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Physician offices should have bigger role in vaccine rollout: MGMA
Physician offices, which have been deemphasized in the COVID-19 vaccine rollout, should have a more prominent role in the effort going forward, said the Medical Group Management Association in a letter sent to President Joe Biden on Jan. 26.
“Due to our members’ role as community providers, we ask that the Administration include medical group practices in COVID-19 vaccine distribution strategies moving forward,” Halee Fischer-Wright, MD, president and CEO of MGMA, stated in the letter.
“Current vaccine efforts are haphazard at best and appear to rely on a passive first come first served approach with the public rushing to sign up for vaccines when scant supply becomes available,” MGMA noted. “This favors patients who can advocate for themselves or have family members able to do the same. Yet medical group practices already have patient relationships and experience vaccinating patients for influenza and other conditions.”
Moreover, physician practices have data on patient demographics, preexisting conditions, and risk factors. This is valuable information not available to hospitals, pharmacies, and state health departments, MGMA said.
“Furthermore, in a time of uncertainty and misinformation, patients are looking to their own physicians as a trusted source for information on vaccine safety and efficacy,” the letter stated. “Physician group practices can and should play a significant role in vaccine education.”
Despite these advantages of vaccinating patients in doctors’ offices, MGMA pointed out that “states have largely not leveraged physician practices in vaccine rollout efforts.”
In an MGMA survey conducted last week, 85% of independent practices and 45% of hospital- or health system–owned practices that sought COVID-19 vaccine for their patients were unable to obtain any. Of the practices able to get vaccine supplies, the majority said they had received only enough to vaccinate 1% or less of their patients.
Susan R. Bailey, MD, president of the American Medical Association commented in an interview that, “once enough supplies are available, we encourage the administration to ensure physician practices have an adequate supply of COVID-19 vaccines to vaccinate their patients. Physician practices will be an integral part of the vaccine administration process. Physicians are a trusted source of information for patients and their direct conversations and recommendations for patients to get vaccinated will help address hesitancy and result in more people getting vaccinated.”
Many groups, MGMA said, had been approved by their states to distribute the vaccine but received little or no inventory. Practice phone lines have been “flooded” by patients wanting to know why their physicians can’t vaccinate them.
Programs vary by state
In an interview, Dr. Fischer-Wright said that most practices want to vaccinate their patients. But only some states have set up programs that allow them to apply for the COVID-19 vaccines. “Most of our practices that were eligible for vaccination have applied for it,” she added.
The New York State Health Department is taking a different approach, according to Dial Hewlett Jr., MD, medical director for disease control services with the Westchester County Department of Health in White Plains, N.Y.. The state health department has designated specific sites across New York as vaccination hubs; in Westchester County, the hub is the Westchester Medical Center. When the hospital receives a vaccine shipment, it distributes some of it to smaller sites such as the county health department, which includes a vaccination clinic.
“So far, they haven’t gotten to the point where they’re distributing to pharmacies or doctors’ offices,” Dr. Hewlett said in an interview.
Right now, he said, the chief limiting factor is vaccine supply. When that expands, he said, physician offices will likely get more vaccine doses.
Both Dr. Hewlett and Dr. Fischer-Wright pointed out that physician offices are limited because they aren’t able to store the Pfizer vaccine, which requires ultracold freezers. “But now that we have the Moderna vaccine, 50% of the 200 million doses that have been promised can be delivered in a physician office,” said Dr. Fischer-Wright.
So why haven’t practices received more vaccine? Besides the inadequate supply across the nation, Dr. Fischer-Wright said, there have been difficulties in getting the vaccine to physician offices. Some MGMA members, she added, did receive vaccine supplies immediately. “These were independent practices that had over 200 physicians.”
Dr. Hewlett noted that some smaller practices have complained to the county department that they couldn’t obtain vaccine because they lacked the clout to compete with larger groups. “They’re not ordering enough product to make it a priority for whoever is involved with the distribution.”
Another problem – evident in the results of MGMA’s recent poll – is that health care systems that have vaccine supplies are sharing them with their own practices before they make any available to community practices.
“If you’re working for Northwell Health, you probably won’t have the kinds of challenges that the small mom-and-pop practice would have,” Dr. Hewlett said.
Overcoming vaccine hesitancy
More than a quarter of the U.S. population has indicated they are hesitant to get the COVID-19 vaccine. This is an area where Dr. Fischer-Wright believes physicians can help immensely.
“The benefit of having that type of activity occur in the physician office is that it’s a place where physicians have already established trust with patients,” she said. “And one of the reasons why some people don’t want a shot is that they don’t trust the vaccine. Having a human being that you have a relationship with provide you with the pros and cons is very compelling to get people to make an alternative choice.”
Physicians and their staff will also need to be educated before they administer the vaccine, Dr. Hewlett noted. “There will have to be education on the handling of the vaccine, but I think that can easily be done. Many practices have physician assistants and nurse practitioners who have been doing a lot of vaccinations in the office setting.”
Complex logistics
Based on the experience of his department’s vaccination clinic, which has been giving COVID-19 shots since Jan. 5, Dr. Hewlett said private practices have a lot to consider before they launch their own vaccination efforts.
To begin with, he said, “it’s a tricky situation with these vaccines that require two doses.” Before his clinic makes an appointment to vaccinate a patient, the scheduler has to make sure that the patient can return in 21 or 28 days, depending on whether they’re getting the Pfizer or Moderna vaccine.
“It’s difficult if they can’t show up 28 days after that date because we expect the same number of people to show up 28 days later for their second dose,” he said. “This is quite different from a standard medical practice. There aren’t too many situations where a person has to come back to the office after 28 days or 21 days.”
While the Centers for Disease Control and Prevention recently said the immunization schedule can be more flexible, Dr. Hewlett added, his clinic prefers to get patients back on the recommended schedule to make sure the vaccine will be maximally effective.
The clinic also has to follow state regulations requiring that all vaccines it receives be administered within a week of receipt. Right now, the clinic is open 6 days a week, giving about 300-400 shots a day. Each morning, a clerk records how many doses were administered the previous day, along with the lot numbers – and all data must be reported to the state.
The operation is fairly labor intensive. The clinic has a staff of about 30 people, most of whom are now engaged full time in the COVID-19 vaccination effort.
“We have people who check patients in and who screen to make sure no one has COVID symptoms. Other people escort patients to the vaccination stations. We have about 15 nurse practitioners and public health nurses who give the shots, and we have to make sure they’re accounting for every dose that’s given. And we have to make sure everybody getting a dose meets the eligibility criteria for shots,” he said. “We also have an area where patients are watched for 15 minutes after they’re vaccinated. Then there’s a group of five data entry people who locate appointment slots 28 days from today.”
It’s all still “a work in progress,” Dr. Hewlett said, but the staff who give COVID-19 shots and the patients who receive them are gratified to be making a difference.
A version of this article first appeared on Medscape.com.
Physician offices, which have been deemphasized in the COVID-19 vaccine rollout, should have a more prominent role in the effort going forward, said the Medical Group Management Association in a letter sent to President Joe Biden on Jan. 26.
“Due to our members’ role as community providers, we ask that the Administration include medical group practices in COVID-19 vaccine distribution strategies moving forward,” Halee Fischer-Wright, MD, president and CEO of MGMA, stated in the letter.
“Current vaccine efforts are haphazard at best and appear to rely on a passive first come first served approach with the public rushing to sign up for vaccines when scant supply becomes available,” MGMA noted. “This favors patients who can advocate for themselves or have family members able to do the same. Yet medical group practices already have patient relationships and experience vaccinating patients for influenza and other conditions.”
Moreover, physician practices have data on patient demographics, preexisting conditions, and risk factors. This is valuable information not available to hospitals, pharmacies, and state health departments, MGMA said.
“Furthermore, in a time of uncertainty and misinformation, patients are looking to their own physicians as a trusted source for information on vaccine safety and efficacy,” the letter stated. “Physician group practices can and should play a significant role in vaccine education.”
Despite these advantages of vaccinating patients in doctors’ offices, MGMA pointed out that “states have largely not leveraged physician practices in vaccine rollout efforts.”
In an MGMA survey conducted last week, 85% of independent practices and 45% of hospital- or health system–owned practices that sought COVID-19 vaccine for their patients were unable to obtain any. Of the practices able to get vaccine supplies, the majority said they had received only enough to vaccinate 1% or less of their patients.
Susan R. Bailey, MD, president of the American Medical Association commented in an interview that, “once enough supplies are available, we encourage the administration to ensure physician practices have an adequate supply of COVID-19 vaccines to vaccinate their patients. Physician practices will be an integral part of the vaccine administration process. Physicians are a trusted source of information for patients and their direct conversations and recommendations for patients to get vaccinated will help address hesitancy and result in more people getting vaccinated.”
Many groups, MGMA said, had been approved by their states to distribute the vaccine but received little or no inventory. Practice phone lines have been “flooded” by patients wanting to know why their physicians can’t vaccinate them.
Programs vary by state
In an interview, Dr. Fischer-Wright said that most practices want to vaccinate their patients. But only some states have set up programs that allow them to apply for the COVID-19 vaccines. “Most of our practices that were eligible for vaccination have applied for it,” she added.
The New York State Health Department is taking a different approach, according to Dial Hewlett Jr., MD, medical director for disease control services with the Westchester County Department of Health in White Plains, N.Y.. The state health department has designated specific sites across New York as vaccination hubs; in Westchester County, the hub is the Westchester Medical Center. When the hospital receives a vaccine shipment, it distributes some of it to smaller sites such as the county health department, which includes a vaccination clinic.
“So far, they haven’t gotten to the point where they’re distributing to pharmacies or doctors’ offices,” Dr. Hewlett said in an interview.
Right now, he said, the chief limiting factor is vaccine supply. When that expands, he said, physician offices will likely get more vaccine doses.
Both Dr. Hewlett and Dr. Fischer-Wright pointed out that physician offices are limited because they aren’t able to store the Pfizer vaccine, which requires ultracold freezers. “But now that we have the Moderna vaccine, 50% of the 200 million doses that have been promised can be delivered in a physician office,” said Dr. Fischer-Wright.
So why haven’t practices received more vaccine? Besides the inadequate supply across the nation, Dr. Fischer-Wright said, there have been difficulties in getting the vaccine to physician offices. Some MGMA members, she added, did receive vaccine supplies immediately. “These were independent practices that had over 200 physicians.”
Dr. Hewlett noted that some smaller practices have complained to the county department that they couldn’t obtain vaccine because they lacked the clout to compete with larger groups. “They’re not ordering enough product to make it a priority for whoever is involved with the distribution.”
Another problem – evident in the results of MGMA’s recent poll – is that health care systems that have vaccine supplies are sharing them with their own practices before they make any available to community practices.
“If you’re working for Northwell Health, you probably won’t have the kinds of challenges that the small mom-and-pop practice would have,” Dr. Hewlett said.
Overcoming vaccine hesitancy
More than a quarter of the U.S. population has indicated they are hesitant to get the COVID-19 vaccine. This is an area where Dr. Fischer-Wright believes physicians can help immensely.
“The benefit of having that type of activity occur in the physician office is that it’s a place where physicians have already established trust with patients,” she said. “And one of the reasons why some people don’t want a shot is that they don’t trust the vaccine. Having a human being that you have a relationship with provide you with the pros and cons is very compelling to get people to make an alternative choice.”
Physicians and their staff will also need to be educated before they administer the vaccine, Dr. Hewlett noted. “There will have to be education on the handling of the vaccine, but I think that can easily be done. Many practices have physician assistants and nurse practitioners who have been doing a lot of vaccinations in the office setting.”
Complex logistics
Based on the experience of his department’s vaccination clinic, which has been giving COVID-19 shots since Jan. 5, Dr. Hewlett said private practices have a lot to consider before they launch their own vaccination efforts.
To begin with, he said, “it’s a tricky situation with these vaccines that require two doses.” Before his clinic makes an appointment to vaccinate a patient, the scheduler has to make sure that the patient can return in 21 or 28 days, depending on whether they’re getting the Pfizer or Moderna vaccine.
“It’s difficult if they can’t show up 28 days after that date because we expect the same number of people to show up 28 days later for their second dose,” he said. “This is quite different from a standard medical practice. There aren’t too many situations where a person has to come back to the office after 28 days or 21 days.”
While the Centers for Disease Control and Prevention recently said the immunization schedule can be more flexible, Dr. Hewlett added, his clinic prefers to get patients back on the recommended schedule to make sure the vaccine will be maximally effective.
The clinic also has to follow state regulations requiring that all vaccines it receives be administered within a week of receipt. Right now, the clinic is open 6 days a week, giving about 300-400 shots a day. Each morning, a clerk records how many doses were administered the previous day, along with the lot numbers – and all data must be reported to the state.
The operation is fairly labor intensive. The clinic has a staff of about 30 people, most of whom are now engaged full time in the COVID-19 vaccination effort.
“We have people who check patients in and who screen to make sure no one has COVID symptoms. Other people escort patients to the vaccination stations. We have about 15 nurse practitioners and public health nurses who give the shots, and we have to make sure they’re accounting for every dose that’s given. And we have to make sure everybody getting a dose meets the eligibility criteria for shots,” he said. “We also have an area where patients are watched for 15 minutes after they’re vaccinated. Then there’s a group of five data entry people who locate appointment slots 28 days from today.”
It’s all still “a work in progress,” Dr. Hewlett said, but the staff who give COVID-19 shots and the patients who receive them are gratified to be making a difference.
A version of this article first appeared on Medscape.com.
Physician offices, which have been deemphasized in the COVID-19 vaccine rollout, should have a more prominent role in the effort going forward, said the Medical Group Management Association in a letter sent to President Joe Biden on Jan. 26.
“Due to our members’ role as community providers, we ask that the Administration include medical group practices in COVID-19 vaccine distribution strategies moving forward,” Halee Fischer-Wright, MD, president and CEO of MGMA, stated in the letter.
“Current vaccine efforts are haphazard at best and appear to rely on a passive first come first served approach with the public rushing to sign up for vaccines when scant supply becomes available,” MGMA noted. “This favors patients who can advocate for themselves or have family members able to do the same. Yet medical group practices already have patient relationships and experience vaccinating patients for influenza and other conditions.”
Moreover, physician practices have data on patient demographics, preexisting conditions, and risk factors. This is valuable information not available to hospitals, pharmacies, and state health departments, MGMA said.
“Furthermore, in a time of uncertainty and misinformation, patients are looking to their own physicians as a trusted source for information on vaccine safety and efficacy,” the letter stated. “Physician group practices can and should play a significant role in vaccine education.”
Despite these advantages of vaccinating patients in doctors’ offices, MGMA pointed out that “states have largely not leveraged physician practices in vaccine rollout efforts.”
In an MGMA survey conducted last week, 85% of independent practices and 45% of hospital- or health system–owned practices that sought COVID-19 vaccine for their patients were unable to obtain any. Of the practices able to get vaccine supplies, the majority said they had received only enough to vaccinate 1% or less of their patients.
Susan R. Bailey, MD, president of the American Medical Association commented in an interview that, “once enough supplies are available, we encourage the administration to ensure physician practices have an adequate supply of COVID-19 vaccines to vaccinate their patients. Physician practices will be an integral part of the vaccine administration process. Physicians are a trusted source of information for patients and their direct conversations and recommendations for patients to get vaccinated will help address hesitancy and result in more people getting vaccinated.”
Many groups, MGMA said, had been approved by their states to distribute the vaccine but received little or no inventory. Practice phone lines have been “flooded” by patients wanting to know why their physicians can’t vaccinate them.
Programs vary by state
In an interview, Dr. Fischer-Wright said that most practices want to vaccinate their patients. But only some states have set up programs that allow them to apply for the COVID-19 vaccines. “Most of our practices that were eligible for vaccination have applied for it,” she added.
The New York State Health Department is taking a different approach, according to Dial Hewlett Jr., MD, medical director for disease control services with the Westchester County Department of Health in White Plains, N.Y.. The state health department has designated specific sites across New York as vaccination hubs; in Westchester County, the hub is the Westchester Medical Center. When the hospital receives a vaccine shipment, it distributes some of it to smaller sites such as the county health department, which includes a vaccination clinic.
“So far, they haven’t gotten to the point where they’re distributing to pharmacies or doctors’ offices,” Dr. Hewlett said in an interview.
Right now, he said, the chief limiting factor is vaccine supply. When that expands, he said, physician offices will likely get more vaccine doses.
Both Dr. Hewlett and Dr. Fischer-Wright pointed out that physician offices are limited because they aren’t able to store the Pfizer vaccine, which requires ultracold freezers. “But now that we have the Moderna vaccine, 50% of the 200 million doses that have been promised can be delivered in a physician office,” said Dr. Fischer-Wright.
So why haven’t practices received more vaccine? Besides the inadequate supply across the nation, Dr. Fischer-Wright said, there have been difficulties in getting the vaccine to physician offices. Some MGMA members, she added, did receive vaccine supplies immediately. “These were independent practices that had over 200 physicians.”
Dr. Hewlett noted that some smaller practices have complained to the county department that they couldn’t obtain vaccine because they lacked the clout to compete with larger groups. “They’re not ordering enough product to make it a priority for whoever is involved with the distribution.”
Another problem – evident in the results of MGMA’s recent poll – is that health care systems that have vaccine supplies are sharing them with their own practices before they make any available to community practices.
“If you’re working for Northwell Health, you probably won’t have the kinds of challenges that the small mom-and-pop practice would have,” Dr. Hewlett said.
Overcoming vaccine hesitancy
More than a quarter of the U.S. population has indicated they are hesitant to get the COVID-19 vaccine. This is an area where Dr. Fischer-Wright believes physicians can help immensely.
“The benefit of having that type of activity occur in the physician office is that it’s a place where physicians have already established trust with patients,” she said. “And one of the reasons why some people don’t want a shot is that they don’t trust the vaccine. Having a human being that you have a relationship with provide you with the pros and cons is very compelling to get people to make an alternative choice.”
Physicians and their staff will also need to be educated before they administer the vaccine, Dr. Hewlett noted. “There will have to be education on the handling of the vaccine, but I think that can easily be done. Many practices have physician assistants and nurse practitioners who have been doing a lot of vaccinations in the office setting.”
Complex logistics
Based on the experience of his department’s vaccination clinic, which has been giving COVID-19 shots since Jan. 5, Dr. Hewlett said private practices have a lot to consider before they launch their own vaccination efforts.
To begin with, he said, “it’s a tricky situation with these vaccines that require two doses.” Before his clinic makes an appointment to vaccinate a patient, the scheduler has to make sure that the patient can return in 21 or 28 days, depending on whether they’re getting the Pfizer or Moderna vaccine.
“It’s difficult if they can’t show up 28 days after that date because we expect the same number of people to show up 28 days later for their second dose,” he said. “This is quite different from a standard medical practice. There aren’t too many situations where a person has to come back to the office after 28 days or 21 days.”
While the Centers for Disease Control and Prevention recently said the immunization schedule can be more flexible, Dr. Hewlett added, his clinic prefers to get patients back on the recommended schedule to make sure the vaccine will be maximally effective.
The clinic also has to follow state regulations requiring that all vaccines it receives be administered within a week of receipt. Right now, the clinic is open 6 days a week, giving about 300-400 shots a day. Each morning, a clerk records how many doses were administered the previous day, along with the lot numbers – and all data must be reported to the state.
The operation is fairly labor intensive. The clinic has a staff of about 30 people, most of whom are now engaged full time in the COVID-19 vaccination effort.
“We have people who check patients in and who screen to make sure no one has COVID symptoms. Other people escort patients to the vaccination stations. We have about 15 nurse practitioners and public health nurses who give the shots, and we have to make sure they’re accounting for every dose that’s given. And we have to make sure everybody getting a dose meets the eligibility criteria for shots,” he said. “We also have an area where patients are watched for 15 minutes after they’re vaccinated. Then there’s a group of five data entry people who locate appointment slots 28 days from today.”
It’s all still “a work in progress,” Dr. Hewlett said, but the staff who give COVID-19 shots and the patients who receive them are gratified to be making a difference.
A version of this article first appeared on Medscape.com.
Biggest challenges practices faced from COVID last year: MGMA
according to a December 2020 report from the Medical Group Management Association.
The report was assembled from the results of weekly Stat polls by MGMA, which consists of 15,000 group practices representing more than 350,000 physicians. During the course of the year, more than 4,800 practice leaders were surveyed, but the individual polls had far fewer respondents.
The 2020 data represents snapshots from different points in the developing public health crisis. Still, much of what practices experienced earlier in the pandemic continues to apply, and it’s likely to persist this year as long as the coronavirus spreads and its toll deepens.
One top-line conclusion of the report: the economic pain felt by practices has resulted in layoffs, furloughs, and/or reduced compensation for providers and staff.
In the May 19 weekly survey, 82% of respondents said some or all of their providers’ compensation had been affected by the crisis. About 62% said every provider had been affected. Provider compensation was cut in several ways, including reduced hours and salaries, reduced or eliminated bonuses, and lower allowances for continuing medical education.
About 61% of health care leaders said in the June 26 poll that their own compensation had decreased.
In the following week’s survey, one in three managers said their organization had reduced staff compensation. Nearly all of the respondents in this category predicted the salary reductions would be temporary.
As of March 17, early in the pandemic, 40% of health care leaders said they were experiencing staff shortages. An April 21 poll found that 53% of health care leaders were taking steps to address their providers’ and staffers’ mental health.
“The mental and emotional toll on everyone continues to be a concern, as public health authorities continue to report alarming numbers of new [COVID-19] cases, hospitalizations, and deaths,” MGMA commented.
Telehealth and remote monitoring
Nearly all of the health care leaders surveyed on March 31 reported that their practices had expanded telehealth access because of COVID-19. The percentage of patient visits handled remotely had dropped substantially by the fall, according to a Harvard University/Commonwealth Fund/Phreesia survey. Still, it remains significantly higher than it was before the pandemic.
“At the end of 2020, telemedicine continues to play a vital role in everyday practice operations and long-term planning,” the MGMA report said. One indication of this, the association said, is that health care leaders are recognizing new best practices in specialty telemedicine, such as pediatrics and ob.gyn.
According to an April 28 poll, the top three coding/billing challenges for telehealth and telephone visits amid COVID-19 were inconsistent payer rules, pay parity and accuracy, and documentation of virtual visits.
While the Centers for Medicare & Medicaid Services has loosened its regulations to allow reimbursement of telehealth in all locations and at the same level as in-person visits, most of those changes will not last beyond the public health crisis without new legislation.
More health care leaders are considering the use of remote patient monitoring, MGMA said, but only 21% of practices offered such services as of Sept. 15. The report drew a connection between these plans and the current challenge of deferred care.
In the July 21 poll, 87% of health care leaders reported that safety concerns were the top reason that patients deferred care amid COVID-19. The MGMA report quoted JaeLynn Williams, CEO of Air Methods, which provides helicopter ambulance services, as saying that many people are staying home even when they face life-threatening conditions such as chest pain, drug symptoms, inflamed appendix, and gallbladder pain.
Operational issues
Overall, MGMA said, practices that have taken a financial risk have done better during the pandemic than fee-for-service practices because their monthly capitation revenue has continued unabated. In contrast, “most groups’ struggles to sustain visits and procedures meant less revenue and lower compensation,” the report said.
In the August 18 survey, one in three health care leaders reported their practices were changing their operational metrics and how often they looked at those measures because of the pandemic. “Practice managers are asking for dashboard data in weeks instead of months to measure the drop in charges and forecast the resulting change in collections,” MGMA noted. “The type of data practice managers are asking for has also changed.”
Among the new metrics that practices are interested in, according to an MGMA article, are measures that track telehealth visits, the productivity of staff working at home, and the number of ancillary services and procedures that new patients might need based on historical data.
Nearly all health care leaders surveyed on Aug. 11 said the cost of obtaining personal protective equipment had increased during 2020. MGMA said it expects this situation to worsen if the pandemic lasts through the summer of 2021.
While everyone is talking about the botched launch of the COVID-19 vaccination campaign, there were also problems with flu vaccination in 2020. In the Sept. 25 poll, 34% of health care leaders reported their practices were experiencing delays in getting the flu vaccine.
Looking ahead
Looking further ahead, the report recommended that practices make plans to boost staff morale by restoring bonuses.
In addition, MGMA suggested that physician groups reassess their space needs. “The equation is simple – fewer nonclinical staff members at your facility means you should repurpose that office space or consider finding a better fit for your new real estate needs in 2021.”
Finally, MGMA noted that the practices expanding rather than contracting their business are those increasing their value-based revenues by taking on more risk. For those groups, “growing the patient panel can help [them] seek better rates in contract negotiations.”
A version of this article first appeared on Medscape.com.
according to a December 2020 report from the Medical Group Management Association.
The report was assembled from the results of weekly Stat polls by MGMA, which consists of 15,000 group practices representing more than 350,000 physicians. During the course of the year, more than 4,800 practice leaders were surveyed, but the individual polls had far fewer respondents.
The 2020 data represents snapshots from different points in the developing public health crisis. Still, much of what practices experienced earlier in the pandemic continues to apply, and it’s likely to persist this year as long as the coronavirus spreads and its toll deepens.
One top-line conclusion of the report: the economic pain felt by practices has resulted in layoffs, furloughs, and/or reduced compensation for providers and staff.
In the May 19 weekly survey, 82% of respondents said some or all of their providers’ compensation had been affected by the crisis. About 62% said every provider had been affected. Provider compensation was cut in several ways, including reduced hours and salaries, reduced or eliminated bonuses, and lower allowances for continuing medical education.
About 61% of health care leaders said in the June 26 poll that their own compensation had decreased.
In the following week’s survey, one in three managers said their organization had reduced staff compensation. Nearly all of the respondents in this category predicted the salary reductions would be temporary.
As of March 17, early in the pandemic, 40% of health care leaders said they were experiencing staff shortages. An April 21 poll found that 53% of health care leaders were taking steps to address their providers’ and staffers’ mental health.
“The mental and emotional toll on everyone continues to be a concern, as public health authorities continue to report alarming numbers of new [COVID-19] cases, hospitalizations, and deaths,” MGMA commented.
Telehealth and remote monitoring
Nearly all of the health care leaders surveyed on March 31 reported that their practices had expanded telehealth access because of COVID-19. The percentage of patient visits handled remotely had dropped substantially by the fall, according to a Harvard University/Commonwealth Fund/Phreesia survey. Still, it remains significantly higher than it was before the pandemic.
“At the end of 2020, telemedicine continues to play a vital role in everyday practice operations and long-term planning,” the MGMA report said. One indication of this, the association said, is that health care leaders are recognizing new best practices in specialty telemedicine, such as pediatrics and ob.gyn.
According to an April 28 poll, the top three coding/billing challenges for telehealth and telephone visits amid COVID-19 were inconsistent payer rules, pay parity and accuracy, and documentation of virtual visits.
While the Centers for Medicare & Medicaid Services has loosened its regulations to allow reimbursement of telehealth in all locations and at the same level as in-person visits, most of those changes will not last beyond the public health crisis without new legislation.
More health care leaders are considering the use of remote patient monitoring, MGMA said, but only 21% of practices offered such services as of Sept. 15. The report drew a connection between these plans and the current challenge of deferred care.
In the July 21 poll, 87% of health care leaders reported that safety concerns were the top reason that patients deferred care amid COVID-19. The MGMA report quoted JaeLynn Williams, CEO of Air Methods, which provides helicopter ambulance services, as saying that many people are staying home even when they face life-threatening conditions such as chest pain, drug symptoms, inflamed appendix, and gallbladder pain.
Operational issues
Overall, MGMA said, practices that have taken a financial risk have done better during the pandemic than fee-for-service practices because their monthly capitation revenue has continued unabated. In contrast, “most groups’ struggles to sustain visits and procedures meant less revenue and lower compensation,” the report said.
In the August 18 survey, one in three health care leaders reported their practices were changing their operational metrics and how often they looked at those measures because of the pandemic. “Practice managers are asking for dashboard data in weeks instead of months to measure the drop in charges and forecast the resulting change in collections,” MGMA noted. “The type of data practice managers are asking for has also changed.”
Among the new metrics that practices are interested in, according to an MGMA article, are measures that track telehealth visits, the productivity of staff working at home, and the number of ancillary services and procedures that new patients might need based on historical data.
Nearly all health care leaders surveyed on Aug. 11 said the cost of obtaining personal protective equipment had increased during 2020. MGMA said it expects this situation to worsen if the pandemic lasts through the summer of 2021.
While everyone is talking about the botched launch of the COVID-19 vaccination campaign, there were also problems with flu vaccination in 2020. In the Sept. 25 poll, 34% of health care leaders reported their practices were experiencing delays in getting the flu vaccine.
Looking ahead
Looking further ahead, the report recommended that practices make plans to boost staff morale by restoring bonuses.
In addition, MGMA suggested that physician groups reassess their space needs. “The equation is simple – fewer nonclinical staff members at your facility means you should repurpose that office space or consider finding a better fit for your new real estate needs in 2021.”
Finally, MGMA noted that the practices expanding rather than contracting their business are those increasing their value-based revenues by taking on more risk. For those groups, “growing the patient panel can help [them] seek better rates in contract negotiations.”
A version of this article first appeared on Medscape.com.
according to a December 2020 report from the Medical Group Management Association.
The report was assembled from the results of weekly Stat polls by MGMA, which consists of 15,000 group practices representing more than 350,000 physicians. During the course of the year, more than 4,800 practice leaders were surveyed, but the individual polls had far fewer respondents.
The 2020 data represents snapshots from different points in the developing public health crisis. Still, much of what practices experienced earlier in the pandemic continues to apply, and it’s likely to persist this year as long as the coronavirus spreads and its toll deepens.
One top-line conclusion of the report: the economic pain felt by practices has resulted in layoffs, furloughs, and/or reduced compensation for providers and staff.
In the May 19 weekly survey, 82% of respondents said some or all of their providers’ compensation had been affected by the crisis. About 62% said every provider had been affected. Provider compensation was cut in several ways, including reduced hours and salaries, reduced or eliminated bonuses, and lower allowances for continuing medical education.
About 61% of health care leaders said in the June 26 poll that their own compensation had decreased.
In the following week’s survey, one in three managers said their organization had reduced staff compensation. Nearly all of the respondents in this category predicted the salary reductions would be temporary.
As of March 17, early in the pandemic, 40% of health care leaders said they were experiencing staff shortages. An April 21 poll found that 53% of health care leaders were taking steps to address their providers’ and staffers’ mental health.
“The mental and emotional toll on everyone continues to be a concern, as public health authorities continue to report alarming numbers of new [COVID-19] cases, hospitalizations, and deaths,” MGMA commented.
Telehealth and remote monitoring
Nearly all of the health care leaders surveyed on March 31 reported that their practices had expanded telehealth access because of COVID-19. The percentage of patient visits handled remotely had dropped substantially by the fall, according to a Harvard University/Commonwealth Fund/Phreesia survey. Still, it remains significantly higher than it was before the pandemic.
“At the end of 2020, telemedicine continues to play a vital role in everyday practice operations and long-term planning,” the MGMA report said. One indication of this, the association said, is that health care leaders are recognizing new best practices in specialty telemedicine, such as pediatrics and ob.gyn.
According to an April 28 poll, the top three coding/billing challenges for telehealth and telephone visits amid COVID-19 were inconsistent payer rules, pay parity and accuracy, and documentation of virtual visits.
While the Centers for Medicare & Medicaid Services has loosened its regulations to allow reimbursement of telehealth in all locations and at the same level as in-person visits, most of those changes will not last beyond the public health crisis without new legislation.
More health care leaders are considering the use of remote patient monitoring, MGMA said, but only 21% of practices offered such services as of Sept. 15. The report drew a connection between these plans and the current challenge of deferred care.
In the July 21 poll, 87% of health care leaders reported that safety concerns were the top reason that patients deferred care amid COVID-19. The MGMA report quoted JaeLynn Williams, CEO of Air Methods, which provides helicopter ambulance services, as saying that many people are staying home even when they face life-threatening conditions such as chest pain, drug symptoms, inflamed appendix, and gallbladder pain.
Operational issues
Overall, MGMA said, practices that have taken a financial risk have done better during the pandemic than fee-for-service practices because their monthly capitation revenue has continued unabated. In contrast, “most groups’ struggles to sustain visits and procedures meant less revenue and lower compensation,” the report said.
In the August 18 survey, one in three health care leaders reported their practices were changing their operational metrics and how often they looked at those measures because of the pandemic. “Practice managers are asking for dashboard data in weeks instead of months to measure the drop in charges and forecast the resulting change in collections,” MGMA noted. “The type of data practice managers are asking for has also changed.”
Among the new metrics that practices are interested in, according to an MGMA article, are measures that track telehealth visits, the productivity of staff working at home, and the number of ancillary services and procedures that new patients might need based on historical data.
Nearly all health care leaders surveyed on Aug. 11 said the cost of obtaining personal protective equipment had increased during 2020. MGMA said it expects this situation to worsen if the pandemic lasts through the summer of 2021.
While everyone is talking about the botched launch of the COVID-19 vaccination campaign, there were also problems with flu vaccination in 2020. In the Sept. 25 poll, 34% of health care leaders reported their practices were experiencing delays in getting the flu vaccine.
Looking ahead
Looking further ahead, the report recommended that practices make plans to boost staff morale by restoring bonuses.
In addition, MGMA suggested that physician groups reassess their space needs. “The equation is simple – fewer nonclinical staff members at your facility means you should repurpose that office space or consider finding a better fit for your new real estate needs in 2021.”
Finally, MGMA noted that the practices expanding rather than contracting their business are those increasing their value-based revenues by taking on more risk. For those groups, “growing the patient panel can help [them] seek better rates in contract negotiations.”
A version of this article first appeared on Medscape.com.
Approval of COVID-19 vaccines will change nature of clinical trials
While stressing the urgent need to vaccinate the whole U.S. population, infectious disease experts and medical ethicists are raising questions about the clinical trials needed to answer important questions about the new COVID-19 vaccines.
In a statement released on Nov. 20, Barbara Alexander, MD, president of the Infectious Diseases Society of America (IDSA) and a professor at Duke University, Durham, N.C., commented on Pfizer and BioNTech’s application to the Food and Drug Administration for an emergency use authorization (EUA) for its COVID-19 vaccine. Besides emphasizing the need for a transparent review of the companies’ trial data prior to the FDA’s granting an EUA, she said, “If emergency use authorization is granted, clinical trials and data collection must continue.”
In an interview, Dr. Alexander said she is convinced that both Pfizer and Moderna, which is also expected to seek an EUA soon, will continue their clinical trials to monitor the long-term safety and efficacy of their vaccines.
“The EUA guidance for COVID vaccine authorization is very clear that clinical trials will move forward,” she said. “Any EUA request would have to include a strategy to ensure that the long-term safety and efficacy of a vaccine could be monitored. I see no evidence that either Pfizer or Moderna is not prepared to follow those regulations.”
Eventually, she added, the drug makers will have to seek full FDA approval to replace an EUA, which as its name signifies, is designed for public health emergencies. “The EUA is a tool to help us get the vaccine into circulation and have it start working as quickly as possible in the current health crisis,” she said. “But once the crisis is over, if the sponsors want to continue to market their vaccines, they have to go forward and get full approval.”
Medical ethicists, however, point out there may be ethical and practical dilemmas involved in continuing or initiating clinical trials once a vaccine has been approved for use even on an emergency basis.
In a commentary in Annals of Internal Medicine, Rafael Dal-Re, MD, PhD, Arthur L. Caplan, PhD, and two other ethicists stipulated that the pandemic requires early licensing and deployment of COVID-19 vaccines. Nevertheless, they noted, additional months of data are required to establish the long-term efficacy and safety of the vaccines. “Moreover, early deployment could interfere with the acquisition of long-term data,” both on these vaccines and on others coming through the pipeline, they wrote.
In countries where an approved vaccine is deployed, the ethicists noted, investigators must inform participants in an ongoing trial about the approved vaccine’s status and ask if they want to continue in the study. If enough participants decline, the trial might have to be terminated early. At that point, researchers may not have sufficient long-term data to identify late-term safety issues, determine how long efficacy lasts, determine whether waning immunity is associated with reduced levels of antibodies, or identify the level of neutralizing antibodies that correlates with immunity.
Moreover, they observed, long-term trials are especially important for vaccines that use mRNA technology, because less is known about them than about traditional kinds of vaccines.
The authors also pointed out that early licensing of any vaccine might make it harder to evaluate vaccines that haven’t yet been approved. “Once a vaccine is licensed, new placebo-controlled RCTs [randomized controlled trials] of other vaccines will not be acceptable ethically, and noninferiority RCTs will be the most likely alternative.
“The goal of noninferiority trials will be to demonstrate that the immune response (that is, neutralizing antibody titers or levels) of the candidate vaccine is not inferior to that of the approved vaccine within a prespecified margin, which the FDA has established as less than 10% for COVID-19 vaccines,” the authors noted.
More data with more study designs
Dial Hewlett Jr., MD, medical director for disease control services, Westchester County Department of Health, White Plains, N.Y., said in an interview that the ethicists raise important issues that have been discussed in other forums, including a recent webinar of the National Academy of Medicine.
“As the authors point out, once you have a vaccine that has been shown to be effective and safe, it’s no longer ethical to enroll people in placebo trials,” he said.
Therefore, he said, Pfizer and Moderna will undoubtedly offer their vaccines to the people in their studies’ placebo groups after the vaccines receive an EUA. Then they will follow everyone who has been vaccinated for 2 years to determine long-term safety. Efficacy will also continue to be measured as an adjunct of safety, he said.
With regard to the difficulty of reconsenting individuals to enter a new clinical trial after a vaccine has been approved, he said, “I’d agree that trying to get all the same participants to come into another study would be a challenge. You can, however, design studies that will allow you to obtain the same information. You will have a large number of people out there who haven’t been vaccinated, and you can do single-arm longitudinal studies and measure a number of things in the individuals who are enrolled in those studies,” he said.
“You can look at the immunologic markers, both antibody and T-cell. You can follow these individuals longitudinally to see if they do develop disease over a period of time. If they do, you can determine what their levels of response were,” he added. “So there are opportunities to design studies that would give you some of the same information, although it would not be in the same population that was in the randomized trials.”
For newer vaccines that have yet to be tested, he said, developers can compare “historical controls” from the trials of approved vaccines, i.e., data from the unvaccinated participants in those studies, with the data from inoculating people with the novel agents. The historical data can be sex- and age-matched, among other things, to individuals in the new trials. Moreover, because the study protocols have been harmonized for all trials under Operation Warp Speed, it doesn’t matter what kind of vaccine they’re testing, he said.
It may be necessary to do additional studies to find out how long immunity lasts after people have been vaccinated, Dr. Hewlett pointed out.
“You may have a different trial design. You don’t need a control arm to determine how long immunity lasts. You’re just comparing the patients who were vaccinated to nothing,” he said. “So you could have a single-arm trial on a group of people who consent to be immunized and followed. You can see what their antibody levels are and other surrogate markers, and you can see when they might develop disease, if they do. You’d need a large sample, but you can do that.”
Dr. Hewlett noted that additional studies will be required to determine whether the new vaccines stop transmission of the coronavirus or just prevent symptoms of COVID-19. Until it’s established that a vaccine halts transmission or the country achieves herd immunity, he said, “we’ll still have to wear masks and take other precautions, because a significant portion of people will still be at risk.”
‘A lot of redundancy’
Dr. Alexander emphasized that any safety or efficacy issues with the first COVID-19 vaccines must be identified before the vaccine is offered to a large portion of the U.S. population.
“While the data from the Pfizer and Moderna trials are said to be favorable, we at IDSA want to make sure that whatever vaccine comes to market is safe,” she said. “Having an unsafe vaccine on the market would be worse than no vaccine, because you’re compromising the public confidence. We have to make sure the public trusts the process and that sufficient data have been evaluated to ensure the vaccine is safe and efficacious.
“I believe the FDA is being very careful and thoughtful in [its] response,” Dr. Alexander said. “They realize how important it is to get a vaccine and save lives. While they’re doing things differently and moving much faster than before, they’re still trying to be thoughtful and reasonable. They don’t seem to be putting people at risk or circumventing the regulatory standards.”
Moreover, she pointed out, the FDA’s Vaccines and Related Biological Products Advisory Committee, which is expected to meet on Dec. 10, will review the trial data before the agency grants an EUA to Pfizer or Moderna. Then the FDA will post the data publicly.
The next step is for the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention to look at the data and decide who in the United States should receive the vaccine first, she pointed out. And both Pfizer and Moderna have shown their data to advisory panels of outside experts.
“There’s a lot of redundancy, and a lot of people are looking at the data,” Dr. Alexander said. “So I don’t think we’re cutting corners to get it out there more quickly.”
A version of this article originally appeared on Medscape.com.
While stressing the urgent need to vaccinate the whole U.S. population, infectious disease experts and medical ethicists are raising questions about the clinical trials needed to answer important questions about the new COVID-19 vaccines.
In a statement released on Nov. 20, Barbara Alexander, MD, president of the Infectious Diseases Society of America (IDSA) and a professor at Duke University, Durham, N.C., commented on Pfizer and BioNTech’s application to the Food and Drug Administration for an emergency use authorization (EUA) for its COVID-19 vaccine. Besides emphasizing the need for a transparent review of the companies’ trial data prior to the FDA’s granting an EUA, she said, “If emergency use authorization is granted, clinical trials and data collection must continue.”
In an interview, Dr. Alexander said she is convinced that both Pfizer and Moderna, which is also expected to seek an EUA soon, will continue their clinical trials to monitor the long-term safety and efficacy of their vaccines.
“The EUA guidance for COVID vaccine authorization is very clear that clinical trials will move forward,” she said. “Any EUA request would have to include a strategy to ensure that the long-term safety and efficacy of a vaccine could be monitored. I see no evidence that either Pfizer or Moderna is not prepared to follow those regulations.”
Eventually, she added, the drug makers will have to seek full FDA approval to replace an EUA, which as its name signifies, is designed for public health emergencies. “The EUA is a tool to help us get the vaccine into circulation and have it start working as quickly as possible in the current health crisis,” she said. “But once the crisis is over, if the sponsors want to continue to market their vaccines, they have to go forward and get full approval.”
Medical ethicists, however, point out there may be ethical and practical dilemmas involved in continuing or initiating clinical trials once a vaccine has been approved for use even on an emergency basis.
In a commentary in Annals of Internal Medicine, Rafael Dal-Re, MD, PhD, Arthur L. Caplan, PhD, and two other ethicists stipulated that the pandemic requires early licensing and deployment of COVID-19 vaccines. Nevertheless, they noted, additional months of data are required to establish the long-term efficacy and safety of the vaccines. “Moreover, early deployment could interfere with the acquisition of long-term data,” both on these vaccines and on others coming through the pipeline, they wrote.
In countries where an approved vaccine is deployed, the ethicists noted, investigators must inform participants in an ongoing trial about the approved vaccine’s status and ask if they want to continue in the study. If enough participants decline, the trial might have to be terminated early. At that point, researchers may not have sufficient long-term data to identify late-term safety issues, determine how long efficacy lasts, determine whether waning immunity is associated with reduced levels of antibodies, or identify the level of neutralizing antibodies that correlates with immunity.
Moreover, they observed, long-term trials are especially important for vaccines that use mRNA technology, because less is known about them than about traditional kinds of vaccines.
The authors also pointed out that early licensing of any vaccine might make it harder to evaluate vaccines that haven’t yet been approved. “Once a vaccine is licensed, new placebo-controlled RCTs [randomized controlled trials] of other vaccines will not be acceptable ethically, and noninferiority RCTs will be the most likely alternative.
“The goal of noninferiority trials will be to demonstrate that the immune response (that is, neutralizing antibody titers or levels) of the candidate vaccine is not inferior to that of the approved vaccine within a prespecified margin, which the FDA has established as less than 10% for COVID-19 vaccines,” the authors noted.
More data with more study designs
Dial Hewlett Jr., MD, medical director for disease control services, Westchester County Department of Health, White Plains, N.Y., said in an interview that the ethicists raise important issues that have been discussed in other forums, including a recent webinar of the National Academy of Medicine.
“As the authors point out, once you have a vaccine that has been shown to be effective and safe, it’s no longer ethical to enroll people in placebo trials,” he said.
Therefore, he said, Pfizer and Moderna will undoubtedly offer their vaccines to the people in their studies’ placebo groups after the vaccines receive an EUA. Then they will follow everyone who has been vaccinated for 2 years to determine long-term safety. Efficacy will also continue to be measured as an adjunct of safety, he said.
With regard to the difficulty of reconsenting individuals to enter a new clinical trial after a vaccine has been approved, he said, “I’d agree that trying to get all the same participants to come into another study would be a challenge. You can, however, design studies that will allow you to obtain the same information. You will have a large number of people out there who haven’t been vaccinated, and you can do single-arm longitudinal studies and measure a number of things in the individuals who are enrolled in those studies,” he said.
“You can look at the immunologic markers, both antibody and T-cell. You can follow these individuals longitudinally to see if they do develop disease over a period of time. If they do, you can determine what their levels of response were,” he added. “So there are opportunities to design studies that would give you some of the same information, although it would not be in the same population that was in the randomized trials.”
For newer vaccines that have yet to be tested, he said, developers can compare “historical controls” from the trials of approved vaccines, i.e., data from the unvaccinated participants in those studies, with the data from inoculating people with the novel agents. The historical data can be sex- and age-matched, among other things, to individuals in the new trials. Moreover, because the study protocols have been harmonized for all trials under Operation Warp Speed, it doesn’t matter what kind of vaccine they’re testing, he said.
It may be necessary to do additional studies to find out how long immunity lasts after people have been vaccinated, Dr. Hewlett pointed out.
“You may have a different trial design. You don’t need a control arm to determine how long immunity lasts. You’re just comparing the patients who were vaccinated to nothing,” he said. “So you could have a single-arm trial on a group of people who consent to be immunized and followed. You can see what their antibody levels are and other surrogate markers, and you can see when they might develop disease, if they do. You’d need a large sample, but you can do that.”
Dr. Hewlett noted that additional studies will be required to determine whether the new vaccines stop transmission of the coronavirus or just prevent symptoms of COVID-19. Until it’s established that a vaccine halts transmission or the country achieves herd immunity, he said, “we’ll still have to wear masks and take other precautions, because a significant portion of people will still be at risk.”
‘A lot of redundancy’
Dr. Alexander emphasized that any safety or efficacy issues with the first COVID-19 vaccines must be identified before the vaccine is offered to a large portion of the U.S. population.
“While the data from the Pfizer and Moderna trials are said to be favorable, we at IDSA want to make sure that whatever vaccine comes to market is safe,” she said. “Having an unsafe vaccine on the market would be worse than no vaccine, because you’re compromising the public confidence. We have to make sure the public trusts the process and that sufficient data have been evaluated to ensure the vaccine is safe and efficacious.
“I believe the FDA is being very careful and thoughtful in [its] response,” Dr. Alexander said. “They realize how important it is to get a vaccine and save lives. While they’re doing things differently and moving much faster than before, they’re still trying to be thoughtful and reasonable. They don’t seem to be putting people at risk or circumventing the regulatory standards.”
Moreover, she pointed out, the FDA’s Vaccines and Related Biological Products Advisory Committee, which is expected to meet on Dec. 10, will review the trial data before the agency grants an EUA to Pfizer or Moderna. Then the FDA will post the data publicly.
The next step is for the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention to look at the data and decide who in the United States should receive the vaccine first, she pointed out. And both Pfizer and Moderna have shown their data to advisory panels of outside experts.
“There’s a lot of redundancy, and a lot of people are looking at the data,” Dr. Alexander said. “So I don’t think we’re cutting corners to get it out there more quickly.”
A version of this article originally appeared on Medscape.com.
While stressing the urgent need to vaccinate the whole U.S. population, infectious disease experts and medical ethicists are raising questions about the clinical trials needed to answer important questions about the new COVID-19 vaccines.
In a statement released on Nov. 20, Barbara Alexander, MD, president of the Infectious Diseases Society of America (IDSA) and a professor at Duke University, Durham, N.C., commented on Pfizer and BioNTech’s application to the Food and Drug Administration for an emergency use authorization (EUA) for its COVID-19 vaccine. Besides emphasizing the need for a transparent review of the companies’ trial data prior to the FDA’s granting an EUA, she said, “If emergency use authorization is granted, clinical trials and data collection must continue.”
In an interview, Dr. Alexander said she is convinced that both Pfizer and Moderna, which is also expected to seek an EUA soon, will continue their clinical trials to monitor the long-term safety and efficacy of their vaccines.
“The EUA guidance for COVID vaccine authorization is very clear that clinical trials will move forward,” she said. “Any EUA request would have to include a strategy to ensure that the long-term safety and efficacy of a vaccine could be monitored. I see no evidence that either Pfizer or Moderna is not prepared to follow those regulations.”
Eventually, she added, the drug makers will have to seek full FDA approval to replace an EUA, which as its name signifies, is designed for public health emergencies. “The EUA is a tool to help us get the vaccine into circulation and have it start working as quickly as possible in the current health crisis,” she said. “But once the crisis is over, if the sponsors want to continue to market their vaccines, they have to go forward and get full approval.”
Medical ethicists, however, point out there may be ethical and practical dilemmas involved in continuing or initiating clinical trials once a vaccine has been approved for use even on an emergency basis.
In a commentary in Annals of Internal Medicine, Rafael Dal-Re, MD, PhD, Arthur L. Caplan, PhD, and two other ethicists stipulated that the pandemic requires early licensing and deployment of COVID-19 vaccines. Nevertheless, they noted, additional months of data are required to establish the long-term efficacy and safety of the vaccines. “Moreover, early deployment could interfere with the acquisition of long-term data,” both on these vaccines and on others coming through the pipeline, they wrote.
In countries where an approved vaccine is deployed, the ethicists noted, investigators must inform participants in an ongoing trial about the approved vaccine’s status and ask if they want to continue in the study. If enough participants decline, the trial might have to be terminated early. At that point, researchers may not have sufficient long-term data to identify late-term safety issues, determine how long efficacy lasts, determine whether waning immunity is associated with reduced levels of antibodies, or identify the level of neutralizing antibodies that correlates with immunity.
Moreover, they observed, long-term trials are especially important for vaccines that use mRNA technology, because less is known about them than about traditional kinds of vaccines.
The authors also pointed out that early licensing of any vaccine might make it harder to evaluate vaccines that haven’t yet been approved. “Once a vaccine is licensed, new placebo-controlled RCTs [randomized controlled trials] of other vaccines will not be acceptable ethically, and noninferiority RCTs will be the most likely alternative.
“The goal of noninferiority trials will be to demonstrate that the immune response (that is, neutralizing antibody titers or levels) of the candidate vaccine is not inferior to that of the approved vaccine within a prespecified margin, which the FDA has established as less than 10% for COVID-19 vaccines,” the authors noted.
More data with more study designs
Dial Hewlett Jr., MD, medical director for disease control services, Westchester County Department of Health, White Plains, N.Y., said in an interview that the ethicists raise important issues that have been discussed in other forums, including a recent webinar of the National Academy of Medicine.
“As the authors point out, once you have a vaccine that has been shown to be effective and safe, it’s no longer ethical to enroll people in placebo trials,” he said.
Therefore, he said, Pfizer and Moderna will undoubtedly offer their vaccines to the people in their studies’ placebo groups after the vaccines receive an EUA. Then they will follow everyone who has been vaccinated for 2 years to determine long-term safety. Efficacy will also continue to be measured as an adjunct of safety, he said.
With regard to the difficulty of reconsenting individuals to enter a new clinical trial after a vaccine has been approved, he said, “I’d agree that trying to get all the same participants to come into another study would be a challenge. You can, however, design studies that will allow you to obtain the same information. You will have a large number of people out there who haven’t been vaccinated, and you can do single-arm longitudinal studies and measure a number of things in the individuals who are enrolled in those studies,” he said.
“You can look at the immunologic markers, both antibody and T-cell. You can follow these individuals longitudinally to see if they do develop disease over a period of time. If they do, you can determine what their levels of response were,” he added. “So there are opportunities to design studies that would give you some of the same information, although it would not be in the same population that was in the randomized trials.”
For newer vaccines that have yet to be tested, he said, developers can compare “historical controls” from the trials of approved vaccines, i.e., data from the unvaccinated participants in those studies, with the data from inoculating people with the novel agents. The historical data can be sex- and age-matched, among other things, to individuals in the new trials. Moreover, because the study protocols have been harmonized for all trials under Operation Warp Speed, it doesn’t matter what kind of vaccine they’re testing, he said.
It may be necessary to do additional studies to find out how long immunity lasts after people have been vaccinated, Dr. Hewlett pointed out.
“You may have a different trial design. You don’t need a control arm to determine how long immunity lasts. You’re just comparing the patients who were vaccinated to nothing,” he said. “So you could have a single-arm trial on a group of people who consent to be immunized and followed. You can see what their antibody levels are and other surrogate markers, and you can see when they might develop disease, if they do. You’d need a large sample, but you can do that.”
Dr. Hewlett noted that additional studies will be required to determine whether the new vaccines stop transmission of the coronavirus or just prevent symptoms of COVID-19. Until it’s established that a vaccine halts transmission or the country achieves herd immunity, he said, “we’ll still have to wear masks and take other precautions, because a significant portion of people will still be at risk.”
‘A lot of redundancy’
Dr. Alexander emphasized that any safety or efficacy issues with the first COVID-19 vaccines must be identified before the vaccine is offered to a large portion of the U.S. population.
“While the data from the Pfizer and Moderna trials are said to be favorable, we at IDSA want to make sure that whatever vaccine comes to market is safe,” she said. “Having an unsafe vaccine on the market would be worse than no vaccine, because you’re compromising the public confidence. We have to make sure the public trusts the process and that sufficient data have been evaluated to ensure the vaccine is safe and efficacious.
“I believe the FDA is being very careful and thoughtful in [its] response,” Dr. Alexander said. “They realize how important it is to get a vaccine and save lives. While they’re doing things differently and moving much faster than before, they’re still trying to be thoughtful and reasonable. They don’t seem to be putting people at risk or circumventing the regulatory standards.”
Moreover, she pointed out, the FDA’s Vaccines and Related Biological Products Advisory Committee, which is expected to meet on Dec. 10, will review the trial data before the agency grants an EUA to Pfizer or Moderna. Then the FDA will post the data publicly.
The next step is for the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention to look at the data and decide who in the United States should receive the vaccine first, she pointed out. And both Pfizer and Moderna have shown their data to advisory panels of outside experts.
“There’s a lot of redundancy, and a lot of people are looking at the data,” Dr. Alexander said. “So I don’t think we’re cutting corners to get it out there more quickly.”
A version of this article originally appeared on Medscape.com.