also been anecdotal reports of symptoms that resemble long COVID – a syndrome that has come to be known as “long Vax” – an extremely rare condition that may or may not be tied to vaccination.

“I have seen people in my clinic who developed symptoms suggestive of long COVID that linger for months – brain fog, fatigue, heart palpitations – soon after they got the COVID-19 vaccine,” said Dr. Purpura. But no published studies have suggested a link, he cautions.

A study called LISTEN is being organized at Yale in an effort to better understand postvaccine adverse events and a potential link to long COVID.
 

Talking to patients

Discussions of vaccination with patients, including those with COVID or long COVID, are often fraught and challenging, said Dr. Purpura.

“There’s a lot of fear that they will have a worsening of their symptoms,” he explained. The conversation he has with his patients mirrors the conversation all physicians should have with their patients about COVID-19 vaccination, even if they don’t have long COVID. He stresses the importance of highlighting the following components:

• Show compassion and empathy. “A lot of people have strongly held opinions – it’s worth it to try to find out why they feel the way that they do,” said Dr. Friedberg.
• Walk them through side effects. “Many people are afraid of the side effects of the vaccine, especially if they already have long COVID,” explained Dr. Purpura. Such patients can be asked how they felt after their last vaccination, such a shingles or flu shot. Then explain that the COVID-19 vaccine is not much different and that they may experience temporary side effects such as fatigue, headache, or a mild fever for 24-48 hours.
• Explain the benefits. Eighty-five percent of people say their health care provider is a trusted source of information on COVID-19 vaccines, according to the Kaiser Family Foundation. That trust is conducive to talks about the vaccine’s benefits, including its ability to protect against long COVID.

Other ways to reduce risk of long COVID

Vaccines can lower the chances of a patient’s developing long COVID. So can the antiviral medication nirmatrelvir (Paxlovid). A March 2023 study published in JAMA Internal Medicine included more than 280,000 people with COVID. The researchers found that vaccination reduced the risk for developing the condition by about 25%.

“I mention that study to all of my long COVID patients who become reinfected with the virus,” said Dr. Purpura. “It not only appears protective against long COVID, but since it lowers levels of virus circulating in their body, it seems to help prevent a flare-up of symptoms.”

Another treatment that may help is the diabetes drug metformin, he added.

A June 2023 study published in The Lancet Infectious Diseases found that when metformin was given within 3 days of symptom onset, the incidence of long COVID was reduced by about 41%.

“We’re still trying to wrap our brains around this one, but the thought is it may help to lower inflammation, which plays a role in long COVID,” Dr. Purpura explained. More studies need to be conducted, though, before recommending its use.

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

Feelings of inadequacy, in terms of skills and expectations in an ever-changing system, are common emotions that many doctors have experienced since the start of the pandemic.

COVID-19 imposed challenges on health care professionals and systems by forcing changes in how doctors organize themselves professionally as well as in their relationships with patients and in their expectations (realistic or not) of their roles. The situation was bound to generate high rates of frustration and discomfort among younger and older physicians. It was compounded by a generational transition of the profession, which was accelerated by the virus. It was not managed by the decision-makers and was painful for doctors and patients.

Impostor syndrome (IS) is a psychological construct characterized by the persistent belief that one’s success is undeserved, rather than stemming from personal effort, skill, and ability. The phenomenon is common among medics for various reasons, including professional burnout. Recent studies have helped to better define the extent and characteristic features of the syndrome, as well as efforts to combat it.
 

Doctors and burnout

Although occupational burnout among physicians is a systemic issue primarily attributable to problems in the practice environment, professional norms and aspects of medical culture often contribute to the distress that individual physicians experience.

These dimensions have been well characterized and include suggestions that physicians should be impervious to normal human limitations (that is, superhuman), that work should always come first, and that seeking help is a sign of weakness. In aggregate, these attitudes lead many physicians to engage in unhealthy levels of self-sacrifice, manifested by excessive work hours, anxiety about missing something that would benefit their patients, and prioritizing work over personal health. These factors are familiar to many hospital-based and family physicians.
 

The impostor phenomenon

The impostor phenomenon (IP) is a psychological experience of intellectual and professional fraud. Individuals who suffer from it believe that others have inflated perceptions of the individual’s abilities and fear being judged. This fear persists despite continual proof of the individual’s successes. These people ignore praise, are highly self-critical, and attribute their successes to external factors, such as luck, hard work, or receiving help from others, rather than to qualities such as skill, intelligence, or ability.

IP is common among men and women. Some studies suggest it may be more prevalent among women. Studies across industries suggest that the phenomenon is associated with personal consequences (for example, low emotional well-being, problems with work-life integration, anxiety, depression, suicide) and professional consequences (for example, impaired job performance, occupational burnout). Studies involving U.S. medical students have revealed that more than one in four medical students experience IP and that those who experience it are at higher risk for burnout.
 

Surveying IS

IS, which is not a formal psychiatric diagnosis, is defined as having feelings of uncertainty, inadequacy, and being undeserving of one’s achievements despite evidence to the contrary. There are five subtypes of IS:

• Perfectionist: insecurity related to self-imposed, unachievable goals
• Expert: feeling inadequate from lacking sufficient knowledge
• Superperson: assuming excessive workloads just to feel okay among peers
• Natural genius: experiencing shame when it takes effort to develop a skill
• Soloist: believing that requesting help is a sign of weakness

Risk factors

Studies suggest that IS is a problem early in the physician training process. There is limited information on IS among physicians in practice.

Because transitions represent a risk factor for IP, the frequent rotation between clerkships and being a “perpetual novice” during medical school training may contribute to the high prevalence. Qualitative studies suggest that, once in practice, other professional experiences (for example, unfavorable patient outcomes, patient complaints, rejection of grants or manuscripts, and poor teaching evaluations or patient satisfaction scores) may contribute to IP.
 

Impact on doctors

Several methods have been used to classify how much the phenomenon interferes with a person’s life. The Clance Impostor Phenomenon Scale is a 20-item scale that asks respondents to indicate how well each item characterizes their experience on a 5-point scale. Options range from “not at all” to “very true.” The sum of responses to the individual items is used to create an aggregate score (IP score). The higher the score, the more frequently and seriously IP interferes with a person’s life.

A simplified version of the IP score was used in a study of 3,237 U.S. doctors that investigated the association between IS and burnout among doctors and to compare their rates of IS with those of other professionals.

Mean IP scores were higher for female physicians than for male physicians (mean, 10.91 vs. 9.12; P < .001). Scores decreased with age and were lower among those who were married or widowed.

With respect to professional characteristics, IP scores were greater among those in academic practice or who worked in the Veterans Affairs medical system and decreased with years in practice.

The highest IP scores were among pediatric subspecialists, general pediatricians, and emergency medicine physicians. Scores were lowest among ophthalmologists, radiologists, and orthopedic surgeons. IP has been independently associated with the risk of burnout and low professional fulfillment.
 

Lessening the impact

An article commenting on the study highlighted the following expert practice strategies that doctors can use to reduce the impact of IS in their professional life.

• Review and celebrate feats that have led to your professional role.
• Share concerns with trusted colleagues who can validate your accomplishments and normalize your feelings by reporting their own struggles with IS.
• Combat perfectionism by accepting that it is okay to be good enough when meeting the challenges of a demanding profession.
• Exercise self-compassion as an alternative to relying on an external locus of self-worth.
• Understand that IS may be common, especially during transitions, such as when entering medical school, graduate medical training, or starting a new career.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

Feelings of inadequacy, in terms of skills and expectations in an ever-changing system, are common emotions that many doctors have experienced since the start of the pandemic.

COVID-19 imposed challenges on health care professionals and systems by forcing changes in how doctors organize themselves professionally as well as in their relationships with patients and in their expectations (realistic or not) of their roles. The situation was bound to generate high rates of frustration and discomfort among younger and older physicians. It was compounded by a generational transition of the profession, which was accelerated by the virus. It was not managed by the decision-makers and was painful for doctors and patients.

Impostor syndrome (IS) is a psychological construct characterized by the persistent belief that one’s success is undeserved, rather than stemming from personal effort, skill, and ability. The phenomenon is common among medics for various reasons, including professional burnout. Recent studies have helped to better define the extent and characteristic features of the syndrome, as well as efforts to combat it.
 

Doctors and burnout

Although occupational burnout among physicians is a systemic issue primarily attributable to problems in the practice environment, professional norms and aspects of medical culture often contribute to the distress that individual physicians experience.

These dimensions have been well characterized and include suggestions that physicians should be impervious to normal human limitations (that is, superhuman), that work should always come first, and that seeking help is a sign of weakness. In aggregate, these attitudes lead many physicians to engage in unhealthy levels of self-sacrifice, manifested by excessive work hours, anxiety about missing something that would benefit their patients, and prioritizing work over personal health. These factors are familiar to many hospital-based and family physicians.
 

The impostor phenomenon

The impostor phenomenon (IP) is a psychological experience of intellectual and professional fraud. Individuals who suffer from it believe that others have inflated perceptions of the individual’s abilities and fear being judged. This fear persists despite continual proof of the individual’s successes. These people ignore praise, are highly self-critical, and attribute their successes to external factors, such as luck, hard work, or receiving help from others, rather than to qualities such as skill, intelligence, or ability.

IP is common among men and women. Some studies suggest it may be more prevalent among women. Studies across industries suggest that the phenomenon is associated with personal consequences (for example, low emotional well-being, problems with work-life integration, anxiety, depression, suicide) and professional consequences (for example, impaired job performance, occupational burnout). Studies involving U.S. medical students have revealed that more than one in four medical students experience IP and that those who experience it are at higher risk for burnout.
 

Surveying IS

IS, which is not a formal psychiatric diagnosis, is defined as having feelings of uncertainty, inadequacy, and being undeserving of one’s achievements despite evidence to the contrary. There are five subtypes of IS:

• Perfectionist: insecurity related to self-imposed, unachievable goals
• Expert: feeling inadequate from lacking sufficient knowledge
• Superperson: assuming excessive workloads just to feel okay among peers
• Natural genius: experiencing shame when it takes effort to develop a skill
• Soloist: believing that requesting help is a sign of weakness

Risk factors

Studies suggest that IS is a problem early in the physician training process. There is limited information on IS among physicians in practice.

Because transitions represent a risk factor for IP, the frequent rotation between clerkships and being a “perpetual novice” during medical school training may contribute to the high prevalence. Qualitative studies suggest that, once in practice, other professional experiences (for example, unfavorable patient outcomes, patient complaints, rejection of grants or manuscripts, and poor teaching evaluations or patient satisfaction scores) may contribute to IP.
 

Impact on doctors

Several methods have been used to classify how much the phenomenon interferes with a person’s life. The Clance Impostor Phenomenon Scale is a 20-item scale that asks respondents to indicate how well each item characterizes their experience on a 5-point scale. Options range from “not at all” to “very true.” The sum of responses to the individual items is used to create an aggregate score (IP score). The higher the score, the more frequently and seriously IP interferes with a person’s life.

A simplified version of the IP score was used in a study of 3,237 U.S. doctors that investigated the association between IS and burnout among doctors and to compare their rates of IS with those of other professionals.

Mean IP scores were higher for female physicians than for male physicians (mean, 10.91 vs. 9.12; P < .001). Scores decreased with age and were lower among those who were married or widowed.

With respect to professional characteristics, IP scores were greater among those in academic practice or who worked in the Veterans Affairs medical system and decreased with years in practice.

The highest IP scores were among pediatric subspecialists, general pediatricians, and emergency medicine physicians. Scores were lowest among ophthalmologists, radiologists, and orthopedic surgeons. IP has been independently associated with the risk of burnout and low professional fulfillment.
 

Lessening the impact

An article commenting on the study highlighted the following expert practice strategies that doctors can use to reduce the impact of IS in their professional life.

• Review and celebrate feats that have led to your professional role.
• Share concerns with trusted colleagues who can validate your accomplishments and normalize your feelings by reporting their own struggles with IS.
• Combat perfectionism by accepting that it is okay to be good enough when meeting the challenges of a demanding profession.
• Exercise self-compassion as an alternative to relying on an external locus of self-worth.
• Understand that IS may be common, especially during transitions, such as when entering medical school, graduate medical training, or starting a new career.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

Feelings of inadequacy, in terms of skills and expectations in an ever-changing system, are common emotions that many doctors have experienced since the start of the pandemic.

COVID-19 imposed challenges on health care professionals and systems by forcing changes in how doctors organize themselves professionally as well as in their relationships with patients and in their expectations (realistic or not) of their roles. The situation was bound to generate high rates of frustration and discomfort among younger and older physicians. It was compounded by a generational transition of the profession, which was accelerated by the virus. It was not managed by the decision-makers and was painful for doctors and patients.

Impostor syndrome (IS) is a psychological construct characterized by the persistent belief that one’s success is undeserved, rather than stemming from personal effort, skill, and ability. The phenomenon is common among medics for various reasons, including professional burnout. Recent studies have helped to better define the extent and characteristic features of the syndrome, as well as efforts to combat it.
 

Doctors and burnout

Although occupational burnout among physicians is a systemic issue primarily attributable to problems in the practice environment, professional norms and aspects of medical culture often contribute to the distress that individual physicians experience.

These dimensions have been well characterized and include suggestions that physicians should be impervious to normal human limitations (that is, superhuman), that work should always come first, and that seeking help is a sign of weakness. In aggregate, these attitudes lead many physicians to engage in unhealthy levels of self-sacrifice, manifested by excessive work hours, anxiety about missing something that would benefit their patients, and prioritizing work over personal health. These factors are familiar to many hospital-based and family physicians.
 

The impostor phenomenon

The impostor phenomenon (IP) is a psychological experience of intellectual and professional fraud. Individuals who suffer from it believe that others have inflated perceptions of the individual’s abilities and fear being judged. This fear persists despite continual proof of the individual’s successes. These people ignore praise, are highly self-critical, and attribute their successes to external factors, such as luck, hard work, or receiving help from others, rather than to qualities such as skill, intelligence, or ability.

IP is common among men and women. Some studies suggest it may be more prevalent among women. Studies across industries suggest that the phenomenon is associated with personal consequences (for example, low emotional well-being, problems with work-life integration, anxiety, depression, suicide) and professional consequences (for example, impaired job performance, occupational burnout). Studies involving U.S. medical students have revealed that more than one in four medical students experience IP and that those who experience it are at higher risk for burnout.
 

Surveying IS

IS, which is not a formal psychiatric diagnosis, is defined as having feelings of uncertainty, inadequacy, and being undeserving of one’s achievements despite evidence to the contrary. There are five subtypes of IS:

• Perfectionist: insecurity related to self-imposed, unachievable goals
• Expert: feeling inadequate from lacking sufficient knowledge
• Superperson: assuming excessive workloads just to feel okay among peers
• Natural genius: experiencing shame when it takes effort to develop a skill
• Soloist: believing that requesting help is a sign of weakness

Risk factors

Studies suggest that IS is a problem early in the physician training process. There is limited information on IS among physicians in practice.

Because transitions represent a risk factor for IP, the frequent rotation between clerkships and being a “perpetual novice” during medical school training may contribute to the high prevalence. Qualitative studies suggest that, once in practice, other professional experiences (for example, unfavorable patient outcomes, patient complaints, rejection of grants or manuscripts, and poor teaching evaluations or patient satisfaction scores) may contribute to IP.
 

Impact on doctors

Several methods have been used to classify how much the phenomenon interferes with a person’s life. The Clance Impostor Phenomenon Scale is a 20-item scale that asks respondents to indicate how well each item characterizes their experience on a 5-point scale. Options range from “not at all” to “very true.” The sum of responses to the individual items is used to create an aggregate score (IP score). The higher the score, the more frequently and seriously IP interferes with a person’s life.

A simplified version of the IP score was used in a study of 3,237 U.S. doctors that investigated the association between IS and burnout among doctors and to compare their rates of IS with those of other professionals.

Mean IP scores were higher for female physicians than for male physicians (mean, 10.91 vs. 9.12; P < .001). Scores decreased with age and were lower among those who were married or widowed.

With respect to professional characteristics, IP scores were greater among those in academic practice or who worked in the Veterans Affairs medical system and decreased with years in practice.

The highest IP scores were among pediatric subspecialists, general pediatricians, and emergency medicine physicians. Scores were lowest among ophthalmologists, radiologists, and orthopedic surgeons. IP has been independently associated with the risk of burnout and low professional fulfillment.
 

Lessening the impact

An article commenting on the study highlighted the following expert practice strategies that doctors can use to reduce the impact of IS in their professional life.

• Review and celebrate feats that have led to your professional role.
• Share concerns with trusted colleagues who can validate your accomplishments and normalize your feelings by reporting their own struggles with IS.
• Combat perfectionism by accepting that it is okay to be good enough when meeting the challenges of a demanding profession.
• Exercise self-compassion as an alternative to relying on an external locus of self-worth.
• Understand that IS may be common, especially during transitions, such as when entering medical school, graduate medical training, or starting a new career.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

Use of inhalers with long-acting muscarinic antagonists and long-acting beta-agonists reduced COPD exacerbations and pneumonia hospitalizations compared with inhalers with corticosteroids and long-acting beta-agonists, based on data from more than 30,000 individuals.

Current clinical guidelines for chronic obstructive pulmonary disease (COPD) patients recommend inhalers with long-acting muscarinic antagonists (LAMAs) and long-acting beta-agonists (LABAs) over those with inhaled corticosteroids (ICSs) and LABAs, but data comparing the two formulations have been inconsistent, and concerns about generalizability persist, wrote William B. Feldman, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

In a study published in JAMA Internal Medicine, the researchers reviewed data from a commercial insurance claims database of individuals diagnosed with COPD who filled a new prescription for a LAMA-LABA inhaler or ICS-LABA inhaler between Jan. 1, 2014, and Dec. 31, 2019. Patients with asthma and those younger than 40 years were excluded. The study population included 137,833 individuals with a mean age of 70.2 years; 50.4% were female. Of the 107,004 ICS-LABA users and 30,829 LAMA-LABA users, 30,216 matched pairs were included in a 1:1 propensity score matched study. The primary outcomes were effectiveness, based on the rate of first moderate or severe COPD exacerbation, and safety, based on the rate of first pneumonia hospitalization.

Use of LAMA-LABA inhalers was associated with an 8% reduction in the rate of first moderate or severe COPD exacerbation and a 20% reduction in the rate of first pneumonia hospitalization compared with use of ICS-LABA (hazard ratios 0.92 and 0.80, respectively). The absolute rate reductions with LAMA-LABA inhalers for first moderate or severe COPD exacerbations and for first pneumonia hospitalizations were was 43.0 events per 1,000 person-years and 91.8 events per person-years, respectively.

The overall rates of total moderate to severe COPD and pneumonia hospitalizations were 5% and 17% lower, respectively, among patients who used LAMA-LABA than those treated with ICS-LABA. The results were consistently robust in subgroup and sensitivity analyses, the researchers wrote in their discussion. However, the results must be interpreted cautiously in comparison to other large studies because of the significant differences in the cohorts of patients studied, notably that most patients in the current study had no received previous inhaler therapy.

The study findings were limited by several factors including the relatively short follow-up time and reliance on prescription fills as an indicator of medication use, the researchers noted. Other limitations included notable differences between the LAMA-LABA patients and ICS-LABA patients, such as more severe COPD and less access to respiratory care, they wrote.

Although the current study is not the definitive answer to conflicting results from previous trials, it is the largest know to date to compare LAMA-LABA with ICS-LABA, and the results support LAMA-LABA as the preferred therapy for COPD patients, the researchers concluded.
 

Findings clarify clinical practice guidelines

“This study was required to provide clarity regarding the optimal choice of treatment for COPD given conflicting data from other recent trials,” Suman Pal, MBBS, of the University of New Mexico, Albuquerque, said in an interview.

“The study findings reinforce the benefits of combined LAMA-LABA in improving clinical outcomes in COPD in a real-world setting,” and the data provide further support for choosing LAMA-LABA over ICS-LABA in COPD patients, said Dr. Pal, who was not involved in the study.

However, availability and affordability of LAMA-LABA inhalers may be barriers to expanding their use in clinical practice, he noted.

“Additional research is needed to accurately define which patient populations would benefit most from the therapy and whether patients who have previously been stabilized on ICS-LABA would derive additional benefit from a change in therapy,” Dr. Pal said.

The study was supported by the National Heart, Lung, and Blood Institute and funding from the Commonwealth Fund and Arnold Ventures.

Dr. Feldman disclosed receiving personal fees from Alosa Health and Aetion, serving as an expert witness in litigation against inhaler manufacturers, and receiving an honorarium for a presentation to Blue Cross Blue Shield of Massachusetts unrelated to the current study. Dr. Pal had no financial conflicts to disclose.

Use of inhalers with long-acting muscarinic antagonists and long-acting beta-agonists reduced COPD exacerbations and pneumonia hospitalizations compared with inhalers with corticosteroids and long-acting beta-agonists, based on data from more than 30,000 individuals.

Current clinical guidelines for chronic obstructive pulmonary disease (COPD) patients recommend inhalers with long-acting muscarinic antagonists (LAMAs) and long-acting beta-agonists (LABAs) over those with inhaled corticosteroids (ICSs) and LABAs, but data comparing the two formulations have been inconsistent, and concerns about generalizability persist, wrote William B. Feldman, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

In a study published in JAMA Internal Medicine, the researchers reviewed data from a commercial insurance claims database of individuals diagnosed with COPD who filled a new prescription for a LAMA-LABA inhaler or ICS-LABA inhaler between Jan. 1, 2014, and Dec. 31, 2019. Patients with asthma and those younger than 40 years were excluded. The study population included 137,833 individuals with a mean age of 70.2 years; 50.4% were female. Of the 107,004 ICS-LABA users and 30,829 LAMA-LABA users, 30,216 matched pairs were included in a 1:1 propensity score matched study. The primary outcomes were effectiveness, based on the rate of first moderate or severe COPD exacerbation, and safety, based on the rate of first pneumonia hospitalization.

Use of LAMA-LABA inhalers was associated with an 8% reduction in the rate of first moderate or severe COPD exacerbation and a 20% reduction in the rate of first pneumonia hospitalization compared with use of ICS-LABA (hazard ratios 0.92 and 0.80, respectively). The absolute rate reductions with LAMA-LABA inhalers for first moderate or severe COPD exacerbations and for first pneumonia hospitalizations were was 43.0 events per 1,000 person-years and 91.8 events per person-years, respectively.

The overall rates of total moderate to severe COPD and pneumonia hospitalizations were 5% and 17% lower, respectively, among patients who used LAMA-LABA than those treated with ICS-LABA. The results were consistently robust in subgroup and sensitivity analyses, the researchers wrote in their discussion. However, the results must be interpreted cautiously in comparison to other large studies because of the significant differences in the cohorts of patients studied, notably that most patients in the current study had no received previous inhaler therapy.

The study findings were limited by several factors including the relatively short follow-up time and reliance on prescription fills as an indicator of medication use, the researchers noted. Other limitations included notable differences between the LAMA-LABA patients and ICS-LABA patients, such as more severe COPD and less access to respiratory care, they wrote.

Although the current study is not the definitive answer to conflicting results from previous trials, it is the largest know to date to compare LAMA-LABA with ICS-LABA, and the results support LAMA-LABA as the preferred therapy for COPD patients, the researchers concluded.
 

Findings clarify clinical practice guidelines

“This study was required to provide clarity regarding the optimal choice of treatment for COPD given conflicting data from other recent trials,” Suman Pal, MBBS, of the University of New Mexico, Albuquerque, said in an interview.

“The study findings reinforce the benefits of combined LAMA-LABA in improving clinical outcomes in COPD in a real-world setting,” and the data provide further support for choosing LAMA-LABA over ICS-LABA in COPD patients, said Dr. Pal, who was not involved in the study.

However, availability and affordability of LAMA-LABA inhalers may be barriers to expanding their use in clinical practice, he noted.

“Additional research is needed to accurately define which patient populations would benefit most from the therapy and whether patients who have previously been stabilized on ICS-LABA would derive additional benefit from a change in therapy,” Dr. Pal said.

The study was supported by the National Heart, Lung, and Blood Institute and funding from the Commonwealth Fund and Arnold Ventures.

Dr. Feldman disclosed receiving personal fees from Alosa Health and Aetion, serving as an expert witness in litigation against inhaler manufacturers, and receiving an honorarium for a presentation to Blue Cross Blue Shield of Massachusetts unrelated to the current study. Dr. Pal had no financial conflicts to disclose.

Use of inhalers with long-acting muscarinic antagonists and long-acting beta-agonists reduced COPD exacerbations and pneumonia hospitalizations compared with inhalers with corticosteroids and long-acting beta-agonists, based on data from more than 30,000 individuals.

Current clinical guidelines for chronic obstructive pulmonary disease (COPD) patients recommend inhalers with long-acting muscarinic antagonists (LAMAs) and long-acting beta-agonists (LABAs) over those with inhaled corticosteroids (ICSs) and LABAs, but data comparing the two formulations have been inconsistent, and concerns about generalizability persist, wrote William B. Feldman, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

In a study published in JAMA Internal Medicine, the researchers reviewed data from a commercial insurance claims database of individuals diagnosed with COPD who filled a new prescription for a LAMA-LABA inhaler or ICS-LABA inhaler between Jan. 1, 2014, and Dec. 31, 2019. Patients with asthma and those younger than 40 years were excluded. The study population included 137,833 individuals with a mean age of 70.2 years; 50.4% were female. Of the 107,004 ICS-LABA users and 30,829 LAMA-LABA users, 30,216 matched pairs were included in a 1:1 propensity score matched study. The primary outcomes were effectiveness, based on the rate of first moderate or severe COPD exacerbation, and safety, based on the rate of first pneumonia hospitalization.

Use of LAMA-LABA inhalers was associated with an 8% reduction in the rate of first moderate or severe COPD exacerbation and a 20% reduction in the rate of first pneumonia hospitalization compared with use of ICS-LABA (hazard ratios 0.92 and 0.80, respectively). The absolute rate reductions with LAMA-LABA inhalers for first moderate or severe COPD exacerbations and for first pneumonia hospitalizations were was 43.0 events per 1,000 person-years and 91.8 events per person-years, respectively.

The overall rates of total moderate to severe COPD and pneumonia hospitalizations were 5% and 17% lower, respectively, among patients who used LAMA-LABA than those treated with ICS-LABA. The results were consistently robust in subgroup and sensitivity analyses, the researchers wrote in their discussion. However, the results must be interpreted cautiously in comparison to other large studies because of the significant differences in the cohorts of patients studied, notably that most patients in the current study had no received previous inhaler therapy.

The study findings were limited by several factors including the relatively short follow-up time and reliance on prescription fills as an indicator of medication use, the researchers noted. Other limitations included notable differences between the LAMA-LABA patients and ICS-LABA patients, such as more severe COPD and less access to respiratory care, they wrote.

Although the current study is not the definitive answer to conflicting results from previous trials, it is the largest know to date to compare LAMA-LABA with ICS-LABA, and the results support LAMA-LABA as the preferred therapy for COPD patients, the researchers concluded.
 

Findings clarify clinical practice guidelines

“This study was required to provide clarity regarding the optimal choice of treatment for COPD given conflicting data from other recent trials,” Suman Pal, MBBS, of the University of New Mexico, Albuquerque, said in an interview.

“The study findings reinforce the benefits of combined LAMA-LABA in improving clinical outcomes in COPD in a real-world setting,” and the data provide further support for choosing LAMA-LABA over ICS-LABA in COPD patients, said Dr. Pal, who was not involved in the study.

However, availability and affordability of LAMA-LABA inhalers may be barriers to expanding their use in clinical practice, he noted.

“Additional research is needed to accurately define which patient populations would benefit most from the therapy and whether patients who have previously been stabilized on ICS-LABA would derive additional benefit from a change in therapy,” Dr. Pal said.

The study was supported by the National Heart, Lung, and Blood Institute and funding from the Commonwealth Fund and Arnold Ventures.

Dr. Feldman disclosed receiving personal fees from Alosa Health and Aetion, serving as an expert witness in litigation against inhaler manufacturers, and receiving an honorarium for a presentation to Blue Cross Blue Shield of Massachusetts unrelated to the current study. Dr. Pal had no financial conflicts to disclose.

An estimated 3 in every 10 white-tailed deer in the United States have had COVID-19, and new research suggests deer populations could be a source of virus mutations that may be passed to humans.

According to the U.S. Department of Agriculture, which led the research project, humans transmitted the virus to deer at least 100 times. The virus then spread widely among free-ranging deer populations, and there were three possible cases of the deer transmitting the virus to humans.

The data comes from tests done between November 2021 and April 2022 on more than 12,000 deer found across half of the United States. Sequencing of the virus found in the deer showed that deer had been exposed to all of the prominent variants, including Alpha, Gamma, Delta, and Omicron.

Some of the findings about transmission were published in the journal Nature Communications, in which researchers noted that in addition to being identified in deer, the virus has been found in wild and domestic animals, including mink, rats, otters, ferrets, hamsters, gorillas, cats, dogs, lions, and tigers. Animal-to-human transmission has been documented or suspected in mink and domestic cats, in addition to white-tailed deer.

The findings are important because the animal populations can become “reservoirs ... in which the virus circulates covertly, persisting in the population and can be transmitted to other animals or humans potentially causing disease outbreaks,” according to the paper, which was a collaboration among scientists from the U.S. Department of Agriculture, CDC, and the University of Missouri–Columbia.

In the three cases of possible deer-to-human transmission, researchers said that mutated versions of the virus previously found only in deer had been found in COVID test samples taken from one person in North Carolina and two people in Massachusetts. Those deer-specific mutated versions of the virus have not been found in any other human samples, lending evidence that the mutations occurred within deer.

“Deer regularly interact with humans and are commonly found in human environments – near our homes, pets, wastewater, and trash,” researcher and University of Missouri–Columbia professor Xiu-Feng “Henry” Wan, PhD, said in a statement. “The potential for SARS-CoV-2, or any zoonotic disease, to persist and evolve in wildlife populations can pose unique public health risks.”

In the Nature Communications paper, the researchers suggested that deer may be exposed to the virus from human food waste, masks, or other waste products. The authors concluded that further study is needed to determine how virus transmission occurs between deer and humans.

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

An estimated 3 in every 10 white-tailed deer in the United States have had COVID-19, and new research suggests deer populations could be a source of virus mutations that may be passed to humans.

According to the U.S. Department of Agriculture, which led the research project, humans transmitted the virus to deer at least 100 times. The virus then spread widely among free-ranging deer populations, and there were three possible cases of the deer transmitting the virus to humans.

The data comes from tests done between November 2021 and April 2022 on more than 12,000 deer found across half of the United States. Sequencing of the virus found in the deer showed that deer had been exposed to all of the prominent variants, including Alpha, Gamma, Delta, and Omicron.

Some of the findings about transmission were published in the journal Nature Communications, in which researchers noted that in addition to being identified in deer, the virus has been found in wild and domestic animals, including mink, rats, otters, ferrets, hamsters, gorillas, cats, dogs, lions, and tigers. Animal-to-human transmission has been documented or suspected in mink and domestic cats, in addition to white-tailed deer.

The findings are important because the animal populations can become “reservoirs ... in which the virus circulates covertly, persisting in the population and can be transmitted to other animals or humans potentially causing disease outbreaks,” according to the paper, which was a collaboration among scientists from the U.S. Department of Agriculture, CDC, and the University of Missouri–Columbia.

In the three cases of possible deer-to-human transmission, researchers said that mutated versions of the virus previously found only in deer had been found in COVID test samples taken from one person in North Carolina and two people in Massachusetts. Those deer-specific mutated versions of the virus have not been found in any other human samples, lending evidence that the mutations occurred within deer.

“Deer regularly interact with humans and are commonly found in human environments – near our homes, pets, wastewater, and trash,” researcher and University of Missouri–Columbia professor Xiu-Feng “Henry” Wan, PhD, said in a statement. “The potential for SARS-CoV-2, or any zoonotic disease, to persist and evolve in wildlife populations can pose unique public health risks.”

In the Nature Communications paper, the researchers suggested that deer may be exposed to the virus from human food waste, masks, or other waste products. The authors concluded that further study is needed to determine how virus transmission occurs between deer and humans.

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

An estimated 3 in every 10 white-tailed deer in the United States have had COVID-19, and new research suggests deer populations could be a source of virus mutations that may be passed to humans.

According to the U.S. Department of Agriculture, which led the research project, humans transmitted the virus to deer at least 100 times. The virus then spread widely among free-ranging deer populations, and there were three possible cases of the deer transmitting the virus to humans.

The data comes from tests done between November 2021 and April 2022 on more than 12,000 deer found across half of the United States. Sequencing of the virus found in the deer showed that deer had been exposed to all of the prominent variants, including Alpha, Gamma, Delta, and Omicron.

Some of the findings about transmission were published in the journal Nature Communications, in which researchers noted that in addition to being identified in deer, the virus has been found in wild and domestic animals, including mink, rats, otters, ferrets, hamsters, gorillas, cats, dogs, lions, and tigers. Animal-to-human transmission has been documented or suspected in mink and domestic cats, in addition to white-tailed deer.

The findings are important because the animal populations can become “reservoirs ... in which the virus circulates covertly, persisting in the population and can be transmitted to other animals or humans potentially causing disease outbreaks,” according to the paper, which was a collaboration among scientists from the U.S. Department of Agriculture, CDC, and the University of Missouri–Columbia.

In the three cases of possible deer-to-human transmission, researchers said that mutated versions of the virus previously found only in deer had been found in COVID test samples taken from one person in North Carolina and two people in Massachusetts. Those deer-specific mutated versions of the virus have not been found in any other human samples, lending evidence that the mutations occurred within deer.

“Deer regularly interact with humans and are commonly found in human environments – near our homes, pets, wastewater, and trash,” researcher and University of Missouri–Columbia professor Xiu-Feng “Henry” Wan, PhD, said in a statement. “The potential for SARS-CoV-2, or any zoonotic disease, to persist and evolve in wildlife populations can pose unique public health risks.”

In the Nature Communications paper, the researchers suggested that deer may be exposed to the virus from human food waste, masks, or other waste products. The authors concluded that further study is needed to determine how virus transmission occurs between deer and humans.

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

In the decade since safe, curative oral treatments were approved for treating hepatitis C virus (HCV) infections, only one in three U.S. patients diagnosed with the disease have been cleared of it, according to new data from the Centers for Disease Control and Prevention.

The findings indicate that current progress falls far short of the goal of the Viral Hepatitis National Strategic Plan for the United States, which calls for eliminating HCV for at least 80% of patients with the virus by 2030.

Lead author Carolyn Wester, MD, with the CDC’s Division of Viral Hepatitis, called the low numbers “stunning” and said that the researchers found that patients face barriers to being cured at every step of the way, from being diagnosed to accessing breakthrough direct-acting antiviral (DAA) agents.

The article was published online in the CDC’s Morbidity and Mortality Weekly Report.
 

Outcomes vary by age and insurance

Using longitudinal data from Quest Diagnostics laboratories, the researchers identified 1.7 million people who had a history of HCV infection from Jan. 1, 2013, to Dec. 31, 2022.

Of those patients, 1.5 million (88%) were categorized as having undergone viral testing.

Among those who underwent such testing, 1 million (69%) were categorized as having an initial infection. Just 356,807 patients with initial infection (34%) were cured or cleared of HCV. Of those found to be cured or cleared, 23,518 (7%) were found to have persistent infection or reinfection.

Viral clearance varied greatly by insurance. While 45% of the people covered under Medicare experienced viral clearance, only 23% of the uninsured and 31% of those on Medicaid did so.

Age also played a role in viral clearance. It was highest (42%) among those aged 60 and older. Clearance was lowest (24%) among patients in the 20-39 age group, the group most likely to be newly infected in light of the surge in HCV cases because of the opioid epidemic, Dr. Wester said. Persistent infection or reinfection was also highest in the 20-39 age group.

With respect to age and insurance type combined, the highest HCV clearance rate (49%) was for patients aged 60 and older who had commercial insurance; the lowest (16%) was for uninsured patients in the 20-39 age group.

The investigators evaluated people who had been diagnosed with HCV, Dr. Wester said. “It’s estimated about 40% of people in the U.S. are unaware of their infection.” Because of this, the numbers reported in the study may vastly underestimate the true picture, she told this news organization.
 

Barriers to treatment ‘insurmountable’ without major transformation

Increased access to diagnosis, treatment, and prevention services for persons with or at risk for acquiring hepatitis C needs to be addressed to prevent progression of disease and ongoing transmission and to achieve national hepatitis C elimination goals, the authors wrote.

The biggest barriers to improving HCV clearance are the high cost of treatment, widely varying insurance coverage, insurer restrictions, and challenges in diagnosing the disease, Dr. Wester added.

Overcoming these barriers requires implementation of universal HCV screening recommendations, including HCV RNA testing for all persons with reactive HCV antibody results, provision of treatment for all persons regardless of payer, and prevention services for persons at risk for acquiring new HCV infection, the authors concluded.

“The current barriers are insurmountable without a major transformation in our nation’s response,” Dr. Wester noted.

She expressed her support of the National Hepatitis C Elimination Program, offered as part of the Biden Administration’s 2024 budget proposal. She said that the initiative “is what we need to prevent the needless suffering from hepatitis C and to potentially save not only tens of thousands of lives but tens of billions of health care dollars.”

The three-part proposal includes a national subscription model to purchase DAA agents for those most underserved: Medicaid beneficiaries, incarcerated people, the uninsured, and American Indian and Alaska Native individuals treated through the Indian Health Service.

Under this model, the federal government would negotiate with manufacturers to buy as much treatment as needed for all individuals in the underserved groups.
 

What can physicians do?

Physicians can help improve HCV treatment and outcomes by being aware of the current testing guidelines, Dr. Wester said.

Guidelines now call for hepatitis C screening at least once in a lifetime for all adults, except in settings where the prevalence of HCV infection is less than 0.1%. They also call for screening during each pregnancy, with the same regional-prevalence exception.

Recommendations include curative treatment “for nearly everybody who is living with hepatitis C,” Dr. Wester added.

These CDC guidelines came out in April 2020, a time when the medical focus shifted to COVID-19, and that may have hurt awareness, she noted.

Physicians can also help by fighting back against non–evidence-based reasons insurance companies give for restricting coverage, Dr. Wester said.

Those restrictions include requiring specialists to prescribe DAA agents instead of allowing primary care physicians to do so, as well as requiring patients to have advanced liver disease or requiring patients to demonstrate sobriety or prove they are receiving counseling prior to their being eligible for treatment, Dr. Wester said.
 

Prior authorization a problem

Stacey B. Trooskin MD, PhD, MPH, assistant professor of medicine at the University of Pennsylvania in Philadelphia, told this news organization that prior authorization has been a major barrier for obtaining medications. Prior authorization requirements differ by state.

The paperwork must be submitted by already-stretched physician offices, and appeals are common. In that time, the window for keeping patients with HCV in the health care system may be lost, said Dr. Trooskin, chief medical adviser to the National Viral Hepatitis Roundtable.

“We know that about half of all Medicaid programs have removed prior authorization for most patients entirely,” she said, “but there are still half that require prior authorization.”

Action at the federal level is also needed, Dr. Trooskin said.

The countries that are successfully eliminating HCV and have successfully deployed the lifesaving medications provide governmental support for meeting patients where they are, she added.

Support can include inpatient and outpatient substance use disorder treatment programs or support in mental health settings, she noted.

“It’s not enough to want patients to come into their primary care provider and for that primary care provider to screen them,” Dr. Trooskin said. “This is about creating health care infrastructure so that we are finding patients at greatest risk for hepatitis C and integrating hepatitis C treatment into the services they are already accessing.”

Coauthor Harvey W. Kaufman, MD, is an employee of and owns stock in Quest Diagnostics. Coauthor William A. Meyer III, PhD, is a consultant to Quest Diagnostics. No other potential conflicts of interest were disclosed. Dr. Trooskin oversees C-Change, a hepatitis C elimination program, which receives funding from Gilead Sciences.

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

In the decade since safe, curative oral treatments were approved for treating hepatitis C virus (HCV) infections, only one in three U.S. patients diagnosed with the disease have been cleared of it, according to new data from the Centers for Disease Control and Prevention.

The findings indicate that current progress falls far short of the goal of the Viral Hepatitis National Strategic Plan for the United States, which calls for eliminating HCV for at least 80% of patients with the virus by 2030.

Lead author Carolyn Wester, MD, with the CDC’s Division of Viral Hepatitis, called the low numbers “stunning” and said that the researchers found that patients face barriers to being cured at every step of the way, from being diagnosed to accessing breakthrough direct-acting antiviral (DAA) agents.

The article was published online in the CDC’s Morbidity and Mortality Weekly Report.
 

Outcomes vary by age and insurance

Using longitudinal data from Quest Diagnostics laboratories, the researchers identified 1.7 million people who had a history of HCV infection from Jan. 1, 2013, to Dec. 31, 2022.

Of those patients, 1.5 million (88%) were categorized as having undergone viral testing.

Among those who underwent such testing, 1 million (69%) were categorized as having an initial infection. Just 356,807 patients with initial infection (34%) were cured or cleared of HCV. Of those found to be cured or cleared, 23,518 (7%) were found to have persistent infection or reinfection.

Viral clearance varied greatly by insurance. While 45% of the people covered under Medicare experienced viral clearance, only 23% of the uninsured and 31% of those on Medicaid did so.

Age also played a role in viral clearance. It was highest (42%) among those aged 60 and older. Clearance was lowest (24%) among patients in the 20-39 age group, the group most likely to be newly infected in light of the surge in HCV cases because of the opioid epidemic, Dr. Wester said. Persistent infection or reinfection was also highest in the 20-39 age group.

With respect to age and insurance type combined, the highest HCV clearance rate (49%) was for patients aged 60 and older who had commercial insurance; the lowest (16%) was for uninsured patients in the 20-39 age group.

The investigators evaluated people who had been diagnosed with HCV, Dr. Wester said. “It’s estimated about 40% of people in the U.S. are unaware of their infection.” Because of this, the numbers reported in the study may vastly underestimate the true picture, she told this news organization.
 

Barriers to treatment ‘insurmountable’ without major transformation

Increased access to diagnosis, treatment, and prevention services for persons with or at risk for acquiring hepatitis C needs to be addressed to prevent progression of disease and ongoing transmission and to achieve national hepatitis C elimination goals, the authors wrote.

The biggest barriers to improving HCV clearance are the high cost of treatment, widely varying insurance coverage, insurer restrictions, and challenges in diagnosing the disease, Dr. Wester added.

Overcoming these barriers requires implementation of universal HCV screening recommendations, including HCV RNA testing for all persons with reactive HCV antibody results, provision of treatment for all persons regardless of payer, and prevention services for persons at risk for acquiring new HCV infection, the authors concluded.

“The current barriers are insurmountable without a major transformation in our nation’s response,” Dr. Wester noted.

She expressed her support of the National Hepatitis C Elimination Program, offered as part of the Biden Administration’s 2024 budget proposal. She said that the initiative “is what we need to prevent the needless suffering from hepatitis C and to potentially save not only tens of thousands of lives but tens of billions of health care dollars.”

The three-part proposal includes a national subscription model to purchase DAA agents for those most underserved: Medicaid beneficiaries, incarcerated people, the uninsured, and American Indian and Alaska Native individuals treated through the Indian Health Service.

Under this model, the federal government would negotiate with manufacturers to buy as much treatment as needed for all individuals in the underserved groups.
 

What can physicians do?

Physicians can help improve HCV treatment and outcomes by being aware of the current testing guidelines, Dr. Wester said.

Guidelines now call for hepatitis C screening at least once in a lifetime for all adults, except in settings where the prevalence of HCV infection is less than 0.1%. They also call for screening during each pregnancy, with the same regional-prevalence exception.

Recommendations include curative treatment “for nearly everybody who is living with hepatitis C,” Dr. Wester added.

These CDC guidelines came out in April 2020, a time when the medical focus shifted to COVID-19, and that may have hurt awareness, she noted.

Physicians can also help by fighting back against non–evidence-based reasons insurance companies give for restricting coverage, Dr. Wester said.

Those restrictions include requiring specialists to prescribe DAA agents instead of allowing primary care physicians to do so, as well as requiring patients to have advanced liver disease or requiring patients to demonstrate sobriety or prove they are receiving counseling prior to their being eligible for treatment, Dr. Wester said.
 

Prior authorization a problem

Stacey B. Trooskin MD, PhD, MPH, assistant professor of medicine at the University of Pennsylvania in Philadelphia, told this news organization that prior authorization has been a major barrier for obtaining medications. Prior authorization requirements differ by state.

The paperwork must be submitted by already-stretched physician offices, and appeals are common. In that time, the window for keeping patients with HCV in the health care system may be lost, said Dr. Trooskin, chief medical adviser to the National Viral Hepatitis Roundtable.

“We know that about half of all Medicaid programs have removed prior authorization for most patients entirely,” she said, “but there are still half that require prior authorization.”

Action at the federal level is also needed, Dr. Trooskin said.

The countries that are successfully eliminating HCV and have successfully deployed the lifesaving medications provide governmental support for meeting patients where they are, she added.

Support can include inpatient and outpatient substance use disorder treatment programs or support in mental health settings, she noted.

“It’s not enough to want patients to come into their primary care provider and for that primary care provider to screen them,” Dr. Trooskin said. “This is about creating health care infrastructure so that we are finding patients at greatest risk for hepatitis C and integrating hepatitis C treatment into the services they are already accessing.”

Coauthor Harvey W. Kaufman, MD, is an employee of and owns stock in Quest Diagnostics. Coauthor William A. Meyer III, PhD, is a consultant to Quest Diagnostics. No other potential conflicts of interest were disclosed. Dr. Trooskin oversees C-Change, a hepatitis C elimination program, which receives funding from Gilead Sciences.

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

In the decade since safe, curative oral treatments were approved for treating hepatitis C virus (HCV) infections, only one in three U.S. patients diagnosed with the disease have been cleared of it, according to new data from the Centers for Disease Control and Prevention.

The findings indicate that current progress falls far short of the goal of the Viral Hepatitis National Strategic Plan for the United States, which calls for eliminating HCV for at least 80% of patients with the virus by 2030.

Lead author Carolyn Wester, MD, with the CDC’s Division of Viral Hepatitis, called the low numbers “stunning” and said that the researchers found that patients face barriers to being cured at every step of the way, from being diagnosed to accessing breakthrough direct-acting antiviral (DAA) agents.

The article was published online in the CDC’s Morbidity and Mortality Weekly Report.
 

Outcomes vary by age and insurance

Using longitudinal data from Quest Diagnostics laboratories, the researchers identified 1.7 million people who had a history of HCV infection from Jan. 1, 2013, to Dec. 31, 2022.

Of those patients, 1.5 million (88%) were categorized as having undergone viral testing.

Among those who underwent such testing, 1 million (69%) were categorized as having an initial infection. Just 356,807 patients with initial infection (34%) were cured or cleared of HCV. Of those found to be cured or cleared, 23,518 (7%) were found to have persistent infection or reinfection.

Viral clearance varied greatly by insurance. While 45% of the people covered under Medicare experienced viral clearance, only 23% of the uninsured and 31% of those on Medicaid did so.

Age also played a role in viral clearance. It was highest (42%) among those aged 60 and older. Clearance was lowest (24%) among patients in the 20-39 age group, the group most likely to be newly infected in light of the surge in HCV cases because of the opioid epidemic, Dr. Wester said. Persistent infection or reinfection was also highest in the 20-39 age group.

With respect to age and insurance type combined, the highest HCV clearance rate (49%) was for patients aged 60 and older who had commercial insurance; the lowest (16%) was for uninsured patients in the 20-39 age group.

The investigators evaluated people who had been diagnosed with HCV, Dr. Wester said. “It’s estimated about 40% of people in the U.S. are unaware of their infection.” Because of this, the numbers reported in the study may vastly underestimate the true picture, she told this news organization.
 

Barriers to treatment ‘insurmountable’ without major transformation

Increased access to diagnosis, treatment, and prevention services for persons with or at risk for acquiring hepatitis C needs to be addressed to prevent progression of disease and ongoing transmission and to achieve national hepatitis C elimination goals, the authors wrote.

The biggest barriers to improving HCV clearance are the high cost of treatment, widely varying insurance coverage, insurer restrictions, and challenges in diagnosing the disease, Dr. Wester added.

Overcoming these barriers requires implementation of universal HCV screening recommendations, including HCV RNA testing for all persons with reactive HCV antibody results, provision of treatment for all persons regardless of payer, and prevention services for persons at risk for acquiring new HCV infection, the authors concluded.

“The current barriers are insurmountable without a major transformation in our nation’s response,” Dr. Wester noted.

She expressed her support of the National Hepatitis C Elimination Program, offered as part of the Biden Administration’s 2024 budget proposal. She said that the initiative “is what we need to prevent the needless suffering from hepatitis C and to potentially save not only tens of thousands of lives but tens of billions of health care dollars.”

The three-part proposal includes a national subscription model to purchase DAA agents for those most underserved: Medicaid beneficiaries, incarcerated people, the uninsured, and American Indian and Alaska Native individuals treated through the Indian Health Service.

Under this model, the federal government would negotiate with manufacturers to buy as much treatment as needed for all individuals in the underserved groups.
 

What can physicians do?

Physicians can help improve HCV treatment and outcomes by being aware of the current testing guidelines, Dr. Wester said.

Guidelines now call for hepatitis C screening at least once in a lifetime for all adults, except in settings where the prevalence of HCV infection is less than 0.1%. They also call for screening during each pregnancy, with the same regional-prevalence exception.

Recommendations include curative treatment “for nearly everybody who is living with hepatitis C,” Dr. Wester added.

These CDC guidelines came out in April 2020, a time when the medical focus shifted to COVID-19, and that may have hurt awareness, she noted.

Physicians can also help by fighting back against non–evidence-based reasons insurance companies give for restricting coverage, Dr. Wester said.

Those restrictions include requiring specialists to prescribe DAA agents instead of allowing primary care physicians to do so, as well as requiring patients to have advanced liver disease or requiring patients to demonstrate sobriety or prove they are receiving counseling prior to their being eligible for treatment, Dr. Wester said.
 

Prior authorization a problem

Stacey B. Trooskin MD, PhD, MPH, assistant professor of medicine at the University of Pennsylvania in Philadelphia, told this news organization that prior authorization has been a major barrier for obtaining medications. Prior authorization requirements differ by state.

The paperwork must be submitted by already-stretched physician offices, and appeals are common. In that time, the window for keeping patients with HCV in the health care system may be lost, said Dr. Trooskin, chief medical adviser to the National Viral Hepatitis Roundtable.

“We know that about half of all Medicaid programs have removed prior authorization for most patients entirely,” she said, “but there are still half that require prior authorization.”

Action at the federal level is also needed, Dr. Trooskin said.

The countries that are successfully eliminating HCV and have successfully deployed the lifesaving medications provide governmental support for meeting patients where they are, she added.

Support can include inpatient and outpatient substance use disorder treatment programs or support in mental health settings, she noted.

“It’s not enough to want patients to come into their primary care provider and for that primary care provider to screen them,” Dr. Trooskin said. “This is about creating health care infrastructure so that we are finding patients at greatest risk for hepatitis C and integrating hepatitis C treatment into the services they are already accessing.”

Coauthor Harvey W. Kaufman, MD, is an employee of and owns stock in Quest Diagnostics. Coauthor William A. Meyer III, PhD, is a consultant to Quest Diagnostics. No other potential conflicts of interest were disclosed. Dr. Trooskin oversees C-Change, a hepatitis C elimination program, which receives funding from Gilead Sciences.

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

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

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

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

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

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

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