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ACIP recommends Shingrix for younger immunocompromised adults; updates pneumococcal vaccine guidance
The U.S. Centers for Disease Control and Prevention Advisory Committee of Immunization Practices has voted to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in immunodeficient or immunosuppressed adults aged 19 or older. The recommendation was approved Oct. 20 by a unanimous vote.
Shingles is a reactivation of varicella zoster virus (VZV), the virus that causes chickenpox. There are about 1 million cases of shingles in the United States every year, according to CDC estimates, and one in three Americans will develop shingles over their lifetime. While adults older than 50 are one of the most vulnerable groups to reinfection – with about 99% having been infected with VZV – a weakened immune system is another common risk factor.
The Food and Drug Administration originally approved Shingrix in 2017 for the prevention of shingles in adults over 50; in July of this year, the vaccine was approved for immunodeficient adults aged 18 or older. The approval and subsequent recommendation by ACIP were based on clinical studies of Shingrix in adults being treated for hematologic malignancies or those who had undergone an autologous hematopoietic stem cell transplant.
According to a press statement from the FDA, “Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.”
For adults with functional immune systems, Shingrix is administered in two doses, 2-6 months apart. For immunocompromised individuals, the second dose can be given 1-2 months after the first dose.
During the same meeting, ACIP also voted to recommend pneumococcal vaccines for routine use in adults older than 65 and in adults aged 19-64 with chronic conditions such as diabetes, chronic heart disease, chronic liver disease, and HIV, and disease risk factors like smoking and alcoholism. The recommendation only applies to those who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The recommendation states that qualifying adults should be vaccinated with the 15-valent pneumococcal conjugate vaccine Vaxneuvance followed by Pneumovax23, or a single dose of the 20-valent pneumococcal conjugate vaccine Prevnar 20.
These ACIP recommendations will now be sent to the directors of the CDC and the U.S. Department of Health & Human Services for review and approval. If approved, the recommendations are considered finalized and will be published in a future Morbidity and Mortality Weekly Report.
A version of this article first appeared on Medscape.com.
The U.S. Centers for Disease Control and Prevention Advisory Committee of Immunization Practices has voted to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in immunodeficient or immunosuppressed adults aged 19 or older. The recommendation was approved Oct. 20 by a unanimous vote.
Shingles is a reactivation of varicella zoster virus (VZV), the virus that causes chickenpox. There are about 1 million cases of shingles in the United States every year, according to CDC estimates, and one in three Americans will develop shingles over their lifetime. While adults older than 50 are one of the most vulnerable groups to reinfection – with about 99% having been infected with VZV – a weakened immune system is another common risk factor.
The Food and Drug Administration originally approved Shingrix in 2017 for the prevention of shingles in adults over 50; in July of this year, the vaccine was approved for immunodeficient adults aged 18 or older. The approval and subsequent recommendation by ACIP were based on clinical studies of Shingrix in adults being treated for hematologic malignancies or those who had undergone an autologous hematopoietic stem cell transplant.
According to a press statement from the FDA, “Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.”
For adults with functional immune systems, Shingrix is administered in two doses, 2-6 months apart. For immunocompromised individuals, the second dose can be given 1-2 months after the first dose.
During the same meeting, ACIP also voted to recommend pneumococcal vaccines for routine use in adults older than 65 and in adults aged 19-64 with chronic conditions such as diabetes, chronic heart disease, chronic liver disease, and HIV, and disease risk factors like smoking and alcoholism. The recommendation only applies to those who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The recommendation states that qualifying adults should be vaccinated with the 15-valent pneumococcal conjugate vaccine Vaxneuvance followed by Pneumovax23, or a single dose of the 20-valent pneumococcal conjugate vaccine Prevnar 20.
These ACIP recommendations will now be sent to the directors of the CDC and the U.S. Department of Health & Human Services for review and approval. If approved, the recommendations are considered finalized and will be published in a future Morbidity and Mortality Weekly Report.
A version of this article first appeared on Medscape.com.
The U.S. Centers for Disease Control and Prevention Advisory Committee of Immunization Practices has voted to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in immunodeficient or immunosuppressed adults aged 19 or older. The recommendation was approved Oct. 20 by a unanimous vote.
Shingles is a reactivation of varicella zoster virus (VZV), the virus that causes chickenpox. There are about 1 million cases of shingles in the United States every year, according to CDC estimates, and one in three Americans will develop shingles over their lifetime. While adults older than 50 are one of the most vulnerable groups to reinfection – with about 99% having been infected with VZV – a weakened immune system is another common risk factor.
The Food and Drug Administration originally approved Shingrix in 2017 for the prevention of shingles in adults over 50; in July of this year, the vaccine was approved for immunodeficient adults aged 18 or older. The approval and subsequent recommendation by ACIP were based on clinical studies of Shingrix in adults being treated for hematologic malignancies or those who had undergone an autologous hematopoietic stem cell transplant.
According to a press statement from the FDA, “Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.”
For adults with functional immune systems, Shingrix is administered in two doses, 2-6 months apart. For immunocompromised individuals, the second dose can be given 1-2 months after the first dose.
During the same meeting, ACIP also voted to recommend pneumococcal vaccines for routine use in adults older than 65 and in adults aged 19-64 with chronic conditions such as diabetes, chronic heart disease, chronic liver disease, and HIV, and disease risk factors like smoking and alcoholism. The recommendation only applies to those who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The recommendation states that qualifying adults should be vaccinated with the 15-valent pneumococcal conjugate vaccine Vaxneuvance followed by Pneumovax23, or a single dose of the 20-valent pneumococcal conjugate vaccine Prevnar 20.
These ACIP recommendations will now be sent to the directors of the CDC and the U.S. Department of Health & Human Services for review and approval. If approved, the recommendations are considered finalized and will be published in a future Morbidity and Mortality Weekly Report.
A version of this article first appeared on Medscape.com.
CDC panel backs COVID-19 boosters for nearly all adults
Editor’s note: This story was updated with the CDC director’s endorsement.
Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.
The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.
“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.
She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.
The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.
Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.
They are:
- Anyone over age 65.
- Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
- Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.
These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.
There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
Questions, concerns
Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.
“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.
She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.
“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.
The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.
But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.
On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.
Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.
The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.
Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.
The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.
These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
“Real world” recommendations
In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.
“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.
Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.
The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.
Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.
Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.
Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.
The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.
In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.
Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.
“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
A version of this article first appeared on WebMD.com.
Editor’s note: This story was updated with the CDC director’s endorsement.
Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.
The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.
“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.
She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.
The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.
Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.
They are:
- Anyone over age 65.
- Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
- Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.
These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.
There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
Questions, concerns
Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.
“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.
She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.
“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.
The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.
But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.
On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.
Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.
The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.
Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.
The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.
These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
“Real world” recommendations
In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.
“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.
Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.
The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.
Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.
Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.
Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.
The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.
In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.
Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.
“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
A version of this article first appeared on WebMD.com.
Editor’s note: This story was updated with the CDC director’s endorsement.
Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.
The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.
“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.
She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.
The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.
Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.
They are:
- Anyone over age 65.
- Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
- Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.
These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.
There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
Questions, concerns
Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.
“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.
She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.
“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.
The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.
But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.
On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.
Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.
The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.
Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.
The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.
These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
“Real world” recommendations
In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.
“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.
Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.
The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.
Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.
Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.
Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.
The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.
In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.
Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.
“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
A version of this article first appeared on WebMD.com.
The compass that points toward food
The new breakfast of champions
We love a good ranking system here at LOTME world headquarters, especially the food-based ones. Luckily for us (and our readers), a new study published in Nature Food offers a food-based ranking system.
Sadly, unlike the last food-related ranking we covered, the Food Compass doesn’t tell you how much life you gain or lose from each food you eat down to the precise minute. Instead, it favors a more simple rating system from 1 to 100, with healthier foods scoring higher, and even incorporates mixed foods, not just single ingredients. This makes it better at assessing and comparing food combinations, rather than trying to mix and match the many ingredients that go into even relatively simple recipes.
The top and bottom of the rankings contain the usual suspects. Legumes and nuts, at 78.6, had the highest average score among the broad food groups, followed by fruits and then vegetables. Rounding out the bottom were sweets and savory snacks at 16.4. Among the individual foods, there were perfect scores in both directions: 100 for raw raspberries, while instant noodle soup and nonchocolate, ready-to-eat, nonfat pudding (very specific there) each earned a 1.
There are a few surprises in between. Nonfat cappuccino received a green light from the investigators, great news for the coffee drinkers out there. A serving of sweet potato chips scored better than a simple grilled chicken breast, and a slice of pizza, loaded up with extra meat and a thick crust, is still more nutritious than a bowl of corn flakes.
Neither is good for you, of course, but we’re still going to take this as a sign that pizza is the ideal breakfast food. Add that to your morning coffee, and you’re ready to start the day. Move over Wheaties, there’s a new breakfast of champions.
COVID-19 resisters, please step forward
Some people have all the luck with good genes, both inside and out.
Genetically speaking, humans are 99.9% the same, but that 0.1% is where things get interesting. Because of that 0.1% difference, some people are more likely to contract diseases such as HIV, while others might be more resistant. These small differences in genetic code could be the key to finding treatments for COVID-19.
“The introduction of SARS-CoV-2 to a naive population, on a global scale, has provided yet another demonstration of the remarkable clinical variability between individuals in the course of infection, ranging from asymptomatic infections to life-threatening disease,” the researchers said in Nature Immunology.
The investigators have been scouring the world to find people who might be resistant to SARS-CoV-2 and have enrolled over 400 individuals in a “dedicated resistance study cohort,” according to ScienceAlert.
The investigators are looking at households in which families were infected but one member did not show severe symptoms, or for individuals who have been around the virus multiple times and haven’t contracted it. They are also looking at blood types.
Enrollment is ongoing, so if you’ve been in contact with COVID-19 multiple times and have not gotten sick, scientists would like to hear from you.
Better living through parasitization
How would you like to triple your life span, while maintaining a youthful appearance and gaining special social standing and privileges?
Sounds pretty good, right, so what’s the catch? Well, you have to be infected with a tapeworm ... and you have to be an ant.
If you are an ant, here’s the deal: Workers of the species Temnothorax nylanderi that have tapeworms live much longer than uninfected workers, and while living out those longer lives they do less work and receive gifts of food.
In a study conducted at Johannes Gutenberg University in Mainz, Germany, infected ants’ metabolic rates and lipid levels were similar to those of younger ants, and they appeared to remain in a permanent juvenile stage as a result of the infection, the investigators reported.
They tracked Temnothorax colonies for 3 years, at which point 95% of the uninfected workers had died but over half of the infected ants were still alive. Pretty great, right? Wrong. There was no joy in antville, for the uninfected workers had struck out. “Strained by the additional burden of their wormed-up nestmates, they seemed to be shunting care away from their queen. They were dying sooner than they might have if the colonies had remained parasite-free,” according to an article in the Atlantic.
Does this situation seem just a wee bit familiar? A small group lives longer, healthier lives and enjoys special privileges while the majority of that society works harder to support them? We’ll put it into the form of a chicken-and-egg argument: Which came first, the tapeworms or the one-percenters?
Laughing the pandemic stress away
Doomscrolling on social media has become one of the world’s favorite pastimes during the pandemic, but research shows that those memes about COVID-19 might combat the doom and gloom of the outside world.
A study recently published in Psychology of Popular Media showed that viewing memes, specifically those that were COVID-19 related, actually lessened the stress of the pandemic.
The researchers conducted a survey of 748 people aged 18-88 years. Each participant viewed three memes with text or three memes with text but no images. All three memes had similar cuteness levels (baby or adult), subject (animal or human), and caption (COVID-19–related or not). The participants were then asked to report on their stress levels and feelings before and after the memes.
The people who looked at memes felt less stressed and a higher humor level, especially the participants who received the COVID-19 memes. Study Finds said that they had more “pandemic-coping confidence” than those who got regular memes.
“While the World Health Organization recommended that people avoid too much COVID-related media for the benefit of their mental health, our research reveals that memes about COVID-19 could help people feel more confident in their ability to deal with the pandemic,” lead author Jessica Gall Myrick, PhD, said in a written statement. “The positive emotions associated with this type of content may make people feel psychologically safer and therefore better able to pay attention to the underlying messages related to health threats.”
So if you think you’ve been wasting time looking at memes during this pandemic, think again. It actually might keep you sane. Keep on scrolling!
Giving the gift of stress reduction
It’s a big week here at LOTME. You’ve just read our 100th edition, and to help celebrate that milestone – along with Count Your Buttons Day, Celebration of the Mind Day, and the International Day of the Nacho – we’re presenting an extra-special bonus feature, courtesy of Sad and Useless: The most depressive humor site on the Internet.
We hope you’ll stop your doomscrolling long enough to enjoy this stress-reducing meme. Thanks for reading!
The new breakfast of champions
We love a good ranking system here at LOTME world headquarters, especially the food-based ones. Luckily for us (and our readers), a new study published in Nature Food offers a food-based ranking system.
Sadly, unlike the last food-related ranking we covered, the Food Compass doesn’t tell you how much life you gain or lose from each food you eat down to the precise minute. Instead, it favors a more simple rating system from 1 to 100, with healthier foods scoring higher, and even incorporates mixed foods, not just single ingredients. This makes it better at assessing and comparing food combinations, rather than trying to mix and match the many ingredients that go into even relatively simple recipes.
The top and bottom of the rankings contain the usual suspects. Legumes and nuts, at 78.6, had the highest average score among the broad food groups, followed by fruits and then vegetables. Rounding out the bottom were sweets and savory snacks at 16.4. Among the individual foods, there were perfect scores in both directions: 100 for raw raspberries, while instant noodle soup and nonchocolate, ready-to-eat, nonfat pudding (very specific there) each earned a 1.
There are a few surprises in between. Nonfat cappuccino received a green light from the investigators, great news for the coffee drinkers out there. A serving of sweet potato chips scored better than a simple grilled chicken breast, and a slice of pizza, loaded up with extra meat and a thick crust, is still more nutritious than a bowl of corn flakes.
Neither is good for you, of course, but we’re still going to take this as a sign that pizza is the ideal breakfast food. Add that to your morning coffee, and you’re ready to start the day. Move over Wheaties, there’s a new breakfast of champions.
COVID-19 resisters, please step forward
Some people have all the luck with good genes, both inside and out.
Genetically speaking, humans are 99.9% the same, but that 0.1% is where things get interesting. Because of that 0.1% difference, some people are more likely to contract diseases such as HIV, while others might be more resistant. These small differences in genetic code could be the key to finding treatments for COVID-19.
“The introduction of SARS-CoV-2 to a naive population, on a global scale, has provided yet another demonstration of the remarkable clinical variability between individuals in the course of infection, ranging from asymptomatic infections to life-threatening disease,” the researchers said in Nature Immunology.
The investigators have been scouring the world to find people who might be resistant to SARS-CoV-2 and have enrolled over 400 individuals in a “dedicated resistance study cohort,” according to ScienceAlert.
The investigators are looking at households in which families were infected but one member did not show severe symptoms, or for individuals who have been around the virus multiple times and haven’t contracted it. They are also looking at blood types.
Enrollment is ongoing, so if you’ve been in contact with COVID-19 multiple times and have not gotten sick, scientists would like to hear from you.
Better living through parasitization
How would you like to triple your life span, while maintaining a youthful appearance and gaining special social standing and privileges?
Sounds pretty good, right, so what’s the catch? Well, you have to be infected with a tapeworm ... and you have to be an ant.
If you are an ant, here’s the deal: Workers of the species Temnothorax nylanderi that have tapeworms live much longer than uninfected workers, and while living out those longer lives they do less work and receive gifts of food.
In a study conducted at Johannes Gutenberg University in Mainz, Germany, infected ants’ metabolic rates and lipid levels were similar to those of younger ants, and they appeared to remain in a permanent juvenile stage as a result of the infection, the investigators reported.
They tracked Temnothorax colonies for 3 years, at which point 95% of the uninfected workers had died but over half of the infected ants were still alive. Pretty great, right? Wrong. There was no joy in antville, for the uninfected workers had struck out. “Strained by the additional burden of their wormed-up nestmates, they seemed to be shunting care away from their queen. They were dying sooner than they might have if the colonies had remained parasite-free,” according to an article in the Atlantic.
Does this situation seem just a wee bit familiar? A small group lives longer, healthier lives and enjoys special privileges while the majority of that society works harder to support them? We’ll put it into the form of a chicken-and-egg argument: Which came first, the tapeworms or the one-percenters?
Laughing the pandemic stress away
Doomscrolling on social media has become one of the world’s favorite pastimes during the pandemic, but research shows that those memes about COVID-19 might combat the doom and gloom of the outside world.
A study recently published in Psychology of Popular Media showed that viewing memes, specifically those that were COVID-19 related, actually lessened the stress of the pandemic.
The researchers conducted a survey of 748 people aged 18-88 years. Each participant viewed three memes with text or three memes with text but no images. All three memes had similar cuteness levels (baby or adult), subject (animal or human), and caption (COVID-19–related or not). The participants were then asked to report on their stress levels and feelings before and after the memes.
The people who looked at memes felt less stressed and a higher humor level, especially the participants who received the COVID-19 memes. Study Finds said that they had more “pandemic-coping confidence” than those who got regular memes.
“While the World Health Organization recommended that people avoid too much COVID-related media for the benefit of their mental health, our research reveals that memes about COVID-19 could help people feel more confident in their ability to deal with the pandemic,” lead author Jessica Gall Myrick, PhD, said in a written statement. “The positive emotions associated with this type of content may make people feel psychologically safer and therefore better able to pay attention to the underlying messages related to health threats.”
So if you think you’ve been wasting time looking at memes during this pandemic, think again. It actually might keep you sane. Keep on scrolling!
Giving the gift of stress reduction
It’s a big week here at LOTME. You’ve just read our 100th edition, and to help celebrate that milestone – along with Count Your Buttons Day, Celebration of the Mind Day, and the International Day of the Nacho – we’re presenting an extra-special bonus feature, courtesy of Sad and Useless: The most depressive humor site on the Internet.
We hope you’ll stop your doomscrolling long enough to enjoy this stress-reducing meme. Thanks for reading!
The new breakfast of champions
We love a good ranking system here at LOTME world headquarters, especially the food-based ones. Luckily for us (and our readers), a new study published in Nature Food offers a food-based ranking system.
Sadly, unlike the last food-related ranking we covered, the Food Compass doesn’t tell you how much life you gain or lose from each food you eat down to the precise minute. Instead, it favors a more simple rating system from 1 to 100, with healthier foods scoring higher, and even incorporates mixed foods, not just single ingredients. This makes it better at assessing and comparing food combinations, rather than trying to mix and match the many ingredients that go into even relatively simple recipes.
The top and bottom of the rankings contain the usual suspects. Legumes and nuts, at 78.6, had the highest average score among the broad food groups, followed by fruits and then vegetables. Rounding out the bottom were sweets and savory snacks at 16.4. Among the individual foods, there were perfect scores in both directions: 100 for raw raspberries, while instant noodle soup and nonchocolate, ready-to-eat, nonfat pudding (very specific there) each earned a 1.
There are a few surprises in between. Nonfat cappuccino received a green light from the investigators, great news for the coffee drinkers out there. A serving of sweet potato chips scored better than a simple grilled chicken breast, and a slice of pizza, loaded up with extra meat and a thick crust, is still more nutritious than a bowl of corn flakes.
Neither is good for you, of course, but we’re still going to take this as a sign that pizza is the ideal breakfast food. Add that to your morning coffee, and you’re ready to start the day. Move over Wheaties, there’s a new breakfast of champions.
COVID-19 resisters, please step forward
Some people have all the luck with good genes, both inside and out.
Genetically speaking, humans are 99.9% the same, but that 0.1% is where things get interesting. Because of that 0.1% difference, some people are more likely to contract diseases such as HIV, while others might be more resistant. These small differences in genetic code could be the key to finding treatments for COVID-19.
“The introduction of SARS-CoV-2 to a naive population, on a global scale, has provided yet another demonstration of the remarkable clinical variability between individuals in the course of infection, ranging from asymptomatic infections to life-threatening disease,” the researchers said in Nature Immunology.
The investigators have been scouring the world to find people who might be resistant to SARS-CoV-2 and have enrolled over 400 individuals in a “dedicated resistance study cohort,” according to ScienceAlert.
The investigators are looking at households in which families were infected but one member did not show severe symptoms, or for individuals who have been around the virus multiple times and haven’t contracted it. They are also looking at blood types.
Enrollment is ongoing, so if you’ve been in contact with COVID-19 multiple times and have not gotten sick, scientists would like to hear from you.
Better living through parasitization
How would you like to triple your life span, while maintaining a youthful appearance and gaining special social standing and privileges?
Sounds pretty good, right, so what’s the catch? Well, you have to be infected with a tapeworm ... and you have to be an ant.
If you are an ant, here’s the deal: Workers of the species Temnothorax nylanderi that have tapeworms live much longer than uninfected workers, and while living out those longer lives they do less work and receive gifts of food.
In a study conducted at Johannes Gutenberg University in Mainz, Germany, infected ants’ metabolic rates and lipid levels were similar to those of younger ants, and they appeared to remain in a permanent juvenile stage as a result of the infection, the investigators reported.
They tracked Temnothorax colonies for 3 years, at which point 95% of the uninfected workers had died but over half of the infected ants were still alive. Pretty great, right? Wrong. There was no joy in antville, for the uninfected workers had struck out. “Strained by the additional burden of their wormed-up nestmates, they seemed to be shunting care away from their queen. They were dying sooner than they might have if the colonies had remained parasite-free,” according to an article in the Atlantic.
Does this situation seem just a wee bit familiar? A small group lives longer, healthier lives and enjoys special privileges while the majority of that society works harder to support them? We’ll put it into the form of a chicken-and-egg argument: Which came first, the tapeworms or the one-percenters?
Laughing the pandemic stress away
Doomscrolling on social media has become one of the world’s favorite pastimes during the pandemic, but research shows that those memes about COVID-19 might combat the doom and gloom of the outside world.
A study recently published in Psychology of Popular Media showed that viewing memes, specifically those that were COVID-19 related, actually lessened the stress of the pandemic.
The researchers conducted a survey of 748 people aged 18-88 years. Each participant viewed three memes with text or three memes with text but no images. All three memes had similar cuteness levels (baby or adult), subject (animal or human), and caption (COVID-19–related or not). The participants were then asked to report on their stress levels and feelings before and after the memes.
The people who looked at memes felt less stressed and a higher humor level, especially the participants who received the COVID-19 memes. Study Finds said that they had more “pandemic-coping confidence” than those who got regular memes.
“While the World Health Organization recommended that people avoid too much COVID-related media for the benefit of their mental health, our research reveals that memes about COVID-19 could help people feel more confident in their ability to deal with the pandemic,” lead author Jessica Gall Myrick, PhD, said in a written statement. “The positive emotions associated with this type of content may make people feel psychologically safer and therefore better able to pay attention to the underlying messages related to health threats.”
So if you think you’ve been wasting time looking at memes during this pandemic, think again. It actually might keep you sane. Keep on scrolling!
Giving the gift of stress reduction
It’s a big week here at LOTME. You’ve just read our 100th edition, and to help celebrate that milestone – along with Count Your Buttons Day, Celebration of the Mind Day, and the International Day of the Nacho – we’re presenting an extra-special bonus feature, courtesy of Sad and Useless: The most depressive humor site on the Internet.
We hope you’ll stop your doomscrolling long enough to enjoy this stress-reducing meme. Thanks for reading!
FDA authorizes boosters for Moderna, J&J, allows mix-and-match
in people who are eligible to get them.
The move to amend the Emergency Use Authorization for these vaccines gives the vaccine experts on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices latitude to recommend a mix-and-match strategy if they feel the science supports it.
The committee convenes Oct. 21 for a day-long meeting to make its recommendations for additional doses.
People who’ve previously received two doses of the Moderna mRNA vaccine, which is now called Spikevax, are eligible for a third dose of any COVID-19 vaccine if they are 6 months past their second dose and are:
- 65 years of age or older
- 18 to 64 years of age, but at high risk for severe COVID-19 because of an underlying health condition
- 18 to 64 years of age and at high risk for exposure to the SARS-CoV-2 virus because they live in a group setting, such as a prison or care home, or work in a risky occupation, such as healthcare
People who’ve previously received a dose of the Johnson & Johnson vaccine are eligible for a second dose of any COVID-19 vaccine if they are over the age of 18 and at least 2 months past their vaccination.
“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD, in a news release. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death.
“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
A version of this article was first published on Medscape.com.
in people who are eligible to get them.
The move to amend the Emergency Use Authorization for these vaccines gives the vaccine experts on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices latitude to recommend a mix-and-match strategy if they feel the science supports it.
The committee convenes Oct. 21 for a day-long meeting to make its recommendations for additional doses.
People who’ve previously received two doses of the Moderna mRNA vaccine, which is now called Spikevax, are eligible for a third dose of any COVID-19 vaccine if they are 6 months past their second dose and are:
- 65 years of age or older
- 18 to 64 years of age, but at high risk for severe COVID-19 because of an underlying health condition
- 18 to 64 years of age and at high risk for exposure to the SARS-CoV-2 virus because they live in a group setting, such as a prison or care home, or work in a risky occupation, such as healthcare
People who’ve previously received a dose of the Johnson & Johnson vaccine are eligible for a second dose of any COVID-19 vaccine if they are over the age of 18 and at least 2 months past their vaccination.
“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD, in a news release. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death.
“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
A version of this article was first published on Medscape.com.
in people who are eligible to get them.
The move to amend the Emergency Use Authorization for these vaccines gives the vaccine experts on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices latitude to recommend a mix-and-match strategy if they feel the science supports it.
The committee convenes Oct. 21 for a day-long meeting to make its recommendations for additional doses.
People who’ve previously received two doses of the Moderna mRNA vaccine, which is now called Spikevax, are eligible for a third dose of any COVID-19 vaccine if they are 6 months past their second dose and are:
- 65 years of age or older
- 18 to 64 years of age, but at high risk for severe COVID-19 because of an underlying health condition
- 18 to 64 years of age and at high risk for exposure to the SARS-CoV-2 virus because they live in a group setting, such as a prison or care home, or work in a risky occupation, such as healthcare
People who’ve previously received a dose of the Johnson & Johnson vaccine are eligible for a second dose of any COVID-19 vaccine if they are over the age of 18 and at least 2 months past their vaccination.
“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD, in a news release. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death.
“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
A version of this article was first published on Medscape.com.
CAR T for ALL: Areas that need optimizing
The success of chimeric antigen receptor T (CAR T)-cell therapy for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) has garnered much attention, but the field is still in its infancy – with toxicity and relapse rates remaining unacceptably high.
in the use of the therapy in this setting, according to review authors Vanessa A. Fabrizio, MD, a fellow at Duke University, Durham, N.C., and Kevin J. Curran, MD, a pediatric oncologist at Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York.
Based on their review of early pivotal clinical trials, relapse data, toxicities, and mechanisms to optimize CAR T-cell therapy, Dr. Fabrizio and Dr. Curran outlined several “practice points” and proposed a research agenda aimed at optimizing the use of CAR T-cell therapy for B-ALL (Best Pract Res Clin Haematol. 2021 Aug 27. doi: 10.1016/j.beha.2021.101305).
Practice points
CAR T-cell therapy has transformed the treatment of both pediatric and adult patients with relapsed/refractory (R/R) B-ALL, the authors said, adding that “[c]linical trial results across multiple institutions with different CAR constructs report significant response rates in treated patients.”
Dr. Fabrizio and Dr. Curran specifically note that only one product (tisagenlecleucel) is currently approved for the treatment of R/R B-ALL in patients under age 26 years. Further, the successful application of this therapy is limited by high relapse rates, significant toxicity in some cases, and challenges related to collection and production issues.
They contend that areas in which optimization of CAR T-cell therapy can occur include apheresis, production, chemotherapy bridging, pretreatment disease burden management, toxicity management, disease monitoring after therapy, and use of consolidative allogeneic hematopoietic stem cell transplantation.
Research agenda
Key ways to heighten the success of CAR T-cell therapy for B-ALL are the development of off-the-shelf CAR T-cell products and the selection of optimal T cells to enhance apheresis and production, they said, adding that research is needed on the use of bridging chemotherapy to reduce tumor burden.
Bridging chemotherapy has been shown to impact outcomes while minimizing toxicity, but it remains undefined.
“Prospective trials are required to determine if the optimization of lymphodepleting chemotherapy can improve outcomes, and if consolidative therapy with transplantation should be considered in select patients,” they wrote. “Continued efforts to improve this technology for patients is ongoing while remaining questions are being investigated.”
The authors acknowledge that CAR T-cell therapy has transformed the treatment landscape for both pediatric and adult patients with R/R B-ALL, but this extensive review of all published data on the subject shows that “the incidence of relapse among responders is unacceptably high, demonstrating the need to improve this therapy.”
In conclusion, they wrote: “To be effective following infusion, CAR T cells must expand, persist, exhibit enduring anti-tumor cytotoxicity, withstand and/or counteract an immunosuppressive tumor microenvironment, and overcome targeted tumor antigen escape. In designing CAR T cells for cancer immunotherapy, all of these factors must be harmonized to generate the optimal therapy,” noting that “[t]oxicity management and, ideally the prediction of toxicity in individualized patients, should continue to be a focus of ongoing efforts.”
Dr. Curran has received research support from Juno Therapeutics and Novartis, and has consulted, participated in advisory boards, or taken part in educational seminars for Juno Therapeutics, Novartis, and Mesoblast. Dr. Fabrizio reported having no conflict of interests.
The success of chimeric antigen receptor T (CAR T)-cell therapy for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) has garnered much attention, but the field is still in its infancy – with toxicity and relapse rates remaining unacceptably high.
in the use of the therapy in this setting, according to review authors Vanessa A. Fabrizio, MD, a fellow at Duke University, Durham, N.C., and Kevin J. Curran, MD, a pediatric oncologist at Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York.
Based on their review of early pivotal clinical trials, relapse data, toxicities, and mechanisms to optimize CAR T-cell therapy, Dr. Fabrizio and Dr. Curran outlined several “practice points” and proposed a research agenda aimed at optimizing the use of CAR T-cell therapy for B-ALL (Best Pract Res Clin Haematol. 2021 Aug 27. doi: 10.1016/j.beha.2021.101305).
Practice points
CAR T-cell therapy has transformed the treatment of both pediatric and adult patients with relapsed/refractory (R/R) B-ALL, the authors said, adding that “[c]linical trial results across multiple institutions with different CAR constructs report significant response rates in treated patients.”
Dr. Fabrizio and Dr. Curran specifically note that only one product (tisagenlecleucel) is currently approved for the treatment of R/R B-ALL in patients under age 26 years. Further, the successful application of this therapy is limited by high relapse rates, significant toxicity in some cases, and challenges related to collection and production issues.
They contend that areas in which optimization of CAR T-cell therapy can occur include apheresis, production, chemotherapy bridging, pretreatment disease burden management, toxicity management, disease monitoring after therapy, and use of consolidative allogeneic hematopoietic stem cell transplantation.
Research agenda
Key ways to heighten the success of CAR T-cell therapy for B-ALL are the development of off-the-shelf CAR T-cell products and the selection of optimal T cells to enhance apheresis and production, they said, adding that research is needed on the use of bridging chemotherapy to reduce tumor burden.
Bridging chemotherapy has been shown to impact outcomes while minimizing toxicity, but it remains undefined.
“Prospective trials are required to determine if the optimization of lymphodepleting chemotherapy can improve outcomes, and if consolidative therapy with transplantation should be considered in select patients,” they wrote. “Continued efforts to improve this technology for patients is ongoing while remaining questions are being investigated.”
The authors acknowledge that CAR T-cell therapy has transformed the treatment landscape for both pediatric and adult patients with R/R B-ALL, but this extensive review of all published data on the subject shows that “the incidence of relapse among responders is unacceptably high, demonstrating the need to improve this therapy.”
In conclusion, they wrote: “To be effective following infusion, CAR T cells must expand, persist, exhibit enduring anti-tumor cytotoxicity, withstand and/or counteract an immunosuppressive tumor microenvironment, and overcome targeted tumor antigen escape. In designing CAR T cells for cancer immunotherapy, all of these factors must be harmonized to generate the optimal therapy,” noting that “[t]oxicity management and, ideally the prediction of toxicity in individualized patients, should continue to be a focus of ongoing efforts.”
Dr. Curran has received research support from Juno Therapeutics and Novartis, and has consulted, participated in advisory boards, or taken part in educational seminars for Juno Therapeutics, Novartis, and Mesoblast. Dr. Fabrizio reported having no conflict of interests.
The success of chimeric antigen receptor T (CAR T)-cell therapy for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) has garnered much attention, but the field is still in its infancy – with toxicity and relapse rates remaining unacceptably high.
in the use of the therapy in this setting, according to review authors Vanessa A. Fabrizio, MD, a fellow at Duke University, Durham, N.C., and Kevin J. Curran, MD, a pediatric oncologist at Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York.
Based on their review of early pivotal clinical trials, relapse data, toxicities, and mechanisms to optimize CAR T-cell therapy, Dr. Fabrizio and Dr. Curran outlined several “practice points” and proposed a research agenda aimed at optimizing the use of CAR T-cell therapy for B-ALL (Best Pract Res Clin Haematol. 2021 Aug 27. doi: 10.1016/j.beha.2021.101305).
Practice points
CAR T-cell therapy has transformed the treatment of both pediatric and adult patients with relapsed/refractory (R/R) B-ALL, the authors said, adding that “[c]linical trial results across multiple institutions with different CAR constructs report significant response rates in treated patients.”
Dr. Fabrizio and Dr. Curran specifically note that only one product (tisagenlecleucel) is currently approved for the treatment of R/R B-ALL in patients under age 26 years. Further, the successful application of this therapy is limited by high relapse rates, significant toxicity in some cases, and challenges related to collection and production issues.
They contend that areas in which optimization of CAR T-cell therapy can occur include apheresis, production, chemotherapy bridging, pretreatment disease burden management, toxicity management, disease monitoring after therapy, and use of consolidative allogeneic hematopoietic stem cell transplantation.
Research agenda
Key ways to heighten the success of CAR T-cell therapy for B-ALL are the development of off-the-shelf CAR T-cell products and the selection of optimal T cells to enhance apheresis and production, they said, adding that research is needed on the use of bridging chemotherapy to reduce tumor burden.
Bridging chemotherapy has been shown to impact outcomes while minimizing toxicity, but it remains undefined.
“Prospective trials are required to determine if the optimization of lymphodepleting chemotherapy can improve outcomes, and if consolidative therapy with transplantation should be considered in select patients,” they wrote. “Continued efforts to improve this technology for patients is ongoing while remaining questions are being investigated.”
The authors acknowledge that CAR T-cell therapy has transformed the treatment landscape for both pediatric and adult patients with R/R B-ALL, but this extensive review of all published data on the subject shows that “the incidence of relapse among responders is unacceptably high, demonstrating the need to improve this therapy.”
In conclusion, they wrote: “To be effective following infusion, CAR T cells must expand, persist, exhibit enduring anti-tumor cytotoxicity, withstand and/or counteract an immunosuppressive tumor microenvironment, and overcome targeted tumor antigen escape. In designing CAR T cells for cancer immunotherapy, all of these factors must be harmonized to generate the optimal therapy,” noting that “[t]oxicity management and, ideally the prediction of toxicity in individualized patients, should continue to be a focus of ongoing efforts.”
Dr. Curran has received research support from Juno Therapeutics and Novartis, and has consulted, participated in advisory boards, or taken part in educational seminars for Juno Therapeutics, Novartis, and Mesoblast. Dr. Fabrizio reported having no conflict of interests.
FROM BEST PRACTICE & RESEARCH CLINICAL HAEMATOLOGY
Pfizer offers refund if drug ‘doesn’t work’
The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.
Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”
For what it says is the first time in the industry,
“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.
Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.
In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.
Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
Pfizer pledge
Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.
Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.
“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”
This program is only available for patients who reside in the United States.
If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.
“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.
The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.
So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.
“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
Previous scheme ended in court
Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).
Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.
Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.
The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.
Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.
The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.
A version of this article first appeared on Medscape.com.
The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.
Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”
For what it says is the first time in the industry,
“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.
Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.
In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.
Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
Pfizer pledge
Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.
Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.
“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”
This program is only available for patients who reside in the United States.
If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.
“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.
The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.
So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.
“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
Previous scheme ended in court
Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).
Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.
Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.
The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.
Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.
The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.
A version of this article first appeared on Medscape.com.
The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.
Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”
For what it says is the first time in the industry,
“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.
Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.
In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.
Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
Pfizer pledge
Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.
Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.
“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”
This program is only available for patients who reside in the United States.
If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.
“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.
The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.
So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.
“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
Previous scheme ended in court
Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).
Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.
Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.
The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.
Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.
The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.
A version of this article first appeared on Medscape.com.
On improving DLBCL outcomes, single-agent regimens fall short
, a review of the relevant literature suggests.
“In addition ... single-agent regimens are most likely not efficient enough to substantially improve the outcome of patients with DLBCL,” Wendan Xu and colleagues at University Hospital Munster, Germany, concluded, based on their review.
Indeed, novel combinations that include B-cell receptor (BCR) signaling and phosphatidylinositol 3-kinase (PI3K) inhibitors are needed for DLBCL treatment, and treatment should also include conventional chemoimmunotherapeutic regimens as well as other targeted agents and novel immunologic approaches, they wrote. Such novel combinations could overcome mechanisms of resistance and increase cure rates in individuals with DLBCL, they contended.
The authors’ observations are based on a search of the available data, from which they summarized the “current understanding of BCR signaling with a special focus on the PI3K pathway and its role in the pathogenesis of DLBCL.”
The addition of the anti-CD20 antibody rituximab to the CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone) significantly improved outcomes for patients with DLBCL, but about a third of patients are not cured by the rituximab-CHOP (R-CHOP) regimen and subsequent therapies, they said, explaining their rationale for the review.
“A better understanding of the molecular pathogenesis is warranted to use novel targeted agents in an optimal manner,” they said.
The authors also addressed clinical implications of the findings, and mechanisms of resistance to PI3k inhibitors. For example, they noted that:
–Bruton’s tyrosine kinase (BTK) inhibitors may be beneficial when added to R-CHOP.
In the randomized phase 3 PHOENIX trial, ibrutinib plus R-CHOP versus R-CHOP alone in patients with non–germinal center B-cell (non-GCB) DLBCL showed a survival benefit in patients over 60 years of age, which suggests a possible role for “an intensified R-CHOP regimen that includes a BTK inhibitor” in these patients, they said. They added that confirmatory trials are under way, including the ESCALADE trial looking at the second-generation BTK inhibitor acalabrutinib combined with R-CHOP versus R-CHOP alone in patients with untreated DLBCL.
–Results have been mixed with PI3K inhibitors.
Various PI3K inhibitors have been evaluated for the treatment of patients with DLBCL.
Idelalisib, a first-in-class PI3K-specific inhibitor approved for treatment of relapsed/refractory (r/r) follicular lymphoma, small lymphocytic lymphoma, and chronic lymphocytic leukemia (CLL), showed only modest activity in preclinical DLBCL models, and no responses were detectable in a small trial of patients with r/r DLBCL, the authors said. “Severe toxic side effects and treatment-related deaths occurred in several clinical trials that tested idelalisib in combination with antibodies alone or with antibodies and chemotherapy, leading to the premature discontinuation of some of these studies,” they noted.
Other studies investigating idelalisib plus lenalidomide and rituximab or the spleen tyrosine kinase (SYK) inhibitor entospletinib in patients with r/r CLL or lymphoma were also halted because of “overwhelming, immune-mediated pulmonary and/or hepatic toxicities.”
Copanlisib, an intravenous pan-class I PI3K inhibitor with preferential inhibition of PI3Ka and PI3Kd, showed some promise as monotherapy in a phase 2 trial of patients with r/r DLBCL. The overall response rate was about 20%, and response was “numerically higher” in activated B-cell like (ABC) DLBCL, compared with GCB DLBCL (32% vs. 13%), confirming preclinical data that showed PI3Ka/d inhibition effectiveness mainly in ABC DLBCL.
“Compared with idelalisib, copanlisib appears to have a more favorable toxicity profile, with a lower incidence of severe complications,” they said, adding that a phase 2 trial of copanlisib plus R-CHOP as first-line therapy for patients with DLBCL is under way.
Further, monotherapy with buparlisib, a pan-class I PI3K inhibitor, was associated with a low response rate of 11.5% in a DLBCL subcohort in a phase 2 study, whereas parsaclisib, a next-generation inhibitor with specificity to the PI3Kd isoform, showed efficacy as a monotherapy in patients with r/r DLBCL in a phase 2 study (overall response rate, 25.5%), they said, adding that other PI3K inhibitors with additional inhibitory effects are under clinical development.
–Various molecular mechanisms of resistance to PI3K inhibitors have been described preclinically and clinically.
In an unbiased exploratory analysis of samples from patients treated with copanlisib, a 16-gene mutation signature that separated responders from nonresponders was identified, the authors said.
The finding suggests that genetic aberrations dictate response to PI3K inhibitors, they noted.
“This 16-gene signature included TNFAIP3, CREBBP, and PRDM1, which are known to be important in the molecular pathogenesis of DLBCL,” they wrote. A composite score was developed to reflect the numerical presence or absence of mutations in the gene set, they explained, adding that patients with a high composite score had a significantly higher overall response rate and longer progression-free survival than did patients with a lower score.
In addition, idelalisib treatment resulted in a feedback activation of PI3Ka in ABC DLBCL cells.
“This rebound of PI3K activity was overcome by subsequent PI3Ka inhibition in preclinical DLBCL models, further underscoring the necessity of inhibiting both PI3Ka and PI3Kd to achieve responses in ABC DLBCL,” they wrote, adding that “[i]n ABC DLBCL models treated with the PI3Ka/PI3Kd inhibitor AZD8835, activated CARD11 mutations were identified as a mechanism of resistance.”
Investigations looking at various treatment combinations to overcome resistance to PI3K inhibition and improve the efficacy of targeted approaches are under way, they said.
For example, copanlisib plus the BCL-2 inhibitor venetoclax showed “synergistic activity in BCR-dependent DLBCLs, with genetic bases for BCL-2 dysregulation in vitro and in vivo,” and combination treatment with umbralisib and the proteasome inhibitor carfilzomib showed synergistic cytotoxicity in B-cell lymphoma, they said, noting that the latter combination is currently being evaluated in patients with DLBCL.
This work was supported by a research grant from the Deutsche Krebshilfe. Dr. Xu reported having no financial disclosures.
, a review of the relevant literature suggests.
“In addition ... single-agent regimens are most likely not efficient enough to substantially improve the outcome of patients with DLBCL,” Wendan Xu and colleagues at University Hospital Munster, Germany, concluded, based on their review.
Indeed, novel combinations that include B-cell receptor (BCR) signaling and phosphatidylinositol 3-kinase (PI3K) inhibitors are needed for DLBCL treatment, and treatment should also include conventional chemoimmunotherapeutic regimens as well as other targeted agents and novel immunologic approaches, they wrote. Such novel combinations could overcome mechanisms of resistance and increase cure rates in individuals with DLBCL, they contended.
The authors’ observations are based on a search of the available data, from which they summarized the “current understanding of BCR signaling with a special focus on the PI3K pathway and its role in the pathogenesis of DLBCL.”
The addition of the anti-CD20 antibody rituximab to the CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone) significantly improved outcomes for patients with DLBCL, but about a third of patients are not cured by the rituximab-CHOP (R-CHOP) regimen and subsequent therapies, they said, explaining their rationale for the review.
“A better understanding of the molecular pathogenesis is warranted to use novel targeted agents in an optimal manner,” they said.
The authors also addressed clinical implications of the findings, and mechanisms of resistance to PI3k inhibitors. For example, they noted that:
–Bruton’s tyrosine kinase (BTK) inhibitors may be beneficial when added to R-CHOP.
In the randomized phase 3 PHOENIX trial, ibrutinib plus R-CHOP versus R-CHOP alone in patients with non–germinal center B-cell (non-GCB) DLBCL showed a survival benefit in patients over 60 years of age, which suggests a possible role for “an intensified R-CHOP regimen that includes a BTK inhibitor” in these patients, they said. They added that confirmatory trials are under way, including the ESCALADE trial looking at the second-generation BTK inhibitor acalabrutinib combined with R-CHOP versus R-CHOP alone in patients with untreated DLBCL.
–Results have been mixed with PI3K inhibitors.
Various PI3K inhibitors have been evaluated for the treatment of patients with DLBCL.
Idelalisib, a first-in-class PI3K-specific inhibitor approved for treatment of relapsed/refractory (r/r) follicular lymphoma, small lymphocytic lymphoma, and chronic lymphocytic leukemia (CLL), showed only modest activity in preclinical DLBCL models, and no responses were detectable in a small trial of patients with r/r DLBCL, the authors said. “Severe toxic side effects and treatment-related deaths occurred in several clinical trials that tested idelalisib in combination with antibodies alone or with antibodies and chemotherapy, leading to the premature discontinuation of some of these studies,” they noted.
Other studies investigating idelalisib plus lenalidomide and rituximab or the spleen tyrosine kinase (SYK) inhibitor entospletinib in patients with r/r CLL or lymphoma were also halted because of “overwhelming, immune-mediated pulmonary and/or hepatic toxicities.”
Copanlisib, an intravenous pan-class I PI3K inhibitor with preferential inhibition of PI3Ka and PI3Kd, showed some promise as monotherapy in a phase 2 trial of patients with r/r DLBCL. The overall response rate was about 20%, and response was “numerically higher” in activated B-cell like (ABC) DLBCL, compared with GCB DLBCL (32% vs. 13%), confirming preclinical data that showed PI3Ka/d inhibition effectiveness mainly in ABC DLBCL.
“Compared with idelalisib, copanlisib appears to have a more favorable toxicity profile, with a lower incidence of severe complications,” they said, adding that a phase 2 trial of copanlisib plus R-CHOP as first-line therapy for patients with DLBCL is under way.
Further, monotherapy with buparlisib, a pan-class I PI3K inhibitor, was associated with a low response rate of 11.5% in a DLBCL subcohort in a phase 2 study, whereas parsaclisib, a next-generation inhibitor with specificity to the PI3Kd isoform, showed efficacy as a monotherapy in patients with r/r DLBCL in a phase 2 study (overall response rate, 25.5%), they said, adding that other PI3K inhibitors with additional inhibitory effects are under clinical development.
–Various molecular mechanisms of resistance to PI3K inhibitors have been described preclinically and clinically.
In an unbiased exploratory analysis of samples from patients treated with copanlisib, a 16-gene mutation signature that separated responders from nonresponders was identified, the authors said.
The finding suggests that genetic aberrations dictate response to PI3K inhibitors, they noted.
“This 16-gene signature included TNFAIP3, CREBBP, and PRDM1, which are known to be important in the molecular pathogenesis of DLBCL,” they wrote. A composite score was developed to reflect the numerical presence or absence of mutations in the gene set, they explained, adding that patients with a high composite score had a significantly higher overall response rate and longer progression-free survival than did patients with a lower score.
In addition, idelalisib treatment resulted in a feedback activation of PI3Ka in ABC DLBCL cells.
“This rebound of PI3K activity was overcome by subsequent PI3Ka inhibition in preclinical DLBCL models, further underscoring the necessity of inhibiting both PI3Ka and PI3Kd to achieve responses in ABC DLBCL,” they wrote, adding that “[i]n ABC DLBCL models treated with the PI3Ka/PI3Kd inhibitor AZD8835, activated CARD11 mutations were identified as a mechanism of resistance.”
Investigations looking at various treatment combinations to overcome resistance to PI3K inhibition and improve the efficacy of targeted approaches are under way, they said.
For example, copanlisib plus the BCL-2 inhibitor venetoclax showed “synergistic activity in BCR-dependent DLBCLs, with genetic bases for BCL-2 dysregulation in vitro and in vivo,” and combination treatment with umbralisib and the proteasome inhibitor carfilzomib showed synergistic cytotoxicity in B-cell lymphoma, they said, noting that the latter combination is currently being evaluated in patients with DLBCL.
This work was supported by a research grant from the Deutsche Krebshilfe. Dr. Xu reported having no financial disclosures.
, a review of the relevant literature suggests.
“In addition ... single-agent regimens are most likely not efficient enough to substantially improve the outcome of patients with DLBCL,” Wendan Xu and colleagues at University Hospital Munster, Germany, concluded, based on their review.
Indeed, novel combinations that include B-cell receptor (BCR) signaling and phosphatidylinositol 3-kinase (PI3K) inhibitors are needed for DLBCL treatment, and treatment should also include conventional chemoimmunotherapeutic regimens as well as other targeted agents and novel immunologic approaches, they wrote. Such novel combinations could overcome mechanisms of resistance and increase cure rates in individuals with DLBCL, they contended.
The authors’ observations are based on a search of the available data, from which they summarized the “current understanding of BCR signaling with a special focus on the PI3K pathway and its role in the pathogenesis of DLBCL.”
The addition of the anti-CD20 antibody rituximab to the CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone) significantly improved outcomes for patients with DLBCL, but about a third of patients are not cured by the rituximab-CHOP (R-CHOP) regimen and subsequent therapies, they said, explaining their rationale for the review.
“A better understanding of the molecular pathogenesis is warranted to use novel targeted agents in an optimal manner,” they said.
The authors also addressed clinical implications of the findings, and mechanisms of resistance to PI3k inhibitors. For example, they noted that:
–Bruton’s tyrosine kinase (BTK) inhibitors may be beneficial when added to R-CHOP.
In the randomized phase 3 PHOENIX trial, ibrutinib plus R-CHOP versus R-CHOP alone in patients with non–germinal center B-cell (non-GCB) DLBCL showed a survival benefit in patients over 60 years of age, which suggests a possible role for “an intensified R-CHOP regimen that includes a BTK inhibitor” in these patients, they said. They added that confirmatory trials are under way, including the ESCALADE trial looking at the second-generation BTK inhibitor acalabrutinib combined with R-CHOP versus R-CHOP alone in patients with untreated DLBCL.
–Results have been mixed with PI3K inhibitors.
Various PI3K inhibitors have been evaluated for the treatment of patients with DLBCL.
Idelalisib, a first-in-class PI3K-specific inhibitor approved for treatment of relapsed/refractory (r/r) follicular lymphoma, small lymphocytic lymphoma, and chronic lymphocytic leukemia (CLL), showed only modest activity in preclinical DLBCL models, and no responses were detectable in a small trial of patients with r/r DLBCL, the authors said. “Severe toxic side effects and treatment-related deaths occurred in several clinical trials that tested idelalisib in combination with antibodies alone or with antibodies and chemotherapy, leading to the premature discontinuation of some of these studies,” they noted.
Other studies investigating idelalisib plus lenalidomide and rituximab or the spleen tyrosine kinase (SYK) inhibitor entospletinib in patients with r/r CLL or lymphoma were also halted because of “overwhelming, immune-mediated pulmonary and/or hepatic toxicities.”
Copanlisib, an intravenous pan-class I PI3K inhibitor with preferential inhibition of PI3Ka and PI3Kd, showed some promise as monotherapy in a phase 2 trial of patients with r/r DLBCL. The overall response rate was about 20%, and response was “numerically higher” in activated B-cell like (ABC) DLBCL, compared with GCB DLBCL (32% vs. 13%), confirming preclinical data that showed PI3Ka/d inhibition effectiveness mainly in ABC DLBCL.
“Compared with idelalisib, copanlisib appears to have a more favorable toxicity profile, with a lower incidence of severe complications,” they said, adding that a phase 2 trial of copanlisib plus R-CHOP as first-line therapy for patients with DLBCL is under way.
Further, monotherapy with buparlisib, a pan-class I PI3K inhibitor, was associated with a low response rate of 11.5% in a DLBCL subcohort in a phase 2 study, whereas parsaclisib, a next-generation inhibitor with specificity to the PI3Kd isoform, showed efficacy as a monotherapy in patients with r/r DLBCL in a phase 2 study (overall response rate, 25.5%), they said, adding that other PI3K inhibitors with additional inhibitory effects are under clinical development.
–Various molecular mechanisms of resistance to PI3K inhibitors have been described preclinically and clinically.
In an unbiased exploratory analysis of samples from patients treated with copanlisib, a 16-gene mutation signature that separated responders from nonresponders was identified, the authors said.
The finding suggests that genetic aberrations dictate response to PI3K inhibitors, they noted.
“This 16-gene signature included TNFAIP3, CREBBP, and PRDM1, which are known to be important in the molecular pathogenesis of DLBCL,” they wrote. A composite score was developed to reflect the numerical presence or absence of mutations in the gene set, they explained, adding that patients with a high composite score had a significantly higher overall response rate and longer progression-free survival than did patients with a lower score.
In addition, idelalisib treatment resulted in a feedback activation of PI3Ka in ABC DLBCL cells.
“This rebound of PI3K activity was overcome by subsequent PI3Ka inhibition in preclinical DLBCL models, further underscoring the necessity of inhibiting both PI3Ka and PI3Kd to achieve responses in ABC DLBCL,” they wrote, adding that “[i]n ABC DLBCL models treated with the PI3Ka/PI3Kd inhibitor AZD8835, activated CARD11 mutations were identified as a mechanism of resistance.”
Investigations looking at various treatment combinations to overcome resistance to PI3K inhibition and improve the efficacy of targeted approaches are under way, they said.
For example, copanlisib plus the BCL-2 inhibitor venetoclax showed “synergistic activity in BCR-dependent DLBCLs, with genetic bases for BCL-2 dysregulation in vitro and in vivo,” and combination treatment with umbralisib and the proteasome inhibitor carfilzomib showed synergistic cytotoxicity in B-cell lymphoma, they said, noting that the latter combination is currently being evaluated in patients with DLBCL.
This work was supported by a research grant from the Deutsche Krebshilfe. Dr. Xu reported having no financial disclosures.
FROM BLOOD
New land mines in your next (and even current) employment contract
Physician employment contracts include some new dangers. This includes physicians taking a new job, but it also includes already-employed doctors who are being asked to resign a new contract that contains new conditions. A number of these new clauses have arisen because of COVID-19. When the pandemic dramatically reduced patient flow, many employers didn’t have enough money to pay doctors and didn’t always have physicians in the right location or practice setting.
Vowing this would never happen again, some employers have rewritten their physician contracts to make it easier to reassign and terminate physicians.
Here are 12 potential land mines in a physician employment contract, some of which were added as a result of the pandemic.
You could be immediately terminated without notice
One outcome of the pandemic is the growing use of “force majeure” clauses, which give the employer the right to reduce your compensation or even terminate you due to a natural disaster, which could include COVID.
“COVID made employers aware of the potential impact of disasters on their operations,” said Dan Shay, a health law attorney at Alice Gosfield & Associates in Philadelphia. “Therefore, even as the threat of COVID abates in many places, employers are continuing to put this provision in the contract.”
What can you do? “One way to get some protection is to rule out a termination without cause in the first year,” said Michael A. Cassidy, a physician contract attorney at Tucker Arensberg in Pittsburgh.
The force majeure clause is less likely to affect salary, but could impact bonus and incentive tied to performance. It’s wise to try to specifically limit how much the force majeure could reduce pay tied to performance, and to be prepared to negotiate that aspect of your contract.
No protections if you’re let go through no fault of your own
You could lose your job if your employer could not generate enough business and has to let some doctors go. This happened quite often in the early days of the COVID pandemic.
In these situations, the doctor has not done anything wrong to prompt the termination, but the restrictive covenant may still apply, meaning that the doctor would have to leave the area to find work.
What can you do? You’re in a good position to get this changed, said Christopher L. Nuland, a solo physician contract attorney in Jacksonville, Fla. “Many employers recognize that it would be draconian to require a restrictive covenant in this case, and they will agree to modify this provision.”
Similarly, the employer may not cover your tail insurance even if you were let go from your work through no fault of your own. Most malpractice policies for employer physicians require buying an extra policy, called a tail, if you leave. In some cases, the employer won’t provide a tail and will make the departing doctor buy it.
In these cases, “try for a compromise, such as stipulating that the party that caused the termination should pay for the tail,” Mr. Nuland said. “The employer may not agree to anything more than that because they want to set up a disincentive against you leaving.”
Employer could unilaterally alter your compensation
Many recent contracts give the employer the option to unilaterally modify compensation, such as changing the base salary or raising the target required for meeting the productivity bonus, said Ericka L. Adler, a physician contract attorney at Roetzel & Andress in Chicago.
Ms. Adler thought this change could have been prompted by employers’ financial problems during the pandemic. In the early months of COVID, many physicians were not making much money for the employer but still had to be paid. So employers added a clause saying they could reduce compensation at any time, she said.
What can you do? Harsh provisions like this often come up in contracts with private equity firms, Mr. Cassidy said. “The contract might say the employer can adjust compensation or even terminate physicians based on productivity or their profitability. And it may say that if they reassign you to a new location and you refuse, they can terminate you.”
“If you can’t get these clauses removed, try to reduce the impact of a termination by providing longer notice periods or by inserting a severance agreement,” Mr. Cassidy said.
Accelerating notice for without-cause terminations
Physicians who are convicted of a felony or other moral issue can usually be terminated immediately. But if you are terminated for other reasons – that is, “without cause” – you are given notice at a certain number of days before you have to leave (typically 60-90 days), so that you have time to find a new job.
Some recent contracts, however, allow for very little notice in without-cause terminations, which allows the employer to fire you in as little as 0 days after providing notice, Ms. Adler said.
“This means that, even if 90 days’ notice is provided in the contract, the employer can decide that your last day will be an earlier date,” she said.
Why is this happening? Ms. Adler said employers want to begin reallocating resources and patients as soon as possible. The problem came to employers’ attention during the COVID pandemic, when they were contractually forced to pay doctors for doing little or nothing during the notice period.
What can you do? Possibly not much, other than attempt to negotiate. “Large employers typically don’t want to drop this provision, but at the least, the doctor needs to understand the risk it creates for them,” she said.
You could be assigned to far-off locations
As patient care needs changed dramatically during the pandemic, employers needed to reassign doctors to new locations.
Some new contracts allow employers to simply inform the doctor that they are changing the work location. However, “you don’t want to be assigned to a new work location that is 50 miles away,” Mr. Nuland said.
What can you do? Mr. Nuland recommended adding new language saying that, if the new assignment is more than 20 miles away, both parties would have to approve it.
You could end up working too many off-hours
“Most employers won’t issue a specific work schedule,” Mr. Nuland said. “They want the flexibility to assign evening or weekend work, and it would be difficult for a young doctor to change this.”
What can you do? Mr. Nuland recommended trying to set some limits. “You can try to limit off-hours work to two times a month or something like that,” she said. And if you need to have a special schedule, such as not working on Fridays, Adler advises that this should be put into the contract.
If you can’t get anything changed in the contract, Mr. Nuland said the next-best thing is to ask employers to tell you specifically what they plan to do with you. “Most employers will give you an informal idea of what’s expected – maybe not an exact schedule, but it’s quite likely they will honor it.”
You wouldn’t be able to work nearby if you left the job
Most contracts have a noncompete clause, also known as a “restrictive covenant,” which prevents employed physicians from working in the area if they left the job.
“Almost every doctor I represent has told me that they’re not concerned about the noncompete clause because, they believe, it is not enforceable anyway,” Ms. Adler said. “This is incorrect.”
Mr. Nuland said the faster pace of job-changing during the pandemic makes it all the more likely that doctors have to deal with a restrictive covenant. At the same time, some employers have been expanding the restriction – either by enlarging the radius where the restriction applies or by making the restriction apply to each of their sites, so that each one has a restricted radius around it.
For example, one contract Mr. Nuland is currently reviewing has a 20-mile radius that in effect becomes a 120-mile radius because the employer is counting four offices.
What can you do? Mr. Nuland advised trying to reduce the impact of the noncompete – for instance, making it apply only to the offices where you worked, or trading more time for less distance. “If you have a 2-year, 20-mile restriction, ask for a 3-year, 10-mile restriction, where the radius could be easier to deal with,” he said.
You might end up with too much call
Contracts rarely detail your call schedule because employers want flexibility to expand call as patient care needs change, but you can try adding some specificity, said Sanja Ord, a physician contract attorney at Greensfelder, Hemker & Gale in St. Louis.
Contracts often use wide-open language to describe call, such as simply making it “subject to the house call policies,” Mr. Cassidy said. Language that is more beneficial to the physician would say that call must be “equal” among “similarly situated” physicians.
But Ms. Ord said even provisions for equal call can turn out to be onerous if there are too few doctors in the call roster, so it’s a good idea to find out just how many doctors will be participating in call.
Still, Adler said even that strategy can’t remove all risk. What happens, she asked, if several physicians participating in call decide to leave? Then you might end up with call every other night.
What can you do? Mr. Cassidy recommends specifying a maximum amount of call – for example, no more frequent than one in four nights.
Physician must pay for reimbursement claw-backs by payers
When auditors for Medicare or other payers find overpayments after the fact, called a ‘claw-back,’ the provider must pay them back. But which provider has to do that – you or your employer?
In many cases, your employer’s billing office may have introduced the error, but there may be a clause in the contract stating that the physician is solely responsible for all claw-backs. That could be costly.
What can you do? Mr. Shay said the clause should state that you have to pay only when it is the result of your own error or omission, and also not when it was made at the direction of the employer.
Some work may be outside of your subspecialty
In some cases, the employer may assign subspecialized doctors to work outside their subspecialty, Mr. Nuland said.
For example, he said he represented an endocrinologist who expected to see only diabetes patients but was assigned to some general internal medicine work as well, and an otolaryngologist client of his who completed a fellowship on facial plastic surgery was expected to do liposuction in a cosmetic surgery group.
What can you do? To prevent this from happening, Mr. Nuland recommends a clause stating that your work will be restricted to your subspecialty.
What the employer promised isn’t in the contract
“Beware of promises that are not in the contract,” Mr. Shay said. “You might feel you can really trust your new boss and what he tells you, but what if that person resigns, or the organization gets a new owner who doesn’t honor unwritten agreements?”
Many contracts have an integration clause, which specifies that the contract constitutes the complete agreement between the two parties, and it nullifies any other oral or written promises made to the physician.
For example, the employer might have promised a relocation bonus and a sign-on bonus, but for some reason it didn’t get into the contract, Ms. Ord said. In those cases, the employer is under no obligation to honor the promise.
What can you do? Mr. Cassidy said it is possible to hold the employer to a commitment made outside the contract. The alternative document, such as an offer letter, has to specifically state that the commitment is protected from the integration clause in the contract, he said, adding: “It is still better to have the commitment put into the contract.”
Contract is simply accepted as is
“Generally, the bigger the employer, the less likely they will alter an agreement just to make you happy,” Mr. Shay said.
But even in these contracts, he said there is still opportunity to fix errors and ambiguities that could harm you later – or even alter a provision if you can’t remove it outright.
The back-and-forth is important, Ms. Adler said. “Negotiation means trying to have some control over your job and your life.”
Mr. Cassidy said a big part of contract review is facing up to the possibility that you may have to resign or be let go.
“Many physicians don’t like to think about leaving when they’re just starting a job, but they need to,” he said. “You need to begin with the end in mind. Think about what would happen if this job didn’t work out.”
A version of this article first appeared on Medscape.com.
Physician employment contracts include some new dangers. This includes physicians taking a new job, but it also includes already-employed doctors who are being asked to resign a new contract that contains new conditions. A number of these new clauses have arisen because of COVID-19. When the pandemic dramatically reduced patient flow, many employers didn’t have enough money to pay doctors and didn’t always have physicians in the right location or practice setting.
Vowing this would never happen again, some employers have rewritten their physician contracts to make it easier to reassign and terminate physicians.
Here are 12 potential land mines in a physician employment contract, some of which were added as a result of the pandemic.
You could be immediately terminated without notice
One outcome of the pandemic is the growing use of “force majeure” clauses, which give the employer the right to reduce your compensation or even terminate you due to a natural disaster, which could include COVID.
“COVID made employers aware of the potential impact of disasters on their operations,” said Dan Shay, a health law attorney at Alice Gosfield & Associates in Philadelphia. “Therefore, even as the threat of COVID abates in many places, employers are continuing to put this provision in the contract.”
What can you do? “One way to get some protection is to rule out a termination without cause in the first year,” said Michael A. Cassidy, a physician contract attorney at Tucker Arensberg in Pittsburgh.
The force majeure clause is less likely to affect salary, but could impact bonus and incentive tied to performance. It’s wise to try to specifically limit how much the force majeure could reduce pay tied to performance, and to be prepared to negotiate that aspect of your contract.
No protections if you’re let go through no fault of your own
You could lose your job if your employer could not generate enough business and has to let some doctors go. This happened quite often in the early days of the COVID pandemic.
In these situations, the doctor has not done anything wrong to prompt the termination, but the restrictive covenant may still apply, meaning that the doctor would have to leave the area to find work.
What can you do? You’re in a good position to get this changed, said Christopher L. Nuland, a solo physician contract attorney in Jacksonville, Fla. “Many employers recognize that it would be draconian to require a restrictive covenant in this case, and they will agree to modify this provision.”
Similarly, the employer may not cover your tail insurance even if you were let go from your work through no fault of your own. Most malpractice policies for employer physicians require buying an extra policy, called a tail, if you leave. In some cases, the employer won’t provide a tail and will make the departing doctor buy it.
In these cases, “try for a compromise, such as stipulating that the party that caused the termination should pay for the tail,” Mr. Nuland said. “The employer may not agree to anything more than that because they want to set up a disincentive against you leaving.”
Employer could unilaterally alter your compensation
Many recent contracts give the employer the option to unilaterally modify compensation, such as changing the base salary or raising the target required for meeting the productivity bonus, said Ericka L. Adler, a physician contract attorney at Roetzel & Andress in Chicago.
Ms. Adler thought this change could have been prompted by employers’ financial problems during the pandemic. In the early months of COVID, many physicians were not making much money for the employer but still had to be paid. So employers added a clause saying they could reduce compensation at any time, she said.
What can you do? Harsh provisions like this often come up in contracts with private equity firms, Mr. Cassidy said. “The contract might say the employer can adjust compensation or even terminate physicians based on productivity or their profitability. And it may say that if they reassign you to a new location and you refuse, they can terminate you.”
“If you can’t get these clauses removed, try to reduce the impact of a termination by providing longer notice periods or by inserting a severance agreement,” Mr. Cassidy said.
Accelerating notice for without-cause terminations
Physicians who are convicted of a felony or other moral issue can usually be terminated immediately. But if you are terminated for other reasons – that is, “without cause” – you are given notice at a certain number of days before you have to leave (typically 60-90 days), so that you have time to find a new job.
Some recent contracts, however, allow for very little notice in without-cause terminations, which allows the employer to fire you in as little as 0 days after providing notice, Ms. Adler said.
“This means that, even if 90 days’ notice is provided in the contract, the employer can decide that your last day will be an earlier date,” she said.
Why is this happening? Ms. Adler said employers want to begin reallocating resources and patients as soon as possible. The problem came to employers’ attention during the COVID pandemic, when they were contractually forced to pay doctors for doing little or nothing during the notice period.
What can you do? Possibly not much, other than attempt to negotiate. “Large employers typically don’t want to drop this provision, but at the least, the doctor needs to understand the risk it creates for them,” she said.
You could be assigned to far-off locations
As patient care needs changed dramatically during the pandemic, employers needed to reassign doctors to new locations.
Some new contracts allow employers to simply inform the doctor that they are changing the work location. However, “you don’t want to be assigned to a new work location that is 50 miles away,” Mr. Nuland said.
What can you do? Mr. Nuland recommended adding new language saying that, if the new assignment is more than 20 miles away, both parties would have to approve it.
You could end up working too many off-hours
“Most employers won’t issue a specific work schedule,” Mr. Nuland said. “They want the flexibility to assign evening or weekend work, and it would be difficult for a young doctor to change this.”
What can you do? Mr. Nuland recommended trying to set some limits. “You can try to limit off-hours work to two times a month or something like that,” she said. And if you need to have a special schedule, such as not working on Fridays, Adler advises that this should be put into the contract.
If you can’t get anything changed in the contract, Mr. Nuland said the next-best thing is to ask employers to tell you specifically what they plan to do with you. “Most employers will give you an informal idea of what’s expected – maybe not an exact schedule, but it’s quite likely they will honor it.”
You wouldn’t be able to work nearby if you left the job
Most contracts have a noncompete clause, also known as a “restrictive covenant,” which prevents employed physicians from working in the area if they left the job.
“Almost every doctor I represent has told me that they’re not concerned about the noncompete clause because, they believe, it is not enforceable anyway,” Ms. Adler said. “This is incorrect.”
Mr. Nuland said the faster pace of job-changing during the pandemic makes it all the more likely that doctors have to deal with a restrictive covenant. At the same time, some employers have been expanding the restriction – either by enlarging the radius where the restriction applies or by making the restriction apply to each of their sites, so that each one has a restricted radius around it.
For example, one contract Mr. Nuland is currently reviewing has a 20-mile radius that in effect becomes a 120-mile radius because the employer is counting four offices.
What can you do? Mr. Nuland advised trying to reduce the impact of the noncompete – for instance, making it apply only to the offices where you worked, or trading more time for less distance. “If you have a 2-year, 20-mile restriction, ask for a 3-year, 10-mile restriction, where the radius could be easier to deal with,” he said.
You might end up with too much call
Contracts rarely detail your call schedule because employers want flexibility to expand call as patient care needs change, but you can try adding some specificity, said Sanja Ord, a physician contract attorney at Greensfelder, Hemker & Gale in St. Louis.
Contracts often use wide-open language to describe call, such as simply making it “subject to the house call policies,” Mr. Cassidy said. Language that is more beneficial to the physician would say that call must be “equal” among “similarly situated” physicians.
But Ms. Ord said even provisions for equal call can turn out to be onerous if there are too few doctors in the call roster, so it’s a good idea to find out just how many doctors will be participating in call.
Still, Adler said even that strategy can’t remove all risk. What happens, she asked, if several physicians participating in call decide to leave? Then you might end up with call every other night.
What can you do? Mr. Cassidy recommends specifying a maximum amount of call – for example, no more frequent than one in four nights.
Physician must pay for reimbursement claw-backs by payers
When auditors for Medicare or other payers find overpayments after the fact, called a ‘claw-back,’ the provider must pay them back. But which provider has to do that – you or your employer?
In many cases, your employer’s billing office may have introduced the error, but there may be a clause in the contract stating that the physician is solely responsible for all claw-backs. That could be costly.
What can you do? Mr. Shay said the clause should state that you have to pay only when it is the result of your own error or omission, and also not when it was made at the direction of the employer.
Some work may be outside of your subspecialty
In some cases, the employer may assign subspecialized doctors to work outside their subspecialty, Mr. Nuland said.
For example, he said he represented an endocrinologist who expected to see only diabetes patients but was assigned to some general internal medicine work as well, and an otolaryngologist client of his who completed a fellowship on facial plastic surgery was expected to do liposuction in a cosmetic surgery group.
What can you do? To prevent this from happening, Mr. Nuland recommends a clause stating that your work will be restricted to your subspecialty.
What the employer promised isn’t in the contract
“Beware of promises that are not in the contract,” Mr. Shay said. “You might feel you can really trust your new boss and what he tells you, but what if that person resigns, or the organization gets a new owner who doesn’t honor unwritten agreements?”
Many contracts have an integration clause, which specifies that the contract constitutes the complete agreement between the two parties, and it nullifies any other oral or written promises made to the physician.
For example, the employer might have promised a relocation bonus and a sign-on bonus, but for some reason it didn’t get into the contract, Ms. Ord said. In those cases, the employer is under no obligation to honor the promise.
What can you do? Mr. Cassidy said it is possible to hold the employer to a commitment made outside the contract. The alternative document, such as an offer letter, has to specifically state that the commitment is protected from the integration clause in the contract, he said, adding: “It is still better to have the commitment put into the contract.”
Contract is simply accepted as is
“Generally, the bigger the employer, the less likely they will alter an agreement just to make you happy,” Mr. Shay said.
But even in these contracts, he said there is still opportunity to fix errors and ambiguities that could harm you later – or even alter a provision if you can’t remove it outright.
The back-and-forth is important, Ms. Adler said. “Negotiation means trying to have some control over your job and your life.”
Mr. Cassidy said a big part of contract review is facing up to the possibility that you may have to resign or be let go.
“Many physicians don’t like to think about leaving when they’re just starting a job, but they need to,” he said. “You need to begin with the end in mind. Think about what would happen if this job didn’t work out.”
A version of this article first appeared on Medscape.com.
Physician employment contracts include some new dangers. This includes physicians taking a new job, but it also includes already-employed doctors who are being asked to resign a new contract that contains new conditions. A number of these new clauses have arisen because of COVID-19. When the pandemic dramatically reduced patient flow, many employers didn’t have enough money to pay doctors and didn’t always have physicians in the right location or practice setting.
Vowing this would never happen again, some employers have rewritten their physician contracts to make it easier to reassign and terminate physicians.
Here are 12 potential land mines in a physician employment contract, some of which were added as a result of the pandemic.
You could be immediately terminated without notice
One outcome of the pandemic is the growing use of “force majeure” clauses, which give the employer the right to reduce your compensation or even terminate you due to a natural disaster, which could include COVID.
“COVID made employers aware of the potential impact of disasters on their operations,” said Dan Shay, a health law attorney at Alice Gosfield & Associates in Philadelphia. “Therefore, even as the threat of COVID abates in many places, employers are continuing to put this provision in the contract.”
What can you do? “One way to get some protection is to rule out a termination without cause in the first year,” said Michael A. Cassidy, a physician contract attorney at Tucker Arensberg in Pittsburgh.
The force majeure clause is less likely to affect salary, but could impact bonus and incentive tied to performance. It’s wise to try to specifically limit how much the force majeure could reduce pay tied to performance, and to be prepared to negotiate that aspect of your contract.
No protections if you’re let go through no fault of your own
You could lose your job if your employer could not generate enough business and has to let some doctors go. This happened quite often in the early days of the COVID pandemic.
In these situations, the doctor has not done anything wrong to prompt the termination, but the restrictive covenant may still apply, meaning that the doctor would have to leave the area to find work.
What can you do? You’re in a good position to get this changed, said Christopher L. Nuland, a solo physician contract attorney in Jacksonville, Fla. “Many employers recognize that it would be draconian to require a restrictive covenant in this case, and they will agree to modify this provision.”
Similarly, the employer may not cover your tail insurance even if you were let go from your work through no fault of your own. Most malpractice policies for employer physicians require buying an extra policy, called a tail, if you leave. In some cases, the employer won’t provide a tail and will make the departing doctor buy it.
In these cases, “try for a compromise, such as stipulating that the party that caused the termination should pay for the tail,” Mr. Nuland said. “The employer may not agree to anything more than that because they want to set up a disincentive against you leaving.”
Employer could unilaterally alter your compensation
Many recent contracts give the employer the option to unilaterally modify compensation, such as changing the base salary or raising the target required for meeting the productivity bonus, said Ericka L. Adler, a physician contract attorney at Roetzel & Andress in Chicago.
Ms. Adler thought this change could have been prompted by employers’ financial problems during the pandemic. In the early months of COVID, many physicians were not making much money for the employer but still had to be paid. So employers added a clause saying they could reduce compensation at any time, she said.
What can you do? Harsh provisions like this often come up in contracts with private equity firms, Mr. Cassidy said. “The contract might say the employer can adjust compensation or even terminate physicians based on productivity or their profitability. And it may say that if they reassign you to a new location and you refuse, they can terminate you.”
“If you can’t get these clauses removed, try to reduce the impact of a termination by providing longer notice periods or by inserting a severance agreement,” Mr. Cassidy said.
Accelerating notice for without-cause terminations
Physicians who are convicted of a felony or other moral issue can usually be terminated immediately. But if you are terminated for other reasons – that is, “without cause” – you are given notice at a certain number of days before you have to leave (typically 60-90 days), so that you have time to find a new job.
Some recent contracts, however, allow for very little notice in without-cause terminations, which allows the employer to fire you in as little as 0 days after providing notice, Ms. Adler said.
“This means that, even if 90 days’ notice is provided in the contract, the employer can decide that your last day will be an earlier date,” she said.
Why is this happening? Ms. Adler said employers want to begin reallocating resources and patients as soon as possible. The problem came to employers’ attention during the COVID pandemic, when they were contractually forced to pay doctors for doing little or nothing during the notice period.
What can you do? Possibly not much, other than attempt to negotiate. “Large employers typically don’t want to drop this provision, but at the least, the doctor needs to understand the risk it creates for them,” she said.
You could be assigned to far-off locations
As patient care needs changed dramatically during the pandemic, employers needed to reassign doctors to new locations.
Some new contracts allow employers to simply inform the doctor that they are changing the work location. However, “you don’t want to be assigned to a new work location that is 50 miles away,” Mr. Nuland said.
What can you do? Mr. Nuland recommended adding new language saying that, if the new assignment is more than 20 miles away, both parties would have to approve it.
You could end up working too many off-hours
“Most employers won’t issue a specific work schedule,” Mr. Nuland said. “They want the flexibility to assign evening or weekend work, and it would be difficult for a young doctor to change this.”
What can you do? Mr. Nuland recommended trying to set some limits. “You can try to limit off-hours work to two times a month or something like that,” she said. And if you need to have a special schedule, such as not working on Fridays, Adler advises that this should be put into the contract.
If you can’t get anything changed in the contract, Mr. Nuland said the next-best thing is to ask employers to tell you specifically what they plan to do with you. “Most employers will give you an informal idea of what’s expected – maybe not an exact schedule, but it’s quite likely they will honor it.”
You wouldn’t be able to work nearby if you left the job
Most contracts have a noncompete clause, also known as a “restrictive covenant,” which prevents employed physicians from working in the area if they left the job.
“Almost every doctor I represent has told me that they’re not concerned about the noncompete clause because, they believe, it is not enforceable anyway,” Ms. Adler said. “This is incorrect.”
Mr. Nuland said the faster pace of job-changing during the pandemic makes it all the more likely that doctors have to deal with a restrictive covenant. At the same time, some employers have been expanding the restriction – either by enlarging the radius where the restriction applies or by making the restriction apply to each of their sites, so that each one has a restricted radius around it.
For example, one contract Mr. Nuland is currently reviewing has a 20-mile radius that in effect becomes a 120-mile radius because the employer is counting four offices.
What can you do? Mr. Nuland advised trying to reduce the impact of the noncompete – for instance, making it apply only to the offices where you worked, or trading more time for less distance. “If you have a 2-year, 20-mile restriction, ask for a 3-year, 10-mile restriction, where the radius could be easier to deal with,” he said.
You might end up with too much call
Contracts rarely detail your call schedule because employers want flexibility to expand call as patient care needs change, but you can try adding some specificity, said Sanja Ord, a physician contract attorney at Greensfelder, Hemker & Gale in St. Louis.
Contracts often use wide-open language to describe call, such as simply making it “subject to the house call policies,” Mr. Cassidy said. Language that is more beneficial to the physician would say that call must be “equal” among “similarly situated” physicians.
But Ms. Ord said even provisions for equal call can turn out to be onerous if there are too few doctors in the call roster, so it’s a good idea to find out just how many doctors will be participating in call.
Still, Adler said even that strategy can’t remove all risk. What happens, she asked, if several physicians participating in call decide to leave? Then you might end up with call every other night.
What can you do? Mr. Cassidy recommends specifying a maximum amount of call – for example, no more frequent than one in four nights.
Physician must pay for reimbursement claw-backs by payers
When auditors for Medicare or other payers find overpayments after the fact, called a ‘claw-back,’ the provider must pay them back. But which provider has to do that – you or your employer?
In many cases, your employer’s billing office may have introduced the error, but there may be a clause in the contract stating that the physician is solely responsible for all claw-backs. That could be costly.
What can you do? Mr. Shay said the clause should state that you have to pay only when it is the result of your own error or omission, and also not when it was made at the direction of the employer.
Some work may be outside of your subspecialty
In some cases, the employer may assign subspecialized doctors to work outside their subspecialty, Mr. Nuland said.
For example, he said he represented an endocrinologist who expected to see only diabetes patients but was assigned to some general internal medicine work as well, and an otolaryngologist client of his who completed a fellowship on facial plastic surgery was expected to do liposuction in a cosmetic surgery group.
What can you do? To prevent this from happening, Mr. Nuland recommends a clause stating that your work will be restricted to your subspecialty.
What the employer promised isn’t in the contract
“Beware of promises that are not in the contract,” Mr. Shay said. “You might feel you can really trust your new boss and what he tells you, but what if that person resigns, or the organization gets a new owner who doesn’t honor unwritten agreements?”
Many contracts have an integration clause, which specifies that the contract constitutes the complete agreement between the two parties, and it nullifies any other oral or written promises made to the physician.
For example, the employer might have promised a relocation bonus and a sign-on bonus, but for some reason it didn’t get into the contract, Ms. Ord said. In those cases, the employer is under no obligation to honor the promise.
What can you do? Mr. Cassidy said it is possible to hold the employer to a commitment made outside the contract. The alternative document, such as an offer letter, has to specifically state that the commitment is protected from the integration clause in the contract, he said, adding: “It is still better to have the commitment put into the contract.”
Contract is simply accepted as is
“Generally, the bigger the employer, the less likely they will alter an agreement just to make you happy,” Mr. Shay said.
But even in these contracts, he said there is still opportunity to fix errors and ambiguities that could harm you later – or even alter a provision if you can’t remove it outright.
The back-and-forth is important, Ms. Adler said. “Negotiation means trying to have some control over your job and your life.”
Mr. Cassidy said a big part of contract review is facing up to the possibility that you may have to resign or be let go.
“Many physicians don’t like to think about leaving when they’re just starting a job, but they need to,” he said. “You need to begin with the end in mind. Think about what would happen if this job didn’t work out.”
A version of this article first appeared on Medscape.com.
FDA panel backs second dose for Johnson & Johnson vaccine recipients
It was the second vote in as many days to back a change to a COVID vaccine timeline.
In its vote, the committee said that boosters could be offered to people as young as age 18. However, it is not clear that everyone who got a Johnson & Johnson vaccine needs to get a second dose. The same panel voted Oct. 14 to recommend booster shots for the Moderna vaccine, but for a narrower group of people.
It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Oct. 21 to discuss issues related to COVID-19 vaccines.
Studies of the effectiveness of the Johnson & Johnson vaccine in the real world show that its protection — while good — has not been as strong as that of the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.
In the end, the members of the FDA’s Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling their second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.
This is an especially important issue for adults over the age of 50. A recent study in the New England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.
Limited data
The company presented data from six studies to the FDA panel in support of a second dose that were limited. The only study looking at second doses after 6 months included just 17 people.
These studies did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.
But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed during the meeting that they did not have ample time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.
Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.
“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”
“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
Archana Chatterjee, MD, PhD, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science, said she had changed her vote during the course of the meeting.
She said that, based on the very limited safety and effectiveness data presented to the committee, she was prepared to vote against the idea of offering second doses of Johnson & Johnson shots.
But after considering the 15 million people who have been vaccinated with a single dose and studies that have suggested that close to 5 million older adults may still be at risk for hospitalization because they’ve just had one shot, “This is still a public health imperative,” she said.
“I’m in agreement with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these individuals to boost up their immunity back into the 90-plus percentile range,” Dr. Chatterjee said.
Who needs a second dose?
On Oct. 14, the committee heard an update on data from Israel, which saw a wave of severe breakthrough infections during the Delta wave.
COVID-19 cases are falling rapidly there after the country widely deployed booster doses of the Pfizer vaccine.
The FDA’s Dr. Marks said Oct. 15 that the agency was leaning toward creating greater flexibility in the emergency use authorizations (EUAs) for the Johnson & Johnson and Moderna vaccines so that boosters could be more widely deployed in the United States too.
The FDA panel on Oct. 14 voted to authorize a 50-milligram dose of Moderna’s vaccine — half the dose used in the primary series of shots — to boost immunity at least 6 months after the second dose.
Those who might need a Moderna booster are the same groups who’ve gotten a green light for third Pfizer doses, including people over 65, adults at higher risk for severe COVID-19, and those who are at higher risk because of where they live or work.
The FDA asked the committee on Oct. 15 to discuss whether boosters should be offered to younger adults, even those without underlying health conditions.
“We’re concerned that what was seen in Israel could be seen here,” Dr. Marks said. “We don’t want to have a wave of severe COVID-19 before we deploy boosters.”
Trying to avoid confusion
Some members of the committee cautioned Dr. Marks to be careful when expanding the EUAs, because it could confuse people.
“When we say immunity is waning, what are the implications of that?” said Michael Kurilla, MD, PhD, director of the division of clinical innovation at the National Institutes of Health.
Overall, data show that all the vaccines currently being used in the United States — including Johnson & Johnson — remain highly effective for preventing severe outcomes from COVID-19, like hospitalization and death.
Booster doses could prevent more people from even getting mild or moderate symptoms from “breakthrough” COVID-19 cases, which began to rise during the recent Delta surge. The additional doses are also expected to prevent severe outcomes like hospitalization in older adults and those with underlying health conditions.
“I think we need to be clear when we say waning immunity and we need to do something about that, I think we need to be clear what we’re really targeting [with boosters] in terms of clinical impact we expect to have,” Dr. Kurilla said.
Others pointed out that preventing even mild-to-moderate infections was a worthy goal, especially considering the implications of long-haul COVID-19.
“COVID does have tremendous downstream effects, even in those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are advantages to that,” said Steven Pergam, MD, MPH, medical director of infection prevention at the Seattle Cancer Care Alliance.
“I’d really be in the camp that would be moving towards a younger age range for allowing boosters,” he said.
This article was updated on 10/18/21. A version of this article first appeared on Medscape.com.
It was the second vote in as many days to back a change to a COVID vaccine timeline.
In its vote, the committee said that boosters could be offered to people as young as age 18. However, it is not clear that everyone who got a Johnson & Johnson vaccine needs to get a second dose. The same panel voted Oct. 14 to recommend booster shots for the Moderna vaccine, but for a narrower group of people.
It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Oct. 21 to discuss issues related to COVID-19 vaccines.
Studies of the effectiveness of the Johnson & Johnson vaccine in the real world show that its protection — while good — has not been as strong as that of the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.
In the end, the members of the FDA’s Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling their second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.
This is an especially important issue for adults over the age of 50. A recent study in the New England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.
Limited data
The company presented data from six studies to the FDA panel in support of a second dose that were limited. The only study looking at second doses after 6 months included just 17 people.
These studies did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.
But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed during the meeting that they did not have ample time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.
Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.
“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”
“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
Archana Chatterjee, MD, PhD, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science, said she had changed her vote during the course of the meeting.
She said that, based on the very limited safety and effectiveness data presented to the committee, she was prepared to vote against the idea of offering second doses of Johnson & Johnson shots.
But after considering the 15 million people who have been vaccinated with a single dose and studies that have suggested that close to 5 million older adults may still be at risk for hospitalization because they’ve just had one shot, “This is still a public health imperative,” she said.
“I’m in agreement with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these individuals to boost up their immunity back into the 90-plus percentile range,” Dr. Chatterjee said.
Who needs a second dose?
On Oct. 14, the committee heard an update on data from Israel, which saw a wave of severe breakthrough infections during the Delta wave.
COVID-19 cases are falling rapidly there after the country widely deployed booster doses of the Pfizer vaccine.
The FDA’s Dr. Marks said Oct. 15 that the agency was leaning toward creating greater flexibility in the emergency use authorizations (EUAs) for the Johnson & Johnson and Moderna vaccines so that boosters could be more widely deployed in the United States too.
The FDA panel on Oct. 14 voted to authorize a 50-milligram dose of Moderna’s vaccine — half the dose used in the primary series of shots — to boost immunity at least 6 months after the second dose.
Those who might need a Moderna booster are the same groups who’ve gotten a green light for third Pfizer doses, including people over 65, adults at higher risk for severe COVID-19, and those who are at higher risk because of where they live or work.
The FDA asked the committee on Oct. 15 to discuss whether boosters should be offered to younger adults, even those without underlying health conditions.
“We’re concerned that what was seen in Israel could be seen here,” Dr. Marks said. “We don’t want to have a wave of severe COVID-19 before we deploy boosters.”
Trying to avoid confusion
Some members of the committee cautioned Dr. Marks to be careful when expanding the EUAs, because it could confuse people.
“When we say immunity is waning, what are the implications of that?” said Michael Kurilla, MD, PhD, director of the division of clinical innovation at the National Institutes of Health.
Overall, data show that all the vaccines currently being used in the United States — including Johnson & Johnson — remain highly effective for preventing severe outcomes from COVID-19, like hospitalization and death.
Booster doses could prevent more people from even getting mild or moderate symptoms from “breakthrough” COVID-19 cases, which began to rise during the recent Delta surge. The additional doses are also expected to prevent severe outcomes like hospitalization in older adults and those with underlying health conditions.
“I think we need to be clear when we say waning immunity and we need to do something about that, I think we need to be clear what we’re really targeting [with boosters] in terms of clinical impact we expect to have,” Dr. Kurilla said.
Others pointed out that preventing even mild-to-moderate infections was a worthy goal, especially considering the implications of long-haul COVID-19.
“COVID does have tremendous downstream effects, even in those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are advantages to that,” said Steven Pergam, MD, MPH, medical director of infection prevention at the Seattle Cancer Care Alliance.
“I’d really be in the camp that would be moving towards a younger age range for allowing boosters,” he said.
This article was updated on 10/18/21. A version of this article first appeared on Medscape.com.
It was the second vote in as many days to back a change to a COVID vaccine timeline.
In its vote, the committee said that boosters could be offered to people as young as age 18. However, it is not clear that everyone who got a Johnson & Johnson vaccine needs to get a second dose. The same panel voted Oct. 14 to recommend booster shots for the Moderna vaccine, but for a narrower group of people.
It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Oct. 21 to discuss issues related to COVID-19 vaccines.
Studies of the effectiveness of the Johnson & Johnson vaccine in the real world show that its protection — while good — has not been as strong as that of the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.
In the end, the members of the FDA’s Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling their second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.
This is an especially important issue for adults over the age of 50. A recent study in the New England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.
Limited data
The company presented data from six studies to the FDA panel in support of a second dose that were limited. The only study looking at second doses after 6 months included just 17 people.
These studies did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.
But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed during the meeting that they did not have ample time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.
Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.
“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”
“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
Archana Chatterjee, MD, PhD, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science, said she had changed her vote during the course of the meeting.
She said that, based on the very limited safety and effectiveness data presented to the committee, she was prepared to vote against the idea of offering second doses of Johnson & Johnson shots.
But after considering the 15 million people who have been vaccinated with a single dose and studies that have suggested that close to 5 million older adults may still be at risk for hospitalization because they’ve just had one shot, “This is still a public health imperative,” she said.
“I’m in agreement with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these individuals to boost up their immunity back into the 90-plus percentile range,” Dr. Chatterjee said.
Who needs a second dose?
On Oct. 14, the committee heard an update on data from Israel, which saw a wave of severe breakthrough infections during the Delta wave.
COVID-19 cases are falling rapidly there after the country widely deployed booster doses of the Pfizer vaccine.
The FDA’s Dr. Marks said Oct. 15 that the agency was leaning toward creating greater flexibility in the emergency use authorizations (EUAs) for the Johnson & Johnson and Moderna vaccines so that boosters could be more widely deployed in the United States too.
The FDA panel on Oct. 14 voted to authorize a 50-milligram dose of Moderna’s vaccine — half the dose used in the primary series of shots — to boost immunity at least 6 months after the second dose.
Those who might need a Moderna booster are the same groups who’ve gotten a green light for third Pfizer doses, including people over 65, adults at higher risk for severe COVID-19, and those who are at higher risk because of where they live or work.
The FDA asked the committee on Oct. 15 to discuss whether boosters should be offered to younger adults, even those without underlying health conditions.
“We’re concerned that what was seen in Israel could be seen here,” Dr. Marks said. “We don’t want to have a wave of severe COVID-19 before we deploy boosters.”
Trying to avoid confusion
Some members of the committee cautioned Dr. Marks to be careful when expanding the EUAs, because it could confuse people.
“When we say immunity is waning, what are the implications of that?” said Michael Kurilla, MD, PhD, director of the division of clinical innovation at the National Institutes of Health.
Overall, data show that all the vaccines currently being used in the United States — including Johnson & Johnson — remain highly effective for preventing severe outcomes from COVID-19, like hospitalization and death.
Booster doses could prevent more people from even getting mild or moderate symptoms from “breakthrough” COVID-19 cases, which began to rise during the recent Delta surge. The additional doses are also expected to prevent severe outcomes like hospitalization in older adults and those with underlying health conditions.
“I think we need to be clear when we say waning immunity and we need to do something about that, I think we need to be clear what we’re really targeting [with boosters] in terms of clinical impact we expect to have,” Dr. Kurilla said.
Others pointed out that preventing even mild-to-moderate infections was a worthy goal, especially considering the implications of long-haul COVID-19.
“COVID does have tremendous downstream effects, even in those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are advantages to that,” said Steven Pergam, MD, MPH, medical director of infection prevention at the Seattle Cancer Care Alliance.
“I’d really be in the camp that would be moving towards a younger age range for allowing boosters,” he said.
This article was updated on 10/18/21. A version of this article first appeared on Medscape.com.
Docs: Insurers’ payment delays, downcoding a ‘revenue grab’
Despite reporting record profits during the COVID-19 pandemic, major insurance companies are delaying claims payments and making it more difficult for hospitals and physicians to get paid the full amount of claims, observers and physicians say.
Kaiser Health News recently reported that hospitals, in particular, are affected by the slowdown in claims payments from Anthem Blue Cross, the nation’s second largest health insurer. The investigative piece did not focus on outpatient or independent practices. Research by this news organization shows that the health plans’ new policies are also reducing cash flow and raising costs for ambulatory care groups. In addition, it showed that other payers besides Anthem have engaged in the same practices.
“What we’ve seen is that with complex claims, such as those with -25 modifiers, plans are routinely requiring documentation,” Jim Donohue, senior manager and associate principal at ECG Management Consultants, said in an interview. “It’s not a denial, it’s a request for more information for medical records prior to processing payments. That has the effect of slowing down payments.”
This is exactly what one internal medicine group in the Southeast has noticed. The internist who heads the practice, who asked not to be identified, says that about 4-6 months ago, United, Humana, and other payers started to require documentation for prepayment review on a higher percentage of complex claims such as 99214 (established patient), 99204 (new patient), and claims with -25 modifiers. (The latter are appended to evaluation and management [E/M] claims in which patients had comorbidities that were addressed in the same visit as the main complaint.)
“That’s really frustrating, because you have to print out or take the record for that particular visit and computer fax it to them,” the practice leader notes. “And invariably, they’ll say they didn’t get a certain percentage of them. It’s our fault because they lost the claim.”
In the past, he says, health plans would occasionally ask for the note related to a complex visit where they saw issues, and they’ve always done random postpayment chart audits. But the percentage of prepayment reviews has significantly increased in recent months, he says.
Until a plan does this review, the claim can’t be processed because it’s not regarded as a clean claim. And this has implications for insurers’ compliance with laws that, in most states, require them to pay claims within 30-40 days of submission. (Medicare’s limit is 30 days.) According to Mr. Donohue, the clock doesn’t start ticking on this requirement unless and until a claim is clean. So by requiring documentation on complex claims, the plans can not only justify downcoding a claim, but can also delay payment without triggering state penalties.
Insurer admits ‘challenges’ with claims processing
VCU Health, a health system affiliated with Virginia Commonwealth University, recently filed a complaint against Anthem with Virginia’s insurance commissioner, asking that the Virginia Bureau of Insurance investigate the company’s claims-processing delays. The complaint claimed Anthem owes VCU more than $385 million, of which $171 million is over 90 days old. Much of that consists of commercial claims, which are subject to the state’s 40-day claims payment rule.
VCU cited several problems it said Anthem had created that slowed claims payments:
Any claim over a certain dollar limit requires an itemized bill.
Anthem requests detailed medical records prior to considering payment of even clean claims.
Documents must be uploaded to a web portal that has technical problems, and Anthem has lost some documents as a result.
Claims are being incorrectly processed for some professionals, “resulting in multi-million-dollar underpayments of anesthesia, nurse practitioners, pathology, and behavioral health providers.”
In addition, as the Kaiser Health News article points out, hospitals have blamed the increase in payment delays or denials partly on “preauthorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers.”
In response to an inquiry from this news organization, an Anthem spokesman admitted that some payments to providers have been delayed, partly because of changes in the company’s claims-processing system. “We recognize there have been some challenges as we work with care providers to update claims processing, and readjust and adapt to a new set of dynamics as we continue to manage the pandemic,” said the spokesman.
The Kaiser Health News piece reported that Anthem’s CFO had told stock analysts on a conference call that the company had slowed claims payments to build up its financial reserves during the pandemic – a statement that some physicians called “outrageous.” But the Anthem spokesman told this news organization the quote was taken out of context and that the CFO was talking not about reserves but about “days in claims payable.” The spokesman said, “The payment delays that the article focuses on are not the primary driver or even a material driver of the increase in our overall reserves or DCPs [defined contribution plans] relative to historical levels. In fact, the vast majority of our claims are being processed in a timely manner.”
Some claims routinely downcoded
Even if that were the case, it would not explain why some physicians are seeing their higher-cost claims routinely downcoded. Will Sawyer, MD, a family physician in Cincinnati, told this news organization, “Anthem has been downcoding relentlessly since October 2020.” More often than not, when his office submits a claim with a 99214 code (office visit, 30-39 minutes, moderate medical decision-making), it’s changed to 99213 (office visit, 20-29 minutes, low medical decision-making) before processing, he says.
This has resulted in a significant diminution of his income, he notes. Anthem pays him less than Medicare for E/M visits, and the downcoding reduces his payment from $86 to $68 for a complex visit that may have taken half an hour or more.
In some cases where his office manager has noticed the downcoding, Dr. Sawyer says, she has resubmitted the claim with a copy of the encounter form. But Anthem hasn’t budged. And the refiling effort takes a toll on his solo practice, which doesn’t have sufficient staff, as it is.
Dr. Sawyer acknowledges that he has sent in a higher percentage of complex claims in the past year than he did previously. But much of that is the result of two factors beyond his control: First, many patients avoided coming into the office early in the pandemic, and when they returned, their preventive and chronic care needs were greater. Second, he says, “There are many comorbidities and mental health aspects, which exacerbate many issues and become an issue. We’re not dealing with engines here; they’re human beings. And it takes time.”
In response to Dr. Sawyer’s comments, Anthem said that it uses “analytical tools to review evaluation and management (E/M) codes during the claims adjudication and processing process.” Physicians who believe that certain claims should not have been downcoded can dispute these decisions; they must supply a statement explaining why they disagree with the decision along with documentation to support their statement, the company said. Anthem added that it reviews claims to lower costs for its members.
‘Revenue-grab strategy’
Dr. Sawyer believes that what Anthem is doing to him and other physicians reflects its desire to increase profits by netting extra revenue and keeping physicians’ money while it delays payments to them – a practice known in the trade as “the float.” Moreover, he says, the company depends on many practices not keeping track of their finances during the pandemic.
“When practices are running at warp speed, trying to keep people healthy and getting burned out, they aren’t paying as close attention to the details of payment. It’s an absolute revenue-grab strategy that’s unconscionable,” says Dr. Sawyer.
The Southeast internist also thinks that insurance companies other than Anthem – including United and Humana – are profiting from the float. Besides delaying his payments with gratuitous demands for documentation, he said, they also downcode many claims, forcing the practice to refile the claims and appeal. That forces the practice to pay overtime or bring on more claims staff, which raises administrative costs.
The plans’ strategy, the internist says, is this: “If they downcode millions of claims, a certain number of physicians will give up without appealing, and they’ll raise their profits.”
A United spokesperson said in an interview, “We pay claims appropriately under members’ plans and within the required time frame.” Humana had not responded to this news organization’s request for comment at press time.
Challenge to practice economics
Insurer policies that delay payments or downcode claims, ECG’s Mr. Donohue points out, are especially harmful to primary care and other ambulatory practices that have many small-dollar claims.
“That’s where it’s challenging, because it’s not like a $10,000 case where you add $100 to it [to meet records requests]. You’re talking about something that’s relatively low dollar, where the practice makes a small surplus, and when you add administrative costs, it can change the economics,” he says.
While the economic burden on ambulatory care practices may be greater, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association (MGMA), said that the payment delays and demands for documentation – along with prior authorization – particularly affect inpatient care. The health plans are questioning big-ticket items more than ever, he said, and most of those services occur in hospitals.
However, the greater level of insurer scrutiny also affects physicians who treat patients in the hospital, including surgeons and emergency department physicians who contract with the facilities, he adds.
Mr. Gilberg views the current situation as an exacerbation of the health plan policies that physicians have long struggled with. “It’s not new to have insurers play the float and not pay claims on time. Unfortunately, this is something that medical practices are used to.”
A version of this article first appeared on Medscape.com.
Despite reporting record profits during the COVID-19 pandemic, major insurance companies are delaying claims payments and making it more difficult for hospitals and physicians to get paid the full amount of claims, observers and physicians say.
Kaiser Health News recently reported that hospitals, in particular, are affected by the slowdown in claims payments from Anthem Blue Cross, the nation’s second largest health insurer. The investigative piece did not focus on outpatient or independent practices. Research by this news organization shows that the health plans’ new policies are also reducing cash flow and raising costs for ambulatory care groups. In addition, it showed that other payers besides Anthem have engaged in the same practices.
“What we’ve seen is that with complex claims, such as those with -25 modifiers, plans are routinely requiring documentation,” Jim Donohue, senior manager and associate principal at ECG Management Consultants, said in an interview. “It’s not a denial, it’s a request for more information for medical records prior to processing payments. That has the effect of slowing down payments.”
This is exactly what one internal medicine group in the Southeast has noticed. The internist who heads the practice, who asked not to be identified, says that about 4-6 months ago, United, Humana, and other payers started to require documentation for prepayment review on a higher percentage of complex claims such as 99214 (established patient), 99204 (new patient), and claims with -25 modifiers. (The latter are appended to evaluation and management [E/M] claims in which patients had comorbidities that were addressed in the same visit as the main complaint.)
“That’s really frustrating, because you have to print out or take the record for that particular visit and computer fax it to them,” the practice leader notes. “And invariably, they’ll say they didn’t get a certain percentage of them. It’s our fault because they lost the claim.”
In the past, he says, health plans would occasionally ask for the note related to a complex visit where they saw issues, and they’ve always done random postpayment chart audits. But the percentage of prepayment reviews has significantly increased in recent months, he says.
Until a plan does this review, the claim can’t be processed because it’s not regarded as a clean claim. And this has implications for insurers’ compliance with laws that, in most states, require them to pay claims within 30-40 days of submission. (Medicare’s limit is 30 days.) According to Mr. Donohue, the clock doesn’t start ticking on this requirement unless and until a claim is clean. So by requiring documentation on complex claims, the plans can not only justify downcoding a claim, but can also delay payment without triggering state penalties.
Insurer admits ‘challenges’ with claims processing
VCU Health, a health system affiliated with Virginia Commonwealth University, recently filed a complaint against Anthem with Virginia’s insurance commissioner, asking that the Virginia Bureau of Insurance investigate the company’s claims-processing delays. The complaint claimed Anthem owes VCU more than $385 million, of which $171 million is over 90 days old. Much of that consists of commercial claims, which are subject to the state’s 40-day claims payment rule.
VCU cited several problems it said Anthem had created that slowed claims payments:
Any claim over a certain dollar limit requires an itemized bill.
Anthem requests detailed medical records prior to considering payment of even clean claims.
Documents must be uploaded to a web portal that has technical problems, and Anthem has lost some documents as a result.
Claims are being incorrectly processed for some professionals, “resulting in multi-million-dollar underpayments of anesthesia, nurse practitioners, pathology, and behavioral health providers.”
In addition, as the Kaiser Health News article points out, hospitals have blamed the increase in payment delays or denials partly on “preauthorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers.”
In response to an inquiry from this news organization, an Anthem spokesman admitted that some payments to providers have been delayed, partly because of changes in the company’s claims-processing system. “We recognize there have been some challenges as we work with care providers to update claims processing, and readjust and adapt to a new set of dynamics as we continue to manage the pandemic,” said the spokesman.
The Kaiser Health News piece reported that Anthem’s CFO had told stock analysts on a conference call that the company had slowed claims payments to build up its financial reserves during the pandemic – a statement that some physicians called “outrageous.” But the Anthem spokesman told this news organization the quote was taken out of context and that the CFO was talking not about reserves but about “days in claims payable.” The spokesman said, “The payment delays that the article focuses on are not the primary driver or even a material driver of the increase in our overall reserves or DCPs [defined contribution plans] relative to historical levels. In fact, the vast majority of our claims are being processed in a timely manner.”
Some claims routinely downcoded
Even if that were the case, it would not explain why some physicians are seeing their higher-cost claims routinely downcoded. Will Sawyer, MD, a family physician in Cincinnati, told this news organization, “Anthem has been downcoding relentlessly since October 2020.” More often than not, when his office submits a claim with a 99214 code (office visit, 30-39 minutes, moderate medical decision-making), it’s changed to 99213 (office visit, 20-29 minutes, low medical decision-making) before processing, he says.
This has resulted in a significant diminution of his income, he notes. Anthem pays him less than Medicare for E/M visits, and the downcoding reduces his payment from $86 to $68 for a complex visit that may have taken half an hour or more.
In some cases where his office manager has noticed the downcoding, Dr. Sawyer says, she has resubmitted the claim with a copy of the encounter form. But Anthem hasn’t budged. And the refiling effort takes a toll on his solo practice, which doesn’t have sufficient staff, as it is.
Dr. Sawyer acknowledges that he has sent in a higher percentage of complex claims in the past year than he did previously. But much of that is the result of two factors beyond his control: First, many patients avoided coming into the office early in the pandemic, and when they returned, their preventive and chronic care needs were greater. Second, he says, “There are many comorbidities and mental health aspects, which exacerbate many issues and become an issue. We’re not dealing with engines here; they’re human beings. And it takes time.”
In response to Dr. Sawyer’s comments, Anthem said that it uses “analytical tools to review evaluation and management (E/M) codes during the claims adjudication and processing process.” Physicians who believe that certain claims should not have been downcoded can dispute these decisions; they must supply a statement explaining why they disagree with the decision along with documentation to support their statement, the company said. Anthem added that it reviews claims to lower costs for its members.
‘Revenue-grab strategy’
Dr. Sawyer believes that what Anthem is doing to him and other physicians reflects its desire to increase profits by netting extra revenue and keeping physicians’ money while it delays payments to them – a practice known in the trade as “the float.” Moreover, he says, the company depends on many practices not keeping track of their finances during the pandemic.
“When practices are running at warp speed, trying to keep people healthy and getting burned out, they aren’t paying as close attention to the details of payment. It’s an absolute revenue-grab strategy that’s unconscionable,” says Dr. Sawyer.
The Southeast internist also thinks that insurance companies other than Anthem – including United and Humana – are profiting from the float. Besides delaying his payments with gratuitous demands for documentation, he said, they also downcode many claims, forcing the practice to refile the claims and appeal. That forces the practice to pay overtime or bring on more claims staff, which raises administrative costs.
The plans’ strategy, the internist says, is this: “If they downcode millions of claims, a certain number of physicians will give up without appealing, and they’ll raise their profits.”
A United spokesperson said in an interview, “We pay claims appropriately under members’ plans and within the required time frame.” Humana had not responded to this news organization’s request for comment at press time.
Challenge to practice economics
Insurer policies that delay payments or downcode claims, ECG’s Mr. Donohue points out, are especially harmful to primary care and other ambulatory practices that have many small-dollar claims.
“That’s where it’s challenging, because it’s not like a $10,000 case where you add $100 to it [to meet records requests]. You’re talking about something that’s relatively low dollar, where the practice makes a small surplus, and when you add administrative costs, it can change the economics,” he says.
While the economic burden on ambulatory care practices may be greater, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association (MGMA), said that the payment delays and demands for documentation – along with prior authorization – particularly affect inpatient care. The health plans are questioning big-ticket items more than ever, he said, and most of those services occur in hospitals.
However, the greater level of insurer scrutiny also affects physicians who treat patients in the hospital, including surgeons and emergency department physicians who contract with the facilities, he adds.
Mr. Gilberg views the current situation as an exacerbation of the health plan policies that physicians have long struggled with. “It’s not new to have insurers play the float and not pay claims on time. Unfortunately, this is something that medical practices are used to.”
A version of this article first appeared on Medscape.com.
Despite reporting record profits during the COVID-19 pandemic, major insurance companies are delaying claims payments and making it more difficult for hospitals and physicians to get paid the full amount of claims, observers and physicians say.
Kaiser Health News recently reported that hospitals, in particular, are affected by the slowdown in claims payments from Anthem Blue Cross, the nation’s second largest health insurer. The investigative piece did not focus on outpatient or independent practices. Research by this news organization shows that the health plans’ new policies are also reducing cash flow and raising costs for ambulatory care groups. In addition, it showed that other payers besides Anthem have engaged in the same practices.
“What we’ve seen is that with complex claims, such as those with -25 modifiers, plans are routinely requiring documentation,” Jim Donohue, senior manager and associate principal at ECG Management Consultants, said in an interview. “It’s not a denial, it’s a request for more information for medical records prior to processing payments. That has the effect of slowing down payments.”
This is exactly what one internal medicine group in the Southeast has noticed. The internist who heads the practice, who asked not to be identified, says that about 4-6 months ago, United, Humana, and other payers started to require documentation for prepayment review on a higher percentage of complex claims such as 99214 (established patient), 99204 (new patient), and claims with -25 modifiers. (The latter are appended to evaluation and management [E/M] claims in which patients had comorbidities that were addressed in the same visit as the main complaint.)
“That’s really frustrating, because you have to print out or take the record for that particular visit and computer fax it to them,” the practice leader notes. “And invariably, they’ll say they didn’t get a certain percentage of them. It’s our fault because they lost the claim.”
In the past, he says, health plans would occasionally ask for the note related to a complex visit where they saw issues, and they’ve always done random postpayment chart audits. But the percentage of prepayment reviews has significantly increased in recent months, he says.
Until a plan does this review, the claim can’t be processed because it’s not regarded as a clean claim. And this has implications for insurers’ compliance with laws that, in most states, require them to pay claims within 30-40 days of submission. (Medicare’s limit is 30 days.) According to Mr. Donohue, the clock doesn’t start ticking on this requirement unless and until a claim is clean. So by requiring documentation on complex claims, the plans can not only justify downcoding a claim, but can also delay payment without triggering state penalties.
Insurer admits ‘challenges’ with claims processing
VCU Health, a health system affiliated with Virginia Commonwealth University, recently filed a complaint against Anthem with Virginia’s insurance commissioner, asking that the Virginia Bureau of Insurance investigate the company’s claims-processing delays. The complaint claimed Anthem owes VCU more than $385 million, of which $171 million is over 90 days old. Much of that consists of commercial claims, which are subject to the state’s 40-day claims payment rule.
VCU cited several problems it said Anthem had created that slowed claims payments:
Any claim over a certain dollar limit requires an itemized bill.
Anthem requests detailed medical records prior to considering payment of even clean claims.
Documents must be uploaded to a web portal that has technical problems, and Anthem has lost some documents as a result.
Claims are being incorrectly processed for some professionals, “resulting in multi-million-dollar underpayments of anesthesia, nurse practitioners, pathology, and behavioral health providers.”
In addition, as the Kaiser Health News article points out, hospitals have blamed the increase in payment delays or denials partly on “preauthorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers.”
In response to an inquiry from this news organization, an Anthem spokesman admitted that some payments to providers have been delayed, partly because of changes in the company’s claims-processing system. “We recognize there have been some challenges as we work with care providers to update claims processing, and readjust and adapt to a new set of dynamics as we continue to manage the pandemic,” said the spokesman.
The Kaiser Health News piece reported that Anthem’s CFO had told stock analysts on a conference call that the company had slowed claims payments to build up its financial reserves during the pandemic – a statement that some physicians called “outrageous.” But the Anthem spokesman told this news organization the quote was taken out of context and that the CFO was talking not about reserves but about “days in claims payable.” The spokesman said, “The payment delays that the article focuses on are not the primary driver or even a material driver of the increase in our overall reserves or DCPs [defined contribution plans] relative to historical levels. In fact, the vast majority of our claims are being processed in a timely manner.”
Some claims routinely downcoded
Even if that were the case, it would not explain why some physicians are seeing their higher-cost claims routinely downcoded. Will Sawyer, MD, a family physician in Cincinnati, told this news organization, “Anthem has been downcoding relentlessly since October 2020.” More often than not, when his office submits a claim with a 99214 code (office visit, 30-39 minutes, moderate medical decision-making), it’s changed to 99213 (office visit, 20-29 minutes, low medical decision-making) before processing, he says.
This has resulted in a significant diminution of his income, he notes. Anthem pays him less than Medicare for E/M visits, and the downcoding reduces his payment from $86 to $68 for a complex visit that may have taken half an hour or more.
In some cases where his office manager has noticed the downcoding, Dr. Sawyer says, she has resubmitted the claim with a copy of the encounter form. But Anthem hasn’t budged. And the refiling effort takes a toll on his solo practice, which doesn’t have sufficient staff, as it is.
Dr. Sawyer acknowledges that he has sent in a higher percentage of complex claims in the past year than he did previously. But much of that is the result of two factors beyond his control: First, many patients avoided coming into the office early in the pandemic, and when they returned, their preventive and chronic care needs were greater. Second, he says, “There are many comorbidities and mental health aspects, which exacerbate many issues and become an issue. We’re not dealing with engines here; they’re human beings. And it takes time.”
In response to Dr. Sawyer’s comments, Anthem said that it uses “analytical tools to review evaluation and management (E/M) codes during the claims adjudication and processing process.” Physicians who believe that certain claims should not have been downcoded can dispute these decisions; they must supply a statement explaining why they disagree with the decision along with documentation to support their statement, the company said. Anthem added that it reviews claims to lower costs for its members.
‘Revenue-grab strategy’
Dr. Sawyer believes that what Anthem is doing to him and other physicians reflects its desire to increase profits by netting extra revenue and keeping physicians’ money while it delays payments to them – a practice known in the trade as “the float.” Moreover, he says, the company depends on many practices not keeping track of their finances during the pandemic.
“When practices are running at warp speed, trying to keep people healthy and getting burned out, they aren’t paying as close attention to the details of payment. It’s an absolute revenue-grab strategy that’s unconscionable,” says Dr. Sawyer.
The Southeast internist also thinks that insurance companies other than Anthem – including United and Humana – are profiting from the float. Besides delaying his payments with gratuitous demands for documentation, he said, they also downcode many claims, forcing the practice to refile the claims and appeal. That forces the practice to pay overtime or bring on more claims staff, which raises administrative costs.
The plans’ strategy, the internist says, is this: “If they downcode millions of claims, a certain number of physicians will give up without appealing, and they’ll raise their profits.”
A United spokesperson said in an interview, “We pay claims appropriately under members’ plans and within the required time frame.” Humana had not responded to this news organization’s request for comment at press time.
Challenge to practice economics
Insurer policies that delay payments or downcode claims, ECG’s Mr. Donohue points out, are especially harmful to primary care and other ambulatory practices that have many small-dollar claims.
“That’s where it’s challenging, because it’s not like a $10,000 case where you add $100 to it [to meet records requests]. You’re talking about something that’s relatively low dollar, where the practice makes a small surplus, and when you add administrative costs, it can change the economics,” he says.
While the economic burden on ambulatory care practices may be greater, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association (MGMA), said that the payment delays and demands for documentation – along with prior authorization – particularly affect inpatient care. The health plans are questioning big-ticket items more than ever, he said, and most of those services occur in hospitals.
However, the greater level of insurer scrutiny also affects physicians who treat patients in the hospital, including surgeons and emergency department physicians who contract with the facilities, he adds.
Mr. Gilberg views the current situation as an exacerbation of the health plan policies that physicians have long struggled with. “It’s not new to have insurers play the float and not pay claims on time. Unfortunately, this is something that medical practices are used to.”
A version of this article first appeared on Medscape.com.