CHEST Physician

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.

CHEST

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.

CHEST

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.

CHEST

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.

CHEST

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.

CHEST

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.

CHEST

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.

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.

CHEST

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).

CHEST

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.

CHEST

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).

CHEST

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.

CHEST

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).

CHEST

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.

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.

CHEST

In 2023, the US Food and Drug Administration approved the adjuvanted RSVPreF3 vaccine (Arexvy, GSK) and the bivalent RSVPreF vaccine (Abrysvo, Pfizer). Both vaccines have been shown to significantly reduce the risk of developing RSV LRTI and are currently recommended for single-dose administration in adults 60 years or older—irrespective of comorbidities.

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.

CHEST

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.

CHEST

In 2023, the US Food and Drug Administration approved the adjuvanted RSVPreF3 vaccine (Arexvy, GSK) and the bivalent RSVPreF vaccine (Abrysvo, Pfizer). Both vaccines have been shown to significantly reduce the risk of developing RSV LRTI and are currently recommended for single-dose administration in adults 60 years or older—irrespective of comorbidities.

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.

CHEST

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.

CHEST

In 2023, the US Food and Drug Administration approved the adjuvanted RSVPreF3 vaccine (Arexvy, GSK) and the bivalent RSVPreF vaccine (Abrysvo, Pfizer). Both vaccines have been shown to significantly reduce the risk of developing RSV LRTI and are currently recommended for single-dose administration in adults 60 years or older—irrespective of comorbidities.

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.

CHEST

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

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.”

CHEST

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.”

CHEST

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.”

CHEST

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 »

To continue to bring awareness to our members, we once again discuss this new add-on Healthcare Common Procedure Coding System code finalized by the Centers for Medicare & Medicaid Services (CMS) for January 1, 2024. 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.

To continue to bring awareness to our members, we once again discuss this new add-on Healthcare Common Procedure Coding System code finalized by the Centers for Medicare & Medicaid Services (CMS) for January 1, 2024. 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.

To continue to bring awareness to our members, we once again discuss this new add-on Healthcare Common Procedure Coding System code finalized by the Centers for Medicare & Medicaid Services (CMS) for January 1, 2024. 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.

Journal CHEST^®

Does Rheumatoid Arthritis Increase the Risk of COPD? 

By: Chiwook Chung, MD, and colleagues

This study utilizing the Korean National Health Insurance Database suggests that patients with rheumatoid arthritis (RA) face a significantly higher risk of developing COPD compared with the general population. Notably, individuals with seropositive RA exhibit a greater risk of COPD onset than those with seronegative RA. Although smoking history didn’t affect the relationship between RA and COPD, monitoring respiratory symptoms and pulmonary function in patients with RA, especially patients who are seropositive, is crucial. These findings underscore the importance of interdisciplinary collaboration between rheumatologists and pulmonologists to enhance early detection and management strategies for pulmonary complications in patients with RA.

CHEST

CHEST Pulmonary^®

The Lung Cancer Prediction Model “Stress Test” 

By: Brent E. Heideman, MD, and colleagues

Current lung cancer prediction models have limited utility in high-risk patients referred for diagnostic biopsy. In a study of 322 indeterminate pulmonary nodules, the Brock, Mayo Clinic, Herder, and Veterans Affairs models showed modest discrimination between benign and malignant nodules (AUCs 0.67-0.77). The models performed poorly for low-risk patients (negative predictive values 63%-71%) and suboptimally for high-risk patients (positive predictive values 73%-87%), suggesting referring physicians use additional clinical information not captured in these models to identify high-risk patients needing biopsy. New prediction models and biomarkers specifically developed and calibrated for high-risk populations are needed to better inform clinical decision-making. Incorporating interval imaging to assess changes in nodule characteristics could potentially improve model performance. Tailored risk assessment tools are crucial for optimizing management and reducing unnecessary invasive procedures in this challenging patient population.

CHEST

CHEST Critical Care ^®

Characterizing Cardiac Function in ICU Survivors of Sepsis 

By: Kevin Garrity, MBChB, and colleagues

While chronic cardiac dysfunction is one of the proposed mechanisms of long-term impairment post critical illness, its prevalence, mechanisms, and associations with disability following admission for sepsis are not well understood. Garrity and colleagues describe the Characterization of Cardiovascular Function in ICU Survivors of Sepsis (CONDUCT-ICU) protocol, a prospective study including two ICUs in Scotland aimed to better define cardiovascular dysfunction in survivors of sepsis. Designed to enroll 69 patients, demographics, cardiac and inflammatory biomarkers, and echocardiograms will be obtained on ICU discharge with additional laboratory data, cardiac magnetic resonance imaging, and patient-reported outcome measures to be obtained at 6 to 10 weeks. This novel multimodal approach will provide understanding into the role of cardiovascular dysfunction following critical illness as well as offer mechanistic insights. The investigators hope to obtain operational and pilot data for larger future studies.

CHEST

– Commentary by Eugene Yuriditsky, MD, FCCP, Member of the CHEST Physician Editorial Board

Journal CHEST^®

Does Rheumatoid Arthritis Increase the Risk of COPD? 

By: Chiwook Chung, MD, and colleagues

This study utilizing the Korean National Health Insurance Database suggests that patients with rheumatoid arthritis (RA) face a significantly higher risk of developing COPD compared with the general population. Notably, individuals with seropositive RA exhibit a greater risk of COPD onset than those with seronegative RA. Although smoking history didn’t affect the relationship between RA and COPD, monitoring respiratory symptoms and pulmonary function in patients with RA, especially patients who are seropositive, is crucial. These findings underscore the importance of interdisciplinary collaboration between rheumatologists and pulmonologists to enhance early detection and management strategies for pulmonary complications in patients with RA.

CHEST

CHEST Pulmonary^®

The Lung Cancer Prediction Model “Stress Test” 

By: Brent E. Heideman, MD, and colleagues

Current lung cancer prediction models have limited utility in high-risk patients referred for diagnostic biopsy. In a study of 322 indeterminate pulmonary nodules, the Brock, Mayo Clinic, Herder, and Veterans Affairs models showed modest discrimination between benign and malignant nodules (AUCs 0.67-0.77). The models performed poorly for low-risk patients (negative predictive values 63%-71%) and suboptimally for high-risk patients (positive predictive values 73%-87%), suggesting referring physicians use additional clinical information not captured in these models to identify high-risk patients needing biopsy. New prediction models and biomarkers specifically developed and calibrated for high-risk populations are needed to better inform clinical decision-making. Incorporating interval imaging to assess changes in nodule characteristics could potentially improve model performance. Tailored risk assessment tools are crucial for optimizing management and reducing unnecessary invasive procedures in this challenging patient population.

CHEST

CHEST Critical Care ^®

Characterizing Cardiac Function in ICU Survivors of Sepsis 

By: Kevin Garrity, MBChB, and colleagues

While chronic cardiac dysfunction is one of the proposed mechanisms of long-term impairment post critical illness, its prevalence, mechanisms, and associations with disability following admission for sepsis are not well understood. Garrity and colleagues describe the Characterization of Cardiovascular Function in ICU Survivors of Sepsis (CONDUCT-ICU) protocol, a prospective study including two ICUs in Scotland aimed to better define cardiovascular dysfunction in survivors of sepsis. Designed to enroll 69 patients, demographics, cardiac and inflammatory biomarkers, and echocardiograms will be obtained on ICU discharge with additional laboratory data, cardiac magnetic resonance imaging, and patient-reported outcome measures to be obtained at 6 to 10 weeks. This novel multimodal approach will provide understanding into the role of cardiovascular dysfunction following critical illness as well as offer mechanistic insights. The investigators hope to obtain operational and pilot data for larger future studies.

CHEST

– Commentary by Eugene Yuriditsky, MD, FCCP, Member of the CHEST Physician Editorial Board

Journal CHEST^®

Does Rheumatoid Arthritis Increase the Risk of COPD? 

By: Chiwook Chung, MD, and colleagues

This study utilizing the Korean National Health Insurance Database suggests that patients with rheumatoid arthritis (RA) face a significantly higher risk of developing COPD compared with the general population. Notably, individuals with seropositive RA exhibit a greater risk of COPD onset than those with seronegative RA. Although smoking history didn’t affect the relationship between RA and COPD, monitoring respiratory symptoms and pulmonary function in patients with RA, especially patients who are seropositive, is crucial. These findings underscore the importance of interdisciplinary collaboration between rheumatologists and pulmonologists to enhance early detection and management strategies for pulmonary complications in patients with RA.

CHEST

CHEST Pulmonary^®

The Lung Cancer Prediction Model “Stress Test” 

By: Brent E. Heideman, MD, and colleagues

Current lung cancer prediction models have limited utility in high-risk patients referred for diagnostic biopsy. In a study of 322 indeterminate pulmonary nodules, the Brock, Mayo Clinic, Herder, and Veterans Affairs models showed modest discrimination between benign and malignant nodules (AUCs 0.67-0.77). The models performed poorly for low-risk patients (negative predictive values 63%-71%) and suboptimally for high-risk patients (positive predictive values 73%-87%), suggesting referring physicians use additional clinical information not captured in these models to identify high-risk patients needing biopsy. New prediction models and biomarkers specifically developed and calibrated for high-risk populations are needed to better inform clinical decision-making. Incorporating interval imaging to assess changes in nodule characteristics could potentially improve model performance. Tailored risk assessment tools are crucial for optimizing management and reducing unnecessary invasive procedures in this challenging patient population.

CHEST

CHEST Critical Care ^®

Characterizing Cardiac Function in ICU Survivors of Sepsis 

By: Kevin Garrity, MBChB, and colleagues

While chronic cardiac dysfunction is one of the proposed mechanisms of long-term impairment post critical illness, its prevalence, mechanisms, and associations with disability following admission for sepsis are not well understood. Garrity and colleagues describe the Characterization of Cardiovascular Function in ICU Survivors of Sepsis (CONDUCT-ICU) protocol, a prospective study including two ICUs in Scotland aimed to better define cardiovascular dysfunction in survivors of sepsis. Designed to enroll 69 patients, demographics, cardiac and inflammatory biomarkers, and echocardiograms will be obtained on ICU discharge with additional laboratory data, cardiac magnetic resonance imaging, and patient-reported outcome measures to be obtained at 6 to 10 weeks. This novel multimodal approach will provide understanding into the role of cardiovascular dysfunction following critical illness as well as offer mechanistic insights. The investigators hope to obtain operational and pilot data for larger future studies.

CHEST

– Commentary by Eugene Yuriditsky, MD, FCCP, Member of the CHEST Physician Editorial Board

Intravenous albumin is a human-derived blood product studied widely in a variety of patient populations. Despite its frequent use in critical care, few high-quality studies have demonstrated improvements in patient-important outcomes. It is important for intensivists to think critically about prescribing albumin and individualize the prescription for each patient, as albumin use is not without risk. Compared with crystalloids, albumin increases the risk of fluid overload and bleeding and infections in patients undergoing cardiac surgery.^1,2 In addition, albumin is costly, and its production is fraught with donor supply chain ethical concerns (the majority of albumin is derived from paid plasma donors).

CHEST

Albumin use is highly variable between countries, hospitals, and even clinicians within the same specialty due to several factors, including the perception of minimal risk with albumin, concerns regarding insufficient short-term hemodynamic response to crystalloid, and lack of high-quality evidence to inform clinical practice. We will discuss when intensivists should consider albumin use (with prescription personalized to patient context) and when it should be avoided due to the concerns for patient harm.

An intensivist might consider albumin as a reasonable treatment option in patients with cirrhosis undergoing large volume paracentesis to prevent paracentesis-induced circulatory dysfunction, and in patients with cirrhosis and spontaneous bacterial peritonitis (SBP), as data suggests use in this setting leads to a reduction in mortality.³ Clinicians should be aware that even for these widely accepted albumin indications, which are supported by published guidelines, the certainty of evidence is low, recommendations are weak (conditional), and, therefore, albumin should always be personalized to the patient based on volume of paracentesis fluid removed, prior history of hypotension after procedures, and degree of renal dysfunction.⁴

CHEST

CHEST

As with any intervention, the use of albumin is associated with risks. In patients undergoing on-pump cardiac surgery, the ALBICS study showed that albumin did not reduce the risk of major adverse events and, instead, increased risk of bleeding, resternotomy, and infection.² The ATTIRE trial showed that in patients hospitalized with decompensated cirrhosis and serum albumin <30 g/L, albumin failed to reduce infection, renal impairment, or mortality while increasing life-threatening adverse events, including pulmonary edema and fluid overload.¹ Similarly, in patients with cirrhosis and extraperitoneal infections, albumin showed no benefit in reducing renal impairment or mortality, and its use was associated with higher rates of pulmonary edema.⁶ Lastly, critically ill patients with traumatic brain injury (TBI) who received fluid resuscitation with albumin have been shown to experience higher mortality compared with saline.⁷ Thus, based on current evidence, intravenous albumin is not recommended for patients undergoing cardiac surgery (priming of the bypass circuit or volume replacement), patients hospitalized with decompensated cirrhosis and hypoalbuminemia, patients hospitalized with cirrhosis and extraperitoneal infections, and critically ill patients with TBI.⁴

CHEST

CHEST

High-quality evidence is currently lacking in many clinical settings, and large randomized controlled trials are underway to provide further insights into the utility of albumin. These trials will address albumin use in the following: acute kidney injury requiring renal replacement therapy (ALTER-AKI, NCT04705896), inpatients with community-acquired pneumonia (NCT04071041), high-risk cardiac surgery (ACTRN1261900135516703), and septic shock (NCT03869385).

CHEST

Financial/nonfinancial disclosures

Nicole Relke: None. Mark Hewitt: None. Bram Rochwerg: None. Jeannie Callum: Research support from Canadian Blood Services and Octapharma.

References

1. China L, Freemantle N, Forrest E, et al. A randomized trial of albumin infusions in hospitalized patients with cirrhosis. N Engl J Med. 2021;384(9):808-817. doi:10.1056/NEJMoa2022166

2. Pesonen E, Vlasov H, Suojaranta R, et al. Effect of 4% albumin solution vs ringer acetate on major adverse events in patients undergoing cardiac surgery with cardiopulmonary bypass: a randomized clinical trial. JAMA. 2022;328(3):251-258. doi:10.1001/jama.2022.10461

3. Sort P, Navasa M, Arroyo V, et al. Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis. NEJM. 1999;341:403-409.

4. Callum J, Skubas NJ, Bathla A, et al. Use of intravenous albumin: a guideline from the international collaboration for transfusion medicine guidelines. Chest. 2024:S0012-3692(24)00285-X. doi:10.1016/j.chest.2024.02.049

5. Torp N. High doses of albumin increases mortality and complications in terlipressin treated patients with cirrhosis: insights from the ATTIRE trial. Paper presented at the AASLD; 2023; San Diego, CA. https://www.aasld.org/the-liver-meeting/high-doses-albumin-increases-mortality-and-complications-terlipressin-treated

6. Wong YJ, Qiu TY, Tam YC, Mohan BP, Gallegos-Orozco JF, Adler DG. Efficacy and safety of IV albumin for non-spontaneous bacterial peritonitis infection among patients with cirrhosis: a systematic review and meta-analysis. Dig Liver Dis. 2020;52(10):1137-1142. doi:10.1016/j.dld.2020.05.047

7. Myburgh J, Cooper JD, Finfer S, et al. Saline or albumin for fluid resuscitation in patients with traumatic brain injury. N Engl J Med. 2007;357(9):874-884.

Intravenous albumin is a human-derived blood product studied widely in a variety of patient populations. Despite its frequent use in critical care, few high-quality studies have demonstrated improvements in patient-important outcomes. It is important for intensivists to think critically about prescribing albumin and individualize the prescription for each patient, as albumin use is not without risk. Compared with crystalloids, albumin increases the risk of fluid overload and bleeding and infections in patients undergoing cardiac surgery.^1,2 In addition, albumin is costly, and its production is fraught with donor supply chain ethical concerns (the majority of albumin is derived from paid plasma donors).

CHEST

Albumin use is highly variable between countries, hospitals, and even clinicians within the same specialty due to several factors, including the perception of minimal risk with albumin, concerns regarding insufficient short-term hemodynamic response to crystalloid, and lack of high-quality evidence to inform clinical practice. We will discuss when intensivists should consider albumin use (with prescription personalized to patient context) and when it should be avoided due to the concerns for patient harm.

An intensivist might consider albumin as a reasonable treatment option in patients with cirrhosis undergoing large volume paracentesis to prevent paracentesis-induced circulatory dysfunction, and in patients with cirrhosis and spontaneous bacterial peritonitis (SBP), as data suggests use in this setting leads to a reduction in mortality.³ Clinicians should be aware that even for these widely accepted albumin indications, which are supported by published guidelines, the certainty of evidence is low, recommendations are weak (conditional), and, therefore, albumin should always be personalized to the patient based on volume of paracentesis fluid removed, prior history of hypotension after procedures, and degree of renal dysfunction.⁴

CHEST

CHEST

As with any intervention, the use of albumin is associated with risks. In patients undergoing on-pump cardiac surgery, the ALBICS study showed that albumin did not reduce the risk of major adverse events and, instead, increased risk of bleeding, resternotomy, and infection.² The ATTIRE trial showed that in patients hospitalized with decompensated cirrhosis and serum albumin <30 g/L, albumin failed to reduce infection, renal impairment, or mortality while increasing life-threatening adverse events, including pulmonary edema and fluid overload.¹ Similarly, in patients with cirrhosis and extraperitoneal infections, albumin showed no benefit in reducing renal impairment or mortality, and its use was associated with higher rates of pulmonary edema.⁶ Lastly, critically ill patients with traumatic brain injury (TBI) who received fluid resuscitation with albumin have been shown to experience higher mortality compared with saline.⁷ Thus, based on current evidence, intravenous albumin is not recommended for patients undergoing cardiac surgery (priming of the bypass circuit or volume replacement), patients hospitalized with decompensated cirrhosis and hypoalbuminemia, patients hospitalized with cirrhosis and extraperitoneal infections, and critically ill patients with TBI.⁴

CHEST

CHEST

High-quality evidence is currently lacking in many clinical settings, and large randomized controlled trials are underway to provide further insights into the utility of albumin. These trials will address albumin use in the following: acute kidney injury requiring renal replacement therapy (ALTER-AKI, NCT04705896), inpatients with community-acquired pneumonia (NCT04071041), high-risk cardiac surgery (ACTRN1261900135516703), and septic shock (NCT03869385).

CHEST

Financial/nonfinancial disclosures

Nicole Relke: None. Mark Hewitt: None. Bram Rochwerg: None. Jeannie Callum: Research support from Canadian Blood Services and Octapharma.

References

1. China L, Freemantle N, Forrest E, et al. A randomized trial of albumin infusions in hospitalized patients with cirrhosis. N Engl J Med. 2021;384(9):808-817. doi:10.1056/NEJMoa2022166

2. Pesonen E, Vlasov H, Suojaranta R, et al. Effect of 4% albumin solution vs ringer acetate on major adverse events in patients undergoing cardiac surgery with cardiopulmonary bypass: a randomized clinical trial. JAMA. 2022;328(3):251-258. doi:10.1001/jama.2022.10461

3. Sort P, Navasa M, Arroyo V, et al. Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis. NEJM. 1999;341:403-409.

4. Callum J, Skubas NJ, Bathla A, et al. Use of intravenous albumin: a guideline from the international collaboration for transfusion medicine guidelines. Chest. 2024:S0012-3692(24)00285-X. doi:10.1016/j.chest.2024.02.049

5. Torp N. High doses of albumin increases mortality and complications in terlipressin treated patients with cirrhosis: insights from the ATTIRE trial. Paper presented at the AASLD; 2023; San Diego, CA. https://www.aasld.org/the-liver-meeting/high-doses-albumin-increases-mortality-and-complications-terlipressin-treated

6. Wong YJ, Qiu TY, Tam YC, Mohan BP, Gallegos-Orozco JF, Adler DG. Efficacy and safety of IV albumin for non-spontaneous bacterial peritonitis infection among patients with cirrhosis: a systematic review and meta-analysis. Dig Liver Dis. 2020;52(10):1137-1142. doi:10.1016/j.dld.2020.05.047

7. Myburgh J, Cooper JD, Finfer S, et al. Saline or albumin for fluid resuscitation in patients with traumatic brain injury. N Engl J Med. 2007;357(9):874-884.

Intravenous albumin is a human-derived blood product studied widely in a variety of patient populations. Despite its frequent use in critical care, few high-quality studies have demonstrated improvements in patient-important outcomes. It is important for intensivists to think critically about prescribing albumin and individualize the prescription for each patient, as albumin use is not without risk. Compared with crystalloids, albumin increases the risk of fluid overload and bleeding and infections in patients undergoing cardiac surgery.^1,2 In addition, albumin is costly, and its production is fraught with donor supply chain ethical concerns (the majority of albumin is derived from paid plasma donors).

CHEST

Albumin use is highly variable between countries, hospitals, and even clinicians within the same specialty due to several factors, including the perception of minimal risk with albumin, concerns regarding insufficient short-term hemodynamic response to crystalloid, and lack of high-quality evidence to inform clinical practice. We will discuss when intensivists should consider albumin use (with prescription personalized to patient context) and when it should be avoided due to the concerns for patient harm.

An intensivist might consider albumin as a reasonable treatment option in patients with cirrhosis undergoing large volume paracentesis to prevent paracentesis-induced circulatory dysfunction, and in patients with cirrhosis and spontaneous bacterial peritonitis (SBP), as data suggests use in this setting leads to a reduction in mortality.³ Clinicians should be aware that even for these widely accepted albumin indications, which are supported by published guidelines, the certainty of evidence is low, recommendations are weak (conditional), and, therefore, albumin should always be personalized to the patient based on volume of paracentesis fluid removed, prior history of hypotension after procedures, and degree of renal dysfunction.⁴

CHEST

CHEST

As with any intervention, the use of albumin is associated with risks. In patients undergoing on-pump cardiac surgery, the ALBICS study showed that albumin did not reduce the risk of major adverse events and, instead, increased risk of bleeding, resternotomy, and infection.² The ATTIRE trial showed that in patients hospitalized with decompensated cirrhosis and serum albumin <30 g/L, albumin failed to reduce infection, renal impairment, or mortality while increasing life-threatening adverse events, including pulmonary edema and fluid overload.¹ Similarly, in patients with cirrhosis and extraperitoneal infections, albumin showed no benefit in reducing renal impairment or mortality, and its use was associated with higher rates of pulmonary edema.⁶ Lastly, critically ill patients with traumatic brain injury (TBI) who received fluid resuscitation with albumin have been shown to experience higher mortality compared with saline.⁷ Thus, based on current evidence, intravenous albumin is not recommended for patients undergoing cardiac surgery (priming of the bypass circuit or volume replacement), patients hospitalized with decompensated cirrhosis and hypoalbuminemia, patients hospitalized with cirrhosis and extraperitoneal infections, and critically ill patients with TBI.⁴

CHEST

CHEST

High-quality evidence is currently lacking in many clinical settings, and large randomized controlled trials are underway to provide further insights into the utility of albumin. These trials will address albumin use in the following: acute kidney injury requiring renal replacement therapy (ALTER-AKI, NCT04705896), inpatients with community-acquired pneumonia (NCT04071041), high-risk cardiac surgery (ACTRN1261900135516703), and septic shock (NCT03869385).

CHEST

Financial/nonfinancial disclosures

Nicole Relke: None. Mark Hewitt: None. Bram Rochwerg: None. Jeannie Callum: Research support from Canadian Blood Services and Octapharma.

References

1. China L, Freemantle N, Forrest E, et al. A randomized trial of albumin infusions in hospitalized patients with cirrhosis. N Engl J Med. 2021;384(9):808-817. doi:10.1056/NEJMoa2022166

2. Pesonen E, Vlasov H, Suojaranta R, et al. Effect of 4% albumin solution vs ringer acetate on major adverse events in patients undergoing cardiac surgery with cardiopulmonary bypass: a randomized clinical trial. JAMA. 2022;328(3):251-258. doi:10.1001/jama.2022.10461

3. Sort P, Navasa M, Arroyo V, et al. Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis. NEJM. 1999;341:403-409.

4. Callum J, Skubas NJ, Bathla A, et al. Use of intravenous albumin: a guideline from the international collaboration for transfusion medicine guidelines. Chest. 2024:S0012-3692(24)00285-X. doi:10.1016/j.chest.2024.02.049

5. Torp N. High doses of albumin increases mortality and complications in terlipressin treated patients with cirrhosis: insights from the ATTIRE trial. Paper presented at the AASLD; 2023; San Diego, CA. https://www.aasld.org/the-liver-meeting/high-doses-albumin-increases-mortality-and-complications-terlipressin-treated

6. Wong YJ, Qiu TY, Tam YC, Mohan BP, Gallegos-Orozco JF, Adler DG. Efficacy and safety of IV albumin for non-spontaneous bacterial peritonitis infection among patients with cirrhosis: a systematic review and meta-analysis. Dig Liver Dis. 2020;52(10):1137-1142. doi:10.1016/j.dld.2020.05.047

7. Myburgh J, Cooper JD, Finfer S, et al. Saline or albumin for fluid resuscitation in patients with traumatic brain injury. N Engl J Med. 2007;357(9):874-884.

A few years ago, Kim Lori Sandler, MD, realized many patients newly diagnosed with lung cancer had never been screened for the disease — they received CT scans only because they were symptomatic.

But Dr. Sandler, a radiologist at Vanderbilt University Medical Center in Nashville, Tennessee, could see in medical charts that most of these patients had been eligible for a screening before becoming symptomatic. And for women, most had received decades worth of mammograms. She saw an opportunity and launched a study to find out if an intervention would work.

Low-dose CT and mammography services often are available in the same imaging facility, so women who qualified for a lung cancer screening were offered the scan during their mammography visit. Over a 3-year period, monthly rates of lung scans in women rose by 50% at one facility and 36% at the other.

“What we found is that women are really receptive, if you talk to them about it,” Dr. Sandler said. “I don’t think that lung cancer is thought of as a disease in women.”

Although lung cancer is the leading cause of cancer deaths in the United States, a recent study in JAMA Internal Medicine found only 18% of eligible patients were screened in 2022, a far cry from the rates of 72% for colon cancer — which itself falls short of goals from US medical groups like the American Cancer Society (ACS). Among those eligible, rates of lung screenings were lowest among younger people without comorbid conditions, who did not have health insurance or a usual source of care, and those living in southern states and states that did not expand Medicaid as part of the Affordable Care Act.

But researchers and clinicians, from those working in an urban health center for the homeless to clinics in the poorest counties in the tobacco belt, have used strategies to raise their rates of screening for lung cancer.

Getting patients screened is lifesaving: 27% of people with lung cancer survive 5 years after diagnosis. But the survival rate rises to 63% when cases are diagnosed at an early stage.
 

Increasing Uptake

The formal recommendation to use low-dose chest CT to screen for lung cancer is only a decade old. The approach was first endorsed by the United States Preventive Services Task Force (USPSTF) on the basis of an influential trial that found such testing was linked to a 20% reduction in mortality from the disease. Updated 2021 USPSTF guidelines call for annual screening of people aged 50-80 years who have a 20 pack-year history of smoking and currently smoke or have quit within the past 15 years.

But implementing the recommendation is not always simple. Unlike a colorectal or breast cancer screening, which is recommended primarily on patient age, eligibility for a lung cancer screening requires calculating pack-years of smoking, and, for past smokers, knowledge of when they quit.

The structured fields in most electronic medical records (EMRs) inquire about current or past use of cigarettes and the number of daily packs smoked. But few EMRs can calculate when a patient starts smoking two cigarettes a day but then increases to a pack a day and cuts down again. EMRs also do not track when a patient has stopped smoking permanently. Individual clinicians or health systems must identify patients who are eligible for screening, but the lack of automated calculations makes that job more difficult.

Dr. Sandler and colleagues turned to the informatics team at Vanderbilt to develop a natural language processing approach that extracts smoking data directly from clinician notes instead of using standard variables in their EMR.

The number of patients identified as needing a screening using the algorithm nearly doubled from baseline, from 5887 to 10,231 over a 3-year period, according to results from another study that Dr. Sandler published.

Although the algorithm may occasionally flag someone who does not need screening as eligible, “you can always have a conversation with the patient to determine if they actually meet eligibility criteria,” Dr. Sandler said.
 

Patient Navigators to the Rescue?

About a decade ago, Travis Baggett, MD, MPH, an associate professor of internal medicine at Harvard Medical School, Boston, Massachusetts, received pilot funding from the ACS to study cancer epidemiology among patients at Boston Health Care for the Homeless Program (BHCHP), which serves nearly 10,000 patients at a variety of Boston-area clinics each year.

“We found that both the incidence and mortality rates for lung cancer were more than twofold higher than in the general population,” Dr. Baggett, who is also the director of research at BHCHP, said.

He also discovered that BHCHP patients were diagnosed at significantly later stages than people in the general population for malignancies like breast and colorectal cancer.

Screening for lung cancer was a new recommendation at the time. With additional funding from the ACS, he launched a clinical trial in 2020 that randomized patients who were eligible for lung cancer screening to either work with a patient navigator or receive usual care.

The navigators eased the burden on primary care clinicians: They facilitated shared decision-making visits, helped participants make and attend appointments for low-dose CT, assisted with transportation, and arranged follow-up as needed.

The 3-year study found 43% of patients who received navigation services underwent screening for lung cancer, compared with 9% in the usual-care arm. Participants said the navigators played a critical role in educating them about the importance of screening, coordinating care, and providing emotional support.

“At the root of it all, it was quite clear that one thing that made the navigator successful was their interpersonal qualities and having someone that the patient could trust to help guide them through the process,” Dr. Baggett said.

The navigator program, however, stopped when the funding for the study ended.

But another health system has implemented navigators in a sustainable way through a quality improvement project. Michael Gieske, MD, director of lung cancer screening at St. Elizabeth Healthcare in Edgewood, Kentucky, starts his Friday morning meeting with a multidisciplinary group, including a thoracic surgeon, radiologist, pulmonologist, and several screening nurse navigators. They review the week’s chest CTs, with approximately one-third from patients who underwent lung cancer screening.

Nurse navigators at St. Elizabeth Healthcare follow up with any patient whose scan is suspicious for lung cancer and guide them through the process of seeing specialists and obtaining additional testing.

“They essentially hold the patient’s hand through this scary time in their life and make sure that everything flows smoothly and efficiently,” said Dr. Gieske, a family medicine physician.

St. Elizabeth’s program also draws on several evidence-based strategies used for other cancer screening programs, such as patient and provider education and quarterly feedback to their 194 primary care clinicians on rates of lung cancer screening among their eligible patients.

Several requirements for reimbursement for a lung cancer screening from the US Centers for Medicare & Medicaid Services can also serve as barriers to getting patients screened: Clinicians must identify who is eligible, provide tobacco cessation counseling, and document the shared decision-making process.

To streamline the steps, St. Elizabeth’s clinicians use an EMR smart set that reminds clinicians to verify smoking history and helps them document the required counseling.

Last year, 47% of eligible patients received their recommended screening, and Dr. Gieske said he expects even more improvement.

“We’re on track this year to complete 60% uptake if things continue,” he said, adding that 76% of the new cases of lung cancer are now diagnosed in stage I, with only 5% diagnosed in stage IV.

Dr. Gieske has shared his experience with many clinics in Appalachia, home to some of the highest rates of mortality from lung cancer in the country. A major part of his role with the Appalachian Community Cancer Alliance is helping educate primary care clinicians in the region about the importance of early detection of lung cancer.

“I think one of the most important things is just to convey a message of hope,” he said. “We’re trying to get the good word out there that if you screen individuals, you’re going to catch it early, when you have an extremely high chance of curing the lung cancer.”

Dr. Baggett reported support from grants from the ACS and the Massachusetts General Hospital Research Scholars Program. Dr. Sandler and Dr. Gieske reported no financial conflicts.

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

A few years ago, Kim Lori Sandler, MD, realized many patients newly diagnosed with lung cancer had never been screened for the disease — they received CT scans only because they were symptomatic.

But Dr. Sandler, a radiologist at Vanderbilt University Medical Center in Nashville, Tennessee, could see in medical charts that most of these patients had been eligible for a screening before becoming symptomatic. And for women, most had received decades worth of mammograms. She saw an opportunity and launched a study to find out if an intervention would work.

Low-dose CT and mammography services often are available in the same imaging facility, so women who qualified for a lung cancer screening were offered the scan during their mammography visit. Over a 3-year period, monthly rates of lung scans in women rose by 50% at one facility and 36% at the other.

“What we found is that women are really receptive, if you talk to them about it,” Dr. Sandler said. “I don’t think that lung cancer is thought of as a disease in women.”

Although lung cancer is the leading cause of cancer deaths in the United States, a recent study in JAMA Internal Medicine found only 18% of eligible patients were screened in 2022, a far cry from the rates of 72% for colon cancer — which itself falls short of goals from US medical groups like the American Cancer Society (ACS). Among those eligible, rates of lung screenings were lowest among younger people without comorbid conditions, who did not have health insurance or a usual source of care, and those living in southern states and states that did not expand Medicaid as part of the Affordable Care Act.

But researchers and clinicians, from those working in an urban health center for the homeless to clinics in the poorest counties in the tobacco belt, have used strategies to raise their rates of screening for lung cancer.

Getting patients screened is lifesaving: 27% of people with lung cancer survive 5 years after diagnosis. But the survival rate rises to 63% when cases are diagnosed at an early stage.
 

Increasing Uptake

The formal recommendation to use low-dose chest CT to screen for lung cancer is only a decade old. The approach was first endorsed by the United States Preventive Services Task Force (USPSTF) on the basis of an influential trial that found such testing was linked to a 20% reduction in mortality from the disease. Updated 2021 USPSTF guidelines call for annual screening of people aged 50-80 years who have a 20 pack-year history of smoking and currently smoke or have quit within the past 15 years.

But implementing the recommendation is not always simple. Unlike a colorectal or breast cancer screening, which is recommended primarily on patient age, eligibility for a lung cancer screening requires calculating pack-years of smoking, and, for past smokers, knowledge of when they quit.

The structured fields in most electronic medical records (EMRs) inquire about current or past use of cigarettes and the number of daily packs smoked. But few EMRs can calculate when a patient starts smoking two cigarettes a day but then increases to a pack a day and cuts down again. EMRs also do not track when a patient has stopped smoking permanently. Individual clinicians or health systems must identify patients who are eligible for screening, but the lack of automated calculations makes that job more difficult.

Dr. Sandler and colleagues turned to the informatics team at Vanderbilt to develop a natural language processing approach that extracts smoking data directly from clinician notes instead of using standard variables in their EMR.

The number of patients identified as needing a screening using the algorithm nearly doubled from baseline, from 5887 to 10,231 over a 3-year period, according to results from another study that Dr. Sandler published.

Although the algorithm may occasionally flag someone who does not need screening as eligible, “you can always have a conversation with the patient to determine if they actually meet eligibility criteria,” Dr. Sandler said.
 

Patient Navigators to the Rescue?

About a decade ago, Travis Baggett, MD, MPH, an associate professor of internal medicine at Harvard Medical School, Boston, Massachusetts, received pilot funding from the ACS to study cancer epidemiology among patients at Boston Health Care for the Homeless Program (BHCHP), which serves nearly 10,000 patients at a variety of Boston-area clinics each year.

“We found that both the incidence and mortality rates for lung cancer were more than twofold higher than in the general population,” Dr. Baggett, who is also the director of research at BHCHP, said.

He also discovered that BHCHP patients were diagnosed at significantly later stages than people in the general population for malignancies like breast and colorectal cancer.

Screening for lung cancer was a new recommendation at the time. With additional funding from the ACS, he launched a clinical trial in 2020 that randomized patients who were eligible for lung cancer screening to either work with a patient navigator or receive usual care.

The navigators eased the burden on primary care clinicians: They facilitated shared decision-making visits, helped participants make and attend appointments for low-dose CT, assisted with transportation, and arranged follow-up as needed.

The 3-year study found 43% of patients who received navigation services underwent screening for lung cancer, compared with 9% in the usual-care arm. Participants said the navigators played a critical role in educating them about the importance of screening, coordinating care, and providing emotional support.

“At the root of it all, it was quite clear that one thing that made the navigator successful was their interpersonal qualities and having someone that the patient could trust to help guide them through the process,” Dr. Baggett said.

The navigator program, however, stopped when the funding for the study ended.

But another health system has implemented navigators in a sustainable way through a quality improvement project. Michael Gieske, MD, director of lung cancer screening at St. Elizabeth Healthcare in Edgewood, Kentucky, starts his Friday morning meeting with a multidisciplinary group, including a thoracic surgeon, radiologist, pulmonologist, and several screening nurse navigators. They review the week’s chest CTs, with approximately one-third from patients who underwent lung cancer screening.

Nurse navigators at St. Elizabeth Healthcare follow up with any patient whose scan is suspicious for lung cancer and guide them through the process of seeing specialists and obtaining additional testing.

“They essentially hold the patient’s hand through this scary time in their life and make sure that everything flows smoothly and efficiently,” said Dr. Gieske, a family medicine physician.

St. Elizabeth’s program also draws on several evidence-based strategies used for other cancer screening programs, such as patient and provider education and quarterly feedback to their 194 primary care clinicians on rates of lung cancer screening among their eligible patients.

Several requirements for reimbursement for a lung cancer screening from the US Centers for Medicare & Medicaid Services can also serve as barriers to getting patients screened: Clinicians must identify who is eligible, provide tobacco cessation counseling, and document the shared decision-making process.

To streamline the steps, St. Elizabeth’s clinicians use an EMR smart set that reminds clinicians to verify smoking history and helps them document the required counseling.

Last year, 47% of eligible patients received their recommended screening, and Dr. Gieske said he expects even more improvement.

“We’re on track this year to complete 60% uptake if things continue,” he said, adding that 76% of the new cases of lung cancer are now diagnosed in stage I, with only 5% diagnosed in stage IV.

Dr. Gieske has shared his experience with many clinics in Appalachia, home to some of the highest rates of mortality from lung cancer in the country. A major part of his role with the Appalachian Community Cancer Alliance is helping educate primary care clinicians in the region about the importance of early detection of lung cancer.

“I think one of the most important things is just to convey a message of hope,” he said. “We’re trying to get the good word out there that if you screen individuals, you’re going to catch it early, when you have an extremely high chance of curing the lung cancer.”

Dr. Baggett reported support from grants from the ACS and the Massachusetts General Hospital Research Scholars Program. Dr. Sandler and Dr. Gieske reported no financial conflicts.

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

A few years ago, Kim Lori Sandler, MD, realized many patients newly diagnosed with lung cancer had never been screened for the disease — they received CT scans only because they were symptomatic.

But Dr. Sandler, a radiologist at Vanderbilt University Medical Center in Nashville, Tennessee, could see in medical charts that most of these patients had been eligible for a screening before becoming symptomatic. And for women, most had received decades worth of mammograms. She saw an opportunity and launched a study to find out if an intervention would work.

Low-dose CT and mammography services often are available in the same imaging facility, so women who qualified for a lung cancer screening were offered the scan during their mammography visit. Over a 3-year period, monthly rates of lung scans in women rose by 50% at one facility and 36% at the other.

“What we found is that women are really receptive, if you talk to them about it,” Dr. Sandler said. “I don’t think that lung cancer is thought of as a disease in women.”

Although lung cancer is the leading cause of cancer deaths in the United States, a recent study in JAMA Internal Medicine found only 18% of eligible patients were screened in 2022, a far cry from the rates of 72% for colon cancer — which itself falls short of goals from US medical groups like the American Cancer Society (ACS). Among those eligible, rates of lung screenings were lowest among younger people without comorbid conditions, who did not have health insurance or a usual source of care, and those living in southern states and states that did not expand Medicaid as part of the Affordable Care Act.

But researchers and clinicians, from those working in an urban health center for the homeless to clinics in the poorest counties in the tobacco belt, have used strategies to raise their rates of screening for lung cancer.

Getting patients screened is lifesaving: 27% of people with lung cancer survive 5 years after diagnosis. But the survival rate rises to 63% when cases are diagnosed at an early stage.
 

Increasing Uptake

The formal recommendation to use low-dose chest CT to screen for lung cancer is only a decade old. The approach was first endorsed by the United States Preventive Services Task Force (USPSTF) on the basis of an influential trial that found such testing was linked to a 20% reduction in mortality from the disease. Updated 2021 USPSTF guidelines call for annual screening of people aged 50-80 years who have a 20 pack-year history of smoking and currently smoke or have quit within the past 15 years.

But implementing the recommendation is not always simple. Unlike a colorectal or breast cancer screening, which is recommended primarily on patient age, eligibility for a lung cancer screening requires calculating pack-years of smoking, and, for past smokers, knowledge of when they quit.

The structured fields in most electronic medical records (EMRs) inquire about current or past use of cigarettes and the number of daily packs smoked. But few EMRs can calculate when a patient starts smoking two cigarettes a day but then increases to a pack a day and cuts down again. EMRs also do not track when a patient has stopped smoking permanently. Individual clinicians or health systems must identify patients who are eligible for screening, but the lack of automated calculations makes that job more difficult.

Dr. Sandler and colleagues turned to the informatics team at Vanderbilt to develop a natural language processing approach that extracts smoking data directly from clinician notes instead of using standard variables in their EMR.

The number of patients identified as needing a screening using the algorithm nearly doubled from baseline, from 5887 to 10,231 over a 3-year period, according to results from another study that Dr. Sandler published.

Although the algorithm may occasionally flag someone who does not need screening as eligible, “you can always have a conversation with the patient to determine if they actually meet eligibility criteria,” Dr. Sandler said.
 

Patient Navigators to the Rescue?

About a decade ago, Travis Baggett, MD, MPH, an associate professor of internal medicine at Harvard Medical School, Boston, Massachusetts, received pilot funding from the ACS to study cancer epidemiology among patients at Boston Health Care for the Homeless Program (BHCHP), which serves nearly 10,000 patients at a variety of Boston-area clinics each year.

“We found that both the incidence and mortality rates for lung cancer were more than twofold higher than in the general population,” Dr. Baggett, who is also the director of research at BHCHP, said.

He also discovered that BHCHP patients were diagnosed at significantly later stages than people in the general population for malignancies like breast and colorectal cancer.

Screening for lung cancer was a new recommendation at the time. With additional funding from the ACS, he launched a clinical trial in 2020 that randomized patients who were eligible for lung cancer screening to either work with a patient navigator or receive usual care.

The navigators eased the burden on primary care clinicians: They facilitated shared decision-making visits, helped participants make and attend appointments for low-dose CT, assisted with transportation, and arranged follow-up as needed.

The 3-year study found 43% of patients who received navigation services underwent screening for lung cancer, compared with 9% in the usual-care arm. Participants said the navigators played a critical role in educating them about the importance of screening, coordinating care, and providing emotional support.

“At the root of it all, it was quite clear that one thing that made the navigator successful was their interpersonal qualities and having someone that the patient could trust to help guide them through the process,” Dr. Baggett said.

The navigator program, however, stopped when the funding for the study ended.

But another health system has implemented navigators in a sustainable way through a quality improvement project. Michael Gieske, MD, director of lung cancer screening at St. Elizabeth Healthcare in Edgewood, Kentucky, starts his Friday morning meeting with a multidisciplinary group, including a thoracic surgeon, radiologist, pulmonologist, and several screening nurse navigators. They review the week’s chest CTs, with approximately one-third from patients who underwent lung cancer screening.

Nurse navigators at St. Elizabeth Healthcare follow up with any patient whose scan is suspicious for lung cancer and guide them through the process of seeing specialists and obtaining additional testing.

“They essentially hold the patient’s hand through this scary time in their life and make sure that everything flows smoothly and efficiently,” said Dr. Gieske, a family medicine physician.

St. Elizabeth’s program also draws on several evidence-based strategies used for other cancer screening programs, such as patient and provider education and quarterly feedback to their 194 primary care clinicians on rates of lung cancer screening among their eligible patients.

Several requirements for reimbursement for a lung cancer screening from the US Centers for Medicare & Medicaid Services can also serve as barriers to getting patients screened: Clinicians must identify who is eligible, provide tobacco cessation counseling, and document the shared decision-making process.

To streamline the steps, St. Elizabeth’s clinicians use an EMR smart set that reminds clinicians to verify smoking history and helps them document the required counseling.

Last year, 47% of eligible patients received their recommended screening, and Dr. Gieske said he expects even more improvement.

“We’re on track this year to complete 60% uptake if things continue,” he said, adding that 76% of the new cases of lung cancer are now diagnosed in stage I, with only 5% diagnosed in stage IV.

Dr. Gieske has shared his experience with many clinics in Appalachia, home to some of the highest rates of mortality from lung cancer in the country. A major part of his role with the Appalachian Community Cancer Alliance is helping educate primary care clinicians in the region about the importance of early detection of lung cancer.

“I think one of the most important things is just to convey a message of hope,” he said. “We’re trying to get the good word out there that if you screen individuals, you’re going to catch it early, when you have an extremely high chance of curing the lung cancer.”

Dr. Baggett reported support from grants from the ACS and the Massachusetts General Hospital Research Scholars Program. Dr. Sandler and Dr. Gieske reported no financial conflicts.

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

Posttraumatic stress disorder (PTSD) may enhance the risk for obstructive sleep apnea (OSA) in older male veterans, the results of a cross-sectional twin study suggested. However, additional high-quality research is needed and may yield important mechanistic insights into both conditions and improve treatment, experts said.

In the trial, increasing PTSD symptom severity was associated with increasing severity of OSA, even after controlling for multiple factors.

“The strength of the association was a bit surprising,” said study investigator Amit J. Shah, MD, MSCR, Emory University, Atlanta, Georgia. “Many physicians and scientists may otherwise assume that the relationship between PTSD and sleep apnea would be primarily mediated by obesity, but we did not find that obesity explained our findings.”

The study was published online in JAMA Network Open.
 

A More Rigorous Evaluation

“Prior studies have shown an association between PTSD and sleep apnea, but the size of the association was not as strong,” Dr. Shah said, possibly because many were based on symptomatic patients referred for clinical evaluation of OSA and some relied on self-report of a sleep apnea diagnosis.

The current study involved 181 male twins, aged 61-71 years, including 66 pairs discordant for PTSD symptoms and 15 pairs discordant for PTSD diagnosis, who were recruited from the Vietnam Era Twin Registry and underwent a formal psychiatric and polysomnography evaluation as follow-up of the Emory Twin Study.

PTSD symptom severity was assessed using the self-administered Posttraumatic Stress Disorder Checklist (PCL). OSA was mild in 74% of participants, moderate to severe in 40%, and severe in 18%.

The mean apnea-hypopnea index (AHI) was 17.7 events per hour, and the mean proportion of the night with SaO₂ less than 90% was 8.9%.

In fully adjusted models, each 15-point within-pair difference in PCL score was associated with a 4.6 events-per-hour higher AHI, a 6.4 events-per-hour higher oxygen desaturation index, and a 4.8% greater sleep duration with SaO₂ less than 90%.

A current PTSD diagnosis is associated with an approximate 10-unit higher adjusted AHI in separate models involving potential cardiovascular mediators (10.5-unit; 95% CI, 5.7-15.3) and sociodemographic and psychiatric confounders (10.7-unit; 95% CI, 4.0-17.4).

The investigators called for more research into the underlying mechanisms but speculated that pharyngeal collapsibility and exaggerated loop gain, among others, may play a role.

“Our findings broaden the concept of OSA as one that may involve stress pathways in addition to the traditional mechanisms involving airway collapse and obesity,” Dr. Shah said. “We should be more suspicious of OSA as an important comorbidity in PTSD, given the high OSA prevalence that we found in PTSD veterans.”
 

Questions Remain

In an accompanying editorial, Steven H. Woodward, PhD, and Ruth M. Benca, MD, PhD, VA Palo Alto Health Care Systems, Palo Alto, California, noted the study affirmatively answers the decades-old question of whether rates of OSA are elevated in PTSD and “eliminates many potential confounders that might cast doubt on the PTSD-OSA association.”

However, they noted, it’s difficult to ascertain the directionality of this association and point out that, in terms of potential mechanisms, the oft-cited 1994 study linking sleep fragmentation with upper airway collapsibility has never been replicated and that a recent study found no difference in airway collapsibility or evidence of differential loop gain in combat veterans with and without PTSD.

Dr. Woodward and Dr. Benca also highlighted the large body of evidence that psychiatric disorders such as bipolar disorder, schizophrenia, and, in particular, major depressive disorder, are strongly associated with higher rates of OSA.

“In sum, we do not believe that a fair reading of the current literature supports a conclusion that PTSD bears an association with OSA that does not overlap with those manifested by other psychiatric disorders,” they wrote.

“This commentary is not intended to discourage any specific line of inquiry. Rather, we seek to keep the door open as wide as possible to hypotheses and research designs aimed at elucidating the relationships between OSA and psychiatric disorders,” Dr. Woodward and Dr. Benca concluded.

In response, Dr. Shah said the editorialists’ “point about psychiatric conditions other than PTSD also being important in OSA is well taken. In our own cohort, we did not see such an association, but that does not mean that this does not exist.

“Autonomic physiology, which we plan to study next, may underlie not only the PTSD-OSA relationship but also the relationship between other psychiatric factors and OSA,” he added.

The study was funded by grants from the National Institutes of Health (NIH). One study author reported receiving personal fees from Idorsia, and another reported receiving personal fees from Clinilabs, Eisai, Ferring Pharmaceuticals, Huxley, Idorsia, and Merck Sharp & Dohme. Dr. Benca reported receiving grants from the NIH and Eisai and personal fees from Eisai, Idorsia, Haleon, and Sage Therapeutics. Dr. Woodward reported having no relevant conflicts of interest.

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

Posttraumatic stress disorder (PTSD) may enhance the risk for obstructive sleep apnea (OSA) in older male veterans, the results of a cross-sectional twin study suggested. However, additional high-quality research is needed and may yield important mechanistic insights into both conditions and improve treatment, experts said.

In the trial, increasing PTSD symptom severity was associated with increasing severity of OSA, even after controlling for multiple factors.

“The strength of the association was a bit surprising,” said study investigator Amit J. Shah, MD, MSCR, Emory University, Atlanta, Georgia. “Many physicians and scientists may otherwise assume that the relationship between PTSD and sleep apnea would be primarily mediated by obesity, but we did not find that obesity explained our findings.”

The study was published online in JAMA Network Open.
 

A More Rigorous Evaluation

“Prior studies have shown an association between PTSD and sleep apnea, but the size of the association was not as strong,” Dr. Shah said, possibly because many were based on symptomatic patients referred for clinical evaluation of OSA and some relied on self-report of a sleep apnea diagnosis.

The current study involved 181 male twins, aged 61-71 years, including 66 pairs discordant for PTSD symptoms and 15 pairs discordant for PTSD diagnosis, who were recruited from the Vietnam Era Twin Registry and underwent a formal psychiatric and polysomnography evaluation as follow-up of the Emory Twin Study.

PTSD symptom severity was assessed using the self-administered Posttraumatic Stress Disorder Checklist (PCL). OSA was mild in 74% of participants, moderate to severe in 40%, and severe in 18%.

The mean apnea-hypopnea index (AHI) was 17.7 events per hour, and the mean proportion of the night with SaO₂ less than 90% was 8.9%.

In fully adjusted models, each 15-point within-pair difference in PCL score was associated with a 4.6 events-per-hour higher AHI, a 6.4 events-per-hour higher oxygen desaturation index, and a 4.8% greater sleep duration with SaO₂ less than 90%.

A current PTSD diagnosis is associated with an approximate 10-unit higher adjusted AHI in separate models involving potential cardiovascular mediators (10.5-unit; 95% CI, 5.7-15.3) and sociodemographic and psychiatric confounders (10.7-unit; 95% CI, 4.0-17.4).

The investigators called for more research into the underlying mechanisms but speculated that pharyngeal collapsibility and exaggerated loop gain, among others, may play a role.

“Our findings broaden the concept of OSA as one that may involve stress pathways in addition to the traditional mechanisms involving airway collapse and obesity,” Dr. Shah said. “We should be more suspicious of OSA as an important comorbidity in PTSD, given the high OSA prevalence that we found in PTSD veterans.”
 

Questions Remain

In an accompanying editorial, Steven H. Woodward, PhD, and Ruth M. Benca, MD, PhD, VA Palo Alto Health Care Systems, Palo Alto, California, noted the study affirmatively answers the decades-old question of whether rates of OSA are elevated in PTSD and “eliminates many potential confounders that might cast doubt on the PTSD-OSA association.”

However, they noted, it’s difficult to ascertain the directionality of this association and point out that, in terms of potential mechanisms, the oft-cited 1994 study linking sleep fragmentation with upper airway collapsibility has never been replicated and that a recent study found no difference in airway collapsibility or evidence of differential loop gain in combat veterans with and without PTSD.

Dr. Woodward and Dr. Benca also highlighted the large body of evidence that psychiatric disorders such as bipolar disorder, schizophrenia, and, in particular, major depressive disorder, are strongly associated with higher rates of OSA.

“In sum, we do not believe that a fair reading of the current literature supports a conclusion that PTSD bears an association with OSA that does not overlap with those manifested by other psychiatric disorders,” they wrote.

“This commentary is not intended to discourage any specific line of inquiry. Rather, we seek to keep the door open as wide as possible to hypotheses and research designs aimed at elucidating the relationships between OSA and psychiatric disorders,” Dr. Woodward and Dr. Benca concluded.

In response, Dr. Shah said the editorialists’ “point about psychiatric conditions other than PTSD also being important in OSA is well taken. In our own cohort, we did not see such an association, but that does not mean that this does not exist.

“Autonomic physiology, which we plan to study next, may underlie not only the PTSD-OSA relationship but also the relationship between other psychiatric factors and OSA,” he added.

The study was funded by grants from the National Institutes of Health (NIH). One study author reported receiving personal fees from Idorsia, and another reported receiving personal fees from Clinilabs, Eisai, Ferring Pharmaceuticals, Huxley, Idorsia, and Merck Sharp & Dohme. Dr. Benca reported receiving grants from the NIH and Eisai and personal fees from Eisai, Idorsia, Haleon, and Sage Therapeutics. Dr. Woodward reported having no relevant conflicts of interest.

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

Posttraumatic stress disorder (PTSD) may enhance the risk for obstructive sleep apnea (OSA) in older male veterans, the results of a cross-sectional twin study suggested. However, additional high-quality research is needed and may yield important mechanistic insights into both conditions and improve treatment, experts said.

In the trial, increasing PTSD symptom severity was associated with increasing severity of OSA, even after controlling for multiple factors.

“The strength of the association was a bit surprising,” said study investigator Amit J. Shah, MD, MSCR, Emory University, Atlanta, Georgia. “Many physicians and scientists may otherwise assume that the relationship between PTSD and sleep apnea would be primarily mediated by obesity, but we did not find that obesity explained our findings.”

The study was published online in JAMA Network Open.
 

A More Rigorous Evaluation

“Prior studies have shown an association between PTSD and sleep apnea, but the size of the association was not as strong,” Dr. Shah said, possibly because many were based on symptomatic patients referred for clinical evaluation of OSA and some relied on self-report of a sleep apnea diagnosis.

The current study involved 181 male twins, aged 61-71 years, including 66 pairs discordant for PTSD symptoms and 15 pairs discordant for PTSD diagnosis, who were recruited from the Vietnam Era Twin Registry and underwent a formal psychiatric and polysomnography evaluation as follow-up of the Emory Twin Study.

PTSD symptom severity was assessed using the self-administered Posttraumatic Stress Disorder Checklist (PCL). OSA was mild in 74% of participants, moderate to severe in 40%, and severe in 18%.

The mean apnea-hypopnea index (AHI) was 17.7 events per hour, and the mean proportion of the night with SaO₂ less than 90% was 8.9%.

In fully adjusted models, each 15-point within-pair difference in PCL score was associated with a 4.6 events-per-hour higher AHI, a 6.4 events-per-hour higher oxygen desaturation index, and a 4.8% greater sleep duration with SaO₂ less than 90%.

A current PTSD diagnosis is associated with an approximate 10-unit higher adjusted AHI in separate models involving potential cardiovascular mediators (10.5-unit; 95% CI, 5.7-15.3) and sociodemographic and psychiatric confounders (10.7-unit; 95% CI, 4.0-17.4).

The investigators called for more research into the underlying mechanisms but speculated that pharyngeal collapsibility and exaggerated loop gain, among others, may play a role.

“Our findings broaden the concept of OSA as one that may involve stress pathways in addition to the traditional mechanisms involving airway collapse and obesity,” Dr. Shah said. “We should be more suspicious of OSA as an important comorbidity in PTSD, given the high OSA prevalence that we found in PTSD veterans.”
 

Questions Remain

In an accompanying editorial, Steven H. Woodward, PhD, and Ruth M. Benca, MD, PhD, VA Palo Alto Health Care Systems, Palo Alto, California, noted the study affirmatively answers the decades-old question of whether rates of OSA are elevated in PTSD and “eliminates many potential confounders that might cast doubt on the PTSD-OSA association.”

However, they noted, it’s difficult to ascertain the directionality of this association and point out that, in terms of potential mechanisms, the oft-cited 1994 study linking sleep fragmentation with upper airway collapsibility has never been replicated and that a recent study found no difference in airway collapsibility or evidence of differential loop gain in combat veterans with and without PTSD.

Dr. Woodward and Dr. Benca also highlighted the large body of evidence that psychiatric disorders such as bipolar disorder, schizophrenia, and, in particular, major depressive disorder, are strongly associated with higher rates of OSA.

“In sum, we do not believe that a fair reading of the current literature supports a conclusion that PTSD bears an association with OSA that does not overlap with those manifested by other psychiatric disorders,” they wrote.

“This commentary is not intended to discourage any specific line of inquiry. Rather, we seek to keep the door open as wide as possible to hypotheses and research designs aimed at elucidating the relationships between OSA and psychiatric disorders,” Dr. Woodward and Dr. Benca concluded.

In response, Dr. Shah said the editorialists’ “point about psychiatric conditions other than PTSD also being important in OSA is well taken. In our own cohort, we did not see such an association, but that does not mean that this does not exist.

“Autonomic physiology, which we plan to study next, may underlie not only the PTSD-OSA relationship but also the relationship between other psychiatric factors and OSA,” he added.

The study was funded by grants from the National Institutes of Health (NIH). One study author reported receiving personal fees from Idorsia, and another reported receiving personal fees from Clinilabs, Eisai, Ferring Pharmaceuticals, Huxley, Idorsia, and Merck Sharp & Dohme. Dr. Benca reported receiving grants from the NIH and Eisai and personal fees from Eisai, Idorsia, Haleon, and Sage Therapeutics. Dr. Woodward reported having no relevant conflicts of interest.

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

The MUC-1 vaccine tecemotide plus standard neoadjuvant systemic therapy was shown to notably improve distant relapse-free survival and overall survival rates in breast cancer patients, in a new study.

“This is the first successful study of a breast cancer vaccine to date,” Christian F. Singer, MD, said during an interview. Dr. Singer, the lead author of the new study, presented the results during a poster session at the 2024 annual meeting of the American Society of Clinical Oncology (ASCO).

Previously known as both liposomal BLP25 and Stimuvax, tecemotide is an antigen-specific immunotherapy that targets the cancer therapy–resistant MUC-1 glycoprotein, which is overexpressed in over 90% of breast cancers. Tecemotide also has been shown to moderately improve overall survival rates in non–small cell lung cancer.

“We are not at all surprised by the results of this study in breast cancer,” Gregory T. Wurz, PhD, senior researcher at RCU Labs in Lincoln, California, said in an interview.

Dr. Wurz is coauthor of several studies on peptide vaccines, including a mouse model study of human MUC-1–expressing mammary tumors showing that tecemotide combined with letrozole had additive antitumor activity. Another paper he coauthored showed that ospemifene enhanced the immune response to tecemotide in both tumor-bearing and non–tumor-bearing mice. These findings, combined with other research, led to the creation of a patented method of combining therapies to enhance the efficacy of immunotherapy in the treatment of cancer and infectious diseases. Dr. Wurz was not involved in the new research that Dr. Singer presented at ASCO.
 

Study Methods and Results

Dr. Singer, head of obstetrics and gynecology at the Medical University of Vienna, Vienna, Austria, and coauthors randomized 400 patients with HER2-negative early breast cancer in a prospective, multicenter, two-arm, phase 2 ABCSG 34 trial to receive preoperative standard of care (SOC) neoadjuvant treatment with or without tecemotide.

Postmenopausal women with luminal A tumors were given 6 months of letrozole as SOC. Postmenopausal patients with triple-negative breast cancer, luminal B tumors, in whom chemotherapy was SOC, as well as all premenopausal study participants, were given four cycles of both epirubicin cyclophosphamide and docetaxel every 3 weeks.

The study’s primary endpoint was the residual cancer burden at the time of surgery.

Long-term outcomes were measured as part of a translational project, while distant relapse-free survival (DRFS) and overall survival (OS) were analyzed with Cox regression models. Long-term outcome data were available for 291 women, of whom 236 had received chemotherapy as SOC.

While tecemotide plus neoadjuvant SOC was not associated with a significant increase in residual cancer burden (RCB) at the time of surgery (36.4% vs 31.5%; P = .42; 40.5% vs 34.8%; P = .37 for the chemotherapy-only cohort), follow-up at 7 years showed 80.8% of patients who had received SOC plus tecemotide were still alive and free from metastasis.

In patients who had received SOC alone, the OS rate at 7 years with no metastasis was 64.7% (hazard ratio [HR] for DRFS, 0.53; 95% CI, 0.34-0.83; P = .005). The OS rate for the study group was 83.0% vs 68.2% in the non-tecemotide cohort (HR for OS, 0.53; 95% CI, 0.33-0.85; P = .008).

The lack of RCB signal at the endpoints, “tells us that pathologic complete response and residual cancer burden simply are not adequate endpoints for cancer vaccination studies and we need to find other predictive/prognostic markers, said Dr. Singer. “We are currently looking into this in exploratory studies.”

The chemotherapy plus tecemotide cohort had a notable outcome with a DRFS of 81.9% vs 65.0% in the SOC group (HR, 0.50; 95% CI, 0.31-0.83; P = .007), and an OS rate of 83.6% vs 67.8% (HR, 0.51; 95% CI, 0.30-0.88; P = .016).

Dr. Singer characterized the HRs as intriguing, saying that they “pave the way for new trials.”
 

Ideas for Further Study of Tecemotide

“What we would like to see next for tecemotide are clinical studies that explore whether immunomodulatory agents can further enhance the response to tecemotide in lung, breast, and potentially other MUC-1–expressing cancers,” Dr. Wurz said.

Future phase 3 studies of MUC-1 cancer vaccines, possibly those using mRNA technology, are yet to come, according to Dr. Singer. “We also need to find out why the vaccine works sometimes and sometimes not.”

Dr. Singer disclosed financial ties to AstraZeneca/MedImmune, Daiichi Sankyo Europe, Novartis, Gilead Sciences, Sanofi/Aventis, Amgen, Myriad Genetics, and Roche. Dr. Wurz had no disclosures, but his research partner and founder of RCU Labs, Michael De Gregorio, is the sole inventor of the patent referenced in the story. That patent has been assigned to the Regents of the University of California.

The MUC-1 vaccine tecemotide plus standard neoadjuvant systemic therapy was shown to notably improve distant relapse-free survival and overall survival rates in breast cancer patients, in a new study.

“This is the first successful study of a breast cancer vaccine to date,” Christian F. Singer, MD, said during an interview. Dr. Singer, the lead author of the new study, presented the results during a poster session at the 2024 annual meeting of the American Society of Clinical Oncology (ASCO).

Previously known as both liposomal BLP25 and Stimuvax, tecemotide is an antigen-specific immunotherapy that targets the cancer therapy–resistant MUC-1 glycoprotein, which is overexpressed in over 90% of breast cancers. Tecemotide also has been shown to moderately improve overall survival rates in non–small cell lung cancer.

“We are not at all surprised by the results of this study in breast cancer,” Gregory T. Wurz, PhD, senior researcher at RCU Labs in Lincoln, California, said in an interview.

Dr. Wurz is coauthor of several studies on peptide vaccines, including a mouse model study of human MUC-1–expressing mammary tumors showing that tecemotide combined with letrozole had additive antitumor activity. Another paper he coauthored showed that ospemifene enhanced the immune response to tecemotide in both tumor-bearing and non–tumor-bearing mice. These findings, combined with other research, led to the creation of a patented method of combining therapies to enhance the efficacy of immunotherapy in the treatment of cancer and infectious diseases. Dr. Wurz was not involved in the new research that Dr. Singer presented at ASCO.
 

Study Methods and Results

Dr. Singer, head of obstetrics and gynecology at the Medical University of Vienna, Vienna, Austria, and coauthors randomized 400 patients with HER2-negative early breast cancer in a prospective, multicenter, two-arm, phase 2 ABCSG 34 trial to receive preoperative standard of care (SOC) neoadjuvant treatment with or without tecemotide.

Postmenopausal women with luminal A tumors were given 6 months of letrozole as SOC. Postmenopausal patients with triple-negative breast cancer, luminal B tumors, in whom chemotherapy was SOC, as well as all premenopausal study participants, were given four cycles of both epirubicin cyclophosphamide and docetaxel every 3 weeks.

The study’s primary endpoint was the residual cancer burden at the time of surgery.

Long-term outcomes were measured as part of a translational project, while distant relapse-free survival (DRFS) and overall survival (OS) were analyzed with Cox regression models. Long-term outcome data were available for 291 women, of whom 236 had received chemotherapy as SOC.

While tecemotide plus neoadjuvant SOC was not associated with a significant increase in residual cancer burden (RCB) at the time of surgery (36.4% vs 31.5%; P = .42; 40.5% vs 34.8%; P = .37 for the chemotherapy-only cohort), follow-up at 7 years showed 80.8% of patients who had received SOC plus tecemotide were still alive and free from metastasis.

In patients who had received SOC alone, the OS rate at 7 years with no metastasis was 64.7% (hazard ratio [HR] for DRFS, 0.53; 95% CI, 0.34-0.83; P = .005). The OS rate for the study group was 83.0% vs 68.2% in the non-tecemotide cohort (HR for OS, 0.53; 95% CI, 0.33-0.85; P = .008).

The lack of RCB signal at the endpoints, “tells us that pathologic complete response and residual cancer burden simply are not adequate endpoints for cancer vaccination studies and we need to find other predictive/prognostic markers, said Dr. Singer. “We are currently looking into this in exploratory studies.”

The chemotherapy plus tecemotide cohort had a notable outcome with a DRFS of 81.9% vs 65.0% in the SOC group (HR, 0.50; 95% CI, 0.31-0.83; P = .007), and an OS rate of 83.6% vs 67.8% (HR, 0.51; 95% CI, 0.30-0.88; P = .016).

Dr. Singer characterized the HRs as intriguing, saying that they “pave the way for new trials.”
 

Ideas for Further Study of Tecemotide

“What we would like to see next for tecemotide are clinical studies that explore whether immunomodulatory agents can further enhance the response to tecemotide in lung, breast, and potentially other MUC-1–expressing cancers,” Dr. Wurz said.

Future phase 3 studies of MUC-1 cancer vaccines, possibly those using mRNA technology, are yet to come, according to Dr. Singer. “We also need to find out why the vaccine works sometimes and sometimes not.”

Dr. Singer disclosed financial ties to AstraZeneca/MedImmune, Daiichi Sankyo Europe, Novartis, Gilead Sciences, Sanofi/Aventis, Amgen, Myriad Genetics, and Roche. Dr. Wurz had no disclosures, but his research partner and founder of RCU Labs, Michael De Gregorio, is the sole inventor of the patent referenced in the story. That patent has been assigned to the Regents of the University of California.

The MUC-1 vaccine tecemotide plus standard neoadjuvant systemic therapy was shown to notably improve distant relapse-free survival and overall survival rates in breast cancer patients, in a new study.

“This is the first successful study of a breast cancer vaccine to date,” Christian F. Singer, MD, said during an interview. Dr. Singer, the lead author of the new study, presented the results during a poster session at the 2024 annual meeting of the American Society of Clinical Oncology (ASCO).

Previously known as both liposomal BLP25 and Stimuvax, tecemotide is an antigen-specific immunotherapy that targets the cancer therapy–resistant MUC-1 glycoprotein, which is overexpressed in over 90% of breast cancers. Tecemotide also has been shown to moderately improve overall survival rates in non–small cell lung cancer.

“We are not at all surprised by the results of this study in breast cancer,” Gregory T. Wurz, PhD, senior researcher at RCU Labs in Lincoln, California, said in an interview.

Dr. Wurz is coauthor of several studies on peptide vaccines, including a mouse model study of human MUC-1–expressing mammary tumors showing that tecemotide combined with letrozole had additive antitumor activity. Another paper he coauthored showed that ospemifene enhanced the immune response to tecemotide in both tumor-bearing and non–tumor-bearing mice. These findings, combined with other research, led to the creation of a patented method of combining therapies to enhance the efficacy of immunotherapy in the treatment of cancer and infectious diseases. Dr. Wurz was not involved in the new research that Dr. Singer presented at ASCO.
 

Study Methods and Results

Dr. Singer, head of obstetrics and gynecology at the Medical University of Vienna, Vienna, Austria, and coauthors randomized 400 patients with HER2-negative early breast cancer in a prospective, multicenter, two-arm, phase 2 ABCSG 34 trial to receive preoperative standard of care (SOC) neoadjuvant treatment with or without tecemotide.

Postmenopausal women with luminal A tumors were given 6 months of letrozole as SOC. Postmenopausal patients with triple-negative breast cancer, luminal B tumors, in whom chemotherapy was SOC, as well as all premenopausal study participants, were given four cycles of both epirubicin cyclophosphamide and docetaxel every 3 weeks.

The study’s primary endpoint was the residual cancer burden at the time of surgery.

Long-term outcomes were measured as part of a translational project, while distant relapse-free survival (DRFS) and overall survival (OS) were analyzed with Cox regression models. Long-term outcome data were available for 291 women, of whom 236 had received chemotherapy as SOC.

While tecemotide plus neoadjuvant SOC was not associated with a significant increase in residual cancer burden (RCB) at the time of surgery (36.4% vs 31.5%; P = .42; 40.5% vs 34.8%; P = .37 for the chemotherapy-only cohort), follow-up at 7 years showed 80.8% of patients who had received SOC plus tecemotide were still alive and free from metastasis.

In patients who had received SOC alone, the OS rate at 7 years with no metastasis was 64.7% (hazard ratio [HR] for DRFS, 0.53; 95% CI, 0.34-0.83; P = .005). The OS rate for the study group was 83.0% vs 68.2% in the non-tecemotide cohort (HR for OS, 0.53; 95% CI, 0.33-0.85; P = .008).

The lack of RCB signal at the endpoints, “tells us that pathologic complete response and residual cancer burden simply are not adequate endpoints for cancer vaccination studies and we need to find other predictive/prognostic markers, said Dr. Singer. “We are currently looking into this in exploratory studies.”

The chemotherapy plus tecemotide cohort had a notable outcome with a DRFS of 81.9% vs 65.0% in the SOC group (HR, 0.50; 95% CI, 0.31-0.83; P = .007), and an OS rate of 83.6% vs 67.8% (HR, 0.51; 95% CI, 0.30-0.88; P = .016).

Dr. Singer characterized the HRs as intriguing, saying that they “pave the way for new trials.”
 

Ideas for Further Study of Tecemotide

“What we would like to see next for tecemotide are clinical studies that explore whether immunomodulatory agents can further enhance the response to tecemotide in lung, breast, and potentially other MUC-1–expressing cancers,” Dr. Wurz said.

Future phase 3 studies of MUC-1 cancer vaccines, possibly those using mRNA technology, are yet to come, according to Dr. Singer. “We also need to find out why the vaccine works sometimes and sometimes not.”

Dr. Singer disclosed financial ties to AstraZeneca/MedImmune, Daiichi Sankyo Europe, Novartis, Gilead Sciences, Sanofi/Aventis, Amgen, Myriad Genetics, and Roche. Dr. Wurz had no disclosures, but his research partner and founder of RCU Labs, Michael De Gregorio, is the sole inventor of the patent referenced in the story. That patent has been assigned to the Regents of the University of California.