MDedge ObGyn

Physician employment contracts include some new dangers. This includes physicians taking a new job, but it also includes already-employed doctors who are being asked to resign a new contract that contains new conditions. A number of these new clauses have arisen because of COVID-19. When the pandemic dramatically reduced patient flow, many employers didn’t have enough money to pay doctors and didn’t always have physicians in the right location or practice setting.

Vowing this would never happen again, some employers have rewritten their physician contracts to make it easier to reassign and terminate physicians.

Here are 12 potential land mines in a physician employment contract, some of which were added as a result of the pandemic.
 

You could be immediately terminated without notice

One outcome of the pandemic is the growing use of “force majeure” clauses, which give the employer the right to reduce your compensation or even terminate you due to a natural disaster, which could include COVID.

“COVID made employers aware of the potential impact of disasters on their operations,” said Dan Shay, a health law attorney at Alice Gosfield & Associates in Philadelphia. “Therefore, even as the threat of COVID abates in many places, employers are continuing to put this provision in the contract.”

What can you do? “One way to get some protection is to rule out a termination without cause in the first year,” said Michael A. Cassidy, a physician contract attorney at Tucker Arensberg in Pittsburgh.

The force majeure clause is less likely to affect salary, but could impact bonus and incentive tied to performance. It’s wise to try to specifically limit how much the force majeure could reduce pay tied to performance, and to be prepared to negotiate that aspect of your contract.
 

No protections if you’re let go through no fault of your own

You could lose your job if your employer could not generate enough business and has to let some doctors go. This happened quite often in the early days of the COVID pandemic.

In these situations, the doctor has not done anything wrong to prompt the termination, but the restrictive covenant may still apply, meaning that the doctor would have to leave the area to find work.

What can you do? You’re in a good position to get this changed, said Christopher L. Nuland, a solo physician contract attorney in Jacksonville, Fla. “Many employers recognize that it would be draconian to require a restrictive covenant in this case, and they will agree to modify this provision.”

Similarly, the employer may not cover your tail insurance even if you were let go from your work through no fault of your own. Most malpractice policies for employer physicians require buying an extra policy, called a tail, if you leave. In some cases, the employer won’t provide a tail and will make the departing doctor buy it.

In these cases, “try for a compromise, such as stipulating that the party that caused the termination should pay for the tail,” Mr. Nuland said. “The employer may not agree to anything more than that because they want to set up a disincentive against you leaving.”
 

Employer could unilaterally alter your compensation

Many recent contracts give the employer the option to unilaterally modify compensation, such as changing the base salary or raising the target required for meeting the productivity bonus, said Ericka L. Adler, a physician contract attorney at Roetzel & Andress in Chicago.

Ms. Adler thought this change could have been prompted by employers’ financial problems during the pandemic. In the early months of COVID, many physicians were not making much money for the employer but still had to be paid. So employers added a clause saying they could reduce compensation at any time, she said.

What can you do? Harsh provisions like this often come up in contracts with private equity firms, Mr. Cassidy said. “The contract might say the employer can adjust compensation or even terminate physicians based on productivity or their profitability. And it may say that if they reassign you to a new location and you refuse, they can terminate you.”

“If you can’t get these clauses removed, try to reduce the impact of a termination by providing longer notice periods or by inserting a severance agreement,” Mr. Cassidy said.
 

Accelerating notice for without-cause terminations

Physicians who are convicted of a felony or other moral issue can usually be terminated immediately. But if you are terminated for other reasons – that is, “without cause” – you are given notice at a certain number of days before you have to leave (typically 60-90 days), so that you have time to find a new job.

Some recent contracts, however, allow for very little notice in without-cause terminations, which allows the employer to fire you in as little as 0 days after providing notice, Ms. Adler said.

“This means that, even if 90 days’ notice is provided in the contract, the employer can decide that your last day will be an earlier date,” she said.

Why is this happening? Ms. Adler said employers want to begin reallocating resources and patients as soon as possible. The problem came to employers’ attention during the COVID pandemic, when they were contractually forced to pay doctors for doing little or nothing during the notice period.

What can you do? Possibly not much, other than attempt to negotiate. “Large employers typically don’t want to drop this provision, but at the least, the doctor needs to understand the risk it creates for them,” she said.
 

You could be assigned to far-off locations

As patient care needs changed dramatically during the pandemic, employers needed to reassign doctors to new locations.

Some new contracts allow employers to simply inform the doctor that they are changing the work location. However, “you don’t want to be assigned to a new work location that is 50 miles away,” Mr. Nuland said.

What can you do? Mr. Nuland recommended adding new language saying that, if the new assignment is more than 20 miles away, both parties would have to approve it.

You could end up working too many off-hours

“Most employers won’t issue a specific work schedule,” Mr. Nuland said. “They want the flexibility to assign evening or weekend work, and it would be difficult for a young doctor to change this.”

What can you do? Mr. Nuland recommended trying to set some limits. “You can try to limit off-hours work to two times a month or something like that,” she said. And if you need to have a special schedule, such as not working on Fridays, Adler advises that this should be put into the contract.

If you can’t get anything changed in the contract, Mr. Nuland said the next-best thing is to ask employers to tell you specifically what they plan to do with you. “Most employers will give you an informal idea of what’s expected – maybe not an exact schedule, but it’s quite likely they will honor it.”
 

You wouldn’t be able to work nearby if you left the job

Most contracts have a noncompete clause, also known as a “restrictive covenant,” which prevents employed physicians from working in the area if they left the job.

“Almost every doctor I represent has told me that they’re not concerned about the noncompete clause because, they believe, it is not enforceable anyway,” Ms. Adler said. “This is incorrect.”

Mr. Nuland said the faster pace of job-changing during the pandemic makes it all the more likely that doctors have to deal with a restrictive covenant. At the same time, some employers have been expanding the restriction – either by enlarging the radius where the restriction applies or by making the restriction apply to each of their sites, so that each one has a restricted radius around it.

For example, one contract Mr. Nuland is currently reviewing has a 20-mile radius that in effect becomes a 120-mile radius because the employer is counting four offices.

What can you do? Mr. Nuland advised trying to reduce the impact of the noncompete – for instance, making it apply only to the offices where you worked, or trading more time for less distance. “If you have a 2-year, 20-mile restriction, ask for a 3-year, 10-mile restriction, where the radius could be easier to deal with,” he said.
 

You might end up with too much call

Contracts rarely detail your call schedule because employers want flexibility to expand call as patient care needs change, but you can try adding some specificity, said Sanja Ord, a physician contract attorney at Greensfelder, Hemker & Gale in St. Louis.

Contracts often use wide-open language to describe call, such as simply making it “subject to the house call policies,” Mr. Cassidy said. Language that is more beneficial to the physician would say that call must be “equal” among “similarly situated” physicians.

But Ms. Ord said even provisions for equal call can turn out to be onerous if there are too few doctors in the call roster, so it’s a good idea to find out just how many doctors will be participating in call.

Still, Adler said even that strategy can’t remove all risk. What happens, she asked, if several physicians participating in call decide to leave? Then you might end up with call every other night.

What can you do? Mr. Cassidy recommends specifying a maximum amount of call – for example, no more frequent than one in four nights.
 

Physician must pay for reimbursement claw-backs by payers

When auditors for Medicare or other payers find overpayments after the fact, called a ‘claw-back,’ the provider must pay them back. But which provider has to do that – you or your employer?

In many cases, your employer’s billing office may have introduced the error, but there may be a clause in the contract stating that the physician is solely responsible for all claw-backs. That could be costly.

What can you do? Mr. Shay said the clause should state that you have to pay only when it is the result of your own error or omission, and also not when it was made at the direction of the employer.
 

Some work may be outside of your subspecialty

In some cases, the employer may assign subspecialized doctors to work outside their subspecialty, Mr. Nuland said.

For example, he said he represented an endocrinologist who expected to see only diabetes patients but was assigned to some general internal medicine work as well, and an otolaryngologist client of his who completed a fellowship on facial plastic surgery was expected to do liposuction in a cosmetic surgery group.

What can you do? To prevent this from happening, Mr. Nuland recommends a clause stating that your work will be restricted to your subspecialty.

What the employer promised isn’t in the contract

“Beware of promises that are not in the contract,” Mr. Shay said. “You might feel you can really trust your new boss and what he tells you, but what if that person resigns, or the organization gets a new owner who doesn’t honor unwritten agreements?”

Many contracts have an integration clause, which specifies that the contract constitutes the complete agreement between the two parties, and it nullifies any other oral or written promises made to the physician.

For example, the employer might have promised a relocation bonus and a sign-on bonus, but for some reason it didn’t get into the contract, Ms. Ord said. In those cases, the employer is under no obligation to honor the promise.

What can you do? Mr. Cassidy said it is possible to hold the employer to a commitment made outside the contract. The alternative document, such as an offer letter, has to specifically state that the commitment is protected from the integration clause in the contract, he said, adding: “It is still better to have the commitment put into the contract.”
 

Contract is simply accepted as is

“Generally, the bigger the employer, the less likely they will alter an agreement just to make you happy,” Mr. Shay said.

But even in these contracts, he said there is still opportunity to fix errors and ambiguities that could harm you later – or even alter a provision if you can’t remove it outright.

The back-and-forth is important, Ms. Adler said. “Negotiation means trying to have some control over your job and your life.”

Mr. Cassidy said a big part of contract review is facing up to the possibility that you may have to resign or be let go.

“Many physicians don’t like to think about leaving when they’re just starting a job, but they need to,” he said. “You need to begin with the end in mind. Think about what would happen if this job didn’t work out.”

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

Physician employment contracts include some new dangers. This includes physicians taking a new job, but it also includes already-employed doctors who are being asked to resign a new contract that contains new conditions. A number of these new clauses have arisen because of COVID-19. When the pandemic dramatically reduced patient flow, many employers didn’t have enough money to pay doctors and didn’t always have physicians in the right location or practice setting.

Vowing this would never happen again, some employers have rewritten their physician contracts to make it easier to reassign and terminate physicians.

Here are 12 potential land mines in a physician employment contract, some of which were added as a result of the pandemic.
 

You could be immediately terminated without notice

One outcome of the pandemic is the growing use of “force majeure” clauses, which give the employer the right to reduce your compensation or even terminate you due to a natural disaster, which could include COVID.

“COVID made employers aware of the potential impact of disasters on their operations,” said Dan Shay, a health law attorney at Alice Gosfield & Associates in Philadelphia. “Therefore, even as the threat of COVID abates in many places, employers are continuing to put this provision in the contract.”

What can you do? “One way to get some protection is to rule out a termination without cause in the first year,” said Michael A. Cassidy, a physician contract attorney at Tucker Arensberg in Pittsburgh.

The force majeure clause is less likely to affect salary, but could impact bonus and incentive tied to performance. It’s wise to try to specifically limit how much the force majeure could reduce pay tied to performance, and to be prepared to negotiate that aspect of your contract.
 

No protections if you’re let go through no fault of your own

You could lose your job if your employer could not generate enough business and has to let some doctors go. This happened quite often in the early days of the COVID pandemic.

In these situations, the doctor has not done anything wrong to prompt the termination, but the restrictive covenant may still apply, meaning that the doctor would have to leave the area to find work.

What can you do? You’re in a good position to get this changed, said Christopher L. Nuland, a solo physician contract attorney in Jacksonville, Fla. “Many employers recognize that it would be draconian to require a restrictive covenant in this case, and they will agree to modify this provision.”

Similarly, the employer may not cover your tail insurance even if you were let go from your work through no fault of your own. Most malpractice policies for employer physicians require buying an extra policy, called a tail, if you leave. In some cases, the employer won’t provide a tail and will make the departing doctor buy it.

In these cases, “try for a compromise, such as stipulating that the party that caused the termination should pay for the tail,” Mr. Nuland said. “The employer may not agree to anything more than that because they want to set up a disincentive against you leaving.”
 

Employer could unilaterally alter your compensation

Many recent contracts give the employer the option to unilaterally modify compensation, such as changing the base salary or raising the target required for meeting the productivity bonus, said Ericka L. Adler, a physician contract attorney at Roetzel & Andress in Chicago.

Ms. Adler thought this change could have been prompted by employers’ financial problems during the pandemic. In the early months of COVID, many physicians were not making much money for the employer but still had to be paid. So employers added a clause saying they could reduce compensation at any time, she said.

What can you do? Harsh provisions like this often come up in contracts with private equity firms, Mr. Cassidy said. “The contract might say the employer can adjust compensation or even terminate physicians based on productivity or their profitability. And it may say that if they reassign you to a new location and you refuse, they can terminate you.”

“If you can’t get these clauses removed, try to reduce the impact of a termination by providing longer notice periods or by inserting a severance agreement,” Mr. Cassidy said.
 

Accelerating notice for without-cause terminations

Physicians who are convicted of a felony or other moral issue can usually be terminated immediately. But if you are terminated for other reasons – that is, “without cause” – you are given notice at a certain number of days before you have to leave (typically 60-90 days), so that you have time to find a new job.

Some recent contracts, however, allow for very little notice in without-cause terminations, which allows the employer to fire you in as little as 0 days after providing notice, Ms. Adler said.

“This means that, even if 90 days’ notice is provided in the contract, the employer can decide that your last day will be an earlier date,” she said.

Why is this happening? Ms. Adler said employers want to begin reallocating resources and patients as soon as possible. The problem came to employers’ attention during the COVID pandemic, when they were contractually forced to pay doctors for doing little or nothing during the notice period.

What can you do? Possibly not much, other than attempt to negotiate. “Large employers typically don’t want to drop this provision, but at the least, the doctor needs to understand the risk it creates for them,” she said.
 

You could be assigned to far-off locations

As patient care needs changed dramatically during the pandemic, employers needed to reassign doctors to new locations.

Some new contracts allow employers to simply inform the doctor that they are changing the work location. However, “you don’t want to be assigned to a new work location that is 50 miles away,” Mr. Nuland said.

What can you do? Mr. Nuland recommended adding new language saying that, if the new assignment is more than 20 miles away, both parties would have to approve it.

You could end up working too many off-hours

“Most employers won’t issue a specific work schedule,” Mr. Nuland said. “They want the flexibility to assign evening or weekend work, and it would be difficult for a young doctor to change this.”

What can you do? Mr. Nuland recommended trying to set some limits. “You can try to limit off-hours work to two times a month or something like that,” she said. And if you need to have a special schedule, such as not working on Fridays, Adler advises that this should be put into the contract.

If you can’t get anything changed in the contract, Mr. Nuland said the next-best thing is to ask employers to tell you specifically what they plan to do with you. “Most employers will give you an informal idea of what’s expected – maybe not an exact schedule, but it’s quite likely they will honor it.”
 

You wouldn’t be able to work nearby if you left the job

Most contracts have a noncompete clause, also known as a “restrictive covenant,” which prevents employed physicians from working in the area if they left the job.

“Almost every doctor I represent has told me that they’re not concerned about the noncompete clause because, they believe, it is not enforceable anyway,” Ms. Adler said. “This is incorrect.”

Mr. Nuland said the faster pace of job-changing during the pandemic makes it all the more likely that doctors have to deal with a restrictive covenant. At the same time, some employers have been expanding the restriction – either by enlarging the radius where the restriction applies or by making the restriction apply to each of their sites, so that each one has a restricted radius around it.

For example, one contract Mr. Nuland is currently reviewing has a 20-mile radius that in effect becomes a 120-mile radius because the employer is counting four offices.

What can you do? Mr. Nuland advised trying to reduce the impact of the noncompete – for instance, making it apply only to the offices where you worked, or trading more time for less distance. “If you have a 2-year, 20-mile restriction, ask for a 3-year, 10-mile restriction, where the radius could be easier to deal with,” he said.
 

You might end up with too much call

Contracts rarely detail your call schedule because employers want flexibility to expand call as patient care needs change, but you can try adding some specificity, said Sanja Ord, a physician contract attorney at Greensfelder, Hemker & Gale in St. Louis.

Contracts often use wide-open language to describe call, such as simply making it “subject to the house call policies,” Mr. Cassidy said. Language that is more beneficial to the physician would say that call must be “equal” among “similarly situated” physicians.

But Ms. Ord said even provisions for equal call can turn out to be onerous if there are too few doctors in the call roster, so it’s a good idea to find out just how many doctors will be participating in call.

Still, Adler said even that strategy can’t remove all risk. What happens, she asked, if several physicians participating in call decide to leave? Then you might end up with call every other night.

What can you do? Mr. Cassidy recommends specifying a maximum amount of call – for example, no more frequent than one in four nights.
 

Physician must pay for reimbursement claw-backs by payers

When auditors for Medicare or other payers find overpayments after the fact, called a ‘claw-back,’ the provider must pay them back. But which provider has to do that – you or your employer?

In many cases, your employer’s billing office may have introduced the error, but there may be a clause in the contract stating that the physician is solely responsible for all claw-backs. That could be costly.

What can you do? Mr. Shay said the clause should state that you have to pay only when it is the result of your own error or omission, and also not when it was made at the direction of the employer.
 

Some work may be outside of your subspecialty

In some cases, the employer may assign subspecialized doctors to work outside their subspecialty, Mr. Nuland said.

For example, he said he represented an endocrinologist who expected to see only diabetes patients but was assigned to some general internal medicine work as well, and an otolaryngologist client of his who completed a fellowship on facial plastic surgery was expected to do liposuction in a cosmetic surgery group.

What can you do? To prevent this from happening, Mr. Nuland recommends a clause stating that your work will be restricted to your subspecialty.

What the employer promised isn’t in the contract

“Beware of promises that are not in the contract,” Mr. Shay said. “You might feel you can really trust your new boss and what he tells you, but what if that person resigns, or the organization gets a new owner who doesn’t honor unwritten agreements?”

Many contracts have an integration clause, which specifies that the contract constitutes the complete agreement between the two parties, and it nullifies any other oral or written promises made to the physician.

For example, the employer might have promised a relocation bonus and a sign-on bonus, but for some reason it didn’t get into the contract, Ms. Ord said. In those cases, the employer is under no obligation to honor the promise.

What can you do? Mr. Cassidy said it is possible to hold the employer to a commitment made outside the contract. The alternative document, such as an offer letter, has to specifically state that the commitment is protected from the integration clause in the contract, he said, adding: “It is still better to have the commitment put into the contract.”
 

Contract is simply accepted as is

“Generally, the bigger the employer, the less likely they will alter an agreement just to make you happy,” Mr. Shay said.

But even in these contracts, he said there is still opportunity to fix errors and ambiguities that could harm you later – or even alter a provision if you can’t remove it outright.

The back-and-forth is important, Ms. Adler said. “Negotiation means trying to have some control over your job and your life.”

Mr. Cassidy said a big part of contract review is facing up to the possibility that you may have to resign or be let go.

“Many physicians don’t like to think about leaving when they’re just starting a job, but they need to,” he said. “You need to begin with the end in mind. Think about what would happen if this job didn’t work out.”

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

Physician employment contracts include some new dangers. This includes physicians taking a new job, but it also includes already-employed doctors who are being asked to resign a new contract that contains new conditions. A number of these new clauses have arisen because of COVID-19. When the pandemic dramatically reduced patient flow, many employers didn’t have enough money to pay doctors and didn’t always have physicians in the right location or practice setting.

Vowing this would never happen again, some employers have rewritten their physician contracts to make it easier to reassign and terminate physicians.

Here are 12 potential land mines in a physician employment contract, some of which were added as a result of the pandemic.
 

You could be immediately terminated without notice

One outcome of the pandemic is the growing use of “force majeure” clauses, which give the employer the right to reduce your compensation or even terminate you due to a natural disaster, which could include COVID.

“COVID made employers aware of the potential impact of disasters on their operations,” said Dan Shay, a health law attorney at Alice Gosfield & Associates in Philadelphia. “Therefore, even as the threat of COVID abates in many places, employers are continuing to put this provision in the contract.”

What can you do? “One way to get some protection is to rule out a termination without cause in the first year,” said Michael A. Cassidy, a physician contract attorney at Tucker Arensberg in Pittsburgh.

The force majeure clause is less likely to affect salary, but could impact bonus and incentive tied to performance. It’s wise to try to specifically limit how much the force majeure could reduce pay tied to performance, and to be prepared to negotiate that aspect of your contract.
 

No protections if you’re let go through no fault of your own

You could lose your job if your employer could not generate enough business and has to let some doctors go. This happened quite often in the early days of the COVID pandemic.

In these situations, the doctor has not done anything wrong to prompt the termination, but the restrictive covenant may still apply, meaning that the doctor would have to leave the area to find work.

What can you do? You’re in a good position to get this changed, said Christopher L. Nuland, a solo physician contract attorney in Jacksonville, Fla. “Many employers recognize that it would be draconian to require a restrictive covenant in this case, and they will agree to modify this provision.”

Similarly, the employer may not cover your tail insurance even if you were let go from your work through no fault of your own. Most malpractice policies for employer physicians require buying an extra policy, called a tail, if you leave. In some cases, the employer won’t provide a tail and will make the departing doctor buy it.

In these cases, “try for a compromise, such as stipulating that the party that caused the termination should pay for the tail,” Mr. Nuland said. “The employer may not agree to anything more than that because they want to set up a disincentive against you leaving.”
 

Employer could unilaterally alter your compensation

Many recent contracts give the employer the option to unilaterally modify compensation, such as changing the base salary or raising the target required for meeting the productivity bonus, said Ericka L. Adler, a physician contract attorney at Roetzel & Andress in Chicago.

Ms. Adler thought this change could have been prompted by employers’ financial problems during the pandemic. In the early months of COVID, many physicians were not making much money for the employer but still had to be paid. So employers added a clause saying they could reduce compensation at any time, she said.

What can you do? Harsh provisions like this often come up in contracts with private equity firms, Mr. Cassidy said. “The contract might say the employer can adjust compensation or even terminate physicians based on productivity or their profitability. And it may say that if they reassign you to a new location and you refuse, they can terminate you.”

“If you can’t get these clauses removed, try to reduce the impact of a termination by providing longer notice periods or by inserting a severance agreement,” Mr. Cassidy said.
 

Accelerating notice for without-cause terminations

Physicians who are convicted of a felony or other moral issue can usually be terminated immediately. But if you are terminated for other reasons – that is, “without cause” – you are given notice at a certain number of days before you have to leave (typically 60-90 days), so that you have time to find a new job.

Some recent contracts, however, allow for very little notice in without-cause terminations, which allows the employer to fire you in as little as 0 days after providing notice, Ms. Adler said.

“This means that, even if 90 days’ notice is provided in the contract, the employer can decide that your last day will be an earlier date,” she said.

Why is this happening? Ms. Adler said employers want to begin reallocating resources and patients as soon as possible. The problem came to employers’ attention during the COVID pandemic, when they were contractually forced to pay doctors for doing little or nothing during the notice period.

What can you do? Possibly not much, other than attempt to negotiate. “Large employers typically don’t want to drop this provision, but at the least, the doctor needs to understand the risk it creates for them,” she said.
 

You could be assigned to far-off locations

As patient care needs changed dramatically during the pandemic, employers needed to reassign doctors to new locations.

Some new contracts allow employers to simply inform the doctor that they are changing the work location. However, “you don’t want to be assigned to a new work location that is 50 miles away,” Mr. Nuland said.

What can you do? Mr. Nuland recommended adding new language saying that, if the new assignment is more than 20 miles away, both parties would have to approve it.

You could end up working too many off-hours

“Most employers won’t issue a specific work schedule,” Mr. Nuland said. “They want the flexibility to assign evening or weekend work, and it would be difficult for a young doctor to change this.”

What can you do? Mr. Nuland recommended trying to set some limits. “You can try to limit off-hours work to two times a month or something like that,” she said. And if you need to have a special schedule, such as not working on Fridays, Adler advises that this should be put into the contract.

If you can’t get anything changed in the contract, Mr. Nuland said the next-best thing is to ask employers to tell you specifically what they plan to do with you. “Most employers will give you an informal idea of what’s expected – maybe not an exact schedule, but it’s quite likely they will honor it.”
 

You wouldn’t be able to work nearby if you left the job

Most contracts have a noncompete clause, also known as a “restrictive covenant,” which prevents employed physicians from working in the area if they left the job.

“Almost every doctor I represent has told me that they’re not concerned about the noncompete clause because, they believe, it is not enforceable anyway,” Ms. Adler said. “This is incorrect.”

Mr. Nuland said the faster pace of job-changing during the pandemic makes it all the more likely that doctors have to deal with a restrictive covenant. At the same time, some employers have been expanding the restriction – either by enlarging the radius where the restriction applies or by making the restriction apply to each of their sites, so that each one has a restricted radius around it.

For example, one contract Mr. Nuland is currently reviewing has a 20-mile radius that in effect becomes a 120-mile radius because the employer is counting four offices.

What can you do? Mr. Nuland advised trying to reduce the impact of the noncompete – for instance, making it apply only to the offices where you worked, or trading more time for less distance. “If you have a 2-year, 20-mile restriction, ask for a 3-year, 10-mile restriction, where the radius could be easier to deal with,” he said.
 

You might end up with too much call

Contracts rarely detail your call schedule because employers want flexibility to expand call as patient care needs change, but you can try adding some specificity, said Sanja Ord, a physician contract attorney at Greensfelder, Hemker & Gale in St. Louis.

Contracts often use wide-open language to describe call, such as simply making it “subject to the house call policies,” Mr. Cassidy said. Language that is more beneficial to the physician would say that call must be “equal” among “similarly situated” physicians.

But Ms. Ord said even provisions for equal call can turn out to be onerous if there are too few doctors in the call roster, so it’s a good idea to find out just how many doctors will be participating in call.

Still, Adler said even that strategy can’t remove all risk. What happens, she asked, if several physicians participating in call decide to leave? Then you might end up with call every other night.

What can you do? Mr. Cassidy recommends specifying a maximum amount of call – for example, no more frequent than one in four nights.
 

Physician must pay for reimbursement claw-backs by payers

When auditors for Medicare or other payers find overpayments after the fact, called a ‘claw-back,’ the provider must pay them back. But which provider has to do that – you or your employer?

In many cases, your employer’s billing office may have introduced the error, but there may be a clause in the contract stating that the physician is solely responsible for all claw-backs. That could be costly.

What can you do? Mr. Shay said the clause should state that you have to pay only when it is the result of your own error or omission, and also not when it was made at the direction of the employer.
 

Some work may be outside of your subspecialty

In some cases, the employer may assign subspecialized doctors to work outside their subspecialty, Mr. Nuland said.

For example, he said he represented an endocrinologist who expected to see only diabetes patients but was assigned to some general internal medicine work as well, and an otolaryngologist client of his who completed a fellowship on facial plastic surgery was expected to do liposuction in a cosmetic surgery group.

What can you do? To prevent this from happening, Mr. Nuland recommends a clause stating that your work will be restricted to your subspecialty.

What the employer promised isn’t in the contract

“Beware of promises that are not in the contract,” Mr. Shay said. “You might feel you can really trust your new boss and what he tells you, but what if that person resigns, or the organization gets a new owner who doesn’t honor unwritten agreements?”

Many contracts have an integration clause, which specifies that the contract constitutes the complete agreement between the two parties, and it nullifies any other oral or written promises made to the physician.

For example, the employer might have promised a relocation bonus and a sign-on bonus, but for some reason it didn’t get into the contract, Ms. Ord said. In those cases, the employer is under no obligation to honor the promise.

What can you do? Mr. Cassidy said it is possible to hold the employer to a commitment made outside the contract. The alternative document, such as an offer letter, has to specifically state that the commitment is protected from the integration clause in the contract, he said, adding: “It is still better to have the commitment put into the contract.”
 

Contract is simply accepted as is

“Generally, the bigger the employer, the less likely they will alter an agreement just to make you happy,” Mr. Shay said.

But even in these contracts, he said there is still opportunity to fix errors and ambiguities that could harm you later – or even alter a provision if you can’t remove it outright.

The back-and-forth is important, Ms. Adler said. “Negotiation means trying to have some control over your job and your life.”

Mr. Cassidy said a big part of contract review is facing up to the possibility that you may have to resign or be let go.

“Many physicians don’t like to think about leaving when they’re just starting a job, but they need to,” he said. “You need to begin with the end in mind. Think about what would happen if this job didn’t work out.”

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

A U.S. Food and Drug Administration (FDA) advisory committee on Oct. 15 voted 19-0 to authorize second doses of the Johnson & Johnson COVID-19 vaccine in an effort to boost immunity. It was the second vote in as many days to back a change to a COVID vaccine timeline.
 

Johnson & Johnson

In its vote, the committee said that boosters could be offered to people as young as age 18. However, it is not clear that everyone who got a Johnson & Johnson vaccine needs to get a second dose. The same panel voted Oct. 14 to recommend booster shots for the Moderna vaccine, but for a narrower group of people.

It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Oct. 21 to discuss issues related to COVID-19 vaccines.

Studies of the effectiveness of the Johnson & Johnson vaccine in the real world show that its protection — while good — has not been as strong as that of the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.

In the end, the members of the FDA’s Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling their second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.

This is an especially important issue for adults over the age of 50. A recent study in the New England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.
 

Limited data

The company presented data from six studies to the FDA panel in support of a second dose that were limited. The only study looking at second doses after 6 months included just 17 people.

These studies did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.

But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed during the meeting that they did not have ample time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.

Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.

“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”

“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.

Archana Chatterjee, MD, PhD, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science, said she had changed her vote during the course of the meeting.

She said that, based on the very limited safety and effectiveness data presented to the committee, she was prepared to vote against the idea of offering second doses of Johnson & Johnson shots.

But after considering the 15 million people who have been vaccinated with a single dose and studies that have suggested that close to 5 million older adults may still be at risk for hospitalization because they’ve just had one shot, “This is still a public health imperative,” she said.

“I’m in agreement with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these individuals to boost up their immunity back into the 90-plus percentile range,” Dr. Chatterjee said.

Who needs a second dose?

On Oct. 14, the committee heard an update on data from Israel, which saw a wave of severe breakthrough infections during the Delta wave.

COVID-19 cases are falling rapidly there after the country widely deployed booster doses of the Pfizer vaccine.

The FDA’s Dr. Marks said Oct. 15 that the agency was leaning toward creating greater flexibility in the emergency use authorizations (EUAs) for the Johnson & Johnson and Moderna vaccines so that boosters could be more widely deployed in the United States too.

The FDA panel on Oct. 14 voted to authorize a 50-milligram dose of Moderna’s vaccine — half the dose used in the primary series of shots — to boost immunity at least 6 months after the second dose.

Those who might need a Moderna booster are the same groups who’ve gotten a green light for third Pfizer doses, including people over 65, adults at higher risk for severe COVID-19, and those who are at higher risk because of where they live or work.

The FDA asked the committee on Oct. 15 to discuss whether boosters should be offered to younger adults, even those without underlying health conditions.

“We’re concerned that what was seen in Israel could be seen here,” Dr. Marks said. “We don’t want to have a wave of severe COVID-19 before we deploy boosters.”
 

Trying to avoid confusion

Some members of the committee cautioned Dr. Marks to be careful when expanding the EUAs, because it could confuse people.

“When we say immunity is waning, what are the implications of that?” said Michael Kurilla, MD, PhD, director of the division of clinical innovation at the National Institutes of Health.

Overall, data show that all the vaccines currently being used in the United States — including Johnson & Johnson — remain highly effective for preventing severe outcomes from COVID-19, like hospitalization and death.

Booster doses could prevent more people from even getting mild or moderate symptoms from “breakthrough” COVID-19 cases, which began to rise during the recent Delta surge. The additional doses are also expected to prevent severe outcomes like hospitalization in older adults and those with underlying health conditions.

“I think we need to be clear when we say waning immunity and we need to do something about that, I think we need to be clear what we’re really targeting [with boosters] in terms of clinical impact we expect to have,” Dr. Kurilla said.

Others pointed out that preventing even mild-to-moderate infections was a worthy goal, especially considering the implications of long-haul COVID-19.

“COVID does have tremendous downstream effects, even in those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are advantages to that,” said Steven Pergam, MD, MPH, medical director of infection prevention at the Seattle Cancer Care Alliance.

“I’d really be in the camp that would be moving towards a younger age range for allowing boosters,” he said.
 

This article was updated on 10/18/21. A version of this article first appeared on Medscape.com.

A U.S. Food and Drug Administration (FDA) advisory committee on Oct. 15 voted 19-0 to authorize second doses of the Johnson & Johnson COVID-19 vaccine in an effort to boost immunity. It was the second vote in as many days to back a change to a COVID vaccine timeline.
 

Johnson & Johnson

In its vote, the committee said that boosters could be offered to people as young as age 18. However, it is not clear that everyone who got a Johnson & Johnson vaccine needs to get a second dose. The same panel voted Oct. 14 to recommend booster shots for the Moderna vaccine, but for a narrower group of people.

It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Oct. 21 to discuss issues related to COVID-19 vaccines.

Studies of the effectiveness of the Johnson & Johnson vaccine in the real world show that its protection — while good — has not been as strong as that of the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.

In the end, the members of the FDA’s Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling their second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.

This is an especially important issue for adults over the age of 50. A recent study in the New England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.
 

Limited data

The company presented data from six studies to the FDA panel in support of a second dose that were limited. The only study looking at second doses after 6 months included just 17 people.

These studies did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.

But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed during the meeting that they did not have ample time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.

Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.

“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”

“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.

Archana Chatterjee, MD, PhD, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science, said she had changed her vote during the course of the meeting.

She said that, based on the very limited safety and effectiveness data presented to the committee, she was prepared to vote against the idea of offering second doses of Johnson & Johnson shots.

But after considering the 15 million people who have been vaccinated with a single dose and studies that have suggested that close to 5 million older adults may still be at risk for hospitalization because they’ve just had one shot, “This is still a public health imperative,” she said.

“I’m in agreement with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these individuals to boost up their immunity back into the 90-plus percentile range,” Dr. Chatterjee said.

Who needs a second dose?

On Oct. 14, the committee heard an update on data from Israel, which saw a wave of severe breakthrough infections during the Delta wave.

COVID-19 cases are falling rapidly there after the country widely deployed booster doses of the Pfizer vaccine.

The FDA’s Dr. Marks said Oct. 15 that the agency was leaning toward creating greater flexibility in the emergency use authorizations (EUAs) for the Johnson & Johnson and Moderna vaccines so that boosters could be more widely deployed in the United States too.

The FDA panel on Oct. 14 voted to authorize a 50-milligram dose of Moderna’s vaccine — half the dose used in the primary series of shots — to boost immunity at least 6 months after the second dose.

Those who might need a Moderna booster are the same groups who’ve gotten a green light for third Pfizer doses, including people over 65, adults at higher risk for severe COVID-19, and those who are at higher risk because of where they live or work.

The FDA asked the committee on Oct. 15 to discuss whether boosters should be offered to younger adults, even those without underlying health conditions.

“We’re concerned that what was seen in Israel could be seen here,” Dr. Marks said. “We don’t want to have a wave of severe COVID-19 before we deploy boosters.”
 

Trying to avoid confusion

Some members of the committee cautioned Dr. Marks to be careful when expanding the EUAs, because it could confuse people.

“When we say immunity is waning, what are the implications of that?” said Michael Kurilla, MD, PhD, director of the division of clinical innovation at the National Institutes of Health.

Overall, data show that all the vaccines currently being used in the United States — including Johnson & Johnson — remain highly effective for preventing severe outcomes from COVID-19, like hospitalization and death.

Booster doses could prevent more people from even getting mild or moderate symptoms from “breakthrough” COVID-19 cases, which began to rise during the recent Delta surge. The additional doses are also expected to prevent severe outcomes like hospitalization in older adults and those with underlying health conditions.

“I think we need to be clear when we say waning immunity and we need to do something about that, I think we need to be clear what we’re really targeting [with boosters] in terms of clinical impact we expect to have,” Dr. Kurilla said.

Others pointed out that preventing even mild-to-moderate infections was a worthy goal, especially considering the implications of long-haul COVID-19.

“COVID does have tremendous downstream effects, even in those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are advantages to that,” said Steven Pergam, MD, MPH, medical director of infection prevention at the Seattle Cancer Care Alliance.

“I’d really be in the camp that would be moving towards a younger age range for allowing boosters,” he said.
 

This article was updated on 10/18/21. A version of this article first appeared on Medscape.com.

A U.S. Food and Drug Administration (FDA) advisory committee on Oct. 15 voted 19-0 to authorize second doses of the Johnson & Johnson COVID-19 vaccine in an effort to boost immunity. It was the second vote in as many days to back a change to a COVID vaccine timeline.
 

Johnson & Johnson

In its vote, the committee said that boosters could be offered to people as young as age 18. However, it is not clear that everyone who got a Johnson & Johnson vaccine needs to get a second dose. The same panel voted Oct. 14 to recommend booster shots for the Moderna vaccine, but for a narrower group of people.

It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Oct. 21 to discuss issues related to COVID-19 vaccines.

Studies of the effectiveness of the Johnson & Johnson vaccine in the real world show that its protection — while good — has not been as strong as that of the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.

In the end, the members of the FDA’s Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling their second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.

This is an especially important issue for adults over the age of 50. A recent study in the New England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.
 

Limited data

The company presented data from six studies to the FDA panel in support of a second dose that were limited. The only study looking at second doses after 6 months included just 17 people.

These studies did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.

But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed during the meeting that they did not have ample time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.

Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.

“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”

“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.

Archana Chatterjee, MD, PhD, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science, said she had changed her vote during the course of the meeting.

She said that, based on the very limited safety and effectiveness data presented to the committee, she was prepared to vote against the idea of offering second doses of Johnson & Johnson shots.

But after considering the 15 million people who have been vaccinated with a single dose and studies that have suggested that close to 5 million older adults may still be at risk for hospitalization because they’ve just had one shot, “This is still a public health imperative,” she said.

“I’m in agreement with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these individuals to boost up their immunity back into the 90-plus percentile range,” Dr. Chatterjee said.

Who needs a second dose?

On Oct. 14, the committee heard an update on data from Israel, which saw a wave of severe breakthrough infections during the Delta wave.

COVID-19 cases are falling rapidly there after the country widely deployed booster doses of the Pfizer vaccine.

The FDA’s Dr. Marks said Oct. 15 that the agency was leaning toward creating greater flexibility in the emergency use authorizations (EUAs) for the Johnson & Johnson and Moderna vaccines so that boosters could be more widely deployed in the United States too.

The FDA panel on Oct. 14 voted to authorize a 50-milligram dose of Moderna’s vaccine — half the dose used in the primary series of shots — to boost immunity at least 6 months after the second dose.

Those who might need a Moderna booster are the same groups who’ve gotten a green light for third Pfizer doses, including people over 65, adults at higher risk for severe COVID-19, and those who are at higher risk because of where they live or work.

The FDA asked the committee on Oct. 15 to discuss whether boosters should be offered to younger adults, even those without underlying health conditions.

“We’re concerned that what was seen in Israel could be seen here,” Dr. Marks said. “We don’t want to have a wave of severe COVID-19 before we deploy boosters.”
 

Trying to avoid confusion

Some members of the committee cautioned Dr. Marks to be careful when expanding the EUAs, because it could confuse people.

“When we say immunity is waning, what are the implications of that?” said Michael Kurilla, MD, PhD, director of the division of clinical innovation at the National Institutes of Health.

Overall, data show that all the vaccines currently being used in the United States — including Johnson & Johnson — remain highly effective for preventing severe outcomes from COVID-19, like hospitalization and death.

Booster doses could prevent more people from even getting mild or moderate symptoms from “breakthrough” COVID-19 cases, which began to rise during the recent Delta surge. The additional doses are also expected to prevent severe outcomes like hospitalization in older adults and those with underlying health conditions.

“I think we need to be clear when we say waning immunity and we need to do something about that, I think we need to be clear what we’re really targeting [with boosters] in terms of clinical impact we expect to have,” Dr. Kurilla said.

Others pointed out that preventing even mild-to-moderate infections was a worthy goal, especially considering the implications of long-haul COVID-19.

“COVID does have tremendous downstream effects, even in those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are advantages to that,” said Steven Pergam, MD, MPH, medical director of infection prevention at the Seattle Cancer Care Alliance.

“I’d really be in the camp that would be moving towards a younger age range for allowing boosters,” he said.
 

This article was updated on 10/18/21. A version of this article first appeared on Medscape.com.

Ready access to maternity services in rural areas is not a given, yet access to obstetric hospitals is associated with decreased rates of preterm birth and neonatal/perinatal mortality.

Little is known, however, about the availability of obstetric centers with respect to birth volume, geographic distribution among states, proximity of obstetric hospitals, and urban adjacency.

“This knowledge is fundamental to inform clinical and policy efforts to optimize perinatal regionalization, care delivery, and outcomes,” wrote Sara C. Handley, MD, MSCE, of the Roberts Center for Pediatric Research at the Children’s Hospital of Philadelphia, and colleagues, who undertook to fill that information gap in a study. It was published online Oct. 8 in JAMA Network Open.

Her group found birth volumes varied among obstetric hospitals, with many low-volume facilities located in rural, even isolated, areas, which suggests a need to ensure better access to perinatal care for women in these locations.

Using American Hospital Association data, the researchers examined the birth volumes and geographic distributions of 3,207 maternity hospitals from 2010 to 2018. In a cohort of 34,054,951 births, 56.8% occurred in high-volume obstetric facilities, and 37.4% in low-volume hospitals. Among the latter, 18.9% were isolated in location and not within 30 miles of any other obstetric hospital.

Most infants (19,327,487) were born in hospitals with more than 2,000 births per year, the study found, but a substantial 2,528,259, or 7.4%, were born in low-volume centers reporting 10 to 500 births annually.

“We were surprised by the number of low-volume hospitals and the number of births in low-volume hospitals,” Dr. Handley said in an interview. Many low-volume hospitals are in rural areas, which may require patients to drive long distances. These hospitals are at high risk of closure and such closures may further increase travel time.

Among low-volume hospitals, 23.9% were within the study proximity threshold of 30 miles of a hospital with more than 2,000 deliveries per year. “And when you’re in labor, even 30 miles is a long drive,” Dr. Handley said.

According to the authors, these findings highlight the need to balance care availability and sufficient patient volume by ensuring access and referral to high-quality perinatal care. They suggest perinatal care regionalization policies need review to improve maternal and infant outcomes.

But although the need is pressing, meeting it will not happen quickly, Dr. Handley said. “Change will require buy-in from multiple stakeholders and investment at many levels.”

The American College of Obstetrics and Gynecology has previously raised the alarm about general health disparities among women in underserved rural communities.

Anne L. Banfield, MD, director of women’s health services at Davis Medical Center in the mountain town of Elkins, W.V., is one obstetrician/gynecologist who is all too familiar with the problem of shrinking perinatal facilities. “Closures have impacted services,” she said in an interview, noting that one hospital in her region closed its birthing unit because of financial considerations. “The next closest facility to ours is 20 miles to the west and more than 60 miles in any other direction,” she said. “And geography can create challenges. Because we’re located in the mountains, it can take 2 hours to get to our facility.”

The hope is that these findings will inform discussions on regionalization policy for perinatal care to improve maternal and infant outcomes and address concerns about isolated obstetric hospitals, the authors said.

Dr. Banfield emphasized that obstetric facilities should be made a priority even if they’re less profitable than other services and not a major contributor to the bottom line. But that will require rethinking reimbursement models to align with community needs. “Everyone has a mother – no one springs from a pod – but the fact is, we’re not paying enough for maternal health care,” she said.

A top priority, she noted, is attracting sufficient staff; not only doctors, but also nurses and midwives with the skill sets required for perinatal care, which differ from those of general surgery and outpatient services. “We have to make financial changes to make this care feasible,” Dr. Banfield said.

In similar recent research, a study published online in the October issue of Health Affairs, showed that with rural hospitals facing increased financial distress, they may merge with other hospitals/systems, potentially reducing service lines that are less profitable or that duplicate services offered by the acquiring institution. Among those often on the chopping block is perinatal care.

“Our analysis of rural hospital discharge data found that merged hospitals were more likely than independent hospitals to eliminate maternal, neonatal, and also surgical care,” lead author Lan Liang, PhD, senior economist at the Agency for Healthcare Research and Quality (AHRQ) in Rockville, Md., said in an interview. This finding was consistent with previous AHRQ research using hospital self-reports, she added.

The study sample comprised 172 rural hospitals that merged during the period 2009-2016 in 32 states and 549 nonmerged comparison hospitals. In the premerger period, 74.5% of hospitals that merged provided maternal/neonatal care. This percentage decreased to 61.1% in the postmerger period. In contrast, the percentage of comparison hospitals providing these services remained stable during both periods (64.3% and 65.1%, respectively).

After weighting and adjusting for variables, the researchers found that from the premerger period to 1 year post merger, the percentage of hospitals providing these services decreased by 6.7 percentage points more for merged than for comparison hospitals (P = .06).

In the second year post merger, the percentage of hospitals providing maternal/neonatal services decreased by 7.2 percentage points more for merged than for comparison hospitals (P = .09).

“We did not, however, see a reduction in the volume of maternity services in rural communities, which suggests that women are just traveling farther to give birth,” Dr. Liang said.

Although mergers might salvage hospitals’ sustainability, the authors wrote, they do not necessarily mean that service lines are retained or that hospitals are as responsive to community needs as they were before the merger.

The analysis concluded that continuing access to maternal/neonatal care in rural areas is not a given. “Stakeholders, including payers, policy makers, and community-based organizations, need to monitor the availability of maternity services to ensure women have options in childbirth providers,” Dr. Liang said.

She and her associates called for payer-supported, multi-stakeholder initiatives to transform rural health care to be both financially sustainable and responsive to population needs.

The study by Dr. Handley and colleagues was supported by the National Institutes of Health (NIH) and the Eunice Shriver National Institute of Child Health and Human Development (NICHD). Dr. Handley reported grants from the NIH outside of the submitted work. Several coauthors reported grants from, variously, the NIH, the NICHD, and the Agency for Healthcare Research and Quality (AHRQ). The study by Dr. Liang and associates was supported by the AHRQ’s Center for Financing, Access, and Cost Trends, and the Healthcare Cost and Utilization Project. The authors disclosed no competing interests.

Ready access to maternity services in rural areas is not a given, yet access to obstetric hospitals is associated with decreased rates of preterm birth and neonatal/perinatal mortality.

Little is known, however, about the availability of obstetric centers with respect to birth volume, geographic distribution among states, proximity of obstetric hospitals, and urban adjacency.

“This knowledge is fundamental to inform clinical and policy efforts to optimize perinatal regionalization, care delivery, and outcomes,” wrote Sara C. Handley, MD, MSCE, of the Roberts Center for Pediatric Research at the Children’s Hospital of Philadelphia, and colleagues, who undertook to fill that information gap in a study. It was published online Oct. 8 in JAMA Network Open.

Her group found birth volumes varied among obstetric hospitals, with many low-volume facilities located in rural, even isolated, areas, which suggests a need to ensure better access to perinatal care for women in these locations.

Using American Hospital Association data, the researchers examined the birth volumes and geographic distributions of 3,207 maternity hospitals from 2010 to 2018. In a cohort of 34,054,951 births, 56.8% occurred in high-volume obstetric facilities, and 37.4% in low-volume hospitals. Among the latter, 18.9% were isolated in location and not within 30 miles of any other obstetric hospital.

Most infants (19,327,487) were born in hospitals with more than 2,000 births per year, the study found, but a substantial 2,528,259, or 7.4%, were born in low-volume centers reporting 10 to 500 births annually.

“We were surprised by the number of low-volume hospitals and the number of births in low-volume hospitals,” Dr. Handley said in an interview. Many low-volume hospitals are in rural areas, which may require patients to drive long distances. These hospitals are at high risk of closure and such closures may further increase travel time.

Among low-volume hospitals, 23.9% were within the study proximity threshold of 30 miles of a hospital with more than 2,000 deliveries per year. “And when you’re in labor, even 30 miles is a long drive,” Dr. Handley said.

According to the authors, these findings highlight the need to balance care availability and sufficient patient volume by ensuring access and referral to high-quality perinatal care. They suggest perinatal care regionalization policies need review to improve maternal and infant outcomes.

But although the need is pressing, meeting it will not happen quickly, Dr. Handley said. “Change will require buy-in from multiple stakeholders and investment at many levels.”

The American College of Obstetrics and Gynecology has previously raised the alarm about general health disparities among women in underserved rural communities.

Anne L. Banfield, MD, director of women’s health services at Davis Medical Center in the mountain town of Elkins, W.V., is one obstetrician/gynecologist who is all too familiar with the problem of shrinking perinatal facilities. “Closures have impacted services,” she said in an interview, noting that one hospital in her region closed its birthing unit because of financial considerations. “The next closest facility to ours is 20 miles to the west and more than 60 miles in any other direction,” she said. “And geography can create challenges. Because we’re located in the mountains, it can take 2 hours to get to our facility.”

The hope is that these findings will inform discussions on regionalization policy for perinatal care to improve maternal and infant outcomes and address concerns about isolated obstetric hospitals, the authors said.

Dr. Banfield emphasized that obstetric facilities should be made a priority even if they’re less profitable than other services and not a major contributor to the bottom line. But that will require rethinking reimbursement models to align with community needs. “Everyone has a mother – no one springs from a pod – but the fact is, we’re not paying enough for maternal health care,” she said.

A top priority, she noted, is attracting sufficient staff; not only doctors, but also nurses and midwives with the skill sets required for perinatal care, which differ from those of general surgery and outpatient services. “We have to make financial changes to make this care feasible,” Dr. Banfield said.

In similar recent research, a study published online in the October issue of Health Affairs, showed that with rural hospitals facing increased financial distress, they may merge with other hospitals/systems, potentially reducing service lines that are less profitable or that duplicate services offered by the acquiring institution. Among those often on the chopping block is perinatal care.

“Our analysis of rural hospital discharge data found that merged hospitals were more likely than independent hospitals to eliminate maternal, neonatal, and also surgical care,” lead author Lan Liang, PhD, senior economist at the Agency for Healthcare Research and Quality (AHRQ) in Rockville, Md., said in an interview. This finding was consistent with previous AHRQ research using hospital self-reports, she added.

The study sample comprised 172 rural hospitals that merged during the period 2009-2016 in 32 states and 549 nonmerged comparison hospitals. In the premerger period, 74.5% of hospitals that merged provided maternal/neonatal care. This percentage decreased to 61.1% in the postmerger period. In contrast, the percentage of comparison hospitals providing these services remained stable during both periods (64.3% and 65.1%, respectively).

After weighting and adjusting for variables, the researchers found that from the premerger period to 1 year post merger, the percentage of hospitals providing these services decreased by 6.7 percentage points more for merged than for comparison hospitals (P = .06).

In the second year post merger, the percentage of hospitals providing maternal/neonatal services decreased by 7.2 percentage points more for merged than for comparison hospitals (P = .09).

“We did not, however, see a reduction in the volume of maternity services in rural communities, which suggests that women are just traveling farther to give birth,” Dr. Liang said.

Although mergers might salvage hospitals’ sustainability, the authors wrote, they do not necessarily mean that service lines are retained or that hospitals are as responsive to community needs as they were before the merger.

The analysis concluded that continuing access to maternal/neonatal care in rural areas is not a given. “Stakeholders, including payers, policy makers, and community-based organizations, need to monitor the availability of maternity services to ensure women have options in childbirth providers,” Dr. Liang said.

She and her associates called for payer-supported, multi-stakeholder initiatives to transform rural health care to be both financially sustainable and responsive to population needs.

The study by Dr. Handley and colleagues was supported by the National Institutes of Health (NIH) and the Eunice Shriver National Institute of Child Health and Human Development (NICHD). Dr. Handley reported grants from the NIH outside of the submitted work. Several coauthors reported grants from, variously, the NIH, the NICHD, and the Agency for Healthcare Research and Quality (AHRQ). The study by Dr. Liang and associates was supported by the AHRQ’s Center for Financing, Access, and Cost Trends, and the Healthcare Cost and Utilization Project. The authors disclosed no competing interests.

Ready access to maternity services in rural areas is not a given, yet access to obstetric hospitals is associated with decreased rates of preterm birth and neonatal/perinatal mortality.

Little is known, however, about the availability of obstetric centers with respect to birth volume, geographic distribution among states, proximity of obstetric hospitals, and urban adjacency.

“This knowledge is fundamental to inform clinical and policy efforts to optimize perinatal regionalization, care delivery, and outcomes,” wrote Sara C. Handley, MD, MSCE, of the Roberts Center for Pediatric Research at the Children’s Hospital of Philadelphia, and colleagues, who undertook to fill that information gap in a study. It was published online Oct. 8 in JAMA Network Open.

Her group found birth volumes varied among obstetric hospitals, with many low-volume facilities located in rural, even isolated, areas, which suggests a need to ensure better access to perinatal care for women in these locations.

Using American Hospital Association data, the researchers examined the birth volumes and geographic distributions of 3,207 maternity hospitals from 2010 to 2018. In a cohort of 34,054,951 births, 56.8% occurred in high-volume obstetric facilities, and 37.4% in low-volume hospitals. Among the latter, 18.9% were isolated in location and not within 30 miles of any other obstetric hospital.

Most infants (19,327,487) were born in hospitals with more than 2,000 births per year, the study found, but a substantial 2,528,259, or 7.4%, were born in low-volume centers reporting 10 to 500 births annually.

“We were surprised by the number of low-volume hospitals and the number of births in low-volume hospitals,” Dr. Handley said in an interview. Many low-volume hospitals are in rural areas, which may require patients to drive long distances. These hospitals are at high risk of closure and such closures may further increase travel time.

Among low-volume hospitals, 23.9% were within the study proximity threshold of 30 miles of a hospital with more than 2,000 deliveries per year. “And when you’re in labor, even 30 miles is a long drive,” Dr. Handley said.

According to the authors, these findings highlight the need to balance care availability and sufficient patient volume by ensuring access and referral to high-quality perinatal care. They suggest perinatal care regionalization policies need review to improve maternal and infant outcomes.

But although the need is pressing, meeting it will not happen quickly, Dr. Handley said. “Change will require buy-in from multiple stakeholders and investment at many levels.”

The American College of Obstetrics and Gynecology has previously raised the alarm about general health disparities among women in underserved rural communities.

Anne L. Banfield, MD, director of women’s health services at Davis Medical Center in the mountain town of Elkins, W.V., is one obstetrician/gynecologist who is all too familiar with the problem of shrinking perinatal facilities. “Closures have impacted services,” she said in an interview, noting that one hospital in her region closed its birthing unit because of financial considerations. “The next closest facility to ours is 20 miles to the west and more than 60 miles in any other direction,” she said. “And geography can create challenges. Because we’re located in the mountains, it can take 2 hours to get to our facility.”

The hope is that these findings will inform discussions on regionalization policy for perinatal care to improve maternal and infant outcomes and address concerns about isolated obstetric hospitals, the authors said.

Dr. Banfield emphasized that obstetric facilities should be made a priority even if they’re less profitable than other services and not a major contributor to the bottom line. But that will require rethinking reimbursement models to align with community needs. “Everyone has a mother – no one springs from a pod – but the fact is, we’re not paying enough for maternal health care,” she said.

A top priority, she noted, is attracting sufficient staff; not only doctors, but also nurses and midwives with the skill sets required for perinatal care, which differ from those of general surgery and outpatient services. “We have to make financial changes to make this care feasible,” Dr. Banfield said.

In similar recent research, a study published online in the October issue of Health Affairs, showed that with rural hospitals facing increased financial distress, they may merge with other hospitals/systems, potentially reducing service lines that are less profitable or that duplicate services offered by the acquiring institution. Among those often on the chopping block is perinatal care.

“Our analysis of rural hospital discharge data found that merged hospitals were more likely than independent hospitals to eliminate maternal, neonatal, and also surgical care,” lead author Lan Liang, PhD, senior economist at the Agency for Healthcare Research and Quality (AHRQ) in Rockville, Md., said in an interview. This finding was consistent with previous AHRQ research using hospital self-reports, she added.

The study sample comprised 172 rural hospitals that merged during the period 2009-2016 in 32 states and 549 nonmerged comparison hospitals. In the premerger period, 74.5% of hospitals that merged provided maternal/neonatal care. This percentage decreased to 61.1% in the postmerger period. In contrast, the percentage of comparison hospitals providing these services remained stable during both periods (64.3% and 65.1%, respectively).

After weighting and adjusting for variables, the researchers found that from the premerger period to 1 year post merger, the percentage of hospitals providing these services decreased by 6.7 percentage points more for merged than for comparison hospitals (P = .06).

In the second year post merger, the percentage of hospitals providing maternal/neonatal services decreased by 7.2 percentage points more for merged than for comparison hospitals (P = .09).

“We did not, however, see a reduction in the volume of maternity services in rural communities, which suggests that women are just traveling farther to give birth,” Dr. Liang said.

Although mergers might salvage hospitals’ sustainability, the authors wrote, they do not necessarily mean that service lines are retained or that hospitals are as responsive to community needs as they were before the merger.

The analysis concluded that continuing access to maternal/neonatal care in rural areas is not a given. “Stakeholders, including payers, policy makers, and community-based organizations, need to monitor the availability of maternity services to ensure women have options in childbirth providers,” Dr. Liang said.

She and her associates called for payer-supported, multi-stakeholder initiatives to transform rural health care to be both financially sustainable and responsive to population needs.

The study by Dr. Handley and colleagues was supported by the National Institutes of Health (NIH) and the Eunice Shriver National Institute of Child Health and Human Development (NICHD). Dr. Handley reported grants from the NIH outside of the submitted work. Several coauthors reported grants from, variously, the NIH, the NICHD, and the Agency for Healthcare Research and Quality (AHRQ). The study by Dr. Liang and associates was supported by the AHRQ’s Center for Financing, Access, and Cost Trends, and the Healthcare Cost and Utilization Project. The authors disclosed no competing interests.

An 8-month high-intensity resistance and impact training program (HiRIT, Onero) led to greater gains in lumbar spine bone mineral density (BMD) and leg/back strength than a low-intensity Pilates-based program (Buff Bones).
 

BeyondImages/Getty Images

These findings are from the Medication and Exercise for Osteoporosis (MEDEX-OP) trial, which included 115 postmenopausal women with low bone mass. Patients were randomly assigned to attend either the HiRIT or Pilates-based exercise program. The participants attended supervised 45-min sessions twice weekly.

HiRIT was better than the low-intensity Pilates-based exercise program for enhancing bone mass, muscle strength, functional performance, and stature, the researchers reported. The low-intensity program did improve function, but to a lesser extent

Of the 115 participants, most (86) were not taking osteoporosis medicine. For the 29 women who were receiving it, the medication appeared to enhance the effect of exercise.

Melanie Fischbacher, PhD candidate, Griffith University, Gold Coast, Australia, presented these findings in an oral session at the annual meeting of the American Society for Bone and Mineral Research; the study was also published in the Journal of Bone and Mineral Research.

The study’s senior author, Belinda R. Beck, PhD, director of the Bone Clinic in Brisbane, Australia, developed the Onero HiRIT program and has licensed it to others in Australia.

“It is a very effective program and we have shown it can be undertaken safely, but it must be supervised because of the heavy weights and high-risk clientele,” Beck stressed to this news organization.

“This is not a program you should just hand to a patient and tell them to do in a gym,” she said.

“Both forms of exercise in our study were beneficial for functional outcomes but Onero improved back extensor strength, mobility and stature considerably more than Buff Bones,” Ms. Fischbacher said in an interview.

Nevertheless, “the contribution of functional capacity to risk of falling and fracture cannot be overstated, and bone medications do not address function,” she noted.

“More trials combining bone medication and bone-targeted exercise are needed,” the researchers concluded.

Compliance stands out, study supports high-intensity exercise

Kristen M. Beavers, PhD, MPH, RD, who was not involved with this research, told this news organization that participant compliance in the study really stands out.

“Compliance to an 8-month, 2 day/week high-intensity resistance training program among older women with low bone mass was quite good in this study [>80%], with very few adverse events reported,” said Dr. Beavers, of the department of health and exercise science, Wake Forest University, Winston Salem, N.C.

“A lot of individuals wouldn’t even consider recommending this type/intensity of exercise to this population, because they are worried it is too risky and/or the uptake will be low,” she said.

Although the benefit in BMD and strength wasn’t seen universally across all bone/muscle outcomes assessed, the findings do reinforce the idea that high-intensity exercise is more efficacious for bone health than low-intensity exercise, she noted.

“The possible additive effect of high-intensity exercise when combined with medication is worth confirming in larger, adequately designed/powered studies,” according to Dr. Beavers.

“The general consensus in the field is that higher-intensity exercise is more osteogenic than low-intensity exercise, but improving muscle mass, quality, and function (including balance) are also important to reduce the risk of falls, which is a major contributor to incident fracture,” she noted.

Exercise, even low-intensity exercise, reduces the risk for falls, as shown in a recent meta-analysis, she added. This is something antiresorptive medications don’t do.
 

Building on the LIFTMOR and LIFTMOR-M Trials

Previously, the Australian group showed that HiRIT is efficacious and safe for bone formation in individuals with low to very low bone mass – in postmenopausal women in the LIFTMOR study (J Bone Miner Res. 2017 Oct 4 .doi: 10.1002/jbmr.3284), and in men in the LIFTMOR-M study.

The current study compared two exercise programs. The researchers randomly assigned 86 women who were not taking antiresorptive medication to the high-intensity (42) or low-intensity (44) exercise program. They also assigned 29 women who were receiving antiresorptive medication to the high-intensity (15) or low-intensity (14) exercise program.

In the high-intensity exercise plus medication subgroup, the women were taking denosumab (12), risedronate (2) or alendronate (1). In the low-intensity exercise plus medication subgroup, the women were taking denosumab (9), risedronate (1), alendronate (3), or zoledronic acid (1).

The mean age of the women was 64-68 years. The mean lumbar spine T score was –1.5 to –2.3, and the mean femoral neck T score was –1.7 to –2.0 (determined by dual-energy x-ray absorptiometry) .

The HiRIT training program consisted of three free-weight resistance training exercises (deadlift, back squat, overhead press), one high-impact exercise (jump drop), and two balance exercises. The exercises varied each session.

The low-intensity training consisted of bone-specific Pilates-based exercises performed on the mat; standing weight-bearing exercise with 1-kg dumbbells; and impact exercises, such as heel drops and stomping.

At 8 months, compared with women in the low-intensity exercise program, those in the HiRIT program demonstrated greater improvement in lumbar spine BMD (1.9% vs. 0.1%) and stature (0.2 cm vs. 0.0 cm), muscle strength, and functional performance.

Functional performance improved with both exercise programs, but the HiRIT program led to greater leg and back muscle strength and better results in the five times sit-to-stand test (P < .05).

HiRIT plus bone medication improved BMD at the femoral neck and total hip, whereas HiRIT alone did not. Low-intensity exercise plus bone medication improved BMD at the lumbar spine and total hip, whereas low-intensity exercise alone did not.

The retention rate was 90%. The rate of exercise compliance was 83% in the high-intensity group and 82% in the low-intensity group.

Thirty falls were reported by 24 participants (21%). One fracture occurred in each exercise group. Three adverse events occurred in the low-intensity group, and four occurred in the high-intensity group.

Dr. Beck owns the Bone Clinic and sells licenses to the Onero program. The other researchers disclosed no relevant financial relationships.

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

An 8-month high-intensity resistance and impact training program (HiRIT, Onero) led to greater gains in lumbar spine bone mineral density (BMD) and leg/back strength than a low-intensity Pilates-based program (Buff Bones).
 

BeyondImages/Getty Images

These findings are from the Medication and Exercise for Osteoporosis (MEDEX-OP) trial, which included 115 postmenopausal women with low bone mass. Patients were randomly assigned to attend either the HiRIT or Pilates-based exercise program. The participants attended supervised 45-min sessions twice weekly.

HiRIT was better than the low-intensity Pilates-based exercise program for enhancing bone mass, muscle strength, functional performance, and stature, the researchers reported. The low-intensity program did improve function, but to a lesser extent

Of the 115 participants, most (86) were not taking osteoporosis medicine. For the 29 women who were receiving it, the medication appeared to enhance the effect of exercise.

Melanie Fischbacher, PhD candidate, Griffith University, Gold Coast, Australia, presented these findings in an oral session at the annual meeting of the American Society for Bone and Mineral Research; the study was also published in the Journal of Bone and Mineral Research.

The study’s senior author, Belinda R. Beck, PhD, director of the Bone Clinic in Brisbane, Australia, developed the Onero HiRIT program and has licensed it to others in Australia.

“It is a very effective program and we have shown it can be undertaken safely, but it must be supervised because of the heavy weights and high-risk clientele,” Beck stressed to this news organization.

“This is not a program you should just hand to a patient and tell them to do in a gym,” she said.

“Both forms of exercise in our study were beneficial for functional outcomes but Onero improved back extensor strength, mobility and stature considerably more than Buff Bones,” Ms. Fischbacher said in an interview.

Nevertheless, “the contribution of functional capacity to risk of falling and fracture cannot be overstated, and bone medications do not address function,” she noted.

“More trials combining bone medication and bone-targeted exercise are needed,” the researchers concluded.

Compliance stands out, study supports high-intensity exercise

Kristen M. Beavers, PhD, MPH, RD, who was not involved with this research, told this news organization that participant compliance in the study really stands out.

“Compliance to an 8-month, 2 day/week high-intensity resistance training program among older women with low bone mass was quite good in this study [>80%], with very few adverse events reported,” said Dr. Beavers, of the department of health and exercise science, Wake Forest University, Winston Salem, N.C.

“A lot of individuals wouldn’t even consider recommending this type/intensity of exercise to this population, because they are worried it is too risky and/or the uptake will be low,” she said.

Although the benefit in BMD and strength wasn’t seen universally across all bone/muscle outcomes assessed, the findings do reinforce the idea that high-intensity exercise is more efficacious for bone health than low-intensity exercise, she noted.

“The possible additive effect of high-intensity exercise when combined with medication is worth confirming in larger, adequately designed/powered studies,” according to Dr. Beavers.

“The general consensus in the field is that higher-intensity exercise is more osteogenic than low-intensity exercise, but improving muscle mass, quality, and function (including balance) are also important to reduce the risk of falls, which is a major contributor to incident fracture,” she noted.

Exercise, even low-intensity exercise, reduces the risk for falls, as shown in a recent meta-analysis, she added. This is something antiresorptive medications don’t do.
 

Building on the LIFTMOR and LIFTMOR-M Trials

Previously, the Australian group showed that HiRIT is efficacious and safe for bone formation in individuals with low to very low bone mass – in postmenopausal women in the LIFTMOR study (J Bone Miner Res. 2017 Oct 4 .doi: 10.1002/jbmr.3284), and in men in the LIFTMOR-M study.

The current study compared two exercise programs. The researchers randomly assigned 86 women who were not taking antiresorptive medication to the high-intensity (42) or low-intensity (44) exercise program. They also assigned 29 women who were receiving antiresorptive medication to the high-intensity (15) or low-intensity (14) exercise program.

In the high-intensity exercise plus medication subgroup, the women were taking denosumab (12), risedronate (2) or alendronate (1). In the low-intensity exercise plus medication subgroup, the women were taking denosumab (9), risedronate (1), alendronate (3), or zoledronic acid (1).

The mean age of the women was 64-68 years. The mean lumbar spine T score was –1.5 to –2.3, and the mean femoral neck T score was –1.7 to –2.0 (determined by dual-energy x-ray absorptiometry) .

The HiRIT training program consisted of three free-weight resistance training exercises (deadlift, back squat, overhead press), one high-impact exercise (jump drop), and two balance exercises. The exercises varied each session.

The low-intensity training consisted of bone-specific Pilates-based exercises performed on the mat; standing weight-bearing exercise with 1-kg dumbbells; and impact exercises, such as heel drops and stomping.

At 8 months, compared with women in the low-intensity exercise program, those in the HiRIT program demonstrated greater improvement in lumbar spine BMD (1.9% vs. 0.1%) and stature (0.2 cm vs. 0.0 cm), muscle strength, and functional performance.

Functional performance improved with both exercise programs, but the HiRIT program led to greater leg and back muscle strength and better results in the five times sit-to-stand test (P < .05).

HiRIT plus bone medication improved BMD at the femoral neck and total hip, whereas HiRIT alone did not. Low-intensity exercise plus bone medication improved BMD at the lumbar spine and total hip, whereas low-intensity exercise alone did not.

The retention rate was 90%. The rate of exercise compliance was 83% in the high-intensity group and 82% in the low-intensity group.

Thirty falls were reported by 24 participants (21%). One fracture occurred in each exercise group. Three adverse events occurred in the low-intensity group, and four occurred in the high-intensity group.

Dr. Beck owns the Bone Clinic and sells licenses to the Onero program. The other researchers disclosed no relevant financial relationships.

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

An 8-month high-intensity resistance and impact training program (HiRIT, Onero) led to greater gains in lumbar spine bone mineral density (BMD) and leg/back strength than a low-intensity Pilates-based program (Buff Bones).
 

BeyondImages/Getty Images

These findings are from the Medication and Exercise for Osteoporosis (MEDEX-OP) trial, which included 115 postmenopausal women with low bone mass. Patients were randomly assigned to attend either the HiRIT or Pilates-based exercise program. The participants attended supervised 45-min sessions twice weekly.

HiRIT was better than the low-intensity Pilates-based exercise program for enhancing bone mass, muscle strength, functional performance, and stature, the researchers reported. The low-intensity program did improve function, but to a lesser extent

Of the 115 participants, most (86) were not taking osteoporosis medicine. For the 29 women who were receiving it, the medication appeared to enhance the effect of exercise.

Melanie Fischbacher, PhD candidate, Griffith University, Gold Coast, Australia, presented these findings in an oral session at the annual meeting of the American Society for Bone and Mineral Research; the study was also published in the Journal of Bone and Mineral Research.

The study’s senior author, Belinda R. Beck, PhD, director of the Bone Clinic in Brisbane, Australia, developed the Onero HiRIT program and has licensed it to others in Australia.

“It is a very effective program and we have shown it can be undertaken safely, but it must be supervised because of the heavy weights and high-risk clientele,” Beck stressed to this news organization.

“This is not a program you should just hand to a patient and tell them to do in a gym,” she said.

“Both forms of exercise in our study were beneficial for functional outcomes but Onero improved back extensor strength, mobility and stature considerably more than Buff Bones,” Ms. Fischbacher said in an interview.

Nevertheless, “the contribution of functional capacity to risk of falling and fracture cannot be overstated, and bone medications do not address function,” she noted.

“More trials combining bone medication and bone-targeted exercise are needed,” the researchers concluded.

Compliance stands out, study supports high-intensity exercise

Kristen M. Beavers, PhD, MPH, RD, who was not involved with this research, told this news organization that participant compliance in the study really stands out.

“Compliance to an 8-month, 2 day/week high-intensity resistance training program among older women with low bone mass was quite good in this study [>80%], with very few adverse events reported,” said Dr. Beavers, of the department of health and exercise science, Wake Forest University, Winston Salem, N.C.

“A lot of individuals wouldn’t even consider recommending this type/intensity of exercise to this population, because they are worried it is too risky and/or the uptake will be low,” she said.

Although the benefit in BMD and strength wasn’t seen universally across all bone/muscle outcomes assessed, the findings do reinforce the idea that high-intensity exercise is more efficacious for bone health than low-intensity exercise, she noted.

“The possible additive effect of high-intensity exercise when combined with medication is worth confirming in larger, adequately designed/powered studies,” according to Dr. Beavers.

“The general consensus in the field is that higher-intensity exercise is more osteogenic than low-intensity exercise, but improving muscle mass, quality, and function (including balance) are also important to reduce the risk of falls, which is a major contributor to incident fracture,” she noted.

Exercise, even low-intensity exercise, reduces the risk for falls, as shown in a recent meta-analysis, she added. This is something antiresorptive medications don’t do.
 

Building on the LIFTMOR and LIFTMOR-M Trials

Previously, the Australian group showed that HiRIT is efficacious and safe for bone formation in individuals with low to very low bone mass – in postmenopausal women in the LIFTMOR study (J Bone Miner Res. 2017 Oct 4 .doi: 10.1002/jbmr.3284), and in men in the LIFTMOR-M study.

The current study compared two exercise programs. The researchers randomly assigned 86 women who were not taking antiresorptive medication to the high-intensity (42) or low-intensity (44) exercise program. They also assigned 29 women who were receiving antiresorptive medication to the high-intensity (15) or low-intensity (14) exercise program.

In the high-intensity exercise plus medication subgroup, the women were taking denosumab (12), risedronate (2) or alendronate (1). In the low-intensity exercise plus medication subgroup, the women were taking denosumab (9), risedronate (1), alendronate (3), or zoledronic acid (1).

The mean age of the women was 64-68 years. The mean lumbar spine T score was –1.5 to –2.3, and the mean femoral neck T score was –1.7 to –2.0 (determined by dual-energy x-ray absorptiometry) .

The HiRIT training program consisted of three free-weight resistance training exercises (deadlift, back squat, overhead press), one high-impact exercise (jump drop), and two balance exercises. The exercises varied each session.

The low-intensity training consisted of bone-specific Pilates-based exercises performed on the mat; standing weight-bearing exercise with 1-kg dumbbells; and impact exercises, such as heel drops and stomping.

At 8 months, compared with women in the low-intensity exercise program, those in the HiRIT program demonstrated greater improvement in lumbar spine BMD (1.9% vs. 0.1%) and stature (0.2 cm vs. 0.0 cm), muscle strength, and functional performance.

Functional performance improved with both exercise programs, but the HiRIT program led to greater leg and back muscle strength and better results in the five times sit-to-stand test (P < .05).

HiRIT plus bone medication improved BMD at the femoral neck and total hip, whereas HiRIT alone did not. Low-intensity exercise plus bone medication improved BMD at the lumbar spine and total hip, whereas low-intensity exercise alone did not.

The retention rate was 90%. The rate of exercise compliance was 83% in the high-intensity group and 82% in the low-intensity group.

Thirty falls were reported by 24 participants (21%). One fracture occurred in each exercise group. Three adverse events occurred in the low-intensity group, and four occurred in the high-intensity group.

Dr. Beck owns the Bone Clinic and sells licenses to the Onero program. The other researchers disclosed no relevant financial relationships.

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

Despite reporting record profits during the COVID-19 pandemic, major insurance companies are delaying claims payments and making it more difficult for hospitals and physicians to get paid the full amount of claims, observers and physicians say.

Kaiser Health News recently reported that hospitals, in particular, are affected by the slowdown in claims payments from Anthem Blue Cross, the nation’s second largest health insurer. The investigative piece did not focus on outpatient or independent practices. Research by this news organization shows that the health plans’ new policies are also reducing cash flow and raising costs for ambulatory care groups. In addition, it showed that other payers besides Anthem have engaged in the same practices.

“What we’ve seen is that with complex claims, such as those with -25 modifiers, plans are routinely requiring documentation,” Jim Donohue, senior manager and associate principal at ECG Management Consultants, said in an interview. “It’s not a denial, it’s a request for more information for medical records prior to processing payments. That has the effect of slowing down payments.”

This is exactly what one internal medicine group in the Southeast has noticed. The internist who heads the practice, who asked not to be identified, says that about 4-6 months ago, United, Humana, and other payers started to require documentation for prepayment review on a higher percentage of complex claims such as 99214 (established patient), 99204 (new patient), and claims with -25 modifiers. (The latter are appended to evaluation and management [E/M] claims in which patients had comorbidities that were addressed in the same visit as the main complaint.)

“That’s really frustrating, because you have to print out or take the record for that particular visit and computer fax it to them,” the practice leader notes. “And invariably, they’ll say they didn’t get a certain percentage of them. It’s our fault because they lost the claim.”

In the past, he says, health plans would occasionally ask for the note related to a complex visit where they saw issues, and they’ve always done random postpayment chart audits. But the percentage of prepayment reviews has significantly increased in recent months, he says.

Until a plan does this review, the claim can’t be processed because it’s not regarded as a clean claim. And this has implications for insurers’ compliance with laws that, in most states, require them to pay claims within 30-40 days of submission. (Medicare’s limit is 30 days.) According to Mr. Donohue, the clock doesn’t start ticking on this requirement unless and until a claim is clean. So by requiring documentation on complex claims, the plans can not only justify downcoding a claim, but can also delay payment without triggering state penalties.
 

Insurer admits ‘challenges’ with claims processing

VCU Health, a health system affiliated with Virginia Commonwealth University, recently filed a complaint against Anthem with Virginia’s insurance commissioner, asking that the Virginia Bureau of Insurance investigate the company’s claims-processing delays. The complaint claimed Anthem owes VCU more than $385 million, of which $171 million is over 90 days old. Much of that consists of commercial claims, which are subject to the state’s 40-day claims payment rule.

VCU cited several problems it said Anthem had created that slowed claims payments:

Any claim over a certain dollar limit requires an itemized bill.

Anthem requests detailed medical records prior to considering payment of even clean claims.

Documents must be uploaded to a web portal that has technical problems, and Anthem has lost some documents as a result.

Claims are being incorrectly processed for some professionals, “resulting in multi-million-dollar underpayments of anesthesia, nurse practitioners, pathology, and behavioral health providers.”

In addition, as the Kaiser Health News article points out, hospitals have blamed the increase in payment delays or denials partly on “preauthorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers.”

In response to an inquiry from this news organization, an Anthem spokesman admitted that some payments to providers have been delayed, partly because of changes in the company’s claims-processing system. “We recognize there have been some challenges as we work with care providers to update claims processing, and readjust and adapt to a new set of dynamics as we continue to manage the pandemic,” said the spokesman.

The Kaiser Health News piece reported that Anthem’s CFO had told stock analysts on a conference call that the company had slowed claims payments to build up its financial reserves during the pandemic – a statement that some physicians called “outrageous.” But the Anthem spokesman told this news organization the quote was taken out of context and that the CFO was talking not about reserves but about “days in claims payable.” The spokesman said, “The payment delays that the article focuses on are not the primary driver or even a material driver of the increase in our overall reserves or DCPs [defined contribution plans] relative to historical levels. In fact, the vast majority of our claims are being processed in a timely manner.”

Some claims routinely downcoded

Even if that were the case, it would not explain why some physicians are seeing their higher-cost claims routinely downcoded. Will Sawyer, MD, a family physician in Cincinnati, told this news organization, “Anthem has been downcoding relentlessly since October 2020.” More often than not, when his office submits a claim with a 99214 code (office visit, 30-39 minutes, moderate medical decision-making), it’s changed to 99213 (office visit, 20-29 minutes, low medical decision-making) before processing, he says.

This has resulted in a significant diminution of his income, he notes. Anthem pays him less than Medicare for E/M visits, and the downcoding reduces his payment from $86 to $68 for a complex visit that may have taken half an hour or more.

In some cases where his office manager has noticed the downcoding, Dr. Sawyer says, she has resubmitted the claim with a copy of the encounter form. But Anthem hasn’t budged. And the refiling effort takes a toll on his solo practice, which doesn’t have sufficient staff, as it is.

Dr. Sawyer acknowledges that he has sent in a higher percentage of complex claims in the past year than he did previously. But much of that is the result of two factors beyond his control: First, many patients avoided coming into the office early in the pandemic, and when they returned, their preventive and chronic care needs were greater. Second, he says, “There are many comorbidities and mental health aspects, which exacerbate many issues and become an issue. We’re not dealing with engines here; they’re human beings. And it takes time.”

In response to Dr. Sawyer’s comments, Anthem said that it uses “analytical tools to review evaluation and management (E/M) codes during the claims adjudication and processing process.” Physicians who believe that certain claims should not have been downcoded can dispute these decisions; they must supply a statement explaining why they disagree with the decision along with documentation to support their statement, the company said. Anthem added that it reviews claims to lower costs for its members.
 

‘Revenue-grab strategy’

Dr. Sawyer believes that what Anthem is doing to him and other physicians reflects its desire to increase profits by netting extra revenue and keeping physicians’ money while it delays payments to them – a practice known in the trade as “the float.” Moreover, he says, the company depends on many practices not keeping track of their finances during the pandemic.

“When practices are running at warp speed, trying to keep people healthy and getting burned out, they aren’t paying as close attention to the details of payment. It’s an absolute revenue-grab strategy that’s unconscionable,” says Dr. Sawyer.

The Southeast internist also thinks that insurance companies other than Anthem – including United and Humana – are profiting from the float. Besides delaying his payments with gratuitous demands for documentation, he said, they also downcode many claims, forcing the practice to refile the claims and appeal. That forces the practice to pay overtime or bring on more claims staff, which raises administrative costs.

The plans’ strategy, the internist says, is this: “If they downcode millions of claims, a certain number of physicians will give up without appealing, and they’ll raise their profits.”

A United spokesperson said in an interview, “We pay claims appropriately under members’ plans and within the required time frame.” Humana had not responded to this news organization’s request for comment at press time.
 

Challenge to practice economics

Insurer policies that delay payments or downcode claims, ECG’s Mr. Donohue points out, are especially harmful to primary care and other ambulatory practices that have many small-dollar claims.

“That’s where it’s challenging, because it’s not like a $10,000 case where you add $100 to it [to meet records requests]. You’re talking about something that’s relatively low dollar, where the practice makes a small surplus, and when you add administrative costs, it can change the economics,” he says.

While the economic burden on ambulatory care practices may be greater, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association (MGMA), said that the payment delays and demands for documentation – along with prior authorization – particularly affect inpatient care. The health plans are questioning big-ticket items more than ever, he said, and most of those services occur in hospitals.

However, the greater level of insurer scrutiny also affects physicians who treat patients in the hospital, including surgeons and emergency department physicians who contract with the facilities, he adds.

Mr. Gilberg views the current situation as an exacerbation of the health plan policies that physicians have long struggled with. “It’s not new to have insurers play the float and not pay claims on time. Unfortunately, this is something that medical practices are used to.”

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

Despite reporting record profits during the COVID-19 pandemic, major insurance companies are delaying claims payments and making it more difficult for hospitals and physicians to get paid the full amount of claims, observers and physicians say.

Kaiser Health News recently reported that hospitals, in particular, are affected by the slowdown in claims payments from Anthem Blue Cross, the nation’s second largest health insurer. The investigative piece did not focus on outpatient or independent practices. Research by this news organization shows that the health plans’ new policies are also reducing cash flow and raising costs for ambulatory care groups. In addition, it showed that other payers besides Anthem have engaged in the same practices.

“What we’ve seen is that with complex claims, such as those with -25 modifiers, plans are routinely requiring documentation,” Jim Donohue, senior manager and associate principal at ECG Management Consultants, said in an interview. “It’s not a denial, it’s a request for more information for medical records prior to processing payments. That has the effect of slowing down payments.”

This is exactly what one internal medicine group in the Southeast has noticed. The internist who heads the practice, who asked not to be identified, says that about 4-6 months ago, United, Humana, and other payers started to require documentation for prepayment review on a higher percentage of complex claims such as 99214 (established patient), 99204 (new patient), and claims with -25 modifiers. (The latter are appended to evaluation and management [E/M] claims in which patients had comorbidities that were addressed in the same visit as the main complaint.)

“That’s really frustrating, because you have to print out or take the record for that particular visit and computer fax it to them,” the practice leader notes. “And invariably, they’ll say they didn’t get a certain percentage of them. It’s our fault because they lost the claim.”

In the past, he says, health plans would occasionally ask for the note related to a complex visit where they saw issues, and they’ve always done random postpayment chart audits. But the percentage of prepayment reviews has significantly increased in recent months, he says.

Until a plan does this review, the claim can’t be processed because it’s not regarded as a clean claim. And this has implications for insurers’ compliance with laws that, in most states, require them to pay claims within 30-40 days of submission. (Medicare’s limit is 30 days.) According to Mr. Donohue, the clock doesn’t start ticking on this requirement unless and until a claim is clean. So by requiring documentation on complex claims, the plans can not only justify downcoding a claim, but can also delay payment without triggering state penalties.
 

Insurer admits ‘challenges’ with claims processing

VCU Health, a health system affiliated with Virginia Commonwealth University, recently filed a complaint against Anthem with Virginia’s insurance commissioner, asking that the Virginia Bureau of Insurance investigate the company’s claims-processing delays. The complaint claimed Anthem owes VCU more than $385 million, of which $171 million is over 90 days old. Much of that consists of commercial claims, which are subject to the state’s 40-day claims payment rule.

VCU cited several problems it said Anthem had created that slowed claims payments:

Any claim over a certain dollar limit requires an itemized bill.

Anthem requests detailed medical records prior to considering payment of even clean claims.

Documents must be uploaded to a web portal that has technical problems, and Anthem has lost some documents as a result.

Claims are being incorrectly processed for some professionals, “resulting in multi-million-dollar underpayments of anesthesia, nurse practitioners, pathology, and behavioral health providers.”

In addition, as the Kaiser Health News article points out, hospitals have blamed the increase in payment delays or denials partly on “preauthorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers.”

In response to an inquiry from this news organization, an Anthem spokesman admitted that some payments to providers have been delayed, partly because of changes in the company’s claims-processing system. “We recognize there have been some challenges as we work with care providers to update claims processing, and readjust and adapt to a new set of dynamics as we continue to manage the pandemic,” said the spokesman.

The Kaiser Health News piece reported that Anthem’s CFO had told stock analysts on a conference call that the company had slowed claims payments to build up its financial reserves during the pandemic – a statement that some physicians called “outrageous.” But the Anthem spokesman told this news organization the quote was taken out of context and that the CFO was talking not about reserves but about “days in claims payable.” The spokesman said, “The payment delays that the article focuses on are not the primary driver or even a material driver of the increase in our overall reserves or DCPs [defined contribution plans] relative to historical levels. In fact, the vast majority of our claims are being processed in a timely manner.”

Some claims routinely downcoded

Even if that were the case, it would not explain why some physicians are seeing their higher-cost claims routinely downcoded. Will Sawyer, MD, a family physician in Cincinnati, told this news organization, “Anthem has been downcoding relentlessly since October 2020.” More often than not, when his office submits a claim with a 99214 code (office visit, 30-39 minutes, moderate medical decision-making), it’s changed to 99213 (office visit, 20-29 minutes, low medical decision-making) before processing, he says.

This has resulted in a significant diminution of his income, he notes. Anthem pays him less than Medicare for E/M visits, and the downcoding reduces his payment from $86 to $68 for a complex visit that may have taken half an hour or more.

In some cases where his office manager has noticed the downcoding, Dr. Sawyer says, she has resubmitted the claim with a copy of the encounter form. But Anthem hasn’t budged. And the refiling effort takes a toll on his solo practice, which doesn’t have sufficient staff, as it is.

Dr. Sawyer acknowledges that he has sent in a higher percentage of complex claims in the past year than he did previously. But much of that is the result of two factors beyond his control: First, many patients avoided coming into the office early in the pandemic, and when they returned, their preventive and chronic care needs were greater. Second, he says, “There are many comorbidities and mental health aspects, which exacerbate many issues and become an issue. We’re not dealing with engines here; they’re human beings. And it takes time.”

In response to Dr. Sawyer’s comments, Anthem said that it uses “analytical tools to review evaluation and management (E/M) codes during the claims adjudication and processing process.” Physicians who believe that certain claims should not have been downcoded can dispute these decisions; they must supply a statement explaining why they disagree with the decision along with documentation to support their statement, the company said. Anthem added that it reviews claims to lower costs for its members.
 

‘Revenue-grab strategy’

Dr. Sawyer believes that what Anthem is doing to him and other physicians reflects its desire to increase profits by netting extra revenue and keeping physicians’ money while it delays payments to them – a practice known in the trade as “the float.” Moreover, he says, the company depends on many practices not keeping track of their finances during the pandemic.

“When practices are running at warp speed, trying to keep people healthy and getting burned out, they aren’t paying as close attention to the details of payment. It’s an absolute revenue-grab strategy that’s unconscionable,” says Dr. Sawyer.

The Southeast internist also thinks that insurance companies other than Anthem – including United and Humana – are profiting from the float. Besides delaying his payments with gratuitous demands for documentation, he said, they also downcode many claims, forcing the practice to refile the claims and appeal. That forces the practice to pay overtime or bring on more claims staff, which raises administrative costs.

The plans’ strategy, the internist says, is this: “If they downcode millions of claims, a certain number of physicians will give up without appealing, and they’ll raise their profits.”

A United spokesperson said in an interview, “We pay claims appropriately under members’ plans and within the required time frame.” Humana had not responded to this news organization’s request for comment at press time.
 

Challenge to practice economics

Insurer policies that delay payments or downcode claims, ECG’s Mr. Donohue points out, are especially harmful to primary care and other ambulatory practices that have many small-dollar claims.

“That’s where it’s challenging, because it’s not like a $10,000 case where you add $100 to it [to meet records requests]. You’re talking about something that’s relatively low dollar, where the practice makes a small surplus, and when you add administrative costs, it can change the economics,” he says.

While the economic burden on ambulatory care practices may be greater, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association (MGMA), said that the payment delays and demands for documentation – along with prior authorization – particularly affect inpatient care. The health plans are questioning big-ticket items more than ever, he said, and most of those services occur in hospitals.

However, the greater level of insurer scrutiny also affects physicians who treat patients in the hospital, including surgeons and emergency department physicians who contract with the facilities, he adds.

Mr. Gilberg views the current situation as an exacerbation of the health plan policies that physicians have long struggled with. “It’s not new to have insurers play the float and not pay claims on time. Unfortunately, this is something that medical practices are used to.”

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

Despite reporting record profits during the COVID-19 pandemic, major insurance companies are delaying claims payments and making it more difficult for hospitals and physicians to get paid the full amount of claims, observers and physicians say.

Kaiser Health News recently reported that hospitals, in particular, are affected by the slowdown in claims payments from Anthem Blue Cross, the nation’s second largest health insurer. The investigative piece did not focus on outpatient or independent practices. Research by this news organization shows that the health plans’ new policies are also reducing cash flow and raising costs for ambulatory care groups. In addition, it showed that other payers besides Anthem have engaged in the same practices.

“What we’ve seen is that with complex claims, such as those with -25 modifiers, plans are routinely requiring documentation,” Jim Donohue, senior manager and associate principal at ECG Management Consultants, said in an interview. “It’s not a denial, it’s a request for more information for medical records prior to processing payments. That has the effect of slowing down payments.”

This is exactly what one internal medicine group in the Southeast has noticed. The internist who heads the practice, who asked not to be identified, says that about 4-6 months ago, United, Humana, and other payers started to require documentation for prepayment review on a higher percentage of complex claims such as 99214 (established patient), 99204 (new patient), and claims with -25 modifiers. (The latter are appended to evaluation and management [E/M] claims in which patients had comorbidities that were addressed in the same visit as the main complaint.)

“That’s really frustrating, because you have to print out or take the record for that particular visit and computer fax it to them,” the practice leader notes. “And invariably, they’ll say they didn’t get a certain percentage of them. It’s our fault because they lost the claim.”

In the past, he says, health plans would occasionally ask for the note related to a complex visit where they saw issues, and they’ve always done random postpayment chart audits. But the percentage of prepayment reviews has significantly increased in recent months, he says.

Until a plan does this review, the claim can’t be processed because it’s not regarded as a clean claim. And this has implications for insurers’ compliance with laws that, in most states, require them to pay claims within 30-40 days of submission. (Medicare’s limit is 30 days.) According to Mr. Donohue, the clock doesn’t start ticking on this requirement unless and until a claim is clean. So by requiring documentation on complex claims, the plans can not only justify downcoding a claim, but can also delay payment without triggering state penalties.
 

Insurer admits ‘challenges’ with claims processing

VCU Health, a health system affiliated with Virginia Commonwealth University, recently filed a complaint against Anthem with Virginia’s insurance commissioner, asking that the Virginia Bureau of Insurance investigate the company’s claims-processing delays. The complaint claimed Anthem owes VCU more than $385 million, of which $171 million is over 90 days old. Much of that consists of commercial claims, which are subject to the state’s 40-day claims payment rule.

VCU cited several problems it said Anthem had created that slowed claims payments:

Any claim over a certain dollar limit requires an itemized bill.

Anthem requests detailed medical records prior to considering payment of even clean claims.

Documents must be uploaded to a web portal that has technical problems, and Anthem has lost some documents as a result.

Claims are being incorrectly processed for some professionals, “resulting in multi-million-dollar underpayments of anesthesia, nurse practitioners, pathology, and behavioral health providers.”

In addition, as the Kaiser Health News article points out, hospitals have blamed the increase in payment delays or denials partly on “preauthorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers.”

In response to an inquiry from this news organization, an Anthem spokesman admitted that some payments to providers have been delayed, partly because of changes in the company’s claims-processing system. “We recognize there have been some challenges as we work with care providers to update claims processing, and readjust and adapt to a new set of dynamics as we continue to manage the pandemic,” said the spokesman.

The Kaiser Health News piece reported that Anthem’s CFO had told stock analysts on a conference call that the company had slowed claims payments to build up its financial reserves during the pandemic – a statement that some physicians called “outrageous.” But the Anthem spokesman told this news organization the quote was taken out of context and that the CFO was talking not about reserves but about “days in claims payable.” The spokesman said, “The payment delays that the article focuses on are not the primary driver or even a material driver of the increase in our overall reserves or DCPs [defined contribution plans] relative to historical levels. In fact, the vast majority of our claims are being processed in a timely manner.”

Some claims routinely downcoded

Even if that were the case, it would not explain why some physicians are seeing their higher-cost claims routinely downcoded. Will Sawyer, MD, a family physician in Cincinnati, told this news organization, “Anthem has been downcoding relentlessly since October 2020.” More often than not, when his office submits a claim with a 99214 code (office visit, 30-39 minutes, moderate medical decision-making), it’s changed to 99213 (office visit, 20-29 minutes, low medical decision-making) before processing, he says.

This has resulted in a significant diminution of his income, he notes. Anthem pays him less than Medicare for E/M visits, and the downcoding reduces his payment from $86 to $68 for a complex visit that may have taken half an hour or more.

In some cases where his office manager has noticed the downcoding, Dr. Sawyer says, she has resubmitted the claim with a copy of the encounter form. But Anthem hasn’t budged. And the refiling effort takes a toll on his solo practice, which doesn’t have sufficient staff, as it is.

Dr. Sawyer acknowledges that he has sent in a higher percentage of complex claims in the past year than he did previously. But much of that is the result of two factors beyond his control: First, many patients avoided coming into the office early in the pandemic, and when they returned, their preventive and chronic care needs were greater. Second, he says, “There are many comorbidities and mental health aspects, which exacerbate many issues and become an issue. We’re not dealing with engines here; they’re human beings. And it takes time.”

In response to Dr. Sawyer’s comments, Anthem said that it uses “analytical tools to review evaluation and management (E/M) codes during the claims adjudication and processing process.” Physicians who believe that certain claims should not have been downcoded can dispute these decisions; they must supply a statement explaining why they disagree with the decision along with documentation to support their statement, the company said. Anthem added that it reviews claims to lower costs for its members.
 

‘Revenue-grab strategy’

Dr. Sawyer believes that what Anthem is doing to him and other physicians reflects its desire to increase profits by netting extra revenue and keeping physicians’ money while it delays payments to them – a practice known in the trade as “the float.” Moreover, he says, the company depends on many practices not keeping track of their finances during the pandemic.

“When practices are running at warp speed, trying to keep people healthy and getting burned out, they aren’t paying as close attention to the details of payment. It’s an absolute revenue-grab strategy that’s unconscionable,” says Dr. Sawyer.

The Southeast internist also thinks that insurance companies other than Anthem – including United and Humana – are profiting from the float. Besides delaying his payments with gratuitous demands for documentation, he said, they also downcode many claims, forcing the practice to refile the claims and appeal. That forces the practice to pay overtime or bring on more claims staff, which raises administrative costs.

The plans’ strategy, the internist says, is this: “If they downcode millions of claims, a certain number of physicians will give up without appealing, and they’ll raise their profits.”

A United spokesperson said in an interview, “We pay claims appropriately under members’ plans and within the required time frame.” Humana had not responded to this news organization’s request for comment at press time.
 

Challenge to practice economics

Insurer policies that delay payments or downcode claims, ECG’s Mr. Donohue points out, are especially harmful to primary care and other ambulatory practices that have many small-dollar claims.

“That’s where it’s challenging, because it’s not like a $10,000 case where you add $100 to it [to meet records requests]. You’re talking about something that’s relatively low dollar, where the practice makes a small surplus, and when you add administrative costs, it can change the economics,” he says.

While the economic burden on ambulatory care practices may be greater, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association (MGMA), said that the payment delays and demands for documentation – along with prior authorization – particularly affect inpatient care. The health plans are questioning big-ticket items more than ever, he said, and most of those services occur in hospitals.

However, the greater level of insurer scrutiny also affects physicians who treat patients in the hospital, including surgeons and emergency department physicians who contract with the facilities, he adds.

Mr. Gilberg views the current situation as an exacerbation of the health plan policies that physicians have long struggled with. “It’s not new to have insurers play the float and not pay claims on time. Unfortunately, this is something that medical practices are used to.”

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

A new U.S. government study shows it isn’t risky and may even be a good idea to mix, rather than match, COVID-19 vaccines when getting a booster dose.

The study also shows mixing different kinds of vaccines appears to spur the body to make higher levels of virus-blocking antibodies than they would have gotten by boosting with a dose of the vaccine the person already had.

If regulators endorse the study findings, it should make getting a COVID-19 booster as easy as getting a yearly influenza vaccine.

“Currently when you go to do your flu shot nobody asks you what kind you had last year. Nobody cares what you had last year. And we were hoping that that was the same — that we would be able to boost regardless of what you had [previously],” said the study’s senior author, John Beigel, MD, who is associate director for clinical research in the division of microbiology and infectious diseases at the National Institutes of Health.

“But we needed to have the data,” he said.

Studies have suggested that higher antibody levels translate into better protection against disease, though the exact level that confers protection is not yet known.

“The antibody responses are so much higher [with mix and match], it’s really impressive,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville, who was not involved in the study.

Dr. Shaffner said if the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) sign off on the approach, he would especially recommend that people who got the Johnson & Johnson vaccine follow up with a dose of an mRNA vaccine from Pfizer or Moderna.

“It is a broader stimulation of the immune system, and I think that broader stimulation is advantageous,” he said.

Minimal side effects

The preprint study was published late Oct. 13 in medRxiv ahead of peer review, just before a slate of meetings involving vaccine experts that advise the FDA and CDC. 

These experts are tasked with trying to figure out whether additional shots of Moderna and Johnson & Johnson vaccines are safe and effective for boosting immunity against COVID-19.

The FDA’s panel is the Vaccines and Related Biological Products Advisory Committee (VRBPAC), and the CDC’s panel is the Advisory Committee on Immunization Practices (ACIP). 

During the pandemic, they have been meeting almost in lock step to tackle important vaccine-related questions.

“We got this data out because we knew VRBPAC was coming and we knew ACIP was going to grapple with these issues,” Dr. Beigel said.

He noted that these are just the first results. The study will continue for a year, and the researchers aim to deeply characterize the breadth and depth of the immune response to all nine of the different vaccine combinations included in the study.

The study included 458 participants at 10 study sites around the country who had been fully vaccinated with one of the three COVID-19 vaccines authorized for use in the United States: Moderna, Johnson & Johnson, or Pfizer-BioNTech. 

About 150 study participants were recruited from each group. Everyone in the study had finished their primary series at least 12 weeks before starting the study. None had a prior SARS-CoV-2 infection.

About 50 participants from each vaccine group were randomly assigned to get a third (booster) dose of either the same vaccine as the one they had already received, or a different vaccine, creating nine possible combinations of shots.

About half of study participants reported mild side effects — including pain at the injection site, fatigue, headache, and muscle aches.

Two study participants had serious medical problems during the study, but they were judged to be unrelated to vaccination. One study participant experienced kidney failure after their muscles broke down following a fall. The other experienced cholecystitis, or an inflamed gallbladder. 

Up to 1 month after the booster shots, no other serious adverse events were seen.

The study didn’t look at whether people got COVID-19, so it’s not possible to say that they were better protected against disease after their boosters.

Increase in antibodies

But all the groups saw substantial increases in their antibody levels, which is thought to indicate that they were better protected.

Overall, groups that got the same vaccine as their primary series saw 4 to 20-fold increases in their antibody levels. Groups that got different shots than the ones in their primary series got 6 to 76 fold increases in their antibody levels.

People who had originally gotten a Johnson & Johnson vaccine saw far bigger increases in antibodies, and were more likely to see a protective rise in antibodies if they got a second dose of an mRNA vaccine.

Dr. Schaffner noted that European countries had already been mixing the vaccine doses this way, giving people who had received the AstraZeneca vaccine, which is similar to the Johnson & Johnson shot, another dose of an mRNA vaccine.

German Chancellor Angela Merkel received a Moderna vaccine for her second dose after an initial shot of the Oxford-AstraZeneca vaccines, for example.

No safety signals related to mixing vaccines has been seen in countries that routinely use the approach for their initial series.

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

A new U.S. government study shows it isn’t risky and may even be a good idea to mix, rather than match, COVID-19 vaccines when getting a booster dose.

The study also shows mixing different kinds of vaccines appears to spur the body to make higher levels of virus-blocking antibodies than they would have gotten by boosting with a dose of the vaccine the person already had.

If regulators endorse the study findings, it should make getting a COVID-19 booster as easy as getting a yearly influenza vaccine.

“Currently when you go to do your flu shot nobody asks you what kind you had last year. Nobody cares what you had last year. And we were hoping that that was the same — that we would be able to boost regardless of what you had [previously],” said the study’s senior author, John Beigel, MD, who is associate director for clinical research in the division of microbiology and infectious diseases at the National Institutes of Health.

“But we needed to have the data,” he said.

Studies have suggested that higher antibody levels translate into better protection against disease, though the exact level that confers protection is not yet known.

“The antibody responses are so much higher [with mix and match], it’s really impressive,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville, who was not involved in the study.

Dr. Shaffner said if the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) sign off on the approach, he would especially recommend that people who got the Johnson & Johnson vaccine follow up with a dose of an mRNA vaccine from Pfizer or Moderna.

“It is a broader stimulation of the immune system, and I think that broader stimulation is advantageous,” he said.

Minimal side effects

The preprint study was published late Oct. 13 in medRxiv ahead of peer review, just before a slate of meetings involving vaccine experts that advise the FDA and CDC. 

These experts are tasked with trying to figure out whether additional shots of Moderna and Johnson & Johnson vaccines are safe and effective for boosting immunity against COVID-19.

The FDA’s panel is the Vaccines and Related Biological Products Advisory Committee (VRBPAC), and the CDC’s panel is the Advisory Committee on Immunization Practices (ACIP). 

During the pandemic, they have been meeting almost in lock step to tackle important vaccine-related questions.

“We got this data out because we knew VRBPAC was coming and we knew ACIP was going to grapple with these issues,” Dr. Beigel said.

He noted that these are just the first results. The study will continue for a year, and the researchers aim to deeply characterize the breadth and depth of the immune response to all nine of the different vaccine combinations included in the study.

The study included 458 participants at 10 study sites around the country who had been fully vaccinated with one of the three COVID-19 vaccines authorized for use in the United States: Moderna, Johnson & Johnson, or Pfizer-BioNTech. 

About 150 study participants were recruited from each group. Everyone in the study had finished their primary series at least 12 weeks before starting the study. None had a prior SARS-CoV-2 infection.

About 50 participants from each vaccine group were randomly assigned to get a third (booster) dose of either the same vaccine as the one they had already received, or a different vaccine, creating nine possible combinations of shots.

About half of study participants reported mild side effects — including pain at the injection site, fatigue, headache, and muscle aches.

Two study participants had serious medical problems during the study, but they were judged to be unrelated to vaccination. One study participant experienced kidney failure after their muscles broke down following a fall. The other experienced cholecystitis, or an inflamed gallbladder. 

Up to 1 month after the booster shots, no other serious adverse events were seen.

The study didn’t look at whether people got COVID-19, so it’s not possible to say that they were better protected against disease after their boosters.

Increase in antibodies

But all the groups saw substantial increases in their antibody levels, which is thought to indicate that they were better protected.

Overall, groups that got the same vaccine as their primary series saw 4 to 20-fold increases in their antibody levels. Groups that got different shots than the ones in their primary series got 6 to 76 fold increases in their antibody levels.

People who had originally gotten a Johnson & Johnson vaccine saw far bigger increases in antibodies, and were more likely to see a protective rise in antibodies if they got a second dose of an mRNA vaccine.

Dr. Schaffner noted that European countries had already been mixing the vaccine doses this way, giving people who had received the AstraZeneca vaccine, which is similar to the Johnson & Johnson shot, another dose of an mRNA vaccine.

German Chancellor Angela Merkel received a Moderna vaccine for her second dose after an initial shot of the Oxford-AstraZeneca vaccines, for example.

No safety signals related to mixing vaccines has been seen in countries that routinely use the approach for their initial series.

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

A new U.S. government study shows it isn’t risky and may even be a good idea to mix, rather than match, COVID-19 vaccines when getting a booster dose.

The study also shows mixing different kinds of vaccines appears to spur the body to make higher levels of virus-blocking antibodies than they would have gotten by boosting with a dose of the vaccine the person already had.

If regulators endorse the study findings, it should make getting a COVID-19 booster as easy as getting a yearly influenza vaccine.

“Currently when you go to do your flu shot nobody asks you what kind you had last year. Nobody cares what you had last year. And we were hoping that that was the same — that we would be able to boost regardless of what you had [previously],” said the study’s senior author, John Beigel, MD, who is associate director for clinical research in the division of microbiology and infectious diseases at the National Institutes of Health.

“But we needed to have the data,” he said.

Studies have suggested that higher antibody levels translate into better protection against disease, though the exact level that confers protection is not yet known.

“The antibody responses are so much higher [with mix and match], it’s really impressive,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville, who was not involved in the study.

Dr. Shaffner said if the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) sign off on the approach, he would especially recommend that people who got the Johnson & Johnson vaccine follow up with a dose of an mRNA vaccine from Pfizer or Moderna.

“It is a broader stimulation of the immune system, and I think that broader stimulation is advantageous,” he said.

Minimal side effects

The preprint study was published late Oct. 13 in medRxiv ahead of peer review, just before a slate of meetings involving vaccine experts that advise the FDA and CDC. 

These experts are tasked with trying to figure out whether additional shots of Moderna and Johnson & Johnson vaccines are safe and effective for boosting immunity against COVID-19.

The FDA’s panel is the Vaccines and Related Biological Products Advisory Committee (VRBPAC), and the CDC’s panel is the Advisory Committee on Immunization Practices (ACIP). 

During the pandemic, they have been meeting almost in lock step to tackle important vaccine-related questions.

“We got this data out because we knew VRBPAC was coming and we knew ACIP was going to grapple with these issues,” Dr. Beigel said.

He noted that these are just the first results. The study will continue for a year, and the researchers aim to deeply characterize the breadth and depth of the immune response to all nine of the different vaccine combinations included in the study.

The study included 458 participants at 10 study sites around the country who had been fully vaccinated with one of the three COVID-19 vaccines authorized for use in the United States: Moderna, Johnson & Johnson, or Pfizer-BioNTech. 

About 150 study participants were recruited from each group. Everyone in the study had finished their primary series at least 12 weeks before starting the study. None had a prior SARS-CoV-2 infection.

About 50 participants from each vaccine group were randomly assigned to get a third (booster) dose of either the same vaccine as the one they had already received, or a different vaccine, creating nine possible combinations of shots.

About half of study participants reported mild side effects — including pain at the injection site, fatigue, headache, and muscle aches.

Two study participants had serious medical problems during the study, but they were judged to be unrelated to vaccination. One study participant experienced kidney failure after their muscles broke down following a fall. The other experienced cholecystitis, or an inflamed gallbladder. 

Up to 1 month after the booster shots, no other serious adverse events were seen.

The study didn’t look at whether people got COVID-19, so it’s not possible to say that they were better protected against disease after their boosters.

Increase in antibodies

But all the groups saw substantial increases in their antibody levels, which is thought to indicate that they were better protected.

Overall, groups that got the same vaccine as their primary series saw 4 to 20-fold increases in their antibody levels. Groups that got different shots than the ones in their primary series got 6 to 76 fold increases in their antibody levels.

People who had originally gotten a Johnson & Johnson vaccine saw far bigger increases in antibodies, and were more likely to see a protective rise in antibodies if they got a second dose of an mRNA vaccine.

Dr. Schaffner noted that European countries had already been mixing the vaccine doses this way, giving people who had received the AstraZeneca vaccine, which is similar to the Johnson & Johnson shot, another dose of an mRNA vaccine.

German Chancellor Angela Merkel received a Moderna vaccine for her second dose after an initial shot of the Oxford-AstraZeneca vaccines, for example.

No safety signals related to mixing vaccines has been seen in countries that routinely use the approach for their initial series.

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

Andrea Rapkin, MD, is Board Certified by the American College of Obstetricians and Gynecologists (of which she is also a fellow). After obtaining her MD, she completed her residency in OBGYN at UCLA then joined the faculty at UCLA and is a Professor of Obstetrics and Gynecology. She was one of the first Obstetrician-Gynecologists to adapt the multidisciplinary pain management approach to the evaluation and treatment of women with pelvic and vulvar pain.

You are the founder and director of a clinic focused on a multidisciplinary pain management approach to the evaluation and treatment of women with pelvic and vulvar pain. How did you identify such a clinic as a therapeutic need for patients? 

Dr. Rapkin: The short answer is that a significant proportion of women were not experiencing pain relief or had incomplete relief with traditional medical or surgical therapy. At the time, we also identified various red flags for traditional treatment failures. These red flags included the following: pain of greater than 6 months duration, pain out of proportion to pathology found on examination, multiple visceral and somatic complaints, and psychosocial abnormalities. We now understand more about the neurobiology underpinning these red flags.  

With the widespread availability of laparoscopy in the late 70s and early 80s, many studies investigated the relationship between endometriosis lesions and pain. The general consensus is that there is no relationship between the location or severity of the endometriosis lesions or the disease stage (American Society for Reproductive Medicine staging) with type of symptoms, symptom severity, treatment response, recurrence, or even prognosis. In fact, pain recurrence after adequate surgical treatment is unrelated to the presence of endometriosis lesions found at the time of repeat laparoscopy. This lack of association between pain and presence of visible disease was supported by a recent New England Journal of Medicine article by Zondervan and colleagues demonstrating that up to 30% of women with chronic pelvic pain, present after excision of endometriotic lesions, become unresponsive to conventional treatment.

The neurobiological responses in an individual with chronic pain are more complicated than those seen in the setting of acute pain. Chronic pain may be triggered or maintained by an inflammatory process such as endometriosis but, over time, altered neural processing and psychosocial maladaptation can occur. The altered processing consists of both peripheral and central sensitization which change the way sensory information from the pelvic viscera and surrounding somatic structures in the periphery is transmitted and interpreted in the central nervous system (spinal cord and brain). Visceral pelvic pain can emanate from the uterus, ovaries and fallopian tubes, the urinary bladder, and the bowel, while the somatic sources include the surrounding abdominal wall, low back and pelvic floor muscles, and fascia, and bones. Signal amplification or peripheral sensitization in the pelvic region in women with endometriosis starts with localized inflammation, neovascularization, invasion and innervation of endometriotic implants. As the pelvic organs share thoracolumbar and sacral autonomic neural pathways, inflammation or dysfunction in one organ or tissue, such as the uterus, over time can sensitize or lead to dysfunction in other pelvic organs, such as the bladder or bowel (called viscero-visceral cross sensitization). Finally, somatic structures sharing intervention with the pelvic viscera, such as the fascia and muscles of the lower abdomen, pelvic floor lower back also become sources of pain because of a process called viscero-somatic sensitization. Women who have endometriosis are therefore more likely to experience IBS, bladder pain syndrome/interstitial cystitis and vulvodynia, and up to 80% of individuals can develop myofascial pain related to trigger points and muscle dysfunction. Up to 50% of women with bladder pain have endometriosis. Those with endometriosis or bladder pain are 2.5 times more likely to also have IBS. 

Over time, other visceral and somatic structures innervated by higher levels of the spinal cord can be affected, leading to more widespread pain. Central sensitization manifests as an amplification of pain in the spinal cord and brain. The presence of more than two chronic “unexplained” pain conditions, such as chronic pelvic pain, vulvodynia, myofascial pain, headache, etc suggest the presence of central sensitization. Anxiety, depression, and maladaptive coping strategies often ensue. Functional MRI studies have documented altered central processing in the brain in many chronic pain states including endometriosis. Interdisciplinary therapy including physical therapy, mental health, and pain management/anesthesiology is more effective compared with medical and or surgical therapy alone for endometriosis-related pain in the setting of peripheral and central sensitization.

What should clinicians look for, or what stands out to them, to confirm the endometriosis diagnosis when pain is the presenting symptom?

Dr. Rapkin: There are no pathognomonic symptoms or biomarkers for endometriosis; however, the following historical features have been shown to be linked with a greater likelihood of finding endometriosis:

• persistent dysmenorrhea (menstrual pain) despite NSAID and hormonal treatment
• cyclical pain that is premenstrual and menstrual that progresses to chronic pain or is accompanied by abnormal or heavy menstrual bleeding
• deep dyspareunia
• dyschezia (pain with bowel movements), and sometimes bloating.

An individual with menstrual pain since menarche can have up to a 5% increased risk of endometriosis. Endometriosis in a first-degree relative elevates the risk for endometriosis by 7% to 10%.

Given the complexity of chronic pain, it is important not to assume endometriosis is the only source of pain. All the pelvic visceral and somatic structures should be evaluated. A thorough history addresses all the patient’s symptoms, including vaginal, gastrointestinal and genitourinary. Aggravating factors such as menstrual cycle, bowel and bladder functioning, physical activity, sexual intercourse and stress should be queried. In addition, assessment of mood, anxiety or depression, sleep disturbance and effect of pain on daily functioning are relevant as is history of abuse or trauma (physical, sexual or emotional). This history can be lengthy, so a detailed pain questionnaire is helpful. (See the pelvicpain.org website for a user-friendly pain questionnaire).

With the previously mentioned risk factors in mind, and after a thorough history has been obtained, a pain-localizing exam should be conducted including the abdominal wall, pelvic floor, and then the bimanual and rectovaginal exams for the abdominal wall myofascial/neuropathic pain assessment for which Carnett’s test can be very useful—tender points on the abdominal wall are palpitated and the patient is asked to give a numerical rating of the pain (1-10/10) and marked with a pen. The patient is then asked to either perform a bilateral straight leg raise or an abdominal crunch, and the areas are re-palpitated. If the marked areas are more painful to palpation during the abdominal crunch or the bilateral straight leg raise, it suggests an abdominal wall pain (myofascial or neuropathic) or component of the pain. Similarly, pelvic floor muscles should be assessed after the abdominal wall exam is completed. This is best accomplished with a unit-digital exam with palpation of pelvic muscles for tenderness and hypertonia on exam. These myofascial findings are often present in the setting of endometriosis, but they can be primary-unrelated to presence or absence of endometriosis.

What are your focused disciplines for approaching endometriosis-associated pain? How do you recommend these clinicians or specialists come together to effectively manage a patient’s conditions? 

Dr. Rapkin: The gynecologist or primary care provider can address the chronic inflammatory, estrogen-dependent aspect of endometriosis. Begin with nonsteroidal, anti-inflammatory medication and combined estrogen-progestin or high-dose progestin-alone hormonal therapy to lower estrogenic stimulation of lesions and decidualize those progestin-sensitive lesions. For menstrual cycle related pain (luteal periovulatory or menstrual phase) cyclical exacerbation of other chronic pain conditions, early intervention is recommended. Adequately dosed preemptive nonsteroidal inflammatory agents and, if not tolerated or effective, begin combined hormonal contraceptives or intrauterine or higher dose progestins menstrual suppression, with either continuous monophasic hormonal contraceptives or progestins, is very important for pain that is cyclical or exacerbated in a cyclical fashion. Progestins can be administered orally, such as norethindrone acetate; intramuscularly or subdermally (depot medroxyprogesterone acetate or etonogestrel implant); or intrauterine (which does not lower estrogen levels but can be therapeutic for suppression of menses and local treatment of endometriosis). Failure of hormonal therapy and management of other co-occurring pain conditions warrants trial of a second-line medical therapy such as gonadotropin-releasing hormone antagonist or agonist or surgery for definitive diagnosis and surgical ablation or excision of endometriosis lesions.

I would suggest that gynecologists who treat women with endometriosis and chronic pain try to build a team in their geographic area. Relevant specialists for an interdisciplinary approach include:

• Pelvic floor physical therapist to evaluate and address myofascial dysfunction and pain and voiding abnormalities, such as urinary urgency or frequency and constipation
• Gastroenterologist for evaluation and treatment of irritable bowel or functional abdominal pain and bloating syndrome or inflammatory bowel disease. Urologist or urogynecologist to assess and treat bladder pain syndrome/interstitial cystitis
• Primary care evaluation for diffuse myofascial pain, fibromyalgia, arthralgias, and other inflammatory conditions, and for management of headache and migraine. Rheumatology and neurology specialists may be needed
• Mental health providers for treatment of anxiety, depression, or PTSD and to address stress management, coping skills and provide cognitive behavioral therapy
• Interventional pain management specialist such as physical medicine and rehabilitation (PM and R), pain anesthiologist, neurologist or interventional radiologist to provide relevant nerve blocks, trigger point injections, or botulinum toxin injection.
• Gynecologists experienced in the management of chronic pelvic pain also provide nerve blocks, trigger point and botulinum toxin injections.

Andrea Rapkin, MD, is Board Certified by the American College of Obstetricians and Gynecologists (of which she is also a fellow). After obtaining her MD, she completed her residency in OBGYN at UCLA then joined the faculty at UCLA and is a Professor of Obstetrics and Gynecology. She was one of the first Obstetrician-Gynecologists to adapt the multidisciplinary pain management approach to the evaluation and treatment of women with pelvic and vulvar pain.

You are the founder and director of a clinic focused on a multidisciplinary pain management approach to the evaluation and treatment of women with pelvic and vulvar pain. How did you identify such a clinic as a therapeutic need for patients? 

Dr. Rapkin: The short answer is that a significant proportion of women were not experiencing pain relief or had incomplete relief with traditional medical or surgical therapy. At the time, we also identified various red flags for traditional treatment failures. These red flags included the following: pain of greater than 6 months duration, pain out of proportion to pathology found on examination, multiple visceral and somatic complaints, and psychosocial abnormalities. We now understand more about the neurobiology underpinning these red flags.  

With the widespread availability of laparoscopy in the late 70s and early 80s, many studies investigated the relationship between endometriosis lesions and pain. The general consensus is that there is no relationship between the location or severity of the endometriosis lesions or the disease stage (American Society for Reproductive Medicine staging) with type of symptoms, symptom severity, treatment response, recurrence, or even prognosis. In fact, pain recurrence after adequate surgical treatment is unrelated to the presence of endometriosis lesions found at the time of repeat laparoscopy. This lack of association between pain and presence of visible disease was supported by a recent New England Journal of Medicine article by Zondervan and colleagues demonstrating that up to 30% of women with chronic pelvic pain, present after excision of endometriotic lesions, become unresponsive to conventional treatment.

The neurobiological responses in an individual with chronic pain are more complicated than those seen in the setting of acute pain. Chronic pain may be triggered or maintained by an inflammatory process such as endometriosis but, over time, altered neural processing and psychosocial maladaptation can occur. The altered processing consists of both peripheral and central sensitization which change the way sensory information from the pelvic viscera and surrounding somatic structures in the periphery is transmitted and interpreted in the central nervous system (spinal cord and brain). Visceral pelvic pain can emanate from the uterus, ovaries and fallopian tubes, the urinary bladder, and the bowel, while the somatic sources include the surrounding abdominal wall, low back and pelvic floor muscles, and fascia, and bones. Signal amplification or peripheral sensitization in the pelvic region in women with endometriosis starts with localized inflammation, neovascularization, invasion and innervation of endometriotic implants. As the pelvic organs share thoracolumbar and sacral autonomic neural pathways, inflammation or dysfunction in one organ or tissue, such as the uterus, over time can sensitize or lead to dysfunction in other pelvic organs, such as the bladder or bowel (called viscero-visceral cross sensitization). Finally, somatic structures sharing intervention with the pelvic viscera, such as the fascia and muscles of the lower abdomen, pelvic floor lower back also become sources of pain because of a process called viscero-somatic sensitization. Women who have endometriosis are therefore more likely to experience IBS, bladder pain syndrome/interstitial cystitis and vulvodynia, and up to 80% of individuals can develop myofascial pain related to trigger points and muscle dysfunction. Up to 50% of women with bladder pain have endometriosis. Those with endometriosis or bladder pain are 2.5 times more likely to also have IBS. 

Over time, other visceral and somatic structures innervated by higher levels of the spinal cord can be affected, leading to more widespread pain. Central sensitization manifests as an amplification of pain in the spinal cord and brain. The presence of more than two chronic “unexplained” pain conditions, such as chronic pelvic pain, vulvodynia, myofascial pain, headache, etc suggest the presence of central sensitization. Anxiety, depression, and maladaptive coping strategies often ensue. Functional MRI studies have documented altered central processing in the brain in many chronic pain states including endometriosis. Interdisciplinary therapy including physical therapy, mental health, and pain management/anesthesiology is more effective compared with medical and or surgical therapy alone for endometriosis-related pain in the setting of peripheral and central sensitization.

What should clinicians look for, or what stands out to them, to confirm the endometriosis diagnosis when pain is the presenting symptom?

Dr. Rapkin: There are no pathognomonic symptoms or biomarkers for endometriosis; however, the following historical features have been shown to be linked with a greater likelihood of finding endometriosis:

• persistent dysmenorrhea (menstrual pain) despite NSAID and hormonal treatment
• cyclical pain that is premenstrual and menstrual that progresses to chronic pain or is accompanied by abnormal or heavy menstrual bleeding
• deep dyspareunia
• dyschezia (pain with bowel movements), and sometimes bloating.

An individual with menstrual pain since menarche can have up to a 5% increased risk of endometriosis. Endometriosis in a first-degree relative elevates the risk for endometriosis by 7% to 10%.

Given the complexity of chronic pain, it is important not to assume endometriosis is the only source of pain. All the pelvic visceral and somatic structures should be evaluated. A thorough history addresses all the patient’s symptoms, including vaginal, gastrointestinal and genitourinary. Aggravating factors such as menstrual cycle, bowel and bladder functioning, physical activity, sexual intercourse and stress should be queried. In addition, assessment of mood, anxiety or depression, sleep disturbance and effect of pain on daily functioning are relevant as is history of abuse or trauma (physical, sexual or emotional). This history can be lengthy, so a detailed pain questionnaire is helpful. (See the pelvicpain.org website for a user-friendly pain questionnaire).

With the previously mentioned risk factors in mind, and after a thorough history has been obtained, a pain-localizing exam should be conducted including the abdominal wall, pelvic floor, and then the bimanual and rectovaginal exams for the abdominal wall myofascial/neuropathic pain assessment for which Carnett’s test can be very useful—tender points on the abdominal wall are palpitated and the patient is asked to give a numerical rating of the pain (1-10/10) and marked with a pen. The patient is then asked to either perform a bilateral straight leg raise or an abdominal crunch, and the areas are re-palpitated. If the marked areas are more painful to palpation during the abdominal crunch or the bilateral straight leg raise, it suggests an abdominal wall pain (myofascial or neuropathic) or component of the pain. Similarly, pelvic floor muscles should be assessed after the abdominal wall exam is completed. This is best accomplished with a unit-digital exam with palpation of pelvic muscles for tenderness and hypertonia on exam. These myofascial findings are often present in the setting of endometriosis, but they can be primary-unrelated to presence or absence of endometriosis.

What are your focused disciplines for approaching endometriosis-associated pain? How do you recommend these clinicians or specialists come together to effectively manage a patient’s conditions? 

Dr. Rapkin: The gynecologist or primary care provider can address the chronic inflammatory, estrogen-dependent aspect of endometriosis. Begin with nonsteroidal, anti-inflammatory medication and combined estrogen-progestin or high-dose progestin-alone hormonal therapy to lower estrogenic stimulation of lesions and decidualize those progestin-sensitive lesions. For menstrual cycle related pain (luteal periovulatory or menstrual phase) cyclical exacerbation of other chronic pain conditions, early intervention is recommended. Adequately dosed preemptive nonsteroidal inflammatory agents and, if not tolerated or effective, begin combined hormonal contraceptives or intrauterine or higher dose progestins menstrual suppression, with either continuous monophasic hormonal contraceptives or progestins, is very important for pain that is cyclical or exacerbated in a cyclical fashion. Progestins can be administered orally, such as norethindrone acetate; intramuscularly or subdermally (depot medroxyprogesterone acetate or etonogestrel implant); or intrauterine (which does not lower estrogen levels but can be therapeutic for suppression of menses and local treatment of endometriosis). Failure of hormonal therapy and management of other co-occurring pain conditions warrants trial of a second-line medical therapy such as gonadotropin-releasing hormone antagonist or agonist or surgery for definitive diagnosis and surgical ablation or excision of endometriosis lesions.

I would suggest that gynecologists who treat women with endometriosis and chronic pain try to build a team in their geographic area. Relevant specialists for an interdisciplinary approach include:

• Pelvic floor physical therapist to evaluate and address myofascial dysfunction and pain and voiding abnormalities, such as urinary urgency or frequency and constipation
• Gastroenterologist for evaluation and treatment of irritable bowel or functional abdominal pain and bloating syndrome or inflammatory bowel disease. Urologist or urogynecologist to assess and treat bladder pain syndrome/interstitial cystitis
• Primary care evaluation for diffuse myofascial pain, fibromyalgia, arthralgias, and other inflammatory conditions, and for management of headache and migraine. Rheumatology and neurology specialists may be needed
• Mental health providers for treatment of anxiety, depression, or PTSD and to address stress management, coping skills and provide cognitive behavioral therapy
• Interventional pain management specialist such as physical medicine and rehabilitation (PM and R), pain anesthiologist, neurologist or interventional radiologist to provide relevant nerve blocks, trigger point injections, or botulinum toxin injection.
• Gynecologists experienced in the management of chronic pelvic pain also provide nerve blocks, trigger point and botulinum toxin injections.

Andrea Rapkin, MD, is Board Certified by the American College of Obstetricians and Gynecologists (of which she is also a fellow). After obtaining her MD, she completed her residency in OBGYN at UCLA then joined the faculty at UCLA and is a Professor of Obstetrics and Gynecology. She was one of the first Obstetrician-Gynecologists to adapt the multidisciplinary pain management approach to the evaluation and treatment of women with pelvic and vulvar pain.

You are the founder and director of a clinic focused on a multidisciplinary pain management approach to the evaluation and treatment of women with pelvic and vulvar pain. How did you identify such a clinic as a therapeutic need for patients? 

Dr. Rapkin: The short answer is that a significant proportion of women were not experiencing pain relief or had incomplete relief with traditional medical or surgical therapy. At the time, we also identified various red flags for traditional treatment failures. These red flags included the following: pain of greater than 6 months duration, pain out of proportion to pathology found on examination, multiple visceral and somatic complaints, and psychosocial abnormalities. We now understand more about the neurobiology underpinning these red flags.  

With the widespread availability of laparoscopy in the late 70s and early 80s, many studies investigated the relationship between endometriosis lesions and pain. The general consensus is that there is no relationship between the location or severity of the endometriosis lesions or the disease stage (American Society for Reproductive Medicine staging) with type of symptoms, symptom severity, treatment response, recurrence, or even prognosis. In fact, pain recurrence after adequate surgical treatment is unrelated to the presence of endometriosis lesions found at the time of repeat laparoscopy. This lack of association between pain and presence of visible disease was supported by a recent New England Journal of Medicine article by Zondervan and colleagues demonstrating that up to 30% of women with chronic pelvic pain, present after excision of endometriotic lesions, become unresponsive to conventional treatment.

The neurobiological responses in an individual with chronic pain are more complicated than those seen in the setting of acute pain. Chronic pain may be triggered or maintained by an inflammatory process such as endometriosis but, over time, altered neural processing and psychosocial maladaptation can occur. The altered processing consists of both peripheral and central sensitization which change the way sensory information from the pelvic viscera and surrounding somatic structures in the periphery is transmitted and interpreted in the central nervous system (spinal cord and brain). Visceral pelvic pain can emanate from the uterus, ovaries and fallopian tubes, the urinary bladder, and the bowel, while the somatic sources include the surrounding abdominal wall, low back and pelvic floor muscles, and fascia, and bones. Signal amplification or peripheral sensitization in the pelvic region in women with endometriosis starts with localized inflammation, neovascularization, invasion and innervation of endometriotic implants. As the pelvic organs share thoracolumbar and sacral autonomic neural pathways, inflammation or dysfunction in one organ or tissue, such as the uterus, over time can sensitize or lead to dysfunction in other pelvic organs, such as the bladder or bowel (called viscero-visceral cross sensitization). Finally, somatic structures sharing intervention with the pelvic viscera, such as the fascia and muscles of the lower abdomen, pelvic floor lower back also become sources of pain because of a process called viscero-somatic sensitization. Women who have endometriosis are therefore more likely to experience IBS, bladder pain syndrome/interstitial cystitis and vulvodynia, and up to 80% of individuals can develop myofascial pain related to trigger points and muscle dysfunction. Up to 50% of women with bladder pain have endometriosis. Those with endometriosis or bladder pain are 2.5 times more likely to also have IBS. 

Over time, other visceral and somatic structures innervated by higher levels of the spinal cord can be affected, leading to more widespread pain. Central sensitization manifests as an amplification of pain in the spinal cord and brain. The presence of more than two chronic “unexplained” pain conditions, such as chronic pelvic pain, vulvodynia, myofascial pain, headache, etc suggest the presence of central sensitization. Anxiety, depression, and maladaptive coping strategies often ensue. Functional MRI studies have documented altered central processing in the brain in many chronic pain states including endometriosis. Interdisciplinary therapy including physical therapy, mental health, and pain management/anesthesiology is more effective compared with medical and or surgical therapy alone for endometriosis-related pain in the setting of peripheral and central sensitization.

What should clinicians look for, or what stands out to them, to confirm the endometriosis diagnosis when pain is the presenting symptom?

Dr. Rapkin: There are no pathognomonic symptoms or biomarkers for endometriosis; however, the following historical features have been shown to be linked with a greater likelihood of finding endometriosis:

• persistent dysmenorrhea (menstrual pain) despite NSAID and hormonal treatment
• cyclical pain that is premenstrual and menstrual that progresses to chronic pain or is accompanied by abnormal or heavy menstrual bleeding
• deep dyspareunia
• dyschezia (pain with bowel movements), and sometimes bloating.

An individual with menstrual pain since menarche can have up to a 5% increased risk of endometriosis. Endometriosis in a first-degree relative elevates the risk for endometriosis by 7% to 10%.

Given the complexity of chronic pain, it is important not to assume endometriosis is the only source of pain. All the pelvic visceral and somatic structures should be evaluated. A thorough history addresses all the patient’s symptoms, including vaginal, gastrointestinal and genitourinary. Aggravating factors such as menstrual cycle, bowel and bladder functioning, physical activity, sexual intercourse and stress should be queried. In addition, assessment of mood, anxiety or depression, sleep disturbance and effect of pain on daily functioning are relevant as is history of abuse or trauma (physical, sexual or emotional). This history can be lengthy, so a detailed pain questionnaire is helpful. (See the pelvicpain.org website for a user-friendly pain questionnaire).

With the previously mentioned risk factors in mind, and after a thorough history has been obtained, a pain-localizing exam should be conducted including the abdominal wall, pelvic floor, and then the bimanual and rectovaginal exams for the abdominal wall myofascial/neuropathic pain assessment for which Carnett’s test can be very useful—tender points on the abdominal wall are palpitated and the patient is asked to give a numerical rating of the pain (1-10/10) and marked with a pen. The patient is then asked to either perform a bilateral straight leg raise or an abdominal crunch, and the areas are re-palpitated. If the marked areas are more painful to palpation during the abdominal crunch or the bilateral straight leg raise, it suggests an abdominal wall pain (myofascial or neuropathic) or component of the pain. Similarly, pelvic floor muscles should be assessed after the abdominal wall exam is completed. This is best accomplished with a unit-digital exam with palpation of pelvic muscles for tenderness and hypertonia on exam. These myofascial findings are often present in the setting of endometriosis, but they can be primary-unrelated to presence or absence of endometriosis.

What are your focused disciplines for approaching endometriosis-associated pain? How do you recommend these clinicians or specialists come together to effectively manage a patient’s conditions? 

Dr. Rapkin: The gynecologist or primary care provider can address the chronic inflammatory, estrogen-dependent aspect of endometriosis. Begin with nonsteroidal, anti-inflammatory medication and combined estrogen-progestin or high-dose progestin-alone hormonal therapy to lower estrogenic stimulation of lesions and decidualize those progestin-sensitive lesions. For menstrual cycle related pain (luteal periovulatory or menstrual phase) cyclical exacerbation of other chronic pain conditions, early intervention is recommended. Adequately dosed preemptive nonsteroidal inflammatory agents and, if not tolerated or effective, begin combined hormonal contraceptives or intrauterine or higher dose progestins menstrual suppression, with either continuous monophasic hormonal contraceptives or progestins, is very important for pain that is cyclical or exacerbated in a cyclical fashion. Progestins can be administered orally, such as norethindrone acetate; intramuscularly or subdermally (depot medroxyprogesterone acetate or etonogestrel implant); or intrauterine (which does not lower estrogen levels but can be therapeutic for suppression of menses and local treatment of endometriosis). Failure of hormonal therapy and management of other co-occurring pain conditions warrants trial of a second-line medical therapy such as gonadotropin-releasing hormone antagonist or agonist or surgery for definitive diagnosis and surgical ablation or excision of endometriosis lesions.

I would suggest that gynecologists who treat women with endometriosis and chronic pain try to build a team in their geographic area. Relevant specialists for an interdisciplinary approach include:

• Pelvic floor physical therapist to evaluate and address myofascial dysfunction and pain and voiding abnormalities, such as urinary urgency or frequency and constipation
• Gastroenterologist for evaluation and treatment of irritable bowel or functional abdominal pain and bloating syndrome or inflammatory bowel disease. Urologist or urogynecologist to assess and treat bladder pain syndrome/interstitial cystitis
• Primary care evaluation for diffuse myofascial pain, fibromyalgia, arthralgias, and other inflammatory conditions, and for management of headache and migraine. Rheumatology and neurology specialists may be needed
• Mental health providers for treatment of anxiety, depression, or PTSD and to address stress management, coping skills and provide cognitive behavioral therapy
• Interventional pain management specialist such as physical medicine and rehabilitation (PM and R), pain anesthiologist, neurologist or interventional radiologist to provide relevant nerve blocks, trigger point injections, or botulinum toxin injection.
• Gynecologists experienced in the management of chronic pelvic pain also provide nerve blocks, trigger point and botulinum toxin injections.

A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.

The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:

• Over age 65
• Ages 18 to 64 who are at higher risk for severe COVID
• Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are

The agency is not bound by the committee’s vote but usually follows its recommendations.

Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.

“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.

Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”

“I’ve got some real issues with this vote,” he said.

“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.

Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.

Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.

After the advisory committee votes, the director of the CDC has to approve its recommendation.

Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.

Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.

In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.

To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.

Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.

The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.

This article was updated Oct. 15 and first appeared on WebMD.com.

A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.

The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:

• Over age 65
• Ages 18 to 64 who are at higher risk for severe COVID
• Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are

The agency is not bound by the committee’s vote but usually follows its recommendations.

Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.

“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.

Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”

“I’ve got some real issues with this vote,” he said.

“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.

Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.

Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.

After the advisory committee votes, the director of the CDC has to approve its recommendation.

Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.

Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.

In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.

To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.

Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.

The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.

This article was updated Oct. 15 and first appeared on WebMD.com.

A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.

The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:

• Over age 65
• Ages 18 to 64 who are at higher risk for severe COVID
• Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are

The agency is not bound by the committee’s vote but usually follows its recommendations.

Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.

“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.

Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”

“I’ve got some real issues with this vote,” he said.

“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.

Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.

Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.

After the advisory committee votes, the director of the CDC has to approve its recommendation.

Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.

Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.

In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.

To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.

Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.

The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.

This article was updated Oct. 15 and first appeared on WebMD.com.

Parsonage-Turner syndrome has been highlighted as a potential adverse effect of mRNA COVID vaccines in a recent pharmacovigilance monitoring report from the French National Agency for the Safety of Medicines and Health Products (ANSM).

The rare condition — more common in men than in women — is characterized by the sudden onset of severe pain in the shoulder, followed by arm paralysis. Its etiopathogenesis is not well understood, but vaccines, in particular the flu vaccine, have been implicated in some cases, the report states.

Six serious cases of the syndrome related to the Comirnaty (Pfizer) vaccine were reported by healthcare professionals and vaccinated individuals or their family and friends since the start of the monitoring program. Four of these cases occurred from September 3 to 16.

All six cases involved patients 19 to 69 years of age — two women and four men — who developed symptoms in the 50 days after vaccination. Half were reported after the first dose and half after the second dose. Four of the patients are currently recovering; the outcomes of the other two are unknown.

In the case of the Spikevax vaccine (Moderna), two cases of Parsonage-Turner syndrome were reported after vaccination (plus one that occurred after 50 days, which is currently being managed). The onset of symptoms in these two men — one in his early 30s and one in his early 60s — occurred less than 18 days after vaccination. One occurred after the first dose and one after the second dose. This timing indicates a possible link between the syndrome and the vaccine. Both men are currently in recovery.

This signal of mRNA vaccines is now “officially recognized,” according to the Pfizer and Moderna reports.

It is also considered a “potential signal” in the Vaxzevria (AstraZeneca) pharmacovigilance report, released October 8, which describes eight cases of Parsonage-Turner syndrome after vaccination.
 

Safety profile of mRNA COVID vaccines in youth

Between June 15, when children 12 years and older became eligible for vaccination, and August 26, there were 591 reports of potential adverse events — out of 6 million Pfizer doses administered — in 12- to 18-year-old children.

Of the 591 cases, 35.2% were deemed serious. The majority of these were cases of reactogenicity, malaise, or postvaccine discomfort (25%), followed by instances of myocarditis and pericarditis (15.9% and 7.2%, respectively). In eight of 10 cases, one of the first symptom reported was chest pain.

Myocarditis occurred in 39.4% of people after the first injection (mean time to onset, 13 days) and 54.5% after the second (mean time to onset, 4 days). Recorded progress was favorable in nearly nine of 10 cases.

Pericarditis occurred in 53.3% of people after the first injection (mean time to onset, 13 days), and 40.0% after the second (mean time to onset, 4 days).

Three cases of multisystem inflammatory syndrome in children (MISC) were reported after monitoring ended.

For this age group, “all reported events will continue to be monitored, especially serious events and multisystem inflammatory syndrome in children,” report authors conclude.

Data for adverse events after the Moderna vaccine remain limited, but the report stipulates that “the adverse events reported in 12- to 18-year-olds who received an injection do not display any particular pattern, compared with those reported in older subjects, with the exception of a roughly 100-fold lower incidence of reported adverse effects in the 12- to 17-year age group.”
 

No safety warnings for pregnant women

The pharmacovigilance report — which covered the period from December 27, 2020 to September 9, 2021 — “raises no safety warnings for pregnant or nursing women with any of the COVID-19 vaccines.” In addition, two recent studies — one published in JAMA and one in the New England Journal of Medicine — have shown no link between spontaneous miscarriage and mRNA vaccines.

“Moreover, it should be stressed that current data from the international literature consistently show that maternal SARS COV-2 infection increases the risk for fetal, maternal, and neonatal complications, and that this risk may increase with the arrival of the Alpha and Delta variants,” they write. “It is therefore important to reiterate the current recommendations to vaccinate all pregnant women, regardless of the stage of pregnancy.”

Some adverse effects, such as thromboembolic effects, in utero death, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, and uterine contractions, will continue to be monitored.
 

Questions regarding menstrual disorders

As for gynecological disorders reported after vaccination, questions still remain. “In most of the reported cases, it is difficult to accurately determine whether the vaccine played a role in the occurrence of menstrual/genital bleeding,” the authors of the pharmacovigilance monitoring report state.

“Nonetheless, these cases warrant attention,” they add, and further discussions with the French National Association of Obstetricians and Gynecologists and the French Society of Endocrinology are needed in regard to these potential safety signals.

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

Parsonage-Turner syndrome has been highlighted as a potential adverse effect of mRNA COVID vaccines in a recent pharmacovigilance monitoring report from the French National Agency for the Safety of Medicines and Health Products (ANSM).

The rare condition — more common in men than in women — is characterized by the sudden onset of severe pain in the shoulder, followed by arm paralysis. Its etiopathogenesis is not well understood, but vaccines, in particular the flu vaccine, have been implicated in some cases, the report states.

Six serious cases of the syndrome related to the Comirnaty (Pfizer) vaccine were reported by healthcare professionals and vaccinated individuals or their family and friends since the start of the monitoring program. Four of these cases occurred from September 3 to 16.

All six cases involved patients 19 to 69 years of age — two women and four men — who developed symptoms in the 50 days after vaccination. Half were reported after the first dose and half after the second dose. Four of the patients are currently recovering; the outcomes of the other two are unknown.

In the case of the Spikevax vaccine (Moderna), two cases of Parsonage-Turner syndrome were reported after vaccination (plus one that occurred after 50 days, which is currently being managed). The onset of symptoms in these two men — one in his early 30s and one in his early 60s — occurred less than 18 days after vaccination. One occurred after the first dose and one after the second dose. This timing indicates a possible link between the syndrome and the vaccine. Both men are currently in recovery.

This signal of mRNA vaccines is now “officially recognized,” according to the Pfizer and Moderna reports.

It is also considered a “potential signal” in the Vaxzevria (AstraZeneca) pharmacovigilance report, released October 8, which describes eight cases of Parsonage-Turner syndrome after vaccination.
 

Safety profile of mRNA COVID vaccines in youth

Between June 15, when children 12 years and older became eligible for vaccination, and August 26, there were 591 reports of potential adverse events — out of 6 million Pfizer doses administered — in 12- to 18-year-old children.

Of the 591 cases, 35.2% were deemed serious. The majority of these were cases of reactogenicity, malaise, or postvaccine discomfort (25%), followed by instances of myocarditis and pericarditis (15.9% and 7.2%, respectively). In eight of 10 cases, one of the first symptom reported was chest pain.

Myocarditis occurred in 39.4% of people after the first injection (mean time to onset, 13 days) and 54.5% after the second (mean time to onset, 4 days). Recorded progress was favorable in nearly nine of 10 cases.

Pericarditis occurred in 53.3% of people after the first injection (mean time to onset, 13 days), and 40.0% after the second (mean time to onset, 4 days).

Three cases of multisystem inflammatory syndrome in children (MISC) were reported after monitoring ended.

For this age group, “all reported events will continue to be monitored, especially serious events and multisystem inflammatory syndrome in children,” report authors conclude.

Data for adverse events after the Moderna vaccine remain limited, but the report stipulates that “the adverse events reported in 12- to 18-year-olds who received an injection do not display any particular pattern, compared with those reported in older subjects, with the exception of a roughly 100-fold lower incidence of reported adverse effects in the 12- to 17-year age group.”
 

No safety warnings for pregnant women

The pharmacovigilance report — which covered the period from December 27, 2020 to September 9, 2021 — “raises no safety warnings for pregnant or nursing women with any of the COVID-19 vaccines.” In addition, two recent studies — one published in JAMA and one in the New England Journal of Medicine — have shown no link between spontaneous miscarriage and mRNA vaccines.

“Moreover, it should be stressed that current data from the international literature consistently show that maternal SARS COV-2 infection increases the risk for fetal, maternal, and neonatal complications, and that this risk may increase with the arrival of the Alpha and Delta variants,” they write. “It is therefore important to reiterate the current recommendations to vaccinate all pregnant women, regardless of the stage of pregnancy.”

Some adverse effects, such as thromboembolic effects, in utero death, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, and uterine contractions, will continue to be monitored.
 

Questions regarding menstrual disorders

As for gynecological disorders reported after vaccination, questions still remain. “In most of the reported cases, it is difficult to accurately determine whether the vaccine played a role in the occurrence of menstrual/genital bleeding,” the authors of the pharmacovigilance monitoring report state.

“Nonetheless, these cases warrant attention,” they add, and further discussions with the French National Association of Obstetricians and Gynecologists and the French Society of Endocrinology are needed in regard to these potential safety signals.

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

Parsonage-Turner syndrome has been highlighted as a potential adverse effect of mRNA COVID vaccines in a recent pharmacovigilance monitoring report from the French National Agency for the Safety of Medicines and Health Products (ANSM).

The rare condition — more common in men than in women — is characterized by the sudden onset of severe pain in the shoulder, followed by arm paralysis. Its etiopathogenesis is not well understood, but vaccines, in particular the flu vaccine, have been implicated in some cases, the report states.

Six serious cases of the syndrome related to the Comirnaty (Pfizer) vaccine were reported by healthcare professionals and vaccinated individuals or their family and friends since the start of the monitoring program. Four of these cases occurred from September 3 to 16.

All six cases involved patients 19 to 69 years of age — two women and four men — who developed symptoms in the 50 days after vaccination. Half were reported after the first dose and half after the second dose. Four of the patients are currently recovering; the outcomes of the other two are unknown.

In the case of the Spikevax vaccine (Moderna), two cases of Parsonage-Turner syndrome were reported after vaccination (plus one that occurred after 50 days, which is currently being managed). The onset of symptoms in these two men — one in his early 30s and one in his early 60s — occurred less than 18 days after vaccination. One occurred after the first dose and one after the second dose. This timing indicates a possible link between the syndrome and the vaccine. Both men are currently in recovery.

This signal of mRNA vaccines is now “officially recognized,” according to the Pfizer and Moderna reports.

It is also considered a “potential signal” in the Vaxzevria (AstraZeneca) pharmacovigilance report, released October 8, which describes eight cases of Parsonage-Turner syndrome after vaccination.
 

Safety profile of mRNA COVID vaccines in youth

Between June 15, when children 12 years and older became eligible for vaccination, and August 26, there were 591 reports of potential adverse events — out of 6 million Pfizer doses administered — in 12- to 18-year-old children.

Of the 591 cases, 35.2% were deemed serious. The majority of these were cases of reactogenicity, malaise, or postvaccine discomfort (25%), followed by instances of myocarditis and pericarditis (15.9% and 7.2%, respectively). In eight of 10 cases, one of the first symptom reported was chest pain.

Myocarditis occurred in 39.4% of people after the first injection (mean time to onset, 13 days) and 54.5% after the second (mean time to onset, 4 days). Recorded progress was favorable in nearly nine of 10 cases.

Pericarditis occurred in 53.3% of people after the first injection (mean time to onset, 13 days), and 40.0% after the second (mean time to onset, 4 days).

Three cases of multisystem inflammatory syndrome in children (MISC) were reported after monitoring ended.

For this age group, “all reported events will continue to be monitored, especially serious events and multisystem inflammatory syndrome in children,” report authors conclude.

Data for adverse events after the Moderna vaccine remain limited, but the report stipulates that “the adverse events reported in 12- to 18-year-olds who received an injection do not display any particular pattern, compared with those reported in older subjects, with the exception of a roughly 100-fold lower incidence of reported adverse effects in the 12- to 17-year age group.”
 

No safety warnings for pregnant women

The pharmacovigilance report — which covered the period from December 27, 2020 to September 9, 2021 — “raises no safety warnings for pregnant or nursing women with any of the COVID-19 vaccines.” In addition, two recent studies — one published in JAMA and one in the New England Journal of Medicine — have shown no link between spontaneous miscarriage and mRNA vaccines.

“Moreover, it should be stressed that current data from the international literature consistently show that maternal SARS COV-2 infection increases the risk for fetal, maternal, and neonatal complications, and that this risk may increase with the arrival of the Alpha and Delta variants,” they write. “It is therefore important to reiterate the current recommendations to vaccinate all pregnant women, regardless of the stage of pregnancy.”

Some adverse effects, such as thromboembolic effects, in utero death, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, and uterine contractions, will continue to be monitored.
 

Questions regarding menstrual disorders

As for gynecological disorders reported after vaccination, questions still remain. “In most of the reported cases, it is difficult to accurately determine whether the vaccine played a role in the occurrence of menstrual/genital bleeding,” the authors of the pharmacovigilance monitoring report state.

“Nonetheless, these cases warrant attention,” they add, and further discussions with the French National Association of Obstetricians and Gynecologists and the French Society of Endocrinology are needed in regard to these potential safety signals.

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

The U.S. Department of Health and Human Services has approved Colorado’s request to require some private insurers in the state to cover gender-affirming care.

The approval means transgender-related care must be included as part of the essential benefits offered on the state’s Affordable Care Act marketplace, which includes private individual and small group insurance plans. The coverage will start Jan. 1, 2023. Colorado is the first state in the United States to require such coverage.

The HHS notes that gender-affirming treatments to be covered include eye and lid modifications, face tightening, facial bone remodeling for facial feminization, breast/chest construction and reductions, and laser hair removal.

“I am proud to stand with Colorado to remove barriers that have historically made it difficult for transgender people to access health coverage and medical care,” said HHS Secretary Xavier Becerra in a statement.

“Colorado’s expansion of their essential health benefits to include gender-affirming surgery and other treatments is a model for other states to follow, and we invite other states to follow suit,” said Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure in the statement.

Medicaid already covers comprehensive transgender care in Colorado.

The LGBTQ+ advocacy group One Colorado estimated that, thanks to the Affordable Care Act, only 5% of the state’s LGBTQ+ community was uninsured in 2019, compared to 10% in 2011.

However, 34% of transgender respondents to a One Colorado poll in 2018 said they had been denied coverage for an LGBTQ-specific medical service, such as gender-affirming care. Sixty-two percent said that a lack of insurance or limited insurance was a barrier to care; 84% said another barrier was the lack of adequately trained mental and behavioral health professionals.
 

Mental health also covered

The Colorado plan requires individual and small group plans to cover an annual 45- to 60-minute mental health wellness exam with a qualified mental health care practitioner. The visit can include behavioral health screening, education and consultation about healthy lifestyle changes, referrals to mental health treatment, and discussion of potential medication options.

The plans also must cover an additional 15 medications as alternatives to opioids and up to six acupuncture visits annually.

“This plan expands access to mental health services for Coloradans while helping those fighting substance abuse to overcome their addiction,” said Governor Jared Polis in a statement.

“This improves care for Coloradans and ensures that even more Coloradans have access to help when they need it,” he said.

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

The U.S. Department of Health and Human Services has approved Colorado’s request to require some private insurers in the state to cover gender-affirming care.

The approval means transgender-related care must be included as part of the essential benefits offered on the state’s Affordable Care Act marketplace, which includes private individual and small group insurance plans. The coverage will start Jan. 1, 2023. Colorado is the first state in the United States to require such coverage.

The HHS notes that gender-affirming treatments to be covered include eye and lid modifications, face tightening, facial bone remodeling for facial feminization, breast/chest construction and reductions, and laser hair removal.

“I am proud to stand with Colorado to remove barriers that have historically made it difficult for transgender people to access health coverage and medical care,” said HHS Secretary Xavier Becerra in a statement.

“Colorado’s expansion of their essential health benefits to include gender-affirming surgery and other treatments is a model for other states to follow, and we invite other states to follow suit,” said Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure in the statement.

Medicaid already covers comprehensive transgender care in Colorado.

The LGBTQ+ advocacy group One Colorado estimated that, thanks to the Affordable Care Act, only 5% of the state’s LGBTQ+ community was uninsured in 2019, compared to 10% in 2011.

However, 34% of transgender respondents to a One Colorado poll in 2018 said they had been denied coverage for an LGBTQ-specific medical service, such as gender-affirming care. Sixty-two percent said that a lack of insurance or limited insurance was a barrier to care; 84% said another barrier was the lack of adequately trained mental and behavioral health professionals.
 

Mental health also covered

The Colorado plan requires individual and small group plans to cover an annual 45- to 60-minute mental health wellness exam with a qualified mental health care practitioner. The visit can include behavioral health screening, education and consultation about healthy lifestyle changes, referrals to mental health treatment, and discussion of potential medication options.

The plans also must cover an additional 15 medications as alternatives to opioids and up to six acupuncture visits annually.

“This plan expands access to mental health services for Coloradans while helping those fighting substance abuse to overcome their addiction,” said Governor Jared Polis in a statement.

“This improves care for Coloradans and ensures that even more Coloradans have access to help when they need it,” he said.

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

The U.S. Department of Health and Human Services has approved Colorado’s request to require some private insurers in the state to cover gender-affirming care.

The approval means transgender-related care must be included as part of the essential benefits offered on the state’s Affordable Care Act marketplace, which includes private individual and small group insurance plans. The coverage will start Jan. 1, 2023. Colorado is the first state in the United States to require such coverage.

The HHS notes that gender-affirming treatments to be covered include eye and lid modifications, face tightening, facial bone remodeling for facial feminization, breast/chest construction and reductions, and laser hair removal.

“I am proud to stand with Colorado to remove barriers that have historically made it difficult for transgender people to access health coverage and medical care,” said HHS Secretary Xavier Becerra in a statement.

“Colorado’s expansion of their essential health benefits to include gender-affirming surgery and other treatments is a model for other states to follow, and we invite other states to follow suit,” said Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure in the statement.

Medicaid already covers comprehensive transgender care in Colorado.

The LGBTQ+ advocacy group One Colorado estimated that, thanks to the Affordable Care Act, only 5% of the state’s LGBTQ+ community was uninsured in 2019, compared to 10% in 2011.

However, 34% of transgender respondents to a One Colorado poll in 2018 said they had been denied coverage for an LGBTQ-specific medical service, such as gender-affirming care. Sixty-two percent said that a lack of insurance or limited insurance was a barrier to care; 84% said another barrier was the lack of adequately trained mental and behavioral health professionals.
 

Mental health also covered

The Colorado plan requires individual and small group plans to cover an annual 45- to 60-minute mental health wellness exam with a qualified mental health care practitioner. The visit can include behavioral health screening, education and consultation about healthy lifestyle changes, referrals to mental health treatment, and discussion of potential medication options.

The plans also must cover an additional 15 medications as alternatives to opioids and up to six acupuncture visits annually.

“This plan expands access to mental health services for Coloradans while helping those fighting substance abuse to overcome their addiction,” said Governor Jared Polis in a statement.

“This improves care for Coloradans and ensures that even more Coloradans have access to help when they need it,” he said.

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