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Cancer Drug Shortages Continue in the US, Survey Finds
Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.
“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.
The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.
“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.
However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.
“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.
In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.
Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).
In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.
In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.
Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.
How are centers dealing with ongoing supply issues?
Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.
“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.
Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.
The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.
“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”
A version of this article appeared on Medscape.com.
Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.
“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.
The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.
“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.
However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.
“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.
In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.
Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).
In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.
In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.
Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.
How are centers dealing with ongoing supply issues?
Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.
“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.
Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.
The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.
“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”
A version of this article appeared on Medscape.com.
Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.
“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.
The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.
“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.
However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.
“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.
In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.
Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).
In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.
In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.
Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.
How are centers dealing with ongoing supply issues?
Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.
“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.
Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.
The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.
“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”
A version of this article appeared on Medscape.com.
Children on Medicaid With Asthma Receive Less Specialty Care
Primary care clinicians successfully manage many children with asthma, but data on specialist care according to insurance coverage are lacking, wrote Kimberley H. Geissler, PhD, of the University of Massachusetts Chan Medical School–Baystate, Springfield, Massachusetts, and colleagues.
Despite many interventions over time, “low-income children insured by Medicaid, many of whom are from minoritized racial and ethnic groups, continue to have worse outcomes and higher rates of poorly controlled asthma than children who are privately insured,” Dr. Geissler said in an interview.
“Because differences in whether a child sees an asthma specialist could contribute to these disparities, better understanding specialist use among both groups of kids may help inform potential solutions,” she said.
In a study published in JAMA Network Open, the researchers identified children with asthma aged 2-17 years using data from the Massachusetts All-Payer Claims Database for the years 2015-2020. The study population included 198,101 children and 432,455 child-year observations from children with asthma during a year when they met at least one of three criteria with any asthma diagnosis: One or more hospital visits, two or more outpatient visits, or at least one outpatient visit and at least one asthma medication.
Outpatient Visit Outcome
The primary outcome of asthma specialist care was defined as at least one outpatient visit with any asthma diagnosis to a clinician with a code of allergy and immunology, pulmonology, or otolaryngology.
A total of 66.2% of the child-year observations involved Medicaid and 33.8% involved private insurance. Approximately 15% of the children received asthma specialist care. However, nearly twice as many children with private insurance received asthma specialty care compared with those with Medicaid (20.6% vs 11.9%). In a full logistic regression analysis, children with Medicaid insurance were 55% less likely to receive asthma specialist treatment than children with private insurance.
Allergy and immunology was the most common specialty used, and the child-years for this specialty among children with Medicaid were less than half of those among children with private insurance (7.1% vs 15.9%).
Rates of persistent asthma were 20.0% and 16.9% in children with Medicaid and private insurance, respectively. Overall, children with persistent asthma were nearly four times as likely to receive asthma specialist care (adjusted odds ratio, 3.96). However, the difference in odds of receiving specialty care based on insurance type in favor of private insurance was greater among children with persistent asthma than among those without persistent asthma (−24.0 percentage points vs −20.8 percentage points).
The researchers found a similar pattern of difference in asthma specialty care in a sensitivity analysis limiting the results to child-year observations with at least one outpatient visit with any asthma diagnosis in a calendar year, although they also found a slight narrowing of the difference between the groups over time.
“Contrary to expectations, disparities in specialist care by insurance type were even more striking in children with persistent asthma,” the researchers wrote in their discussion. Notably, the growth of specialty drugs such as biologics for moderate to severe asthma are mainly prescribed by specialists, and ensuring access to specialists for children with Medicaid may reduce disparities in asthma control for those with severe or poorly controlled disease, they added.
The study findings were limited by several factors including the use only of data from Massachusetts, which may not generalize to other states, and the use of completed specialist visits without data on referrals, the researchers noted. Other limitations included a lack of data on asthma symptom frequency or control and on the setting in which an asthma diagnosis was made.
However, the results suggest a need for more attention to disparities in asthma care by insurance type, and more research is needed to determine whether these disparities persist in subsets of children with asthma, such as those with allergies or chronic medical conditions, they concluded.
Takeaways and Next Steps
“Perhaps unsurprisingly, children with private insurance were more likely to receive asthma specialist care than children with Medicaid,” Dr. Geissler told this news organization. The researchers expected a smaller gap between insurance types among children with persistent asthma, a marker for asthma severity, she said. However, “we found that the gap between those with Medicaid and those with private insurance is actually larger” for children with persistent asthma, she added.
As improved treatments for hard-to-control asthma become more available, pediatricians and primary care clinicians should follow the latest clinical guidelines for referring children to specialists for asthma care, said Dr. Geissler.
“Additionally, asthma specialists should ensure that their practices are accessible to children with Medicaid, as these families may face higher barriers to care; for example, transportation needs or scheduling challenges,” she said. Other strategies to overcome barriers to care might include electronic consultations with specialists or primary care–oriented interdisciplinary asthma clinics, which may be useful for all children with asthma but may particularly benefit those insured by Medicaid, she noted.
“Based on data limitations, we could not examine why we observed such big differences in specialist use by insurance type; for example, whether pediatricians were referring to specialists less for Medicaid-insured kids, or whether kids with Medicaid were less likely to see a specialist after a referral was made,” Dr. Geissler said. More research is needed to examine not only these factors but also the appropriateness of specialty care based on clinical guidelines to ensure high-quality evidence-based care for children with asthma who are insured by Medicaid, she said.
Improve Access and Expand Analysis
Asthma is a chronic and prevalent disease and requires a comprehensive approach that sometimes calls for specialist care, Anne Coates, MD, a pediatric pulmonologist in Portland, Maine, said in an interview.
Dr. Coates said she was surprised by the results of the current study but commended the authors for highlighting the limitations of the study, which illustrate areas for additional research. Notably, “the authors couldn’t observe referrals to specialists from primary care physicians; they used completed visits as a proxy,” Dr. Coates said.
More studies are needed to assess the completion of referral visits regardless of children’s insurance in order to better understand and address the barriers to specialty care, she added.
The current study is important because of the extent of asthma coupled with the significant number of children across the United States who are insured by Medicaid, especially underserved populations, she said.
“The burden of asthma differentially affects people of color who are living in lower resourced areas, and it is important in further research to understanding the barriers to helping people get the care they need,” Dr. Coates told this news organization. Some alternatives might include telehealth visits or even a hybrid visit to a primary care provider (PCP) who has high-speed internet, and the specialist could then conduct a telehealth visit from the PCP’s office, with the PCP acting as on-site eyes and ears, said Dr. Coates, who has used this strategy in her practice in Maine, where many patients live far from specialist care.
The study was supported by the National Heart, Lung, and Blood Institute and the University of Massachusetts Center for Clinical and Translational Science-Biostatistics, Epidemiology & Research Design Component. Dr. Geissler and Dr. Coates had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Primary care clinicians successfully manage many children with asthma, but data on specialist care according to insurance coverage are lacking, wrote Kimberley H. Geissler, PhD, of the University of Massachusetts Chan Medical School–Baystate, Springfield, Massachusetts, and colleagues.
Despite many interventions over time, “low-income children insured by Medicaid, many of whom are from minoritized racial and ethnic groups, continue to have worse outcomes and higher rates of poorly controlled asthma than children who are privately insured,” Dr. Geissler said in an interview.
“Because differences in whether a child sees an asthma specialist could contribute to these disparities, better understanding specialist use among both groups of kids may help inform potential solutions,” she said.
In a study published in JAMA Network Open, the researchers identified children with asthma aged 2-17 years using data from the Massachusetts All-Payer Claims Database for the years 2015-2020. The study population included 198,101 children and 432,455 child-year observations from children with asthma during a year when they met at least one of three criteria with any asthma diagnosis: One or more hospital visits, two or more outpatient visits, or at least one outpatient visit and at least one asthma medication.
Outpatient Visit Outcome
The primary outcome of asthma specialist care was defined as at least one outpatient visit with any asthma diagnosis to a clinician with a code of allergy and immunology, pulmonology, or otolaryngology.
A total of 66.2% of the child-year observations involved Medicaid and 33.8% involved private insurance. Approximately 15% of the children received asthma specialist care. However, nearly twice as many children with private insurance received asthma specialty care compared with those with Medicaid (20.6% vs 11.9%). In a full logistic regression analysis, children with Medicaid insurance were 55% less likely to receive asthma specialist treatment than children with private insurance.
Allergy and immunology was the most common specialty used, and the child-years for this specialty among children with Medicaid were less than half of those among children with private insurance (7.1% vs 15.9%).
Rates of persistent asthma were 20.0% and 16.9% in children with Medicaid and private insurance, respectively. Overall, children with persistent asthma were nearly four times as likely to receive asthma specialist care (adjusted odds ratio, 3.96). However, the difference in odds of receiving specialty care based on insurance type in favor of private insurance was greater among children with persistent asthma than among those without persistent asthma (−24.0 percentage points vs −20.8 percentage points).
The researchers found a similar pattern of difference in asthma specialty care in a sensitivity analysis limiting the results to child-year observations with at least one outpatient visit with any asthma diagnosis in a calendar year, although they also found a slight narrowing of the difference between the groups over time.
“Contrary to expectations, disparities in specialist care by insurance type were even more striking in children with persistent asthma,” the researchers wrote in their discussion. Notably, the growth of specialty drugs such as biologics for moderate to severe asthma are mainly prescribed by specialists, and ensuring access to specialists for children with Medicaid may reduce disparities in asthma control for those with severe or poorly controlled disease, they added.
The study findings were limited by several factors including the use only of data from Massachusetts, which may not generalize to other states, and the use of completed specialist visits without data on referrals, the researchers noted. Other limitations included a lack of data on asthma symptom frequency or control and on the setting in which an asthma diagnosis was made.
However, the results suggest a need for more attention to disparities in asthma care by insurance type, and more research is needed to determine whether these disparities persist in subsets of children with asthma, such as those with allergies or chronic medical conditions, they concluded.
Takeaways and Next Steps
“Perhaps unsurprisingly, children with private insurance were more likely to receive asthma specialist care than children with Medicaid,” Dr. Geissler told this news organization. The researchers expected a smaller gap between insurance types among children with persistent asthma, a marker for asthma severity, she said. However, “we found that the gap between those with Medicaid and those with private insurance is actually larger” for children with persistent asthma, she added.
As improved treatments for hard-to-control asthma become more available, pediatricians and primary care clinicians should follow the latest clinical guidelines for referring children to specialists for asthma care, said Dr. Geissler.
“Additionally, asthma specialists should ensure that their practices are accessible to children with Medicaid, as these families may face higher barriers to care; for example, transportation needs or scheduling challenges,” she said. Other strategies to overcome barriers to care might include electronic consultations with specialists or primary care–oriented interdisciplinary asthma clinics, which may be useful for all children with asthma but may particularly benefit those insured by Medicaid, she noted.
“Based on data limitations, we could not examine why we observed such big differences in specialist use by insurance type; for example, whether pediatricians were referring to specialists less for Medicaid-insured kids, or whether kids with Medicaid were less likely to see a specialist after a referral was made,” Dr. Geissler said. More research is needed to examine not only these factors but also the appropriateness of specialty care based on clinical guidelines to ensure high-quality evidence-based care for children with asthma who are insured by Medicaid, she said.
Improve Access and Expand Analysis
Asthma is a chronic and prevalent disease and requires a comprehensive approach that sometimes calls for specialist care, Anne Coates, MD, a pediatric pulmonologist in Portland, Maine, said in an interview.
Dr. Coates said she was surprised by the results of the current study but commended the authors for highlighting the limitations of the study, which illustrate areas for additional research. Notably, “the authors couldn’t observe referrals to specialists from primary care physicians; they used completed visits as a proxy,” Dr. Coates said.
More studies are needed to assess the completion of referral visits regardless of children’s insurance in order to better understand and address the barriers to specialty care, she added.
The current study is important because of the extent of asthma coupled with the significant number of children across the United States who are insured by Medicaid, especially underserved populations, she said.
“The burden of asthma differentially affects people of color who are living in lower resourced areas, and it is important in further research to understanding the barriers to helping people get the care they need,” Dr. Coates told this news organization. Some alternatives might include telehealth visits or even a hybrid visit to a primary care provider (PCP) who has high-speed internet, and the specialist could then conduct a telehealth visit from the PCP’s office, with the PCP acting as on-site eyes and ears, said Dr. Coates, who has used this strategy in her practice in Maine, where many patients live far from specialist care.
The study was supported by the National Heart, Lung, and Blood Institute and the University of Massachusetts Center for Clinical and Translational Science-Biostatistics, Epidemiology & Research Design Component. Dr. Geissler and Dr. Coates had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Primary care clinicians successfully manage many children with asthma, but data on specialist care according to insurance coverage are lacking, wrote Kimberley H. Geissler, PhD, of the University of Massachusetts Chan Medical School–Baystate, Springfield, Massachusetts, and colleagues.
Despite many interventions over time, “low-income children insured by Medicaid, many of whom are from minoritized racial and ethnic groups, continue to have worse outcomes and higher rates of poorly controlled asthma than children who are privately insured,” Dr. Geissler said in an interview.
“Because differences in whether a child sees an asthma specialist could contribute to these disparities, better understanding specialist use among both groups of kids may help inform potential solutions,” she said.
In a study published in JAMA Network Open, the researchers identified children with asthma aged 2-17 years using data from the Massachusetts All-Payer Claims Database for the years 2015-2020. The study population included 198,101 children and 432,455 child-year observations from children with asthma during a year when they met at least one of three criteria with any asthma diagnosis: One or more hospital visits, two or more outpatient visits, or at least one outpatient visit and at least one asthma medication.
Outpatient Visit Outcome
The primary outcome of asthma specialist care was defined as at least one outpatient visit with any asthma diagnosis to a clinician with a code of allergy and immunology, pulmonology, or otolaryngology.
A total of 66.2% of the child-year observations involved Medicaid and 33.8% involved private insurance. Approximately 15% of the children received asthma specialist care. However, nearly twice as many children with private insurance received asthma specialty care compared with those with Medicaid (20.6% vs 11.9%). In a full logistic regression analysis, children with Medicaid insurance were 55% less likely to receive asthma specialist treatment than children with private insurance.
Allergy and immunology was the most common specialty used, and the child-years for this specialty among children with Medicaid were less than half of those among children with private insurance (7.1% vs 15.9%).
Rates of persistent asthma were 20.0% and 16.9% in children with Medicaid and private insurance, respectively. Overall, children with persistent asthma were nearly four times as likely to receive asthma specialist care (adjusted odds ratio, 3.96). However, the difference in odds of receiving specialty care based on insurance type in favor of private insurance was greater among children with persistent asthma than among those without persistent asthma (−24.0 percentage points vs −20.8 percentage points).
The researchers found a similar pattern of difference in asthma specialty care in a sensitivity analysis limiting the results to child-year observations with at least one outpatient visit with any asthma diagnosis in a calendar year, although they also found a slight narrowing of the difference between the groups over time.
“Contrary to expectations, disparities in specialist care by insurance type were even more striking in children with persistent asthma,” the researchers wrote in their discussion. Notably, the growth of specialty drugs such as biologics for moderate to severe asthma are mainly prescribed by specialists, and ensuring access to specialists for children with Medicaid may reduce disparities in asthma control for those with severe or poorly controlled disease, they added.
The study findings were limited by several factors including the use only of data from Massachusetts, which may not generalize to other states, and the use of completed specialist visits without data on referrals, the researchers noted. Other limitations included a lack of data on asthma symptom frequency or control and on the setting in which an asthma diagnosis was made.
However, the results suggest a need for more attention to disparities in asthma care by insurance type, and more research is needed to determine whether these disparities persist in subsets of children with asthma, such as those with allergies or chronic medical conditions, they concluded.
Takeaways and Next Steps
“Perhaps unsurprisingly, children with private insurance were more likely to receive asthma specialist care than children with Medicaid,” Dr. Geissler told this news organization. The researchers expected a smaller gap between insurance types among children with persistent asthma, a marker for asthma severity, she said. However, “we found that the gap between those with Medicaid and those with private insurance is actually larger” for children with persistent asthma, she added.
As improved treatments for hard-to-control asthma become more available, pediatricians and primary care clinicians should follow the latest clinical guidelines for referring children to specialists for asthma care, said Dr. Geissler.
“Additionally, asthma specialists should ensure that their practices are accessible to children with Medicaid, as these families may face higher barriers to care; for example, transportation needs or scheduling challenges,” she said. Other strategies to overcome barriers to care might include electronic consultations with specialists or primary care–oriented interdisciplinary asthma clinics, which may be useful for all children with asthma but may particularly benefit those insured by Medicaid, she noted.
“Based on data limitations, we could not examine why we observed such big differences in specialist use by insurance type; for example, whether pediatricians were referring to specialists less for Medicaid-insured kids, or whether kids with Medicaid were less likely to see a specialist after a referral was made,” Dr. Geissler said. More research is needed to examine not only these factors but also the appropriateness of specialty care based on clinical guidelines to ensure high-quality evidence-based care for children with asthma who are insured by Medicaid, she said.
Improve Access and Expand Analysis
Asthma is a chronic and prevalent disease and requires a comprehensive approach that sometimes calls for specialist care, Anne Coates, MD, a pediatric pulmonologist in Portland, Maine, said in an interview.
Dr. Coates said she was surprised by the results of the current study but commended the authors for highlighting the limitations of the study, which illustrate areas for additional research. Notably, “the authors couldn’t observe referrals to specialists from primary care physicians; they used completed visits as a proxy,” Dr. Coates said.
More studies are needed to assess the completion of referral visits regardless of children’s insurance in order to better understand and address the barriers to specialty care, she added.
The current study is important because of the extent of asthma coupled with the significant number of children across the United States who are insured by Medicaid, especially underserved populations, she said.
“The burden of asthma differentially affects people of color who are living in lower resourced areas, and it is important in further research to understanding the barriers to helping people get the care they need,” Dr. Coates told this news organization. Some alternatives might include telehealth visits or even a hybrid visit to a primary care provider (PCP) who has high-speed internet, and the specialist could then conduct a telehealth visit from the PCP’s office, with the PCP acting as on-site eyes and ears, said Dr. Coates, who has used this strategy in her practice in Maine, where many patients live far from specialist care.
The study was supported by the National Heart, Lung, and Blood Institute and the University of Massachusetts Center for Clinical and Translational Science-Biostatistics, Epidemiology & Research Design Component. Dr. Geissler and Dr. Coates had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Could Tuberculosis Medication Management Be as Simple as Monitoring Sweat?
Analysis of finger sweat detected isoniazid in adults with tuberculosis (TB) for ≤ 6 hours after administration, based on data from a new pilot study.
Katherine Longman, a PhD student at the University of Surrey, Guildford, England, and colleagues wrote.
Although TB is treatable, “it is well known that insufficient drug dosing leads to treatment failure and drug resistance, and so ensuring that patients have sufficient drug exposure is important,” said corresponding author Melanie J. Bailey, PhD, also of the University of Surrey.
“This can be carried out using blood, but blood is painful to collect and difficult to transport. Finger sweat offers a completely noninvasive way to sample patients,” but its use to determine medication adherence has not been examined, she said.
In a pilot study published in the International Journal of Antimicrobial Agents, the researchers reviewed data from 10 adults with TB who provided finger sweat, blood, and saliva samples at several time points ≤ 6 hours after receiving a controlled dose of isoniazid (median of 300 mg daily). They used liquid chromatography–mass spectrometry to examine the samples.
Overall, “isoniazid and acetyl isoniazid were detected in at least one finger sweat sample from all patients,” with detection rates of 96% and 77%, respectively, the researchers wrote. Given the short half-life of isoniazid, they used a window of 1-6 hours after administration. Isoniazid was consistently detected between 1 and 6 hours after administration, while acetyl isoniazid had a noticeably higher detection rate at 6 hours.
The researchers also examined creatinine to account for variability in volume of sweat samples, and found that finger sweat was significantly correlated to isoniazid concentration. The maximum isoniazid to creatinine ratio in finger sweat occurred mainly in the first hour after drug administration, and the activity of isoniazid in finger sweat over time reflected isoniazid concentration in serum more closely after normalization to creatinine, they said. The Pearson’s correlation coefficient (r) was 0.98 (P < .001; one-tailed), with normalization to creatinine, compared with r = 0.52 without normalization (P = .051).
The study findings were limited by several factors including the lack of knowledge of the last drug dose and lack of confirmation testing with an established method of analysis, the researchers noted. However, the results support the potential of the finger sweat test as a screening tool to indicate patients’ nonadherence or to identify patients at risk of low medication exposure.
“We were surprised that we were able to detect the drug in so many patient samples because the sample volume is so low, and so detection is challenging,” said Dr. Bailey. “We were also surprised that fingerprint and drug levels correlated so well after normalizing to creatinine. This is exciting as it unlocks the possibility to test drug levels, as well as providing a yes/no test.”
In practice, the finger sweat technique could reduce the burden on clinics by offering a completely noninvasive way to test a patient’s medication adherence. Looking ahead, more research is needed to explore whether creatinine normalization is widely applicable, such as whether it works for patients with abnormal kidney function, she added.
Noninvasive Option May Mitigate Treatment Challenges
The current study presents a strategy that might address current limitations in TB management, said Krishna Thavarajah, MD, a pulmonologist and director of the interstitial lung disease program at Henry Ford Hospital, Detroit, Michigan, in an interview.
Both self-administered treatment and directly observed therapy (DOT) for TB therapy have limitations, including adherence as low as 50% for TB regimens, she said. In addition, “DOT availability and efficacy can be limited by cost, personnel availability from an administration perspective, and by distrust of those being treated.”
In the current study, “I was struck by the correlation between the sweat and serum values of [isoniazid] and by the level of sophistication of noninvasive testing, being able to normalize for creatinine to account for different volumes of sweat,” said Dr. Thavarajah. In clinical practice, finger sweat isoniazid could potentially serve as an adjunct or alternative to DOT in patients with TB.
Although adherence to the sampling protocol and possible patient distrust of the process (such as concerns over what else is being collected in their sweat) might be barriers to the use of a finger sweat strategy in the clinical setting, appropriate patient selection, patient training, and encouraging clinicians to incorporate this testing into practice could overcome these barriers, said Dr. Thavarajah.
However, more research is needed to study the finger sweat strategy in larger, real-world samples and to study accuracy and treatment adherence with monitoring in a population undergoing DOT, she said.
The study was supported by the Engineering & Physical Sciences Research Council and by Santander PhD Mobility Awards 2019. The researchers had no financial conflicts to disclose. Dr. Thavarajah had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Analysis of finger sweat detected isoniazid in adults with tuberculosis (TB) for ≤ 6 hours after administration, based on data from a new pilot study.
Katherine Longman, a PhD student at the University of Surrey, Guildford, England, and colleagues wrote.
Although TB is treatable, “it is well known that insufficient drug dosing leads to treatment failure and drug resistance, and so ensuring that patients have sufficient drug exposure is important,” said corresponding author Melanie J. Bailey, PhD, also of the University of Surrey.
“This can be carried out using blood, but blood is painful to collect and difficult to transport. Finger sweat offers a completely noninvasive way to sample patients,” but its use to determine medication adherence has not been examined, she said.
In a pilot study published in the International Journal of Antimicrobial Agents, the researchers reviewed data from 10 adults with TB who provided finger sweat, blood, and saliva samples at several time points ≤ 6 hours after receiving a controlled dose of isoniazid (median of 300 mg daily). They used liquid chromatography–mass spectrometry to examine the samples.
Overall, “isoniazid and acetyl isoniazid were detected in at least one finger sweat sample from all patients,” with detection rates of 96% and 77%, respectively, the researchers wrote. Given the short half-life of isoniazid, they used a window of 1-6 hours after administration. Isoniazid was consistently detected between 1 and 6 hours after administration, while acetyl isoniazid had a noticeably higher detection rate at 6 hours.
The researchers also examined creatinine to account for variability in volume of sweat samples, and found that finger sweat was significantly correlated to isoniazid concentration. The maximum isoniazid to creatinine ratio in finger sweat occurred mainly in the first hour after drug administration, and the activity of isoniazid in finger sweat over time reflected isoniazid concentration in serum more closely after normalization to creatinine, they said. The Pearson’s correlation coefficient (r) was 0.98 (P < .001; one-tailed), with normalization to creatinine, compared with r = 0.52 without normalization (P = .051).
The study findings were limited by several factors including the lack of knowledge of the last drug dose and lack of confirmation testing with an established method of analysis, the researchers noted. However, the results support the potential of the finger sweat test as a screening tool to indicate patients’ nonadherence or to identify patients at risk of low medication exposure.
“We were surprised that we were able to detect the drug in so many patient samples because the sample volume is so low, and so detection is challenging,” said Dr. Bailey. “We were also surprised that fingerprint and drug levels correlated so well after normalizing to creatinine. This is exciting as it unlocks the possibility to test drug levels, as well as providing a yes/no test.”
In practice, the finger sweat technique could reduce the burden on clinics by offering a completely noninvasive way to test a patient’s medication adherence. Looking ahead, more research is needed to explore whether creatinine normalization is widely applicable, such as whether it works for patients with abnormal kidney function, she added.
Noninvasive Option May Mitigate Treatment Challenges
The current study presents a strategy that might address current limitations in TB management, said Krishna Thavarajah, MD, a pulmonologist and director of the interstitial lung disease program at Henry Ford Hospital, Detroit, Michigan, in an interview.
Both self-administered treatment and directly observed therapy (DOT) for TB therapy have limitations, including adherence as low as 50% for TB regimens, she said. In addition, “DOT availability and efficacy can be limited by cost, personnel availability from an administration perspective, and by distrust of those being treated.”
In the current study, “I was struck by the correlation between the sweat and serum values of [isoniazid] and by the level of sophistication of noninvasive testing, being able to normalize for creatinine to account for different volumes of sweat,” said Dr. Thavarajah. In clinical practice, finger sweat isoniazid could potentially serve as an adjunct or alternative to DOT in patients with TB.
Although adherence to the sampling protocol and possible patient distrust of the process (such as concerns over what else is being collected in their sweat) might be barriers to the use of a finger sweat strategy in the clinical setting, appropriate patient selection, patient training, and encouraging clinicians to incorporate this testing into practice could overcome these barriers, said Dr. Thavarajah.
However, more research is needed to study the finger sweat strategy in larger, real-world samples and to study accuracy and treatment adherence with monitoring in a population undergoing DOT, she said.
The study was supported by the Engineering & Physical Sciences Research Council and by Santander PhD Mobility Awards 2019. The researchers had no financial conflicts to disclose. Dr. Thavarajah had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Analysis of finger sweat detected isoniazid in adults with tuberculosis (TB) for ≤ 6 hours after administration, based on data from a new pilot study.
Katherine Longman, a PhD student at the University of Surrey, Guildford, England, and colleagues wrote.
Although TB is treatable, “it is well known that insufficient drug dosing leads to treatment failure and drug resistance, and so ensuring that patients have sufficient drug exposure is important,” said corresponding author Melanie J. Bailey, PhD, also of the University of Surrey.
“This can be carried out using blood, but blood is painful to collect and difficult to transport. Finger sweat offers a completely noninvasive way to sample patients,” but its use to determine medication adherence has not been examined, she said.
In a pilot study published in the International Journal of Antimicrobial Agents, the researchers reviewed data from 10 adults with TB who provided finger sweat, blood, and saliva samples at several time points ≤ 6 hours after receiving a controlled dose of isoniazid (median of 300 mg daily). They used liquid chromatography–mass spectrometry to examine the samples.
Overall, “isoniazid and acetyl isoniazid were detected in at least one finger sweat sample from all patients,” with detection rates of 96% and 77%, respectively, the researchers wrote. Given the short half-life of isoniazid, they used a window of 1-6 hours after administration. Isoniazid was consistently detected between 1 and 6 hours after administration, while acetyl isoniazid had a noticeably higher detection rate at 6 hours.
The researchers also examined creatinine to account for variability in volume of sweat samples, and found that finger sweat was significantly correlated to isoniazid concentration. The maximum isoniazid to creatinine ratio in finger sweat occurred mainly in the first hour after drug administration, and the activity of isoniazid in finger sweat over time reflected isoniazid concentration in serum more closely after normalization to creatinine, they said. The Pearson’s correlation coefficient (r) was 0.98 (P < .001; one-tailed), with normalization to creatinine, compared with r = 0.52 without normalization (P = .051).
The study findings were limited by several factors including the lack of knowledge of the last drug dose and lack of confirmation testing with an established method of analysis, the researchers noted. However, the results support the potential of the finger sweat test as a screening tool to indicate patients’ nonadherence or to identify patients at risk of low medication exposure.
“We were surprised that we were able to detect the drug in so many patient samples because the sample volume is so low, and so detection is challenging,” said Dr. Bailey. “We were also surprised that fingerprint and drug levels correlated so well after normalizing to creatinine. This is exciting as it unlocks the possibility to test drug levels, as well as providing a yes/no test.”
In practice, the finger sweat technique could reduce the burden on clinics by offering a completely noninvasive way to test a patient’s medication adherence. Looking ahead, more research is needed to explore whether creatinine normalization is widely applicable, such as whether it works for patients with abnormal kidney function, she added.
Noninvasive Option May Mitigate Treatment Challenges
The current study presents a strategy that might address current limitations in TB management, said Krishna Thavarajah, MD, a pulmonologist and director of the interstitial lung disease program at Henry Ford Hospital, Detroit, Michigan, in an interview.
Both self-administered treatment and directly observed therapy (DOT) for TB therapy have limitations, including adherence as low as 50% for TB regimens, she said. In addition, “DOT availability and efficacy can be limited by cost, personnel availability from an administration perspective, and by distrust of those being treated.”
In the current study, “I was struck by the correlation between the sweat and serum values of [isoniazid] and by the level of sophistication of noninvasive testing, being able to normalize for creatinine to account for different volumes of sweat,” said Dr. Thavarajah. In clinical practice, finger sweat isoniazid could potentially serve as an adjunct or alternative to DOT in patients with TB.
Although adherence to the sampling protocol and possible patient distrust of the process (such as concerns over what else is being collected in their sweat) might be barriers to the use of a finger sweat strategy in the clinical setting, appropriate patient selection, patient training, and encouraging clinicians to incorporate this testing into practice could overcome these barriers, said Dr. Thavarajah.
However, more research is needed to study the finger sweat strategy in larger, real-world samples and to study accuracy and treatment adherence with monitoring in a population undergoing DOT, she said.
The study was supported by the Engineering & Physical Sciences Research Council and by Santander PhD Mobility Awards 2019. The researchers had no financial conflicts to disclose. Dr. Thavarajah had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
FROM THE INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
Does Semaglutide Reduce Inflammation?
LYON, FRANCE — The anti-obesity drug semaglutide is associated with significant reductions in the inflammatory marker high-sensitivity C-reactive protein (CRP), even in patients who do not lose substantial amounts of weight with the drug, according to data from the SELECT clinical trial.
The research, presented at the European Atherosclerosis Society 2024, involved over 17,600 patients with overweight or obesity and had established cardiovascular disease but not diabetes.
“Weight loss was associated with greater high-sensitivity CRP reduction in both treatment groups,” said study presenter Jorge Plutzky, MD, director of Preventive Cardiology at Brigham and Women’s Hospital, Boston, but “with increased high-sensitivity CRP reductions in those receiving semaglutide.”
The drug also “significantly reduced high-sensitivity CRP early,” he said, “prior to major weight loss and in those who did not lose significant amounts of weight.” The reductions reached approximately 12% at 4 weeks and around 20% at 8 weeks, when the weight loss “was still quite modest,” at 2% and 3% of body weight, respectively. Even among patients who achieved weight loss of less than 2% body weight, semaglutide was associated with a reduction in high-sensitivity CRP levels.
In the SELECT trial, semaglutide also resulted in a consistent reduction of around 20% vs placebo in major adverse cardiovascular events such as cardiovascular mortality, nonfatal myocardial infarction, or nonfatal stroke.
But Naveed Sattar, MD, PhD, professor of cardiometabolic medicine at the University of Glasgow, Scotland, said in an interview that body weight “is probably the major driver” of CRP levels in the population, accounting for between 20% and 30% of the variation.
Dr. Sattar, who was not involved in the study, said that because drugs like semaglutide lower weight but also have anti-inflammatory effects, the question becomes: “Could the anti-inflammatory effects be part of the mechanisms by which these drugs affect the risk of major adverse cardiovascular events?”
Reducing Cardiovascular Events
The current analysis, however, cannot answer the question, he said. “All it tells us is about associations.”
“What we do know is semaglutide, predominantly by lowering weight, is lowering CRP levels and equally, we know that when you lose weight, you improve blood pressure, you improve lipids, and you reduce the risk of diabetes,” he said.
Dr. Sattar also took issue with the researchers’ conclusion that the high-sensitivity CRP reductions seen in SELECT occurred prior to major weight loss because the “pattern of CRP reduction and weight reduction is almost identical.”
Dr. Sattar also pointed out in a recent editorial that the drug appears to have a direct effect on blood vessels and the heart, which may lead to improvements in systemic inflammation. Consequently, he said, any assertion that semaglutide is genuinely anti-inflammatory is, at this stage, “speculation.”
Dr. Plutzky said that “systemic, chronic inflammation is implicated as a potential mechanism and therapeutic target in atherosclerosis and major adverse cardiovascular events, as well as obesity,” and high-sensitivity CRP levels are an “established biomarker of inflammation and have been shown to predict cardiovascular risk.”
However, the relationship between high-sensitivity CRP, responses to glucagon-like peptide 1 receptor agonists like semaglutide, and cardiovascular outcomes in obesity “remains incompletely understood,” said Dr. Plutzky.
A version of this article appeared on Medscape.com.
LYON, FRANCE — The anti-obesity drug semaglutide is associated with significant reductions in the inflammatory marker high-sensitivity C-reactive protein (CRP), even in patients who do not lose substantial amounts of weight with the drug, according to data from the SELECT clinical trial.
The research, presented at the European Atherosclerosis Society 2024, involved over 17,600 patients with overweight or obesity and had established cardiovascular disease but not diabetes.
“Weight loss was associated with greater high-sensitivity CRP reduction in both treatment groups,” said study presenter Jorge Plutzky, MD, director of Preventive Cardiology at Brigham and Women’s Hospital, Boston, but “with increased high-sensitivity CRP reductions in those receiving semaglutide.”
The drug also “significantly reduced high-sensitivity CRP early,” he said, “prior to major weight loss and in those who did not lose significant amounts of weight.” The reductions reached approximately 12% at 4 weeks and around 20% at 8 weeks, when the weight loss “was still quite modest,” at 2% and 3% of body weight, respectively. Even among patients who achieved weight loss of less than 2% body weight, semaglutide was associated with a reduction in high-sensitivity CRP levels.
In the SELECT trial, semaglutide also resulted in a consistent reduction of around 20% vs placebo in major adverse cardiovascular events such as cardiovascular mortality, nonfatal myocardial infarction, or nonfatal stroke.
But Naveed Sattar, MD, PhD, professor of cardiometabolic medicine at the University of Glasgow, Scotland, said in an interview that body weight “is probably the major driver” of CRP levels in the population, accounting for between 20% and 30% of the variation.
Dr. Sattar, who was not involved in the study, said that because drugs like semaglutide lower weight but also have anti-inflammatory effects, the question becomes: “Could the anti-inflammatory effects be part of the mechanisms by which these drugs affect the risk of major adverse cardiovascular events?”
Reducing Cardiovascular Events
The current analysis, however, cannot answer the question, he said. “All it tells us is about associations.”
“What we do know is semaglutide, predominantly by lowering weight, is lowering CRP levels and equally, we know that when you lose weight, you improve blood pressure, you improve lipids, and you reduce the risk of diabetes,” he said.
Dr. Sattar also took issue with the researchers’ conclusion that the high-sensitivity CRP reductions seen in SELECT occurred prior to major weight loss because the “pattern of CRP reduction and weight reduction is almost identical.”
Dr. Sattar also pointed out in a recent editorial that the drug appears to have a direct effect on blood vessels and the heart, which may lead to improvements in systemic inflammation. Consequently, he said, any assertion that semaglutide is genuinely anti-inflammatory is, at this stage, “speculation.”
Dr. Plutzky said that “systemic, chronic inflammation is implicated as a potential mechanism and therapeutic target in atherosclerosis and major adverse cardiovascular events, as well as obesity,” and high-sensitivity CRP levels are an “established biomarker of inflammation and have been shown to predict cardiovascular risk.”
However, the relationship between high-sensitivity CRP, responses to glucagon-like peptide 1 receptor agonists like semaglutide, and cardiovascular outcomes in obesity “remains incompletely understood,” said Dr. Plutzky.
A version of this article appeared on Medscape.com.
LYON, FRANCE — The anti-obesity drug semaglutide is associated with significant reductions in the inflammatory marker high-sensitivity C-reactive protein (CRP), even in patients who do not lose substantial amounts of weight with the drug, according to data from the SELECT clinical trial.
The research, presented at the European Atherosclerosis Society 2024, involved over 17,600 patients with overweight or obesity and had established cardiovascular disease but not diabetes.
“Weight loss was associated with greater high-sensitivity CRP reduction in both treatment groups,” said study presenter Jorge Plutzky, MD, director of Preventive Cardiology at Brigham and Women’s Hospital, Boston, but “with increased high-sensitivity CRP reductions in those receiving semaglutide.”
The drug also “significantly reduced high-sensitivity CRP early,” he said, “prior to major weight loss and in those who did not lose significant amounts of weight.” The reductions reached approximately 12% at 4 weeks and around 20% at 8 weeks, when the weight loss “was still quite modest,” at 2% and 3% of body weight, respectively. Even among patients who achieved weight loss of less than 2% body weight, semaglutide was associated with a reduction in high-sensitivity CRP levels.
In the SELECT trial, semaglutide also resulted in a consistent reduction of around 20% vs placebo in major adverse cardiovascular events such as cardiovascular mortality, nonfatal myocardial infarction, or nonfatal stroke.
But Naveed Sattar, MD, PhD, professor of cardiometabolic medicine at the University of Glasgow, Scotland, said in an interview that body weight “is probably the major driver” of CRP levels in the population, accounting for between 20% and 30% of the variation.
Dr. Sattar, who was not involved in the study, said that because drugs like semaglutide lower weight but also have anti-inflammatory effects, the question becomes: “Could the anti-inflammatory effects be part of the mechanisms by which these drugs affect the risk of major adverse cardiovascular events?”
Reducing Cardiovascular Events
The current analysis, however, cannot answer the question, he said. “All it tells us is about associations.”
“What we do know is semaglutide, predominantly by lowering weight, is lowering CRP levels and equally, we know that when you lose weight, you improve blood pressure, you improve lipids, and you reduce the risk of diabetes,” he said.
Dr. Sattar also took issue with the researchers’ conclusion that the high-sensitivity CRP reductions seen in SELECT occurred prior to major weight loss because the “pattern of CRP reduction and weight reduction is almost identical.”
Dr. Sattar also pointed out in a recent editorial that the drug appears to have a direct effect on blood vessels and the heart, which may lead to improvements in systemic inflammation. Consequently, he said, any assertion that semaglutide is genuinely anti-inflammatory is, at this stage, “speculation.”
Dr. Plutzky said that “systemic, chronic inflammation is implicated as a potential mechanism and therapeutic target in atherosclerosis and major adverse cardiovascular events, as well as obesity,” and high-sensitivity CRP levels are an “established biomarker of inflammation and have been shown to predict cardiovascular risk.”
However, the relationship between high-sensitivity CRP, responses to glucagon-like peptide 1 receptor agonists like semaglutide, and cardiovascular outcomes in obesity “remains incompletely understood,” said Dr. Plutzky.
A version of this article appeared on Medscape.com.
Diagnostic yield reporting of bronchoscopic peripheral pulmonary nodule biopsies: A call for standardization
THORACIC ONCOLOGY AND CHEST PROCEDURES NETWORK
Interventional Procedures Section
More than 1.5 million Americans are diagnosed with an incidental CT scan-detected lung nodule annually. Advanced bronchoscopy, as a diagnostic tool for evaluation of these nodules, has evolved rapidly, incorporating a range of techniques and tools beyond CT scan-guided biopsies to assess peripheral lesions. The primary goal is to provide patients with accurate benign or malignant diagnoses. However, accurately determining the effectiveness of innovative technologies in providing a diagnosis remains challenging, in part due to limitations in study design and outcome reporting, along with the scarcity of comparative and randomized controlled studies.1,2 Current literature shows significant variability in diagnostic yield definition, lacking generalizability.
To address this issue, an official research statement by the American Thoracic Society and CHEST defines the diagnostic yield as “the proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific malignant or benign diagnosis is established.”3 To achieve this measure, the numerator includes all patients with lung nodules in whom the result of a diagnostic procedure establishes a specific benign or malignant diagnosis that is readily sufficient to inform patient care without additional diagnostic workup, and the denominator should include all patients in whom the procedure was attempted or performed. This standardized definition is crucial for ensuring consistency across studies, allowing for comparison or pooling of results, enhancing the reliability of diagnostic yield data, and informing clinical decisions.
The adoption of standardized outcome definitions is essential to critically evaluate modern, minimally invasive procedures for peripheral lung nodules diagnosis and to guide patient-centered care while minimizing the downstream effects of nondiagnostic biopsies. Clear, transparent, and consistent reporting will enable physicians to choose the most appropriate diagnostic tools, improve patient outcomes by reducing unnecessary procedures, and expedite accurate diagnoses. This initiative is a crucial first step toward creating high-quality studies that can inform technology implementation decisions and promote equitable health care.
References
1. Tanner NT, Yarmus L, Chen A, et al. Standard bronchoscopy with fluoroscopy vs thin bronchoscopy and radial endobronchial ultrasound for biopsy of pulmonary lesions: a multicenter, prospective, randomized trial. Chest. 2018;154(5):1035-1043.
2. Ost DE, Ernst A, Lei X, et al. Diagnostic yield and complications of bronchoscopy for peripheral lung lesions. Results of the AQuIRE Registry. Am J Resp Crit Care Med. 2016;193(1):68-77.
3. Gonzalez AV, Silvestri GA, Korevaar DA, et al. Assessment of advanced diagnostic bronchoscopy outcomes for peripheral lung lesions: a Delphi consensus definition of diagnostic yield and recommendations for patient-centered study designs. An official American Thoracic Society/American College of Chest Physicians research statement. Am J Respir Crit Care Med. 2024;209(6):634-646.
THORACIC ONCOLOGY AND CHEST PROCEDURES NETWORK
Interventional Procedures Section
More than 1.5 million Americans are diagnosed with an incidental CT scan-detected lung nodule annually. Advanced bronchoscopy, as a diagnostic tool for evaluation of these nodules, has evolved rapidly, incorporating a range of techniques and tools beyond CT scan-guided biopsies to assess peripheral lesions. The primary goal is to provide patients with accurate benign or malignant diagnoses. However, accurately determining the effectiveness of innovative technologies in providing a diagnosis remains challenging, in part due to limitations in study design and outcome reporting, along with the scarcity of comparative and randomized controlled studies.1,2 Current literature shows significant variability in diagnostic yield definition, lacking generalizability.
To address this issue, an official research statement by the American Thoracic Society and CHEST defines the diagnostic yield as “the proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific malignant or benign diagnosis is established.”3 To achieve this measure, the numerator includes all patients with lung nodules in whom the result of a diagnostic procedure establishes a specific benign or malignant diagnosis that is readily sufficient to inform patient care without additional diagnostic workup, and the denominator should include all patients in whom the procedure was attempted or performed. This standardized definition is crucial for ensuring consistency across studies, allowing for comparison or pooling of results, enhancing the reliability of diagnostic yield data, and informing clinical decisions.
The adoption of standardized outcome definitions is essential to critically evaluate modern, minimally invasive procedures for peripheral lung nodules diagnosis and to guide patient-centered care while minimizing the downstream effects of nondiagnostic biopsies. Clear, transparent, and consistent reporting will enable physicians to choose the most appropriate diagnostic tools, improve patient outcomes by reducing unnecessary procedures, and expedite accurate diagnoses. This initiative is a crucial first step toward creating high-quality studies that can inform technology implementation decisions and promote equitable health care.
References
1. Tanner NT, Yarmus L, Chen A, et al. Standard bronchoscopy with fluoroscopy vs thin bronchoscopy and radial endobronchial ultrasound for biopsy of pulmonary lesions: a multicenter, prospective, randomized trial. Chest. 2018;154(5):1035-1043.
2. Ost DE, Ernst A, Lei X, et al. Diagnostic yield and complications of bronchoscopy for peripheral lung lesions. Results of the AQuIRE Registry. Am J Resp Crit Care Med. 2016;193(1):68-77.
3. Gonzalez AV, Silvestri GA, Korevaar DA, et al. Assessment of advanced diagnostic bronchoscopy outcomes for peripheral lung lesions: a Delphi consensus definition of diagnostic yield and recommendations for patient-centered study designs. An official American Thoracic Society/American College of Chest Physicians research statement. Am J Respir Crit Care Med. 2024;209(6):634-646.
THORACIC ONCOLOGY AND CHEST PROCEDURES NETWORK
Interventional Procedures Section
More than 1.5 million Americans are diagnosed with an incidental CT scan-detected lung nodule annually. Advanced bronchoscopy, as a diagnostic tool for evaluation of these nodules, has evolved rapidly, incorporating a range of techniques and tools beyond CT scan-guided biopsies to assess peripheral lesions. The primary goal is to provide patients with accurate benign or malignant diagnoses. However, accurately determining the effectiveness of innovative technologies in providing a diagnosis remains challenging, in part due to limitations in study design and outcome reporting, along with the scarcity of comparative and randomized controlled studies.1,2 Current literature shows significant variability in diagnostic yield definition, lacking generalizability.
To address this issue, an official research statement by the American Thoracic Society and CHEST defines the diagnostic yield as “the proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific malignant or benign diagnosis is established.”3 To achieve this measure, the numerator includes all patients with lung nodules in whom the result of a diagnostic procedure establishes a specific benign or malignant diagnosis that is readily sufficient to inform patient care without additional diagnostic workup, and the denominator should include all patients in whom the procedure was attempted or performed. This standardized definition is crucial for ensuring consistency across studies, allowing for comparison or pooling of results, enhancing the reliability of diagnostic yield data, and informing clinical decisions.
The adoption of standardized outcome definitions is essential to critically evaluate modern, minimally invasive procedures for peripheral lung nodules diagnosis and to guide patient-centered care while minimizing the downstream effects of nondiagnostic biopsies. Clear, transparent, and consistent reporting will enable physicians to choose the most appropriate diagnostic tools, improve patient outcomes by reducing unnecessary procedures, and expedite accurate diagnoses. This initiative is a crucial first step toward creating high-quality studies that can inform technology implementation decisions and promote equitable health care.
References
1. Tanner NT, Yarmus L, Chen A, et al. Standard bronchoscopy with fluoroscopy vs thin bronchoscopy and radial endobronchial ultrasound for biopsy of pulmonary lesions: a multicenter, prospective, randomized trial. Chest. 2018;154(5):1035-1043.
2. Ost DE, Ernst A, Lei X, et al. Diagnostic yield and complications of bronchoscopy for peripheral lung lesions. Results of the AQuIRE Registry. Am J Resp Crit Care Med. 2016;193(1):68-77.
3. Gonzalez AV, Silvestri GA, Korevaar DA, et al. Assessment of advanced diagnostic bronchoscopy outcomes for peripheral lung lesions: a Delphi consensus definition of diagnostic yield and recommendations for patient-centered study designs. An official American Thoracic Society/American College of Chest Physicians research statement. Am J Respir Crit Care Med. 2024;209(6):634-646.
Post–intensive care syndrome and insomnia
SLEEP MEDICINE NETWORK
Nonrespiratory Sleep Section
There has been a recent interest in post–intensive care syndrome (PICS), as an increasing number of patients are surviving critical illness. PICS is defined as “new onset or worsening of impairments in physical, cognitive, and/or mental health that arises after an ICU stay and persists beyond hospital discharge.1 We know that poor sleep is a common occurrence in the ICU, which can contribute to cognitive impairment and could be due to various risk factors, including age, individual comorbidities, reason for admission, and ICU interventions.2 Sleep impairment after hospital discharge is highly prevalent for up to 1 year after hospitalization.
The most common sleep impairment described after hospital discharge from the ICU is insomnia, which coexists with anxiety, depression, and posttraumatic stress disorder.3 When patients are seen in a post-ICU clinic, a multimodal strategy is needed for the treatment of insomnia, which includes practicing good sleep hygiene, cognitive behavioral therapy for insomnia (CBT-I), and pharmacotherapy if indicated.
Since the American Academy of Sleep Medicine (AASM) 2021 clinical practice guideline on behavioral and psychological treatments for chronic insomnia, which made a strong recommendation for CBT-I, we continue to face barriers to incorporating CBT-I into our own clinical practice.4 This is due to limited access to CBT-I psychotherapists and patients’ lack of knowledge or treatment beliefs, among other reasons. However, there are numerous digital CBT-I platforms that patients can freely access from their mobile phone and are listed in the AASM article, “Digital cognitive behavioral therapy for insomnia: Platforms and characteristics,” which can help with treatment of insomnia.
For patients who are seen in post-ICU clinics, the first step in treating insomnia is discussing good sleep hygiene, providing resources for CBT-I (digital or in person), and treating coexistent psychiatric conditions.
References
1. Rawal G, Yadav S, Kumar R. Post-intensive care syndrome: an overview. J Transl Int Med. 2017;5(2):90-92.
2. Zampieri FG, et al. Ann Am Thorac Soc. 2023;20(11):1558-1560.
3. Altman MT, Knauert MP, Pisani MA. Sleep disturbance after hospitalization and critical illness: a systematic review. Ann Am Thorac Soc. 2017;14(9):1457-1468.
4. Edinger JD, Arnedt JT, Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021;17(2):255-262.
SLEEP MEDICINE NETWORK
Nonrespiratory Sleep Section
There has been a recent interest in post–intensive care syndrome (PICS), as an increasing number of patients are surviving critical illness. PICS is defined as “new onset or worsening of impairments in physical, cognitive, and/or mental health that arises after an ICU stay and persists beyond hospital discharge.1 We know that poor sleep is a common occurrence in the ICU, which can contribute to cognitive impairment and could be due to various risk factors, including age, individual comorbidities, reason for admission, and ICU interventions.2 Sleep impairment after hospital discharge is highly prevalent for up to 1 year after hospitalization.
The most common sleep impairment described after hospital discharge from the ICU is insomnia, which coexists with anxiety, depression, and posttraumatic stress disorder.3 When patients are seen in a post-ICU clinic, a multimodal strategy is needed for the treatment of insomnia, which includes practicing good sleep hygiene, cognitive behavioral therapy for insomnia (CBT-I), and pharmacotherapy if indicated.
Since the American Academy of Sleep Medicine (AASM) 2021 clinical practice guideline on behavioral and psychological treatments for chronic insomnia, which made a strong recommendation for CBT-I, we continue to face barriers to incorporating CBT-I into our own clinical practice.4 This is due to limited access to CBT-I psychotherapists and patients’ lack of knowledge or treatment beliefs, among other reasons. However, there are numerous digital CBT-I platforms that patients can freely access from their mobile phone and are listed in the AASM article, “Digital cognitive behavioral therapy for insomnia: Platforms and characteristics,” which can help with treatment of insomnia.
For patients who are seen in post-ICU clinics, the first step in treating insomnia is discussing good sleep hygiene, providing resources for CBT-I (digital or in person), and treating coexistent psychiatric conditions.
References
1. Rawal G, Yadav S, Kumar R. Post-intensive care syndrome: an overview. J Transl Int Med. 2017;5(2):90-92.
2. Zampieri FG, et al. Ann Am Thorac Soc. 2023;20(11):1558-1560.
3. Altman MT, Knauert MP, Pisani MA. Sleep disturbance after hospitalization and critical illness: a systematic review. Ann Am Thorac Soc. 2017;14(9):1457-1468.
4. Edinger JD, Arnedt JT, Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021;17(2):255-262.
SLEEP MEDICINE NETWORK
Nonrespiratory Sleep Section
There has been a recent interest in post–intensive care syndrome (PICS), as an increasing number of patients are surviving critical illness. PICS is defined as “new onset or worsening of impairments in physical, cognitive, and/or mental health that arises after an ICU stay and persists beyond hospital discharge.1 We know that poor sleep is a common occurrence in the ICU, which can contribute to cognitive impairment and could be due to various risk factors, including age, individual comorbidities, reason for admission, and ICU interventions.2 Sleep impairment after hospital discharge is highly prevalent for up to 1 year after hospitalization.
The most common sleep impairment described after hospital discharge from the ICU is insomnia, which coexists with anxiety, depression, and posttraumatic stress disorder.3 When patients are seen in a post-ICU clinic, a multimodal strategy is needed for the treatment of insomnia, which includes practicing good sleep hygiene, cognitive behavioral therapy for insomnia (CBT-I), and pharmacotherapy if indicated.
Since the American Academy of Sleep Medicine (AASM) 2021 clinical practice guideline on behavioral and psychological treatments for chronic insomnia, which made a strong recommendation for CBT-I, we continue to face barriers to incorporating CBT-I into our own clinical practice.4 This is due to limited access to CBT-I psychotherapists and patients’ lack of knowledge or treatment beliefs, among other reasons. However, there are numerous digital CBT-I platforms that patients can freely access from their mobile phone and are listed in the AASM article, “Digital cognitive behavioral therapy for insomnia: Platforms and characteristics,” which can help with treatment of insomnia.
For patients who are seen in post-ICU clinics, the first step in treating insomnia is discussing good sleep hygiene, providing resources for CBT-I (digital or in person), and treating coexistent psychiatric conditions.
References
1. Rawal G, Yadav S, Kumar R. Post-intensive care syndrome: an overview. J Transl Int Med. 2017;5(2):90-92.
2. Zampieri FG, et al. Ann Am Thorac Soc. 2023;20(11):1558-1560.
3. Altman MT, Knauert MP, Pisani MA. Sleep disturbance after hospitalization and critical illness: a systematic review. Ann Am Thorac Soc. 2017;14(9):1457-1468.
4. Edinger JD, Arnedt JT, Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021;17(2):255-262.
Short telomere length and immunosuppression: Updates in nonidiopathic pulmonary fibrosis, interstitial lung disease
DIFFUSE LUNG DISEASE AND LUNG TRANSPLANT NETWORK
Interstitial Lung Disease Section
Interstitial lung diseases (ILDs) are a diverse group of relentlessly progressive fibroinflammatory disorders. Pharmacotherapy includes antifibrotics and immunosuppressants as foundational strategies to mitigate loss of lung function. There has been a growing interest in telomere length and its response to immunosuppression in the ILD community.
Telomeres are repetitive nucleotide sequences that “cap” chromosomes and protect against chromosomal shortening during cell replication. Genetic and environmental factors can lead to premature shortening of telomeres. Once a critical length is reached, the cell enters senescence. Short telomere length has been linked to rapid progression, worse outcomes, and poor response to immunosuppressants in idiopathic pulmonary fibrosis (IPF).
Data in patients with non-IPF ILD (which is arguably more difficult to diagnose and manage) were lacking until a recent retrospective cohort study of patients from five centers across the US demonstrated that immunosuppressant exposure in patients with age-adjusted telomere length <10th percentile was associated with a reduced 2-year transplant-free survival in fibrotic hypersensitivity pneumonitis and unclassifiable ILD subgroups.1 This study was underpowered to detect associations in the connective tissue disease-ILD group. Interestingly, authors noted that immunosuppressant exposure was not associated with lung function decline in the short telomere group, suggesting that worse outcomes may be attributable to unmasking extrapulmonary manifestations of short telomeres, such as bone marrow failure and impaired adaptive immunity. Studies like these are essential to guide decision-making in the age of personalized medicine and underscore the necessity for prospective studies to validate these findings.
References
1. Zhang D, Adegunsoye A, Oldham JM, et al. Telomere length and immunosuppression in non-idiopathic pulmonary fibrosis interstitial lung disease. Eur Respir J. 2023;62(5):2300441.
DIFFUSE LUNG DISEASE AND LUNG TRANSPLANT NETWORK
Interstitial Lung Disease Section
Interstitial lung diseases (ILDs) are a diverse group of relentlessly progressive fibroinflammatory disorders. Pharmacotherapy includes antifibrotics and immunosuppressants as foundational strategies to mitigate loss of lung function. There has been a growing interest in telomere length and its response to immunosuppression in the ILD community.
Telomeres are repetitive nucleotide sequences that “cap” chromosomes and protect against chromosomal shortening during cell replication. Genetic and environmental factors can lead to premature shortening of telomeres. Once a critical length is reached, the cell enters senescence. Short telomere length has been linked to rapid progression, worse outcomes, and poor response to immunosuppressants in idiopathic pulmonary fibrosis (IPF).
Data in patients with non-IPF ILD (which is arguably more difficult to diagnose and manage) were lacking until a recent retrospective cohort study of patients from five centers across the US demonstrated that immunosuppressant exposure in patients with age-adjusted telomere length <10th percentile was associated with a reduced 2-year transplant-free survival in fibrotic hypersensitivity pneumonitis and unclassifiable ILD subgroups.1 This study was underpowered to detect associations in the connective tissue disease-ILD group. Interestingly, authors noted that immunosuppressant exposure was not associated with lung function decline in the short telomere group, suggesting that worse outcomes may be attributable to unmasking extrapulmonary manifestations of short telomeres, such as bone marrow failure and impaired adaptive immunity. Studies like these are essential to guide decision-making in the age of personalized medicine and underscore the necessity for prospective studies to validate these findings.
References
1. Zhang D, Adegunsoye A, Oldham JM, et al. Telomere length and immunosuppression in non-idiopathic pulmonary fibrosis interstitial lung disease. Eur Respir J. 2023;62(5):2300441.
DIFFUSE LUNG DISEASE AND LUNG TRANSPLANT NETWORK
Interstitial Lung Disease Section
Interstitial lung diseases (ILDs) are a diverse group of relentlessly progressive fibroinflammatory disorders. Pharmacotherapy includes antifibrotics and immunosuppressants as foundational strategies to mitigate loss of lung function. There has been a growing interest in telomere length and its response to immunosuppression in the ILD community.
Telomeres are repetitive nucleotide sequences that “cap” chromosomes and protect against chromosomal shortening during cell replication. Genetic and environmental factors can lead to premature shortening of telomeres. Once a critical length is reached, the cell enters senescence. Short telomere length has been linked to rapid progression, worse outcomes, and poor response to immunosuppressants in idiopathic pulmonary fibrosis (IPF).
Data in patients with non-IPF ILD (which is arguably more difficult to diagnose and manage) were lacking until a recent retrospective cohort study of patients from five centers across the US demonstrated that immunosuppressant exposure in patients with age-adjusted telomere length <10th percentile was associated with a reduced 2-year transplant-free survival in fibrotic hypersensitivity pneumonitis and unclassifiable ILD subgroups.1 This study was underpowered to detect associations in the connective tissue disease-ILD group. Interestingly, authors noted that immunosuppressant exposure was not associated with lung function decline in the short telomere group, suggesting that worse outcomes may be attributable to unmasking extrapulmonary manifestations of short telomeres, such as bone marrow failure and impaired adaptive immunity. Studies like these are essential to guide decision-making in the age of personalized medicine and underscore the necessity for prospective studies to validate these findings.
References
1. Zhang D, Adegunsoye A, Oldham JM, et al. Telomere length and immunosuppression in non-idiopathic pulmonary fibrosis interstitial lung disease. Eur Respir J. 2023;62(5):2300441.
Expanding recommendations for RSV vaccination
AIRWAYS DISORDERS NETWORK
Asthma and COPD Section
Respiratory syncytial virus (RSV) has been increasingly recognized as a prevalent cause of lower respiratory tract infection (LRTI) among adults in the United States. The risk of hospitalization and mortality from RSV-associated respiratory failure is higher in those with chronic lung disease. In adults aged 65 years or older, RSV has shown to cause up to 160,000 hospitalizations and 10,000 deaths annually.
RSV has been well established as a major cause of LRTI and morbidity among infants. Maternal vaccination with RSVPreF in patients who are pregnant is suggested between 32 0/7 and 36 6/7 weeks of gestation if the date of delivery falls during RSV season to prevent severe illness in young infants in their first months of life. At present, there are no data supporting vaccine administration to patients who are pregnant delivering outside of the RSV season.
What about the rest of the patients? A phase 3b clinical trial to assess the safety and immunogenicity of the RSVPreF3 vaccine in individuals 18 to 49 years of age at increased risk for RSV LRTI, including those with chronic respiratory diseases, is currently underway with projected completion in April 2025 (clinical trials.gov; ID NCT06389487). Additional studies examining safety and immunogenicity combining RSV vaccines with PCV20, influenza, COVID, or Tdap vaccines are also underway. These outcomes will be significant for future recommendations to further lower the risk of developing LRTI, hospitalization, and death among patients less than the age of 60 with chronic lung diseases.
Resources
1. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(29):793-801.
2. Healthcare Providers: RSV Vaccination for Adults 60 Years of Age and Over. Centers for Disease Control and Prevention. Updated March 1, 2024. https://www.cdc.gov/vaccines/vpd/rsv/hcp/older-adults.html
3. Ault KA, Hughes BL, Riley LE. Maternal Respiratory Syncytial Virus Vaccination. The American College of Obstetricians and Gynecologists. Updated December 11, 2023. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccination
AIRWAYS DISORDERS NETWORK
Asthma and COPD Section
Respiratory syncytial virus (RSV) has been increasingly recognized as a prevalent cause of lower respiratory tract infection (LRTI) among adults in the United States. The risk of hospitalization and mortality from RSV-associated respiratory failure is higher in those with chronic lung disease. In adults aged 65 years or older, RSV has shown to cause up to 160,000 hospitalizations and 10,000 deaths annually.
RSV has been well established as a major cause of LRTI and morbidity among infants. Maternal vaccination with RSVPreF in patients who are pregnant is suggested between 32 0/7 and 36 6/7 weeks of gestation if the date of delivery falls during RSV season to prevent severe illness in young infants in their first months of life. At present, there are no data supporting vaccine administration to patients who are pregnant delivering outside of the RSV season.
What about the rest of the patients? A phase 3b clinical trial to assess the safety and immunogenicity of the RSVPreF3 vaccine in individuals 18 to 49 years of age at increased risk for RSV LRTI, including those with chronic respiratory diseases, is currently underway with projected completion in April 2025 (clinical trials.gov; ID NCT06389487). Additional studies examining safety and immunogenicity combining RSV vaccines with PCV20, influenza, COVID, or Tdap vaccines are also underway. These outcomes will be significant for future recommendations to further lower the risk of developing LRTI, hospitalization, and death among patients less than the age of 60 with chronic lung diseases.
Resources
1. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(29):793-801.
2. Healthcare Providers: RSV Vaccination for Adults 60 Years of Age and Over. Centers for Disease Control and Prevention. Updated March 1, 2024. https://www.cdc.gov/vaccines/vpd/rsv/hcp/older-adults.html
3. Ault KA, Hughes BL, Riley LE. Maternal Respiratory Syncytial Virus Vaccination. The American College of Obstetricians and Gynecologists. Updated December 11, 2023. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccination
AIRWAYS DISORDERS NETWORK
Asthma and COPD Section
Respiratory syncytial virus (RSV) has been increasingly recognized as a prevalent cause of lower respiratory tract infection (LRTI) among adults in the United States. The risk of hospitalization and mortality from RSV-associated respiratory failure is higher in those with chronic lung disease. In adults aged 65 years or older, RSV has shown to cause up to 160,000 hospitalizations and 10,000 deaths annually.
RSV has been well established as a major cause of LRTI and morbidity among infants. Maternal vaccination with RSVPreF in patients who are pregnant is suggested between 32 0/7 and 36 6/7 weeks of gestation if the date of delivery falls during RSV season to prevent severe illness in young infants in their first months of life. At present, there are no data supporting vaccine administration to patients who are pregnant delivering outside of the RSV season.
What about the rest of the patients? A phase 3b clinical trial to assess the safety and immunogenicity of the RSVPreF3 vaccine in individuals 18 to 49 years of age at increased risk for RSV LRTI, including those with chronic respiratory diseases, is currently underway with projected completion in April 2025 (clinical trials.gov; ID NCT06389487). Additional studies examining safety and immunogenicity combining RSV vaccines with PCV20, influenza, COVID, or Tdap vaccines are also underway. These outcomes will be significant for future recommendations to further lower the risk of developing LRTI, hospitalization, and death among patients less than the age of 60 with chronic lung diseases.
Resources
1. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(29):793-801.
2. Healthcare Providers: RSV Vaccination for Adults 60 Years of Age and Over. Centers for Disease Control and Prevention. Updated March 1, 2024. https://www.cdc.gov/vaccines/vpd/rsv/hcp/older-adults.html
3. Ault KA, Hughes BL, Riley LE. Maternal Respiratory Syncytial Virus Vaccination. The American College of Obstetricians and Gynecologists. Updated December 11, 2023. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccination
Bringing trainee wellness to the forefront
Researching the impact of reflection in medical training
Before the spread of COVID-19, and increasingly during the pandemic, Ilana Krumm, MD, noticed a burgeoning focus on wellness for trainees and how to combat burnout in the medical space.
But Dr. Krumm also noticed that most of the existing programs focused on the individual level, rather than the system level. The onus was on the trainees to manage their wellness and burnout.
“I wanted to look at something that could be instituted at a systems level as opposed to putting all the burden of this wellness on the resident, as someone who already has a huge burden of work, stress, and time constraints as they try to learn their discipline,” Dr. Krumm said. “Asking them to meditate on their own time seemed very impractical.”
Eager to research this idea, Dr. Krumm applied for the CHEST Research Grant in Medical Education.
“The fact that CHEST is willing to support medical education research is really important for all those trying to better the educational environment. Although there’s a movement toward more support for medical education research and more recognition of its value, I think the fact that CHEST has already done so has helped advance the field and the support for the field as a whole,” Dr. Krumm said.
“Having the support from a reputable institution like CHEST inherently gave the work that I was doing value,” Dr. Krumm said. “It gave folks an understanding that this research in medical education has importance.”
Dr. Krumm’s project focused on the monthly Reflection Rounds between the ICU, palliative care, and chaplaincy staff that were held at the Seattle VA Medical Center, where residents could discuss the challenges of caring for critically ill patients during a protected time. While similar interventions around death and dying have been shown to help residents reduce burnout in medical intensive care rotations, it was unknown which aspects of these sessions would be most effective.
Participant interviews were conducted before and after the residents’ monthly sessions to understand the impact these sessions had on wellness and burnout levels.
“With the grant funding from CHEST, our team was able to purchase the recording equipment, transcription, and software necessary to complete a thorough qualitative research project, which greatly accelerated the project timeline,” she said.
Through these interviews, Dr. Krumm’s team identified three key themes that shed light on the impact of Reflection Rounds.
1. Cultural precedent
Participants were encouraged to participate as little or as much as they wanted during the session. Despite some residents being less vocal during these discussions, every resident agreed that this type of session set an important cultural precedent in their program and acknowledged the value of a program that encouraged space for decompression and reflection.
2. Shared experiences
During this project, many residents experienced an increased sense of isolation, as COVID-19 precautions were stricter in the ICU. Having this protected time together allowed residents to discover their shared experiences and find comfort in them while feeling supported.
“A lot of residents commented that it was nice to know that others were going through this as well or that they were also finding this particular instance difficult,” Dr. Krumm said.
3. Ritual
At the opening of each hour-long session, participants were invited to light a candle and say aloud or think to themselves the name of a patient they had lost, had a hard time with, or cared for during their time in the ICU.
“Every single person pointed to that moment as meaningful and impactful,” Dr. Krumm said.
This ritual gave the residents time to center and have a common focus with their peers to think about patient stories that they were carrying with them.
“Maybe just incorporating a small moment like that, a point of reflection, could potentially have a big impact on the weight we carry as providers who care for [patients who are] critically ill,” Dr. Krumm said. “What I’ve learned from this project will make me a better leader in the ICU, not only in taking care of critically ill individuals but also in taking care of the team doing that work.”
Dr. Krumm credits the CHEST grant funding and subsequent research project with helping her join a highly competitive fellowship program at the University of California San Francisco, where she can continue to conduct research in the field of medical education.
“I am working closely with medical education faculty and peers to design new research studies and further establish myself in the field of medical education, leading to my ultimate goal of becoming a program director at a strong med-ed-focused program.”
This article was adapted from the Spring 2024 online issue of CHEST Advocates. For the full article—and to engage with the other content from this issue—visit chestnet.org/chest-advocates.
Support CHEST grants like this
Through clinical research grants, CHEST assists in acquiring vital data and clinically important results that can advance medical care. You can help support projects like this by making a gift to CHEST.
MAKE A GIFT » | LEARN ABOUT CHEST PHILANTHROPY »
Researching the impact of reflection in medical training
Researching the impact of reflection in medical training
Before the spread of COVID-19, and increasingly during the pandemic, Ilana Krumm, MD, noticed a burgeoning focus on wellness for trainees and how to combat burnout in the medical space.
But Dr. Krumm also noticed that most of the existing programs focused on the individual level, rather than the system level. The onus was on the trainees to manage their wellness and burnout.
“I wanted to look at something that could be instituted at a systems level as opposed to putting all the burden of this wellness on the resident, as someone who already has a huge burden of work, stress, and time constraints as they try to learn their discipline,” Dr. Krumm said. “Asking them to meditate on their own time seemed very impractical.”
Eager to research this idea, Dr. Krumm applied for the CHEST Research Grant in Medical Education.
“The fact that CHEST is willing to support medical education research is really important for all those trying to better the educational environment. Although there’s a movement toward more support for medical education research and more recognition of its value, I think the fact that CHEST has already done so has helped advance the field and the support for the field as a whole,” Dr. Krumm said.
“Having the support from a reputable institution like CHEST inherently gave the work that I was doing value,” Dr. Krumm said. “It gave folks an understanding that this research in medical education has importance.”
Dr. Krumm’s project focused on the monthly Reflection Rounds between the ICU, palliative care, and chaplaincy staff that were held at the Seattle VA Medical Center, where residents could discuss the challenges of caring for critically ill patients during a protected time. While similar interventions around death and dying have been shown to help residents reduce burnout in medical intensive care rotations, it was unknown which aspects of these sessions would be most effective.
Participant interviews were conducted before and after the residents’ monthly sessions to understand the impact these sessions had on wellness and burnout levels.
“With the grant funding from CHEST, our team was able to purchase the recording equipment, transcription, and software necessary to complete a thorough qualitative research project, which greatly accelerated the project timeline,” she said.
Through these interviews, Dr. Krumm’s team identified three key themes that shed light on the impact of Reflection Rounds.
1. Cultural precedent
Participants were encouraged to participate as little or as much as they wanted during the session. Despite some residents being less vocal during these discussions, every resident agreed that this type of session set an important cultural precedent in their program and acknowledged the value of a program that encouraged space for decompression and reflection.
2. Shared experiences
During this project, many residents experienced an increased sense of isolation, as COVID-19 precautions were stricter in the ICU. Having this protected time together allowed residents to discover their shared experiences and find comfort in them while feeling supported.
“A lot of residents commented that it was nice to know that others were going through this as well or that they were also finding this particular instance difficult,” Dr. Krumm said.
3. Ritual
At the opening of each hour-long session, participants were invited to light a candle and say aloud or think to themselves the name of a patient they had lost, had a hard time with, or cared for during their time in the ICU.
“Every single person pointed to that moment as meaningful and impactful,” Dr. Krumm said.
This ritual gave the residents time to center and have a common focus with their peers to think about patient stories that they were carrying with them.
“Maybe just incorporating a small moment like that, a point of reflection, could potentially have a big impact on the weight we carry as providers who care for [patients who are] critically ill,” Dr. Krumm said. “What I’ve learned from this project will make me a better leader in the ICU, not only in taking care of critically ill individuals but also in taking care of the team doing that work.”
Dr. Krumm credits the CHEST grant funding and subsequent research project with helping her join a highly competitive fellowship program at the University of California San Francisco, where she can continue to conduct research in the field of medical education.
“I am working closely with medical education faculty and peers to design new research studies and further establish myself in the field of medical education, leading to my ultimate goal of becoming a program director at a strong med-ed-focused program.”
This article was adapted from the Spring 2024 online issue of CHEST Advocates. For the full article—and to engage with the other content from this issue—visit chestnet.org/chest-advocates.
Support CHEST grants like this
Through clinical research grants, CHEST assists in acquiring vital data and clinically important results that can advance medical care. You can help support projects like this by making a gift to CHEST.
MAKE A GIFT » | LEARN ABOUT CHEST PHILANTHROPY »
Before the spread of COVID-19, and increasingly during the pandemic, Ilana Krumm, MD, noticed a burgeoning focus on wellness for trainees and how to combat burnout in the medical space.
But Dr. Krumm also noticed that most of the existing programs focused on the individual level, rather than the system level. The onus was on the trainees to manage their wellness and burnout.
“I wanted to look at something that could be instituted at a systems level as opposed to putting all the burden of this wellness on the resident, as someone who already has a huge burden of work, stress, and time constraints as they try to learn their discipline,” Dr. Krumm said. “Asking them to meditate on their own time seemed very impractical.”
Eager to research this idea, Dr. Krumm applied for the CHEST Research Grant in Medical Education.
“The fact that CHEST is willing to support medical education research is really important for all those trying to better the educational environment. Although there’s a movement toward more support for medical education research and more recognition of its value, I think the fact that CHEST has already done so has helped advance the field and the support for the field as a whole,” Dr. Krumm said.
“Having the support from a reputable institution like CHEST inherently gave the work that I was doing value,” Dr. Krumm said. “It gave folks an understanding that this research in medical education has importance.”
Dr. Krumm’s project focused on the monthly Reflection Rounds between the ICU, palliative care, and chaplaincy staff that were held at the Seattle VA Medical Center, where residents could discuss the challenges of caring for critically ill patients during a protected time. While similar interventions around death and dying have been shown to help residents reduce burnout in medical intensive care rotations, it was unknown which aspects of these sessions would be most effective.
Participant interviews were conducted before and after the residents’ monthly sessions to understand the impact these sessions had on wellness and burnout levels.
“With the grant funding from CHEST, our team was able to purchase the recording equipment, transcription, and software necessary to complete a thorough qualitative research project, which greatly accelerated the project timeline,” she said.
Through these interviews, Dr. Krumm’s team identified three key themes that shed light on the impact of Reflection Rounds.
1. Cultural precedent
Participants were encouraged to participate as little or as much as they wanted during the session. Despite some residents being less vocal during these discussions, every resident agreed that this type of session set an important cultural precedent in their program and acknowledged the value of a program that encouraged space for decompression and reflection.
2. Shared experiences
During this project, many residents experienced an increased sense of isolation, as COVID-19 precautions were stricter in the ICU. Having this protected time together allowed residents to discover their shared experiences and find comfort in them while feeling supported.
“A lot of residents commented that it was nice to know that others were going through this as well or that they were also finding this particular instance difficult,” Dr. Krumm said.
3. Ritual
At the opening of each hour-long session, participants were invited to light a candle and say aloud or think to themselves the name of a patient they had lost, had a hard time with, or cared for during their time in the ICU.
“Every single person pointed to that moment as meaningful and impactful,” Dr. Krumm said.
This ritual gave the residents time to center and have a common focus with their peers to think about patient stories that they were carrying with them.
“Maybe just incorporating a small moment like that, a point of reflection, could potentially have a big impact on the weight we carry as providers who care for [patients who are] critically ill,” Dr. Krumm said. “What I’ve learned from this project will make me a better leader in the ICU, not only in taking care of critically ill individuals but also in taking care of the team doing that work.”
Dr. Krumm credits the CHEST grant funding and subsequent research project with helping her join a highly competitive fellowship program at the University of California San Francisco, where she can continue to conduct research in the field of medical education.
“I am working closely with medical education faculty and peers to design new research studies and further establish myself in the field of medical education, leading to my ultimate goal of becoming a program director at a strong med-ed-focused program.”
This article was adapted from the Spring 2024 online issue of CHEST Advocates. For the full article—and to engage with the other content from this issue—visit chestnet.org/chest-advocates.
Support CHEST grants like this
Through clinical research grants, CHEST assists in acquiring vital data and clinically important results that can advance medical care. You can help support projects like this by making a gift to CHEST.
MAKE A GIFT » | LEARN ABOUT CHEST PHILANTHROPY »
Coding & billing: A look into G2211 for visit complexities
This add-on code is for new (99202-99205) and established (99212-99215) office visits. CMS created this add-on code to address the additional costs and resources associated with providing longitudinal care.
G2211 – Visit complexity inherent to evaluation and management (E/M) associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious condition, or a complex condition (Add-on code; list separately in addition to office/outpatient (O/O) E/M visit, new or established)
The documentation should demonstrate the intent and need for ongoing care. Otherwise, no additional documentation is required. CMS pays $16.04 for each service (wRVU = 0.33). It may be reported each time the patient is seen, and there is currently no limit to how often it may be used. Also, there is no additional copay requirement for patients.
Do’s and don’ts
Do report in the following situations when longitudinal care is provided:
- The provider has or intends to have a long-term, ongoing relationship with the patient (ie, G2211 can be used for a new patient visit)
- Audio/video virtual visits
- May be reported with Prolonged Care Services G2212
- When advanced practice providers or physician colleagues in the same specialty practice see the patient (ie, if you see the patient for an urgent visit, but the patient is usually followed by your partner, you can still use G2211)
- When working with graduate medical education trainees (along with the -GC modifier), and as long as the conditions described in the description of G2211 are met
Do NOT report in the following situations:
- If modifier -25 is appended to the E/M service when another service is provided on the same day (eg, pulmonary function tests, 6-minute walk tests, immunization)
- Audio-only virtual visits, hospital, skilled nursing facility, or long-term acute care hospital
- If the patient is not expected to return for ongoing care
- If the reason for longitudinal care does not include a “single, serious condition or a complex condition” (eg, annual visits for a stable 6 mm lung nodule)
CMS expects that this will be billed with 38% of all E/M services initially and potentially up to 54% over time. We feel this is reimbursement for the work being done to care for our patients with single, serious, or complex conditions. Both Medicare and Medicare Advantage plans are expected to reimburse for this service. Whether other payers will do the same is unclear, but it will become clear with time and further negotiation at the local level. In the meantime, members are encouraged to report this code for all appropriate patient encounters.
Questions and answers — G2211
Question: What private insurances cover G2211?
Answer: As of March 1, 2024, four national payers have confirmed coverage of G2211:
- Cigna (Medicare Advantage only),
- Humana (commercial and Medicare Advantage),
- United Healthcare (commercial and Medicare Advantage), and
- Aetna (Medicare Advantage).
Question: What needs to be documented for G2211?
Answer: CMS states, “You must document the reason for billing the office and outpatient (O/O) and evaluation and management (E/M). The visits themselves would need to be medically reasonable and necessary for the practitioner to report G2211. In addition, the documentation would need to illustrate medical necessity of the O/O E/M visit. We [CMS] haven’t required additional documentation.”
American Thoracic Society (ATS) and CHEST also recommend including a detailed assessment and plan for the visit, as well as any follow-up. The complexity of the visit should be clear in your documentation to support the medical necessity for reporting the G2211.
Question: How can a provider show that a new patient visit (99202-99205) is part of continuing care?
Answer: The treating practitioner should make sure their documentation supports their intent to provide ongoing care to the patient. Establishing such intent goes beyond a statement that the provider plans to provide ongoing care or schedule a follow-up visit. The circumstances of the visit should support the extra work involved in becoming the focal point of the patient’s care or providing ongoing care for a serious or complex condition.
Question: Dr. Red works at a primary care practice, is the focal point for a patient’s care, and has reported G2211. If Dr. Yellow, who is in the same specialty, or Mr. Green, a nurse practitioner, is covering for Dr. Red, and the patient comes in for a visit, can they report G2211 for that visit?
Answer: Yes. The same specialty/same provider rules would apply in this situation. But remember that Dr. Yellow’s or Mr. Green’s documentation for that encounter must support the code.
Question: Can a resident report G2211 under the primary care exemption?
Answer: Yes, according to CMS staff, so long as the service and the documentation meet all the requirements for the exemption and the visit complexity code. For example, the resident can only report low-level E/M codes, and the resident must be “the focal point for that person’s care.”
Question: Are there frequency limits for how often we can report G2211, either for a single patient in a given time period or by a provider or a practice?
Answer: Not at this time, but make sure your providers are following the rules for reporting the code. “There’s got to be documentation that suggests why the practitioner believes they are treating the patient on this long-standing, longitudinal trajectory, and we’ll be able to see how that interaction is happening,” senior CMS staff said. CMS staff further issued a subtle warning to providers by reminding them that CMS has a very strong integrity program. Your practice can avoid problems with thorough training, frequent chart review, and encouraging the team to ask questions until you feel that everyone is comfortable with the code.
Question: Are there any limits on the specialties that can report the code? Is it just for primary care providers?
Answer: No. Remember that a provider who is managing a single serious or complex condition can also report the code. But CMS expects the documentation to support the ongoing nature of the treatment. If a patient sees a provider as a one-off encounter, perhaps to manage an acute problem, that visit wouldn’t qualify. But if the provider clearly documents that they are actively managing the patient’s condition, the encounters could qualify.
Question: Will CMS issue a list of conditions that meet the code’s serious or complex condition requirement?
Answer: CMS has included the examples of HIV and sickle cell anemia in existing guidance, and it plans to issue a few more examples “that help folks understand what is expected.” However, it won’t be a complete list of every condition that might qualify.
Originally published in the May 2023 issue of the American Thoracic Society’s ATS Coding & Billing Quarterly. Republished with permission from the American Thoracic Society.
This add-on code is for new (99202-99205) and established (99212-99215) office visits. CMS created this add-on code to address the additional costs and resources associated with providing longitudinal care.
G2211 – Visit complexity inherent to evaluation and management (E/M) associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious condition, or a complex condition (Add-on code; list separately in addition to office/outpatient (O/O) E/M visit, new or established)
The documentation should demonstrate the intent and need for ongoing care. Otherwise, no additional documentation is required. CMS pays $16.04 for each service (wRVU = 0.33). It may be reported each time the patient is seen, and there is currently no limit to how often it may be used. Also, there is no additional copay requirement for patients.
Do’s and don’ts
Do report in the following situations when longitudinal care is provided:
- The provider has or intends to have a long-term, ongoing relationship with the patient (ie, G2211 can be used for a new patient visit)
- Audio/video virtual visits
- May be reported with Prolonged Care Services G2212
- When advanced practice providers or physician colleagues in the same specialty practice see the patient (ie, if you see the patient for an urgent visit, but the patient is usually followed by your partner, you can still use G2211)
- When working with graduate medical education trainees (along with the -GC modifier), and as long as the conditions described in the description of G2211 are met
Do NOT report in the following situations:
- If modifier -25 is appended to the E/M service when another service is provided on the same day (eg, pulmonary function tests, 6-minute walk tests, immunization)
- Audio-only virtual visits, hospital, skilled nursing facility, or long-term acute care hospital
- If the patient is not expected to return for ongoing care
- If the reason for longitudinal care does not include a “single, serious condition or a complex condition” (eg, annual visits for a stable 6 mm lung nodule)
CMS expects that this will be billed with 38% of all E/M services initially and potentially up to 54% over time. We feel this is reimbursement for the work being done to care for our patients with single, serious, or complex conditions. Both Medicare and Medicare Advantage plans are expected to reimburse for this service. Whether other payers will do the same is unclear, but it will become clear with time and further negotiation at the local level. In the meantime, members are encouraged to report this code for all appropriate patient encounters.
Questions and answers — G2211
Question: What private insurances cover G2211?
Answer: As of March 1, 2024, four national payers have confirmed coverage of G2211:
- Cigna (Medicare Advantage only),
- Humana (commercial and Medicare Advantage),
- United Healthcare (commercial and Medicare Advantage), and
- Aetna (Medicare Advantage).
Question: What needs to be documented for G2211?
Answer: CMS states, “You must document the reason for billing the office and outpatient (O/O) and evaluation and management (E/M). The visits themselves would need to be medically reasonable and necessary for the practitioner to report G2211. In addition, the documentation would need to illustrate medical necessity of the O/O E/M visit. We [CMS] haven’t required additional documentation.”
American Thoracic Society (ATS) and CHEST also recommend including a detailed assessment and plan for the visit, as well as any follow-up. The complexity of the visit should be clear in your documentation to support the medical necessity for reporting the G2211.
Question: How can a provider show that a new patient visit (99202-99205) is part of continuing care?
Answer: The treating practitioner should make sure their documentation supports their intent to provide ongoing care to the patient. Establishing such intent goes beyond a statement that the provider plans to provide ongoing care or schedule a follow-up visit. The circumstances of the visit should support the extra work involved in becoming the focal point of the patient’s care or providing ongoing care for a serious or complex condition.
Question: Dr. Red works at a primary care practice, is the focal point for a patient’s care, and has reported G2211. If Dr. Yellow, who is in the same specialty, or Mr. Green, a nurse practitioner, is covering for Dr. Red, and the patient comes in for a visit, can they report G2211 for that visit?
Answer: Yes. The same specialty/same provider rules would apply in this situation. But remember that Dr. Yellow’s or Mr. Green’s documentation for that encounter must support the code.
Question: Can a resident report G2211 under the primary care exemption?
Answer: Yes, according to CMS staff, so long as the service and the documentation meet all the requirements for the exemption and the visit complexity code. For example, the resident can only report low-level E/M codes, and the resident must be “the focal point for that person’s care.”
Question: Are there frequency limits for how often we can report G2211, either for a single patient in a given time period or by a provider or a practice?
Answer: Not at this time, but make sure your providers are following the rules for reporting the code. “There’s got to be documentation that suggests why the practitioner believes they are treating the patient on this long-standing, longitudinal trajectory, and we’ll be able to see how that interaction is happening,” senior CMS staff said. CMS staff further issued a subtle warning to providers by reminding them that CMS has a very strong integrity program. Your practice can avoid problems with thorough training, frequent chart review, and encouraging the team to ask questions until you feel that everyone is comfortable with the code.
Question: Are there any limits on the specialties that can report the code? Is it just for primary care providers?
Answer: No. Remember that a provider who is managing a single serious or complex condition can also report the code. But CMS expects the documentation to support the ongoing nature of the treatment. If a patient sees a provider as a one-off encounter, perhaps to manage an acute problem, that visit wouldn’t qualify. But if the provider clearly documents that they are actively managing the patient’s condition, the encounters could qualify.
Question: Will CMS issue a list of conditions that meet the code’s serious or complex condition requirement?
Answer: CMS has included the examples of HIV and sickle cell anemia in existing guidance, and it plans to issue a few more examples “that help folks understand what is expected.” However, it won’t be a complete list of every condition that might qualify.
Originally published in the May 2023 issue of the American Thoracic Society’s ATS Coding & Billing Quarterly. Republished with permission from the American Thoracic Society.
This add-on code is for new (99202-99205) and established (99212-99215) office visits. CMS created this add-on code to address the additional costs and resources associated with providing longitudinal care.
G2211 – Visit complexity inherent to evaluation and management (E/M) associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious condition, or a complex condition (Add-on code; list separately in addition to office/outpatient (O/O) E/M visit, new or established)
The documentation should demonstrate the intent and need for ongoing care. Otherwise, no additional documentation is required. CMS pays $16.04 for each service (wRVU = 0.33). It may be reported each time the patient is seen, and there is currently no limit to how often it may be used. Also, there is no additional copay requirement for patients.
Do’s and don’ts
Do report in the following situations when longitudinal care is provided:
- The provider has or intends to have a long-term, ongoing relationship with the patient (ie, G2211 can be used for a new patient visit)
- Audio/video virtual visits
- May be reported with Prolonged Care Services G2212
- When advanced practice providers or physician colleagues in the same specialty practice see the patient (ie, if you see the patient for an urgent visit, but the patient is usually followed by your partner, you can still use G2211)
- When working with graduate medical education trainees (along with the -GC modifier), and as long as the conditions described in the description of G2211 are met
Do NOT report in the following situations:
- If modifier -25 is appended to the E/M service when another service is provided on the same day (eg, pulmonary function tests, 6-minute walk tests, immunization)
- Audio-only virtual visits, hospital, skilled nursing facility, or long-term acute care hospital
- If the patient is not expected to return for ongoing care
- If the reason for longitudinal care does not include a “single, serious condition or a complex condition” (eg, annual visits for a stable 6 mm lung nodule)
CMS expects that this will be billed with 38% of all E/M services initially and potentially up to 54% over time. We feel this is reimbursement for the work being done to care for our patients with single, serious, or complex conditions. Both Medicare and Medicare Advantage plans are expected to reimburse for this service. Whether other payers will do the same is unclear, but it will become clear with time and further negotiation at the local level. In the meantime, members are encouraged to report this code for all appropriate patient encounters.
Questions and answers — G2211
Question: What private insurances cover G2211?
Answer: As of March 1, 2024, four national payers have confirmed coverage of G2211:
- Cigna (Medicare Advantage only),
- Humana (commercial and Medicare Advantage),
- United Healthcare (commercial and Medicare Advantage), and
- Aetna (Medicare Advantage).
Question: What needs to be documented for G2211?
Answer: CMS states, “You must document the reason for billing the office and outpatient (O/O) and evaluation and management (E/M). The visits themselves would need to be medically reasonable and necessary for the practitioner to report G2211. In addition, the documentation would need to illustrate medical necessity of the O/O E/M visit. We [CMS] haven’t required additional documentation.”
American Thoracic Society (ATS) and CHEST also recommend including a detailed assessment and plan for the visit, as well as any follow-up. The complexity of the visit should be clear in your documentation to support the medical necessity for reporting the G2211.
Question: How can a provider show that a new patient visit (99202-99205) is part of continuing care?
Answer: The treating practitioner should make sure their documentation supports their intent to provide ongoing care to the patient. Establishing such intent goes beyond a statement that the provider plans to provide ongoing care or schedule a follow-up visit. The circumstances of the visit should support the extra work involved in becoming the focal point of the patient’s care or providing ongoing care for a serious or complex condition.
Question: Dr. Red works at a primary care practice, is the focal point for a patient’s care, and has reported G2211. If Dr. Yellow, who is in the same specialty, or Mr. Green, a nurse practitioner, is covering for Dr. Red, and the patient comes in for a visit, can they report G2211 for that visit?
Answer: Yes. The same specialty/same provider rules would apply in this situation. But remember that Dr. Yellow’s or Mr. Green’s documentation for that encounter must support the code.
Question: Can a resident report G2211 under the primary care exemption?
Answer: Yes, according to CMS staff, so long as the service and the documentation meet all the requirements for the exemption and the visit complexity code. For example, the resident can only report low-level E/M codes, and the resident must be “the focal point for that person’s care.”
Question: Are there frequency limits for how often we can report G2211, either for a single patient in a given time period or by a provider or a practice?
Answer: Not at this time, but make sure your providers are following the rules for reporting the code. “There’s got to be documentation that suggests why the practitioner believes they are treating the patient on this long-standing, longitudinal trajectory, and we’ll be able to see how that interaction is happening,” senior CMS staff said. CMS staff further issued a subtle warning to providers by reminding them that CMS has a very strong integrity program. Your practice can avoid problems with thorough training, frequent chart review, and encouraging the team to ask questions until you feel that everyone is comfortable with the code.
Question: Are there any limits on the specialties that can report the code? Is it just for primary care providers?
Answer: No. Remember that a provider who is managing a single serious or complex condition can also report the code. But CMS expects the documentation to support the ongoing nature of the treatment. If a patient sees a provider as a one-off encounter, perhaps to manage an acute problem, that visit wouldn’t qualify. But if the provider clearly documents that they are actively managing the patient’s condition, the encounters could qualify.
Question: Will CMS issue a list of conditions that meet the code’s serious or complex condition requirement?
Answer: CMS has included the examples of HIV and sickle cell anemia in existing guidance, and it plans to issue a few more examples “that help folks understand what is expected.” However, it won’t be a complete list of every condition that might qualify.
Originally published in the May 2023 issue of the American Thoracic Society’s ATS Coding & Billing Quarterly. Republished with permission from the American Thoracic Society.