Feature

A 28-year-old pediatrician working in a large group practice in California found a new job in Pennsylvania. The job would allow her to live with her husband, who was a nonphysician.

On her last day of work at the California job, the practice’s office manager asked her, “Do you know about the tail coverage?”

He explained that it is malpractice insurance for any cases filed against her after leaving the job. Without it, he said, she would not be covered for those claims.

The physician (who asked not to be identified) had very little savings and suddenly had to pay a five-figure bill for tail coverage. To provide the extra malpractice coverage, she and her husband had to use savings they’d set aside to buy a house.

Getting tail coverage, known formally as an extended reporting endorsement, often comes as a complete and costly surprise for new doctors, says Dennis Hursh, Esq, a health care attorney based in Middletown, Penn., who deals with physicians’ employment contracts.

“Having to pay for a tail can disrupt lives,” Hursh said. “A tail can cost about one third of a young doctor’s salary. If you don’t feel you can afford to pay that, you may be forced to stay with a job you don’t like.”

Most medical residents don’t think about tail coverage until they apply for their first job, but last year, residents at Hahnemann University Hospital in Philadelphia got a painful early lesson.

In the summer, the hospital went out of business because of financial problems. Hundreds of medical residents and fellows not only were forced to find new programs but also had to prepare to buy tail coverage for their training years at Hahnemann.

“All the guarantees have been yanked out from under us,” said Tom Sibert, MD, a former internal medicine resident at the hospital, who is now finishing his training in California. “Residents don’t have that kind of money.”

Hahnemann trainees have asked the judge in the bankruptcy proceedings to put them ahead of other creditors and to ensure their tail coverage is paid. As of early February, the issue had not been resolved.

Meanwhile, Sibert and many other former trainees were trying to get quotes for purchasing tail coverage. They have been shocked by the amounts they would have to pay.
 

How tail coverage works

Medical malpractice tail coverage protects from incidents that took place when doctors were at their previous jobs but that later resulted in malpractice claims after they had left that employer.

One type of malpractice insurance, an occurrence policy, does not need tail coverage. Occurrence policies cover any incident that occurred when the policy was in force, no matter when a claim was filed – even if it is filed many years after the claims-filing period of the policy ends.

However, most malpractice policies – as many as 85%, according to one estimate – are claims-made policies. Claims-made policies are more much common because they’re significantly less expensive than occurrence policies.

Under a claims-made policy, coverage for malpractice claims completely stops when the policy ends. It does not cover incidents that occurred when the policy was in force but for which the patients later filed claims, as the occurrence policy does. So a tail is needed to cover these claims.

Physicians in all stages of their career may need tail coverage when they leave a job, change malpractice carriers, or retire.

But young physicians often have greater problems with tail coverage, for several reasons. They tend to be employed, and as such, they cannot choose the coverage they want. As a result, they most likely get claims-made coverage. In addition, the job turnover tends to be higher for these doctors. When leaving a job, the tail comes into play. More than half of new physicians leave their first job within 5 years, and of those, more than half leave after only 1 or 2 years.

Young physicians have no experience with tails and may not even know what they are. “In training, malpractice coverage is not a problem because the program handles it,” Mr. Hursh said. Accreditation standards require that teaching hospitals buy coverage, including a tail when residents leave.

So when young physicians are offered their first job and are handed an employment contract to sign, they may not even look for tail coverage, says Mr. Hursh, who wrote The Final Hurdle, a Physician’s Guide to Negotiating a Fair Employment Agreement. Instead, “young physicians tend to focus on issues like salary, benefits, and signing bonuses,” he said.

Mr. Hursh says the tail is usually the most expensive potential cost in the contract.

There’s no easy way to get out of paying the tail coverage once it is enshrined in the contract. The full tail can cost five or even six figures, depending on the physicians’ specialty, the local malpractice premium, and the physician’s own claims history.
 

Can you negotiate your tail coverage?

Negotiating tail coverage in the employment contract involves some familiarity with medical malpractice insurance and a close reading of the contract. First, you have to determine that the employer is providing claims-made coverage, which would require a tail if you leave. Then you have to determine whether the employer will pay for the tail coverage.

Often, the contract does not even mention tail coverage. “It could merely state that the practice will be responsible for malpractice coverage while you are working there,” Mr. Hursh said. Although it never specifies the tail, this language indicates that you will be paying for it, he says.

Therefore, it’s wise to have a conversation with your prospective employer about the tail. “Some new doctors never ask the question ‘What happens if I leave? Do I get tail coverage?’ ” said Israel Teitelbaum, an attorney who is chairman of Contemporary Insurance Services, an insurance broker in Silver Spring, Md.

Talking about the tail, however, can be a touchy subject for many young doctors applying for their first job. The tail matters only if you leave the job, and you may not want to imply that you would ever want to leave. Too much money, however, is on the line for you not to ask, Mr. Teitelbaum said.

Even if the employer verbally agrees to pay for the tail coverage, experts advise that you try to get the employer’s commitment in writing and have it put it into the contract.

Getting the employer to cover the tail in the initial contract is crucial because once you have agreed to work there, “it’s much more difficult to get it changed,” Mr. Teitelbaum said. However, even if tail coverage is not in the first contract, you shouldn’t give up, he says. You should try again in the next contract a few years later.

“It’s never too late to bring it up,” Mr. Teitelbaum said. After a few years of employment, you have a track record at the job. “A doctor who is very desirable to the employer may be able to get tail coverage on contract renewal.”
 

Coverage: Large employers vs. small employers

Willingness to pay for an employee’s tail coverage varies depending on the size of the employer. Large employers – systems, hospitals, and large practices – are much more likely to cover the tail than small and medium-sized practices.

Large employers tend to pay for at least part of the tail because they realize that it is in their interest to do so. Since they have the deepest pockets, they’re often the first to be named in a lawsuit. They might have to pay the whole claim if the physician did not have tail coverage.

However, many large employers want to use tail coverage as a bargaining chip to make sure doctors stay for a while at least. One typical arrangement, Mr. Hursh says, is to pay only one-fifth of the tail if the physician leaves in the first year of employment and then to pay one fifth more in each succeeding year until year five, when the employer assumes the entire cost of the tail.

Smaller practices, on the other hand, are usually close-fisted about tail coverage. “They tend to view the tail as an unnecessary expense,” Mr. Hursh said. “They don’t want to pay for a doctor who is not generating revenue for them any more.”

Traditionally, when physicians become partners, practices are more generous and agree to pay their tails if they leave, Mr. Hursh says. But he thinks this is changing, too – recent partnership contracts he has reviewed did not provide for tail coverage.
 

Times you don’t need to pay for tail coverage

Even if you’re responsible for the tail coverage, your insurance arrangement may be such that you don’t have to pay for it, says Michelle Perron, a malpractice insurance broker in North Hampton, N.H.

For example, if the carrier at your new job is the same as the one at your old job, your coverage would continue with no break, and you would not need a tail, she says. Even if you move to another state, your old carrier might also sell policies there, and you would then likely have seamless coverage, Ms. Perron says. This would be handy if you could choose your new carrier.

Even when you change carriers, Ms. Perron says, the new one might agree to pick up the old carrier’s coverage in return for getting your business, assuming you are an independent physician buying your own coverage. The new carrier would issue prior acts coverage, also known as nose coverage.

Older doctors going into retirement also have a potential tail coverage problem, but their tail coverage premium is often waived, Ms. Perron says. The need for a tail has to do with claims arising post retirement, after your coverage has ended. Typically, if you have been with the carrier for at least 5 years and you are age 55 years or older, your carrier will waive the tail coverage premium, she says.

However, if the retired doctor starts practicing again, even part time, the carrier may want to take back the free tail, she says. Some retired doctors get around this by buying a lower-priced tail from another company, but the former carrier may still want its money back, Ms. Perron says.
 

Can you just go without tail coverage?

What happens if physicians with a tail commitment choose to wing it and not pay for the tail? If a claim was never made against them, they may believe that the expense is unnecessary. The situation, however, is not so simple.

Some states require having tail coverage. Malpractice coverage is required in seven states, and at least some of those states explicitly extend this requirement to tails. They are Colorado, Connecticut, Kansas, Massachusetts, New Jersey, Rhode Island, and Wisconsin. Eleven more states tie malpractice coverage, perhaps including tails, to some benefit for the doctor, such as tort reform. These states include Indiana, Nebraska, New Mexico, New York, and Pennsylvania.

Many hospitals require tail coverage for privileges, and some insurers do as well. In addition, Ms. Perron says a missing tail reduces your prospects when looking for a job. “For the employer, having to pay coverage for a new hire will cost more than starting fresh with someone else,” she said.

Still, it’s important to remember the risk of being sued. “If you don’t buy the tail coverage, you are at risk for a lawsuit for many years to come,” Mr. Teitelbaum said.

Doctors should consider their potential lifetime risk, not just their current risk. Although only 8% of doctors younger than age 40 have been sued for malpractice, that figure climbs to almost half by the time doctors reach age 55.

The risks are higher in some specialties. About 63% of general surgeons and ob.gyns. have been sued.

Many of these claims are without merit, and doctors pay only the legal expenses of defending the case. Some doctors may think they could risk frivolous suits and cover legal expenses out of pocket. An American Medical Association survey showed that 68% of closed claims against doctors were dropped, dismissed, or withdrawn. It said these claims cost an average of more than $30,000 to defend.

However, Mr. Teitelbaum puts the defense costs for so-called frivolous suits much higher than the AMA, at $250,000 or more. “Even if you’re sure you won’t have to pay a claim, you still have to defend yourself against frivolous suits,” he said. “You won’t recover those expenses.”
 

How to lower your tail coverage cost

Physicians typically have 60 days to buy tail coverage after their regular coverage has ended. Specialized brokers such as Mr. Teitelbaum and Ms. Perron help physicians look for the best tails to buy.

The cost of the tail depends on how long you’ve been at your job when you leave it, Ms. Perron says. If you leave in the first 1 or 2 years of the policy, she says, the tail price will be lower because the coverage period is shorter.

Usually the most expensive tail available is from the carrier that issued the original policy. Why is this? “Carriers rarely sell a tail that undercuts their retail price,” Mr. Teitelbaum said. “They don’t want to compete with themselves, and in fact doing so could pose regulatory problems for them.”

Instead of buying from their own carrier, doctors can purchase stand-alone tails from competitors, which Mr. Teitelbaum says are 10%-30% less expensive than the policy the original carrier issues. However, stand-alone tails are not always easy to find, especially for high-cost specialties such as neurosurgery and ob.gyn., he says.

Some physicians try to bring down the cost of the tail by limiting the duration of the tail. You can buy tails that only cover claims filed 1-5 years after the incident took place, rather than indefinitely. These limits mirror the typical statute of limitations – the time limit to file a claim in each state. This limit is as little as 2 years in some states, though it can be as long as 6 years in others.

However, some states make exceptions to the statute of limitations. The 2- to 6-year clock doesn’t start ticking until the mistake is discovered or, in the case of children, when they reach adulthood. “This means that with a limited tail, you always have risk,” Perron said.

And yet some doctors insist on these time-limited tails. “If a doctor opts for 3 years’ coverage, that’s better than no years,” Mr. Teitelbaum said. “But I would advise them to take at least 5 years because that gives you coverage for the basic statute of limitations in most states. Three-year tails do yield savings, but often they’re not enough to warrant the risk.”

Another way to reduce costs is to lower the coverage limits of the tail. The standard coverage limit is $1 million per case and $3 million per year, so doctors might be able to save money on the premium by buying limits of $200,000/$600,000. But Mr. Teitelbaum says most companies would refuse to sell a policy with a limit lower than that of the expiring policy.

Further ways to reduce the cost of the tail include buying tail coverage that doesn’t give the physician the right to approve a settlement or that doesn’t include legal fees in the coverage limits. But these options, too, raise the physician’s risks. Whichever option you choose, the important thing is to protect yourself against costly lawsuits.
 

This article first appeared on Medscape.com.

A 28-year-old pediatrician working in a large group practice in California found a new job in Pennsylvania. The job would allow her to live with her husband, who was a nonphysician.

On her last day of work at the California job, the practice’s office manager asked her, “Do you know about the tail coverage?”

He explained that it is malpractice insurance for any cases filed against her after leaving the job. Without it, he said, she would not be covered for those claims.

The physician (who asked not to be identified) had very little savings and suddenly had to pay a five-figure bill for tail coverage. To provide the extra malpractice coverage, she and her husband had to use savings they’d set aside to buy a house.

Getting tail coverage, known formally as an extended reporting endorsement, often comes as a complete and costly surprise for new doctors, says Dennis Hursh, Esq, a health care attorney based in Middletown, Penn., who deals with physicians’ employment contracts.

“Having to pay for a tail can disrupt lives,” Hursh said. “A tail can cost about one third of a young doctor’s salary. If you don’t feel you can afford to pay that, you may be forced to stay with a job you don’t like.”

Most medical residents don’t think about tail coverage until they apply for their first job, but last year, residents at Hahnemann University Hospital in Philadelphia got a painful early lesson.

In the summer, the hospital went out of business because of financial problems. Hundreds of medical residents and fellows not only were forced to find new programs but also had to prepare to buy tail coverage for their training years at Hahnemann.

“All the guarantees have been yanked out from under us,” said Tom Sibert, MD, a former internal medicine resident at the hospital, who is now finishing his training in California. “Residents don’t have that kind of money.”

Hahnemann trainees have asked the judge in the bankruptcy proceedings to put them ahead of other creditors and to ensure their tail coverage is paid. As of early February, the issue had not been resolved.

Meanwhile, Sibert and many other former trainees were trying to get quotes for purchasing tail coverage. They have been shocked by the amounts they would have to pay.
 

How tail coverage works

Medical malpractice tail coverage protects from incidents that took place when doctors were at their previous jobs but that later resulted in malpractice claims after they had left that employer.

One type of malpractice insurance, an occurrence policy, does not need tail coverage. Occurrence policies cover any incident that occurred when the policy was in force, no matter when a claim was filed – even if it is filed many years after the claims-filing period of the policy ends.

However, most malpractice policies – as many as 85%, according to one estimate – are claims-made policies. Claims-made policies are more much common because they’re significantly less expensive than occurrence policies.

Under a claims-made policy, coverage for malpractice claims completely stops when the policy ends. It does not cover incidents that occurred when the policy was in force but for which the patients later filed claims, as the occurrence policy does. So a tail is needed to cover these claims.

Physicians in all stages of their career may need tail coverage when they leave a job, change malpractice carriers, or retire.

But young physicians often have greater problems with tail coverage, for several reasons. They tend to be employed, and as such, they cannot choose the coverage they want. As a result, they most likely get claims-made coverage. In addition, the job turnover tends to be higher for these doctors. When leaving a job, the tail comes into play. More than half of new physicians leave their first job within 5 years, and of those, more than half leave after only 1 or 2 years.

Young physicians have no experience with tails and may not even know what they are. “In training, malpractice coverage is not a problem because the program handles it,” Mr. Hursh said. Accreditation standards require that teaching hospitals buy coverage, including a tail when residents leave.

So when young physicians are offered their first job and are handed an employment contract to sign, they may not even look for tail coverage, says Mr. Hursh, who wrote The Final Hurdle, a Physician’s Guide to Negotiating a Fair Employment Agreement. Instead, “young physicians tend to focus on issues like salary, benefits, and signing bonuses,” he said.

Mr. Hursh says the tail is usually the most expensive potential cost in the contract.

There’s no easy way to get out of paying the tail coverage once it is enshrined in the contract. The full tail can cost five or even six figures, depending on the physicians’ specialty, the local malpractice premium, and the physician’s own claims history.
 

Can you negotiate your tail coverage?

Negotiating tail coverage in the employment contract involves some familiarity with medical malpractice insurance and a close reading of the contract. First, you have to determine that the employer is providing claims-made coverage, which would require a tail if you leave. Then you have to determine whether the employer will pay for the tail coverage.

Often, the contract does not even mention tail coverage. “It could merely state that the practice will be responsible for malpractice coverage while you are working there,” Mr. Hursh said. Although it never specifies the tail, this language indicates that you will be paying for it, he says.

Therefore, it’s wise to have a conversation with your prospective employer about the tail. “Some new doctors never ask the question ‘What happens if I leave? Do I get tail coverage?’ ” said Israel Teitelbaum, an attorney who is chairman of Contemporary Insurance Services, an insurance broker in Silver Spring, Md.

Talking about the tail, however, can be a touchy subject for many young doctors applying for their first job. The tail matters only if you leave the job, and you may not want to imply that you would ever want to leave. Too much money, however, is on the line for you not to ask, Mr. Teitelbaum said.

Even if the employer verbally agrees to pay for the tail coverage, experts advise that you try to get the employer’s commitment in writing and have it put it into the contract.

Getting the employer to cover the tail in the initial contract is crucial because once you have agreed to work there, “it’s much more difficult to get it changed,” Mr. Teitelbaum said. However, even if tail coverage is not in the first contract, you shouldn’t give up, he says. You should try again in the next contract a few years later.

“It’s never too late to bring it up,” Mr. Teitelbaum said. After a few years of employment, you have a track record at the job. “A doctor who is very desirable to the employer may be able to get tail coverage on contract renewal.”
 

Coverage: Large employers vs. small employers

Willingness to pay for an employee’s tail coverage varies depending on the size of the employer. Large employers – systems, hospitals, and large practices – are much more likely to cover the tail than small and medium-sized practices.

Large employers tend to pay for at least part of the tail because they realize that it is in their interest to do so. Since they have the deepest pockets, they’re often the first to be named in a lawsuit. They might have to pay the whole claim if the physician did not have tail coverage.

However, many large employers want to use tail coverage as a bargaining chip to make sure doctors stay for a while at least. One typical arrangement, Mr. Hursh says, is to pay only one-fifth of the tail if the physician leaves in the first year of employment and then to pay one fifth more in each succeeding year until year five, when the employer assumes the entire cost of the tail.

Smaller practices, on the other hand, are usually close-fisted about tail coverage. “They tend to view the tail as an unnecessary expense,” Mr. Hursh said. “They don’t want to pay for a doctor who is not generating revenue for them any more.”

Traditionally, when physicians become partners, practices are more generous and agree to pay their tails if they leave, Mr. Hursh says. But he thinks this is changing, too – recent partnership contracts he has reviewed did not provide for tail coverage.
 

Times you don’t need to pay for tail coverage

Even if you’re responsible for the tail coverage, your insurance arrangement may be such that you don’t have to pay for it, says Michelle Perron, a malpractice insurance broker in North Hampton, N.H.

For example, if the carrier at your new job is the same as the one at your old job, your coverage would continue with no break, and you would not need a tail, she says. Even if you move to another state, your old carrier might also sell policies there, and you would then likely have seamless coverage, Ms. Perron says. This would be handy if you could choose your new carrier.

Even when you change carriers, Ms. Perron says, the new one might agree to pick up the old carrier’s coverage in return for getting your business, assuming you are an independent physician buying your own coverage. The new carrier would issue prior acts coverage, also known as nose coverage.

Older doctors going into retirement also have a potential tail coverage problem, but their tail coverage premium is often waived, Ms. Perron says. The need for a tail has to do with claims arising post retirement, after your coverage has ended. Typically, if you have been with the carrier for at least 5 years and you are age 55 years or older, your carrier will waive the tail coverage premium, she says.

However, if the retired doctor starts practicing again, even part time, the carrier may want to take back the free tail, she says. Some retired doctors get around this by buying a lower-priced tail from another company, but the former carrier may still want its money back, Ms. Perron says.
 

Can you just go without tail coverage?

What happens if physicians with a tail commitment choose to wing it and not pay for the tail? If a claim was never made against them, they may believe that the expense is unnecessary. The situation, however, is not so simple.

Some states require having tail coverage. Malpractice coverage is required in seven states, and at least some of those states explicitly extend this requirement to tails. They are Colorado, Connecticut, Kansas, Massachusetts, New Jersey, Rhode Island, and Wisconsin. Eleven more states tie malpractice coverage, perhaps including tails, to some benefit for the doctor, such as tort reform. These states include Indiana, Nebraska, New Mexico, New York, and Pennsylvania.

Many hospitals require tail coverage for privileges, and some insurers do as well. In addition, Ms. Perron says a missing tail reduces your prospects when looking for a job. “For the employer, having to pay coverage for a new hire will cost more than starting fresh with someone else,” she said.

Still, it’s important to remember the risk of being sued. “If you don’t buy the tail coverage, you are at risk for a lawsuit for many years to come,” Mr. Teitelbaum said.

Doctors should consider their potential lifetime risk, not just their current risk. Although only 8% of doctors younger than age 40 have been sued for malpractice, that figure climbs to almost half by the time doctors reach age 55.

The risks are higher in some specialties. About 63% of general surgeons and ob.gyns. have been sued.

Many of these claims are without merit, and doctors pay only the legal expenses of defending the case. Some doctors may think they could risk frivolous suits and cover legal expenses out of pocket. An American Medical Association survey showed that 68% of closed claims against doctors were dropped, dismissed, or withdrawn. It said these claims cost an average of more than $30,000 to defend.

However, Mr. Teitelbaum puts the defense costs for so-called frivolous suits much higher than the AMA, at $250,000 or more. “Even if you’re sure you won’t have to pay a claim, you still have to defend yourself against frivolous suits,” he said. “You won’t recover those expenses.”
 

How to lower your tail coverage cost

Physicians typically have 60 days to buy tail coverage after their regular coverage has ended. Specialized brokers such as Mr. Teitelbaum and Ms. Perron help physicians look for the best tails to buy.

The cost of the tail depends on how long you’ve been at your job when you leave it, Ms. Perron says. If you leave in the first 1 or 2 years of the policy, she says, the tail price will be lower because the coverage period is shorter.

Usually the most expensive tail available is from the carrier that issued the original policy. Why is this? “Carriers rarely sell a tail that undercuts their retail price,” Mr. Teitelbaum said. “They don’t want to compete with themselves, and in fact doing so could pose regulatory problems for them.”

Instead of buying from their own carrier, doctors can purchase stand-alone tails from competitors, which Mr. Teitelbaum says are 10%-30% less expensive than the policy the original carrier issues. However, stand-alone tails are not always easy to find, especially for high-cost specialties such as neurosurgery and ob.gyn., he says.

Some physicians try to bring down the cost of the tail by limiting the duration of the tail. You can buy tails that only cover claims filed 1-5 years after the incident took place, rather than indefinitely. These limits mirror the typical statute of limitations – the time limit to file a claim in each state. This limit is as little as 2 years in some states, though it can be as long as 6 years in others.

However, some states make exceptions to the statute of limitations. The 2- to 6-year clock doesn’t start ticking until the mistake is discovered or, in the case of children, when they reach adulthood. “This means that with a limited tail, you always have risk,” Perron said.

And yet some doctors insist on these time-limited tails. “If a doctor opts for 3 years’ coverage, that’s better than no years,” Mr. Teitelbaum said. “But I would advise them to take at least 5 years because that gives you coverage for the basic statute of limitations in most states. Three-year tails do yield savings, but often they’re not enough to warrant the risk.”

Another way to reduce costs is to lower the coverage limits of the tail. The standard coverage limit is $1 million per case and $3 million per year, so doctors might be able to save money on the premium by buying limits of $200,000/$600,000. But Mr. Teitelbaum says most companies would refuse to sell a policy with a limit lower than that of the expiring policy.

Further ways to reduce the cost of the tail include buying tail coverage that doesn’t give the physician the right to approve a settlement or that doesn’t include legal fees in the coverage limits. But these options, too, raise the physician’s risks. Whichever option you choose, the important thing is to protect yourself against costly lawsuits.
 

This article first appeared on Medscape.com.

A 28-year-old pediatrician working in a large group practice in California found a new job in Pennsylvania. The job would allow her to live with her husband, who was a nonphysician.

On her last day of work at the California job, the practice’s office manager asked her, “Do you know about the tail coverage?”

He explained that it is malpractice insurance for any cases filed against her after leaving the job. Without it, he said, she would not be covered for those claims.

The physician (who asked not to be identified) had very little savings and suddenly had to pay a five-figure bill for tail coverage. To provide the extra malpractice coverage, she and her husband had to use savings they’d set aside to buy a house.

Getting tail coverage, known formally as an extended reporting endorsement, often comes as a complete and costly surprise for new doctors, says Dennis Hursh, Esq, a health care attorney based in Middletown, Penn., who deals with physicians’ employment contracts.

“Having to pay for a tail can disrupt lives,” Hursh said. “A tail can cost about one third of a young doctor’s salary. If you don’t feel you can afford to pay that, you may be forced to stay with a job you don’t like.”

Most medical residents don’t think about tail coverage until they apply for their first job, but last year, residents at Hahnemann University Hospital in Philadelphia got a painful early lesson.

In the summer, the hospital went out of business because of financial problems. Hundreds of medical residents and fellows not only were forced to find new programs but also had to prepare to buy tail coverage for their training years at Hahnemann.

“All the guarantees have been yanked out from under us,” said Tom Sibert, MD, a former internal medicine resident at the hospital, who is now finishing his training in California. “Residents don’t have that kind of money.”

Hahnemann trainees have asked the judge in the bankruptcy proceedings to put them ahead of other creditors and to ensure their tail coverage is paid. As of early February, the issue had not been resolved.

Meanwhile, Sibert and many other former trainees were trying to get quotes for purchasing tail coverage. They have been shocked by the amounts they would have to pay.
 

How tail coverage works

Medical malpractice tail coverage protects from incidents that took place when doctors were at their previous jobs but that later resulted in malpractice claims after they had left that employer.

One type of malpractice insurance, an occurrence policy, does not need tail coverage. Occurrence policies cover any incident that occurred when the policy was in force, no matter when a claim was filed – even if it is filed many years after the claims-filing period of the policy ends.

However, most malpractice policies – as many as 85%, according to one estimate – are claims-made policies. Claims-made policies are more much common because they’re significantly less expensive than occurrence policies.

Under a claims-made policy, coverage for malpractice claims completely stops when the policy ends. It does not cover incidents that occurred when the policy was in force but for which the patients later filed claims, as the occurrence policy does. So a tail is needed to cover these claims.

Physicians in all stages of their career may need tail coverage when they leave a job, change malpractice carriers, or retire.

But young physicians often have greater problems with tail coverage, for several reasons. They tend to be employed, and as such, they cannot choose the coverage they want. As a result, they most likely get claims-made coverage. In addition, the job turnover tends to be higher for these doctors. When leaving a job, the tail comes into play. More than half of new physicians leave their first job within 5 years, and of those, more than half leave after only 1 or 2 years.

Young physicians have no experience with tails and may not even know what they are. “In training, malpractice coverage is not a problem because the program handles it,” Mr. Hursh said. Accreditation standards require that teaching hospitals buy coverage, including a tail when residents leave.

So when young physicians are offered their first job and are handed an employment contract to sign, they may not even look for tail coverage, says Mr. Hursh, who wrote The Final Hurdle, a Physician’s Guide to Negotiating a Fair Employment Agreement. Instead, “young physicians tend to focus on issues like salary, benefits, and signing bonuses,” he said.

Mr. Hursh says the tail is usually the most expensive potential cost in the contract.

There’s no easy way to get out of paying the tail coverage once it is enshrined in the contract. The full tail can cost five or even six figures, depending on the physicians’ specialty, the local malpractice premium, and the physician’s own claims history.
 

Can you negotiate your tail coverage?

Negotiating tail coverage in the employment contract involves some familiarity with medical malpractice insurance and a close reading of the contract. First, you have to determine that the employer is providing claims-made coverage, which would require a tail if you leave. Then you have to determine whether the employer will pay for the tail coverage.

Often, the contract does not even mention tail coverage. “It could merely state that the practice will be responsible for malpractice coverage while you are working there,” Mr. Hursh said. Although it never specifies the tail, this language indicates that you will be paying for it, he says.

Therefore, it’s wise to have a conversation with your prospective employer about the tail. “Some new doctors never ask the question ‘What happens if I leave? Do I get tail coverage?’ ” said Israel Teitelbaum, an attorney who is chairman of Contemporary Insurance Services, an insurance broker in Silver Spring, Md.

Talking about the tail, however, can be a touchy subject for many young doctors applying for their first job. The tail matters only if you leave the job, and you may not want to imply that you would ever want to leave. Too much money, however, is on the line for you not to ask, Mr. Teitelbaum said.

Even if the employer verbally agrees to pay for the tail coverage, experts advise that you try to get the employer’s commitment in writing and have it put it into the contract.

Getting the employer to cover the tail in the initial contract is crucial because once you have agreed to work there, “it’s much more difficult to get it changed,” Mr. Teitelbaum said. However, even if tail coverage is not in the first contract, you shouldn’t give up, he says. You should try again in the next contract a few years later.

“It’s never too late to bring it up,” Mr. Teitelbaum said. After a few years of employment, you have a track record at the job. “A doctor who is very desirable to the employer may be able to get tail coverage on contract renewal.”
 

Coverage: Large employers vs. small employers

Willingness to pay for an employee’s tail coverage varies depending on the size of the employer. Large employers – systems, hospitals, and large practices – are much more likely to cover the tail than small and medium-sized practices.

Large employers tend to pay for at least part of the tail because they realize that it is in their interest to do so. Since they have the deepest pockets, they’re often the first to be named in a lawsuit. They might have to pay the whole claim if the physician did not have tail coverage.

However, many large employers want to use tail coverage as a bargaining chip to make sure doctors stay for a while at least. One typical arrangement, Mr. Hursh says, is to pay only one-fifth of the tail if the physician leaves in the first year of employment and then to pay one fifth more in each succeeding year until year five, when the employer assumes the entire cost of the tail.

Smaller practices, on the other hand, are usually close-fisted about tail coverage. “They tend to view the tail as an unnecessary expense,” Mr. Hursh said. “They don’t want to pay for a doctor who is not generating revenue for them any more.”

Traditionally, when physicians become partners, practices are more generous and agree to pay their tails if they leave, Mr. Hursh says. But he thinks this is changing, too – recent partnership contracts he has reviewed did not provide for tail coverage.
 

Times you don’t need to pay for tail coverage

Even if you’re responsible for the tail coverage, your insurance arrangement may be such that you don’t have to pay for it, says Michelle Perron, a malpractice insurance broker in North Hampton, N.H.

For example, if the carrier at your new job is the same as the one at your old job, your coverage would continue with no break, and you would not need a tail, she says. Even if you move to another state, your old carrier might also sell policies there, and you would then likely have seamless coverage, Ms. Perron says. This would be handy if you could choose your new carrier.

Even when you change carriers, Ms. Perron says, the new one might agree to pick up the old carrier’s coverage in return for getting your business, assuming you are an independent physician buying your own coverage. The new carrier would issue prior acts coverage, also known as nose coverage.

Older doctors going into retirement also have a potential tail coverage problem, but their tail coverage premium is often waived, Ms. Perron says. The need for a tail has to do with claims arising post retirement, after your coverage has ended. Typically, if you have been with the carrier for at least 5 years and you are age 55 years or older, your carrier will waive the tail coverage premium, she says.

However, if the retired doctor starts practicing again, even part time, the carrier may want to take back the free tail, she says. Some retired doctors get around this by buying a lower-priced tail from another company, but the former carrier may still want its money back, Ms. Perron says.
 

Can you just go without tail coverage?

What happens if physicians with a tail commitment choose to wing it and not pay for the tail? If a claim was never made against them, they may believe that the expense is unnecessary. The situation, however, is not so simple.

Some states require having tail coverage. Malpractice coverage is required in seven states, and at least some of those states explicitly extend this requirement to tails. They are Colorado, Connecticut, Kansas, Massachusetts, New Jersey, Rhode Island, and Wisconsin. Eleven more states tie malpractice coverage, perhaps including tails, to some benefit for the doctor, such as tort reform. These states include Indiana, Nebraska, New Mexico, New York, and Pennsylvania.

Many hospitals require tail coverage for privileges, and some insurers do as well. In addition, Ms. Perron says a missing tail reduces your prospects when looking for a job. “For the employer, having to pay coverage for a new hire will cost more than starting fresh with someone else,” she said.

Still, it’s important to remember the risk of being sued. “If you don’t buy the tail coverage, you are at risk for a lawsuit for many years to come,” Mr. Teitelbaum said.

Doctors should consider their potential lifetime risk, not just their current risk. Although only 8% of doctors younger than age 40 have been sued for malpractice, that figure climbs to almost half by the time doctors reach age 55.

The risks are higher in some specialties. About 63% of general surgeons and ob.gyns. have been sued.

Many of these claims are without merit, and doctors pay only the legal expenses of defending the case. Some doctors may think they could risk frivolous suits and cover legal expenses out of pocket. An American Medical Association survey showed that 68% of closed claims against doctors were dropped, dismissed, or withdrawn. It said these claims cost an average of more than $30,000 to defend.

However, Mr. Teitelbaum puts the defense costs for so-called frivolous suits much higher than the AMA, at $250,000 or more. “Even if you’re sure you won’t have to pay a claim, you still have to defend yourself against frivolous suits,” he said. “You won’t recover those expenses.”
 

How to lower your tail coverage cost

Physicians typically have 60 days to buy tail coverage after their regular coverage has ended. Specialized brokers such as Mr. Teitelbaum and Ms. Perron help physicians look for the best tails to buy.

The cost of the tail depends on how long you’ve been at your job when you leave it, Ms. Perron says. If you leave in the first 1 or 2 years of the policy, she says, the tail price will be lower because the coverage period is shorter.

Usually the most expensive tail available is from the carrier that issued the original policy. Why is this? “Carriers rarely sell a tail that undercuts their retail price,” Mr. Teitelbaum said. “They don’t want to compete with themselves, and in fact doing so could pose regulatory problems for them.”

Instead of buying from their own carrier, doctors can purchase stand-alone tails from competitors, which Mr. Teitelbaum says are 10%-30% less expensive than the policy the original carrier issues. However, stand-alone tails are not always easy to find, especially for high-cost specialties such as neurosurgery and ob.gyn., he says.

Some physicians try to bring down the cost of the tail by limiting the duration of the tail. You can buy tails that only cover claims filed 1-5 years after the incident took place, rather than indefinitely. These limits mirror the typical statute of limitations – the time limit to file a claim in each state. This limit is as little as 2 years in some states, though it can be as long as 6 years in others.

However, some states make exceptions to the statute of limitations. The 2- to 6-year clock doesn’t start ticking until the mistake is discovered or, in the case of children, when they reach adulthood. “This means that with a limited tail, you always have risk,” Perron said.

And yet some doctors insist on these time-limited tails. “If a doctor opts for 3 years’ coverage, that’s better than no years,” Mr. Teitelbaum said. “But I would advise them to take at least 5 years because that gives you coverage for the basic statute of limitations in most states. Three-year tails do yield savings, but often they’re not enough to warrant the risk.”

Another way to reduce costs is to lower the coverage limits of the tail. The standard coverage limit is $1 million per case and $3 million per year, so doctors might be able to save money on the premium by buying limits of $200,000/$600,000. But Mr. Teitelbaum says most companies would refuse to sell a policy with a limit lower than that of the expiring policy.

Further ways to reduce the cost of the tail include buying tail coverage that doesn’t give the physician the right to approve a settlement or that doesn’t include legal fees in the coverage limits. But these options, too, raise the physician’s risks. Whichever option you choose, the important thing is to protect yourself against costly lawsuits.
 

This article first appeared on Medscape.com.

The Centers for Medicare & Medicaid Services’ latest maneuver to combat rising drug prices is the proposed addition of a second specialty drug tier for the Medicare Part D prescription drug benefit.

The proposal is part of a broader proposed update to Medicare Parts C and D for contract years 2021 and 2022.

Gurzzza/Thinkstock

The Centers for Medicare & Medicaid Services’ latest maneuver to combat rising drug prices is the proposed addition of a second specialty drug tier for the Medicare Part D prescription drug benefit.

The proposal is part of a broader proposed update to Medicare Parts C and D for contract years 2021 and 2022.

Gurzzza/Thinkstock

The Centers for Medicare & Medicaid Services’ latest maneuver to combat rising drug prices is the proposed addition of a second specialty drug tier for the Medicare Part D prescription drug benefit.

The proposal is part of a broader proposed update to Medicare Parts C and D for contract years 2021 and 2022.

Gurzzza/Thinkstock

Despite national legislation that raised the minimum age of sale for tobacco to 21 in the United States, policies to curb tobacco use fell short in 2019, according to a report on federal and state policies.

istockphoto.com

In its annual “State of Tobacco Control” report, the American Lung Association called out the federal government for issuing “inadequate guidance on flavored e-cigarettes that leaves thousands of flavored e-cigarettes on the market.” The organization urged Congress and the Food and Drug Administration “to eliminate all flavored tobacco products from the marketplace, including menthol cigarettes, flavored cigars, and e-cigarettes,” in 2020.

“Flavored tobacco products cause kids to become hooked, and now more than one in four teens (27.5%) are vaping, a staggering 135% increase over the past 2 years,” the association wrote in a news release. Federal guidance on Jan. 2, 2020, permits the sale of flavored e-cigarettes that do not use cartridges. This guidance represented a reversal after officials said in a prior announcement that regulators would “clear the market” of flavored e-cigarettes.

Graphic warning labels

The report also asked the FDA to reject product marketing applications that fail to meet public health standards, calls on the U.S. Department of Health & Human Services to “clarify and ensure that all tobacco users have access to a comprehensive tobacco cessation benefit,” and urges Congress to increase federal funding for the Centers for Disease Control and Prevention’s Office on Smoking and Health to help stop youth e-cigarette use.

“Raising the federal minimum age of sale to 21, which took effect immediately on Dec. 30, was an important first step forward,” the report says. “The American Lung Association successfully advocated for the legislation to be comprehensive and to close state exemptions, such as for military personnel, while also not limiting states from pursuing stronger protections. Additional rules from FDA to provide guidance on the law’s implementation are forthcoming.”

The FDA is expected to release graphic warning labels for cigarette packs in March. After legal setbacks to the Tobacco Control Act of 2009, which required the FDA to ensure all cigarette packs had graphic warning labels by 2011, a judgment “compels FDA to release final graphic warnings by March 15, 2020, with the warning labels appearing on all cigarette packs by June of 2021,” the American Lung Association report said.

“While the American Lung Association recognizes the federal government with an A grade for passage of a strong federal Tobacco 21 law [raising the minimum age of purchase], it also earns an F for its failure to comprehensively oversee tobacco products,” said Harold P. Wimmer, national president and CEO of the American Lung Association, in the news release. “Without meaningful actions by the federal government, the health and the future of our nation’s children are being compromised.”

The federal government received an F for its tobacco tax policies, a D for cessation coverage, and an A for its mass media campaigns, “Tips from Former Smokers” and “The Real Cost.”

Grading states

In addition, the report graded each state and the District of Columbia in terms of funding for tobacco prevention programs, strength of smoke-free workplace laws, level of state tobacco taxes, and coverage of and access to services to quit tobacco. None scored all A’s, but California, the District of Columbia, Maine, New York, and Vermont ranked the highest. Alabama, Mississippi, and North Carolina, on the other hand, received all F’s.

In November, Massachusetts became the first state to prohibit the sale of flavored tobacco products, including menthol cigarettes, and more states should follow suit, according to the association.

jremaly@mdedge.com

Despite national legislation that raised the minimum age of sale for tobacco to 21 in the United States, policies to curb tobacco use fell short in 2019, according to a report on federal and state policies.

istockphoto.com

In its annual “State of Tobacco Control” report, the American Lung Association called out the federal government for issuing “inadequate guidance on flavored e-cigarettes that leaves thousands of flavored e-cigarettes on the market.” The organization urged Congress and the Food and Drug Administration “to eliminate all flavored tobacco products from the marketplace, including menthol cigarettes, flavored cigars, and e-cigarettes,” in 2020.

“Flavored tobacco products cause kids to become hooked, and now more than one in four teens (27.5%) are vaping, a staggering 135% increase over the past 2 years,” the association wrote in a news release. Federal guidance on Jan. 2, 2020, permits the sale of flavored e-cigarettes that do not use cartridges. This guidance represented a reversal after officials said in a prior announcement that regulators would “clear the market” of flavored e-cigarettes.

Graphic warning labels

The report also asked the FDA to reject product marketing applications that fail to meet public health standards, calls on the U.S. Department of Health & Human Services to “clarify and ensure that all tobacco users have access to a comprehensive tobacco cessation benefit,” and urges Congress to increase federal funding for the Centers for Disease Control and Prevention’s Office on Smoking and Health to help stop youth e-cigarette use.

“Raising the federal minimum age of sale to 21, which took effect immediately on Dec. 30, was an important first step forward,” the report says. “The American Lung Association successfully advocated for the legislation to be comprehensive and to close state exemptions, such as for military personnel, while also not limiting states from pursuing stronger protections. Additional rules from FDA to provide guidance on the law’s implementation are forthcoming.”

The FDA is expected to release graphic warning labels for cigarette packs in March. After legal setbacks to the Tobacco Control Act of 2009, which required the FDA to ensure all cigarette packs had graphic warning labels by 2011, a judgment “compels FDA to release final graphic warnings by March 15, 2020, with the warning labels appearing on all cigarette packs by June of 2021,” the American Lung Association report said.

“While the American Lung Association recognizes the federal government with an A grade for passage of a strong federal Tobacco 21 law [raising the minimum age of purchase], it also earns an F for its failure to comprehensively oversee tobacco products,” said Harold P. Wimmer, national president and CEO of the American Lung Association, in the news release. “Without meaningful actions by the federal government, the health and the future of our nation’s children are being compromised.”

The federal government received an F for its tobacco tax policies, a D for cessation coverage, and an A for its mass media campaigns, “Tips from Former Smokers” and “The Real Cost.”

Grading states

In addition, the report graded each state and the District of Columbia in terms of funding for tobacco prevention programs, strength of smoke-free workplace laws, level of state tobacco taxes, and coverage of and access to services to quit tobacco. None scored all A’s, but California, the District of Columbia, Maine, New York, and Vermont ranked the highest. Alabama, Mississippi, and North Carolina, on the other hand, received all F’s.

In November, Massachusetts became the first state to prohibit the sale of flavored tobacco products, including menthol cigarettes, and more states should follow suit, according to the association.

jremaly@mdedge.com

Despite national legislation that raised the minimum age of sale for tobacco to 21 in the United States, policies to curb tobacco use fell short in 2019, according to a report on federal and state policies.

istockphoto.com

In its annual “State of Tobacco Control” report, the American Lung Association called out the federal government for issuing “inadequate guidance on flavored e-cigarettes that leaves thousands of flavored e-cigarettes on the market.” The organization urged Congress and the Food and Drug Administration “to eliminate all flavored tobacco products from the marketplace, including menthol cigarettes, flavored cigars, and e-cigarettes,” in 2020.

“Flavored tobacco products cause kids to become hooked, and now more than one in four teens (27.5%) are vaping, a staggering 135% increase over the past 2 years,” the association wrote in a news release. Federal guidance on Jan. 2, 2020, permits the sale of flavored e-cigarettes that do not use cartridges. This guidance represented a reversal after officials said in a prior announcement that regulators would “clear the market” of flavored e-cigarettes.

Graphic warning labels

The report also asked the FDA to reject product marketing applications that fail to meet public health standards, calls on the U.S. Department of Health & Human Services to “clarify and ensure that all tobacco users have access to a comprehensive tobacco cessation benefit,” and urges Congress to increase federal funding for the Centers for Disease Control and Prevention’s Office on Smoking and Health to help stop youth e-cigarette use.

“Raising the federal minimum age of sale to 21, which took effect immediately on Dec. 30, was an important first step forward,” the report says. “The American Lung Association successfully advocated for the legislation to be comprehensive and to close state exemptions, such as for military personnel, while also not limiting states from pursuing stronger protections. Additional rules from FDA to provide guidance on the law’s implementation are forthcoming.”

The FDA is expected to release graphic warning labels for cigarette packs in March. After legal setbacks to the Tobacco Control Act of 2009, which required the FDA to ensure all cigarette packs had graphic warning labels by 2011, a judgment “compels FDA to release final graphic warnings by March 15, 2020, with the warning labels appearing on all cigarette packs by June of 2021,” the American Lung Association report said.

“While the American Lung Association recognizes the federal government with an A grade for passage of a strong federal Tobacco 21 law [raising the minimum age of purchase], it also earns an F for its failure to comprehensively oversee tobacco products,” said Harold P. Wimmer, national president and CEO of the American Lung Association, in the news release. “Without meaningful actions by the federal government, the health and the future of our nation’s children are being compromised.”

The federal government received an F for its tobacco tax policies, a D for cessation coverage, and an A for its mass media campaigns, “Tips from Former Smokers” and “The Real Cost.”

Grading states

In addition, the report graded each state and the District of Columbia in terms of funding for tobacco prevention programs, strength of smoke-free workplace laws, level of state tobacco taxes, and coverage of and access to services to quit tobacco. None scored all A’s, but California, the District of Columbia, Maine, New York, and Vermont ranked the highest. Alabama, Mississippi, and North Carolina, on the other hand, received all F’s.

In November, Massachusetts became the first state to prohibit the sale of flavored tobacco products, including menthol cigarettes, and more states should follow suit, according to the association.

jremaly@mdedge.com

When it comes to state funding for tobacco prevention and cessation, the American Lung Association grades on a curve. It did not help.

The ALA gave failing grades to 43 states in its new State of Tobacco Control report, along with three A’s, one C, and four D’s, despite a grading formula that passed anything better than a 50%.

Each state’s annual funding for tobacco prevention and cessation was calculated and then compared with the Centers for Disease Control and Prevention’s recommended spending level. That percentage became the grade, with any level of funding at 80% or more of the CDC’s recommendation getting an A and anything below 50% getting an F, the ALA explained.

The three A’s went to Alaska – which spent $10.14 million, or 99.4% of the CDC-recommended $10.2 million – California (96.0%), and Maine (83.5%). The lowest levels of spending came from Georgia, which spend just 2.8% of the CDC’s recommendation of $106 million, and Missouri, which spent 3.0%, the ALA reported.

States’ grades were generally better in the four other areas of tobacco-control policy: There were 24 A’s and 9 F’s for smoke-free air laws, 1 A and 35 F’s for tobacco excise taxes, 3 A’s and 17 F’s for access to cessation treatment, and 10 A’s and 30 F’s for laws to raise the tobacco sales age to 21 years, the ALA said in the report.

Despite an overall grade of F, the federal government managed to earn some praise in that last area: “In what could only be described as unimaginable even 2 years ago, in December 2019, Congress passed bipartisan legislation to raise the minimum age of sale for tobacco products to 21,” the ALA said.

The federal government was strongly criticized on the subject of e-cigarettes. “The Trump Administration failed to prioritize public health over the tobacco industry with its Jan. 2, 2020, announcement that will leave thousands of flavored e-cigarettes on the market,” the ALA said, while concluding that the rising use of e-cigarettes in recent years “is a real-world demonstration of the failure of the U.S. Food and Drug Administration to properly oversee all tobacco products. … This failure places the lung health and lives of Americans at risk.”

rfranki@mdedge.com

When it comes to state funding for tobacco prevention and cessation, the American Lung Association grades on a curve. It did not help.

The ALA gave failing grades to 43 states in its new State of Tobacco Control report, along with three A’s, one C, and four D’s, despite a grading formula that passed anything better than a 50%.

Each state’s annual funding for tobacco prevention and cessation was calculated and then compared with the Centers for Disease Control and Prevention’s recommended spending level. That percentage became the grade, with any level of funding at 80% or more of the CDC’s recommendation getting an A and anything below 50% getting an F, the ALA explained.

The three A’s went to Alaska – which spent $10.14 million, or 99.4% of the CDC-recommended $10.2 million – California (96.0%), and Maine (83.5%). The lowest levels of spending came from Georgia, which spend just 2.8% of the CDC’s recommendation of $106 million, and Missouri, which spent 3.0%, the ALA reported.

States’ grades were generally better in the four other areas of tobacco-control policy: There were 24 A’s and 9 F’s for smoke-free air laws, 1 A and 35 F’s for tobacco excise taxes, 3 A’s and 17 F’s for access to cessation treatment, and 10 A’s and 30 F’s for laws to raise the tobacco sales age to 21 years, the ALA said in the report.

Despite an overall grade of F, the federal government managed to earn some praise in that last area: “In what could only be described as unimaginable even 2 years ago, in December 2019, Congress passed bipartisan legislation to raise the minimum age of sale for tobacco products to 21,” the ALA said.

The federal government was strongly criticized on the subject of e-cigarettes. “The Trump Administration failed to prioritize public health over the tobacco industry with its Jan. 2, 2020, announcement that will leave thousands of flavored e-cigarettes on the market,” the ALA said, while concluding that the rising use of e-cigarettes in recent years “is a real-world demonstration of the failure of the U.S. Food and Drug Administration to properly oversee all tobacco products. … This failure places the lung health and lives of Americans at risk.”

rfranki@mdedge.com

When it comes to state funding for tobacco prevention and cessation, the American Lung Association grades on a curve. It did not help.

The ALA gave failing grades to 43 states in its new State of Tobacco Control report, along with three A’s, one C, and four D’s, despite a grading formula that passed anything better than a 50%.

Each state’s annual funding for tobacco prevention and cessation was calculated and then compared with the Centers for Disease Control and Prevention’s recommended spending level. That percentage became the grade, with any level of funding at 80% or more of the CDC’s recommendation getting an A and anything below 50% getting an F, the ALA explained.

The three A’s went to Alaska – which spent $10.14 million, or 99.4% of the CDC-recommended $10.2 million – California (96.0%), and Maine (83.5%). The lowest levels of spending came from Georgia, which spend just 2.8% of the CDC’s recommendation of $106 million, and Missouri, which spent 3.0%, the ALA reported.

States’ grades were generally better in the four other areas of tobacco-control policy: There were 24 A’s and 9 F’s for smoke-free air laws, 1 A and 35 F’s for tobacco excise taxes, 3 A’s and 17 F’s for access to cessation treatment, and 10 A’s and 30 F’s for laws to raise the tobacco sales age to 21 years, the ALA said in the report.

Despite an overall grade of F, the federal government managed to earn some praise in that last area: “In what could only be described as unimaginable even 2 years ago, in December 2019, Congress passed bipartisan legislation to raise the minimum age of sale for tobacco products to 21,” the ALA said.

The federal government was strongly criticized on the subject of e-cigarettes. “The Trump Administration failed to prioritize public health over the tobacco industry with its Jan. 2, 2020, announcement that will leave thousands of flavored e-cigarettes on the market,” the ALA said, while concluding that the rising use of e-cigarettes in recent years “is a real-world demonstration of the failure of the U.S. Food and Drug Administration to properly oversee all tobacco products. … This failure places the lung health and lives of Americans at risk.”

rfranki@mdedge.com

In October 2012, Pamela Wible, MD, attended a memorial service in her town for a physician who had died by suicide. Sitting in the third row, she began to count all the colleagues she had lost to suicide, and the result shocked her: 3 in her small town alone, 10 if she expanded her scope to all the doctors she’d ever known.

And so she set out on a mission to document as many physician suicides as she could, in an attempt to understand why her fellow doctors were taking their lives. “I viewed this as a personal quest,” she said in an interview. “I wanted to find out why my friends were dying.” Over the course of 7 years, she documented more than 1,300 physician suicides in the United States with the help of individuals who have lost colleagues and loved ones. She maintains a suicide prevention hotline for medical students and doctors.

On her website, Dr. Wible calls high physician suicide rates a “public health crisis.” She states many conclusions from the stories she’s collected, among them that anesthesiologists are at highest risk for suicide among physicians.

The claim that doctors have a high suicide rate is a common one beyond Dr. Wible’s documentation project. Frequently cited papers contend that 300 physicians commit suicide per year, and that physicians’ suicide rate is higher than the general population. Researchers presenting at the American Psychiatric Association meeting in 2018 said physicians have the highest suicide rate of any profession – double that of the general population, with one completed suicide every day – and Medscape’s coverage of the talk has been widely referenced as supporting evidence.

A closer look at the data behind these claims, however, reveals the difficulty of establishing reliable statistics. Dr. Wible acknowledges that her data are limited. “We do not have accurate numbers. These [statistics] have come to me organically,” she said. Incorrectly coded death certificates are one reason it’s hard to get solid information. “When we’re trying to figure out how many doctors do die by suicide, it’s very hard to know.”

Similar claims have been made at various times about dentists, construction workers, and farmers, perhaps in an effort to call attention to difficult working conditions and inadequate mental health care. Overall, the claims about physician suicide are “widely quoted as fact without any clear evidence,” said Katherine J. Gold, MD, MSW, MS, an associate professor at the University of Michigan, Ann Arbor, who researches physician wellness, mental health, and suicide. It’s critical to know the accurate numbers, she said, “so we can know if we’re making progress.”

Scrutinizing a statistic

The idea for the research presented at the APA meeting in 2018 came up a year earlier “when there were quite a number of physician deaths by suicide,” lead author Omotola T’Sarumi, MD, psychiatrist and chief resident at Columbia University’s Harlem Hospital in New York at the time of the presentation, said in an interview. The poster describes the methodology as a systematic review of research articles published in the last 10 years. Dr. T’Sarumi and colleagues concluded that the rate was 28-40 suicides per 100,000 doctors, compared with a rate of 12.3 per 100,000 for the general population. “That just stunned me,” she said. “We should be doing better.” A peer-reviewed article on the work has not been published.

The references on the poster show limited data to support the headline conclusion that physicians have the highest suicide rate of any profession: four papers and a book chapter. The poster itself does not describe the methodology used to arrive at the numbers stated, and Dr. T’Sarumi said that she was unable to gain access to her previous research since moving to a new institution. Dr. Gold, the first author on one of the papers the poster cites, said there are “huge issues” with the work. “In my paper that they’re citing, I was not looking at rates of suicide,” she said. “This is just picking a couple of studies and highlighting them.”

Dr. Gold’s paper uses data from the Centers for Disease Control and Prevention’s National Violent Death Reporting System (NVDRS) to identify differences in risk factors and suicide methods between physicians and others who died by suicide in 17 states. The researchers did not attempt to quantify a difference in overall rates, but found that physicians who end their own lives are more likely to have a known mental health disorder with lower rates of medication treatment than nonphysicians. “Inadequate treatment and increased problems related to job stress may be potentially modifiable risk factors to reduce suicidal death among physicians,” the authors conclude.

The second study referenced in the 2018 poster, “A History of Physician Suicide in America” by Rupinder Legha, MD, offers a narrative history of physician suicide, including a reference to an 1897 editorial in the Philadelphia Medical and Surgical Reporter that says: “Our profession is more prone to suicide than any other.” The study does not, however, attempt to quantify that risk.

The third study referenced does offer a quantitative analysis based on death and census data in 26 states, and concludes that the suicide rate for white female physicians was about two times higher than the general population. For white male physicians and dentists, however, the study found that the overall rate of suicide was lower than in the general population, but higher in male physicians and dentists older than 55 years.

In search of reliable data

With all of the popular but poorly substantiated claims about physician suicide, Dr. Gold argues that getting accurate numbers is critical. Without them, there is no way to know if rates are increasing or decreasing over time, or if attempts to help physicians in crisis are effective.

The CDC just released its own updated analysis of NVDRS data by major occupational groups across 32 states in 2016. It shows that males and females in the construction and extraction industries had the highest suicide rates: 49.4 per 100,000 and 25.5 per 100,000 respectively. Males in the “health care practitioners and technical” occupation group had a lower than average rate, while females in the same group had a higher than average rate.

The most reliable data that exist, according to Dr. Gold, are found in the CDC’s National Occupational Mortality Surveillance catalog, though it does not contain information from all states and is missing several years of records. Based on its data, the CDC provides a proportionate mortality ratio (PMR) that indicates whether the proportion of deaths tied to a given cause for a given occupation appears high or low, compared with all other occupations. But occupation data are often missing from the CDC’s records, which could make the PMRs unreliable. “You’re talking about relatively small numbers,” said Dr. Gold. “Even if we’re talking about 400 a year, the difference in one or two or five people being physicians could make a huge difference in the rate.”

The PMR for physicians who have died by intentional self-harm suggests that they are 2.5 times as likely as other populations to die by suicide. Filtering the data by race and gender, it appears black female physicians are at highest risk, more than five times as likely to die by suicide as other populations, while white males are twice as likely. Overall, the professionals with highest suicide risk in the database are hunters and trappers, followed by podiatrists, dentists, veterans, and nuclear engineers. Physicians follow with the fifth-highest rate.

The only way to get a true sense of physician suicide rates would be to collect all of the vital records data that states report to the federal government, according to Dr. Gold. “That would require 50 separate institutional review boards, so I doubt anyone is going to go to the effort to do that study,” she said.

Even without a reliable, exact number, it’s clear there are more physician suicides than there should be, Dr. Gold said. “This is a population that really should not be having a relatively high number of suicide deaths, whether it’s highest or not.”

As Dr. Legha wrote in his “History of Physician Suicide,” cited in the 2018 APA poster: “The problem of physician suicide is not solely a matter of whether or not it takes place at a rate higher than the general public. That a professional caregiver can fall ill and not receive adequate care and support, despite being surrounded by other caregivers, begs for a thoughtful assessment to determine why it happens at all.”

If you or someone you know is in need of support, the National Suicide Prevention Lifeline’s toll-free number is 1-800-273-TALK (8255). A version of this article first appeared on Medscape.com.

In October 2012, Pamela Wible, MD, attended a memorial service in her town for a physician who had died by suicide. Sitting in the third row, she began to count all the colleagues she had lost to suicide, and the result shocked her: 3 in her small town alone, 10 if she expanded her scope to all the doctors she’d ever known.

And so she set out on a mission to document as many physician suicides as she could, in an attempt to understand why her fellow doctors were taking their lives. “I viewed this as a personal quest,” she said in an interview. “I wanted to find out why my friends were dying.” Over the course of 7 years, she documented more than 1,300 physician suicides in the United States with the help of individuals who have lost colleagues and loved ones. She maintains a suicide prevention hotline for medical students and doctors.

On her website, Dr. Wible calls high physician suicide rates a “public health crisis.” She states many conclusions from the stories she’s collected, among them that anesthesiologists are at highest risk for suicide among physicians.

The claim that doctors have a high suicide rate is a common one beyond Dr. Wible’s documentation project. Frequently cited papers contend that 300 physicians commit suicide per year, and that physicians’ suicide rate is higher than the general population. Researchers presenting at the American Psychiatric Association meeting in 2018 said physicians have the highest suicide rate of any profession – double that of the general population, with one completed suicide every day – and Medscape’s coverage of the talk has been widely referenced as supporting evidence.

A closer look at the data behind these claims, however, reveals the difficulty of establishing reliable statistics. Dr. Wible acknowledges that her data are limited. “We do not have accurate numbers. These [statistics] have come to me organically,” she said. Incorrectly coded death certificates are one reason it’s hard to get solid information. “When we’re trying to figure out how many doctors do die by suicide, it’s very hard to know.”

Similar claims have been made at various times about dentists, construction workers, and farmers, perhaps in an effort to call attention to difficult working conditions and inadequate mental health care. Overall, the claims about physician suicide are “widely quoted as fact without any clear evidence,” said Katherine J. Gold, MD, MSW, MS, an associate professor at the University of Michigan, Ann Arbor, who researches physician wellness, mental health, and suicide. It’s critical to know the accurate numbers, she said, “so we can know if we’re making progress.”

Scrutinizing a statistic

The idea for the research presented at the APA meeting in 2018 came up a year earlier “when there were quite a number of physician deaths by suicide,” lead author Omotola T’Sarumi, MD, psychiatrist and chief resident at Columbia University’s Harlem Hospital in New York at the time of the presentation, said in an interview. The poster describes the methodology as a systematic review of research articles published in the last 10 years. Dr. T’Sarumi and colleagues concluded that the rate was 28-40 suicides per 100,000 doctors, compared with a rate of 12.3 per 100,000 for the general population. “That just stunned me,” she said. “We should be doing better.” A peer-reviewed article on the work has not been published.

The references on the poster show limited data to support the headline conclusion that physicians have the highest suicide rate of any profession: four papers and a book chapter. The poster itself does not describe the methodology used to arrive at the numbers stated, and Dr. T’Sarumi said that she was unable to gain access to her previous research since moving to a new institution. Dr. Gold, the first author on one of the papers the poster cites, said there are “huge issues” with the work. “In my paper that they’re citing, I was not looking at rates of suicide,” she said. “This is just picking a couple of studies and highlighting them.”

Dr. Gold’s paper uses data from the Centers for Disease Control and Prevention’s National Violent Death Reporting System (NVDRS) to identify differences in risk factors and suicide methods between physicians and others who died by suicide in 17 states. The researchers did not attempt to quantify a difference in overall rates, but found that physicians who end their own lives are more likely to have a known mental health disorder with lower rates of medication treatment than nonphysicians. “Inadequate treatment and increased problems related to job stress may be potentially modifiable risk factors to reduce suicidal death among physicians,” the authors conclude.

The second study referenced in the 2018 poster, “A History of Physician Suicide in America” by Rupinder Legha, MD, offers a narrative history of physician suicide, including a reference to an 1897 editorial in the Philadelphia Medical and Surgical Reporter that says: “Our profession is more prone to suicide than any other.” The study does not, however, attempt to quantify that risk.

The third study referenced does offer a quantitative analysis based on death and census data in 26 states, and concludes that the suicide rate for white female physicians was about two times higher than the general population. For white male physicians and dentists, however, the study found that the overall rate of suicide was lower than in the general population, but higher in male physicians and dentists older than 55 years.

In search of reliable data

With all of the popular but poorly substantiated claims about physician suicide, Dr. Gold argues that getting accurate numbers is critical. Without them, there is no way to know if rates are increasing or decreasing over time, or if attempts to help physicians in crisis are effective.

The CDC just released its own updated analysis of NVDRS data by major occupational groups across 32 states in 2016. It shows that males and females in the construction and extraction industries had the highest suicide rates: 49.4 per 100,000 and 25.5 per 100,000 respectively. Males in the “health care practitioners and technical” occupation group had a lower than average rate, while females in the same group had a higher than average rate.

The most reliable data that exist, according to Dr. Gold, are found in the CDC’s National Occupational Mortality Surveillance catalog, though it does not contain information from all states and is missing several years of records. Based on its data, the CDC provides a proportionate mortality ratio (PMR) that indicates whether the proportion of deaths tied to a given cause for a given occupation appears high or low, compared with all other occupations. But occupation data are often missing from the CDC’s records, which could make the PMRs unreliable. “You’re talking about relatively small numbers,” said Dr. Gold. “Even if we’re talking about 400 a year, the difference in one or two or five people being physicians could make a huge difference in the rate.”

The PMR for physicians who have died by intentional self-harm suggests that they are 2.5 times as likely as other populations to die by suicide. Filtering the data by race and gender, it appears black female physicians are at highest risk, more than five times as likely to die by suicide as other populations, while white males are twice as likely. Overall, the professionals with highest suicide risk in the database are hunters and trappers, followed by podiatrists, dentists, veterans, and nuclear engineers. Physicians follow with the fifth-highest rate.

The only way to get a true sense of physician suicide rates would be to collect all of the vital records data that states report to the federal government, according to Dr. Gold. “That would require 50 separate institutional review boards, so I doubt anyone is going to go to the effort to do that study,” she said.

Even without a reliable, exact number, it’s clear there are more physician suicides than there should be, Dr. Gold said. “This is a population that really should not be having a relatively high number of suicide deaths, whether it’s highest or not.”

As Dr. Legha wrote in his “History of Physician Suicide,” cited in the 2018 APA poster: “The problem of physician suicide is not solely a matter of whether or not it takes place at a rate higher than the general public. That a professional caregiver can fall ill and not receive adequate care and support, despite being surrounded by other caregivers, begs for a thoughtful assessment to determine why it happens at all.”

If you or someone you know is in need of support, the National Suicide Prevention Lifeline’s toll-free number is 1-800-273-TALK (8255). A version of this article first appeared on Medscape.com.

In October 2012, Pamela Wible, MD, attended a memorial service in her town for a physician who had died by suicide. Sitting in the third row, she began to count all the colleagues she had lost to suicide, and the result shocked her: 3 in her small town alone, 10 if she expanded her scope to all the doctors she’d ever known.

And so she set out on a mission to document as many physician suicides as she could, in an attempt to understand why her fellow doctors were taking their lives. “I viewed this as a personal quest,” she said in an interview. “I wanted to find out why my friends were dying.” Over the course of 7 years, she documented more than 1,300 physician suicides in the United States with the help of individuals who have lost colleagues and loved ones. She maintains a suicide prevention hotline for medical students and doctors.

On her website, Dr. Wible calls high physician suicide rates a “public health crisis.” She states many conclusions from the stories she’s collected, among them that anesthesiologists are at highest risk for suicide among physicians.

The claim that doctors have a high suicide rate is a common one beyond Dr. Wible’s documentation project. Frequently cited papers contend that 300 physicians commit suicide per year, and that physicians’ suicide rate is higher than the general population. Researchers presenting at the American Psychiatric Association meeting in 2018 said physicians have the highest suicide rate of any profession – double that of the general population, with one completed suicide every day – and Medscape’s coverage of the talk has been widely referenced as supporting evidence.

A closer look at the data behind these claims, however, reveals the difficulty of establishing reliable statistics. Dr. Wible acknowledges that her data are limited. “We do not have accurate numbers. These [statistics] have come to me organically,” she said. Incorrectly coded death certificates are one reason it’s hard to get solid information. “When we’re trying to figure out how many doctors do die by suicide, it’s very hard to know.”

Similar claims have been made at various times about dentists, construction workers, and farmers, perhaps in an effort to call attention to difficult working conditions and inadequate mental health care. Overall, the claims about physician suicide are “widely quoted as fact without any clear evidence,” said Katherine J. Gold, MD, MSW, MS, an associate professor at the University of Michigan, Ann Arbor, who researches physician wellness, mental health, and suicide. It’s critical to know the accurate numbers, she said, “so we can know if we’re making progress.”

Scrutinizing a statistic

The idea for the research presented at the APA meeting in 2018 came up a year earlier “when there were quite a number of physician deaths by suicide,” lead author Omotola T’Sarumi, MD, psychiatrist and chief resident at Columbia University’s Harlem Hospital in New York at the time of the presentation, said in an interview. The poster describes the methodology as a systematic review of research articles published in the last 10 years. Dr. T’Sarumi and colleagues concluded that the rate was 28-40 suicides per 100,000 doctors, compared with a rate of 12.3 per 100,000 for the general population. “That just stunned me,” she said. “We should be doing better.” A peer-reviewed article on the work has not been published.

The references on the poster show limited data to support the headline conclusion that physicians have the highest suicide rate of any profession: four papers and a book chapter. The poster itself does not describe the methodology used to arrive at the numbers stated, and Dr. T’Sarumi said that she was unable to gain access to her previous research since moving to a new institution. Dr. Gold, the first author on one of the papers the poster cites, said there are “huge issues” with the work. “In my paper that they’re citing, I was not looking at rates of suicide,” she said. “This is just picking a couple of studies and highlighting them.”

Dr. Gold’s paper uses data from the Centers for Disease Control and Prevention’s National Violent Death Reporting System (NVDRS) to identify differences in risk factors and suicide methods between physicians and others who died by suicide in 17 states. The researchers did not attempt to quantify a difference in overall rates, but found that physicians who end their own lives are more likely to have a known mental health disorder with lower rates of medication treatment than nonphysicians. “Inadequate treatment and increased problems related to job stress may be potentially modifiable risk factors to reduce suicidal death among physicians,” the authors conclude.

The second study referenced in the 2018 poster, “A History of Physician Suicide in America” by Rupinder Legha, MD, offers a narrative history of physician suicide, including a reference to an 1897 editorial in the Philadelphia Medical and Surgical Reporter that says: “Our profession is more prone to suicide than any other.” The study does not, however, attempt to quantify that risk.

The third study referenced does offer a quantitative analysis based on death and census data in 26 states, and concludes that the suicide rate for white female physicians was about two times higher than the general population. For white male physicians and dentists, however, the study found that the overall rate of suicide was lower than in the general population, but higher in male physicians and dentists older than 55 years.

In search of reliable data

With all of the popular but poorly substantiated claims about physician suicide, Dr. Gold argues that getting accurate numbers is critical. Without them, there is no way to know if rates are increasing or decreasing over time, or if attempts to help physicians in crisis are effective.

The CDC just released its own updated analysis of NVDRS data by major occupational groups across 32 states in 2016. It shows that males and females in the construction and extraction industries had the highest suicide rates: 49.4 per 100,000 and 25.5 per 100,000 respectively. Males in the “health care practitioners and technical” occupation group had a lower than average rate, while females in the same group had a higher than average rate.

The most reliable data that exist, according to Dr. Gold, are found in the CDC’s National Occupational Mortality Surveillance catalog, though it does not contain information from all states and is missing several years of records. Based on its data, the CDC provides a proportionate mortality ratio (PMR) that indicates whether the proportion of deaths tied to a given cause for a given occupation appears high or low, compared with all other occupations. But occupation data are often missing from the CDC’s records, which could make the PMRs unreliable. “You’re talking about relatively small numbers,” said Dr. Gold. “Even if we’re talking about 400 a year, the difference in one or two or five people being physicians could make a huge difference in the rate.”

The PMR for physicians who have died by intentional self-harm suggests that they are 2.5 times as likely as other populations to die by suicide. Filtering the data by race and gender, it appears black female physicians are at highest risk, more than five times as likely to die by suicide as other populations, while white males are twice as likely. Overall, the professionals with highest suicide risk in the database are hunters and trappers, followed by podiatrists, dentists, veterans, and nuclear engineers. Physicians follow with the fifth-highest rate.

The only way to get a true sense of physician suicide rates would be to collect all of the vital records data that states report to the federal government, according to Dr. Gold. “That would require 50 separate institutional review boards, so I doubt anyone is going to go to the effort to do that study,” she said.

Even without a reliable, exact number, it’s clear there are more physician suicides than there should be, Dr. Gold said. “This is a population that really should not be having a relatively high number of suicide deaths, whether it’s highest or not.”

As Dr. Legha wrote in his “History of Physician Suicide,” cited in the 2018 APA poster: “The problem of physician suicide is not solely a matter of whether or not it takes place at a rate higher than the general public. That a professional caregiver can fall ill and not receive adequate care and support, despite being surrounded by other caregivers, begs for a thoughtful assessment to determine why it happens at all.”

If you or someone you know is in need of support, the National Suicide Prevention Lifeline’s toll-free number is 1-800-273-TALK (8255). A version of this article first appeared on Medscape.com.

President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.

Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”

That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.

A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.

But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.

“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.

A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.

The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.

The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.

“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”

Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.

Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.

Preexisting conditions

The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.

“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.

In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.

During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.

“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.

Socialist takeover

Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.

“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.

He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”

Added Mr. Trump: “We will never let socialism destroy American health care!”

Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.

Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
 

Opioids, the coronavirus, and abortion

In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.

He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.

Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.

The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.

“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.

Insulin costs?

In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.

At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.

But Mr. Trump never mentioned insulin in his speech.

This article first appeared on Medscape.com.

President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.

Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”

That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.

A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.

But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.

“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.

A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.

The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.

The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.

“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”

Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.

Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.

Preexisting conditions

The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.

“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.

In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.

During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.

“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.

Socialist takeover

Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.

“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.

He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”

Added Mr. Trump: “We will never let socialism destroy American health care!”

Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.

Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
 

Opioids, the coronavirus, and abortion

In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.

He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.

Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.

The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.

“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.

Insulin costs?

In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.

At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.

But Mr. Trump never mentioned insulin in his speech.

This article first appeared on Medscape.com.

President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.

Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”

That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.

A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.

But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.

“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.

A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.

The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.

The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.

“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”

Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.

Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.

Preexisting conditions

The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.

“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.

In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.

During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.

“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.

Socialist takeover

Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.

“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.

He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”

Added Mr. Trump: “We will never let socialism destroy American health care!”

Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.

Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
 

Opioids, the coronavirus, and abortion

In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.

He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.

Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.

The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.

“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.

Insulin costs?

In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.

At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.

But Mr. Trump never mentioned insulin in his speech.

This article first appeared on Medscape.com.

Academic cancer centers around the United States continue to get caught up in an ever-evolving investigation into researchers – American and Chinese – who did not disclose payments from or the work they did for Chinese institutions while simultaneously accepting taxpayer money through U.S. government grants.

The U.S. Federal Bureau of Investigation has been ferreting out researchers it says have acted illegally.

On Jan. 28, the agency arrested Charles Lieber, a chemist from Harvard University, Cambridge, Mass., and also unveiled charges against Zheng Zaosong, a cancer researcher who is in the United States on a Harvard-sponsored visa.

The FBI said Mr. Zheng, who worked at the Harvard-affiliated Beth Israel Deaconess Medical Center, Boston, tried to smuggle 21 vials of biological material and research to China. Mr. Zheng was arrested in December at Boston’s Logan Airport. He admitted he planned to conduct and publish research in China using the stolen samples, said the FBI.

“All of the individuals charged today were either directly or indirectly working for the Chinese government, at our country’s expense,” said the agent in charge of the FBI’s Boston office, Joseph R. Bonavolonta.

Sen. Charles Grassley (R-IA), who has been pushing for more government action against foreign theft of U.S. research, said in a statement, “I’m glad the FBI appears to be taking foreign threats to taxpayer-funded research seriously, but I fear that this case is only the tip of the iceberg.”

The FBI said it is investigating China-related cases in all 50 states.

Ross McKinney, MD, the chief scientific officer at the Association of American Medical Colleges (AAMC), said he is aware of some 200 investigations, not all of which are cancer related, at 70-75 institutions.

“It’s a very ubiquitous problem,” Dr. McKinney said in an interview.

He also pointed out that some 6,000 National Institutes of Health–funded principal investigators are of Asian background. “So that 200 is a pretty small proportion,” said Dr. McKinney.

The NIH warned some 10,000 institutions in August 2018 that it had uncovered Chinese manipulation of peer review and a lack of disclosure of work for Chinese institutions. It urged the institutions to report irregularities.

For universities, “the trouble is sorting out who is the violator from who is not,” said Dr. McKinney. He noted that they are not set up to investigate whether someone has a laboratory in China.

“The fact that the Chinese government exploited the fact that universities are typically fairly trusting is extremely disappointing,” he said.
 

Moffitt story still unfolding

The most serious allegations have been leveled against six former employees of the Moffitt Cancer Center and Research Institute in Tampa, Florida.

In December 2019, Moffitt announced that the six – including President and CEO Alan List, MD, and the center director, Thomas Sellers, PhD – had left Moffitt as a result of “violations of conflict of interest rules through their work in China.”

New details have emerged, thanks to a new investigative report from a committee of the Florida House of Representatives.

The report said that Sheng Wei, a naturalized U.S. citizen who had worked at Moffitt since 2008 – when Moffitt began its affiliation with the Tianjin Medical University Cancer Institute and Hospital – was instrumental in recruiting top executives into the Thousand Talents program, which Wei had joined in 2010, according to the report. These executives included Dr. List, Dr. Sellers, and also Daniel Sullivan, head of Moffitt’s clinical science program, and cancer biologist Pearlie Epling-Burnette, it noted.

Begun in 2008, China’s Thousand Talents Plan gave salaries, funding, laboratory space, and other incentives to researchers who promised to bring U.S.-gained knowledge and research to China.

All information about this program has been removed from the Internet, but the program may still be active, Dr. McKinney commented.

According to the report, Dr. List pledged to work for the Tianjin cancer center 9 months a year for $71,000 annually. He was appointed head of the hematology department ($85,300 a year) in 2016. He opened a bank account in China to receive that salary and other Thousand Talents payments, the report found. The report notes that the exact amount Dr. List was paid is still not known.

Initially, Dr. Sellers, who was the principal investigator for Moffitt’s National Cancer Institute core grant, said he had not been involved in the Thousand Talents program. He later admitted that he had pledged to work in China 2 months a year for the program and that he’d opened a Chinese bank account and had deposited at least $35,000 into the account, the report notes.

The others pledged to work for the Thousand Talents program and also opened bank accounts in China and received money in those accounts.

Another Moffitt employee, Howard McLeod, MD, had worked for Thousand Talents before he joined Moffitt but did not disclose his China work. Dr. McLeod also supervised and had a close relationship with another researcher, Yijing (Bob) He, MD, who was employed by Moffitt but who lived in China, unbeknownst to Moffitt. “Dr. He appears to have functioned as an agent of Dr. McLeod in China,” said the report.

The report concluded that “none of the Moffitt faculty who were Talents program participants properly or timely disclosed their Talents program involvement to Moffitt, and none disclosed the full extent of their Talents program activities prior to Moffitt’s internal investigation.”

No charges have been filed against any of the former Moffitt employees.

However, the Cancer Letter has reported that Dr. Sellers is claiming he was not involved in the program and that he is preparing to sue Moffitt.

AAMC’s Dr. McKinney notes that it is illegal for researchers to take U.S. government grant money and pledge a certain amount of time but not deliver on that commitment because they are working for someone else – in this case, China. They also lied about not having any other research support, which is also illegal, he said.

The researchers received Chinese money and deposited it in Chinese accounts, which was never reported to the U.S. Internal Revenue Service.

“One of the hallmarks of the Chinese recruitment program was that people were instructed to not tell their normal U.S. host institution and not tell any U.S. government agency about their relationship with China,” Dr. McKinney said. “It was creating a culture where dishonesty in this situation was norm,” he added.

The lack of honesty brings up bigger questions for the field, he said. “Once you start lying about one thing, do you lie about your science, too?”
 

Lack of oversight?

Dr. McKinney said the NIH, as well as universities and hospitals, had a long and trusting relationship with China and should not be blamed for falling prey to the Chinese government’s concerted effort to steal intellectual property.

But some government watchdog groups have chided the NIH for lax oversight. In February 2019, the federal Health & Human Services’ Office of Inspector General found that “NIH has not assessed the risks to national security when permitting data access to foreign [principal investigators].”

Federal investigators have said that Thousand Talents has been one of the biggest threats.

The U.S. Senate Permanent Subcommittee on Investigations reported in November 2019 that “the federal government’s grant-making agencies did little to prevent this from happening, nor did the FBI and other federal agencies develop a coordinated response to mitigate the threat.”

The NIH invests $31 billion a year in medical research through 50,000 competitive grants to more than 300,000 researchers, according to that report. Even after uncovering grant fraud and peer-review manipulation that benefited China, “significant gaps in NIH’s grant integrity process remain,” the report states. Site visits by the NIH’s Division of Grants Compliance and Oversight dropped from 28 in 2012 to just 3 in 2018, the report noted.
 

Widening dragnet

In April 2019, Science reported that the NIH identified five researchers at MD Anderson Cancer Center in Houston who had failed to disclose their ties to Chinese enterprises and who had failed to keep peer review confidential.

Two resigned before they could be fired, one was fired, another eventually left the institution, and the fifth was found to have not willfully engaged in subterfuge.

Just a month later, Emory University in Atlanta announced that it had fired a husband and wife research team. The neuroscientists were known for their studies of Huntington disease. Both were U.S. citizens and had worked at Emory for more than 2 decades, according to the Science report.

The Moffitt situation led to the Florida legislature’s investigation, and also prompted some soul searching. The Tampa Bay Times reported that U.S. Senator Rick Scott (R-FL) asked state universities to provide information on what they are doing to stop foreign influence. The University of Florida then acknowledged that four faculty members resigned or were terminated because of ties to a foreign recruitment program.
 

This article first appeared on Medscape.com.

Academic cancer centers around the United States continue to get caught up in an ever-evolving investigation into researchers – American and Chinese – who did not disclose payments from or the work they did for Chinese institutions while simultaneously accepting taxpayer money through U.S. government grants.

The U.S. Federal Bureau of Investigation has been ferreting out researchers it says have acted illegally.

On Jan. 28, the agency arrested Charles Lieber, a chemist from Harvard University, Cambridge, Mass., and also unveiled charges against Zheng Zaosong, a cancer researcher who is in the United States on a Harvard-sponsored visa.

The FBI said Mr. Zheng, who worked at the Harvard-affiliated Beth Israel Deaconess Medical Center, Boston, tried to smuggle 21 vials of biological material and research to China. Mr. Zheng was arrested in December at Boston’s Logan Airport. He admitted he planned to conduct and publish research in China using the stolen samples, said the FBI.

“All of the individuals charged today were either directly or indirectly working for the Chinese government, at our country’s expense,” said the agent in charge of the FBI’s Boston office, Joseph R. Bonavolonta.

Sen. Charles Grassley (R-IA), who has been pushing for more government action against foreign theft of U.S. research, said in a statement, “I’m glad the FBI appears to be taking foreign threats to taxpayer-funded research seriously, but I fear that this case is only the tip of the iceberg.”

The FBI said it is investigating China-related cases in all 50 states.

Ross McKinney, MD, the chief scientific officer at the Association of American Medical Colleges (AAMC), said he is aware of some 200 investigations, not all of which are cancer related, at 70-75 institutions.

“It’s a very ubiquitous problem,” Dr. McKinney said in an interview.

He also pointed out that some 6,000 National Institutes of Health–funded principal investigators are of Asian background. “So that 200 is a pretty small proportion,” said Dr. McKinney.

The NIH warned some 10,000 institutions in August 2018 that it had uncovered Chinese manipulation of peer review and a lack of disclosure of work for Chinese institutions. It urged the institutions to report irregularities.

For universities, “the trouble is sorting out who is the violator from who is not,” said Dr. McKinney. He noted that they are not set up to investigate whether someone has a laboratory in China.

“The fact that the Chinese government exploited the fact that universities are typically fairly trusting is extremely disappointing,” he said.
 

Moffitt story still unfolding

The most serious allegations have been leveled against six former employees of the Moffitt Cancer Center and Research Institute in Tampa, Florida.

In December 2019, Moffitt announced that the six – including President and CEO Alan List, MD, and the center director, Thomas Sellers, PhD – had left Moffitt as a result of “violations of conflict of interest rules through their work in China.”

New details have emerged, thanks to a new investigative report from a committee of the Florida House of Representatives.

The report said that Sheng Wei, a naturalized U.S. citizen who had worked at Moffitt since 2008 – when Moffitt began its affiliation with the Tianjin Medical University Cancer Institute and Hospital – was instrumental in recruiting top executives into the Thousand Talents program, which Wei had joined in 2010, according to the report. These executives included Dr. List, Dr. Sellers, and also Daniel Sullivan, head of Moffitt’s clinical science program, and cancer biologist Pearlie Epling-Burnette, it noted.

Begun in 2008, China’s Thousand Talents Plan gave salaries, funding, laboratory space, and other incentives to researchers who promised to bring U.S.-gained knowledge and research to China.

All information about this program has been removed from the Internet, but the program may still be active, Dr. McKinney commented.

According to the report, Dr. List pledged to work for the Tianjin cancer center 9 months a year for $71,000 annually. He was appointed head of the hematology department ($85,300 a year) in 2016. He opened a bank account in China to receive that salary and other Thousand Talents payments, the report found. The report notes that the exact amount Dr. List was paid is still not known.

Initially, Dr. Sellers, who was the principal investigator for Moffitt’s National Cancer Institute core grant, said he had not been involved in the Thousand Talents program. He later admitted that he had pledged to work in China 2 months a year for the program and that he’d opened a Chinese bank account and had deposited at least $35,000 into the account, the report notes.

The others pledged to work for the Thousand Talents program and also opened bank accounts in China and received money in those accounts.

Another Moffitt employee, Howard McLeod, MD, had worked for Thousand Talents before he joined Moffitt but did not disclose his China work. Dr. McLeod also supervised and had a close relationship with another researcher, Yijing (Bob) He, MD, who was employed by Moffitt but who lived in China, unbeknownst to Moffitt. “Dr. He appears to have functioned as an agent of Dr. McLeod in China,” said the report.

The report concluded that “none of the Moffitt faculty who were Talents program participants properly or timely disclosed their Talents program involvement to Moffitt, and none disclosed the full extent of their Talents program activities prior to Moffitt’s internal investigation.”

No charges have been filed against any of the former Moffitt employees.

However, the Cancer Letter has reported that Dr. Sellers is claiming he was not involved in the program and that he is preparing to sue Moffitt.

AAMC’s Dr. McKinney notes that it is illegal for researchers to take U.S. government grant money and pledge a certain amount of time but not deliver on that commitment because they are working for someone else – in this case, China. They also lied about not having any other research support, which is also illegal, he said.

The researchers received Chinese money and deposited it in Chinese accounts, which was never reported to the U.S. Internal Revenue Service.

“One of the hallmarks of the Chinese recruitment program was that people were instructed to not tell their normal U.S. host institution and not tell any U.S. government agency about their relationship with China,” Dr. McKinney said. “It was creating a culture where dishonesty in this situation was norm,” he added.

The lack of honesty brings up bigger questions for the field, he said. “Once you start lying about one thing, do you lie about your science, too?”
 

Lack of oversight?

Dr. McKinney said the NIH, as well as universities and hospitals, had a long and trusting relationship with China and should not be blamed for falling prey to the Chinese government’s concerted effort to steal intellectual property.

But some government watchdog groups have chided the NIH for lax oversight. In February 2019, the federal Health & Human Services’ Office of Inspector General found that “NIH has not assessed the risks to national security when permitting data access to foreign [principal investigators].”

Federal investigators have said that Thousand Talents has been one of the biggest threats.

The U.S. Senate Permanent Subcommittee on Investigations reported in November 2019 that “the federal government’s grant-making agencies did little to prevent this from happening, nor did the FBI and other federal agencies develop a coordinated response to mitigate the threat.”

The NIH invests $31 billion a year in medical research through 50,000 competitive grants to more than 300,000 researchers, according to that report. Even after uncovering grant fraud and peer-review manipulation that benefited China, “significant gaps in NIH’s grant integrity process remain,” the report states. Site visits by the NIH’s Division of Grants Compliance and Oversight dropped from 28 in 2012 to just 3 in 2018, the report noted.
 

Widening dragnet

In April 2019, Science reported that the NIH identified five researchers at MD Anderson Cancer Center in Houston who had failed to disclose their ties to Chinese enterprises and who had failed to keep peer review confidential.

Two resigned before they could be fired, one was fired, another eventually left the institution, and the fifth was found to have not willfully engaged in subterfuge.

Just a month later, Emory University in Atlanta announced that it had fired a husband and wife research team. The neuroscientists were known for their studies of Huntington disease. Both were U.S. citizens and had worked at Emory for more than 2 decades, according to the Science report.

The Moffitt situation led to the Florida legislature’s investigation, and also prompted some soul searching. The Tampa Bay Times reported that U.S. Senator Rick Scott (R-FL) asked state universities to provide information on what they are doing to stop foreign influence. The University of Florida then acknowledged that four faculty members resigned or were terminated because of ties to a foreign recruitment program.
 

This article first appeared on Medscape.com.

Academic cancer centers around the United States continue to get caught up in an ever-evolving investigation into researchers – American and Chinese – who did not disclose payments from or the work they did for Chinese institutions while simultaneously accepting taxpayer money through U.S. government grants.

The U.S. Federal Bureau of Investigation has been ferreting out researchers it says have acted illegally.

On Jan. 28, the agency arrested Charles Lieber, a chemist from Harvard University, Cambridge, Mass., and also unveiled charges against Zheng Zaosong, a cancer researcher who is in the United States on a Harvard-sponsored visa.

The FBI said Mr. Zheng, who worked at the Harvard-affiliated Beth Israel Deaconess Medical Center, Boston, tried to smuggle 21 vials of biological material and research to China. Mr. Zheng was arrested in December at Boston’s Logan Airport. He admitted he planned to conduct and publish research in China using the stolen samples, said the FBI.

“All of the individuals charged today were either directly or indirectly working for the Chinese government, at our country’s expense,” said the agent in charge of the FBI’s Boston office, Joseph R. Bonavolonta.

Sen. Charles Grassley (R-IA), who has been pushing for more government action against foreign theft of U.S. research, said in a statement, “I’m glad the FBI appears to be taking foreign threats to taxpayer-funded research seriously, but I fear that this case is only the tip of the iceberg.”

The FBI said it is investigating China-related cases in all 50 states.

Ross McKinney, MD, the chief scientific officer at the Association of American Medical Colleges (AAMC), said he is aware of some 200 investigations, not all of which are cancer related, at 70-75 institutions.

“It’s a very ubiquitous problem,” Dr. McKinney said in an interview.

He also pointed out that some 6,000 National Institutes of Health–funded principal investigators are of Asian background. “So that 200 is a pretty small proportion,” said Dr. McKinney.

The NIH warned some 10,000 institutions in August 2018 that it had uncovered Chinese manipulation of peer review and a lack of disclosure of work for Chinese institutions. It urged the institutions to report irregularities.

For universities, “the trouble is sorting out who is the violator from who is not,” said Dr. McKinney. He noted that they are not set up to investigate whether someone has a laboratory in China.

“The fact that the Chinese government exploited the fact that universities are typically fairly trusting is extremely disappointing,” he said.
 

Moffitt story still unfolding

The most serious allegations have been leveled against six former employees of the Moffitt Cancer Center and Research Institute in Tampa, Florida.

In December 2019, Moffitt announced that the six – including President and CEO Alan List, MD, and the center director, Thomas Sellers, PhD – had left Moffitt as a result of “violations of conflict of interest rules through their work in China.”

New details have emerged, thanks to a new investigative report from a committee of the Florida House of Representatives.

The report said that Sheng Wei, a naturalized U.S. citizen who had worked at Moffitt since 2008 – when Moffitt began its affiliation with the Tianjin Medical University Cancer Institute and Hospital – was instrumental in recruiting top executives into the Thousand Talents program, which Wei had joined in 2010, according to the report. These executives included Dr. List, Dr. Sellers, and also Daniel Sullivan, head of Moffitt’s clinical science program, and cancer biologist Pearlie Epling-Burnette, it noted.

Begun in 2008, China’s Thousand Talents Plan gave salaries, funding, laboratory space, and other incentives to researchers who promised to bring U.S.-gained knowledge and research to China.

All information about this program has been removed from the Internet, but the program may still be active, Dr. McKinney commented.

According to the report, Dr. List pledged to work for the Tianjin cancer center 9 months a year for $71,000 annually. He was appointed head of the hematology department ($85,300 a year) in 2016. He opened a bank account in China to receive that salary and other Thousand Talents payments, the report found. The report notes that the exact amount Dr. List was paid is still not known.

Initially, Dr. Sellers, who was the principal investigator for Moffitt’s National Cancer Institute core grant, said he had not been involved in the Thousand Talents program. He later admitted that he had pledged to work in China 2 months a year for the program and that he’d opened a Chinese bank account and had deposited at least $35,000 into the account, the report notes.

The others pledged to work for the Thousand Talents program and also opened bank accounts in China and received money in those accounts.

Another Moffitt employee, Howard McLeod, MD, had worked for Thousand Talents before he joined Moffitt but did not disclose his China work. Dr. McLeod also supervised and had a close relationship with another researcher, Yijing (Bob) He, MD, who was employed by Moffitt but who lived in China, unbeknownst to Moffitt. “Dr. He appears to have functioned as an agent of Dr. McLeod in China,” said the report.

The report concluded that “none of the Moffitt faculty who were Talents program participants properly or timely disclosed their Talents program involvement to Moffitt, and none disclosed the full extent of their Talents program activities prior to Moffitt’s internal investigation.”

No charges have been filed against any of the former Moffitt employees.

However, the Cancer Letter has reported that Dr. Sellers is claiming he was not involved in the program and that he is preparing to sue Moffitt.

AAMC’s Dr. McKinney notes that it is illegal for researchers to take U.S. government grant money and pledge a certain amount of time but not deliver on that commitment because they are working for someone else – in this case, China. They also lied about not having any other research support, which is also illegal, he said.

The researchers received Chinese money and deposited it in Chinese accounts, which was never reported to the U.S. Internal Revenue Service.

“One of the hallmarks of the Chinese recruitment program was that people were instructed to not tell their normal U.S. host institution and not tell any U.S. government agency about their relationship with China,” Dr. McKinney said. “It was creating a culture where dishonesty in this situation was norm,” he added.

The lack of honesty brings up bigger questions for the field, he said. “Once you start lying about one thing, do you lie about your science, too?”
 

Lack of oversight?

Dr. McKinney said the NIH, as well as universities and hospitals, had a long and trusting relationship with China and should not be blamed for falling prey to the Chinese government’s concerted effort to steal intellectual property.

But some government watchdog groups have chided the NIH for lax oversight. In February 2019, the federal Health & Human Services’ Office of Inspector General found that “NIH has not assessed the risks to national security when permitting data access to foreign [principal investigators].”

Federal investigators have said that Thousand Talents has been one of the biggest threats.

The U.S. Senate Permanent Subcommittee on Investigations reported in November 2019 that “the federal government’s grant-making agencies did little to prevent this from happening, nor did the FBI and other federal agencies develop a coordinated response to mitigate the threat.”

The NIH invests $31 billion a year in medical research through 50,000 competitive grants to more than 300,000 researchers, according to that report. Even after uncovering grant fraud and peer-review manipulation that benefited China, “significant gaps in NIH’s grant integrity process remain,” the report states. Site visits by the NIH’s Division of Grants Compliance and Oversight dropped from 28 in 2012 to just 3 in 2018, the report noted.
 

Widening dragnet

In April 2019, Science reported that the NIH identified five researchers at MD Anderson Cancer Center in Houston who had failed to disclose their ties to Chinese enterprises and who had failed to keep peer review confidential.

Two resigned before they could be fired, one was fired, another eventually left the institution, and the fifth was found to have not willfully engaged in subterfuge.

Just a month later, Emory University in Atlanta announced that it had fired a husband and wife research team. The neuroscientists were known for their studies of Huntington disease. Both were U.S. citizens and had worked at Emory for more than 2 decades, according to the Science report.

The Moffitt situation led to the Florida legislature’s investigation, and also prompted some soul searching. The Tampa Bay Times reported that U.S. Senator Rick Scott (R-FL) asked state universities to provide information on what they are doing to stop foreign influence. The University of Florida then acknowledged that four faculty members resigned or were terminated because of ties to a foreign recruitment program.
 

This article first appeared on Medscape.com.

A new line of Barbie dolls unveiled by Mattel earlier this month includes one with vitiligo, much to the delight of clinicians who treat children and adolescents with the condition.

Mattel, Inc.

“When I see young children and adolescents with vitiligo, it is very common for me to feel their emotional suffering from their skin condition,” Seemal R. Desai, MD, a dermatologist at the University of Texas Southwestern Medical Center in Dallas said in an interview. “Kids can be cruel. Name calling, social ostracizing, [and] effects on self-esteem are all things I have seen amongst my patients and their families in their own struggles with vitiligo.”

According to a brand communications representative from toymaker Mattel, which began manufacturing Barbie dolls in 1959, the company worked with a board-certified dermatologist to include a doll with vitiligo in its 2020 “Fashionistas” line. “As we continue to redefine what it means to be a ‘Barbie’ or look like Barbie, offering a doll with vitiligo in our main doll line allows kids to play out even more stories they see in the world around them,” the representative wrote in an email message. Other dolls debuting as part of the lineup include one with no hair, one with a darker skin tone that uses a gold prosthetic limb, and a Ken doll with long rooted hair (think Jeff Spicoli in “Fast Times at Ridgemont High,” but about six inches longer).

Such efforts to celebrate diversity and inclusiveness go far in helping children and young adults to embrace their skin and their own identities, said Dr. Desai, the immediate past president of the Skin of Color Society and a member of the American Academy of Dermatology board of directors. “One nuance, perhaps even more important, is that the Barbie can help to break down barriers, create awareness, and potentially even reduce bullying, stigma, and lack of knowledge about vitiligo amongst the general public who don’t understand vitiligo,” he said. “I hope the public and social media will embrace this new Barbie. Who knows? Pretty soon, vitiligo may no longer be a ‘thing’ that causes ‘stares’ and ‘glares.’ ”

Referring to the Barbie with no hair in the new line of dolls, the Mattel statement said, “ if a girl is experiencing hair loss for any reason, she can see herself reflected in the line.”

Mattel, Inc.

In 2019, Mattel introduced a lineup of Barbie dolls reflecting permanent disabilities, including one with a prosthetic limb. For that effort, the company collaborated with then-12-year-old Jordan Reeves, the “Born Just Right” coauthor “who is on a mission to build creative solutions that help kids with disabilities, to create a play experience that is as representative as possible,” the Mattel representative wrote.

dbrunk@mdedge.com

A new line of Barbie dolls unveiled by Mattel earlier this month includes one with vitiligo, much to the delight of clinicians who treat children and adolescents with the condition.

Mattel, Inc.

“When I see young children and adolescents with vitiligo, it is very common for me to feel their emotional suffering from their skin condition,” Seemal R. Desai, MD, a dermatologist at the University of Texas Southwestern Medical Center in Dallas said in an interview. “Kids can be cruel. Name calling, social ostracizing, [and] effects on self-esteem are all things I have seen amongst my patients and their families in their own struggles with vitiligo.”

According to a brand communications representative from toymaker Mattel, which began manufacturing Barbie dolls in 1959, the company worked with a board-certified dermatologist to include a doll with vitiligo in its 2020 “Fashionistas” line. “As we continue to redefine what it means to be a ‘Barbie’ or look like Barbie, offering a doll with vitiligo in our main doll line allows kids to play out even more stories they see in the world around them,” the representative wrote in an email message. Other dolls debuting as part of the lineup include one with no hair, one with a darker skin tone that uses a gold prosthetic limb, and a Ken doll with long rooted hair (think Jeff Spicoli in “Fast Times at Ridgemont High,” but about six inches longer).

Such efforts to celebrate diversity and inclusiveness go far in helping children and young adults to embrace their skin and their own identities, said Dr. Desai, the immediate past president of the Skin of Color Society and a member of the American Academy of Dermatology board of directors. “One nuance, perhaps even more important, is that the Barbie can help to break down barriers, create awareness, and potentially even reduce bullying, stigma, and lack of knowledge about vitiligo amongst the general public who don’t understand vitiligo,” he said. “I hope the public and social media will embrace this new Barbie. Who knows? Pretty soon, vitiligo may no longer be a ‘thing’ that causes ‘stares’ and ‘glares.’ ”

Referring to the Barbie with no hair in the new line of dolls, the Mattel statement said, “ if a girl is experiencing hair loss for any reason, she can see herself reflected in the line.”

Mattel, Inc.

In 2019, Mattel introduced a lineup of Barbie dolls reflecting permanent disabilities, including one with a prosthetic limb. For that effort, the company collaborated with then-12-year-old Jordan Reeves, the “Born Just Right” coauthor “who is on a mission to build creative solutions that help kids with disabilities, to create a play experience that is as representative as possible,” the Mattel representative wrote.

dbrunk@mdedge.com

A new line of Barbie dolls unveiled by Mattel earlier this month includes one with vitiligo, much to the delight of clinicians who treat children and adolescents with the condition.

Mattel, Inc.

“When I see young children and adolescents with vitiligo, it is very common for me to feel their emotional suffering from their skin condition,” Seemal R. Desai, MD, a dermatologist at the University of Texas Southwestern Medical Center in Dallas said in an interview. “Kids can be cruel. Name calling, social ostracizing, [and] effects on self-esteem are all things I have seen amongst my patients and their families in their own struggles with vitiligo.”

According to a brand communications representative from toymaker Mattel, which began manufacturing Barbie dolls in 1959, the company worked with a board-certified dermatologist to include a doll with vitiligo in its 2020 “Fashionistas” line. “As we continue to redefine what it means to be a ‘Barbie’ or look like Barbie, offering a doll with vitiligo in our main doll line allows kids to play out even more stories they see in the world around them,” the representative wrote in an email message. Other dolls debuting as part of the lineup include one with no hair, one with a darker skin tone that uses a gold prosthetic limb, and a Ken doll with long rooted hair (think Jeff Spicoli in “Fast Times at Ridgemont High,” but about six inches longer).

Such efforts to celebrate diversity and inclusiveness go far in helping children and young adults to embrace their skin and their own identities, said Dr. Desai, the immediate past president of the Skin of Color Society and a member of the American Academy of Dermatology board of directors. “One nuance, perhaps even more important, is that the Barbie can help to break down barriers, create awareness, and potentially even reduce bullying, stigma, and lack of knowledge about vitiligo amongst the general public who don’t understand vitiligo,” he said. “I hope the public and social media will embrace this new Barbie. Who knows? Pretty soon, vitiligo may no longer be a ‘thing’ that causes ‘stares’ and ‘glares.’ ”

Referring to the Barbie with no hair in the new line of dolls, the Mattel statement said, “ if a girl is experiencing hair loss for any reason, she can see herself reflected in the line.”

Mattel, Inc.

In 2019, Mattel introduced a lineup of Barbie dolls reflecting permanent disabilities, including one with a prosthetic limb. For that effort, the company collaborated with then-12-year-old Jordan Reeves, the “Born Just Right” coauthor “who is on a mission to build creative solutions that help kids with disabilities, to create a play experience that is as representative as possible,” the Mattel representative wrote.

dbrunk@mdedge.com

It took less than a day for physician groups to start pushing back at the Centers for Medicare & Medicaid Services over its new Medicaid block grant plan, which was introduced on Jan. 30.

Dubbed “Healthy Adult Opportunity,” the agency is offering all states the chance to participate in a block grant program through the 1115 waiver process.

According to a fact sheet issued by the agency, the program will focus on “adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan. Other very low-income parents, children, pregnant women, elderly adults, and people eligible on the basis of a disability will not be directly affected – except from the improvement that results from states reinvesting savings into strengthening their overall programs.”

States will be operating within a defined budget when participating in the program and expenditures exceeding that defined budget will not be eligible for additional federal funding. Budgets will be based on a state’s historic costs, as well as national and regional trends, and will be tied to inflation with the potential to have adjustments made for extraordinary events. States can set their baseline using the prior year’s total spending or a per-enrollee spending model.

A Jan. 30 letter to state Medicaid directors notes that states participating in the program “will be granted extensive flexibility to test alternative approaches to implementing their Medicaid programs, including the ability to make many ongoing program adjustments without the need for demonstration or state plan amendments that require prior approval.”

Among the activities states can engage in under this plan are adjusting cost-sharing requirements, adopting a closed formulary, and applying additional conditions of eligibility. Requests, if approved, will be approved for a 5-year initial period, with a renewal option of up to 10 years.

But physician groups are not seeing a benefit with this new block grant program.

“Moving to a block grant system will likely limit the ability of Medicaid patients to receive preventive and needed medical care from their family physicians, and it will only increase the health disparities that exist in these communities, worsen overall health outcomes, and ultimately increase costs,” Gary LeRoy, MD, president of the American Academy of Family Physicians, said in a statement.

The American Medical Association concurred.

“The AMA opposes caps on federal Medicaid funding, such as block grants, because they would increase the number of uninsured and undermine Medicaid’s role as an indispensable safety net,” Patrice Harris, MD, the AMA’s president, said in a statement. “The AMA supports flexibility in Medicaid and encourages CMS to work with states to develop and test new Medicaid models that best meet the needs and priorities of low-income patients. While encouraging flexibility, the AMA is mindful that expanding Medicaid has been a literal lifesaver for low-income patients. We need to find ways to build on this success. We look forward to reviewing the proposal in detail.”

Officials at the American College of Obstetricians and Gynecologists said the changes have the potential to harm women and children’s health, as well as negatively impact physician reimbursement and ultimately access to care.

“Limits on the federal contribution to the Medicaid program would negatively impact patients by forcing states to reduce the number of people who are eligible for Medicaid coverage, eliminate covered services, and increase beneficiary cost-sharing,” ACOG President Ted Anderson, MD, said in a statement. “ACOG is also concerned that this block grant opportunity could lower physician reimbursement for certain services, forcing providers out of the program and jeopardizing patients’ ability to access health care services. Given our nation’s stark rates of maternal mortality and severe maternal morbidity, we are alarmed by the Administration’s willingness to weaken physician payment in Medicaid.”

gtwachtman@mdedge.com

It took less than a day for physician groups to start pushing back at the Centers for Medicare & Medicaid Services over its new Medicaid block grant plan, which was introduced on Jan. 30.

Dubbed “Healthy Adult Opportunity,” the agency is offering all states the chance to participate in a block grant program through the 1115 waiver process.

According to a fact sheet issued by the agency, the program will focus on “adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan. Other very low-income parents, children, pregnant women, elderly adults, and people eligible on the basis of a disability will not be directly affected – except from the improvement that results from states reinvesting savings into strengthening their overall programs.”

States will be operating within a defined budget when participating in the program and expenditures exceeding that defined budget will not be eligible for additional federal funding. Budgets will be based on a state’s historic costs, as well as national and regional trends, and will be tied to inflation with the potential to have adjustments made for extraordinary events. States can set their baseline using the prior year’s total spending or a per-enrollee spending model.

A Jan. 30 letter to state Medicaid directors notes that states participating in the program “will be granted extensive flexibility to test alternative approaches to implementing their Medicaid programs, including the ability to make many ongoing program adjustments without the need for demonstration or state plan amendments that require prior approval.”

Among the activities states can engage in under this plan are adjusting cost-sharing requirements, adopting a closed formulary, and applying additional conditions of eligibility. Requests, if approved, will be approved for a 5-year initial period, with a renewal option of up to 10 years.

But physician groups are not seeing a benefit with this new block grant program.

“Moving to a block grant system will likely limit the ability of Medicaid patients to receive preventive and needed medical care from their family physicians, and it will only increase the health disparities that exist in these communities, worsen overall health outcomes, and ultimately increase costs,” Gary LeRoy, MD, president of the American Academy of Family Physicians, said in a statement.

The American Medical Association concurred.

“The AMA opposes caps on federal Medicaid funding, such as block grants, because they would increase the number of uninsured and undermine Medicaid’s role as an indispensable safety net,” Patrice Harris, MD, the AMA’s president, said in a statement. “The AMA supports flexibility in Medicaid and encourages CMS to work with states to develop and test new Medicaid models that best meet the needs and priorities of low-income patients. While encouraging flexibility, the AMA is mindful that expanding Medicaid has been a literal lifesaver for low-income patients. We need to find ways to build on this success. We look forward to reviewing the proposal in detail.”

Officials at the American College of Obstetricians and Gynecologists said the changes have the potential to harm women and children’s health, as well as negatively impact physician reimbursement and ultimately access to care.

“Limits on the federal contribution to the Medicaid program would negatively impact patients by forcing states to reduce the number of people who are eligible for Medicaid coverage, eliminate covered services, and increase beneficiary cost-sharing,” ACOG President Ted Anderson, MD, said in a statement. “ACOG is also concerned that this block grant opportunity could lower physician reimbursement for certain services, forcing providers out of the program and jeopardizing patients’ ability to access health care services. Given our nation’s stark rates of maternal mortality and severe maternal morbidity, we are alarmed by the Administration’s willingness to weaken physician payment in Medicaid.”

gtwachtman@mdedge.com

It took less than a day for physician groups to start pushing back at the Centers for Medicare & Medicaid Services over its new Medicaid block grant plan, which was introduced on Jan. 30.

Dubbed “Healthy Adult Opportunity,” the agency is offering all states the chance to participate in a block grant program through the 1115 waiver process.

According to a fact sheet issued by the agency, the program will focus on “adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan. Other very low-income parents, children, pregnant women, elderly adults, and people eligible on the basis of a disability will not be directly affected – except from the improvement that results from states reinvesting savings into strengthening their overall programs.”

States will be operating within a defined budget when participating in the program and expenditures exceeding that defined budget will not be eligible for additional federal funding. Budgets will be based on a state’s historic costs, as well as national and regional trends, and will be tied to inflation with the potential to have adjustments made for extraordinary events. States can set their baseline using the prior year’s total spending or a per-enrollee spending model.

A Jan. 30 letter to state Medicaid directors notes that states participating in the program “will be granted extensive flexibility to test alternative approaches to implementing their Medicaid programs, including the ability to make many ongoing program adjustments without the need for demonstration or state plan amendments that require prior approval.”

Among the activities states can engage in under this plan are adjusting cost-sharing requirements, adopting a closed formulary, and applying additional conditions of eligibility. Requests, if approved, will be approved for a 5-year initial period, with a renewal option of up to 10 years.

But physician groups are not seeing a benefit with this new block grant program.

“Moving to a block grant system will likely limit the ability of Medicaid patients to receive preventive and needed medical care from their family physicians, and it will only increase the health disparities that exist in these communities, worsen overall health outcomes, and ultimately increase costs,” Gary LeRoy, MD, president of the American Academy of Family Physicians, said in a statement.

The American Medical Association concurred.

“The AMA opposes caps on federal Medicaid funding, such as block grants, because they would increase the number of uninsured and undermine Medicaid’s role as an indispensable safety net,” Patrice Harris, MD, the AMA’s president, said in a statement. “The AMA supports flexibility in Medicaid and encourages CMS to work with states to develop and test new Medicaid models that best meet the needs and priorities of low-income patients. While encouraging flexibility, the AMA is mindful that expanding Medicaid has been a literal lifesaver for low-income patients. We need to find ways to build on this success. We look forward to reviewing the proposal in detail.”

Officials at the American College of Obstetricians and Gynecologists said the changes have the potential to harm women and children’s health, as well as negatively impact physician reimbursement and ultimately access to care.

“Limits on the federal contribution to the Medicaid program would negatively impact patients by forcing states to reduce the number of people who are eligible for Medicaid coverage, eliminate covered services, and increase beneficiary cost-sharing,” ACOG President Ted Anderson, MD, said in a statement. “ACOG is also concerned that this block grant opportunity could lower physician reimbursement for certain services, forcing providers out of the program and jeopardizing patients’ ability to access health care services. Given our nation’s stark rates of maternal mortality and severe maternal morbidity, we are alarmed by the Administration’s willingness to weaken physician payment in Medicaid.”

gtwachtman@mdedge.com

Imagine a patient suffering with horrible psoriasis for decades having failed “every available treatment.” Imagine him living all that time with “flaking, cracking, painful, itchy skin,” only to develop cirrhosis after exposure to toxic therapies.

Then imagine the experience for that patient when, 2 weeks after initiating treatment with a new interleukin-17 inhibitor, his skin clears completely.

“Two weeks later it’s all gone – it was a moment to behold,” said Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, who had cared for the man for many years before a psoriasis treatment revolution of sorts took the field of dermatology by storm.

“The progress has been breathtaking – there’s no other way to describe it – and it feels like a miracle every time I see a new patient who has tough disease and I have all these things to offer them,” he continued. “For most patients, I can really help them and make a major difference in their life.”

Much of the progress in psoriasis treatment in the past 50 years unfolded over the past 2 decades, with biologics emerging for psoriasis, said Mark Lebwohl, MD, Waldman professor of dermatology and chair of the Kimberly and Eric J. Waldman department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

Dr. Lebwohl recounted some of his own experiences with psoriasis patients before the advent of treatments – particularly biologics – that have transformed practice.

There was a time when psoriasis patients had little more to turn to than the effective – but “disgusting” – Goeckerman Regimen involving cycles of UVB light exposure and topical crude coal tar application. Initially, the regimen, which was introduced in the 1920s, was used around the clock on an inpatient basis until the skin cleared, Dr. Lebwohl said.

In the 1970s, the immunosuppressive chemotherapy drug methotrexate became the first oral systemic therapy approved for severe psoriasis. For those with disabling disease, it offered some hope for relief, but only about 40% of patients achieved at least a 75% reduction in the Psoriasis Area and Severity Index score (PASI 75), he said, adding that they did so at the expense of the liver and bone marrow. “But it was the only thing we had for severe psoriasis other than light treatments.”

In the 1980s and 1990s, oral retinoids emerged as a treatment for psoriasis, and the immunosuppressive drug cyclosporine used to prevent organ rejection in some transplant patients was found to clear psoriasis in affected transplant recipients. Although they brought relief to some patients with severe, disabling disease, these also came with a high price. “It’s not that effective, and it has lots of side effects ... and causes kidney damage in essentially 100% of patients,” Dr. Lebwohl said of cyclosporine.

“So we had treatments that worked, but because the side effects were sufficiently severe, a lot of patients were not treated,” he said.

Enter the biologics era

The early 2000s brought the first two approvals for psoriasis: alefacept (Amevive), a “modestly effective, but quite safe” immunosuppressive dimeric fusion protein approved in early 2003 for moderate to severe plaque psoriasis, and efalizumab (Raptiva), a recombinant humanized monoclonal antibody approved in October 2003; both were T-cell–targeted therapies. The former was withdrawn from the market voluntarily as newer agents became available, and the latter was withdrawn in 2009 because of a link with development of progressive multifocal leukoencephalopathy.

Tumor necrosis factor (TNF) blockers, which had been used effectively for RA and Crohn’s disease, emerged next, and were highly effective, much safer than the systemic treatments, and gained “very widespread use,” Dr. Lebwohl said.

Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, also a prolific researcher – and chair of the guidelines committee that published two new sets of guidelines for psoriasis treatment in 2019 – said that the field of dermatology was “late to the biologic evolution,” as many of the early biologics were first approved for PsA.

“But over the last 10 years, things have changed dramatically,” he said. “After that we suddenly leapt ahead of everybody. ... We now have 11 biologic drugs approved for psoriasis, which is more than any other disease has available.”

It’s been “highly exciting” to see this “evolution and revolution,” he commented, adding that one of the next challenges is to address the comorbidities, such as cardiovascular disease, associated with psoriasis.

“The big question now ... is if you improve skin and you improve joints, can you potentially reduce the risk of coronary artery disease,” he said. “Everybody is looking at that, and to me it’s one of the most exciting things that we’re doing.”

Work is ongoing to look at whether the IL-17s and IL-23s have “other indications outside of the skin and joints,” both within and outside of dermatology.

Like Dr. Gottlieb, Dr. Menter also mentioned the potential for hidradenitis suppurativa, and also for a condition that is rarely discussed or studied: genital psoriasis. Ixekizumab has recently been shown to work in about 75% of patients with genital psoriasis, he noted.

Another important area of research is the identification of biomarkers for predicting response and relapse, he said. For now, biomarker research has disappointed, he added, predicting that it will take at least 3-5 years before biomarkers to help guide treatment are identified.

Indeed, Dr. Gelfand, who also is director of the Psoriasis and Phototherapy Treatment Center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, agreed there is a need for research to improve treatment selection.

Advances are being made in genetics – with more than 80 different genes now identified as being related to psoriasis – and in medical informatics – which allow thousands of patients to be followed for years, he said, noting that this could elucidate immunopathological features that can improve treatments, predict and prevent comorbidity, and further improve outcomes.

“We also need care that is more patient centered,” he said, describing the ongoing pragmatic LITE trial of home- or office-based phototherapy for which he is the lead investigator, and other studies that he hopes will expand access to care.

Kenneth Brian Gordon, MD, chair and professor of dermatology at the Medical College of Wisconsin, Milwaukee, whose career started in the basic science immunology arena, added the need for expanding benefit to patients with more-moderate disease. Like Dr. Menter, he identified psoriasis as the area in medicine that has had the greatest degree of advancement, except perhaps for hepatitis C.

He described the process not as a “bench-to-bedside” story, but as a bedside-to-bench, then “back-to-bedside” story.

It was really about taking those early T-cell–targeted biologics and anti-TNF agents from bedside to bench with the realization of the importance of the IL-23 and IL-17 pathways, and that understanding led back to the bedside with the development of the newest agents – and to a “huge difference in patient’s lives.”

“But we’ve gotten so good at treating patients with severe disease ... the question now is how to take care of those with more-moderate disease,” he said, noting that a focus on cost and better delivery systems will be needed for that population.

That research is underway, and the future looks bright – and clear.
 

“I think with psoriasis therapy and where we’ve come in the last 20 years ... we have a hard time remembering what it was like before we had biologic agents” he said. “Our perspective has changed a lot, and sometimes we forget that.”

In fact, “psoriasis has sort of dragged dermatology into the world of modern clinical trial science, and we can now apply that to all sorts of other diseases,” he said. “The psoriasis trials were the first really well-done large-scale trials in dermatology, and I think that has given dermatology a real leg up in how we do clinical research and how we do evidence-based medicine.”

All of the doctors interviewed for this story have received funds and/or honoraria from, consulted with, are employed with, or served on the advisory boards of manufacturers of biologics. Dr. Gelfand is a copatent holder of resiquimod for treatment of cutaneous T-cell lymphoma and is deputy editor of the Journal of Investigative Dermatology.

sworcester@mdedge.com
 

Imagine a patient suffering with horrible psoriasis for decades having failed “every available treatment.” Imagine him living all that time with “flaking, cracking, painful, itchy skin,” only to develop cirrhosis after exposure to toxic therapies.

Then imagine the experience for that patient when, 2 weeks after initiating treatment with a new interleukin-17 inhibitor, his skin clears completely.

“Two weeks later it’s all gone – it was a moment to behold,” said Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, who had cared for the man for many years before a psoriasis treatment revolution of sorts took the field of dermatology by storm.

“The progress has been breathtaking – there’s no other way to describe it – and it feels like a miracle every time I see a new patient who has tough disease and I have all these things to offer them,” he continued. “For most patients, I can really help them and make a major difference in their life.”

Much of the progress in psoriasis treatment in the past 50 years unfolded over the past 2 decades, with biologics emerging for psoriasis, said Mark Lebwohl, MD, Waldman professor of dermatology and chair of the Kimberly and Eric J. Waldman department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

Dr. Lebwohl recounted some of his own experiences with psoriasis patients before the advent of treatments – particularly biologics – that have transformed practice.

There was a time when psoriasis patients had little more to turn to than the effective – but “disgusting” – Goeckerman Regimen involving cycles of UVB light exposure and topical crude coal tar application. Initially, the regimen, which was introduced in the 1920s, was used around the clock on an inpatient basis until the skin cleared, Dr. Lebwohl said.

In the 1970s, the immunosuppressive chemotherapy drug methotrexate became the first oral systemic therapy approved for severe psoriasis. For those with disabling disease, it offered some hope for relief, but only about 40% of patients achieved at least a 75% reduction in the Psoriasis Area and Severity Index score (PASI 75), he said, adding that they did so at the expense of the liver and bone marrow. “But it was the only thing we had for severe psoriasis other than light treatments.”

In the 1980s and 1990s, oral retinoids emerged as a treatment for psoriasis, and the immunosuppressive drug cyclosporine used to prevent organ rejection in some transplant patients was found to clear psoriasis in affected transplant recipients. Although they brought relief to some patients with severe, disabling disease, these also came with a high price. “It’s not that effective, and it has lots of side effects ... and causes kidney damage in essentially 100% of patients,” Dr. Lebwohl said of cyclosporine.

“So we had treatments that worked, but because the side effects were sufficiently severe, a lot of patients were not treated,” he said.

Enter the biologics era

The early 2000s brought the first two approvals for psoriasis: alefacept (Amevive), a “modestly effective, but quite safe” immunosuppressive dimeric fusion protein approved in early 2003 for moderate to severe plaque psoriasis, and efalizumab (Raptiva), a recombinant humanized monoclonal antibody approved in October 2003; both were T-cell–targeted therapies. The former was withdrawn from the market voluntarily as newer agents became available, and the latter was withdrawn in 2009 because of a link with development of progressive multifocal leukoencephalopathy.

Tumor necrosis factor (TNF) blockers, which had been used effectively for RA and Crohn’s disease, emerged next, and were highly effective, much safer than the systemic treatments, and gained “very widespread use,” Dr. Lebwohl said.

Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, also a prolific researcher – and chair of the guidelines committee that published two new sets of guidelines for psoriasis treatment in 2019 – said that the field of dermatology was “late to the biologic evolution,” as many of the early biologics were first approved for PsA.

“But over the last 10 years, things have changed dramatically,” he said. “After that we suddenly leapt ahead of everybody. ... We now have 11 biologic drugs approved for psoriasis, which is more than any other disease has available.”

It’s been “highly exciting” to see this “evolution and revolution,” he commented, adding that one of the next challenges is to address the comorbidities, such as cardiovascular disease, associated with psoriasis.

“The big question now ... is if you improve skin and you improve joints, can you potentially reduce the risk of coronary artery disease,” he said. “Everybody is looking at that, and to me it’s one of the most exciting things that we’re doing.”

Work is ongoing to look at whether the IL-17s and IL-23s have “other indications outside of the skin and joints,” both within and outside of dermatology.

Like Dr. Gottlieb, Dr. Menter also mentioned the potential for hidradenitis suppurativa, and also for a condition that is rarely discussed or studied: genital psoriasis. Ixekizumab has recently been shown to work in about 75% of patients with genital psoriasis, he noted.

Another important area of research is the identification of biomarkers for predicting response and relapse, he said. For now, biomarker research has disappointed, he added, predicting that it will take at least 3-5 years before biomarkers to help guide treatment are identified.

Indeed, Dr. Gelfand, who also is director of the Psoriasis and Phototherapy Treatment Center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, agreed there is a need for research to improve treatment selection.

Advances are being made in genetics – with more than 80 different genes now identified as being related to psoriasis – and in medical informatics – which allow thousands of patients to be followed for years, he said, noting that this could elucidate immunopathological features that can improve treatments, predict and prevent comorbidity, and further improve outcomes.

“We also need care that is more patient centered,” he said, describing the ongoing pragmatic LITE trial of home- or office-based phototherapy for which he is the lead investigator, and other studies that he hopes will expand access to care.

Kenneth Brian Gordon, MD, chair and professor of dermatology at the Medical College of Wisconsin, Milwaukee, whose career started in the basic science immunology arena, added the need for expanding benefit to patients with more-moderate disease. Like Dr. Menter, he identified psoriasis as the area in medicine that has had the greatest degree of advancement, except perhaps for hepatitis C.

He described the process not as a “bench-to-bedside” story, but as a bedside-to-bench, then “back-to-bedside” story.

It was really about taking those early T-cell–targeted biologics and anti-TNF agents from bedside to bench with the realization of the importance of the IL-23 and IL-17 pathways, and that understanding led back to the bedside with the development of the newest agents – and to a “huge difference in patient’s lives.”

“But we’ve gotten so good at treating patients with severe disease ... the question now is how to take care of those with more-moderate disease,” he said, noting that a focus on cost and better delivery systems will be needed for that population.

That research is underway, and the future looks bright – and clear.
 

“I think with psoriasis therapy and where we’ve come in the last 20 years ... we have a hard time remembering what it was like before we had biologic agents” he said. “Our perspective has changed a lot, and sometimes we forget that.”

In fact, “psoriasis has sort of dragged dermatology into the world of modern clinical trial science, and we can now apply that to all sorts of other diseases,” he said. “The psoriasis trials were the first really well-done large-scale trials in dermatology, and I think that has given dermatology a real leg up in how we do clinical research and how we do evidence-based medicine.”

All of the doctors interviewed for this story have received funds and/or honoraria from, consulted with, are employed with, or served on the advisory boards of manufacturers of biologics. Dr. Gelfand is a copatent holder of resiquimod for treatment of cutaneous T-cell lymphoma and is deputy editor of the Journal of Investigative Dermatology.

sworcester@mdedge.com
 

Imagine a patient suffering with horrible psoriasis for decades having failed “every available treatment.” Imagine him living all that time with “flaking, cracking, painful, itchy skin,” only to develop cirrhosis after exposure to toxic therapies.

Then imagine the experience for that patient when, 2 weeks after initiating treatment with a new interleukin-17 inhibitor, his skin clears completely.

“Two weeks later it’s all gone – it was a moment to behold,” said Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, who had cared for the man for many years before a psoriasis treatment revolution of sorts took the field of dermatology by storm.

“The progress has been breathtaking – there’s no other way to describe it – and it feels like a miracle every time I see a new patient who has tough disease and I have all these things to offer them,” he continued. “For most patients, I can really help them and make a major difference in their life.”

Much of the progress in psoriasis treatment in the past 50 years unfolded over the past 2 decades, with biologics emerging for psoriasis, said Mark Lebwohl, MD, Waldman professor of dermatology and chair of the Kimberly and Eric J. Waldman department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

Dr. Lebwohl recounted some of his own experiences with psoriasis patients before the advent of treatments – particularly biologics – that have transformed practice.

There was a time when psoriasis patients had little more to turn to than the effective – but “disgusting” – Goeckerman Regimen involving cycles of UVB light exposure and topical crude coal tar application. Initially, the regimen, which was introduced in the 1920s, was used around the clock on an inpatient basis until the skin cleared, Dr. Lebwohl said.

In the 1970s, the immunosuppressive chemotherapy drug methotrexate became the first oral systemic therapy approved for severe psoriasis. For those with disabling disease, it offered some hope for relief, but only about 40% of patients achieved at least a 75% reduction in the Psoriasis Area and Severity Index score (PASI 75), he said, adding that they did so at the expense of the liver and bone marrow. “But it was the only thing we had for severe psoriasis other than light treatments.”

In the 1980s and 1990s, oral retinoids emerged as a treatment for psoriasis, and the immunosuppressive drug cyclosporine used to prevent organ rejection in some transplant patients was found to clear psoriasis in affected transplant recipients. Although they brought relief to some patients with severe, disabling disease, these also came with a high price. “It’s not that effective, and it has lots of side effects ... and causes kidney damage in essentially 100% of patients,” Dr. Lebwohl said of cyclosporine.

“So we had treatments that worked, but because the side effects were sufficiently severe, a lot of patients were not treated,” he said.

Enter the biologics era

The early 2000s brought the first two approvals for psoriasis: alefacept (Amevive), a “modestly effective, but quite safe” immunosuppressive dimeric fusion protein approved in early 2003 for moderate to severe plaque psoriasis, and efalizumab (Raptiva), a recombinant humanized monoclonal antibody approved in October 2003; both were T-cell–targeted therapies. The former was withdrawn from the market voluntarily as newer agents became available, and the latter was withdrawn in 2009 because of a link with development of progressive multifocal leukoencephalopathy.

Tumor necrosis factor (TNF) blockers, which had been used effectively for RA and Crohn’s disease, emerged next, and were highly effective, much safer than the systemic treatments, and gained “very widespread use,” Dr. Lebwohl said.

Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, also a prolific researcher – and chair of the guidelines committee that published two new sets of guidelines for psoriasis treatment in 2019 – said that the field of dermatology was “late to the biologic evolution,” as many of the early biologics were first approved for PsA.

“But over the last 10 years, things have changed dramatically,” he said. “After that we suddenly leapt ahead of everybody. ... We now have 11 biologic drugs approved for psoriasis, which is more than any other disease has available.”

It’s been “highly exciting” to see this “evolution and revolution,” he commented, adding that one of the next challenges is to address the comorbidities, such as cardiovascular disease, associated with psoriasis.

“The big question now ... is if you improve skin and you improve joints, can you potentially reduce the risk of coronary artery disease,” he said. “Everybody is looking at that, and to me it’s one of the most exciting things that we’re doing.”

Work is ongoing to look at whether the IL-17s and IL-23s have “other indications outside of the skin and joints,” both within and outside of dermatology.

Like Dr. Gottlieb, Dr. Menter also mentioned the potential for hidradenitis suppurativa, and also for a condition that is rarely discussed or studied: genital psoriasis. Ixekizumab has recently been shown to work in about 75% of patients with genital psoriasis, he noted.

Another important area of research is the identification of biomarkers for predicting response and relapse, he said. For now, biomarker research has disappointed, he added, predicting that it will take at least 3-5 years before biomarkers to help guide treatment are identified.

Indeed, Dr. Gelfand, who also is director of the Psoriasis and Phototherapy Treatment Center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, agreed there is a need for research to improve treatment selection.

Advances are being made in genetics – with more than 80 different genes now identified as being related to psoriasis – and in medical informatics – which allow thousands of patients to be followed for years, he said, noting that this could elucidate immunopathological features that can improve treatments, predict and prevent comorbidity, and further improve outcomes.

“We also need care that is more patient centered,” he said, describing the ongoing pragmatic LITE trial of home- or office-based phototherapy for which he is the lead investigator, and other studies that he hopes will expand access to care.

Kenneth Brian Gordon, MD, chair and professor of dermatology at the Medical College of Wisconsin, Milwaukee, whose career started in the basic science immunology arena, added the need for expanding benefit to patients with more-moderate disease. Like Dr. Menter, he identified psoriasis as the area in medicine that has had the greatest degree of advancement, except perhaps for hepatitis C.

He described the process not as a “bench-to-bedside” story, but as a bedside-to-bench, then “back-to-bedside” story.

It was really about taking those early T-cell–targeted biologics and anti-TNF agents from bedside to bench with the realization of the importance of the IL-23 and IL-17 pathways, and that understanding led back to the bedside with the development of the newest agents – and to a “huge difference in patient’s lives.”

“But we’ve gotten so good at treating patients with severe disease ... the question now is how to take care of those with more-moderate disease,” he said, noting that a focus on cost and better delivery systems will be needed for that population.

That research is underway, and the future looks bright – and clear.
 

“I think with psoriasis therapy and where we’ve come in the last 20 years ... we have a hard time remembering what it was like before we had biologic agents” he said. “Our perspective has changed a lot, and sometimes we forget that.”

In fact, “psoriasis has sort of dragged dermatology into the world of modern clinical trial science, and we can now apply that to all sorts of other diseases,” he said. “The psoriasis trials were the first really well-done large-scale trials in dermatology, and I think that has given dermatology a real leg up in how we do clinical research and how we do evidence-based medicine.”

All of the doctors interviewed for this story have received funds and/or honoraria from, consulted with, are employed with, or served on the advisory boards of manufacturers of biologics. Dr. Gelfand is a copatent holder of resiquimod for treatment of cutaneous T-cell lymphoma and is deputy editor of the Journal of Investigative Dermatology.

sworcester@mdedge.com