Ob.Gyn. News

If the initial success of the Pfizer-BioNTech rollout continues, and emergency use authorization (EAU) is granted to Moderna and Johnson & Johnson vaccines in development, Operation Warp Speed officials expect to have 300 million doses of COVID-19 vaccines to distribute across the United States between now and March 31.

The initial rollout remains on track, said Alex Azar, US Department of Health and Human Services (HHS) secretary, during a media briefing today. “We continue to have good news to report. As of today, shipments of vaccine will have been delivered to every delivery site identified by public health jurisdictions for our first wave of shipments.”

Anomalies in shipments to California and Alabama arose when temperature monitors showed the Pfizer vaccine dropped lower than the recommended -80 ºC (-112 °F). These vaccine trays remained on delivery trucks and were returned to Pfizer for prompt replacement, said Operation Warp Speed Chief Operating Officer Gen. Gustave F. Perna.

Azar estimated another 2 million doses of the Pfizer vaccine will be available next week. “And if the Moderna vaccine is authorized by the FDA in the coming days, we have allocated nearly 5.9 million doses of that product.”

The Moderna vaccine data released this week look promising, said Moncef Slaoui, PhD, Operation Warp Speed chief scientific adviser. “In the short term, I expect the protection to be quite significant.”

The findings in the first 2 weeks after the first dose show up to 65% protection, he said, and predicted the second-dose efficacy data will be coming in the next few weeks.

Enrollment in the phase 3 Johnson & Johnson trial with nearly 44,000 participants is expected to end December 17. Initial efficacy results are anticipated by early January, with more complete efficacy numbers by late January, Slaoui said.

The AstraZeneca COVID-19 vaccine trial also is underway with enrollment continuing. “We expect accruement to end in late December or early next year, with first results expected probably in February,” Slaoui said.
 

Antibody treatments underutilized

The media briefing also addressed COVID-19 therapeutics. Azar reported low uptake of available antibody therapies. “I want to remind Americans that there are two authorized antibody treatments that Operation Warp Speed has supported. They can help prevent hospitalization in those patients with the highest risk for severe disease.”

The higher-risk group includes those who are 65 and older and people with comorbid conditions that put them at increased risk for COVID-19 hospitalization.

The federal government allocated more than 330,000 doses of these treatments and many states have product available, Azar said.

Slaoui agreed, saying there is a “disappointing level of usage of monoclonal antibody therapy in hospitals. We look forward to that improving.”
 

Up to 3 billion vaccine doses possible

“We now have more than 900 million doses of the vaccine we have contracted delivery for,” Azar said. The government has options to increase that to a total of 3 billion doses.

In addition to the 100 million Pfizer vaccine doses and 100 million Moderna doses already ordered, the government just took an option for another 100 million Moderna doses for the second quarter of 2021. Operation Warp Speed officials are negotiating with Pfizer for additional product as well.

Azar added that there are 100 million doses of the Johnson & Johnson vaccine in active production and expects AstraZeneca can provide 300 million doses of their product.

With the possibility of three or more vaccine products and with 330 million Americans, minus the 70 million or so children under age 16, “we believe we will actually have surplus supplies,” Azar said. Plans are to take the US surplus vaccine and surplus manufacturing capacity “and use that for the benefit of the world community.”

This article first appeared on Medscape.com.

If the initial success of the Pfizer-BioNTech rollout continues, and emergency use authorization (EAU) is granted to Moderna and Johnson & Johnson vaccines in development, Operation Warp Speed officials expect to have 300 million doses of COVID-19 vaccines to distribute across the United States between now and March 31.

The initial rollout remains on track, said Alex Azar, US Department of Health and Human Services (HHS) secretary, during a media briefing today. “We continue to have good news to report. As of today, shipments of vaccine will have been delivered to every delivery site identified by public health jurisdictions for our first wave of shipments.”

Anomalies in shipments to California and Alabama arose when temperature monitors showed the Pfizer vaccine dropped lower than the recommended -80 ºC (-112 °F). These vaccine trays remained on delivery trucks and were returned to Pfizer for prompt replacement, said Operation Warp Speed Chief Operating Officer Gen. Gustave F. Perna.

Azar estimated another 2 million doses of the Pfizer vaccine will be available next week. “And if the Moderna vaccine is authorized by the FDA in the coming days, we have allocated nearly 5.9 million doses of that product.”

The Moderna vaccine data released this week look promising, said Moncef Slaoui, PhD, Operation Warp Speed chief scientific adviser. “In the short term, I expect the protection to be quite significant.”

The findings in the first 2 weeks after the first dose show up to 65% protection, he said, and predicted the second-dose efficacy data will be coming in the next few weeks.

Enrollment in the phase 3 Johnson & Johnson trial with nearly 44,000 participants is expected to end December 17. Initial efficacy results are anticipated by early January, with more complete efficacy numbers by late January, Slaoui said.

The AstraZeneca COVID-19 vaccine trial also is underway with enrollment continuing. “We expect accruement to end in late December or early next year, with first results expected probably in February,” Slaoui said.
 

Antibody treatments underutilized

The media briefing also addressed COVID-19 therapeutics. Azar reported low uptake of available antibody therapies. “I want to remind Americans that there are two authorized antibody treatments that Operation Warp Speed has supported. They can help prevent hospitalization in those patients with the highest risk for severe disease.”

The higher-risk group includes those who are 65 and older and people with comorbid conditions that put them at increased risk for COVID-19 hospitalization.

The federal government allocated more than 330,000 doses of these treatments and many states have product available, Azar said.

Slaoui agreed, saying there is a “disappointing level of usage of monoclonal antibody therapy in hospitals. We look forward to that improving.”
 

Up to 3 billion vaccine doses possible

“We now have more than 900 million doses of the vaccine we have contracted delivery for,” Azar said. The government has options to increase that to a total of 3 billion doses.

In addition to the 100 million Pfizer vaccine doses and 100 million Moderna doses already ordered, the government just took an option for another 100 million Moderna doses for the second quarter of 2021. Operation Warp Speed officials are negotiating with Pfizer for additional product as well.

Azar added that there are 100 million doses of the Johnson & Johnson vaccine in active production and expects AstraZeneca can provide 300 million doses of their product.

With the possibility of three or more vaccine products and with 330 million Americans, minus the 70 million or so children under age 16, “we believe we will actually have surplus supplies,” Azar said. Plans are to take the US surplus vaccine and surplus manufacturing capacity “and use that for the benefit of the world community.”

This article first appeared on Medscape.com.

If the initial success of the Pfizer-BioNTech rollout continues, and emergency use authorization (EAU) is granted to Moderna and Johnson & Johnson vaccines in development, Operation Warp Speed officials expect to have 300 million doses of COVID-19 vaccines to distribute across the United States between now and March 31.

The initial rollout remains on track, said Alex Azar, US Department of Health and Human Services (HHS) secretary, during a media briefing today. “We continue to have good news to report. As of today, shipments of vaccine will have been delivered to every delivery site identified by public health jurisdictions for our first wave of shipments.”

Anomalies in shipments to California and Alabama arose when temperature monitors showed the Pfizer vaccine dropped lower than the recommended -80 ºC (-112 °F). These vaccine trays remained on delivery trucks and were returned to Pfizer for prompt replacement, said Operation Warp Speed Chief Operating Officer Gen. Gustave F. Perna.

Azar estimated another 2 million doses of the Pfizer vaccine will be available next week. “And if the Moderna vaccine is authorized by the FDA in the coming days, we have allocated nearly 5.9 million doses of that product.”

The Moderna vaccine data released this week look promising, said Moncef Slaoui, PhD, Operation Warp Speed chief scientific adviser. “In the short term, I expect the protection to be quite significant.”

The findings in the first 2 weeks after the first dose show up to 65% protection, he said, and predicted the second-dose efficacy data will be coming in the next few weeks.

Enrollment in the phase 3 Johnson & Johnson trial with nearly 44,000 participants is expected to end December 17. Initial efficacy results are anticipated by early January, with more complete efficacy numbers by late January, Slaoui said.

The AstraZeneca COVID-19 vaccine trial also is underway with enrollment continuing. “We expect accruement to end in late December or early next year, with first results expected probably in February,” Slaoui said.
 

Antibody treatments underutilized

The media briefing also addressed COVID-19 therapeutics. Azar reported low uptake of available antibody therapies. “I want to remind Americans that there are two authorized antibody treatments that Operation Warp Speed has supported. They can help prevent hospitalization in those patients with the highest risk for severe disease.”

The higher-risk group includes those who are 65 and older and people with comorbid conditions that put them at increased risk for COVID-19 hospitalization.

The federal government allocated more than 330,000 doses of these treatments and many states have product available, Azar said.

Slaoui agreed, saying there is a “disappointing level of usage of monoclonal antibody therapy in hospitals. We look forward to that improving.”
 

Up to 3 billion vaccine doses possible

“We now have more than 900 million doses of the vaccine we have contracted delivery for,” Azar said. The government has options to increase that to a total of 3 billion doses.

In addition to the 100 million Pfizer vaccine doses and 100 million Moderna doses already ordered, the government just took an option for another 100 million Moderna doses for the second quarter of 2021. Operation Warp Speed officials are negotiating with Pfizer for additional product as well.

Azar added that there are 100 million doses of the Johnson & Johnson vaccine in active production and expects AstraZeneca can provide 300 million doses of their product.

With the possibility of three or more vaccine products and with 330 million Americans, minus the 70 million or so children under age 16, “we believe we will actually have surplus supplies,” Azar said. Plans are to take the US surplus vaccine and surplus manufacturing capacity “and use that for the benefit of the world community.”

This article first appeared on Medscape.com.

COVID-19 became a leading cause of death in the United States in 2020, particularly for people over age 35, according to a new report published in JAMA on Thursday.

Adults over age 45 were more likely to die from COVID-19 than car crashes, respiratory diseases, drug overdoses, and suicide. And those over age 55 faced even higher rates of dying because of the coronavirus.

“The current exponential increase in COVID-19 is reaching a calamitous scale in the U.S.,” the authors wrote. “Putting these numbers in perspective may be difficult.”

Population health researchers at Virginia Commonwealth University put COVID-19 deaths into context by comparing this year’s numbers to the leading causes of death for March through October 2018, sorting by age.

By October 2020, COVID-19 had become the third leading cause of death overall for those between the ages of 45 and 84 years, following after heart disease and cancer. For those over age 85, COVID-19 was the second leading cause of death, surpassing cancer and following behind heart disease.

For people aged 35-44 years, COVID-19 surpassed car crashes and respiratory diseases and was slightly lower than suicide, heart disease, and cancer. For those under age 35, drug overdoses, suicide, and car crashes remained the leading causes of death.

Importantly, the authors wrote, death rates for the two leading causes – heart disease and cancer – are about 1,700 and 1,600 per day, respectively. COVID-19 deaths have surpassed these numbers individually throughout December and, on Wednesday, beat them combined. More than 3,400 deaths were reported, according to the COVID Tracking Project, marking an all-time high that continues to increase. Hospitalizations were also at a new high, with more than 113,000 COVID-19 patients in hospitals across the country, and another 232,000 new cases were reported.

“With COVID-19 mortality rates now exceeding these thresholds, this infectious disease has become deadlier than heart disease and cancer,” the authors wrote. “Its lethality may increase further as transmission increases with holiday travel and gatherings and with the intensified indoor exposure that winter brings.”

The reported number of COVID-19 deaths is likely a 20% underestimate, they wrote, attributable to delays in reporting and an increase in non–COVID-19 deaths that were undetected and untreated because of pandemic-related disruptions. Since the coronavirus is communicable and spreads easily, COVID-19 deaths are particularly unique and worrying, they said.

“Individuals who die from homicide or cancer do not transmit the risk of morbidity and mortality to those nearby,” they wrote. “Every COVID-19 death signals the possibility of more deaths among close contacts.”

The fall surge in cases and deaths is widespread nationally, as compared to the spring, with hot spots on both coasts and in rural areas, according to an accompanying editorial in JAMA from public health researchers at the Harvard T.H. Chan School of Public Health, Boston. People of color have faced twice the death rate as well, with one in 875 Black people and one in 925 Indigenous people dying from COVID-19, as compared with one in 1,625 White people.

“The year 2020 ends with COVID-19 massively surging, as it was in the spring, to be the leading cause of death,” they wrote. “The accelerating numbers of deaths fall far short of fully capturing each devastating human story: Every death represents untold loss for countless families.”

Vaccines offer hope, they said, but won’t prevent the upcoming increase in COVID-19 hospitalizations and deaths this winter. In 2021, containing the pandemic will require national coordination, resources to help overwhelmed health care workers, new support for state and local public health officials, a stimulus package for schools and businesses, and financial aid for people on the brink of eviction. The country needs federal coordination of testing, contact tracing, personal protective equipment, travel precautions, and a face mask mandate, they wrote.

“Ending this crisis will require not only further advances in treatment but also unprecedented commitment to all aspects of prevention, vaccination, and public health,” they wrote. “Only by doing so can future years see this illness revert back to the unfamiliar and unknown condition it once was.”

This article first appeared on WebMD.com.

COVID-19 became a leading cause of death in the United States in 2020, particularly for people over age 35, according to a new report published in JAMA on Thursday.

Adults over age 45 were more likely to die from COVID-19 than car crashes, respiratory diseases, drug overdoses, and suicide. And those over age 55 faced even higher rates of dying because of the coronavirus.

“The current exponential increase in COVID-19 is reaching a calamitous scale in the U.S.,” the authors wrote. “Putting these numbers in perspective may be difficult.”

Population health researchers at Virginia Commonwealth University put COVID-19 deaths into context by comparing this year’s numbers to the leading causes of death for March through October 2018, sorting by age.

By October 2020, COVID-19 had become the third leading cause of death overall for those between the ages of 45 and 84 years, following after heart disease and cancer. For those over age 85, COVID-19 was the second leading cause of death, surpassing cancer and following behind heart disease.

For people aged 35-44 years, COVID-19 surpassed car crashes and respiratory diseases and was slightly lower than suicide, heart disease, and cancer. For those under age 35, drug overdoses, suicide, and car crashes remained the leading causes of death.

Importantly, the authors wrote, death rates for the two leading causes – heart disease and cancer – are about 1,700 and 1,600 per day, respectively. COVID-19 deaths have surpassed these numbers individually throughout December and, on Wednesday, beat them combined. More than 3,400 deaths were reported, according to the COVID Tracking Project, marking an all-time high that continues to increase. Hospitalizations were also at a new high, with more than 113,000 COVID-19 patients in hospitals across the country, and another 232,000 new cases were reported.

“With COVID-19 mortality rates now exceeding these thresholds, this infectious disease has become deadlier than heart disease and cancer,” the authors wrote. “Its lethality may increase further as transmission increases with holiday travel and gatherings and with the intensified indoor exposure that winter brings.”

The reported number of COVID-19 deaths is likely a 20% underestimate, they wrote, attributable to delays in reporting and an increase in non–COVID-19 deaths that were undetected and untreated because of pandemic-related disruptions. Since the coronavirus is communicable and spreads easily, COVID-19 deaths are particularly unique and worrying, they said.

“Individuals who die from homicide or cancer do not transmit the risk of morbidity and mortality to those nearby,” they wrote. “Every COVID-19 death signals the possibility of more deaths among close contacts.”

The fall surge in cases and deaths is widespread nationally, as compared to the spring, with hot spots on both coasts and in rural areas, according to an accompanying editorial in JAMA from public health researchers at the Harvard T.H. Chan School of Public Health, Boston. People of color have faced twice the death rate as well, with one in 875 Black people and one in 925 Indigenous people dying from COVID-19, as compared with one in 1,625 White people.

“The year 2020 ends with COVID-19 massively surging, as it was in the spring, to be the leading cause of death,” they wrote. “The accelerating numbers of deaths fall far short of fully capturing each devastating human story: Every death represents untold loss for countless families.”

Vaccines offer hope, they said, but won’t prevent the upcoming increase in COVID-19 hospitalizations and deaths this winter. In 2021, containing the pandemic will require national coordination, resources to help overwhelmed health care workers, new support for state and local public health officials, a stimulus package for schools and businesses, and financial aid for people on the brink of eviction. The country needs federal coordination of testing, contact tracing, personal protective equipment, travel precautions, and a face mask mandate, they wrote.

“Ending this crisis will require not only further advances in treatment but also unprecedented commitment to all aspects of prevention, vaccination, and public health,” they wrote. “Only by doing so can future years see this illness revert back to the unfamiliar and unknown condition it once was.”

This article first appeared on WebMD.com.

COVID-19 became a leading cause of death in the United States in 2020, particularly for people over age 35, according to a new report published in JAMA on Thursday.

Adults over age 45 were more likely to die from COVID-19 than car crashes, respiratory diseases, drug overdoses, and suicide. And those over age 55 faced even higher rates of dying because of the coronavirus.

“The current exponential increase in COVID-19 is reaching a calamitous scale in the U.S.,” the authors wrote. “Putting these numbers in perspective may be difficult.”

Population health researchers at Virginia Commonwealth University put COVID-19 deaths into context by comparing this year’s numbers to the leading causes of death for March through October 2018, sorting by age.

By October 2020, COVID-19 had become the third leading cause of death overall for those between the ages of 45 and 84 years, following after heart disease and cancer. For those over age 85, COVID-19 was the second leading cause of death, surpassing cancer and following behind heart disease.

For people aged 35-44 years, COVID-19 surpassed car crashes and respiratory diseases and was slightly lower than suicide, heart disease, and cancer. For those under age 35, drug overdoses, suicide, and car crashes remained the leading causes of death.

Importantly, the authors wrote, death rates for the two leading causes – heart disease and cancer – are about 1,700 and 1,600 per day, respectively. COVID-19 deaths have surpassed these numbers individually throughout December and, on Wednesday, beat them combined. More than 3,400 deaths were reported, according to the COVID Tracking Project, marking an all-time high that continues to increase. Hospitalizations were also at a new high, with more than 113,000 COVID-19 patients in hospitals across the country, and another 232,000 new cases were reported.

“With COVID-19 mortality rates now exceeding these thresholds, this infectious disease has become deadlier than heart disease and cancer,” the authors wrote. “Its lethality may increase further as transmission increases with holiday travel and gatherings and with the intensified indoor exposure that winter brings.”

The reported number of COVID-19 deaths is likely a 20% underestimate, they wrote, attributable to delays in reporting and an increase in non–COVID-19 deaths that were undetected and untreated because of pandemic-related disruptions. Since the coronavirus is communicable and spreads easily, COVID-19 deaths are particularly unique and worrying, they said.

“Individuals who die from homicide or cancer do not transmit the risk of morbidity and mortality to those nearby,” they wrote. “Every COVID-19 death signals the possibility of more deaths among close contacts.”

The fall surge in cases and deaths is widespread nationally, as compared to the spring, with hot spots on both coasts and in rural areas, according to an accompanying editorial in JAMA from public health researchers at the Harvard T.H. Chan School of Public Health, Boston. People of color have faced twice the death rate as well, with one in 875 Black people and one in 925 Indigenous people dying from COVID-19, as compared with one in 1,625 White people.

“The year 2020 ends with COVID-19 massively surging, as it was in the spring, to be the leading cause of death,” they wrote. “The accelerating numbers of deaths fall far short of fully capturing each devastating human story: Every death represents untold loss for countless families.”

Vaccines offer hope, they said, but won’t prevent the upcoming increase in COVID-19 hospitalizations and deaths this winter. In 2021, containing the pandemic will require national coordination, resources to help overwhelmed health care workers, new support for state and local public health officials, a stimulus package for schools and businesses, and financial aid for people on the brink of eviction. The country needs federal coordination of testing, contact tracing, personal protective equipment, travel precautions, and a face mask mandate, they wrote.

“Ending this crisis will require not only further advances in treatment but also unprecedented commitment to all aspects of prevention, vaccination, and public health,” they wrote. “Only by doing so can future years see this illness revert back to the unfamiliar and unknown condition it once was.”

This article first appeared on WebMD.com.

Rheumatoid arthritis patients who are on both oral glucocorticoids (CGs) and proton pump inhibitors (PPIs) have an increased risk of osteoporotic fractures, according to a retrospective study of RA patients in the United Kingdom.

“Considering the increasing life expectancies and high consumption of PPIs among elderly patients, fracture risk assessment could be considered when a patient with RA is co-prescribed oral GCs and PPIs,” wrote Shahab Abtahi, MD, of Maastricht (Netherlands) University Medical Centre and colleagues. The study was published in Annals of the Rheumatic Diseases.

To determine if concomitant use of the two medications – both already associated with osteoporotic fractures – would lead to a notable increase in fracture risk, the researchers conducted a population-based cohort study of RA patients aged 50 years or older who were diagnosed during 1997-2017. Patient data was gathered via the Clinical Practice Research Datalink, a primary care database of millions of U.K. medical records.

Patients with a recent history of GC/PPI use or those with a previous osteoporotic fracture were excluded from the study. Osteoporotic fractures were defined as fractures of the hip, vertebrae, humerus, forearm, pelvis, or rib. The study population included 12,351 patients, roughly two-thirds of whom were women, with a mean age of 68 years. Of the population, 4,254 patients were concomitant users of oral GCs and PPIs, compared with 3,138 patients who were not on either medication.

Among all patients, 1,411 osteoporotic fractures occurred, 264 of which occurred in the concomitant users group. After adjustments for age and sex, patients on both medications had a higher risk of fracture (adjusted hazard ratio, 1.93; 95% confidence interval, 1.65-2.27), compared to patients on oral GCs alone (aHR, 1.34; 95% CI, 1.12-1.59) or PPIs alone (aHR, 1.32; 95% CI, 1.14-1.54). After full adjustment, concomitant users again had a higher risk of fracture (aHR, 1.60; 95% CI, 1.35-1.89).

Regarding specific types of breaks, the concomitant users had a notably higher risk of hip (aHR, 1.45; 95% CI, 1.11-1.91), vertebrae (aHR, 2.84; 95% CI, 1.87-4.32), pelvis (aHR, 2.47; 95% CI, 1.41-4.34), and rib fractures (aHR, 4.03; 95% CI, 2.13-7.63). No increased risk was found for either humerus or forearm fractures. The risk of fracture did not rise for concomitant users who had either increasing daily doses of PPI or a longer duration of use.

The authors noted their study’s potential limitations, including having access to data on prescriptions only, not the actual use of medication, and a lack of information in the medical records regarding biologic therapies or certain indicators of RA disease activity. In addition, there was a likelihood that some patients who were improving might have stopped taking the drugs and lessened their risk of fracture, though the researchers attempted to account for this by “adjusting our analyses for six indicators of RA severity, including analgesics and csDMARDs.”

Two of the authors reported receiving research grants and speakers’ fees from various pharmaceutical companies. The others reported no conflicts of interest.

SOURCE: Abtahi S et al. Ann Rheum Dis. 2020 Dec 11. doi: 10.1136/annrheumdis-2020-218758.

Rheumatoid arthritis patients who are on both oral glucocorticoids (CGs) and proton pump inhibitors (PPIs) have an increased risk of osteoporotic fractures, according to a retrospective study of RA patients in the United Kingdom.

“Considering the increasing life expectancies and high consumption of PPIs among elderly patients, fracture risk assessment could be considered when a patient with RA is co-prescribed oral GCs and PPIs,” wrote Shahab Abtahi, MD, of Maastricht (Netherlands) University Medical Centre and colleagues. The study was published in Annals of the Rheumatic Diseases.

To determine if concomitant use of the two medications – both already associated with osteoporotic fractures – would lead to a notable increase in fracture risk, the researchers conducted a population-based cohort study of RA patients aged 50 years or older who were diagnosed during 1997-2017. Patient data was gathered via the Clinical Practice Research Datalink, a primary care database of millions of U.K. medical records.

Patients with a recent history of GC/PPI use or those with a previous osteoporotic fracture were excluded from the study. Osteoporotic fractures were defined as fractures of the hip, vertebrae, humerus, forearm, pelvis, or rib. The study population included 12,351 patients, roughly two-thirds of whom were women, with a mean age of 68 years. Of the population, 4,254 patients were concomitant users of oral GCs and PPIs, compared with 3,138 patients who were not on either medication.

Among all patients, 1,411 osteoporotic fractures occurred, 264 of which occurred in the concomitant users group. After adjustments for age and sex, patients on both medications had a higher risk of fracture (adjusted hazard ratio, 1.93; 95% confidence interval, 1.65-2.27), compared to patients on oral GCs alone (aHR, 1.34; 95% CI, 1.12-1.59) or PPIs alone (aHR, 1.32; 95% CI, 1.14-1.54). After full adjustment, concomitant users again had a higher risk of fracture (aHR, 1.60; 95% CI, 1.35-1.89).

Regarding specific types of breaks, the concomitant users had a notably higher risk of hip (aHR, 1.45; 95% CI, 1.11-1.91), vertebrae (aHR, 2.84; 95% CI, 1.87-4.32), pelvis (aHR, 2.47; 95% CI, 1.41-4.34), and rib fractures (aHR, 4.03; 95% CI, 2.13-7.63). No increased risk was found for either humerus or forearm fractures. The risk of fracture did not rise for concomitant users who had either increasing daily doses of PPI or a longer duration of use.

The authors noted their study’s potential limitations, including having access to data on prescriptions only, not the actual use of medication, and a lack of information in the medical records regarding biologic therapies or certain indicators of RA disease activity. In addition, there was a likelihood that some patients who were improving might have stopped taking the drugs and lessened their risk of fracture, though the researchers attempted to account for this by “adjusting our analyses for six indicators of RA severity, including analgesics and csDMARDs.”

Two of the authors reported receiving research grants and speakers’ fees from various pharmaceutical companies. The others reported no conflicts of interest.

SOURCE: Abtahi S et al. Ann Rheum Dis. 2020 Dec 11. doi: 10.1136/annrheumdis-2020-218758.

Rheumatoid arthritis patients who are on both oral glucocorticoids (CGs) and proton pump inhibitors (PPIs) have an increased risk of osteoporotic fractures, according to a retrospective study of RA patients in the United Kingdom.

“Considering the increasing life expectancies and high consumption of PPIs among elderly patients, fracture risk assessment could be considered when a patient with RA is co-prescribed oral GCs and PPIs,” wrote Shahab Abtahi, MD, of Maastricht (Netherlands) University Medical Centre and colleagues. The study was published in Annals of the Rheumatic Diseases.

To determine if concomitant use of the two medications – both already associated with osteoporotic fractures – would lead to a notable increase in fracture risk, the researchers conducted a population-based cohort study of RA patients aged 50 years or older who were diagnosed during 1997-2017. Patient data was gathered via the Clinical Practice Research Datalink, a primary care database of millions of U.K. medical records.

Patients with a recent history of GC/PPI use or those with a previous osteoporotic fracture were excluded from the study. Osteoporotic fractures were defined as fractures of the hip, vertebrae, humerus, forearm, pelvis, or rib. The study population included 12,351 patients, roughly two-thirds of whom were women, with a mean age of 68 years. Of the population, 4,254 patients were concomitant users of oral GCs and PPIs, compared with 3,138 patients who were not on either medication.

Among all patients, 1,411 osteoporotic fractures occurred, 264 of which occurred in the concomitant users group. After adjustments for age and sex, patients on both medications had a higher risk of fracture (adjusted hazard ratio, 1.93; 95% confidence interval, 1.65-2.27), compared to patients on oral GCs alone (aHR, 1.34; 95% CI, 1.12-1.59) or PPIs alone (aHR, 1.32; 95% CI, 1.14-1.54). After full adjustment, concomitant users again had a higher risk of fracture (aHR, 1.60; 95% CI, 1.35-1.89).

Regarding specific types of breaks, the concomitant users had a notably higher risk of hip (aHR, 1.45; 95% CI, 1.11-1.91), vertebrae (aHR, 2.84; 95% CI, 1.87-4.32), pelvis (aHR, 2.47; 95% CI, 1.41-4.34), and rib fractures (aHR, 4.03; 95% CI, 2.13-7.63). No increased risk was found for either humerus or forearm fractures. The risk of fracture did not rise for concomitant users who had either increasing daily doses of PPI or a longer duration of use.

The authors noted their study’s potential limitations, including having access to data on prescriptions only, not the actual use of medication, and a lack of information in the medical records regarding biologic therapies or certain indicators of RA disease activity. In addition, there was a likelihood that some patients who were improving might have stopped taking the drugs and lessened their risk of fracture, though the researchers attempted to account for this by “adjusting our analyses for six indicators of RA severity, including analgesics and csDMARDs.”

Two of the authors reported receiving research grants and speakers’ fees from various pharmaceutical companies. The others reported no conflicts of interest.

SOURCE: Abtahi S et al. Ann Rheum Dis. 2020 Dec 11. doi: 10.1136/annrheumdis-2020-218758.

Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.

scyther5/thinkstock

The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.

At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.

In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”

That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.

“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”
 

Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”

Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”

However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.

The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.


 

COVID-19 vaccines

Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.

But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.

In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.

The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.

“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”

Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.

It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.

According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.

As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?


 

Risk vs. benefit

Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.

“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”

The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”

That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”

Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”

So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.

“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
 

No waiting needed

Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.

“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”

However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”

Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.

The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.

He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.

Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”

He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”


 

Boosting efficacy

Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”

With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”

As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”

There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”

The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”

Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”

Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”

Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”

Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”

He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”

The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”
 

*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.

Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.

scyther5/thinkstock

The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.

At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.

In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”

That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.

“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”
 

Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”

Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”

However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.

The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.


 

COVID-19 vaccines

Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.

But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.

In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.

The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.

“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”

Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.

It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.

According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.

As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?


 

Risk vs. benefit

Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.

“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”

The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”

That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”

Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”

So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.

“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
 

No waiting needed

Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.

“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”

However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”

Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.

The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.

He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.

Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”

He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”


 

Boosting efficacy

Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”

With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”

As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”

There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”

The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”

Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”

Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”

Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”

Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”

He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”

The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”
 

*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.

Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.

scyther5/thinkstock

The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.

At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.

In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”

That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.

“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”
 

Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”

Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”

However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.

The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.


 

COVID-19 vaccines

Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.

But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.

In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.

The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.

“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”

Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.

It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.

According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.

As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?


 

Risk vs. benefit

Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.

“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”

The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”

That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”

Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”

So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.

“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
 

No waiting needed

Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.

“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”

However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”

Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.

The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.

He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.

Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”

He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”


 

Boosting efficacy

Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”

With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”

As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”

There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”

The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”

Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”

Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”

Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”

Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”

He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”

The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”
 

*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.

The Food and Drug Administration has issued an emergency-use authorization (EUA) for the first COVID-19 diagnostic test that can be completed at home without a prescription.

Authorization of the Ellume COVID-19 Home Test is “a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen M. Hahn, MD, said in a news release.

“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” said Dr. Hahn.

The Ellume COVID-19 Home Test is a rapid antigen test that detects fragments of the SARS-CoV-2 virus from a nasal swab sample taken from anyone aged 2 years and older, including those not showing any symptoms.

In testing, the Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms.

In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples, the FDA said.

The test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with an app on the user’s smartphone. The sample is analyzed and results are automatically transmitted to the user’s smartphone.

“The Ellume COVID-19 home test’s core technology combines ultra-sensitive optics, electronics, and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology,” the company said in a news release.

The mobile app requires individuals to input their ZIP code and date of birth, with optional fields including name and email address. The app automatically reports the results as appropriate to public health authorities to monitor disease prevalence.

Ellume expects to produce more than 3 million tests in January 2021. The company said the test will cost around $30.

FDA authorization of this first fully at-home nonprescription COVID-19 diagnostic test follows last month’s EUA for the first prescription COVID-19 test for home use, as reported this news organization.

Since the start of the pandemic, the FDA has authorized more than 225 diagnostic tests for COVID-19, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Dr. Hahn said.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in the release. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

As with other antigen tests, a small percentage of positive and negative results from the Ellume test may be false. In patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible, the FDA advised.

This is especially true if there are fewer infections in a particular community, as false-positive results can be more common when antigen tests are used in populations where there is a low prevalence of COVID-19, the agency said.

Because all tests can give false-negative and false-positive results, individuals with positive results should self-isolate and seek additional care from their health care provider.

Individuals who test negative and have symptoms of COVID-19 should follow up with their health care provider, as negative results don’t preclude an individual from SARS-CoV-2 infection.

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

The Food and Drug Administration has issued an emergency-use authorization (EUA) for the first COVID-19 diagnostic test that can be completed at home without a prescription.

Authorization of the Ellume COVID-19 Home Test is “a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen M. Hahn, MD, said in a news release.

“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” said Dr. Hahn.

The Ellume COVID-19 Home Test is a rapid antigen test that detects fragments of the SARS-CoV-2 virus from a nasal swab sample taken from anyone aged 2 years and older, including those not showing any symptoms.

In testing, the Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms.

In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples, the FDA said.

The test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with an app on the user’s smartphone. The sample is analyzed and results are automatically transmitted to the user’s smartphone.

“The Ellume COVID-19 home test’s core technology combines ultra-sensitive optics, electronics, and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology,” the company said in a news release.

The mobile app requires individuals to input their ZIP code and date of birth, with optional fields including name and email address. The app automatically reports the results as appropriate to public health authorities to monitor disease prevalence.

Ellume expects to produce more than 3 million tests in January 2021. The company said the test will cost around $30.

FDA authorization of this first fully at-home nonprescription COVID-19 diagnostic test follows last month’s EUA for the first prescription COVID-19 test for home use, as reported this news organization.

Since the start of the pandemic, the FDA has authorized more than 225 diagnostic tests for COVID-19, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Dr. Hahn said.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in the release. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

As with other antigen tests, a small percentage of positive and negative results from the Ellume test may be false. In patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible, the FDA advised.

This is especially true if there are fewer infections in a particular community, as false-positive results can be more common when antigen tests are used in populations where there is a low prevalence of COVID-19, the agency said.

Because all tests can give false-negative and false-positive results, individuals with positive results should self-isolate and seek additional care from their health care provider.

Individuals who test negative and have symptoms of COVID-19 should follow up with their health care provider, as negative results don’t preclude an individual from SARS-CoV-2 infection.

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

The Food and Drug Administration has issued an emergency-use authorization (EUA) for the first COVID-19 diagnostic test that can be completed at home without a prescription.

Authorization of the Ellume COVID-19 Home Test is “a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen M. Hahn, MD, said in a news release.

“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” said Dr. Hahn.

The Ellume COVID-19 Home Test is a rapid antigen test that detects fragments of the SARS-CoV-2 virus from a nasal swab sample taken from anyone aged 2 years and older, including those not showing any symptoms.

In testing, the Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms.

In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples, the FDA said.

The test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with an app on the user’s smartphone. The sample is analyzed and results are automatically transmitted to the user’s smartphone.

“The Ellume COVID-19 home test’s core technology combines ultra-sensitive optics, electronics, and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology,” the company said in a news release.

The mobile app requires individuals to input their ZIP code and date of birth, with optional fields including name and email address. The app automatically reports the results as appropriate to public health authorities to monitor disease prevalence.

Ellume expects to produce more than 3 million tests in January 2021. The company said the test will cost around $30.

FDA authorization of this first fully at-home nonprescription COVID-19 diagnostic test follows last month’s EUA for the first prescription COVID-19 test for home use, as reported this news organization.

Since the start of the pandemic, the FDA has authorized more than 225 diagnostic tests for COVID-19, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Dr. Hahn said.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in the release. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

As with other antigen tests, a small percentage of positive and negative results from the Ellume test may be false. In patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible, the FDA advised.

This is especially true if there are fewer infections in a particular community, as false-positive results can be more common when antigen tests are used in populations where there is a low prevalence of COVID-19, the agency said.

Because all tests can give false-negative and false-positive results, individuals with positive results should self-isolate and seek additional care from their health care provider.

Individuals who test negative and have symptoms of COVID-19 should follow up with their health care provider, as negative results don’t preclude an individual from SARS-CoV-2 infection.

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

Science should be the cornerstone for health policy, and decisions on medical care of transgender and gender-diverse (TGD) individuals should be between a patient and their doctor.

That’s according to a joint policy statement from the Endocrine Society and Pediatric Endocrine Society published in the Journal of Clinical Endocrinology & Metabolism expressing concern about recent proposed legislation that would limit access to medical care for TGD individuals.

“The main emphasis is that we are simply medical people trying to be conservative and science driven in the care of our patients,” Joshua D. Safer, MD, coauthor and executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System, and professor of medicine at Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Why the health care for a particular group of people should be considered political is a mystery to me.”

TGD individuals have seen a recent uptick in efforts to limit or restrict their access to medical care at the federal and state levels. In June 2020, the Department of Health & Human Services finalized a revision to Section 1557 of the Affordable Care Act, rolling back a 2016 rule that determined the phrase “on the basis of sex” included nondiscrimination based on a person’s sex and gender identity. The Endocrine Society opposed this rule revision, arguing that it would allow “providers to deny care to TGD persons as well as discourage patients from seeking routine and gender-affirming care or reporting discrimination.”

Over a dozen U.S. states have introduced proposed legislation concerning medical care of TGD individuals that contain erroneous and misleading information. Proposed laws in Alabama, Missouri, and Texas, for example, would prohibit any use of medical treatments for minors for the purpose of gender-affirming medical care, including “gonadotropin-releasing hormone agonist therapy for pubertal suppression and gender-affirming hormonal therapy,” the authors of the joint statement wrote. In some cases, medical professionals who provide medical care for TGD patients could face criminal charges.

Outside the United States, three High Court judges in the United Kingdom recently ruled that minors aged under 16 years could not legally consent to pubertal suppression. “The recent U.K. court decision could be very disruptive because it would raise a barrier to transgender children receiving puberty blockers at exactly the ages that puberty blockers would be typically used,” Dr. Safer said.

Misleading characterizations of gender-affirming medical care for TGD individuals have also been spread to the general public. A recent Republican primary ballot proposition in Texas asked whether the state should ban “chemical castration, puberty blockers, cross-sex hormones, and genital mutilation surgery on all minor children for transition purposes,” falsely asserting that “Texas children as young as 3 are being transitioned from their biological sex to the opposite sex,” referencing a high-profile custody battle of a transgender child in Texas.

There are several tiers of misinformation that exist within these statements, Dr. Safer noted. “Some statements have suggested that gender-affirming treatment for young children can include hormone therapy or even surgery. Of course, there are no medical treatments for transgender and gender-diverse children prior to puberty.”

For adolescents aged under 18 years, Endocrine Society guidelines released in 2017 state that pubertal suppression is fully reversible and “offered to adolescents who meet diagnostic and treatment criteria, and are requesting care, for gender dysphoria/gender incongruence after they exhibit physical changes of puberty,” Dr. Safer and coauthors wrote in the joint policy statement. Other, more permanent – but still partially reversible – treatments such as hormone therapy are available as options for adolescents with confirmed and persistent gender dysphoria/gender incongruence, after meeting with a team of medical and mental health professionals and giving informed consent, according to the guidelines.

Dr. Safer expressed surprise at the opposition to puberty blockers in proposed state legislation. “Puberty blockers are the conservative option so that we can avoid permanent changes while thoughtful decisions are being made by our adolescent patients with their families and health care providers,” he said.

The perception that puberty blockers will lead to hormone therapy is another misunderstanding and source of misinformation, Dr. Safer explained.

“The fear is that these data suggest that puberty blockers are a ‘gateway drug’ of some sort. But that is false. The reason that most adolescents who take puberty blockers go on to hormone therapy is because most of the adolescents who are identified in our conservative systems are actually transgender and interested in more gender-affirming care as they age,” he said.
 

Effects of discrimination on TGD persons

Many of these proposed state bills have not advanced through state legislatures, but a few – such as the proposed laws in Alabama, Missouri, and Texas – are still currently under consideration.

“In the United States, most recent efforts to single out transgender and gender-diverse people for discrimination in health care have failed. However, the demonization of trans people and attempts to disrupt care have been the source of much stress among our patients,” Dr. Safer said.

Restricting access to health care has “multiple implications” for TGD patients. “In the era when we did not provide care to transgender youth, we had a situation where approximately 40% of transgender people had considered suicide in their lives,” Dr. Safer said. In contrast, having access to these treatments has been shown to improve mental health outcomes in these patients, according to an Endocrine Society position statement.

The purpose of earlier interventions such as puberty blockers is to allow an adolescent to “explore options and live in the experienced gender before making a decision to proceed with gender-affirming hormone therapy,” the authors of the Endocrine Society and Pediatric Endocrine Society joint statement said.

Blocking access to puberty blockers, on the other hand, forces transgender youth to experience a puberty that doesn’t match their gender identity, Dr. Safer noted. “The puberty will include permanent changes which will then have to be reversed with surgery. Why would we intentionally allow that to happen?”

Dr. Safer reported that his spouse is an employee of Parexel. Dr. Tangpricha is the current president of the World Association for Transgender Health and a board member of the American Association of Clinical Endocrinology. The other authors reported no relevant conflicts of interests.

SOURCE: Safer JD et al. J Clin Endocrinol Metab. 2020. doi: 10.1210/clinem/dgaa816.

Science should be the cornerstone for health policy, and decisions on medical care of transgender and gender-diverse (TGD) individuals should be between a patient and their doctor.

That’s according to a joint policy statement from the Endocrine Society and Pediatric Endocrine Society published in the Journal of Clinical Endocrinology & Metabolism expressing concern about recent proposed legislation that would limit access to medical care for TGD individuals.

“The main emphasis is that we are simply medical people trying to be conservative and science driven in the care of our patients,” Joshua D. Safer, MD, coauthor and executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System, and professor of medicine at Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Why the health care for a particular group of people should be considered political is a mystery to me.”

TGD individuals have seen a recent uptick in efforts to limit or restrict their access to medical care at the federal and state levels. In June 2020, the Department of Health & Human Services finalized a revision to Section 1557 of the Affordable Care Act, rolling back a 2016 rule that determined the phrase “on the basis of sex” included nondiscrimination based on a person’s sex and gender identity. The Endocrine Society opposed this rule revision, arguing that it would allow “providers to deny care to TGD persons as well as discourage patients from seeking routine and gender-affirming care or reporting discrimination.”

Over a dozen U.S. states have introduced proposed legislation concerning medical care of TGD individuals that contain erroneous and misleading information. Proposed laws in Alabama, Missouri, and Texas, for example, would prohibit any use of medical treatments for minors for the purpose of gender-affirming medical care, including “gonadotropin-releasing hormone agonist therapy for pubertal suppression and gender-affirming hormonal therapy,” the authors of the joint statement wrote. In some cases, medical professionals who provide medical care for TGD patients could face criminal charges.

Outside the United States, three High Court judges in the United Kingdom recently ruled that minors aged under 16 years could not legally consent to pubertal suppression. “The recent U.K. court decision could be very disruptive because it would raise a barrier to transgender children receiving puberty blockers at exactly the ages that puberty blockers would be typically used,” Dr. Safer said.

Misleading characterizations of gender-affirming medical care for TGD individuals have also been spread to the general public. A recent Republican primary ballot proposition in Texas asked whether the state should ban “chemical castration, puberty blockers, cross-sex hormones, and genital mutilation surgery on all minor children for transition purposes,” falsely asserting that “Texas children as young as 3 are being transitioned from their biological sex to the opposite sex,” referencing a high-profile custody battle of a transgender child in Texas.

There are several tiers of misinformation that exist within these statements, Dr. Safer noted. “Some statements have suggested that gender-affirming treatment for young children can include hormone therapy or even surgery. Of course, there are no medical treatments for transgender and gender-diverse children prior to puberty.”

For adolescents aged under 18 years, Endocrine Society guidelines released in 2017 state that pubertal suppression is fully reversible and “offered to adolescents who meet diagnostic and treatment criteria, and are requesting care, for gender dysphoria/gender incongruence after they exhibit physical changes of puberty,” Dr. Safer and coauthors wrote in the joint policy statement. Other, more permanent – but still partially reversible – treatments such as hormone therapy are available as options for adolescents with confirmed and persistent gender dysphoria/gender incongruence, after meeting with a team of medical and mental health professionals and giving informed consent, according to the guidelines.

Dr. Safer expressed surprise at the opposition to puberty blockers in proposed state legislation. “Puberty blockers are the conservative option so that we can avoid permanent changes while thoughtful decisions are being made by our adolescent patients with their families and health care providers,” he said.

The perception that puberty blockers will lead to hormone therapy is another misunderstanding and source of misinformation, Dr. Safer explained.

“The fear is that these data suggest that puberty blockers are a ‘gateway drug’ of some sort. But that is false. The reason that most adolescents who take puberty blockers go on to hormone therapy is because most of the adolescents who are identified in our conservative systems are actually transgender and interested in more gender-affirming care as they age,” he said.
 

Effects of discrimination on TGD persons

Many of these proposed state bills have not advanced through state legislatures, but a few – such as the proposed laws in Alabama, Missouri, and Texas – are still currently under consideration.

“In the United States, most recent efforts to single out transgender and gender-diverse people for discrimination in health care have failed. However, the demonization of trans people and attempts to disrupt care have been the source of much stress among our patients,” Dr. Safer said.

Restricting access to health care has “multiple implications” for TGD patients. “In the era when we did not provide care to transgender youth, we had a situation where approximately 40% of transgender people had considered suicide in their lives,” Dr. Safer said. In contrast, having access to these treatments has been shown to improve mental health outcomes in these patients, according to an Endocrine Society position statement.

The purpose of earlier interventions such as puberty blockers is to allow an adolescent to “explore options and live in the experienced gender before making a decision to proceed with gender-affirming hormone therapy,” the authors of the Endocrine Society and Pediatric Endocrine Society joint statement said.

Blocking access to puberty blockers, on the other hand, forces transgender youth to experience a puberty that doesn’t match their gender identity, Dr. Safer noted. “The puberty will include permanent changes which will then have to be reversed with surgery. Why would we intentionally allow that to happen?”

Dr. Safer reported that his spouse is an employee of Parexel. Dr. Tangpricha is the current president of the World Association for Transgender Health and a board member of the American Association of Clinical Endocrinology. The other authors reported no relevant conflicts of interests.

SOURCE: Safer JD et al. J Clin Endocrinol Metab. 2020. doi: 10.1210/clinem/dgaa816.

Science should be the cornerstone for health policy, and decisions on medical care of transgender and gender-diverse (TGD) individuals should be between a patient and their doctor.

That’s according to a joint policy statement from the Endocrine Society and Pediatric Endocrine Society published in the Journal of Clinical Endocrinology & Metabolism expressing concern about recent proposed legislation that would limit access to medical care for TGD individuals.

“The main emphasis is that we are simply medical people trying to be conservative and science driven in the care of our patients,” Joshua D. Safer, MD, coauthor and executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System, and professor of medicine at Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Why the health care for a particular group of people should be considered political is a mystery to me.”

TGD individuals have seen a recent uptick in efforts to limit or restrict their access to medical care at the federal and state levels. In June 2020, the Department of Health & Human Services finalized a revision to Section 1557 of the Affordable Care Act, rolling back a 2016 rule that determined the phrase “on the basis of sex” included nondiscrimination based on a person’s sex and gender identity. The Endocrine Society opposed this rule revision, arguing that it would allow “providers to deny care to TGD persons as well as discourage patients from seeking routine and gender-affirming care or reporting discrimination.”

Over a dozen U.S. states have introduced proposed legislation concerning medical care of TGD individuals that contain erroneous and misleading information. Proposed laws in Alabama, Missouri, and Texas, for example, would prohibit any use of medical treatments for minors for the purpose of gender-affirming medical care, including “gonadotropin-releasing hormone agonist therapy for pubertal suppression and gender-affirming hormonal therapy,” the authors of the joint statement wrote. In some cases, medical professionals who provide medical care for TGD patients could face criminal charges.

Outside the United States, three High Court judges in the United Kingdom recently ruled that minors aged under 16 years could not legally consent to pubertal suppression. “The recent U.K. court decision could be very disruptive because it would raise a barrier to transgender children receiving puberty blockers at exactly the ages that puberty blockers would be typically used,” Dr. Safer said.

Misleading characterizations of gender-affirming medical care for TGD individuals have also been spread to the general public. A recent Republican primary ballot proposition in Texas asked whether the state should ban “chemical castration, puberty blockers, cross-sex hormones, and genital mutilation surgery on all minor children for transition purposes,” falsely asserting that “Texas children as young as 3 are being transitioned from their biological sex to the opposite sex,” referencing a high-profile custody battle of a transgender child in Texas.

There are several tiers of misinformation that exist within these statements, Dr. Safer noted. “Some statements have suggested that gender-affirming treatment for young children can include hormone therapy or even surgery. Of course, there are no medical treatments for transgender and gender-diverse children prior to puberty.”

For adolescents aged under 18 years, Endocrine Society guidelines released in 2017 state that pubertal suppression is fully reversible and “offered to adolescents who meet diagnostic and treatment criteria, and are requesting care, for gender dysphoria/gender incongruence after they exhibit physical changes of puberty,” Dr. Safer and coauthors wrote in the joint policy statement. Other, more permanent – but still partially reversible – treatments such as hormone therapy are available as options for adolescents with confirmed and persistent gender dysphoria/gender incongruence, after meeting with a team of medical and mental health professionals and giving informed consent, according to the guidelines.

Dr. Safer expressed surprise at the opposition to puberty blockers in proposed state legislation. “Puberty blockers are the conservative option so that we can avoid permanent changes while thoughtful decisions are being made by our adolescent patients with their families and health care providers,” he said.

The perception that puberty blockers will lead to hormone therapy is another misunderstanding and source of misinformation, Dr. Safer explained.

“The fear is that these data suggest that puberty blockers are a ‘gateway drug’ of some sort. But that is false. The reason that most adolescents who take puberty blockers go on to hormone therapy is because most of the adolescents who are identified in our conservative systems are actually transgender and interested in more gender-affirming care as they age,” he said.
 

Effects of discrimination on TGD persons

Many of these proposed state bills have not advanced through state legislatures, but a few – such as the proposed laws in Alabama, Missouri, and Texas – are still currently under consideration.

“In the United States, most recent efforts to single out transgender and gender-diverse people for discrimination in health care have failed. However, the demonization of trans people and attempts to disrupt care have been the source of much stress among our patients,” Dr. Safer said.

Restricting access to health care has “multiple implications” for TGD patients. “In the era when we did not provide care to transgender youth, we had a situation where approximately 40% of transgender people had considered suicide in their lives,” Dr. Safer said. In contrast, having access to these treatments has been shown to improve mental health outcomes in these patients, according to an Endocrine Society position statement.

The purpose of earlier interventions such as puberty blockers is to allow an adolescent to “explore options and live in the experienced gender before making a decision to proceed with gender-affirming hormone therapy,” the authors of the Endocrine Society and Pediatric Endocrine Society joint statement said.

Blocking access to puberty blockers, on the other hand, forces transgender youth to experience a puberty that doesn’t match their gender identity, Dr. Safer noted. “The puberty will include permanent changes which will then have to be reversed with surgery. Why would we intentionally allow that to happen?”

Dr. Safer reported that his spouse is an employee of Parexel. Dr. Tangpricha is the current president of the World Association for Transgender Health and a board member of the American Association of Clinical Endocrinology. The other authors reported no relevant conflicts of interests.

SOURCE: Safer JD et al. J Clin Endocrinol Metab. 2020. doi: 10.1210/clinem/dgaa816.

Betsy Nicoletti, MS, a nationally recognized coding expert, will take your coding questions via email and provide guidance on how to code properly to maximize reimbursement. Have a question about coding? Send it to [email protected].

Physicians will soon start having an easier time – and perhaps get paid more money – when they code for evaluation and management (E/M) services, thanks to the American Medical Association.

The first major changes to the definitions for E/M services will be in effect as of Jan. 1, 2021, with all payers expected to adopt these new guidelines. In particular, the AMA has revised the definitions for E/M codes 99202-99215 in the Current Procedural Terminology (CPT) 2021 codebook. The existing guidelines were developed in 1995 and 1997 and remain in effect for all other E/M services determined by history, exam, and medical decision-making (MDM).

What do the new changes mean to you? In 2021, for new and established office and other outpatient services reported with codes 99202-99215, a clinician may select the code on the basis of time or MDM.

There are three elements in MDM, and two of three are required. These elements are the number and complexity of problems addressed, amount and/or complexity of data to be reviewed and analyzed, and risk of complications and/or morbidity or mortality of patient management.

Make sure you familiarize yourself with these six big changes. It may take a bit of time to integrate these new processes into your daily routine, but wrapping your head around them as soon as possible can help boost your bottom line:
 

1. History and exam don’t count toward level of service

Physicians, advanced practice registered nurses, and physician assistants won’t use history or exam to select what level of code to bill for office visits 99202-99215, as they did in the past. They need only document a medically appropriate history and exam. The history may be obtained by staff members and reviewed by the billing practitioner.

While specific history and exam requirements disappear for office visit codes, they remain for all other types of visits, selected on the basis of history, exam, and MDM, such as hospital services, nursing facility services, and home and domiciliary care. So, say goodbye to “all other systems reviewed and negative” in office notes, but keep it handy for those other E/M codes.

2. All time spent caring for the patient on a particular day counts

This includes all time spent on the day of service, including preparing to see the patient, seeing the patient, phone calls or other work done after the visit (if not billed with a care management or other CPT code), and documenting in the medical record. The AMA developed new guidelines for using time for office and other outpatient services. For codes 99202-99215, count all of the face-to-face and non–face-to-face time spent by the billing clinician on the day of the visit. Counseling does not need to be more than 50% of the total time.

Do not include any staff time or time spent on any days before or after the visit. This allows clinicians to capture the work when a significant amount of it takes place before or after the visit with the patient, and to bill for it on the day of the visit.

According to the 2021 CPT codebook, physician or other qualified health care professional time includes the following activities:

• Preparing to see the patient (e.g., review of tests).
• Obtaining and/or reviewing separately obtained history.
• Performing a medically appropriate examination and/or evaluation.
• Counseling and educating the patient/family/caregiver.
• Ordering medications, tests, or procedures.
• Referring and communicating with other health care professionals (when not separately reported).
• Documenting clinical information in the electronic or other health record.
• Independently interpreting results (not separately reported) and communicating results to the patient/family/caregiver.
• Care coordination (not separately reported).

3. Soon to be gone: ‘new to the examiner’ and ‘workup planned’

The current guidelines don’t differentiate between a new problem to the clinician or an established problem to the clinician. So it doesn’t matter whether you’re hearing about a particular problem for the first time or the fifth time. The new office and outpatient services guidelines define problems only as they relate to the patient. For example, when selecting a level of service, a chronic problem with a mild exacerbation is the same level whether it’s the primary care physician seeing the patient for the 10th time to help manage her diabetes or the endocrinologist seeing the patient for the first time.

In the current guidelines (1995 and 1997), additional weight is given in selecting the level of MDM for a problem that’s new to the examiner with a workup planned, yet when the diagnostic test couldn’t be completed at the visit. This concept is gone from element of number and complexity of new problems. Ordering diagnostic tests is part of the second element, the amount and/or complexity of data to be reviewed.

4. Different guidelines if you need a history from a parent or other source

The new guidelines recognize the additional work required by the clinician when the patient is unable to give a history or when the practitioner doesn’t find the history to be reliable.

For example, in the case of a baby or child who is unable to give a history, the parent counts as an “independent historian,” according to the new guidelines. Likewise, for a patient with dementia, the caregiver counts as a historian. Note, however, that the criteria is not met simply because the patient is accompanied by another person. The additional weight in selecting the level of service is based on the patient being unable to give a reliable history.

Bottom line: In cases where patients are unable to communicate clearly, physicians or other providers should document the necessity of getting a complete history and who provided it.

5. A new spin on social determinants of health (SDoH)

In the risk of morbidity and/or mortality element, conditions described as “social determinants of health” are considered moderate complexity. SDoH are social and environmental factors that affect a patient’s health and medical outcomes. These include homelessness, inability to afford medications, food insecurity, and occupational exposure to risk factors. These circumstances are reported with codes in categories Z55-Z65.

In the past, physicians often documented this information in their office notes but rarely added a diagnosis code that described the patient’s situation. The ICD-10-CM code set includes codes that describe these factors. Using them allows the practice to track patients who have increased needs, and it communicates to payers the complexity of caring for these patients.

6. Risks related to surgery are defined

The current guidelines assign different levels of risk to minor and major surgery. They also include differentiation for “minor surgery with no identified risk factors,” “minor surgery with identified risk factors,” “elective major surgery with no identified risk factors,” and “elective major surgery with identified risk factors.” The old guidelines didn’t state whether the risk factors pertained to the patient – such as smoking, heart disease, or high body mass index – or to the procedure itself.

The new guidelines specifically say that it’s both. In the risk column, “decision regarding minor surgery with identified patient or procedure risk factors” and “decision regarding elective major surgery without patient or procedure risk factors” are both considered moderate. “Decision regarding elective major surgery with identified patient or procedure risk factors” and “decision regarding emergency major surgery” are in the high complexity column for risk.

Keep in mind that two of three elements are required: the number and complexity of problems, amount of data, and morbidity/mortality risk. Risk of morbidity/mortality alone doesn’t count as the basis for selecting the code. Of course, when surgeons see this, they ask, “What major procedures don’t have identified risk factors?”

Note, too, that these new CPT guidelines do not define the terms “minor” and “major” surgery. For payment reasons related to the postop period, the Centers for Medicare & Medicaid Services defines minor surgery as a procedure with 0-10 global days and a major surgery as a procedure with 90 global days. However, there are many procedures with 0 global days (endoscopy, cardiac catheterization) that are not minor procedures. Hopefully, the AMA will clarify this in 2021.
 

What’s the take-away for clinicians?

There are sure to be shifts in coding patterns based on these new guidelines. Some specialties will find that not being able to select a service based on history and exam alone will lower the level of service for which they can bill. Some practices, on the other hand, will be able to code for more high-level visits, without the need for a complete review of systems or a comprehensive exam.

The biggest challenge will be for practices that provide services both in the hospital and in the office, because they’ll have to use both sets of guidelines, depending on which type of service they’re performing.

For more details on what’s coming your way beginning on New Year’s Day, you may want to read the 16-page AMA document .
 

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

Betsy Nicoletti, MS, a nationally recognized coding expert, will take your coding questions via email and provide guidance on how to code properly to maximize reimbursement. Have a question about coding? Send it to [email protected].

Physicians will soon start having an easier time – and perhaps get paid more money – when they code for evaluation and management (E/M) services, thanks to the American Medical Association.

The first major changes to the definitions for E/M services will be in effect as of Jan. 1, 2021, with all payers expected to adopt these new guidelines. In particular, the AMA has revised the definitions for E/M codes 99202-99215 in the Current Procedural Terminology (CPT) 2021 codebook. The existing guidelines were developed in 1995 and 1997 and remain in effect for all other E/M services determined by history, exam, and medical decision-making (MDM).

What do the new changes mean to you? In 2021, for new and established office and other outpatient services reported with codes 99202-99215, a clinician may select the code on the basis of time or MDM.

There are three elements in MDM, and two of three are required. These elements are the number and complexity of problems addressed, amount and/or complexity of data to be reviewed and analyzed, and risk of complications and/or morbidity or mortality of patient management.

Make sure you familiarize yourself with these six big changes. It may take a bit of time to integrate these new processes into your daily routine, but wrapping your head around them as soon as possible can help boost your bottom line:
 

1. History and exam don’t count toward level of service

Physicians, advanced practice registered nurses, and physician assistants won’t use history or exam to select what level of code to bill for office visits 99202-99215, as they did in the past. They need only document a medically appropriate history and exam. The history may be obtained by staff members and reviewed by the billing practitioner.

While specific history and exam requirements disappear for office visit codes, they remain for all other types of visits, selected on the basis of history, exam, and MDM, such as hospital services, nursing facility services, and home and domiciliary care. So, say goodbye to “all other systems reviewed and negative” in office notes, but keep it handy for those other E/M codes.

2. All time spent caring for the patient on a particular day counts

This includes all time spent on the day of service, including preparing to see the patient, seeing the patient, phone calls or other work done after the visit (if not billed with a care management or other CPT code), and documenting in the medical record. The AMA developed new guidelines for using time for office and other outpatient services. For codes 99202-99215, count all of the face-to-face and non–face-to-face time spent by the billing clinician on the day of the visit. Counseling does not need to be more than 50% of the total time.

Do not include any staff time or time spent on any days before or after the visit. This allows clinicians to capture the work when a significant amount of it takes place before or after the visit with the patient, and to bill for it on the day of the visit.

According to the 2021 CPT codebook, physician or other qualified health care professional time includes the following activities:

• Preparing to see the patient (e.g., review of tests).
• Obtaining and/or reviewing separately obtained history.
• Performing a medically appropriate examination and/or evaluation.
• Counseling and educating the patient/family/caregiver.
• Ordering medications, tests, or procedures.
• Referring and communicating with other health care professionals (when not separately reported).
• Documenting clinical information in the electronic or other health record.
• Independently interpreting results (not separately reported) and communicating results to the patient/family/caregiver.
• Care coordination (not separately reported).

3. Soon to be gone: ‘new to the examiner’ and ‘workup planned’

The current guidelines don’t differentiate between a new problem to the clinician or an established problem to the clinician. So it doesn’t matter whether you’re hearing about a particular problem for the first time or the fifth time. The new office and outpatient services guidelines define problems only as they relate to the patient. For example, when selecting a level of service, a chronic problem with a mild exacerbation is the same level whether it’s the primary care physician seeing the patient for the 10th time to help manage her diabetes or the endocrinologist seeing the patient for the first time.

In the current guidelines (1995 and 1997), additional weight is given in selecting the level of MDM for a problem that’s new to the examiner with a workup planned, yet when the diagnostic test couldn’t be completed at the visit. This concept is gone from element of number and complexity of new problems. Ordering diagnostic tests is part of the second element, the amount and/or complexity of data to be reviewed.

4. Different guidelines if you need a history from a parent or other source

The new guidelines recognize the additional work required by the clinician when the patient is unable to give a history or when the practitioner doesn’t find the history to be reliable.

For example, in the case of a baby or child who is unable to give a history, the parent counts as an “independent historian,” according to the new guidelines. Likewise, for a patient with dementia, the caregiver counts as a historian. Note, however, that the criteria is not met simply because the patient is accompanied by another person. The additional weight in selecting the level of service is based on the patient being unable to give a reliable history.

Bottom line: In cases where patients are unable to communicate clearly, physicians or other providers should document the necessity of getting a complete history and who provided it.

5. A new spin on social determinants of health (SDoH)

In the risk of morbidity and/or mortality element, conditions described as “social determinants of health” are considered moderate complexity. SDoH are social and environmental factors that affect a patient’s health and medical outcomes. These include homelessness, inability to afford medications, food insecurity, and occupational exposure to risk factors. These circumstances are reported with codes in categories Z55-Z65.

In the past, physicians often documented this information in their office notes but rarely added a diagnosis code that described the patient’s situation. The ICD-10-CM code set includes codes that describe these factors. Using them allows the practice to track patients who have increased needs, and it communicates to payers the complexity of caring for these patients.

6. Risks related to surgery are defined

The current guidelines assign different levels of risk to minor and major surgery. They also include differentiation for “minor surgery with no identified risk factors,” “minor surgery with identified risk factors,” “elective major surgery with no identified risk factors,” and “elective major surgery with identified risk factors.” The old guidelines didn’t state whether the risk factors pertained to the patient – such as smoking, heart disease, or high body mass index – or to the procedure itself.

The new guidelines specifically say that it’s both. In the risk column, “decision regarding minor surgery with identified patient or procedure risk factors” and “decision regarding elective major surgery without patient or procedure risk factors” are both considered moderate. “Decision regarding elective major surgery with identified patient or procedure risk factors” and “decision regarding emergency major surgery” are in the high complexity column for risk.

Keep in mind that two of three elements are required: the number and complexity of problems, amount of data, and morbidity/mortality risk. Risk of morbidity/mortality alone doesn’t count as the basis for selecting the code. Of course, when surgeons see this, they ask, “What major procedures don’t have identified risk factors?”

Note, too, that these new CPT guidelines do not define the terms “minor” and “major” surgery. For payment reasons related to the postop period, the Centers for Medicare & Medicaid Services defines minor surgery as a procedure with 0-10 global days and a major surgery as a procedure with 90 global days. However, there are many procedures with 0 global days (endoscopy, cardiac catheterization) that are not minor procedures. Hopefully, the AMA will clarify this in 2021.
 

What’s the take-away for clinicians?

There are sure to be shifts in coding patterns based on these new guidelines. Some specialties will find that not being able to select a service based on history and exam alone will lower the level of service for which they can bill. Some practices, on the other hand, will be able to code for more high-level visits, without the need for a complete review of systems or a comprehensive exam.

The biggest challenge will be for practices that provide services both in the hospital and in the office, because they’ll have to use both sets of guidelines, depending on which type of service they’re performing.

For more details on what’s coming your way beginning on New Year’s Day, you may want to read the 16-page AMA document .
 

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

Betsy Nicoletti, MS, a nationally recognized coding expert, will take your coding questions via email and provide guidance on how to code properly to maximize reimbursement. Have a question about coding? Send it to [email protected].

Physicians will soon start having an easier time – and perhaps get paid more money – when they code for evaluation and management (E/M) services, thanks to the American Medical Association.

The first major changes to the definitions for E/M services will be in effect as of Jan. 1, 2021, with all payers expected to adopt these new guidelines. In particular, the AMA has revised the definitions for E/M codes 99202-99215 in the Current Procedural Terminology (CPT) 2021 codebook. The existing guidelines were developed in 1995 and 1997 and remain in effect for all other E/M services determined by history, exam, and medical decision-making (MDM).

What do the new changes mean to you? In 2021, for new and established office and other outpatient services reported with codes 99202-99215, a clinician may select the code on the basis of time or MDM.

There are three elements in MDM, and two of three are required. These elements are the number and complexity of problems addressed, amount and/or complexity of data to be reviewed and analyzed, and risk of complications and/or morbidity or mortality of patient management.

Make sure you familiarize yourself with these six big changes. It may take a bit of time to integrate these new processes into your daily routine, but wrapping your head around them as soon as possible can help boost your bottom line:
 

1. History and exam don’t count toward level of service

Physicians, advanced practice registered nurses, and physician assistants won’t use history or exam to select what level of code to bill for office visits 99202-99215, as they did in the past. They need only document a medically appropriate history and exam. The history may be obtained by staff members and reviewed by the billing practitioner.

While specific history and exam requirements disappear for office visit codes, they remain for all other types of visits, selected on the basis of history, exam, and MDM, such as hospital services, nursing facility services, and home and domiciliary care. So, say goodbye to “all other systems reviewed and negative” in office notes, but keep it handy for those other E/M codes.

2. All time spent caring for the patient on a particular day counts

This includes all time spent on the day of service, including preparing to see the patient, seeing the patient, phone calls or other work done after the visit (if not billed with a care management or other CPT code), and documenting in the medical record. The AMA developed new guidelines for using time for office and other outpatient services. For codes 99202-99215, count all of the face-to-face and non–face-to-face time spent by the billing clinician on the day of the visit. Counseling does not need to be more than 50% of the total time.

Do not include any staff time or time spent on any days before or after the visit. This allows clinicians to capture the work when a significant amount of it takes place before or after the visit with the patient, and to bill for it on the day of the visit.

According to the 2021 CPT codebook, physician or other qualified health care professional time includes the following activities:

• Preparing to see the patient (e.g., review of tests).
• Obtaining and/or reviewing separately obtained history.
• Performing a medically appropriate examination and/or evaluation.
• Counseling and educating the patient/family/caregiver.
• Ordering medications, tests, or procedures.
• Referring and communicating with other health care professionals (when not separately reported).
• Documenting clinical information in the electronic or other health record.
• Independently interpreting results (not separately reported) and communicating results to the patient/family/caregiver.
• Care coordination (not separately reported).

3. Soon to be gone: ‘new to the examiner’ and ‘workup planned’

The current guidelines don’t differentiate between a new problem to the clinician or an established problem to the clinician. So it doesn’t matter whether you’re hearing about a particular problem for the first time or the fifth time. The new office and outpatient services guidelines define problems only as they relate to the patient. For example, when selecting a level of service, a chronic problem with a mild exacerbation is the same level whether it’s the primary care physician seeing the patient for the 10th time to help manage her diabetes or the endocrinologist seeing the patient for the first time.

In the current guidelines (1995 and 1997), additional weight is given in selecting the level of MDM for a problem that’s new to the examiner with a workup planned, yet when the diagnostic test couldn’t be completed at the visit. This concept is gone from element of number and complexity of new problems. Ordering diagnostic tests is part of the second element, the amount and/or complexity of data to be reviewed.

4. Different guidelines if you need a history from a parent or other source

The new guidelines recognize the additional work required by the clinician when the patient is unable to give a history or when the practitioner doesn’t find the history to be reliable.

For example, in the case of a baby or child who is unable to give a history, the parent counts as an “independent historian,” according to the new guidelines. Likewise, for a patient with dementia, the caregiver counts as a historian. Note, however, that the criteria is not met simply because the patient is accompanied by another person. The additional weight in selecting the level of service is based on the patient being unable to give a reliable history.

Bottom line: In cases where patients are unable to communicate clearly, physicians or other providers should document the necessity of getting a complete history and who provided it.

5. A new spin on social determinants of health (SDoH)

In the risk of morbidity and/or mortality element, conditions described as “social determinants of health” are considered moderate complexity. SDoH are social and environmental factors that affect a patient’s health and medical outcomes. These include homelessness, inability to afford medications, food insecurity, and occupational exposure to risk factors. These circumstances are reported with codes in categories Z55-Z65.

In the past, physicians often documented this information in their office notes but rarely added a diagnosis code that described the patient’s situation. The ICD-10-CM code set includes codes that describe these factors. Using them allows the practice to track patients who have increased needs, and it communicates to payers the complexity of caring for these patients.

6. Risks related to surgery are defined

The current guidelines assign different levels of risk to minor and major surgery. They also include differentiation for “minor surgery with no identified risk factors,” “minor surgery with identified risk factors,” “elective major surgery with no identified risk factors,” and “elective major surgery with identified risk factors.” The old guidelines didn’t state whether the risk factors pertained to the patient – such as smoking, heart disease, or high body mass index – or to the procedure itself.

The new guidelines specifically say that it’s both. In the risk column, “decision regarding minor surgery with identified patient or procedure risk factors” and “decision regarding elective major surgery without patient or procedure risk factors” are both considered moderate. “Decision regarding elective major surgery with identified patient or procedure risk factors” and “decision regarding emergency major surgery” are in the high complexity column for risk.

Keep in mind that two of three elements are required: the number and complexity of problems, amount of data, and morbidity/mortality risk. Risk of morbidity/mortality alone doesn’t count as the basis for selecting the code. Of course, when surgeons see this, they ask, “What major procedures don’t have identified risk factors?”

Note, too, that these new CPT guidelines do not define the terms “minor” and “major” surgery. For payment reasons related to the postop period, the Centers for Medicare & Medicaid Services defines minor surgery as a procedure with 0-10 global days and a major surgery as a procedure with 90 global days. However, there are many procedures with 0 global days (endoscopy, cardiac catheterization) that are not minor procedures. Hopefully, the AMA will clarify this in 2021.
 

What’s the take-away for clinicians?

There are sure to be shifts in coding patterns based on these new guidelines. Some specialties will find that not being able to select a service based on history and exam alone will lower the level of service for which they can bill. Some practices, on the other hand, will be able to code for more high-level visits, without the need for a complete review of systems or a comprehensive exam.

The biggest challenge will be for practices that provide services both in the hospital and in the office, because they’ll have to use both sets of guidelines, depending on which type of service they’re performing.

For more details on what’s coming your way beginning on New Year’s Day, you may want to read the 16-page AMA document .
 

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

In 2017, Global Pediatric Health published a case report series associated with the use of long-acting reversible contraceptives, specifically the etonogestrel implant. The cases highlighted challenging removals of the etonogestrel implants because of migration, fracture, or a bent device, and served as a caution to providers.

In November 2020, the makers of the etonogestrel implant (Merck) recommended a change in practice with the release of a notice to health care providers certified in the training of this product. This mass marketing blast included an updated warning and cautions for prescribers as well as patient information on the potential risks of migration, fracture, and bent devices attributable to trauma or sports. “Broken or Bent Implant (Section 5.16). The addition of the following underlined language: “There have been reports of broken or bent implants, which may be related to external forces (e.g., manipulation of the implant or contact sports) while in the patient’s arm. There have also been reports of migration of a broken implant fragment within the arm.”

Clearly the etonogestrel subdermal hormonal implant is an effective form of contraception and particularly beneficial in nonadherent sexually active teens who struggle to remember oral contraceptives. But it is important to be aware of this alert. Little is known about the type of trauma or rate of external force required to cause migration, fracture, or bend implants. This update requires adequate counseling of potential risks and complications of the etonogestrel implant, including the risk of migration, fracture, or bent devices specifically in the event of contact sports and trauma.
 

Ms. Thew is medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She had no relevant financial disclosures. Email Ms. Thew at [email protected].