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CDC playbook prepares states for rollout of COVID-19 vaccine if one is approved
States have begun preparing to distribute a COVID-19 vaccine if one is approved, a CDC official said today.
The CDC released guidance for states on Sept. 16 titled COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. The document discusses vaccine ordering, storage, and handling and says that states should submit their plans for vaccine distribution to the agency by Oct. 16.
“Every jurisdiction is heavily involved right now in their plan development,” CDC official Janell Routh, MD, told the Advisory Committee on Immunization Practices during its Sept. 22 meeting. “It was really impressive to me that, even though the playbook only went out last week, states and jurisdictions have been thinking about this for quite some time.”
However, one committee member suggested that setting a deadline before more safety, efficacy, and storage information is known may be premature.
“I cannot imagine that we will actually know the final storage requirements for this vaccine by Oct. 16, which makes me a little concerned about finalizing state plans,” said Helen “Keipp” Talbot, MD, MPH, associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn. “We also don’t know the best populations yet when it comes to efficacy and safety.”
Dr. Routh said the CDC is asking states to plan on the basis of assumptions. “We know those plans will constantly be improving, changing, as we learn more information,” Dr. Routh said. States agreed to return a plan 30 days after the playbook was released, which is how the Oct. 16 deadline was established, she said.
States are encouraged to think broadly. Plans may include contingencies for a product that requires ultracold storage or for distributing more than one vaccine product, Dr. Routh said.
“One goal is to be ready on the first day that we can actually distribute vaccine,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the meeting. “Our colleagues in Operation Warp Speed say that they expect there will be vaccine as early as November, and therefore we need to be ready so there is no delay in distributing that vaccine. And that phase, that early phase, is really close upon us.”
Many states have already developed plans, and the CDC is providing technical assistance as needed to monitor the plans regularly, Dr. Routh said.
Key issues identified
From holding pilot meetings with five jurisdictions, officials learned that public confidence in the vaccine is among states’ greatest concerns, Dr. Routh said. In addition, distribution is resource intensive, and social distancing adds logistical complexity.
Specific guidance on whom to vaccinate in the early stages will smooth the process, officials suggested during the pilot meetings. For the first several weeks, vaccine doses may be limited to priority populations, such as health care workers.
“This interim playbook is a living document,” Dr. Routh emphasized. “We definitely plan to update the content regularly as we learn more information about what vaccines and when they will be released.”
During the early stages of COVID-19 vaccination, officials plan to implement an enhanced monitoring program in which vaccine recipients would complete surveys about adverse events, in addition to the traditional vaccine safety monitoring programs that already exist, officials said.
A version of this article originally appeared on Medscape.com.
States have begun preparing to distribute a COVID-19 vaccine if one is approved, a CDC official said today.
The CDC released guidance for states on Sept. 16 titled COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. The document discusses vaccine ordering, storage, and handling and says that states should submit their plans for vaccine distribution to the agency by Oct. 16.
“Every jurisdiction is heavily involved right now in their plan development,” CDC official Janell Routh, MD, told the Advisory Committee on Immunization Practices during its Sept. 22 meeting. “It was really impressive to me that, even though the playbook only went out last week, states and jurisdictions have been thinking about this for quite some time.”
However, one committee member suggested that setting a deadline before more safety, efficacy, and storage information is known may be premature.
“I cannot imagine that we will actually know the final storage requirements for this vaccine by Oct. 16, which makes me a little concerned about finalizing state plans,” said Helen “Keipp” Talbot, MD, MPH, associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn. “We also don’t know the best populations yet when it comes to efficacy and safety.”
Dr. Routh said the CDC is asking states to plan on the basis of assumptions. “We know those plans will constantly be improving, changing, as we learn more information,” Dr. Routh said. States agreed to return a plan 30 days after the playbook was released, which is how the Oct. 16 deadline was established, she said.
States are encouraged to think broadly. Plans may include contingencies for a product that requires ultracold storage or for distributing more than one vaccine product, Dr. Routh said.
“One goal is to be ready on the first day that we can actually distribute vaccine,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the meeting. “Our colleagues in Operation Warp Speed say that they expect there will be vaccine as early as November, and therefore we need to be ready so there is no delay in distributing that vaccine. And that phase, that early phase, is really close upon us.”
Many states have already developed plans, and the CDC is providing technical assistance as needed to monitor the plans regularly, Dr. Routh said.
Key issues identified
From holding pilot meetings with five jurisdictions, officials learned that public confidence in the vaccine is among states’ greatest concerns, Dr. Routh said. In addition, distribution is resource intensive, and social distancing adds logistical complexity.
Specific guidance on whom to vaccinate in the early stages will smooth the process, officials suggested during the pilot meetings. For the first several weeks, vaccine doses may be limited to priority populations, such as health care workers.
“This interim playbook is a living document,” Dr. Routh emphasized. “We definitely plan to update the content regularly as we learn more information about what vaccines and when they will be released.”
During the early stages of COVID-19 vaccination, officials plan to implement an enhanced monitoring program in which vaccine recipients would complete surveys about adverse events, in addition to the traditional vaccine safety monitoring programs that already exist, officials said.
A version of this article originally appeared on Medscape.com.
States have begun preparing to distribute a COVID-19 vaccine if one is approved, a CDC official said today.
The CDC released guidance for states on Sept. 16 titled COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. The document discusses vaccine ordering, storage, and handling and says that states should submit their plans for vaccine distribution to the agency by Oct. 16.
“Every jurisdiction is heavily involved right now in their plan development,” CDC official Janell Routh, MD, told the Advisory Committee on Immunization Practices during its Sept. 22 meeting. “It was really impressive to me that, even though the playbook only went out last week, states and jurisdictions have been thinking about this for quite some time.”
However, one committee member suggested that setting a deadline before more safety, efficacy, and storage information is known may be premature.
“I cannot imagine that we will actually know the final storage requirements for this vaccine by Oct. 16, which makes me a little concerned about finalizing state plans,” said Helen “Keipp” Talbot, MD, MPH, associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn. “We also don’t know the best populations yet when it comes to efficacy and safety.”
Dr. Routh said the CDC is asking states to plan on the basis of assumptions. “We know those plans will constantly be improving, changing, as we learn more information,” Dr. Routh said. States agreed to return a plan 30 days after the playbook was released, which is how the Oct. 16 deadline was established, she said.
States are encouraged to think broadly. Plans may include contingencies for a product that requires ultracold storage or for distributing more than one vaccine product, Dr. Routh said.
“One goal is to be ready on the first day that we can actually distribute vaccine,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the meeting. “Our colleagues in Operation Warp Speed say that they expect there will be vaccine as early as November, and therefore we need to be ready so there is no delay in distributing that vaccine. And that phase, that early phase, is really close upon us.”
Many states have already developed plans, and the CDC is providing technical assistance as needed to monitor the plans regularly, Dr. Routh said.
Key issues identified
From holding pilot meetings with five jurisdictions, officials learned that public confidence in the vaccine is among states’ greatest concerns, Dr. Routh said. In addition, distribution is resource intensive, and social distancing adds logistical complexity.
Specific guidance on whom to vaccinate in the early stages will smooth the process, officials suggested during the pilot meetings. For the first several weeks, vaccine doses may be limited to priority populations, such as health care workers.
“This interim playbook is a living document,” Dr. Routh emphasized. “We definitely plan to update the content regularly as we learn more information about what vaccines and when they will be released.”
During the early stages of COVID-19 vaccination, officials plan to implement an enhanced monitoring program in which vaccine recipients would complete surveys about adverse events, in addition to the traditional vaccine safety monitoring programs that already exist, officials said.
A version of this article originally appeared on Medscape.com.
Three major COVID vaccine developers release detailed trial protocols
Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.
On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.
The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.
“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
AstraZeneca takes a shot at transparency
The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.
The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.
“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.
“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
Moderna methodology
The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.
A statement that was requested from ModernaTX was not received by press time.
Pfizer protocol
In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.
Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.
“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.
“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.
If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.
Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
A positive move
“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.
“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.
Kruse has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.
On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.
The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.
“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
AstraZeneca takes a shot at transparency
The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.
The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.
“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.
“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
Moderna methodology
The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.
A statement that was requested from ModernaTX was not received by press time.
Pfizer protocol
In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.
Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.
“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.
“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.
If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.
Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
A positive move
“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.
“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.
Kruse has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.
On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.
The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.
“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
AstraZeneca takes a shot at transparency
The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.
The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.
“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.
“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
Moderna methodology
The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.
A statement that was requested from ModernaTX was not received by press time.
Pfizer protocol
In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.
Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.
“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.
“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.
If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.
Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
A positive move
“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.
“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.
Kruse has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
More female specialists, but gender gap persists in pay, survey finds
More female physicians are becoming specialists, a Medscape survey finds, and five specialties have seen particularly large increases during the last 5 years.
Obstetrician/gynecologists and pediatricians had the largest female representation at 58% and those percentages were both up from 50% in 2015, according to the Medscape Female Physician Compensation Report 2020.
Rheumatology saw a dramatic jump in numbers of women from 29% in 2015 to 54% now. Dermatology increased from 32% to 49%, and family medicine rose from 35% to 43% during that time.
Specialist pay gap narrows slightly
The gender gap was the same this year in primary care — women made 25% less ($212,000 vs. $264,000).
The gap in specialists narrowed slightly. Women made 31% less this year ($286,000 vs $375,000) instead of the 33% less reported in last year’s survey, a difference of $89,000 this year.
The gender pay gap was consistent across all race and age groups and was consistent in responses about net worth. Whereas 57% of male physicians had a net worth of $1 million or more, only 40% of female physicians did. Twice as many male physicians as female physicians had a net worth of more than $5 million (10% vs. 5%).
“Many physicians expect the gender pay gap to narrow in the coming years,” John Prescott, MD, chief academic officer of the Association of American Medical Colleges, said in an interview.
“Yet, it is a challenging task, requiring an institutional commitment to transparency, cross-campus collaboration, ongoing communication, dedicated resources, and enlightened leadership,” he said.
Female physicians working in office-based, solo practices made the most overall at $290,000; women in outpatient settings made the least at $223,000.
The survey included more than 4,500 responses. The responses were collected during the early part of the year and do not reflect changes in income expected from the COVID-19 pandemic.
An analysis in Health Affairs, for instance, predicted that primary care practices would lose $67,774 in gross revenue per full-time-equivalent physician in calendar year 2020 because of the pandemic.
Most physicians did not experience a significant financial loss in 2019, but COVID-19 may, at least temporarily, change those answers in next year’s report, physicians predicted.
Women more likely than men to live above their means
More women this year (39%) said they live below their means than answered that way last year (31%). Female physicians were more likely to say they lived above their means than were their male counterparts (8% vs. 6%).
Greenwald Wealth Management in St. Louis Park, Minn., says aiming for putting away 20% of total gross salary is a good financial goal.
Women in this year’s survey spent about 7% less time seeing patients than did their male counterparts (35.9 hours a week vs. 38.8). The average for all physicians was 37.8 hours a week. Add the 15.6 average hours per week physicians spend on paperwork, and they are putting in 53-hour workweeks on average overall.
Asked what parts of their job they found most rewarding, women were more likely than were men to say “gratitude/relationships with patients” (31% vs. 25%). They were less likely than were men to answer that the most rewarding part was “being very good at what I do/finding answers/diagnoses” (22% vs. 25%) or “making good money at a job I like” (9% vs. 13%).
Most female physicians — and physicians overall — said they would choose medicine again. But two specialties saw a substantial increase in that answer.
This year, 79% of those in physical medicine and rehabilitation said they would choose medicine again (compared with 66% last year) and 84% of gastroenterologists answered that way (compared with 76% in 2019).
Psychiatrists, however, were in the group least likely to say they would choose their specialty again along with those in internal medicine, family medicine, and diabetes and endocrinology.
Female physicians in orthopedics, radiology, and dermatology were most likely to choose their specialties again (91% - 92%).
Female physicians were less likely to use physician assistants in their practices than were their male colleagues (31% vs. 38%) but more likely to use NPs (52% vs. 50%). More than a third (38%) of male and female physicians reported they use neither.
A version of this article originally appeared on Medscape.com.
More female physicians are becoming specialists, a Medscape survey finds, and five specialties have seen particularly large increases during the last 5 years.
Obstetrician/gynecologists and pediatricians had the largest female representation at 58% and those percentages were both up from 50% in 2015, according to the Medscape Female Physician Compensation Report 2020.
Rheumatology saw a dramatic jump in numbers of women from 29% in 2015 to 54% now. Dermatology increased from 32% to 49%, and family medicine rose from 35% to 43% during that time.
Specialist pay gap narrows slightly
The gender gap was the same this year in primary care — women made 25% less ($212,000 vs. $264,000).
The gap in specialists narrowed slightly. Women made 31% less this year ($286,000 vs $375,000) instead of the 33% less reported in last year’s survey, a difference of $89,000 this year.
The gender pay gap was consistent across all race and age groups and was consistent in responses about net worth. Whereas 57% of male physicians had a net worth of $1 million or more, only 40% of female physicians did. Twice as many male physicians as female physicians had a net worth of more than $5 million (10% vs. 5%).
“Many physicians expect the gender pay gap to narrow in the coming years,” John Prescott, MD, chief academic officer of the Association of American Medical Colleges, said in an interview.
“Yet, it is a challenging task, requiring an institutional commitment to transparency, cross-campus collaboration, ongoing communication, dedicated resources, and enlightened leadership,” he said.
Female physicians working in office-based, solo practices made the most overall at $290,000; women in outpatient settings made the least at $223,000.
The survey included more than 4,500 responses. The responses were collected during the early part of the year and do not reflect changes in income expected from the COVID-19 pandemic.
An analysis in Health Affairs, for instance, predicted that primary care practices would lose $67,774 in gross revenue per full-time-equivalent physician in calendar year 2020 because of the pandemic.
Most physicians did not experience a significant financial loss in 2019, but COVID-19 may, at least temporarily, change those answers in next year’s report, physicians predicted.
Women more likely than men to live above their means
More women this year (39%) said they live below their means than answered that way last year (31%). Female physicians were more likely to say they lived above their means than were their male counterparts (8% vs. 6%).
Greenwald Wealth Management in St. Louis Park, Minn., says aiming for putting away 20% of total gross salary is a good financial goal.
Women in this year’s survey spent about 7% less time seeing patients than did their male counterparts (35.9 hours a week vs. 38.8). The average for all physicians was 37.8 hours a week. Add the 15.6 average hours per week physicians spend on paperwork, and they are putting in 53-hour workweeks on average overall.
Asked what parts of their job they found most rewarding, women were more likely than were men to say “gratitude/relationships with patients” (31% vs. 25%). They were less likely than were men to answer that the most rewarding part was “being very good at what I do/finding answers/diagnoses” (22% vs. 25%) or “making good money at a job I like” (9% vs. 13%).
Most female physicians — and physicians overall — said they would choose medicine again. But two specialties saw a substantial increase in that answer.
This year, 79% of those in physical medicine and rehabilitation said they would choose medicine again (compared with 66% last year) and 84% of gastroenterologists answered that way (compared with 76% in 2019).
Psychiatrists, however, were in the group least likely to say they would choose their specialty again along with those in internal medicine, family medicine, and diabetes and endocrinology.
Female physicians in orthopedics, radiology, and dermatology were most likely to choose their specialties again (91% - 92%).
Female physicians were less likely to use physician assistants in their practices than were their male colleagues (31% vs. 38%) but more likely to use NPs (52% vs. 50%). More than a third (38%) of male and female physicians reported they use neither.
A version of this article originally appeared on Medscape.com.
More female physicians are becoming specialists, a Medscape survey finds, and five specialties have seen particularly large increases during the last 5 years.
Obstetrician/gynecologists and pediatricians had the largest female representation at 58% and those percentages were both up from 50% in 2015, according to the Medscape Female Physician Compensation Report 2020.
Rheumatology saw a dramatic jump in numbers of women from 29% in 2015 to 54% now. Dermatology increased from 32% to 49%, and family medicine rose from 35% to 43% during that time.
Specialist pay gap narrows slightly
The gender gap was the same this year in primary care — women made 25% less ($212,000 vs. $264,000).
The gap in specialists narrowed slightly. Women made 31% less this year ($286,000 vs $375,000) instead of the 33% less reported in last year’s survey, a difference of $89,000 this year.
The gender pay gap was consistent across all race and age groups and was consistent in responses about net worth. Whereas 57% of male physicians had a net worth of $1 million or more, only 40% of female physicians did. Twice as many male physicians as female physicians had a net worth of more than $5 million (10% vs. 5%).
“Many physicians expect the gender pay gap to narrow in the coming years,” John Prescott, MD, chief academic officer of the Association of American Medical Colleges, said in an interview.
“Yet, it is a challenging task, requiring an institutional commitment to transparency, cross-campus collaboration, ongoing communication, dedicated resources, and enlightened leadership,” he said.
Female physicians working in office-based, solo practices made the most overall at $290,000; women in outpatient settings made the least at $223,000.
The survey included more than 4,500 responses. The responses were collected during the early part of the year and do not reflect changes in income expected from the COVID-19 pandemic.
An analysis in Health Affairs, for instance, predicted that primary care practices would lose $67,774 in gross revenue per full-time-equivalent physician in calendar year 2020 because of the pandemic.
Most physicians did not experience a significant financial loss in 2019, but COVID-19 may, at least temporarily, change those answers in next year’s report, physicians predicted.
Women more likely than men to live above their means
More women this year (39%) said they live below their means than answered that way last year (31%). Female physicians were more likely to say they lived above their means than were their male counterparts (8% vs. 6%).
Greenwald Wealth Management in St. Louis Park, Minn., says aiming for putting away 20% of total gross salary is a good financial goal.
Women in this year’s survey spent about 7% less time seeing patients than did their male counterparts (35.9 hours a week vs. 38.8). The average for all physicians was 37.8 hours a week. Add the 15.6 average hours per week physicians spend on paperwork, and they are putting in 53-hour workweeks on average overall.
Asked what parts of their job they found most rewarding, women were more likely than were men to say “gratitude/relationships with patients” (31% vs. 25%). They were less likely than were men to answer that the most rewarding part was “being very good at what I do/finding answers/diagnoses” (22% vs. 25%) or “making good money at a job I like” (9% vs. 13%).
Most female physicians — and physicians overall — said they would choose medicine again. But two specialties saw a substantial increase in that answer.
This year, 79% of those in physical medicine and rehabilitation said they would choose medicine again (compared with 66% last year) and 84% of gastroenterologists answered that way (compared with 76% in 2019).
Psychiatrists, however, were in the group least likely to say they would choose their specialty again along with those in internal medicine, family medicine, and diabetes and endocrinology.
Female physicians in orthopedics, radiology, and dermatology were most likely to choose their specialties again (91% - 92%).
Female physicians were less likely to use physician assistants in their practices than were their male colleagues (31% vs. 38%) but more likely to use NPs (52% vs. 50%). More than a third (38%) of male and female physicians reported they use neither.
A version of this article originally appeared on Medscape.com.
Observational study again suggests lasting impact of COVID-19 on heart
A new study using cardiac magnetic resonance (CMR) imaging to examine the effects of novel coronavirus infection on the heart showed signs suggestive of myocarditis in 4 out of 26 competitive athletes who recovered from asymptomatic or mild cases of COVID-19.
While these and other similar findings are concerning, commentators are saying the results are preliminary and do not indicate widespread CMR screening is appropriate.
Two of the 4 patients showing signs of myocarditis in this series had no symptoms of COVID-19 but tested positive on routine testing. An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (30.8%) had LGE without T2 elevation suggestive of prior myocardial injury.
An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (31%) had LGE without T2 elevation suggestive of prior myocardial injury.
This finding, said Saurabh Rajpal, MBBS, MD, the study’s lead author, “could suggest prior myocardial injury or it could suggest athletic myocardial adaptation.”
In a research letter published in JAMA Cardiology, Rajpal and colleagues at Ohio State University in Columbus, described the findings of comprehensive CMR examinations in competitive athletes referred to the sport medicine clinic after testing positive for COVID-19 on reverse transcriptase-polymerase chain reaction between June and August 2020.
The university had made the decision in the spring to use CMR imaging as a screening tool for return to play, said Dr. Rajpal. While CMR is being used for research purposes, the American College of Cardiology’s recent “consensus expert opinion” statement on resumption of sport and exercise after COVID-19 infection does not require CMR imaging for resumption of competitive activity (JAMA Cardiol. 2020 May 13. doi:10.1001/jamacardio.2020.2136).
None of the athletes required hospitalization for their illness, and only 27% reported mild symptoms during the short-term infection, including sore throat, shortness of breath, myalgia, and fever.
On the day of CMR imaging, ECG and transthoracic echocardiography were performed, and serum troponin I was measured. There were no diagnostic ST/T wave changes, ventricular function and volumes were normal, and no athletes showed elevated serum troponin levels.
The updated Lake Louise Criteria were used to assess CMR findings consistent with myocarditis.
“I don’t think this is a COVID-specific issue. We have seen myocarditis after other viral infections; it’s just that COVID-19 is the most studied thus far, and with strenuous activity, inflammation in the heart can be risky,” Dr. Rajpal said in an interview. He added that more long-term and larger studies with control populations are needed.
His group is continuing to follow these athletes and has suggested that CMR “may provide an excellent risk-stratification assessment for myocarditis in athletes who have recovered from COVID-19 to guide safe competitive sports participation.”
Significance still unknown
Matthew Martinez, MD, the director of sports cardiology at Atlantic Health – Morristown (N.J.) Medical Center and the Gagnon Cardiovascular Institute, urged caution in making too much of the findings of this small study.
“We know that viruses cause myocardial damage and myocarditis. What we don’t know is how important these findings are. And in terms of risk, would we find the same phenomenon if we did this, say, in flu patients or in other age groups?” Dr. Martinez said in an interview.
“I haven’t seen all the images, but what I’d want to know is are these very subtle findings? Are these overt findings? Is this part of an active individual with symptoms? I need to know a little more data before I can tell if this influences the increased risk of sudden cardiac death that we often associate with myocarditis. I’m not sure how this should influence making decisions with regards to return to play.”
Dr. Martinez, who is the ACC’s chair of Sports and Exercise but was not an author of their recent guidance on return to sport, said that he is not routinely using CMR to assess athletes post-infection, as per the ACC’s recommendations.
“My approach is to evaluate anybody with a history of COVID infection and, first, determine whether it was an important infection with significant symptoms or not. And then, if they’re participating at a high level or are professional athletes, I would suggest an ECG, echo, and troponin. That’s our recommendation for the last several months and is still an appropriate way to evaluate that group.”
“In the presence of an abnormality or ongoing symptoms, I would ask for an MRI at that point,” said Dr. Martinez.
“We just don’t have much data on athletes with no symptoms to use to interpret these CMR findings and the study didn’t offer any controls. We don’t even know if these findings are new findings or old findings that have just been identified now,” he added.
New, updated recommendations from the ACC are coming soon, said Dr. Martinez. “I do not expect them to include CMR as first line.”
Cardiologists concerned about misinformation
This is at least the fourth study showing myocardial damage post-COVID-19 infection and there is concern in the medical community that the media has overstated the risks of heart damage, especially in athletes, and at the same time overstated the benefits of CMR.
In particular, Puntmann et al reported in July a 100-patient study that showed evidence of myocardial inflammation by CMR in 78% of patients recently recovered from a bout of COVID-19 (JAMA Cardiol. 2020 Jul 27; doi:10.1001/jamacardio.2020.3557).
“That paper is completely problematic,” John Mandrola, MD, of Baptists Medical Associates, Louisville, Ky., said in an interview. “It has the same overarching weaknesses [of other studies] that it’s observational and retrospective, but there were also numerical issues. So to me that paper is an interesting observation, but utterly unconvincing and preliminary,” said Dr. Mandrola.
Those limitations didn’t stop the study from garnering media attention, however. The Altmetric score (an attention score that tracks all mentions of an article in the media and on social media) for the Puntmann et al paper is approaching 13,000, including coverage from 276 news outlets and more than 19,000 tweets, putting it in the 99th percentile of all research outputs tracked by Altmetric to date.
To counter this, an “open letter” posted online just days before the Rajpal study published urging professional societies to “offer clear guidance discouraging CMR screening for COVID-19 related heart abnormalities in asymptomatic members of the general public.” The letter was signed by 51 clinicians, researchers, and imaging specialists from around the world.
Dr. Mandrola, one of the signatories, said: “This topic really scares people, and when it gets in the media like this, I think the leaders of these societies need to come out and say something really clear on major news networks letting people know that it’s just way too premature to start doing CMRs on every athlete that’s gotten this virus.”
“I understand that the current guidelines may be clear that CMR is not a first-line test for this indication, but when the media coverage is so extensive and so overblown, I wonder how much impact the guidelines will have in countering this fear that’s in the community,” he added.
Asked to comment on the letter, Dr. Rajpal said he agrees with the signatories that asymptomatic people from general population do not need routine cardiac MRI. “However, competitive athletes are a different story. Testing depends on risk assessment in specific population and competitive athletes as per our protocol will get enhanced cardiac workup including CMR for responsible and safe start of competitive sports. ... In the present scenario, while we get more data including control data, we will continue with our current protocol.”
Dr. Mandrola is Medscape Cardiology’s Chief Cardiology Consultant. MDedge is part of the Medscape Professional Network.
This article first appeared on Medscape.com.
A new study using cardiac magnetic resonance (CMR) imaging to examine the effects of novel coronavirus infection on the heart showed signs suggestive of myocarditis in 4 out of 26 competitive athletes who recovered from asymptomatic or mild cases of COVID-19.
While these and other similar findings are concerning, commentators are saying the results are preliminary and do not indicate widespread CMR screening is appropriate.
Two of the 4 patients showing signs of myocarditis in this series had no symptoms of COVID-19 but tested positive on routine testing. An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (30.8%) had LGE without T2 elevation suggestive of prior myocardial injury.
An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (31%) had LGE without T2 elevation suggestive of prior myocardial injury.
This finding, said Saurabh Rajpal, MBBS, MD, the study’s lead author, “could suggest prior myocardial injury or it could suggest athletic myocardial adaptation.”
In a research letter published in JAMA Cardiology, Rajpal and colleagues at Ohio State University in Columbus, described the findings of comprehensive CMR examinations in competitive athletes referred to the sport medicine clinic after testing positive for COVID-19 on reverse transcriptase-polymerase chain reaction between June and August 2020.
The university had made the decision in the spring to use CMR imaging as a screening tool for return to play, said Dr. Rajpal. While CMR is being used for research purposes, the American College of Cardiology’s recent “consensus expert opinion” statement on resumption of sport and exercise after COVID-19 infection does not require CMR imaging for resumption of competitive activity (JAMA Cardiol. 2020 May 13. doi:10.1001/jamacardio.2020.2136).
None of the athletes required hospitalization for their illness, and only 27% reported mild symptoms during the short-term infection, including sore throat, shortness of breath, myalgia, and fever.
On the day of CMR imaging, ECG and transthoracic echocardiography were performed, and serum troponin I was measured. There were no diagnostic ST/T wave changes, ventricular function and volumes were normal, and no athletes showed elevated serum troponin levels.
The updated Lake Louise Criteria were used to assess CMR findings consistent with myocarditis.
“I don’t think this is a COVID-specific issue. We have seen myocarditis after other viral infections; it’s just that COVID-19 is the most studied thus far, and with strenuous activity, inflammation in the heart can be risky,” Dr. Rajpal said in an interview. He added that more long-term and larger studies with control populations are needed.
His group is continuing to follow these athletes and has suggested that CMR “may provide an excellent risk-stratification assessment for myocarditis in athletes who have recovered from COVID-19 to guide safe competitive sports participation.”
Significance still unknown
Matthew Martinez, MD, the director of sports cardiology at Atlantic Health – Morristown (N.J.) Medical Center and the Gagnon Cardiovascular Institute, urged caution in making too much of the findings of this small study.
“We know that viruses cause myocardial damage and myocarditis. What we don’t know is how important these findings are. And in terms of risk, would we find the same phenomenon if we did this, say, in flu patients or in other age groups?” Dr. Martinez said in an interview.
“I haven’t seen all the images, but what I’d want to know is are these very subtle findings? Are these overt findings? Is this part of an active individual with symptoms? I need to know a little more data before I can tell if this influences the increased risk of sudden cardiac death that we often associate with myocarditis. I’m not sure how this should influence making decisions with regards to return to play.”
Dr. Martinez, who is the ACC’s chair of Sports and Exercise but was not an author of their recent guidance on return to sport, said that he is not routinely using CMR to assess athletes post-infection, as per the ACC’s recommendations.
“My approach is to evaluate anybody with a history of COVID infection and, first, determine whether it was an important infection with significant symptoms or not. And then, if they’re participating at a high level or are professional athletes, I would suggest an ECG, echo, and troponin. That’s our recommendation for the last several months and is still an appropriate way to evaluate that group.”
“In the presence of an abnormality or ongoing symptoms, I would ask for an MRI at that point,” said Dr. Martinez.
“We just don’t have much data on athletes with no symptoms to use to interpret these CMR findings and the study didn’t offer any controls. We don’t even know if these findings are new findings or old findings that have just been identified now,” he added.
New, updated recommendations from the ACC are coming soon, said Dr. Martinez. “I do not expect them to include CMR as first line.”
Cardiologists concerned about misinformation
This is at least the fourth study showing myocardial damage post-COVID-19 infection and there is concern in the medical community that the media has overstated the risks of heart damage, especially in athletes, and at the same time overstated the benefits of CMR.
In particular, Puntmann et al reported in July a 100-patient study that showed evidence of myocardial inflammation by CMR in 78% of patients recently recovered from a bout of COVID-19 (JAMA Cardiol. 2020 Jul 27; doi:10.1001/jamacardio.2020.3557).
“That paper is completely problematic,” John Mandrola, MD, of Baptists Medical Associates, Louisville, Ky., said in an interview. “It has the same overarching weaknesses [of other studies] that it’s observational and retrospective, but there were also numerical issues. So to me that paper is an interesting observation, but utterly unconvincing and preliminary,” said Dr. Mandrola.
Those limitations didn’t stop the study from garnering media attention, however. The Altmetric score (an attention score that tracks all mentions of an article in the media and on social media) for the Puntmann et al paper is approaching 13,000, including coverage from 276 news outlets and more than 19,000 tweets, putting it in the 99th percentile of all research outputs tracked by Altmetric to date.
To counter this, an “open letter” posted online just days before the Rajpal study published urging professional societies to “offer clear guidance discouraging CMR screening for COVID-19 related heart abnormalities in asymptomatic members of the general public.” The letter was signed by 51 clinicians, researchers, and imaging specialists from around the world.
Dr. Mandrola, one of the signatories, said: “This topic really scares people, and when it gets in the media like this, I think the leaders of these societies need to come out and say something really clear on major news networks letting people know that it’s just way too premature to start doing CMRs on every athlete that’s gotten this virus.”
“I understand that the current guidelines may be clear that CMR is not a first-line test for this indication, but when the media coverage is so extensive and so overblown, I wonder how much impact the guidelines will have in countering this fear that’s in the community,” he added.
Asked to comment on the letter, Dr. Rajpal said he agrees with the signatories that asymptomatic people from general population do not need routine cardiac MRI. “However, competitive athletes are a different story. Testing depends on risk assessment in specific population and competitive athletes as per our protocol will get enhanced cardiac workup including CMR for responsible and safe start of competitive sports. ... In the present scenario, while we get more data including control data, we will continue with our current protocol.”
Dr. Mandrola is Medscape Cardiology’s Chief Cardiology Consultant. MDedge is part of the Medscape Professional Network.
This article first appeared on Medscape.com.
A new study using cardiac magnetic resonance (CMR) imaging to examine the effects of novel coronavirus infection on the heart showed signs suggestive of myocarditis in 4 out of 26 competitive athletes who recovered from asymptomatic or mild cases of COVID-19.
While these and other similar findings are concerning, commentators are saying the results are preliminary and do not indicate widespread CMR screening is appropriate.
Two of the 4 patients showing signs of myocarditis in this series had no symptoms of COVID-19 but tested positive on routine testing. An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (30.8%) had LGE without T2 elevation suggestive of prior myocardial injury.
An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (31%) had LGE without T2 elevation suggestive of prior myocardial injury.
This finding, said Saurabh Rajpal, MBBS, MD, the study’s lead author, “could suggest prior myocardial injury or it could suggest athletic myocardial adaptation.”
In a research letter published in JAMA Cardiology, Rajpal and colleagues at Ohio State University in Columbus, described the findings of comprehensive CMR examinations in competitive athletes referred to the sport medicine clinic after testing positive for COVID-19 on reverse transcriptase-polymerase chain reaction between June and August 2020.
The university had made the decision in the spring to use CMR imaging as a screening tool for return to play, said Dr. Rajpal. While CMR is being used for research purposes, the American College of Cardiology’s recent “consensus expert opinion” statement on resumption of sport and exercise after COVID-19 infection does not require CMR imaging for resumption of competitive activity (JAMA Cardiol. 2020 May 13. doi:10.1001/jamacardio.2020.2136).
None of the athletes required hospitalization for their illness, and only 27% reported mild symptoms during the short-term infection, including sore throat, shortness of breath, myalgia, and fever.
On the day of CMR imaging, ECG and transthoracic echocardiography were performed, and serum troponin I was measured. There were no diagnostic ST/T wave changes, ventricular function and volumes were normal, and no athletes showed elevated serum troponin levels.
The updated Lake Louise Criteria were used to assess CMR findings consistent with myocarditis.
“I don’t think this is a COVID-specific issue. We have seen myocarditis after other viral infections; it’s just that COVID-19 is the most studied thus far, and with strenuous activity, inflammation in the heart can be risky,” Dr. Rajpal said in an interview. He added that more long-term and larger studies with control populations are needed.
His group is continuing to follow these athletes and has suggested that CMR “may provide an excellent risk-stratification assessment for myocarditis in athletes who have recovered from COVID-19 to guide safe competitive sports participation.”
Significance still unknown
Matthew Martinez, MD, the director of sports cardiology at Atlantic Health – Morristown (N.J.) Medical Center and the Gagnon Cardiovascular Institute, urged caution in making too much of the findings of this small study.
“We know that viruses cause myocardial damage and myocarditis. What we don’t know is how important these findings are. And in terms of risk, would we find the same phenomenon if we did this, say, in flu patients or in other age groups?” Dr. Martinez said in an interview.
“I haven’t seen all the images, but what I’d want to know is are these very subtle findings? Are these overt findings? Is this part of an active individual with symptoms? I need to know a little more data before I can tell if this influences the increased risk of sudden cardiac death that we often associate with myocarditis. I’m not sure how this should influence making decisions with regards to return to play.”
Dr. Martinez, who is the ACC’s chair of Sports and Exercise but was not an author of their recent guidance on return to sport, said that he is not routinely using CMR to assess athletes post-infection, as per the ACC’s recommendations.
“My approach is to evaluate anybody with a history of COVID infection and, first, determine whether it was an important infection with significant symptoms or not. And then, if they’re participating at a high level or are professional athletes, I would suggest an ECG, echo, and troponin. That’s our recommendation for the last several months and is still an appropriate way to evaluate that group.”
“In the presence of an abnormality or ongoing symptoms, I would ask for an MRI at that point,” said Dr. Martinez.
“We just don’t have much data on athletes with no symptoms to use to interpret these CMR findings and the study didn’t offer any controls. We don’t even know if these findings are new findings or old findings that have just been identified now,” he added.
New, updated recommendations from the ACC are coming soon, said Dr. Martinez. “I do not expect them to include CMR as first line.”
Cardiologists concerned about misinformation
This is at least the fourth study showing myocardial damage post-COVID-19 infection and there is concern in the medical community that the media has overstated the risks of heart damage, especially in athletes, and at the same time overstated the benefits of CMR.
In particular, Puntmann et al reported in July a 100-patient study that showed evidence of myocardial inflammation by CMR in 78% of patients recently recovered from a bout of COVID-19 (JAMA Cardiol. 2020 Jul 27; doi:10.1001/jamacardio.2020.3557).
“That paper is completely problematic,” John Mandrola, MD, of Baptists Medical Associates, Louisville, Ky., said in an interview. “It has the same overarching weaknesses [of other studies] that it’s observational and retrospective, but there were also numerical issues. So to me that paper is an interesting observation, but utterly unconvincing and preliminary,” said Dr. Mandrola.
Those limitations didn’t stop the study from garnering media attention, however. The Altmetric score (an attention score that tracks all mentions of an article in the media and on social media) for the Puntmann et al paper is approaching 13,000, including coverage from 276 news outlets and more than 19,000 tweets, putting it in the 99th percentile of all research outputs tracked by Altmetric to date.
To counter this, an “open letter” posted online just days before the Rajpal study published urging professional societies to “offer clear guidance discouraging CMR screening for COVID-19 related heart abnormalities in asymptomatic members of the general public.” The letter was signed by 51 clinicians, researchers, and imaging specialists from around the world.
Dr. Mandrola, one of the signatories, said: “This topic really scares people, and when it gets in the media like this, I think the leaders of these societies need to come out and say something really clear on major news networks letting people know that it’s just way too premature to start doing CMRs on every athlete that’s gotten this virus.”
“I understand that the current guidelines may be clear that CMR is not a first-line test for this indication, but when the media coverage is so extensive and so overblown, I wonder how much impact the guidelines will have in countering this fear that’s in the community,” he added.
Asked to comment on the letter, Dr. Rajpal said he agrees with the signatories that asymptomatic people from general population do not need routine cardiac MRI. “However, competitive athletes are a different story. Testing depends on risk assessment in specific population and competitive athletes as per our protocol will get enhanced cardiac workup including CMR for responsible and safe start of competitive sports. ... In the present scenario, while we get more data including control data, we will continue with our current protocol.”
Dr. Mandrola is Medscape Cardiology’s Chief Cardiology Consultant. MDedge is part of the Medscape Professional Network.
This article first appeared on Medscape.com.
Physician reimbursement 2021: Who are the big winners?
Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.
But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.
Some good news has made primary care and some other physicians happy.
The government’s proposal includes significant changes to reimbursement for all physicians.
Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.
According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.
The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.
These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.
If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.
The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.
For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.
Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.
The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.
A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.
The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.
Other key changes include the following:
- The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
- Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
- Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
- A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”
To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.
Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.
The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.
Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.
CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.
MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.
The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.
CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.
The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.
Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.
Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.
The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.
If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).
This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
A version of this article originally appeared on Medscape.com.
Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.
But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.
Some good news has made primary care and some other physicians happy.
The government’s proposal includes significant changes to reimbursement for all physicians.
Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.
According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.
The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.
These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.
If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.
The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.
For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.
Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.
The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.
A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.
The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.
Other key changes include the following:
- The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
- Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
- Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
- A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”
To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.
Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.
The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.
Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.
CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.
MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.
The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.
CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.
The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.
Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.
Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.
The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.
If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).
This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
A version of this article originally appeared on Medscape.com.
Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.
But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.
Some good news has made primary care and some other physicians happy.
The government’s proposal includes significant changes to reimbursement for all physicians.
Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.
According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.
The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.
These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.
If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.
The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.
For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.
Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.
The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.
A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.
The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.
Other key changes include the following:
- The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
- Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
- Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
- A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”
To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.
Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.
The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.
Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.
CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.
MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.
The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.
CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.
The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.
Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.
Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.
The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.
If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).
This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
A version of this article originally appeared on Medscape.com.
Low vitamin D in COVID-19 predicts ICU admission, poor survival
Having low serum vitamin D levels was an independent risk factor for having symptomatic COVID-19 with respiratory distress requiring admission to intensive care – as opposed to having mild COVID-19 – and for not surviving, in a new study from Italy.
“Our data give strong observational support to previous suggestions that reduced vitamin D levels may favor the appearance of severe respiratory dysfunction and increase the mortality risk in patients affected with COVID-19,” the researchers report.
Luigi Gennari, MD, PhD, Department of Medicine, Surgery, and Neurosciences, University of Siena, Italy, presented these findings during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.
Gennari told Medscape Medical News that this analysis suggests determining vitamin D levels (25 hydroxyvitamin D) in people testing positive for SARS-Cov-2 infection might help predict their risk of severe disease.
However, further research is needed to explore whether vitamin D supplements could prevent the risk of respiratory failure in patients with SARS-Cov-2 infection, he stressed.
In the meantime, Gennari said: “I believe that, particularly in the winter season (when the solar ultraviolet-B (UVB) radiation exposure does not allow the skin to synthesize vitamin D in most countries), the use of vitamin D supplementation and correction of vitamin D deficiency might be of major relevance for the reduction of the clinical burden of the ongoing and future outbreaks of SARS-CoV-2 infection.
Invited to comment, David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, who was not involved with the study, agrees.
“I think this body of work suggests that people should be taking supplements if they cannot increase sun exposure on a sustained basis,” Meltzer said. “The abstract supports multiple prior findings that suggest that higher vitamin D levels are associated with improved outcomes.”
And JoAnn E. Manson, MD, DrPH, of Harvard Medical School and Brigham and Women’s Hospital, who was not involved with the research but has spoken about the topic in a video report for Medscape, said: “We know from several studies that a low vitamin D level is associated with a higher risk of having COVID-19 and severe illness, but correlation does not prove causation.”
“I think that improving vitamin D status is a promising way to reduce the risk of severe illness, but we need randomized controlled trials to prove cause and effect,” she told Medscape Medical News.
103 patients with severe COVID-19, 52 with mild COVID-19, 206 controls
Gennari said several lines of evidence suggest that vitamin D deficiency might be a risk factor for COVID-19 severity.
Countries with lower average levels of vitamin D or lower UVB radiation exposure have higher COVID-19 mortality, and “demographic groups known to be at higher risk of vitamin D deficiency (such as black individuals, the elderly, nursing home residents, and those with obesity and diabetes) are at high risk of COVID-19 hospitalization/mortality, he noted.
There is a high prevalence of vitamin D deficiency in Italy, where mortality rates from COVID-19 have been particularly high.
To examine the relationship between vitamin D levels and COVID-19 severity/mortality, the researchers studied three groups:
- 103 symptomatic patients with COVID-19 with respiratory insufficiency who were admitted to a Milan hospital from March 9 to April 30.
- 52 patients with mild COVID-19, recruited from patients and staff from a nearby nursing home who had a positive test for COVID-19.
- 206 healthy controls, matched 2:1 with symptomatic patients of the same age, weight, and gender, from 3174 patients who had vitamin D measured during a routine check-up from January to March 2020.
Patients in the hospitalized group had lower mean vitamin D levels (18.2 ng/mL) than those with mild COVID-19 (30.3 ng/mL) or those in the control group (25.4 ng/mL).
Patients with symptomatic versus mild COVID-19 were slightly older and more likely to have at least one comorbidity and less likely to be taking a vitamin D supplement at baseline (30% vs 79%).
Among symptomatic patients, mean vitamin D levels were inversely associated with interleukin (IL)-6 and C-reactive protein, “both of which are a direct expression of the inflammatory status,” Gennari noted.
About half of the hospitalized patients (49) were admitted to a ward and discharged after a mean stay of 16 days (none died).
The other 54 hospitalized patients were admitted to the intensive care unit with severe acute respiratory distress; 38 patients received continuous positive airway pressure (CPAP) and 16 patients received endotracheal intubation.
Of the 54 patients admitted to ICU, 19 patients died from respiratory distress after a mean of 19 days, “consistent with the literature,” and the other 35 patients were discharged after a mean of 21 days.
Patients with severe COVID-19 who were admitted to the ICU, as opposed to a ward, were more likely to be male, have at least one comorbidity, have higher baseline IL-6 levels and neutrophil counts, and lower lymphocyte and platelet counts.
They also had lower mean vitamin D levels (14.4 vs 22.4 ng/mL) and were more likely to have vitamin D deficiency (vitamin D <20 ng/mL; 80% vs. 45%).
Patients admitted to ICU who died had lower baseline vitamin D levels than those who survived (13.2 vs. 19.3 ng/mL).
Vitamin D levels were inversely associated with respiratory distress requiring ICU admission (odds ratio, 1.06; P = .038) and with mortality (OR, 1.18, P = 029), independent of IL-6 levels and other comorbidities.
“That vitamin D levels are associated with improved outcomes independent of IL-6 could reflect that IL-6 is an imperfect measure of the inflammatory process or that vitamin D is related to outcomes for other reasons, such as enhancement of innate or adaptive immunity,” said Meltzer.
He added that “this is not to exclude the possibility that vitamin D has important immunomodulatory effects.”
Gennari, Meltzer, and Manson have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Having low serum vitamin D levels was an independent risk factor for having symptomatic COVID-19 with respiratory distress requiring admission to intensive care – as opposed to having mild COVID-19 – and for not surviving, in a new study from Italy.
“Our data give strong observational support to previous suggestions that reduced vitamin D levels may favor the appearance of severe respiratory dysfunction and increase the mortality risk in patients affected with COVID-19,” the researchers report.
Luigi Gennari, MD, PhD, Department of Medicine, Surgery, and Neurosciences, University of Siena, Italy, presented these findings during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.
Gennari told Medscape Medical News that this analysis suggests determining vitamin D levels (25 hydroxyvitamin D) in people testing positive for SARS-Cov-2 infection might help predict their risk of severe disease.
However, further research is needed to explore whether vitamin D supplements could prevent the risk of respiratory failure in patients with SARS-Cov-2 infection, he stressed.
In the meantime, Gennari said: “I believe that, particularly in the winter season (when the solar ultraviolet-B (UVB) radiation exposure does not allow the skin to synthesize vitamin D in most countries), the use of vitamin D supplementation and correction of vitamin D deficiency might be of major relevance for the reduction of the clinical burden of the ongoing and future outbreaks of SARS-CoV-2 infection.
Invited to comment, David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, who was not involved with the study, agrees.
“I think this body of work suggests that people should be taking supplements if they cannot increase sun exposure on a sustained basis,” Meltzer said. “The abstract supports multiple prior findings that suggest that higher vitamin D levels are associated with improved outcomes.”
And JoAnn E. Manson, MD, DrPH, of Harvard Medical School and Brigham and Women’s Hospital, who was not involved with the research but has spoken about the topic in a video report for Medscape, said: “We know from several studies that a low vitamin D level is associated with a higher risk of having COVID-19 and severe illness, but correlation does not prove causation.”
“I think that improving vitamin D status is a promising way to reduce the risk of severe illness, but we need randomized controlled trials to prove cause and effect,” she told Medscape Medical News.
103 patients with severe COVID-19, 52 with mild COVID-19, 206 controls
Gennari said several lines of evidence suggest that vitamin D deficiency might be a risk factor for COVID-19 severity.
Countries with lower average levels of vitamin D or lower UVB radiation exposure have higher COVID-19 mortality, and “demographic groups known to be at higher risk of vitamin D deficiency (such as black individuals, the elderly, nursing home residents, and those with obesity and diabetes) are at high risk of COVID-19 hospitalization/mortality, he noted.
There is a high prevalence of vitamin D deficiency in Italy, where mortality rates from COVID-19 have been particularly high.
To examine the relationship between vitamin D levels and COVID-19 severity/mortality, the researchers studied three groups:
- 103 symptomatic patients with COVID-19 with respiratory insufficiency who were admitted to a Milan hospital from March 9 to April 30.
- 52 patients with mild COVID-19, recruited from patients and staff from a nearby nursing home who had a positive test for COVID-19.
- 206 healthy controls, matched 2:1 with symptomatic patients of the same age, weight, and gender, from 3174 patients who had vitamin D measured during a routine check-up from January to March 2020.
Patients in the hospitalized group had lower mean vitamin D levels (18.2 ng/mL) than those with mild COVID-19 (30.3 ng/mL) or those in the control group (25.4 ng/mL).
Patients with symptomatic versus mild COVID-19 were slightly older and more likely to have at least one comorbidity and less likely to be taking a vitamin D supplement at baseline (30% vs 79%).
Among symptomatic patients, mean vitamin D levels were inversely associated with interleukin (IL)-6 and C-reactive protein, “both of which are a direct expression of the inflammatory status,” Gennari noted.
About half of the hospitalized patients (49) were admitted to a ward and discharged after a mean stay of 16 days (none died).
The other 54 hospitalized patients were admitted to the intensive care unit with severe acute respiratory distress; 38 patients received continuous positive airway pressure (CPAP) and 16 patients received endotracheal intubation.
Of the 54 patients admitted to ICU, 19 patients died from respiratory distress after a mean of 19 days, “consistent with the literature,” and the other 35 patients were discharged after a mean of 21 days.
Patients with severe COVID-19 who were admitted to the ICU, as opposed to a ward, were more likely to be male, have at least one comorbidity, have higher baseline IL-6 levels and neutrophil counts, and lower lymphocyte and platelet counts.
They also had lower mean vitamin D levels (14.4 vs 22.4 ng/mL) and were more likely to have vitamin D deficiency (vitamin D <20 ng/mL; 80% vs. 45%).
Patients admitted to ICU who died had lower baseline vitamin D levels than those who survived (13.2 vs. 19.3 ng/mL).
Vitamin D levels were inversely associated with respiratory distress requiring ICU admission (odds ratio, 1.06; P = .038) and with mortality (OR, 1.18, P = 029), independent of IL-6 levels and other comorbidities.
“That vitamin D levels are associated with improved outcomes independent of IL-6 could reflect that IL-6 is an imperfect measure of the inflammatory process or that vitamin D is related to outcomes for other reasons, such as enhancement of innate or adaptive immunity,” said Meltzer.
He added that “this is not to exclude the possibility that vitamin D has important immunomodulatory effects.”
Gennari, Meltzer, and Manson have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Having low serum vitamin D levels was an independent risk factor for having symptomatic COVID-19 with respiratory distress requiring admission to intensive care – as opposed to having mild COVID-19 – and for not surviving, in a new study from Italy.
“Our data give strong observational support to previous suggestions that reduced vitamin D levels may favor the appearance of severe respiratory dysfunction and increase the mortality risk in patients affected with COVID-19,” the researchers report.
Luigi Gennari, MD, PhD, Department of Medicine, Surgery, and Neurosciences, University of Siena, Italy, presented these findings during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.
Gennari told Medscape Medical News that this analysis suggests determining vitamin D levels (25 hydroxyvitamin D) in people testing positive for SARS-Cov-2 infection might help predict their risk of severe disease.
However, further research is needed to explore whether vitamin D supplements could prevent the risk of respiratory failure in patients with SARS-Cov-2 infection, he stressed.
In the meantime, Gennari said: “I believe that, particularly in the winter season (when the solar ultraviolet-B (UVB) radiation exposure does not allow the skin to synthesize vitamin D in most countries), the use of vitamin D supplementation and correction of vitamin D deficiency might be of major relevance for the reduction of the clinical burden of the ongoing and future outbreaks of SARS-CoV-2 infection.
Invited to comment, David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, who was not involved with the study, agrees.
“I think this body of work suggests that people should be taking supplements if they cannot increase sun exposure on a sustained basis,” Meltzer said. “The abstract supports multiple prior findings that suggest that higher vitamin D levels are associated with improved outcomes.”
And JoAnn E. Manson, MD, DrPH, of Harvard Medical School and Brigham and Women’s Hospital, who was not involved with the research but has spoken about the topic in a video report for Medscape, said: “We know from several studies that a low vitamin D level is associated with a higher risk of having COVID-19 and severe illness, but correlation does not prove causation.”
“I think that improving vitamin D status is a promising way to reduce the risk of severe illness, but we need randomized controlled trials to prove cause and effect,” she told Medscape Medical News.
103 patients with severe COVID-19, 52 with mild COVID-19, 206 controls
Gennari said several lines of evidence suggest that vitamin D deficiency might be a risk factor for COVID-19 severity.
Countries with lower average levels of vitamin D or lower UVB radiation exposure have higher COVID-19 mortality, and “demographic groups known to be at higher risk of vitamin D deficiency (such as black individuals, the elderly, nursing home residents, and those with obesity and diabetes) are at high risk of COVID-19 hospitalization/mortality, he noted.
There is a high prevalence of vitamin D deficiency in Italy, where mortality rates from COVID-19 have been particularly high.
To examine the relationship between vitamin D levels and COVID-19 severity/mortality, the researchers studied three groups:
- 103 symptomatic patients with COVID-19 with respiratory insufficiency who were admitted to a Milan hospital from March 9 to April 30.
- 52 patients with mild COVID-19, recruited from patients and staff from a nearby nursing home who had a positive test for COVID-19.
- 206 healthy controls, matched 2:1 with symptomatic patients of the same age, weight, and gender, from 3174 patients who had vitamin D measured during a routine check-up from January to March 2020.
Patients in the hospitalized group had lower mean vitamin D levels (18.2 ng/mL) than those with mild COVID-19 (30.3 ng/mL) or those in the control group (25.4 ng/mL).
Patients with symptomatic versus mild COVID-19 were slightly older and more likely to have at least one comorbidity and less likely to be taking a vitamin D supplement at baseline (30% vs 79%).
Among symptomatic patients, mean vitamin D levels were inversely associated with interleukin (IL)-6 and C-reactive protein, “both of which are a direct expression of the inflammatory status,” Gennari noted.
About half of the hospitalized patients (49) were admitted to a ward and discharged after a mean stay of 16 days (none died).
The other 54 hospitalized patients were admitted to the intensive care unit with severe acute respiratory distress; 38 patients received continuous positive airway pressure (CPAP) and 16 patients received endotracheal intubation.
Of the 54 patients admitted to ICU, 19 patients died from respiratory distress after a mean of 19 days, “consistent with the literature,” and the other 35 patients were discharged after a mean of 21 days.
Patients with severe COVID-19 who were admitted to the ICU, as opposed to a ward, were more likely to be male, have at least one comorbidity, have higher baseline IL-6 levels and neutrophil counts, and lower lymphocyte and platelet counts.
They also had lower mean vitamin D levels (14.4 vs 22.4 ng/mL) and were more likely to have vitamin D deficiency (vitamin D <20 ng/mL; 80% vs. 45%).
Patients admitted to ICU who died had lower baseline vitamin D levels than those who survived (13.2 vs. 19.3 ng/mL).
Vitamin D levels were inversely associated with respiratory distress requiring ICU admission (odds ratio, 1.06; P = .038) and with mortality (OR, 1.18, P = 029), independent of IL-6 levels and other comorbidities.
“That vitamin D levels are associated with improved outcomes independent of IL-6 could reflect that IL-6 is an imperfect measure of the inflammatory process or that vitamin D is related to outcomes for other reasons, such as enhancement of innate or adaptive immunity,” said Meltzer.
He added that “this is not to exclude the possibility that vitamin D has important immunomodulatory effects.”
Gennari, Meltzer, and Manson have reported no relevant financial relationships.
This article first appeared on Medscape.com.
FROM ASBMR 2020
Too many patient call messages
In a recent study published in the Journal of the American Medical Informatics Association that used EHR logs, researchers found that “Clinicians with the highest volume of patient call messages have almost 4 times the odds of burnout compared with clinicians with the fewest.” And they discovered that “No other workload measures were significantly associated with burnout.” Like the majority of papers I skim through, it states the obvious. Doesn’t it makes sense that the busiest of providers should be more vulnerable to stress related symptoms? But is that really true for every provider? Being “busy” doesn’t guarantee that you are productive nor does it mean that the stuff you are doing while you are busy is fulfilling or rewarding either emotionally or financially. Certainly, slogging through a long list of patient call messages at the end of the day does qualify as being busy, but it is more likely to generate anger and frustration than it is fulfillment.
Just because you have a large practice, does that mean that you will necessarily have more messages to review and calls to return than a provider with a smaller practice. Maybe you manage your practice and your time so well that you actually have fewer messages and calls to return and, therefore, are less vulnerable to burnout.
There are three general strategies that you might be employing that result in fewer messages and calls that require your response. It may be that you have developed a handbook of frequently asked questions and trained your staff to use it as a reference in a way that reduces the number of messages that filter to you. Creating this triage book and finding the right personnel took time, but it didn’t necessarily mean that you had to hire staff with extensive training, which can be expensive. In-house training of raw talent that has demonstrated common sense and good communication skills can be cost effective and rewarding. You probably already have discovered that continued attention to quality control is an important part of this strategy. Included in your handbook you may have included a clearcut triage system for the questions that the staff can’t answer. Is it a question you must answer (a) as soon as you finish with this patient, (b) before lunch, or (c) at the end of the day? (Category (c) is of course strongly discouraged).
The second general group of strategies you may be using to keep your calls and messages to a minimum is anticipatory guidance. As you wrap up each visit, are you anticipating what calls it might generate? This of course depends on the nature of the problem and the personality of the patient. From your experience you can probably predict most of the questions that are likely going to crop up after the patient arrives home. Preemptively answering these before patients leave and providing a personalized handout that you discuss with them may easily be saving you two or three calls a day. Because you can’t anticipate every question, you have found that promising a follow-up call in a day or 2 encourages the patients to hold their questions and wait for you or your assistant to call.
Finally, you may have discovered long ago that in many cases it is easier and more efficient to see the patient rather than having your staff spend half their time building and maintaining a communication wall around you. This is particularly true if, during the initial contact with your office, the patients have made it clear that they would like to be seen. This strategy is based on commons sense, but for many physicians and their office staff it may require a dramatic shift in attitude. You may have needed to become more comfortable squeezing in short visits at which the goal is to simply begin the dual processes of anxiety relief and diagnosis. In the beginning, you may have had to frequently remind your staff that their primary goal is patient satisfaction and not protecting you from seeing “too many” patients. Ironically, by being over protective, they may have been contributing to burnout when simply cutting to the chase and having the patient come in to be seen would have generated fewer stress-producing calls and messages.
Enabling a system that generates an excess of patient messages is looking for trouble.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
In a recent study published in the Journal of the American Medical Informatics Association that used EHR logs, researchers found that “Clinicians with the highest volume of patient call messages have almost 4 times the odds of burnout compared with clinicians with the fewest.” And they discovered that “No other workload measures were significantly associated with burnout.” Like the majority of papers I skim through, it states the obvious. Doesn’t it makes sense that the busiest of providers should be more vulnerable to stress related symptoms? But is that really true for every provider? Being “busy” doesn’t guarantee that you are productive nor does it mean that the stuff you are doing while you are busy is fulfilling or rewarding either emotionally or financially. Certainly, slogging through a long list of patient call messages at the end of the day does qualify as being busy, but it is more likely to generate anger and frustration than it is fulfillment.
Just because you have a large practice, does that mean that you will necessarily have more messages to review and calls to return than a provider with a smaller practice. Maybe you manage your practice and your time so well that you actually have fewer messages and calls to return and, therefore, are less vulnerable to burnout.
There are three general strategies that you might be employing that result in fewer messages and calls that require your response. It may be that you have developed a handbook of frequently asked questions and trained your staff to use it as a reference in a way that reduces the number of messages that filter to you. Creating this triage book and finding the right personnel took time, but it didn’t necessarily mean that you had to hire staff with extensive training, which can be expensive. In-house training of raw talent that has demonstrated common sense and good communication skills can be cost effective and rewarding. You probably already have discovered that continued attention to quality control is an important part of this strategy. Included in your handbook you may have included a clearcut triage system for the questions that the staff can’t answer. Is it a question you must answer (a) as soon as you finish with this patient, (b) before lunch, or (c) at the end of the day? (Category (c) is of course strongly discouraged).
The second general group of strategies you may be using to keep your calls and messages to a minimum is anticipatory guidance. As you wrap up each visit, are you anticipating what calls it might generate? This of course depends on the nature of the problem and the personality of the patient. From your experience you can probably predict most of the questions that are likely going to crop up after the patient arrives home. Preemptively answering these before patients leave and providing a personalized handout that you discuss with them may easily be saving you two or three calls a day. Because you can’t anticipate every question, you have found that promising a follow-up call in a day or 2 encourages the patients to hold their questions and wait for you or your assistant to call.
Finally, you may have discovered long ago that in many cases it is easier and more efficient to see the patient rather than having your staff spend half their time building and maintaining a communication wall around you. This is particularly true if, during the initial contact with your office, the patients have made it clear that they would like to be seen. This strategy is based on commons sense, but for many physicians and their office staff it may require a dramatic shift in attitude. You may have needed to become more comfortable squeezing in short visits at which the goal is to simply begin the dual processes of anxiety relief and diagnosis. In the beginning, you may have had to frequently remind your staff that their primary goal is patient satisfaction and not protecting you from seeing “too many” patients. Ironically, by being over protective, they may have been contributing to burnout when simply cutting to the chase and having the patient come in to be seen would have generated fewer stress-producing calls and messages.
Enabling a system that generates an excess of patient messages is looking for trouble.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
In a recent study published in the Journal of the American Medical Informatics Association that used EHR logs, researchers found that “Clinicians with the highest volume of patient call messages have almost 4 times the odds of burnout compared with clinicians with the fewest.” And they discovered that “No other workload measures were significantly associated with burnout.” Like the majority of papers I skim through, it states the obvious. Doesn’t it makes sense that the busiest of providers should be more vulnerable to stress related symptoms? But is that really true for every provider? Being “busy” doesn’t guarantee that you are productive nor does it mean that the stuff you are doing while you are busy is fulfilling or rewarding either emotionally or financially. Certainly, slogging through a long list of patient call messages at the end of the day does qualify as being busy, but it is more likely to generate anger and frustration than it is fulfillment.
Just because you have a large practice, does that mean that you will necessarily have more messages to review and calls to return than a provider with a smaller practice. Maybe you manage your practice and your time so well that you actually have fewer messages and calls to return and, therefore, are less vulnerable to burnout.
There are three general strategies that you might be employing that result in fewer messages and calls that require your response. It may be that you have developed a handbook of frequently asked questions and trained your staff to use it as a reference in a way that reduces the number of messages that filter to you. Creating this triage book and finding the right personnel took time, but it didn’t necessarily mean that you had to hire staff with extensive training, which can be expensive. In-house training of raw talent that has demonstrated common sense and good communication skills can be cost effective and rewarding. You probably already have discovered that continued attention to quality control is an important part of this strategy. Included in your handbook you may have included a clearcut triage system for the questions that the staff can’t answer. Is it a question you must answer (a) as soon as you finish with this patient, (b) before lunch, or (c) at the end of the day? (Category (c) is of course strongly discouraged).
The second general group of strategies you may be using to keep your calls and messages to a minimum is anticipatory guidance. As you wrap up each visit, are you anticipating what calls it might generate? This of course depends on the nature of the problem and the personality of the patient. From your experience you can probably predict most of the questions that are likely going to crop up after the patient arrives home. Preemptively answering these before patients leave and providing a personalized handout that you discuss with them may easily be saving you two or three calls a day. Because you can’t anticipate every question, you have found that promising a follow-up call in a day or 2 encourages the patients to hold their questions and wait for you or your assistant to call.
Finally, you may have discovered long ago that in many cases it is easier and more efficient to see the patient rather than having your staff spend half their time building and maintaining a communication wall around you. This is particularly true if, during the initial contact with your office, the patients have made it clear that they would like to be seen. This strategy is based on commons sense, but for many physicians and their office staff it may require a dramatic shift in attitude. You may have needed to become more comfortable squeezing in short visits at which the goal is to simply begin the dual processes of anxiety relief and diagnosis. In the beginning, you may have had to frequently remind your staff that their primary goal is patient satisfaction and not protecting you from seeing “too many” patients. Ironically, by being over protective, they may have been contributing to burnout when simply cutting to the chase and having the patient come in to be seen would have generated fewer stress-producing calls and messages.
Enabling a system that generates an excess of patient messages is looking for trouble.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
Election gift for Florida? Trump poised to approve drug imports from Canada
Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.
Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.
But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.
The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.
“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a health consultant who has worked with Colorado on its importation proposal.
Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.
Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.
The DeSantis administration did not respond to requests for comment.
Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”
The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.
The proposal would regulate how states set up their own programs for importing drugs from Canada.
Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.
The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.
But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.
“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”
Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.
Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.
For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.
About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.
The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.
The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.
The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.
Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”
The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.
Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.
The second program would be geared to the broader state population.
In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.
“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.
Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.
Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.
Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.
However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.
Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.
“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.
Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.
Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.
“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald.
Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.
Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.
But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.
The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.
“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a health consultant who has worked with Colorado on its importation proposal.
Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.
Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.
The DeSantis administration did not respond to requests for comment.
Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”
The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.
The proposal would regulate how states set up their own programs for importing drugs from Canada.
Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.
The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.
But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.
“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”
Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.
Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.
For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.
About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.
The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.
The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.
The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.
Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”
The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.
Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.
The second program would be geared to the broader state population.
In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.
“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.
Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.
Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.
Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.
However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.
Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.
“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.
Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.
Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.
“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald.
Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.
Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.
But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.
The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.
“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a health consultant who has worked with Colorado on its importation proposal.
Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.
Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.
The DeSantis administration did not respond to requests for comment.
Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”
The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.
The proposal would regulate how states set up their own programs for importing drugs from Canada.
Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.
The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.
But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.
“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”
Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.
Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.
For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.
About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.
The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.
The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.
The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.
Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”
The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.
Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.
The second program would be geared to the broader state population.
In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.
“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.
Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.
Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.
Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.
However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.
Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.
“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.
Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.
Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.
“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald.
Many Americans still concerned about access to health care
according to the results of a survey conducted Aug. 7-26.
Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.
At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.
When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.
Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:
- Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
- Frequently washing hands: 74.7% very, 1.6% not at all.
- Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
- Wearing a face mask in public: 75.7% very, 3.5% not at all.
The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.
according to the results of a survey conducted Aug. 7-26.
Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.
At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.
When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.
Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:
- Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
- Frequently washing hands: 74.7% very, 1.6% not at all.
- Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
- Wearing a face mask in public: 75.7% very, 3.5% not at all.
The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.
according to the results of a survey conducted Aug. 7-26.
Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.
At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.
When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.
Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:
- Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
- Frequently washing hands: 74.7% very, 1.6% not at all.
- Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
- Wearing a face mask in public: 75.7% very, 3.5% not at all.
The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.
2020-2021 respiratory viral season: Onset, presentations, and testing likely to differ in pandemic
Respiratory virus seasons usually follow a fairly well-known pattern. Enterovirus 68 (EV-D68) is a summer-to-early fall virus with biennial peak years. Rhinovirus (HRv) and adenovirus (Adv) occur nearly year-round but may have small upticks in the first month or so that children return to school. Early in the school year, upper respiratory infections from both HRv and Adv and viral sore throats from Adv are common, with conjunctivitis from Adv outbreaks in some years. October to November is human parainfluenza (HPiV) 1 and 2 season, often presenting as croup. Human metapneumovirus infections span October through April. In late November to December, influenza begins, usually with an A type, later transitioning to a B type in February through April. Also in December, respiratory syncytial virus (RSV) starts, characteristically with bronchiolitis presentations, peaking in February to March and tapering off in May. In late March to April, HPiV 3 also appears for 4-6 weeks.
Will 2020-2021 be different?
Summer was remarkably free of expected enterovirus activity, suggesting that the seasonal parade may differ this year. Remember that the 2019-2020 respiratory season suddenly and nearly completely stopped in March because of social distancing and lockdowns needed to address the SARS-CoV-2 pandemic.
The mild influenza season in the southern hemisphere suggests that our influenza season also could be mild. But perhaps not – most southern hemisphere countries that are surveyed for influenza activities had the most intense SARS-CoV-2 mitigations, making the observed mildness potentially related more to social mitigation than less virulent influenza strains. If so, southern hemisphere influenza data may not apply to the United States, where social distancing and masks are ignored or used inconsistently by almost half the population.
Further, the stop-and-go pattern of in-person school/college attendance adds to uncertainties for the usual orderly virus-specific seasonality. The result may be multiple stop-and-go “pop-up” or “mini” outbreaks for any given virus potentially reflected as exaggerated local or regional differences in circulation of various viruses. The erratic seasonality also would increase coinfections, which could present with more severe or different symptoms.
SARS-CoV-2’s potential interaction
Will the relatively mild presentations for most children with SARS-CoV-2 hold up in the setting of coinfections or sequential respiratory viral infections? Could SARS-CoV-2 cause worse/more prolonged symptoms or more sequelae if paired simultaneously or in tandem with a traditional respiratory virus? To date, data on the frequency and severity of SARS-CoV-2 coinfections are conflicting and sparse, but it appears that non-SARS-CoV-2 viruses can be involved in 15%-50% pediatric acute respiratory infections.1,2
However, it may not be important to know about coinfecting viruses other than influenza (can be treated) or SARS-CoV-2 (needs quarantine and contact tracing), unless symptoms are atypical or more severe than usual. For example, a young child with bronchiolitis is most likely infected with RSV, but HPiV, influenza, metapneumovirus, HRv, and even SARS-CoV-2 can cause bronchiolitis. Even so, testing outpatients for RSV or non-influenza is not routine or even clinically helpful. Supportive treatment and restriction from daycare attendance are sufficient management for outpatient ARIs whether presenting as bronchiolitis or not.
Considerations for SARS-CoV-2 testing: Outpatient bronchiolitis
If a child presents with classic bronchiolitis but has above moderate to severe symptoms, is SARS-CoV-2 a consideration? Perhaps, if SARS-CoV-2 acts similarly to non-SARS-CoV-2s.
A recent report from the 30th Multicenter Airway Research Collaboration (MARC-30) surveillance study (2007-2014) of children hospitalized with clinical bronchiolitis evaluated respiratory viruses, including RSV and the four common non-SARS coronaviruses using molecular testing.3 Among 1,880 subjects, a CoV (alpha CoV: NL63 or 229E, or beta CoV: KKU1 or OC43) was detected in 12%. Yet most had only RSV (n = 1,661); 32 had only CoV (n = 32). But note that 219 had both.
Bronchiolitis subjects with CoV were older – median 3.7 (1.4-5.8) vs. 2.8 (1.9-7.2) years – and more likely male than were RSV subjects (68% vs. 58%). OC43 was most frequent followed by equal numbers of HKU1 and NL63, while 229E was the least frequent. Medical utilization and severity did not differ among the CoVs, or between RSV+CoV vs. RSV alone, unless one considered CoV viral load as a variable. ICU use increased when the polymerase chain reaction cycle threshold result indicated a high CoV viral load.
These data suggest CoVs are not infrequent coinfectors with RSV in bronchiolitis – and that SARS-CoV-2 is the same. Therefore, a bronchiolitis presentation doesn’t necessarily take us off the hook for the need to consider SARS-CoV-2 testing, particularly in the somewhat older bronchiolitis patient with more than mild symptoms.
Considerations for SARS-CoV-2 testing: Outpatient influenza-like illness
In 2020-2021, the Centers for Disease Control and Prevention recommends considering empiric antiviral treatment for ILIs (fever plus either cough or sore throat) based upon our clinical judgement, even in non-high-risk children.4
While pediatric COVID-19 illnesses are predominantly asymptomatic or mild, a febrile ARI is also a SARS-CoV-2 compatible presentation. So, if all we use is our clinical judgment, how do we know if the febrile ARI is due to influenza or SARS-CoV-2 or both? At least one study used a highly sensitive and specific molecular influenza test to show that the accuracy of clinically diagnosing influenza in children is not much better than flipping a coin and would lead to potential antiviral overuse.5
So, it seems ideal to test for influenza when possible. Point-of-care (POC) tests are frequently used for outpatients. Eight POC Clinical Laboratory Improvement Amendments (CLIA)–waived kits, some also detecting RSV, are available but most have modest sensitivity (60%-80%) compared with lab-based molecular tests.6 That said, if supplies and kits for one of the POC tests are available to us during these SARS-CoV-2 stressed times (back orders seem more common this year), a positive influenza test in the first 48 hours of symptoms confirms the option to prescribe an antiviral. Yet how will we have confidence that the febrile ARI is not also partly due to SARS-CoV-2? Currently febrile ARIs usually are considered SARS-CoV-2 and the children are sent for SARS-CoV-2 testing. During influenza season, it seems we will need to continue to send febrile outpatients for SARS-CoV-2 testing, even if POC influenza positive, via whatever mechanisms are available as time goes on.
We expect more rapid pediatric testing modalities for SARS-CoV-2 (maybe even saliva tests) to become available over the next months. Indeed, rapid antigen tests and rapid molecular tests are being evaluated in adults and seem destined for CLIA waivers as POC tests, and even home testing kits. Pediatric approvals hopefully also will occur. So, the pathways for SARS-CoV-2 testing available now will likely change over this winter. But be aware that supplies/kits will be prioritized to locations within high need areas and bulk purchase contracts. So POC kits may remain scarce for practices, meaning a reference laboratory still could be the way to go for SARS-CoV-2 for at least the rest of 2020. Reference labs are becoming creative as well; one combined detection of influenza A, influenza B, RSV, and SARS-CoV-2 into one test, and hopes to get approval for swab collection that can be done by families at home and mailed in.
Summary
Expect variations on the traditional parade of seasonal respiratory viruses, with increased numbers of coinfections. Choosing the outpatient who needs influenza testing is the same as in past years, although we have CDC permissive recommendations to prescribe antivirals for any outpatient ILI within the first 48 hours of symptoms. Still, POC testing for influenza remains potentially valuable in the ILI patient. The choice of whether and how to test for SARS-CoV-2 given its potential to be a primary or coinfecting agent in presentations linked more closely to a traditional virus (e.g. RSV bronchiolitis) will be a test of our clinical judgement until more data and easier testing are available. Further complicating coinfection recognition is the fact that many sick visits occur by telehealth and much testing is done at drive-through SARS-CoV-2 testing facilities with no clinician exam. Unless we are liberal in SARS-CoV-2 testing, detecting SARS-CoV-2 coinfections is easier said than done given its usually mild presentation being overshadowed by any coinfecting virus.
But understanding who has SARS-CoV-2, even as a coinfection, still is essential in controlling the pandemic. We will need to be vigilant for evolving approaches to SARS-CoV-2 testing in the context of symptomatic ARI presentations, knowing this will likely remain a moving target for the foreseeable future.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital-Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at [email protected].
References
1. Pediatrics. 2020;146(1):e20200961.
2. JAMA. 2020 May 26;323(20):2085-6.
3. Pediatrics. 2020. doi: 10.1542/peds.2020-1267.
4. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.
5. J. Pediatr. 2020. doi: 10.1016/j.jpeds.2020.08.007.
6. www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html.
Respiratory virus seasons usually follow a fairly well-known pattern. Enterovirus 68 (EV-D68) is a summer-to-early fall virus with biennial peak years. Rhinovirus (HRv) and adenovirus (Adv) occur nearly year-round but may have small upticks in the first month or so that children return to school. Early in the school year, upper respiratory infections from both HRv and Adv and viral sore throats from Adv are common, with conjunctivitis from Adv outbreaks in some years. October to November is human parainfluenza (HPiV) 1 and 2 season, often presenting as croup. Human metapneumovirus infections span October through April. In late November to December, influenza begins, usually with an A type, later transitioning to a B type in February through April. Also in December, respiratory syncytial virus (RSV) starts, characteristically with bronchiolitis presentations, peaking in February to March and tapering off in May. In late March to April, HPiV 3 also appears for 4-6 weeks.
Will 2020-2021 be different?
Summer was remarkably free of expected enterovirus activity, suggesting that the seasonal parade may differ this year. Remember that the 2019-2020 respiratory season suddenly and nearly completely stopped in March because of social distancing and lockdowns needed to address the SARS-CoV-2 pandemic.
The mild influenza season in the southern hemisphere suggests that our influenza season also could be mild. But perhaps not – most southern hemisphere countries that are surveyed for influenza activities had the most intense SARS-CoV-2 mitigations, making the observed mildness potentially related more to social mitigation than less virulent influenza strains. If so, southern hemisphere influenza data may not apply to the United States, where social distancing and masks are ignored or used inconsistently by almost half the population.
Further, the stop-and-go pattern of in-person school/college attendance adds to uncertainties for the usual orderly virus-specific seasonality. The result may be multiple stop-and-go “pop-up” or “mini” outbreaks for any given virus potentially reflected as exaggerated local or regional differences in circulation of various viruses. The erratic seasonality also would increase coinfections, which could present with more severe or different symptoms.
SARS-CoV-2’s potential interaction
Will the relatively mild presentations for most children with SARS-CoV-2 hold up in the setting of coinfections or sequential respiratory viral infections? Could SARS-CoV-2 cause worse/more prolonged symptoms or more sequelae if paired simultaneously or in tandem with a traditional respiratory virus? To date, data on the frequency and severity of SARS-CoV-2 coinfections are conflicting and sparse, but it appears that non-SARS-CoV-2 viruses can be involved in 15%-50% pediatric acute respiratory infections.1,2
However, it may not be important to know about coinfecting viruses other than influenza (can be treated) or SARS-CoV-2 (needs quarantine and contact tracing), unless symptoms are atypical or more severe than usual. For example, a young child with bronchiolitis is most likely infected with RSV, but HPiV, influenza, metapneumovirus, HRv, and even SARS-CoV-2 can cause bronchiolitis. Even so, testing outpatients for RSV or non-influenza is not routine or even clinically helpful. Supportive treatment and restriction from daycare attendance are sufficient management for outpatient ARIs whether presenting as bronchiolitis or not.
Considerations for SARS-CoV-2 testing: Outpatient bronchiolitis
If a child presents with classic bronchiolitis but has above moderate to severe symptoms, is SARS-CoV-2 a consideration? Perhaps, if SARS-CoV-2 acts similarly to non-SARS-CoV-2s.
A recent report from the 30th Multicenter Airway Research Collaboration (MARC-30) surveillance study (2007-2014) of children hospitalized with clinical bronchiolitis evaluated respiratory viruses, including RSV and the four common non-SARS coronaviruses using molecular testing.3 Among 1,880 subjects, a CoV (alpha CoV: NL63 or 229E, or beta CoV: KKU1 or OC43) was detected in 12%. Yet most had only RSV (n = 1,661); 32 had only CoV (n = 32). But note that 219 had both.
Bronchiolitis subjects with CoV were older – median 3.7 (1.4-5.8) vs. 2.8 (1.9-7.2) years – and more likely male than were RSV subjects (68% vs. 58%). OC43 was most frequent followed by equal numbers of HKU1 and NL63, while 229E was the least frequent. Medical utilization and severity did not differ among the CoVs, or between RSV+CoV vs. RSV alone, unless one considered CoV viral load as a variable. ICU use increased when the polymerase chain reaction cycle threshold result indicated a high CoV viral load.
These data suggest CoVs are not infrequent coinfectors with RSV in bronchiolitis – and that SARS-CoV-2 is the same. Therefore, a bronchiolitis presentation doesn’t necessarily take us off the hook for the need to consider SARS-CoV-2 testing, particularly in the somewhat older bronchiolitis patient with more than mild symptoms.
Considerations for SARS-CoV-2 testing: Outpatient influenza-like illness
In 2020-2021, the Centers for Disease Control and Prevention recommends considering empiric antiviral treatment for ILIs (fever plus either cough or sore throat) based upon our clinical judgement, even in non-high-risk children.4
While pediatric COVID-19 illnesses are predominantly asymptomatic or mild, a febrile ARI is also a SARS-CoV-2 compatible presentation. So, if all we use is our clinical judgment, how do we know if the febrile ARI is due to influenza or SARS-CoV-2 or both? At least one study used a highly sensitive and specific molecular influenza test to show that the accuracy of clinically diagnosing influenza in children is not much better than flipping a coin and would lead to potential antiviral overuse.5
So, it seems ideal to test for influenza when possible. Point-of-care (POC) tests are frequently used for outpatients. Eight POC Clinical Laboratory Improvement Amendments (CLIA)–waived kits, some also detecting RSV, are available but most have modest sensitivity (60%-80%) compared with lab-based molecular tests.6 That said, if supplies and kits for one of the POC tests are available to us during these SARS-CoV-2 stressed times (back orders seem more common this year), a positive influenza test in the first 48 hours of symptoms confirms the option to prescribe an antiviral. Yet how will we have confidence that the febrile ARI is not also partly due to SARS-CoV-2? Currently febrile ARIs usually are considered SARS-CoV-2 and the children are sent for SARS-CoV-2 testing. During influenza season, it seems we will need to continue to send febrile outpatients for SARS-CoV-2 testing, even if POC influenza positive, via whatever mechanisms are available as time goes on.
We expect more rapid pediatric testing modalities for SARS-CoV-2 (maybe even saliva tests) to become available over the next months. Indeed, rapid antigen tests and rapid molecular tests are being evaluated in adults and seem destined for CLIA waivers as POC tests, and even home testing kits. Pediatric approvals hopefully also will occur. So, the pathways for SARS-CoV-2 testing available now will likely change over this winter. But be aware that supplies/kits will be prioritized to locations within high need areas and bulk purchase contracts. So POC kits may remain scarce for practices, meaning a reference laboratory still could be the way to go for SARS-CoV-2 for at least the rest of 2020. Reference labs are becoming creative as well; one combined detection of influenza A, influenza B, RSV, and SARS-CoV-2 into one test, and hopes to get approval for swab collection that can be done by families at home and mailed in.
Summary
Expect variations on the traditional parade of seasonal respiratory viruses, with increased numbers of coinfections. Choosing the outpatient who needs influenza testing is the same as in past years, although we have CDC permissive recommendations to prescribe antivirals for any outpatient ILI within the first 48 hours of symptoms. Still, POC testing for influenza remains potentially valuable in the ILI patient. The choice of whether and how to test for SARS-CoV-2 given its potential to be a primary or coinfecting agent in presentations linked more closely to a traditional virus (e.g. RSV bronchiolitis) will be a test of our clinical judgement until more data and easier testing are available. Further complicating coinfection recognition is the fact that many sick visits occur by telehealth and much testing is done at drive-through SARS-CoV-2 testing facilities with no clinician exam. Unless we are liberal in SARS-CoV-2 testing, detecting SARS-CoV-2 coinfections is easier said than done given its usually mild presentation being overshadowed by any coinfecting virus.
But understanding who has SARS-CoV-2, even as a coinfection, still is essential in controlling the pandemic. We will need to be vigilant for evolving approaches to SARS-CoV-2 testing in the context of symptomatic ARI presentations, knowing this will likely remain a moving target for the foreseeable future.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital-Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at [email protected].
References
1. Pediatrics. 2020;146(1):e20200961.
2. JAMA. 2020 May 26;323(20):2085-6.
3. Pediatrics. 2020. doi: 10.1542/peds.2020-1267.
4. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.
5. J. Pediatr. 2020. doi: 10.1016/j.jpeds.2020.08.007.
6. www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html.
Respiratory virus seasons usually follow a fairly well-known pattern. Enterovirus 68 (EV-D68) is a summer-to-early fall virus with biennial peak years. Rhinovirus (HRv) and adenovirus (Adv) occur nearly year-round but may have small upticks in the first month or so that children return to school. Early in the school year, upper respiratory infections from both HRv and Adv and viral sore throats from Adv are common, with conjunctivitis from Adv outbreaks in some years. October to November is human parainfluenza (HPiV) 1 and 2 season, often presenting as croup. Human metapneumovirus infections span October through April. In late November to December, influenza begins, usually with an A type, later transitioning to a B type in February through April. Also in December, respiratory syncytial virus (RSV) starts, characteristically with bronchiolitis presentations, peaking in February to March and tapering off in May. In late March to April, HPiV 3 also appears for 4-6 weeks.
Will 2020-2021 be different?
Summer was remarkably free of expected enterovirus activity, suggesting that the seasonal parade may differ this year. Remember that the 2019-2020 respiratory season suddenly and nearly completely stopped in March because of social distancing and lockdowns needed to address the SARS-CoV-2 pandemic.
The mild influenza season in the southern hemisphere suggests that our influenza season also could be mild. But perhaps not – most southern hemisphere countries that are surveyed for influenza activities had the most intense SARS-CoV-2 mitigations, making the observed mildness potentially related more to social mitigation than less virulent influenza strains. If so, southern hemisphere influenza data may not apply to the United States, where social distancing and masks are ignored or used inconsistently by almost half the population.
Further, the stop-and-go pattern of in-person school/college attendance adds to uncertainties for the usual orderly virus-specific seasonality. The result may be multiple stop-and-go “pop-up” or “mini” outbreaks for any given virus potentially reflected as exaggerated local or regional differences in circulation of various viruses. The erratic seasonality also would increase coinfections, which could present with more severe or different symptoms.
SARS-CoV-2’s potential interaction
Will the relatively mild presentations for most children with SARS-CoV-2 hold up in the setting of coinfections or sequential respiratory viral infections? Could SARS-CoV-2 cause worse/more prolonged symptoms or more sequelae if paired simultaneously or in tandem with a traditional respiratory virus? To date, data on the frequency and severity of SARS-CoV-2 coinfections are conflicting and sparse, but it appears that non-SARS-CoV-2 viruses can be involved in 15%-50% pediatric acute respiratory infections.1,2
However, it may not be important to know about coinfecting viruses other than influenza (can be treated) or SARS-CoV-2 (needs quarantine and contact tracing), unless symptoms are atypical or more severe than usual. For example, a young child with bronchiolitis is most likely infected with RSV, but HPiV, influenza, metapneumovirus, HRv, and even SARS-CoV-2 can cause bronchiolitis. Even so, testing outpatients for RSV or non-influenza is not routine or even clinically helpful. Supportive treatment and restriction from daycare attendance are sufficient management for outpatient ARIs whether presenting as bronchiolitis or not.
Considerations for SARS-CoV-2 testing: Outpatient bronchiolitis
If a child presents with classic bronchiolitis but has above moderate to severe symptoms, is SARS-CoV-2 a consideration? Perhaps, if SARS-CoV-2 acts similarly to non-SARS-CoV-2s.
A recent report from the 30th Multicenter Airway Research Collaboration (MARC-30) surveillance study (2007-2014) of children hospitalized with clinical bronchiolitis evaluated respiratory viruses, including RSV and the four common non-SARS coronaviruses using molecular testing.3 Among 1,880 subjects, a CoV (alpha CoV: NL63 or 229E, or beta CoV: KKU1 or OC43) was detected in 12%. Yet most had only RSV (n = 1,661); 32 had only CoV (n = 32). But note that 219 had both.
Bronchiolitis subjects with CoV were older – median 3.7 (1.4-5.8) vs. 2.8 (1.9-7.2) years – and more likely male than were RSV subjects (68% vs. 58%). OC43 was most frequent followed by equal numbers of HKU1 and NL63, while 229E was the least frequent. Medical utilization and severity did not differ among the CoVs, or between RSV+CoV vs. RSV alone, unless one considered CoV viral load as a variable. ICU use increased when the polymerase chain reaction cycle threshold result indicated a high CoV viral load.
These data suggest CoVs are not infrequent coinfectors with RSV in bronchiolitis – and that SARS-CoV-2 is the same. Therefore, a bronchiolitis presentation doesn’t necessarily take us off the hook for the need to consider SARS-CoV-2 testing, particularly in the somewhat older bronchiolitis patient with more than mild symptoms.
Considerations for SARS-CoV-2 testing: Outpatient influenza-like illness
In 2020-2021, the Centers for Disease Control and Prevention recommends considering empiric antiviral treatment for ILIs (fever plus either cough or sore throat) based upon our clinical judgement, even in non-high-risk children.4
While pediatric COVID-19 illnesses are predominantly asymptomatic or mild, a febrile ARI is also a SARS-CoV-2 compatible presentation. So, if all we use is our clinical judgment, how do we know if the febrile ARI is due to influenza or SARS-CoV-2 or both? At least one study used a highly sensitive and specific molecular influenza test to show that the accuracy of clinically diagnosing influenza in children is not much better than flipping a coin and would lead to potential antiviral overuse.5
So, it seems ideal to test for influenza when possible. Point-of-care (POC) tests are frequently used for outpatients. Eight POC Clinical Laboratory Improvement Amendments (CLIA)–waived kits, some also detecting RSV, are available but most have modest sensitivity (60%-80%) compared with lab-based molecular tests.6 That said, if supplies and kits for one of the POC tests are available to us during these SARS-CoV-2 stressed times (back orders seem more common this year), a positive influenza test in the first 48 hours of symptoms confirms the option to prescribe an antiviral. Yet how will we have confidence that the febrile ARI is not also partly due to SARS-CoV-2? Currently febrile ARIs usually are considered SARS-CoV-2 and the children are sent for SARS-CoV-2 testing. During influenza season, it seems we will need to continue to send febrile outpatients for SARS-CoV-2 testing, even if POC influenza positive, via whatever mechanisms are available as time goes on.
We expect more rapid pediatric testing modalities for SARS-CoV-2 (maybe even saliva tests) to become available over the next months. Indeed, rapid antigen tests and rapid molecular tests are being evaluated in adults and seem destined for CLIA waivers as POC tests, and even home testing kits. Pediatric approvals hopefully also will occur. So, the pathways for SARS-CoV-2 testing available now will likely change over this winter. But be aware that supplies/kits will be prioritized to locations within high need areas and bulk purchase contracts. So POC kits may remain scarce for practices, meaning a reference laboratory still could be the way to go for SARS-CoV-2 for at least the rest of 2020. Reference labs are becoming creative as well; one combined detection of influenza A, influenza B, RSV, and SARS-CoV-2 into one test, and hopes to get approval for swab collection that can be done by families at home and mailed in.
Summary
Expect variations on the traditional parade of seasonal respiratory viruses, with increased numbers of coinfections. Choosing the outpatient who needs influenza testing is the same as in past years, although we have CDC permissive recommendations to prescribe antivirals for any outpatient ILI within the first 48 hours of symptoms. Still, POC testing for influenza remains potentially valuable in the ILI patient. The choice of whether and how to test for SARS-CoV-2 given its potential to be a primary or coinfecting agent in presentations linked more closely to a traditional virus (e.g. RSV bronchiolitis) will be a test of our clinical judgement until more data and easier testing are available. Further complicating coinfection recognition is the fact that many sick visits occur by telehealth and much testing is done at drive-through SARS-CoV-2 testing facilities with no clinician exam. Unless we are liberal in SARS-CoV-2 testing, detecting SARS-CoV-2 coinfections is easier said than done given its usually mild presentation being overshadowed by any coinfecting virus.
But understanding who has SARS-CoV-2, even as a coinfection, still is essential in controlling the pandemic. We will need to be vigilant for evolving approaches to SARS-CoV-2 testing in the context of symptomatic ARI presentations, knowing this will likely remain a moving target for the foreseeable future.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital-Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at [email protected].
References
1. Pediatrics. 2020;146(1):e20200961.
2. JAMA. 2020 May 26;323(20):2085-6.
3. Pediatrics. 2020. doi: 10.1542/peds.2020-1267.
4. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.
5. J. Pediatr. 2020. doi: 10.1016/j.jpeds.2020.08.007.
6. www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html.