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Decreasing the burden of postacute sequelae of SARS-CoV-2 infection: What we know
On March 11, 2020, the World Health Organization (WHO) declared SARS-CoV-2 a pandemic. As of October 2021, there are over 240 million confirmed COVID-19 cases and over 4 million deaths globally, with the United States having the highest incidence of both cases and deaths (https://covid.cdc.gov/covid-data-tracker/#datatracker-home). As many as 87% of COVID-19 survivors experience persistent symptoms that last beyond the acute phase of illness (Carfi A, et al. JAMA. 2020;324[6]:603-5). In February 2021, the National Institutes of Health (NIH) called for a consensus term to describe this protracted form of COVID-19, and defined it as Post-acute Sequelae of SARS-CoV-2 infection (PASC) (https://www.nih.gov/about-nih/who-we-are/nih-director/statements/nih-launches-new-initiative-study-long-covid).
What are the PASC manifestations?
PASC has a heterogeneous presentation with a broad spectrum of manifestations and can vary from single to multiorgan system involvement. Commonly, PASC involves pulmonary abnormalities (shortness of breath, exercise intolerance, abnormal pulmonary functional test [PFT] and chest imaging), neurocognitive impairments (difficulty concentrating and memory loss), mental health disorders (anxiety, depression, and post-traumatic stress disorder), functional mobility impairments, as well as general and constitutional symptoms (fatigue and muscle weakness) (Groff D, et al. JAMA Netw Open. 2021;4[10]). The most prevalent pulmonary physiologic impairment is reduced diffusion capacity that has been shown to be associated with the severity of acute illness, while the most common radiologic abnormalities on chest CT scan are ground glass opacities. Some studies have shown a temporal improvement in pulmonary physiology and exercise capacity; however, persistent physiological and radiographic abnormalities persist in some patients up to 12 months after discharge (Wu X, et al. Lancet Respir Med. 2021;9:747-54). An abnormal or persistent hyper-inflammatory state, viral-induced autoimmune reaction, and ongoing viral activity have been proposed as possible biological mechanisms for PASC; however, the pathophysiology remains mostly unknown.
Who does PASC affect?
PASC affects patients irrespective of premorbid condition and severity of symptoms in the acute phase. It spans from those who had mild disease not requiring hospitalization to those who had critical illness requiring intensive care unit (ICU) management. COVID-19 ICU survivors seem to have an overlap of PASC and post-intensive care syndrome (PICS), defined by new or worsening physical, cognitive, and/or psychiatric impairments after critical illness. (Biehl M, et al. Cleve Clin J Med. 2020 Aug 5).
Who do we evaluate for PASC?
Given the complexity and chronicity of the associated symptoms and their impact on several major organ systems, a comprehensive and multidisciplinary approach is essential to assist with diagnosis and management of PASC. Listening empathically to patients and acknowledging their symptoms are key factors. Access to ambulatory care, establishment of rapport, effective collaboration and coordination of care among different disciplines, management of comorbidities, continuity of care, access to rehabilitation programs, and reduction of disease burden are some of the principles that guided the creation of dedicated COVID-19 clinics throughout the world. The most common services offered are primary care, pulmonology, cardiology, mental health, neurology, speech and language pathology, physical and occupational therapy, pharmacy, and case management. The involvement of specialties varies depending on the specific patient’s needs (Parker A, et al. The Lancet Respir Med. 2021;S2213-2600[21]00385-4).
The development of diagnostic and care pathways by different specialties ensures standardization of clinical assessment and management while allowing for individualized care. The commonly used tools to assess the respiratory system are the 6-minute walk test, PFT, chest imaging including radiographs and high-resolution CT scan, ventilation perfusion scan, and echocardiography. Some patients exhibit persistent cardiopulmonary symptoms with no evidence of organ injury. These patients have persistent exertional and functional limitation with normal PFT, resting echocardiography, and chest imaging. Cardiopulmonary exercise testing (CPET) and, more specifically, invasive CPET can be used to further investigate the decreased exercise capacity. CPET studies have identified an augmented exercise hyperventilation, and the causes of exercise limitation varied from anemia and reduced oxygen extraction by peripheral muscles to deconditioning, obesity, and lower ventilatory efficiency. A study looking at invasive CPET showed reduced peak exercise aerobic capacity in post COVID-19 patients compared with control participants and was associated with impaired systemic oxygen extraction and an exaggerated hyperventilatory response (Singh, et al. Chest. 2021;S0012-3692[21]03635). A subset of COVID-19 survivors presents with symptoms of autonomic dysfunction such as orthostatic intolerance and postural orthostatic tachycardia. These symptoms have been reported after other viral infections and could be secondary to gastrointestinal fluid loss, prolonged bed rest, and deconditioning of the cardiovascular system. More research is needed to characterize the dysautonomia in patients post–COVID-19.
What is the treatment?
Therapies depend on symptoms and organ involvement. The duration of pulmonary symptoms in long-haulers is not yet known, with cough and exercise intolerance/dyspnea ranking among the most common complaints in these patients. Exercise therapy plays an essential part in the rehabilitation of long-haulers and several studies are underway to assess different exercise and rehabilitation programs. For most patients with normal laboratory, physiologic, and imaging tests, post–COVID-19 clinics are offering physical therapy, occupational therapy, and neuropsychological rehabilitation. While steroids have been shown to improve mortality in hospitalized patients with COVID-19 requiring mechanical ventilation or supplemental oxygen, their role in outpatient COVID-19 infections and for post–COVID-19 lung disease/organizing pneumonia remains unclear. In a UK study of patients admitted to the hospital with COVID-19 disease of varying severity, interstitial abnormalities were noted in ~5% of patients at 6 weeks postdischarge and in 10.8% of patients with persistent respiratory symptoms (Myall, et al. Ann Am Thorac Soc. 2021;18[5]:799). The most common radiological findings (in > 50% of cases) were consistent with organizing pneumonia. Patients with persistent physiological abnormalities and interstitial findings improved with steroids. However, since the trajectory of the disease is unknown, further studies are required to understand the natural history of the disease and assess treatment strategies in patients with persistent inflammatory lung changes. Several studies looking at systemic or inhaled steroids in different phases of COVID-19 infection and varying disease severity are ongoing (ClinicalTrials.gov). Antifibrotics used to treat idiopathic pulmonary fibrosis and progressive fibrotic ILD are also being investigated in COVID-19 lung disease. The rationale for their use is to treat and prevent severe COVID-19 lung injury and prevent lung fibrosis.
The role of vaccinations
Whether patients who were infected with COVID-19, and, more specifically, patients with long-term symptoms post-COVID-19, should get vaccinated is actively being investigated. Vaccinations are protective at preventing infections and severe illness. Studies showed that patients who had COVID-19 infection and got vaccinated had a significantly higher antibody response than previously uninfected vaccine recipients. A review showed that the protective effect of prior SARS-CoV-2 infection on reinfection is high and similar to that of vaccination. However, a recent study of hospitalized patients revealed higher rates of COVID-19 among unvaccinated adults with previous infection compared with vaccinated adults (http://dx.doi.org/10.15585/mmwr.mm7044e1). On the other hand, the impact of vaccine on long-hauler symptoms has raised interest. A UK survey (not peer reviewed) on more than 800 long-haulers reported about 57% with overall improvement in their symptoms, 24% no change, and 19% with worsening symptoms after their first dose of vaccine, suggesting that the chances of experiencing an overall worsening of symptoms after vaccination is small, with more than half experiencing improvement (go.nature.com/3yfqem2). While awaiting longitudinal trials, the main argument to guide vaccination in long-haulers is that COVID-19 vaccinations provide protection from reinfection and appear to have the potential to improve symptoms.
The availability of a patient’s support system, peer support, and patient advocacy groups assist in providing equitable care and are critical in sustaining the recovery of COVID-19 survivors. Providing social, financial, and cultural support is imperative in decreasing the burden of COVID-19. The dedicated post–COVID-19 clinics will not only offer care to COVID-19 survivors, but will also help our understanding of the determinants and course of PASC, and will provide opportunities for research. Long-term longitudinal observational studies and clinical trials are critical to identify those at high risk for PASC, clarify the extent of health consequences attributable to COVID-19, and define best practices for COVID-19 survivors.
Dr. Biehl is Staff Physician, Pulmonary & Critical Care Medicine, Director, Post-ICU Recovery Clinic Respiratory Institute, Cleveland Clinic; Dr.Farha is with Respiratory and Lerner Institutes, Cleveland Clinic.
On March 11, 2020, the World Health Organization (WHO) declared SARS-CoV-2 a pandemic. As of October 2021, there are over 240 million confirmed COVID-19 cases and over 4 million deaths globally, with the United States having the highest incidence of both cases and deaths (https://covid.cdc.gov/covid-data-tracker/#datatracker-home). As many as 87% of COVID-19 survivors experience persistent symptoms that last beyond the acute phase of illness (Carfi A, et al. JAMA. 2020;324[6]:603-5). In February 2021, the National Institutes of Health (NIH) called for a consensus term to describe this protracted form of COVID-19, and defined it as Post-acute Sequelae of SARS-CoV-2 infection (PASC) (https://www.nih.gov/about-nih/who-we-are/nih-director/statements/nih-launches-new-initiative-study-long-covid).
What are the PASC manifestations?
PASC has a heterogeneous presentation with a broad spectrum of manifestations and can vary from single to multiorgan system involvement. Commonly, PASC involves pulmonary abnormalities (shortness of breath, exercise intolerance, abnormal pulmonary functional test [PFT] and chest imaging), neurocognitive impairments (difficulty concentrating and memory loss), mental health disorders (anxiety, depression, and post-traumatic stress disorder), functional mobility impairments, as well as general and constitutional symptoms (fatigue and muscle weakness) (Groff D, et al. JAMA Netw Open. 2021;4[10]). The most prevalent pulmonary physiologic impairment is reduced diffusion capacity that has been shown to be associated with the severity of acute illness, while the most common radiologic abnormalities on chest CT scan are ground glass opacities. Some studies have shown a temporal improvement in pulmonary physiology and exercise capacity; however, persistent physiological and radiographic abnormalities persist in some patients up to 12 months after discharge (Wu X, et al. Lancet Respir Med. 2021;9:747-54). An abnormal or persistent hyper-inflammatory state, viral-induced autoimmune reaction, and ongoing viral activity have been proposed as possible biological mechanisms for PASC; however, the pathophysiology remains mostly unknown.
Who does PASC affect?
PASC affects patients irrespective of premorbid condition and severity of symptoms in the acute phase. It spans from those who had mild disease not requiring hospitalization to those who had critical illness requiring intensive care unit (ICU) management. COVID-19 ICU survivors seem to have an overlap of PASC and post-intensive care syndrome (PICS), defined by new or worsening physical, cognitive, and/or psychiatric impairments after critical illness. (Biehl M, et al. Cleve Clin J Med. 2020 Aug 5).
Who do we evaluate for PASC?
Given the complexity and chronicity of the associated symptoms and their impact on several major organ systems, a comprehensive and multidisciplinary approach is essential to assist with diagnosis and management of PASC. Listening empathically to patients and acknowledging their symptoms are key factors. Access to ambulatory care, establishment of rapport, effective collaboration and coordination of care among different disciplines, management of comorbidities, continuity of care, access to rehabilitation programs, and reduction of disease burden are some of the principles that guided the creation of dedicated COVID-19 clinics throughout the world. The most common services offered are primary care, pulmonology, cardiology, mental health, neurology, speech and language pathology, physical and occupational therapy, pharmacy, and case management. The involvement of specialties varies depending on the specific patient’s needs (Parker A, et al. The Lancet Respir Med. 2021;S2213-2600[21]00385-4).
The development of diagnostic and care pathways by different specialties ensures standardization of clinical assessment and management while allowing for individualized care. The commonly used tools to assess the respiratory system are the 6-minute walk test, PFT, chest imaging including radiographs and high-resolution CT scan, ventilation perfusion scan, and echocardiography. Some patients exhibit persistent cardiopulmonary symptoms with no evidence of organ injury. These patients have persistent exertional and functional limitation with normal PFT, resting echocardiography, and chest imaging. Cardiopulmonary exercise testing (CPET) and, more specifically, invasive CPET can be used to further investigate the decreased exercise capacity. CPET studies have identified an augmented exercise hyperventilation, and the causes of exercise limitation varied from anemia and reduced oxygen extraction by peripheral muscles to deconditioning, obesity, and lower ventilatory efficiency. A study looking at invasive CPET showed reduced peak exercise aerobic capacity in post COVID-19 patients compared with control participants and was associated with impaired systemic oxygen extraction and an exaggerated hyperventilatory response (Singh, et al. Chest. 2021;S0012-3692[21]03635). A subset of COVID-19 survivors presents with symptoms of autonomic dysfunction such as orthostatic intolerance and postural orthostatic tachycardia. These symptoms have been reported after other viral infections and could be secondary to gastrointestinal fluid loss, prolonged bed rest, and deconditioning of the cardiovascular system. More research is needed to characterize the dysautonomia in patients post–COVID-19.
What is the treatment?
Therapies depend on symptoms and organ involvement. The duration of pulmonary symptoms in long-haulers is not yet known, with cough and exercise intolerance/dyspnea ranking among the most common complaints in these patients. Exercise therapy plays an essential part in the rehabilitation of long-haulers and several studies are underway to assess different exercise and rehabilitation programs. For most patients with normal laboratory, physiologic, and imaging tests, post–COVID-19 clinics are offering physical therapy, occupational therapy, and neuropsychological rehabilitation. While steroids have been shown to improve mortality in hospitalized patients with COVID-19 requiring mechanical ventilation or supplemental oxygen, their role in outpatient COVID-19 infections and for post–COVID-19 lung disease/organizing pneumonia remains unclear. In a UK study of patients admitted to the hospital with COVID-19 disease of varying severity, interstitial abnormalities were noted in ~5% of patients at 6 weeks postdischarge and in 10.8% of patients with persistent respiratory symptoms (Myall, et al. Ann Am Thorac Soc. 2021;18[5]:799). The most common radiological findings (in > 50% of cases) were consistent with organizing pneumonia. Patients with persistent physiological abnormalities and interstitial findings improved with steroids. However, since the trajectory of the disease is unknown, further studies are required to understand the natural history of the disease and assess treatment strategies in patients with persistent inflammatory lung changes. Several studies looking at systemic or inhaled steroids in different phases of COVID-19 infection and varying disease severity are ongoing (ClinicalTrials.gov). Antifibrotics used to treat idiopathic pulmonary fibrosis and progressive fibrotic ILD are also being investigated in COVID-19 lung disease. The rationale for their use is to treat and prevent severe COVID-19 lung injury and prevent lung fibrosis.
The role of vaccinations
Whether patients who were infected with COVID-19, and, more specifically, patients with long-term symptoms post-COVID-19, should get vaccinated is actively being investigated. Vaccinations are protective at preventing infections and severe illness. Studies showed that patients who had COVID-19 infection and got vaccinated had a significantly higher antibody response than previously uninfected vaccine recipients. A review showed that the protective effect of prior SARS-CoV-2 infection on reinfection is high and similar to that of vaccination. However, a recent study of hospitalized patients revealed higher rates of COVID-19 among unvaccinated adults with previous infection compared with vaccinated adults (http://dx.doi.org/10.15585/mmwr.mm7044e1). On the other hand, the impact of vaccine on long-hauler symptoms has raised interest. A UK survey (not peer reviewed) on more than 800 long-haulers reported about 57% with overall improvement in their symptoms, 24% no change, and 19% with worsening symptoms after their first dose of vaccine, suggesting that the chances of experiencing an overall worsening of symptoms after vaccination is small, with more than half experiencing improvement (go.nature.com/3yfqem2). While awaiting longitudinal trials, the main argument to guide vaccination in long-haulers is that COVID-19 vaccinations provide protection from reinfection and appear to have the potential to improve symptoms.
The availability of a patient’s support system, peer support, and patient advocacy groups assist in providing equitable care and are critical in sustaining the recovery of COVID-19 survivors. Providing social, financial, and cultural support is imperative in decreasing the burden of COVID-19. The dedicated post–COVID-19 clinics will not only offer care to COVID-19 survivors, but will also help our understanding of the determinants and course of PASC, and will provide opportunities for research. Long-term longitudinal observational studies and clinical trials are critical to identify those at high risk for PASC, clarify the extent of health consequences attributable to COVID-19, and define best practices for COVID-19 survivors.
Dr. Biehl is Staff Physician, Pulmonary & Critical Care Medicine, Director, Post-ICU Recovery Clinic Respiratory Institute, Cleveland Clinic; Dr.Farha is with Respiratory and Lerner Institutes, Cleveland Clinic.
On March 11, 2020, the World Health Organization (WHO) declared SARS-CoV-2 a pandemic. As of October 2021, there are over 240 million confirmed COVID-19 cases and over 4 million deaths globally, with the United States having the highest incidence of both cases and deaths (https://covid.cdc.gov/covid-data-tracker/#datatracker-home). As many as 87% of COVID-19 survivors experience persistent symptoms that last beyond the acute phase of illness (Carfi A, et al. JAMA. 2020;324[6]:603-5). In February 2021, the National Institutes of Health (NIH) called for a consensus term to describe this protracted form of COVID-19, and defined it as Post-acute Sequelae of SARS-CoV-2 infection (PASC) (https://www.nih.gov/about-nih/who-we-are/nih-director/statements/nih-launches-new-initiative-study-long-covid).
What are the PASC manifestations?
PASC has a heterogeneous presentation with a broad spectrum of manifestations and can vary from single to multiorgan system involvement. Commonly, PASC involves pulmonary abnormalities (shortness of breath, exercise intolerance, abnormal pulmonary functional test [PFT] and chest imaging), neurocognitive impairments (difficulty concentrating and memory loss), mental health disorders (anxiety, depression, and post-traumatic stress disorder), functional mobility impairments, as well as general and constitutional symptoms (fatigue and muscle weakness) (Groff D, et al. JAMA Netw Open. 2021;4[10]). The most prevalent pulmonary physiologic impairment is reduced diffusion capacity that has been shown to be associated with the severity of acute illness, while the most common radiologic abnormalities on chest CT scan are ground glass opacities. Some studies have shown a temporal improvement in pulmonary physiology and exercise capacity; however, persistent physiological and radiographic abnormalities persist in some patients up to 12 months after discharge (Wu X, et al. Lancet Respir Med. 2021;9:747-54). An abnormal or persistent hyper-inflammatory state, viral-induced autoimmune reaction, and ongoing viral activity have been proposed as possible biological mechanisms for PASC; however, the pathophysiology remains mostly unknown.
Who does PASC affect?
PASC affects patients irrespective of premorbid condition and severity of symptoms in the acute phase. It spans from those who had mild disease not requiring hospitalization to those who had critical illness requiring intensive care unit (ICU) management. COVID-19 ICU survivors seem to have an overlap of PASC and post-intensive care syndrome (PICS), defined by new or worsening physical, cognitive, and/or psychiatric impairments after critical illness. (Biehl M, et al. Cleve Clin J Med. 2020 Aug 5).
Who do we evaluate for PASC?
Given the complexity and chronicity of the associated symptoms and their impact on several major organ systems, a comprehensive and multidisciplinary approach is essential to assist with diagnosis and management of PASC. Listening empathically to patients and acknowledging their symptoms are key factors. Access to ambulatory care, establishment of rapport, effective collaboration and coordination of care among different disciplines, management of comorbidities, continuity of care, access to rehabilitation programs, and reduction of disease burden are some of the principles that guided the creation of dedicated COVID-19 clinics throughout the world. The most common services offered are primary care, pulmonology, cardiology, mental health, neurology, speech and language pathology, physical and occupational therapy, pharmacy, and case management. The involvement of specialties varies depending on the specific patient’s needs (Parker A, et al. The Lancet Respir Med. 2021;S2213-2600[21]00385-4).
The development of diagnostic and care pathways by different specialties ensures standardization of clinical assessment and management while allowing for individualized care. The commonly used tools to assess the respiratory system are the 6-minute walk test, PFT, chest imaging including radiographs and high-resolution CT scan, ventilation perfusion scan, and echocardiography. Some patients exhibit persistent cardiopulmonary symptoms with no evidence of organ injury. These patients have persistent exertional and functional limitation with normal PFT, resting echocardiography, and chest imaging. Cardiopulmonary exercise testing (CPET) and, more specifically, invasive CPET can be used to further investigate the decreased exercise capacity. CPET studies have identified an augmented exercise hyperventilation, and the causes of exercise limitation varied from anemia and reduced oxygen extraction by peripheral muscles to deconditioning, obesity, and lower ventilatory efficiency. A study looking at invasive CPET showed reduced peak exercise aerobic capacity in post COVID-19 patients compared with control participants and was associated with impaired systemic oxygen extraction and an exaggerated hyperventilatory response (Singh, et al. Chest. 2021;S0012-3692[21]03635). A subset of COVID-19 survivors presents with symptoms of autonomic dysfunction such as orthostatic intolerance and postural orthostatic tachycardia. These symptoms have been reported after other viral infections and could be secondary to gastrointestinal fluid loss, prolonged bed rest, and deconditioning of the cardiovascular system. More research is needed to characterize the dysautonomia in patients post–COVID-19.
What is the treatment?
Therapies depend on symptoms and organ involvement. The duration of pulmonary symptoms in long-haulers is not yet known, with cough and exercise intolerance/dyspnea ranking among the most common complaints in these patients. Exercise therapy plays an essential part in the rehabilitation of long-haulers and several studies are underway to assess different exercise and rehabilitation programs. For most patients with normal laboratory, physiologic, and imaging tests, post–COVID-19 clinics are offering physical therapy, occupational therapy, and neuropsychological rehabilitation. While steroids have been shown to improve mortality in hospitalized patients with COVID-19 requiring mechanical ventilation or supplemental oxygen, their role in outpatient COVID-19 infections and for post–COVID-19 lung disease/organizing pneumonia remains unclear. In a UK study of patients admitted to the hospital with COVID-19 disease of varying severity, interstitial abnormalities were noted in ~5% of patients at 6 weeks postdischarge and in 10.8% of patients with persistent respiratory symptoms (Myall, et al. Ann Am Thorac Soc. 2021;18[5]:799). The most common radiological findings (in > 50% of cases) were consistent with organizing pneumonia. Patients with persistent physiological abnormalities and interstitial findings improved with steroids. However, since the trajectory of the disease is unknown, further studies are required to understand the natural history of the disease and assess treatment strategies in patients with persistent inflammatory lung changes. Several studies looking at systemic or inhaled steroids in different phases of COVID-19 infection and varying disease severity are ongoing (ClinicalTrials.gov). Antifibrotics used to treat idiopathic pulmonary fibrosis and progressive fibrotic ILD are also being investigated in COVID-19 lung disease. The rationale for their use is to treat and prevent severe COVID-19 lung injury and prevent lung fibrosis.
The role of vaccinations
Whether patients who were infected with COVID-19, and, more specifically, patients with long-term symptoms post-COVID-19, should get vaccinated is actively being investigated. Vaccinations are protective at preventing infections and severe illness. Studies showed that patients who had COVID-19 infection and got vaccinated had a significantly higher antibody response than previously uninfected vaccine recipients. A review showed that the protective effect of prior SARS-CoV-2 infection on reinfection is high and similar to that of vaccination. However, a recent study of hospitalized patients revealed higher rates of COVID-19 among unvaccinated adults with previous infection compared with vaccinated adults (http://dx.doi.org/10.15585/mmwr.mm7044e1). On the other hand, the impact of vaccine on long-hauler symptoms has raised interest. A UK survey (not peer reviewed) on more than 800 long-haulers reported about 57% with overall improvement in their symptoms, 24% no change, and 19% with worsening symptoms after their first dose of vaccine, suggesting that the chances of experiencing an overall worsening of symptoms after vaccination is small, with more than half experiencing improvement (go.nature.com/3yfqem2). While awaiting longitudinal trials, the main argument to guide vaccination in long-haulers is that COVID-19 vaccinations provide protection from reinfection and appear to have the potential to improve symptoms.
The availability of a patient’s support system, peer support, and patient advocacy groups assist in providing equitable care and are critical in sustaining the recovery of COVID-19 survivors. Providing social, financial, and cultural support is imperative in decreasing the burden of COVID-19. The dedicated post–COVID-19 clinics will not only offer care to COVID-19 survivors, but will also help our understanding of the determinants and course of PASC, and will provide opportunities for research. Long-term longitudinal observational studies and clinical trials are critical to identify those at high risk for PASC, clarify the extent of health consequences attributable to COVID-19, and define best practices for COVID-19 survivors.
Dr. Biehl is Staff Physician, Pulmonary & Critical Care Medicine, Director, Post-ICU Recovery Clinic Respiratory Institute, Cleveland Clinic; Dr.Farha is with Respiratory and Lerner Institutes, Cleveland Clinic.
Final rule update – November 2021
The 2,414 page final rule for the CMS Physician Fee Schedule (PFS) was published on November 2, 2021, and contains a number of changes that are important for pulmonary/critical care/ sleep providers. As is typical, the rule does bring some good news, as well as decisions that are seemingly contrary to logic and precedence. Most of the changes will be effective on January 1, 2022, although some will become effective when the inpatient evaluation and management (E/M) changes take effect in 2023. For more information, please see 2021-23972.pdf (federalregister.gov).
The first change to be noted is a decrease in the conversion factor from $34.89 to $33.59. This is due primarily to the expiration of the 3.75% increase that was mandated by the Consolidated Appropriations Act of 2021. On a positive note, CMS did institute a plan to update clinical labor prices over the next 4 years, which will result in an increase in reimbursement for practice expense costs. CMS predicts that the combined impact of these two changes will result in no change in reimbursement for pulmonary or critical care medicine. Unfortunately, CMS did not publish data for sleep medicine.
There will be substantial changes in critical care services beginning next year. The CPT® definition of critical care will continue to be recognized by CMS, and the list of bundled services remains the same. Providers may now report critical care services with E/M visits done on the same day. The E/M visit must precede the critical care service, and it must be documented that the patient did not require critical care services at that time. The critical care visit must also be billed with a –25 modifier. This also applies to multiple practitioners in the same group of the same specialty. Critical care services provided concurrently by multiple practitioners of different specialties may now be billed by each individual practitioner if the services are medically necessary. There was a concern that CMS would not allow billing of critical care services during a surgical global period, but this will be allowed if the critical care services are unrelated to the general surgical procedure performed. There will be a new modifier developed to allow CMS to track this care. If critical care management is transferred from the surgeon to an intensivist, then the latter will append modifier –55 (postoperative management only), as well as the new modifier. Finally, and most importantly, CMS now recognizes the benefit of team-based care and will allow split (or shared) billing of critical care services. Physicians and qualified nonphysician providers (NPP) add their times to determine the level of critical care services. The provider who is responsible for more than half of the critical care time should be the billing provider.
Pulmonary rehabilitation CPT codes 94625 and 94626 were accepted by CMS but the RVU values recommended by the RUC were not. CPT code 94625 received a finalized work RVU of 0.36 and code 94626 received 0.56. On a more positive note, patients hospitalized with COVID-19 who are having persistent symptoms, including respiratory dysfunction, for at least 4 weeks after hospitalization would now qualify for pulmonary rehab services. The current pulmonary rehabilitation HCPCS code G0424 is replaced by the two new CPT codes and should no longer be used after December 31, 2021.
These are but a few of the changes in the final rule that may impact one’s practice. Additional changes may be found in the final rule link 2021-23972.pdf (federalregister.gov) and in future CHEST Physician editions.
The 2,414 page final rule for the CMS Physician Fee Schedule (PFS) was published on November 2, 2021, and contains a number of changes that are important for pulmonary/critical care/ sleep providers. As is typical, the rule does bring some good news, as well as decisions that are seemingly contrary to logic and precedence. Most of the changes will be effective on January 1, 2022, although some will become effective when the inpatient evaluation and management (E/M) changes take effect in 2023. For more information, please see 2021-23972.pdf (federalregister.gov).
The first change to be noted is a decrease in the conversion factor from $34.89 to $33.59. This is due primarily to the expiration of the 3.75% increase that was mandated by the Consolidated Appropriations Act of 2021. On a positive note, CMS did institute a plan to update clinical labor prices over the next 4 years, which will result in an increase in reimbursement for practice expense costs. CMS predicts that the combined impact of these two changes will result in no change in reimbursement for pulmonary or critical care medicine. Unfortunately, CMS did not publish data for sleep medicine.
There will be substantial changes in critical care services beginning next year. The CPT® definition of critical care will continue to be recognized by CMS, and the list of bundled services remains the same. Providers may now report critical care services with E/M visits done on the same day. The E/M visit must precede the critical care service, and it must be documented that the patient did not require critical care services at that time. The critical care visit must also be billed with a –25 modifier. This also applies to multiple practitioners in the same group of the same specialty. Critical care services provided concurrently by multiple practitioners of different specialties may now be billed by each individual practitioner if the services are medically necessary. There was a concern that CMS would not allow billing of critical care services during a surgical global period, but this will be allowed if the critical care services are unrelated to the general surgical procedure performed. There will be a new modifier developed to allow CMS to track this care. If critical care management is transferred from the surgeon to an intensivist, then the latter will append modifier –55 (postoperative management only), as well as the new modifier. Finally, and most importantly, CMS now recognizes the benefit of team-based care and will allow split (or shared) billing of critical care services. Physicians and qualified nonphysician providers (NPP) add their times to determine the level of critical care services. The provider who is responsible for more than half of the critical care time should be the billing provider.
Pulmonary rehabilitation CPT codes 94625 and 94626 were accepted by CMS but the RVU values recommended by the RUC were not. CPT code 94625 received a finalized work RVU of 0.36 and code 94626 received 0.56. On a more positive note, patients hospitalized with COVID-19 who are having persistent symptoms, including respiratory dysfunction, for at least 4 weeks after hospitalization would now qualify for pulmonary rehab services. The current pulmonary rehabilitation HCPCS code G0424 is replaced by the two new CPT codes and should no longer be used after December 31, 2021.
These are but a few of the changes in the final rule that may impact one’s practice. Additional changes may be found in the final rule link 2021-23972.pdf (federalregister.gov) and in future CHEST Physician editions.
The 2,414 page final rule for the CMS Physician Fee Schedule (PFS) was published on November 2, 2021, and contains a number of changes that are important for pulmonary/critical care/ sleep providers. As is typical, the rule does bring some good news, as well as decisions that are seemingly contrary to logic and precedence. Most of the changes will be effective on January 1, 2022, although some will become effective when the inpatient evaluation and management (E/M) changes take effect in 2023. For more information, please see 2021-23972.pdf (federalregister.gov).
The first change to be noted is a decrease in the conversion factor from $34.89 to $33.59. This is due primarily to the expiration of the 3.75% increase that was mandated by the Consolidated Appropriations Act of 2021. On a positive note, CMS did institute a plan to update clinical labor prices over the next 4 years, which will result in an increase in reimbursement for practice expense costs. CMS predicts that the combined impact of these two changes will result in no change in reimbursement for pulmonary or critical care medicine. Unfortunately, CMS did not publish data for sleep medicine.
There will be substantial changes in critical care services beginning next year. The CPT® definition of critical care will continue to be recognized by CMS, and the list of bundled services remains the same. Providers may now report critical care services with E/M visits done on the same day. The E/M visit must precede the critical care service, and it must be documented that the patient did not require critical care services at that time. The critical care visit must also be billed with a –25 modifier. This also applies to multiple practitioners in the same group of the same specialty. Critical care services provided concurrently by multiple practitioners of different specialties may now be billed by each individual practitioner if the services are medically necessary. There was a concern that CMS would not allow billing of critical care services during a surgical global period, but this will be allowed if the critical care services are unrelated to the general surgical procedure performed. There will be a new modifier developed to allow CMS to track this care. If critical care management is transferred from the surgeon to an intensivist, then the latter will append modifier –55 (postoperative management only), as well as the new modifier. Finally, and most importantly, CMS now recognizes the benefit of team-based care and will allow split (or shared) billing of critical care services. Physicians and qualified nonphysician providers (NPP) add their times to determine the level of critical care services. The provider who is responsible for more than half of the critical care time should be the billing provider.
Pulmonary rehabilitation CPT codes 94625 and 94626 were accepted by CMS but the RVU values recommended by the RUC were not. CPT code 94625 received a finalized work RVU of 0.36 and code 94626 received 0.56. On a more positive note, patients hospitalized with COVID-19 who are having persistent symptoms, including respiratory dysfunction, for at least 4 weeks after hospitalization would now qualify for pulmonary rehab services. The current pulmonary rehabilitation HCPCS code G0424 is replaced by the two new CPT codes and should no longer be used after December 31, 2021.
These are but a few of the changes in the final rule that may impact one’s practice. Additional changes may be found in the final rule link 2021-23972.pdf (federalregister.gov) and in future CHEST Physician editions.
CHEST SEEK™ Education enhances learning with interactive discussions
If you’ve ever wondered about the content creation process that goes into exam study material, SEEK is offering you an insider perspective.
Recently added to the SEEK Library, CHEST SEEK™ Peer Review Discussions are behind-the-scenes recordings of the deliberations and debates between SEEK Editorial Board members as they review their draft questions. Each video showcases CHEST authors reviewing and finessing a case-based chest medicine question to prepare for its inclusion in printed SEEK books and the electronic library.
With an opportunity to glean invaluable knowledge from distinguished practitioners in the pulmonary, critical care, and sleep medicine fields, SEEK Peer Review Discussions can be used to help supplement board exam study, advance one’s clinical knowledge, and learn from the peer review process for their own professional development.
“The opportunity to observe how much critical review there is from a scientific content standpoint – and also from a test creation standpoint – is really interesting,” said CHEST SEEK Sleep Editor and President-Elect David Schulman, MD, MPH, FCCP.
“Many of us on SEEK have written for some of the standardized exams that readers will take,” he said. “Somebody can learn how writers come up with wrong answers and think, ‘‘If I can see how this test is constructed, I may have a better chance of doing well on it.’”
SEEK Peer Review Discussions not only offer a more engaging form of education but also provide an opportunity to watch leaders in the field test, challenge, and collaborate with one another.
“The audience gets to see that these big names you see on the page – authors, coauthors, and editors – are just normal people like anybody else,” Dr. Schulman said. “They joke around a little bit, and they push each other a little bit. I think getting to see under the hood of CHEST and seeing what leadership is like is a really valuable experience.”
Through these discussions, CHEST SEEK learners discover the intensity and rigorousness of the conversations with a window into CHEST leaders’ discourse.
The collection of SEEK Peer Review Discussions is part of the new, enhanced CHEST SEEK subscription option, SEEK Library Plus. Available for subscription viewing now are three question videos from the SEEK Pulmonary Medicine Editorial Board and three question videos from the SEEK Sleep Medicine Editorial Board.
Subscribers to SEEK Library Plus also gain access to SEEK Session videos from CHEST Board Review 2021, a print export study pack plus a compilation of favorite questions from SEEK’s 30-year history.
For a sneak peek of the peer review videos and to subscribe to SEEK Library Plus, visit seeklibrary.chestnet.org.
If you’ve ever wondered about the content creation process that goes into exam study material, SEEK is offering you an insider perspective.
Recently added to the SEEK Library, CHEST SEEK™ Peer Review Discussions are behind-the-scenes recordings of the deliberations and debates between SEEK Editorial Board members as they review their draft questions. Each video showcases CHEST authors reviewing and finessing a case-based chest medicine question to prepare for its inclusion in printed SEEK books and the electronic library.
With an opportunity to glean invaluable knowledge from distinguished practitioners in the pulmonary, critical care, and sleep medicine fields, SEEK Peer Review Discussions can be used to help supplement board exam study, advance one’s clinical knowledge, and learn from the peer review process for their own professional development.
“The opportunity to observe how much critical review there is from a scientific content standpoint – and also from a test creation standpoint – is really interesting,” said CHEST SEEK Sleep Editor and President-Elect David Schulman, MD, MPH, FCCP.
“Many of us on SEEK have written for some of the standardized exams that readers will take,” he said. “Somebody can learn how writers come up with wrong answers and think, ‘‘If I can see how this test is constructed, I may have a better chance of doing well on it.’”
SEEK Peer Review Discussions not only offer a more engaging form of education but also provide an opportunity to watch leaders in the field test, challenge, and collaborate with one another.
“The audience gets to see that these big names you see on the page – authors, coauthors, and editors – are just normal people like anybody else,” Dr. Schulman said. “They joke around a little bit, and they push each other a little bit. I think getting to see under the hood of CHEST and seeing what leadership is like is a really valuable experience.”
Through these discussions, CHEST SEEK learners discover the intensity and rigorousness of the conversations with a window into CHEST leaders’ discourse.
The collection of SEEK Peer Review Discussions is part of the new, enhanced CHEST SEEK subscription option, SEEK Library Plus. Available for subscription viewing now are three question videos from the SEEK Pulmonary Medicine Editorial Board and three question videos from the SEEK Sleep Medicine Editorial Board.
Subscribers to SEEK Library Plus also gain access to SEEK Session videos from CHEST Board Review 2021, a print export study pack plus a compilation of favorite questions from SEEK’s 30-year history.
For a sneak peek of the peer review videos and to subscribe to SEEK Library Plus, visit seeklibrary.chestnet.org.
If you’ve ever wondered about the content creation process that goes into exam study material, SEEK is offering you an insider perspective.
Recently added to the SEEK Library, CHEST SEEK™ Peer Review Discussions are behind-the-scenes recordings of the deliberations and debates between SEEK Editorial Board members as they review their draft questions. Each video showcases CHEST authors reviewing and finessing a case-based chest medicine question to prepare for its inclusion in printed SEEK books and the electronic library.
With an opportunity to glean invaluable knowledge from distinguished practitioners in the pulmonary, critical care, and sleep medicine fields, SEEK Peer Review Discussions can be used to help supplement board exam study, advance one’s clinical knowledge, and learn from the peer review process for their own professional development.
“The opportunity to observe how much critical review there is from a scientific content standpoint – and also from a test creation standpoint – is really interesting,” said CHEST SEEK Sleep Editor and President-Elect David Schulman, MD, MPH, FCCP.
“Many of us on SEEK have written for some of the standardized exams that readers will take,” he said. “Somebody can learn how writers come up with wrong answers and think, ‘‘If I can see how this test is constructed, I may have a better chance of doing well on it.’”
SEEK Peer Review Discussions not only offer a more engaging form of education but also provide an opportunity to watch leaders in the field test, challenge, and collaborate with one another.
“The audience gets to see that these big names you see on the page – authors, coauthors, and editors – are just normal people like anybody else,” Dr. Schulman said. “They joke around a little bit, and they push each other a little bit. I think getting to see under the hood of CHEST and seeing what leadership is like is a really valuable experience.”
Through these discussions, CHEST SEEK learners discover the intensity and rigorousness of the conversations with a window into CHEST leaders’ discourse.
The collection of SEEK Peer Review Discussions is part of the new, enhanced CHEST SEEK subscription option, SEEK Library Plus. Available for subscription viewing now are three question videos from the SEEK Pulmonary Medicine Editorial Board and three question videos from the SEEK Sleep Medicine Editorial Board.
Subscribers to SEEK Library Plus also gain access to SEEK Session videos from CHEST Board Review 2021, a print export study pack plus a compilation of favorite questions from SEEK’s 30-year history.
For a sneak peek of the peer review videos and to subscribe to SEEK Library Plus, visit seeklibrary.chestnet.org.
This month in the journal CHEST®
Editor’s picks
Fertility and pregnancy in cystic fibrosis By Dr. M. Shteinberg, et al.Changes in purchases for intensive care medicines during the COVID-19 pandemic: A global time series study By Dr. K. Kim, et al.The impact of obesity in critical illness By Drs. M.R. Anderson and M. Shashaty
Strategies to improve bedside clinical skills teaching By Drs. B. Garibaldi and S.W. RussellAntithrombotic therapy for VTE Disease: Second update of the CHEST guideline and expert panel report – executive summary By Dr. S.M. Stevens, et al.
Editor’s picks
Editor’s picks
Fertility and pregnancy in cystic fibrosis By Dr. M. Shteinberg, et al.Changes in purchases for intensive care medicines during the COVID-19 pandemic: A global time series study By Dr. K. Kim, et al.The impact of obesity in critical illness By Drs. M.R. Anderson and M. Shashaty
Strategies to improve bedside clinical skills teaching By Drs. B. Garibaldi and S.W. RussellAntithrombotic therapy for VTE Disease: Second update of the CHEST guideline and expert panel report – executive summary By Dr. S.M. Stevens, et al.
Fertility and pregnancy in cystic fibrosis By Dr. M. Shteinberg, et al.Changes in purchases for intensive care medicines during the COVID-19 pandemic: A global time series study By Dr. K. Kim, et al.The impact of obesity in critical illness By Drs. M.R. Anderson and M. Shashaty
Strategies to improve bedside clinical skills teaching By Drs. B. Garibaldi and S.W. RussellAntithrombotic therapy for VTE Disease: Second update of the CHEST guideline and expert panel report – executive summary By Dr. S.M. Stevens, et al.
Transitioning from fellow to attending
It’s day 1 of “attendingship,” and I’m back to wearing my white coat after years of being confident enough in myself to think I didn’t need it to look like “the doctor.” Is it okay to park here? Does my clinic have a staff bathroom? Will my log in work? Oh my gosh, how do I place orders?! I remember this feeling – it’s intern year all over again, except there’s no senior resident to rescue me now – here we go!
Starting off
As a new attending, the amount of responsibility can be intimidating and overwhelming. It is important to remember that you are not alone, you have a whole team supporting you whether you are in clinic or the ICU. Be sure to introduce yourself to those who you will be working with, get to know them, their roles, and figure out the best way that you can help each other with the ultimate goal of helping patients. In addition to meeting your own team, it is important to introduce yourself to your new colleagues – especially if you are new to the institution. Drs. Fielder and Sihag suggest putting together an introductory email to those who may be referring to you that includes an overview of what you do and how you can help, as well as your contact information. They also suggest maintaining an open line of communication and keeping the referring provider updated on your mutual patient (Fiedler AG, Sihag S. J Thorac Cardiovasc Surg. 2020 Mar;159[3]:1156-60). While this may sound antiquated, in my experience thus far, my colleagues have greatly appreciated this gesture.
Finding support
Even though you will be surrounded by a plethora of new colleagues, the transition to attending can be lonely – especially if you are moving to a new institution. Be sure to keep in touch with your co-residents, co-fellows, mentors, and, of course, your friends and family. Studies have shown that support mitigates stress and reduces job strain, which can lead to better health outcomes in the long term (Fiedler AG, Sihag S. [above]). Another great source of support for me is my CHEST colleagues. If you have not already, I highly suggest joining the CHEST Network(s) that aligns with your career interests. This is a great way to not only network with those who share the same niche as you but also to explore academic opportunities outside of your institution. Through the CHEST Home Mechanical Ventilation and Sleep NetWorks, I have gained mentors, made friends, and have become more involved in CHEST’s annual meeting, chairing my first session this year.
Staying organized
Adjusting to your new schedule can be just as hard as adjusting to a new role or new institution. After years of moving through the well-oiled, regimented machine that is medical training, there are suddenly no more rotations, no more research blocks, and no more protected time for learning. Dr. Okereke suggests creating a weekly calendar, which blocks time for not only your clinical duties but for studying (as you will be taking boards during your first year), academic endeavors (teaching and/or research), and, most importantly – for fun (Okereke I. J Thorac Cardiovasc Surg. 2020 Mar;159[3]:1161-2). Being cognizant about maintaining work-life balance is key once you become an attending. It is finally time to learn how to take time off, away from all things work, and to not feel guilty about it.
Saying no
This brings me to saying “no.” We are taught to say “yes” to every opportunity throughout our careers and, while that can certainly help us get far, it can also lead to burnout. Once you’re an attending, you’re in it for the long haul, so best to say yes to the things you are most interested in and “spark joy,” as Marie Kondo says, and say no to the things that do not make you happy and are not congruent with your overall goals. Fielder and Sihag (above) note that your division director or chief typically has a vision in mind for you within the department. It is important to communicate with leadership so that everyone is on the same page and the administrative and academic opportunities afforded to you are in alignment with your career goals going forward.
Teaching trainees
To prepare for teaching as an attending, Dr. Greco recommends starting during your own training. She suggests cataloging your study materials and notes for later reference, curating talks throughout your training, and exploring different rounding styles prior to graduation (Greco, A. CHEST Thought Leader Blog. 2021 June). To get more experience in formal speaking, Dr. Shen and colleagues encourage getting involved in resident noon conferences (Shen JZ, Memon AA, Lin C. Stroke. 2019 Sep;50[9]:e250-e252). A benefit of being a critical care attending is that you can gain experience teaching not only with the internal medicine residents but with emergency medicine, anesthesiology, and critical care advanced practice provider residents, as well.
While lecturing is one thing, teaching on service is a whole different ball game. No matter how young, fun, and relatable you think you are, you’re the boss now. You’re the giver of grades and the writer of evaluations. It is important to be self-aware of your influence and be deliberate with the environment you create on rounds and in clinic. Set expectations on day 1 so that everyone understands. Be open with what you are working on. For example, I make daily goals for myself that I share with the team before rounds. Drs. Fielder and Sihag (above) suggest sharing anecdotes from your own time in training that can help both you and your trainees remember that you were just in their shoes. Allowing yourself to be vulnerable creates a safe space in which your learners feel more comfortable doing the same.
Lastly, delegation is key. While many of us have done this since residency, Dr. Shen et al (above) suggest deliberately practicing this during fellowship. If you were the fellow who was able to handle a lot on your own, trust that your own fellows will be able to do that. Delegating to your trainees helps you improve personal and team efficiency, provides fellows with needed autonomy, and allows you to further grow into the role of attending physician.
Conclusion
While you may be nervous starting out, trust that you have been well trained and have the clinical knowledge and skills you need to do your job – you are ready. Get to know the staff you will be working with, your colleagues, and keep in touch with your co-trainees and mentors who have helped you along the way. Make daily goals for yourself, and make time to read and reflect so that you can continue to learn and grow. Most of all, make time for yourself, your friends, and your family, because after years of supporting you through all of your hard work, you’ve finally made it – congrats!
Dr. Greer is Assistant Professor of Medicine, Emory University Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Atlanta, GA.
It’s day 1 of “attendingship,” and I’m back to wearing my white coat after years of being confident enough in myself to think I didn’t need it to look like “the doctor.” Is it okay to park here? Does my clinic have a staff bathroom? Will my log in work? Oh my gosh, how do I place orders?! I remember this feeling – it’s intern year all over again, except there’s no senior resident to rescue me now – here we go!
Starting off
As a new attending, the amount of responsibility can be intimidating and overwhelming. It is important to remember that you are not alone, you have a whole team supporting you whether you are in clinic or the ICU. Be sure to introduce yourself to those who you will be working with, get to know them, their roles, and figure out the best way that you can help each other with the ultimate goal of helping patients. In addition to meeting your own team, it is important to introduce yourself to your new colleagues – especially if you are new to the institution. Drs. Fielder and Sihag suggest putting together an introductory email to those who may be referring to you that includes an overview of what you do and how you can help, as well as your contact information. They also suggest maintaining an open line of communication and keeping the referring provider updated on your mutual patient (Fiedler AG, Sihag S. J Thorac Cardiovasc Surg. 2020 Mar;159[3]:1156-60). While this may sound antiquated, in my experience thus far, my colleagues have greatly appreciated this gesture.
Finding support
Even though you will be surrounded by a plethora of new colleagues, the transition to attending can be lonely – especially if you are moving to a new institution. Be sure to keep in touch with your co-residents, co-fellows, mentors, and, of course, your friends and family. Studies have shown that support mitigates stress and reduces job strain, which can lead to better health outcomes in the long term (Fiedler AG, Sihag S. [above]). Another great source of support for me is my CHEST colleagues. If you have not already, I highly suggest joining the CHEST Network(s) that aligns with your career interests. This is a great way to not only network with those who share the same niche as you but also to explore academic opportunities outside of your institution. Through the CHEST Home Mechanical Ventilation and Sleep NetWorks, I have gained mentors, made friends, and have become more involved in CHEST’s annual meeting, chairing my first session this year.
Staying organized
Adjusting to your new schedule can be just as hard as adjusting to a new role or new institution. After years of moving through the well-oiled, regimented machine that is medical training, there are suddenly no more rotations, no more research blocks, and no more protected time for learning. Dr. Okereke suggests creating a weekly calendar, which blocks time for not only your clinical duties but for studying (as you will be taking boards during your first year), academic endeavors (teaching and/or research), and, most importantly – for fun (Okereke I. J Thorac Cardiovasc Surg. 2020 Mar;159[3]:1161-2). Being cognizant about maintaining work-life balance is key once you become an attending. It is finally time to learn how to take time off, away from all things work, and to not feel guilty about it.
Saying no
This brings me to saying “no.” We are taught to say “yes” to every opportunity throughout our careers and, while that can certainly help us get far, it can also lead to burnout. Once you’re an attending, you’re in it for the long haul, so best to say yes to the things you are most interested in and “spark joy,” as Marie Kondo says, and say no to the things that do not make you happy and are not congruent with your overall goals. Fielder and Sihag (above) note that your division director or chief typically has a vision in mind for you within the department. It is important to communicate with leadership so that everyone is on the same page and the administrative and academic opportunities afforded to you are in alignment with your career goals going forward.
Teaching trainees
To prepare for teaching as an attending, Dr. Greco recommends starting during your own training. She suggests cataloging your study materials and notes for later reference, curating talks throughout your training, and exploring different rounding styles prior to graduation (Greco, A. CHEST Thought Leader Blog. 2021 June). To get more experience in formal speaking, Dr. Shen and colleagues encourage getting involved in resident noon conferences (Shen JZ, Memon AA, Lin C. Stroke. 2019 Sep;50[9]:e250-e252). A benefit of being a critical care attending is that you can gain experience teaching not only with the internal medicine residents but with emergency medicine, anesthesiology, and critical care advanced practice provider residents, as well.
While lecturing is one thing, teaching on service is a whole different ball game. No matter how young, fun, and relatable you think you are, you’re the boss now. You’re the giver of grades and the writer of evaluations. It is important to be self-aware of your influence and be deliberate with the environment you create on rounds and in clinic. Set expectations on day 1 so that everyone understands. Be open with what you are working on. For example, I make daily goals for myself that I share with the team before rounds. Drs. Fielder and Sihag (above) suggest sharing anecdotes from your own time in training that can help both you and your trainees remember that you were just in their shoes. Allowing yourself to be vulnerable creates a safe space in which your learners feel more comfortable doing the same.
Lastly, delegation is key. While many of us have done this since residency, Dr. Shen et al (above) suggest deliberately practicing this during fellowship. If you were the fellow who was able to handle a lot on your own, trust that your own fellows will be able to do that. Delegating to your trainees helps you improve personal and team efficiency, provides fellows with needed autonomy, and allows you to further grow into the role of attending physician.
Conclusion
While you may be nervous starting out, trust that you have been well trained and have the clinical knowledge and skills you need to do your job – you are ready. Get to know the staff you will be working with, your colleagues, and keep in touch with your co-trainees and mentors who have helped you along the way. Make daily goals for yourself, and make time to read and reflect so that you can continue to learn and grow. Most of all, make time for yourself, your friends, and your family, because after years of supporting you through all of your hard work, you’ve finally made it – congrats!
Dr. Greer is Assistant Professor of Medicine, Emory University Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Atlanta, GA.
It’s day 1 of “attendingship,” and I’m back to wearing my white coat after years of being confident enough in myself to think I didn’t need it to look like “the doctor.” Is it okay to park here? Does my clinic have a staff bathroom? Will my log in work? Oh my gosh, how do I place orders?! I remember this feeling – it’s intern year all over again, except there’s no senior resident to rescue me now – here we go!
Starting off
As a new attending, the amount of responsibility can be intimidating and overwhelming. It is important to remember that you are not alone, you have a whole team supporting you whether you are in clinic or the ICU. Be sure to introduce yourself to those who you will be working with, get to know them, their roles, and figure out the best way that you can help each other with the ultimate goal of helping patients. In addition to meeting your own team, it is important to introduce yourself to your new colleagues – especially if you are new to the institution. Drs. Fielder and Sihag suggest putting together an introductory email to those who may be referring to you that includes an overview of what you do and how you can help, as well as your contact information. They also suggest maintaining an open line of communication and keeping the referring provider updated on your mutual patient (Fiedler AG, Sihag S. J Thorac Cardiovasc Surg. 2020 Mar;159[3]:1156-60). While this may sound antiquated, in my experience thus far, my colleagues have greatly appreciated this gesture.
Finding support
Even though you will be surrounded by a plethora of new colleagues, the transition to attending can be lonely – especially if you are moving to a new institution. Be sure to keep in touch with your co-residents, co-fellows, mentors, and, of course, your friends and family. Studies have shown that support mitigates stress and reduces job strain, which can lead to better health outcomes in the long term (Fiedler AG, Sihag S. [above]). Another great source of support for me is my CHEST colleagues. If you have not already, I highly suggest joining the CHEST Network(s) that aligns with your career interests. This is a great way to not only network with those who share the same niche as you but also to explore academic opportunities outside of your institution. Through the CHEST Home Mechanical Ventilation and Sleep NetWorks, I have gained mentors, made friends, and have become more involved in CHEST’s annual meeting, chairing my first session this year.
Staying organized
Adjusting to your new schedule can be just as hard as adjusting to a new role or new institution. After years of moving through the well-oiled, regimented machine that is medical training, there are suddenly no more rotations, no more research blocks, and no more protected time for learning. Dr. Okereke suggests creating a weekly calendar, which blocks time for not only your clinical duties but for studying (as you will be taking boards during your first year), academic endeavors (teaching and/or research), and, most importantly – for fun (Okereke I. J Thorac Cardiovasc Surg. 2020 Mar;159[3]:1161-2). Being cognizant about maintaining work-life balance is key once you become an attending. It is finally time to learn how to take time off, away from all things work, and to not feel guilty about it.
Saying no
This brings me to saying “no.” We are taught to say “yes” to every opportunity throughout our careers and, while that can certainly help us get far, it can also lead to burnout. Once you’re an attending, you’re in it for the long haul, so best to say yes to the things you are most interested in and “spark joy,” as Marie Kondo says, and say no to the things that do not make you happy and are not congruent with your overall goals. Fielder and Sihag (above) note that your division director or chief typically has a vision in mind for you within the department. It is important to communicate with leadership so that everyone is on the same page and the administrative and academic opportunities afforded to you are in alignment with your career goals going forward.
Teaching trainees
To prepare for teaching as an attending, Dr. Greco recommends starting during your own training. She suggests cataloging your study materials and notes for later reference, curating talks throughout your training, and exploring different rounding styles prior to graduation (Greco, A. CHEST Thought Leader Blog. 2021 June). To get more experience in formal speaking, Dr. Shen and colleagues encourage getting involved in resident noon conferences (Shen JZ, Memon AA, Lin C. Stroke. 2019 Sep;50[9]:e250-e252). A benefit of being a critical care attending is that you can gain experience teaching not only with the internal medicine residents but with emergency medicine, anesthesiology, and critical care advanced practice provider residents, as well.
While lecturing is one thing, teaching on service is a whole different ball game. No matter how young, fun, and relatable you think you are, you’re the boss now. You’re the giver of grades and the writer of evaluations. It is important to be self-aware of your influence and be deliberate with the environment you create on rounds and in clinic. Set expectations on day 1 so that everyone understands. Be open with what you are working on. For example, I make daily goals for myself that I share with the team before rounds. Drs. Fielder and Sihag (above) suggest sharing anecdotes from your own time in training that can help both you and your trainees remember that you were just in their shoes. Allowing yourself to be vulnerable creates a safe space in which your learners feel more comfortable doing the same.
Lastly, delegation is key. While many of us have done this since residency, Dr. Shen et al (above) suggest deliberately practicing this during fellowship. If you were the fellow who was able to handle a lot on your own, trust that your own fellows will be able to do that. Delegating to your trainees helps you improve personal and team efficiency, provides fellows with needed autonomy, and allows you to further grow into the role of attending physician.
Conclusion
While you may be nervous starting out, trust that you have been well trained and have the clinical knowledge and skills you need to do your job – you are ready. Get to know the staff you will be working with, your colleagues, and keep in touch with your co-trainees and mentors who have helped you along the way. Make daily goals for yourself, and make time to read and reflect so that you can continue to learn and grow. Most of all, make time for yourself, your friends, and your family, because after years of supporting you through all of your hard work, you’ve finally made it – congrats!
Dr. Greer is Assistant Professor of Medicine, Emory University Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Atlanta, GA.
Chronically interrupted: The importance of communication with patient and family during the COVID-19 pandemic
Case narrative
A 35-year-old woman has worsening alcoholic cirrhosis and repeated admissions for ascites, hepato-renal syndrome, and alcoholic hepatitis. Upon recognition of her grave prognosis, we proceeded with a shared-management approach involving medicine, gastroenterology, social work, chaplaincy, and palliative care. When the team spoke with the patient’s health care proxy (HCP), family, and friends for collateral information and involvement in goals of care conversation, we realized that none were aware of her months-long decline and poor prognosis for recovery to hospital discharge.
Although several factors contributed to the disconnect between the patient and her support system, the obstacles were greatly exacerbated by profound changes in hospital protocol because of the COVID-19 pandemic. Physicians feel underprepared and challenged by prognostication and discussion of end of life during normal times; we believe COVID-19 has limited this essential physician role and led to tragic delays in effective communication and end of life planning.
Closing the loop
For patients with complex medical issues or those reaching end of life, effective communication within the health care system is critical. While inpatient teams often drive the plan, they care for their patients during a snapshot in time; contrarily, primary care providers and specialists often have established longitudinal relationships with their patients. Ergo, clinicians should communicate directly, and ideally with both patients and families, to achieve patient-centered and goal-concordant care.
For medically complex patients, PCPs tend to prefer verbal hand-offs. Timely and reliable communication between inpatient and outpatient providers has also been shown to prevent medical adverse events.1 Despite this, direct communication occurs infrequently.2 Given that hospitalists serve as primary inpatient providers for most general admissions, it is their responsibility to communicate with outpatient providers.
A multidisciplinary team redesigned the process by which PCPs were contacted following patient discharge. The transmission of information should ideally occur prior to discharge.3 Deficits in communication are extremely common and may negatively impact patient care, patient satisfaction, and patient safety.
Changes during the COVID-19 era
During the pandemic, patients have only one visitor per day, restricted visiting hours, and limited interactions with clinicians per implemented policies. Along with the increased burdens from personal protective equipment, remote hospital providers (social workers, case managers), and increased bureaucratic duties, COVID-19 has elucidated limitations in medical capacity and revealed the difficulties that clinicians face in communicating with patients and families, especially about serious illness.
Tasks include facilitating virtual goodbyes between dying patients and families, conducting family meetings via teleconference, and discussing patient care with specialists through virtual technologies.4 While these tasks are arguably more important during a global disaster, COVID-19 paradoxically restricts physical presence and severely hinders communication.5 Clinicians should continue to utilize core skills like building rapport, assessing patient/family perspectives and agenda, and using empathy.6 Patients tend to more frequently value functional outcomes while clinicians tend to default to treatment modalities.7 Additionally, goals of care and end of life discussions are associated with improved quality of life, fewer aggressive medical interventions near death, and even increased survival.
Given the limited resources and difficulties in communication during the pandemic, clinicians should place greater emphasis on values-based shared decision-making. Internet-based solutions are essential and widely used, and videoconferencing has been initiated at the institutional scale at many hospitals. Many clinicians with little experience are broadly implementing these technologies.7 Despite these technological innovations, issues still arise in how to communicate effectively in the hospital setting, and we must acknowledge that strategies require devices, Internet access, and technological literacy, highlighting disparities in access to quality health care.6 Conversations during the pandemic will require listening, empathy, responsive action, and the acknowledgment of the social determinants of health.7
Improving communication and transition of care
Multiple steps will be warranted to implement the safe transition process and improve communication. High-quality patient care encompasses careful review of medications, communication between inpatient and outpatient providers, and close follow-up at discharge. These steps serve to increase our reliance on patient compliance and the exchange of information about global progression of disease.
The quantitative and qualitative steps of transition of care should overcome disconnect between teams, specifically deficit areas regarding postdischarge communication, monitoring, and understanding of prognosis around the relevance to this era of COVID-19.
Dr. Haddad is a resident physician in the psychiatry residency program at Brigham and Women’s Hospital, Boston. Dr. Halporn is clinic director, Division of Adult Palliative Care, in the department of psychosocial oncology and palliative care, Dana-Farber Cancer Institute and Brigham and Women’s Hospital. Dr. Barkoudah is associate director of the Hospital Medicine Unit at Brigham and Women’s Hospital.
References
1. Goldman L et al. Passing the clinical baton: 6 principles to guide the hospitalist. Am J Med. 2001;111(9B):36S-39S. doi: 10.1016/s0002-9343(01)00968-8.
2. Kripalani S et al. Deficits in communication and information transfer between hospital-based and primary care physicians. JAMA. 2007 Feb 28;297(8):831-41. doi: 10.1001/jama.297.8.831.
3. Scotten M et al. Minding the gap: Interprofessional communication during inpatient and post discharge chasm care. Patient Educ Couns. 2015 Jul;98(7):895-900. doi: 10.1016/j.pec.2015.03.009.
4. Back A et al. Communication skills in the age of COVID-19. Ann Intern Med. 2020 Jun 2;172(11):759-60. doi: 10.7326/M20-1376.
5. Hart JL et al. Family-centered care during the COVID-19 era. J Pain Symptom Manage. 2020 Aug;60(2):e93-7. doi: 10.1016/j.jpainsymman.2020.04.017.
6. Rubinelli S et al. Implications of the current COVID-19 pandemic for communication in healthcare. Patient Educ Couns. 2020 Jun;103(6):1067-9. doi: 10.1016/j.pec.2020.04.021.
7. Simpson N et al. Don’t forget shared decision-making in the COVID-19 crisis. Intern Med J. 2020 Jun;50(6):761-3. doi: 10.1111/imj.14862.
Case narrative
A 35-year-old woman has worsening alcoholic cirrhosis and repeated admissions for ascites, hepato-renal syndrome, and alcoholic hepatitis. Upon recognition of her grave prognosis, we proceeded with a shared-management approach involving medicine, gastroenterology, social work, chaplaincy, and palliative care. When the team spoke with the patient’s health care proxy (HCP), family, and friends for collateral information and involvement in goals of care conversation, we realized that none were aware of her months-long decline and poor prognosis for recovery to hospital discharge.
Although several factors contributed to the disconnect between the patient and her support system, the obstacles were greatly exacerbated by profound changes in hospital protocol because of the COVID-19 pandemic. Physicians feel underprepared and challenged by prognostication and discussion of end of life during normal times; we believe COVID-19 has limited this essential physician role and led to tragic delays in effective communication and end of life planning.
Closing the loop
For patients with complex medical issues or those reaching end of life, effective communication within the health care system is critical. While inpatient teams often drive the plan, they care for their patients during a snapshot in time; contrarily, primary care providers and specialists often have established longitudinal relationships with their patients. Ergo, clinicians should communicate directly, and ideally with both patients and families, to achieve patient-centered and goal-concordant care.
For medically complex patients, PCPs tend to prefer verbal hand-offs. Timely and reliable communication between inpatient and outpatient providers has also been shown to prevent medical adverse events.1 Despite this, direct communication occurs infrequently.2 Given that hospitalists serve as primary inpatient providers for most general admissions, it is their responsibility to communicate with outpatient providers.
A multidisciplinary team redesigned the process by which PCPs were contacted following patient discharge. The transmission of information should ideally occur prior to discharge.3 Deficits in communication are extremely common and may negatively impact patient care, patient satisfaction, and patient safety.
Changes during the COVID-19 era
During the pandemic, patients have only one visitor per day, restricted visiting hours, and limited interactions with clinicians per implemented policies. Along with the increased burdens from personal protective equipment, remote hospital providers (social workers, case managers), and increased bureaucratic duties, COVID-19 has elucidated limitations in medical capacity and revealed the difficulties that clinicians face in communicating with patients and families, especially about serious illness.
Tasks include facilitating virtual goodbyes between dying patients and families, conducting family meetings via teleconference, and discussing patient care with specialists through virtual technologies.4 While these tasks are arguably more important during a global disaster, COVID-19 paradoxically restricts physical presence and severely hinders communication.5 Clinicians should continue to utilize core skills like building rapport, assessing patient/family perspectives and agenda, and using empathy.6 Patients tend to more frequently value functional outcomes while clinicians tend to default to treatment modalities.7 Additionally, goals of care and end of life discussions are associated with improved quality of life, fewer aggressive medical interventions near death, and even increased survival.
Given the limited resources and difficulties in communication during the pandemic, clinicians should place greater emphasis on values-based shared decision-making. Internet-based solutions are essential and widely used, and videoconferencing has been initiated at the institutional scale at many hospitals. Many clinicians with little experience are broadly implementing these technologies.7 Despite these technological innovations, issues still arise in how to communicate effectively in the hospital setting, and we must acknowledge that strategies require devices, Internet access, and technological literacy, highlighting disparities in access to quality health care.6 Conversations during the pandemic will require listening, empathy, responsive action, and the acknowledgment of the social determinants of health.7
Improving communication and transition of care
Multiple steps will be warranted to implement the safe transition process and improve communication. High-quality patient care encompasses careful review of medications, communication between inpatient and outpatient providers, and close follow-up at discharge. These steps serve to increase our reliance on patient compliance and the exchange of information about global progression of disease.
The quantitative and qualitative steps of transition of care should overcome disconnect between teams, specifically deficit areas regarding postdischarge communication, monitoring, and understanding of prognosis around the relevance to this era of COVID-19.
Dr. Haddad is a resident physician in the psychiatry residency program at Brigham and Women’s Hospital, Boston. Dr. Halporn is clinic director, Division of Adult Palliative Care, in the department of psychosocial oncology and palliative care, Dana-Farber Cancer Institute and Brigham and Women’s Hospital. Dr. Barkoudah is associate director of the Hospital Medicine Unit at Brigham and Women’s Hospital.
References
1. Goldman L et al. Passing the clinical baton: 6 principles to guide the hospitalist. Am J Med. 2001;111(9B):36S-39S. doi: 10.1016/s0002-9343(01)00968-8.
2. Kripalani S et al. Deficits in communication and information transfer between hospital-based and primary care physicians. JAMA. 2007 Feb 28;297(8):831-41. doi: 10.1001/jama.297.8.831.
3. Scotten M et al. Minding the gap: Interprofessional communication during inpatient and post discharge chasm care. Patient Educ Couns. 2015 Jul;98(7):895-900. doi: 10.1016/j.pec.2015.03.009.
4. Back A et al. Communication skills in the age of COVID-19. Ann Intern Med. 2020 Jun 2;172(11):759-60. doi: 10.7326/M20-1376.
5. Hart JL et al. Family-centered care during the COVID-19 era. J Pain Symptom Manage. 2020 Aug;60(2):e93-7. doi: 10.1016/j.jpainsymman.2020.04.017.
6. Rubinelli S et al. Implications of the current COVID-19 pandemic for communication in healthcare. Patient Educ Couns. 2020 Jun;103(6):1067-9. doi: 10.1016/j.pec.2020.04.021.
7. Simpson N et al. Don’t forget shared decision-making in the COVID-19 crisis. Intern Med J. 2020 Jun;50(6):761-3. doi: 10.1111/imj.14862.
Case narrative
A 35-year-old woman has worsening alcoholic cirrhosis and repeated admissions for ascites, hepato-renal syndrome, and alcoholic hepatitis. Upon recognition of her grave prognosis, we proceeded with a shared-management approach involving medicine, gastroenterology, social work, chaplaincy, and palliative care. When the team spoke with the patient’s health care proxy (HCP), family, and friends for collateral information and involvement in goals of care conversation, we realized that none were aware of her months-long decline and poor prognosis for recovery to hospital discharge.
Although several factors contributed to the disconnect between the patient and her support system, the obstacles were greatly exacerbated by profound changes in hospital protocol because of the COVID-19 pandemic. Physicians feel underprepared and challenged by prognostication and discussion of end of life during normal times; we believe COVID-19 has limited this essential physician role and led to tragic delays in effective communication and end of life planning.
Closing the loop
For patients with complex medical issues or those reaching end of life, effective communication within the health care system is critical. While inpatient teams often drive the plan, they care for their patients during a snapshot in time; contrarily, primary care providers and specialists often have established longitudinal relationships with their patients. Ergo, clinicians should communicate directly, and ideally with both patients and families, to achieve patient-centered and goal-concordant care.
For medically complex patients, PCPs tend to prefer verbal hand-offs. Timely and reliable communication between inpatient and outpatient providers has also been shown to prevent medical adverse events.1 Despite this, direct communication occurs infrequently.2 Given that hospitalists serve as primary inpatient providers for most general admissions, it is their responsibility to communicate with outpatient providers.
A multidisciplinary team redesigned the process by which PCPs were contacted following patient discharge. The transmission of information should ideally occur prior to discharge.3 Deficits in communication are extremely common and may negatively impact patient care, patient satisfaction, and patient safety.
Changes during the COVID-19 era
During the pandemic, patients have only one visitor per day, restricted visiting hours, and limited interactions with clinicians per implemented policies. Along with the increased burdens from personal protective equipment, remote hospital providers (social workers, case managers), and increased bureaucratic duties, COVID-19 has elucidated limitations in medical capacity and revealed the difficulties that clinicians face in communicating with patients and families, especially about serious illness.
Tasks include facilitating virtual goodbyes between dying patients and families, conducting family meetings via teleconference, and discussing patient care with specialists through virtual technologies.4 While these tasks are arguably more important during a global disaster, COVID-19 paradoxically restricts physical presence and severely hinders communication.5 Clinicians should continue to utilize core skills like building rapport, assessing patient/family perspectives and agenda, and using empathy.6 Patients tend to more frequently value functional outcomes while clinicians tend to default to treatment modalities.7 Additionally, goals of care and end of life discussions are associated with improved quality of life, fewer aggressive medical interventions near death, and even increased survival.
Given the limited resources and difficulties in communication during the pandemic, clinicians should place greater emphasis on values-based shared decision-making. Internet-based solutions are essential and widely used, and videoconferencing has been initiated at the institutional scale at many hospitals. Many clinicians with little experience are broadly implementing these technologies.7 Despite these technological innovations, issues still arise in how to communicate effectively in the hospital setting, and we must acknowledge that strategies require devices, Internet access, and technological literacy, highlighting disparities in access to quality health care.6 Conversations during the pandemic will require listening, empathy, responsive action, and the acknowledgment of the social determinants of health.7
Improving communication and transition of care
Multiple steps will be warranted to implement the safe transition process and improve communication. High-quality patient care encompasses careful review of medications, communication between inpatient and outpatient providers, and close follow-up at discharge. These steps serve to increase our reliance on patient compliance and the exchange of information about global progression of disease.
The quantitative and qualitative steps of transition of care should overcome disconnect between teams, specifically deficit areas regarding postdischarge communication, monitoring, and understanding of prognosis around the relevance to this era of COVID-19.
Dr. Haddad is a resident physician in the psychiatry residency program at Brigham and Women’s Hospital, Boston. Dr. Halporn is clinic director, Division of Adult Palliative Care, in the department of psychosocial oncology and palliative care, Dana-Farber Cancer Institute and Brigham and Women’s Hospital. Dr. Barkoudah is associate director of the Hospital Medicine Unit at Brigham and Women’s Hospital.
References
1. Goldman L et al. Passing the clinical baton: 6 principles to guide the hospitalist. Am J Med. 2001;111(9B):36S-39S. doi: 10.1016/s0002-9343(01)00968-8.
2. Kripalani S et al. Deficits in communication and information transfer between hospital-based and primary care physicians. JAMA. 2007 Feb 28;297(8):831-41. doi: 10.1001/jama.297.8.831.
3. Scotten M et al. Minding the gap: Interprofessional communication during inpatient and post discharge chasm care. Patient Educ Couns. 2015 Jul;98(7):895-900. doi: 10.1016/j.pec.2015.03.009.
4. Back A et al. Communication skills in the age of COVID-19. Ann Intern Med. 2020 Jun 2;172(11):759-60. doi: 10.7326/M20-1376.
5. Hart JL et al. Family-centered care during the COVID-19 era. J Pain Symptom Manage. 2020 Aug;60(2):e93-7. doi: 10.1016/j.jpainsymman.2020.04.017.
6. Rubinelli S et al. Implications of the current COVID-19 pandemic for communication in healthcare. Patient Educ Couns. 2020 Jun;103(6):1067-9. doi: 10.1016/j.pec.2020.04.021.
7. Simpson N et al. Don’t forget shared decision-making in the COVID-19 crisis. Intern Med J. 2020 Jun;50(6):761-3. doi: 10.1111/imj.14862.
Customizing pre-CAR T chemotherapy could improve ALL patient outcomes
The findings, if validated in a prospective study, could help cut the rate of relapses after initial response to CAR T-cell therapy, which currently approaches 50%, the investigators noted.
In 152 pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who underwent CD-19-directed CAR T-cell therapy after cyclophosphamide/fludarabine lymphodepleting chemotherapy, estimated fludarabine exposure was associated with cumulative incidence of relapse (CIR) and a composite endpoint that included loss of B-cell aplasia (BCA) or relapse, Vanessa Fabrizio, MD, and colleagues found.
Dr. Fabrizio, a pediatric hematologist and oncologist at Children’s Hospital Colorado and the University of Colorado Cancer Center in Aurora, was a fellow at Memorial Sloan Kettering (MSK) Cancer Center during the study.
Optimal fludarabine exposure was identified by the investigators as an area under the curve (AUC) of at least 13.8 mg*hr/L. The fludarabine exposure AUC was calculated for each patient by using a validated pharmacokinetics population model.
Multivariable analyses controlling for baseline patient factors and fludarabine exposure showed that patients without optimal exposure had a 2.5-fold higher CIR (hazard ratio, 2.45), and a twofold higher risk of relapse or loss of BCA (HR, 1.96), compared with those who had optimal fludarabine exposure, they reported.
High pre-infusion disease burden was associated with an increased risk of relapse and death (HRs, 2.66 and 4.77, respectively), they said.
The study was published online Nov. 17 in Blood Advances.
“We know that [with] fludarabine ... everyone’s body clears it differently,” principal investigator Kevin J. Curran, MD, said in an interview.
Factors affecting clearance include kidney function and weight, and it is simple to determine the optimal dose based on these factors and apply that in practice, said Dr. Curran, a pediatric oncologist and assistant attending physician specializing in cellular therapy at MSK Kids.
In fact, in prior studies, optimal fludarabine exposure in patients undergoing allogeneic hematopoietic cell transplantation has been shown to “decrease nonrelapse mortality due to improved immune reconstitution and subsequently improve survival,” he and his colleagues wrote, explaining the rationale for the study.
The participants, who were part of the Pediatric Real-World CAR Consortium (PRWCC), had a median age of 12.5 years, and 131 of 152 (86%) responded to CAR T-cell therapy. The 12-month OS was 75.1%, the 12-month CIR was 36.4%, and 67% of patients had optimal fludarabine exposure, the authors said.
The findings indeed suggest that one way to improve outcomes without changing the actual cell therapy is to tailor the lymphodepleting therapy prior to CAR T-cell therapy, said Dr. Curran.
“That’s what this does. It’s exciting because cell therapy is very effective [in terms of] initial response, but what we don’t like is the durability of the response,” he said “The next step is to prove it in a prospective study.”
A phase 2 study looking at personalized dosing, as opposed to the standard 30 mg/m2 that most patients receive, is planned for 2022, he noted.
The study was supported by a St Baldrick’s/Stand Up 2 Cancer Pediatric Dream Team Translational Cancer Research Grant, the Virginia and D.K. Ludwig Fund for Cancer Research, and a National Cancer Institute Cancer Center Support Grant. Dr. Curran has served as a consultant for Novartis and Mesoblast, and received research funding from Novartis and Celgene. Dr. Fabrizio reported having no disclosures.
The findings, if validated in a prospective study, could help cut the rate of relapses after initial response to CAR T-cell therapy, which currently approaches 50%, the investigators noted.
In 152 pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who underwent CD-19-directed CAR T-cell therapy after cyclophosphamide/fludarabine lymphodepleting chemotherapy, estimated fludarabine exposure was associated with cumulative incidence of relapse (CIR) and a composite endpoint that included loss of B-cell aplasia (BCA) or relapse, Vanessa Fabrizio, MD, and colleagues found.
Dr. Fabrizio, a pediatric hematologist and oncologist at Children’s Hospital Colorado and the University of Colorado Cancer Center in Aurora, was a fellow at Memorial Sloan Kettering (MSK) Cancer Center during the study.
Optimal fludarabine exposure was identified by the investigators as an area under the curve (AUC) of at least 13.8 mg*hr/L. The fludarabine exposure AUC was calculated for each patient by using a validated pharmacokinetics population model.
Multivariable analyses controlling for baseline patient factors and fludarabine exposure showed that patients without optimal exposure had a 2.5-fold higher CIR (hazard ratio, 2.45), and a twofold higher risk of relapse or loss of BCA (HR, 1.96), compared with those who had optimal fludarabine exposure, they reported.
High pre-infusion disease burden was associated with an increased risk of relapse and death (HRs, 2.66 and 4.77, respectively), they said.
The study was published online Nov. 17 in Blood Advances.
“We know that [with] fludarabine ... everyone’s body clears it differently,” principal investigator Kevin J. Curran, MD, said in an interview.
Factors affecting clearance include kidney function and weight, and it is simple to determine the optimal dose based on these factors and apply that in practice, said Dr. Curran, a pediatric oncologist and assistant attending physician specializing in cellular therapy at MSK Kids.
In fact, in prior studies, optimal fludarabine exposure in patients undergoing allogeneic hematopoietic cell transplantation has been shown to “decrease nonrelapse mortality due to improved immune reconstitution and subsequently improve survival,” he and his colleagues wrote, explaining the rationale for the study.
The participants, who were part of the Pediatric Real-World CAR Consortium (PRWCC), had a median age of 12.5 years, and 131 of 152 (86%) responded to CAR T-cell therapy. The 12-month OS was 75.1%, the 12-month CIR was 36.4%, and 67% of patients had optimal fludarabine exposure, the authors said.
The findings indeed suggest that one way to improve outcomes without changing the actual cell therapy is to tailor the lymphodepleting therapy prior to CAR T-cell therapy, said Dr. Curran.
“That’s what this does. It’s exciting because cell therapy is very effective [in terms of] initial response, but what we don’t like is the durability of the response,” he said “The next step is to prove it in a prospective study.”
A phase 2 study looking at personalized dosing, as opposed to the standard 30 mg/m2 that most patients receive, is planned for 2022, he noted.
The study was supported by a St Baldrick’s/Stand Up 2 Cancer Pediatric Dream Team Translational Cancer Research Grant, the Virginia and D.K. Ludwig Fund for Cancer Research, and a National Cancer Institute Cancer Center Support Grant. Dr. Curran has served as a consultant for Novartis and Mesoblast, and received research funding from Novartis and Celgene. Dr. Fabrizio reported having no disclosures.
The findings, if validated in a prospective study, could help cut the rate of relapses after initial response to CAR T-cell therapy, which currently approaches 50%, the investigators noted.
In 152 pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who underwent CD-19-directed CAR T-cell therapy after cyclophosphamide/fludarabine lymphodepleting chemotherapy, estimated fludarabine exposure was associated with cumulative incidence of relapse (CIR) and a composite endpoint that included loss of B-cell aplasia (BCA) or relapse, Vanessa Fabrizio, MD, and colleagues found.
Dr. Fabrizio, a pediatric hematologist and oncologist at Children’s Hospital Colorado and the University of Colorado Cancer Center in Aurora, was a fellow at Memorial Sloan Kettering (MSK) Cancer Center during the study.
Optimal fludarabine exposure was identified by the investigators as an area under the curve (AUC) of at least 13.8 mg*hr/L. The fludarabine exposure AUC was calculated for each patient by using a validated pharmacokinetics population model.
Multivariable analyses controlling for baseline patient factors and fludarabine exposure showed that patients without optimal exposure had a 2.5-fold higher CIR (hazard ratio, 2.45), and a twofold higher risk of relapse or loss of BCA (HR, 1.96), compared with those who had optimal fludarabine exposure, they reported.
High pre-infusion disease burden was associated with an increased risk of relapse and death (HRs, 2.66 and 4.77, respectively), they said.
The study was published online Nov. 17 in Blood Advances.
“We know that [with] fludarabine ... everyone’s body clears it differently,” principal investigator Kevin J. Curran, MD, said in an interview.
Factors affecting clearance include kidney function and weight, and it is simple to determine the optimal dose based on these factors and apply that in practice, said Dr. Curran, a pediatric oncologist and assistant attending physician specializing in cellular therapy at MSK Kids.
In fact, in prior studies, optimal fludarabine exposure in patients undergoing allogeneic hematopoietic cell transplantation has been shown to “decrease nonrelapse mortality due to improved immune reconstitution and subsequently improve survival,” he and his colleagues wrote, explaining the rationale for the study.
The participants, who were part of the Pediatric Real-World CAR Consortium (PRWCC), had a median age of 12.5 years, and 131 of 152 (86%) responded to CAR T-cell therapy. The 12-month OS was 75.1%, the 12-month CIR was 36.4%, and 67% of patients had optimal fludarabine exposure, the authors said.
The findings indeed suggest that one way to improve outcomes without changing the actual cell therapy is to tailor the lymphodepleting therapy prior to CAR T-cell therapy, said Dr. Curran.
“That’s what this does. It’s exciting because cell therapy is very effective [in terms of] initial response, but what we don’t like is the durability of the response,” he said “The next step is to prove it in a prospective study.”
A phase 2 study looking at personalized dosing, as opposed to the standard 30 mg/m2 that most patients receive, is planned for 2022, he noted.
The study was supported by a St Baldrick’s/Stand Up 2 Cancer Pediatric Dream Team Translational Cancer Research Grant, the Virginia and D.K. Ludwig Fund for Cancer Research, and a National Cancer Institute Cancer Center Support Grant. Dr. Curran has served as a consultant for Novartis and Mesoblast, and received research funding from Novartis and Celgene. Dr. Fabrizio reported having no disclosures.
FROM BLOOD ADVANCES
FDA authorizes Pfizer boosters for 16- and 17-year-olds
, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose.
The FDA said it was basing its emergency authorization of boosters for 16- and 17-year-olds on data from 200 individuals who were 18-55 years of age when they received a booster dose. They are requiring Pfizer to collect data on safety in postauthorization studies.
“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said in a news release.
Israel has been giving booster doses of Pfizer’s vaccine to everyone 12 and up since late August. Data from that country show that myocarditis cases continue to be very rare, even in younger age groups, and are mild and temporary.
The authorization comes as the effectiveness of the current vaccines against the new Omicron variant has become a point of intense scientific inquiry.
Early studies suggest that booster doses may be necessary to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.
Current evidence suggests that the protection of the vaccines is holding up well against severe disease and death, at least with Delta and early iterations of the virus.
How well they will do against Omicron, and how severe Omicron infections may be for different age groups, remain open questions.
On Dec. 8, the World Health Organization urged countries not to wait for all the science to come in, but to act now to contain any potential threat.
The first pieces of evidence on Omicron suggest that it is highly contagious, perhaps even more than Delta, though early reports suggest symptoms caused by this version of the new coronavirus may be less severe than in previous waves. Experts have cautioned that the true severity of Omicron infections isn’t yet known, since the first cases have been detected in younger people, who tend to have milder COVID-19 symptoms than those of adults and seniors.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
In mid-November, the FDA authorized boosters of the Pfizer vaccine for all individuals 18 and older, but the agency held off on expanding the use of boosters for younger age groups, partly because they have the highest risk of myocarditis, a very rare side effect.
Myocarditis cases seem to be temporary, with patients making a full recovery, though they need to be monitored in the hospital. The risk of myocarditis with a COVID-19 infection is many times higher than it is from a vaccine.
There have been little data to support the need for boosters in this age group, because children and teens tend to experience milder COVID-19 disease, though they are still at risk for post–COVID-19 complications such as long COVID and a delayed reaction to the virus called Post Acute Sequelae of SARS-CoV2 Infection among Children, or PAS-C.
All that changed with the arrival of Omicron.
A version of this article first appeared on WebMD.com.
, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose.
The FDA said it was basing its emergency authorization of boosters for 16- and 17-year-olds on data from 200 individuals who were 18-55 years of age when they received a booster dose. They are requiring Pfizer to collect data on safety in postauthorization studies.
“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said in a news release.
Israel has been giving booster doses of Pfizer’s vaccine to everyone 12 and up since late August. Data from that country show that myocarditis cases continue to be very rare, even in younger age groups, and are mild and temporary.
The authorization comes as the effectiveness of the current vaccines against the new Omicron variant has become a point of intense scientific inquiry.
Early studies suggest that booster doses may be necessary to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.
Current evidence suggests that the protection of the vaccines is holding up well against severe disease and death, at least with Delta and early iterations of the virus.
How well they will do against Omicron, and how severe Omicron infections may be for different age groups, remain open questions.
On Dec. 8, the World Health Organization urged countries not to wait for all the science to come in, but to act now to contain any potential threat.
The first pieces of evidence on Omicron suggest that it is highly contagious, perhaps even more than Delta, though early reports suggest symptoms caused by this version of the new coronavirus may be less severe than in previous waves. Experts have cautioned that the true severity of Omicron infections isn’t yet known, since the first cases have been detected in younger people, who tend to have milder COVID-19 symptoms than those of adults and seniors.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
In mid-November, the FDA authorized boosters of the Pfizer vaccine for all individuals 18 and older, but the agency held off on expanding the use of boosters for younger age groups, partly because they have the highest risk of myocarditis, a very rare side effect.
Myocarditis cases seem to be temporary, with patients making a full recovery, though they need to be monitored in the hospital. The risk of myocarditis with a COVID-19 infection is many times higher than it is from a vaccine.
There have been little data to support the need for boosters in this age group, because children and teens tend to experience milder COVID-19 disease, though they are still at risk for post–COVID-19 complications such as long COVID and a delayed reaction to the virus called Post Acute Sequelae of SARS-CoV2 Infection among Children, or PAS-C.
All that changed with the arrival of Omicron.
A version of this article first appeared on WebMD.com.
, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose.
The FDA said it was basing its emergency authorization of boosters for 16- and 17-year-olds on data from 200 individuals who were 18-55 years of age when they received a booster dose. They are requiring Pfizer to collect data on safety in postauthorization studies.
“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said in a news release.
Israel has been giving booster doses of Pfizer’s vaccine to everyone 12 and up since late August. Data from that country show that myocarditis cases continue to be very rare, even in younger age groups, and are mild and temporary.
The authorization comes as the effectiveness of the current vaccines against the new Omicron variant has become a point of intense scientific inquiry.
Early studies suggest that booster doses may be necessary to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.
Current evidence suggests that the protection of the vaccines is holding up well against severe disease and death, at least with Delta and early iterations of the virus.
How well they will do against Omicron, and how severe Omicron infections may be for different age groups, remain open questions.
On Dec. 8, the World Health Organization urged countries not to wait for all the science to come in, but to act now to contain any potential threat.
The first pieces of evidence on Omicron suggest that it is highly contagious, perhaps even more than Delta, though early reports suggest symptoms caused by this version of the new coronavirus may be less severe than in previous waves. Experts have cautioned that the true severity of Omicron infections isn’t yet known, since the first cases have been detected in younger people, who tend to have milder COVID-19 symptoms than those of adults and seniors.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
In mid-November, the FDA authorized boosters of the Pfizer vaccine for all individuals 18 and older, but the agency held off on expanding the use of boosters for younger age groups, partly because they have the highest risk of myocarditis, a very rare side effect.
Myocarditis cases seem to be temporary, with patients making a full recovery, though they need to be monitored in the hospital. The risk of myocarditis with a COVID-19 infection is many times higher than it is from a vaccine.
There have been little data to support the need for boosters in this age group, because children and teens tend to experience milder COVID-19 disease, though they are still at risk for post–COVID-19 complications such as long COVID and a delayed reaction to the virus called Post Acute Sequelae of SARS-CoV2 Infection among Children, or PAS-C.
All that changed with the arrival of Omicron.
A version of this article first appeared on WebMD.com.
Medical board stops warning docs against giving false COVID information
Under pressure from Republican state lawmakers, t
The board’s 7-3 vote on December 7 to delete the statement followed repeated threats by a powerful state House Republican to dissolve the board and appoint all new members if it did not immediately take it down.
The Tennessee board’s statement was a verbatim restatement of a warning to physicians issued by the Federation of State Medical Boards in July. The federation cited a “dramatic increase” in dissemination of misinformation and disinformation about the COVID-19 vaccine by physicians. It said that’s dangerous because physicians enjoy a high degree of public credibility.
Across the country, state medical licensing boards and state and national medical associations and specialty boards are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians, which they say are increasing public confusion, political conflict, and preventable illnesses and deaths.
There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. As an example, they cite the State Medical Board of Ohio’s September renewal of the medical license of Sherri Tenpenny, DO, who had previously testified before Ohio lawmakers that COVID-19 vaccines magnetize their recipients and “interface” with cell phone towers.
“I’m not satisfied with what medical boards have done, and we are ramping up our efforts to press the boards to hold these physicians accountable,” said Nick Sawyer, MD, an emergency physician in Sacramento, Calif., who heads a group of healthcare professionals called No License for Disinformation.
Still, Tennessee board members insisted that the board’s policy of disciplining physicians who disseminate false information about COVID-19 vaccinations remains in effect, because state law empowers the board to take action against doctors whose unprofessional behavior endangers the public.
“COVID misinformation and disinformation has caused undue loss of life and jobs and other incalculable loss in our society,” said Melanie Blake, MD, MBA, a Chattanooga internist who’s president of the board. “Physicians have a responsibility to uphold their oath and put forward consensus-driven medical principles.”
But state Rep. John Ragan, the Republican co-chairman of the Joint Government Operations Committee, told the Tennessean newspaper that deleting the statement from the board’s website was equivalent to rescinding the policy. Ragan, who identifies himself as a business consultant and retired Air Force pilot, did not respond to a request for comment for this article.
Blake acknowledged that removing the statement from the board’s website has the potential to confuse Tennessee physicians. And the pressure from GOP lawmakers, who overwhelmingly control the Tennessee legislature, could discourage investigations and disciplinary actions against physicians who allegedly spread COVID-19 misinformation, she added. “It’s hard for me to answer whether this puts a chill on us,” she said.
In September, the Tennessee board, besides approving the general statement that physicians who spread COVID-19 disinformation could face licensure action, also directed the State Department of Health to prioritize investigations of physicians who spread outrageous claims. The board cited statements such as the vaccines are poisonous, cause infertility, contain microchips, or magnetize the body.
In response, the Tennessee General Assembly passed a bill in late October prohibiting the board from implementing any disciplinary process regarding the prescribing of “medication for COVID-19” without review and approval by Ragan’s committee. It’s not clear whether that language covers vaccines.
Last summer, in a similar move, Ragan threatened to dissolve the State Department of Health because its top vaccination official wrote a letter to medical providers explaining that state law allowed them to give COVID-19 vaccinations to minors older than 14 without parental consent. That official, Michelle Fiscus, MD, was fired in July.
Republican Sen. Richard Briggs, MD, a cardiothoracic surgeon who voted against the October legislation affecting COVID-related disciplinary actions, criticized his GOP colleagues’ interference in the medical board’s licensure decisions. “The mission of the board is to protect the health and safety of Tennessee citizens, and this was in complete conflict with that mission,” he said.
The Federation of State Medical Boards similarly condemned the Tennessee lawmakers’ moves. “The FSMB strongly opposes restricting a board’s authority to evaluate the standard of care and assess potential risk for patient harm,” a spokesman said. “Any interference, politically motivated or otherwise, is unhelpful and dangerous.”
But Arthur Caplan, PhD, a professor of bioethics at NYU School of Medicine, doubts that state medical boards are up to the task of policing disinformation spread by physicians. That’s because they ultimately are under the control of elected state officials, who may force the boards to base policy on ideology rather than science.
He said medical board members in Florida and another GOP-controlled state have told him they do not want to pursue disciplinary actions against physicians for COVID-19 misinformation for fear of political backlash.
Michele Heisler, MD, medical director of Physicians for Human Rights, agreed that the Tennessee situation highlights the looming political threat to the independence of state medical boards. She urged other medical organizations, particularly medical specialty boards, to step in.
“As a profession, we need to take a stance against this,” said Heisler, who’s a professor of internal medicine and public health at the University of Michigan. “Our credibility as physicians is at stake.”
A version of this article first appeared on Medscape.com.
Under pressure from Republican state lawmakers, t
The board’s 7-3 vote on December 7 to delete the statement followed repeated threats by a powerful state House Republican to dissolve the board and appoint all new members if it did not immediately take it down.
The Tennessee board’s statement was a verbatim restatement of a warning to physicians issued by the Federation of State Medical Boards in July. The federation cited a “dramatic increase” in dissemination of misinformation and disinformation about the COVID-19 vaccine by physicians. It said that’s dangerous because physicians enjoy a high degree of public credibility.
Across the country, state medical licensing boards and state and national medical associations and specialty boards are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians, which they say are increasing public confusion, political conflict, and preventable illnesses and deaths.
There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. As an example, they cite the State Medical Board of Ohio’s September renewal of the medical license of Sherri Tenpenny, DO, who had previously testified before Ohio lawmakers that COVID-19 vaccines magnetize their recipients and “interface” with cell phone towers.
“I’m not satisfied with what medical boards have done, and we are ramping up our efforts to press the boards to hold these physicians accountable,” said Nick Sawyer, MD, an emergency physician in Sacramento, Calif., who heads a group of healthcare professionals called No License for Disinformation.
Still, Tennessee board members insisted that the board’s policy of disciplining physicians who disseminate false information about COVID-19 vaccinations remains in effect, because state law empowers the board to take action against doctors whose unprofessional behavior endangers the public.
“COVID misinformation and disinformation has caused undue loss of life and jobs and other incalculable loss in our society,” said Melanie Blake, MD, MBA, a Chattanooga internist who’s president of the board. “Physicians have a responsibility to uphold their oath and put forward consensus-driven medical principles.”
But state Rep. John Ragan, the Republican co-chairman of the Joint Government Operations Committee, told the Tennessean newspaper that deleting the statement from the board’s website was equivalent to rescinding the policy. Ragan, who identifies himself as a business consultant and retired Air Force pilot, did not respond to a request for comment for this article.
Blake acknowledged that removing the statement from the board’s website has the potential to confuse Tennessee physicians. And the pressure from GOP lawmakers, who overwhelmingly control the Tennessee legislature, could discourage investigations and disciplinary actions against physicians who allegedly spread COVID-19 misinformation, she added. “It’s hard for me to answer whether this puts a chill on us,” she said.
In September, the Tennessee board, besides approving the general statement that physicians who spread COVID-19 disinformation could face licensure action, also directed the State Department of Health to prioritize investigations of physicians who spread outrageous claims. The board cited statements such as the vaccines are poisonous, cause infertility, contain microchips, or magnetize the body.
In response, the Tennessee General Assembly passed a bill in late October prohibiting the board from implementing any disciplinary process regarding the prescribing of “medication for COVID-19” without review and approval by Ragan’s committee. It’s not clear whether that language covers vaccines.
Last summer, in a similar move, Ragan threatened to dissolve the State Department of Health because its top vaccination official wrote a letter to medical providers explaining that state law allowed them to give COVID-19 vaccinations to minors older than 14 without parental consent. That official, Michelle Fiscus, MD, was fired in July.
Republican Sen. Richard Briggs, MD, a cardiothoracic surgeon who voted against the October legislation affecting COVID-related disciplinary actions, criticized his GOP colleagues’ interference in the medical board’s licensure decisions. “The mission of the board is to protect the health and safety of Tennessee citizens, and this was in complete conflict with that mission,” he said.
The Federation of State Medical Boards similarly condemned the Tennessee lawmakers’ moves. “The FSMB strongly opposes restricting a board’s authority to evaluate the standard of care and assess potential risk for patient harm,” a spokesman said. “Any interference, politically motivated or otherwise, is unhelpful and dangerous.”
But Arthur Caplan, PhD, a professor of bioethics at NYU School of Medicine, doubts that state medical boards are up to the task of policing disinformation spread by physicians. That’s because they ultimately are under the control of elected state officials, who may force the boards to base policy on ideology rather than science.
He said medical board members in Florida and another GOP-controlled state have told him they do not want to pursue disciplinary actions against physicians for COVID-19 misinformation for fear of political backlash.
Michele Heisler, MD, medical director of Physicians for Human Rights, agreed that the Tennessee situation highlights the looming political threat to the independence of state medical boards. She urged other medical organizations, particularly medical specialty boards, to step in.
“As a profession, we need to take a stance against this,” said Heisler, who’s a professor of internal medicine and public health at the University of Michigan. “Our credibility as physicians is at stake.”
A version of this article first appeared on Medscape.com.
Under pressure from Republican state lawmakers, t
The board’s 7-3 vote on December 7 to delete the statement followed repeated threats by a powerful state House Republican to dissolve the board and appoint all new members if it did not immediately take it down.
The Tennessee board’s statement was a verbatim restatement of a warning to physicians issued by the Federation of State Medical Boards in July. The federation cited a “dramatic increase” in dissemination of misinformation and disinformation about the COVID-19 vaccine by physicians. It said that’s dangerous because physicians enjoy a high degree of public credibility.
Across the country, state medical licensing boards and state and national medical associations and specialty boards are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians, which they say are increasing public confusion, political conflict, and preventable illnesses and deaths.
There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. As an example, they cite the State Medical Board of Ohio’s September renewal of the medical license of Sherri Tenpenny, DO, who had previously testified before Ohio lawmakers that COVID-19 vaccines magnetize their recipients and “interface” with cell phone towers.
“I’m not satisfied with what medical boards have done, and we are ramping up our efforts to press the boards to hold these physicians accountable,” said Nick Sawyer, MD, an emergency physician in Sacramento, Calif., who heads a group of healthcare professionals called No License for Disinformation.
Still, Tennessee board members insisted that the board’s policy of disciplining physicians who disseminate false information about COVID-19 vaccinations remains in effect, because state law empowers the board to take action against doctors whose unprofessional behavior endangers the public.
“COVID misinformation and disinformation has caused undue loss of life and jobs and other incalculable loss in our society,” said Melanie Blake, MD, MBA, a Chattanooga internist who’s president of the board. “Physicians have a responsibility to uphold their oath and put forward consensus-driven medical principles.”
But state Rep. John Ragan, the Republican co-chairman of the Joint Government Operations Committee, told the Tennessean newspaper that deleting the statement from the board’s website was equivalent to rescinding the policy. Ragan, who identifies himself as a business consultant and retired Air Force pilot, did not respond to a request for comment for this article.
Blake acknowledged that removing the statement from the board’s website has the potential to confuse Tennessee physicians. And the pressure from GOP lawmakers, who overwhelmingly control the Tennessee legislature, could discourage investigations and disciplinary actions against physicians who allegedly spread COVID-19 misinformation, she added. “It’s hard for me to answer whether this puts a chill on us,” she said.
In September, the Tennessee board, besides approving the general statement that physicians who spread COVID-19 disinformation could face licensure action, also directed the State Department of Health to prioritize investigations of physicians who spread outrageous claims. The board cited statements such as the vaccines are poisonous, cause infertility, contain microchips, or magnetize the body.
In response, the Tennessee General Assembly passed a bill in late October prohibiting the board from implementing any disciplinary process regarding the prescribing of “medication for COVID-19” without review and approval by Ragan’s committee. It’s not clear whether that language covers vaccines.
Last summer, in a similar move, Ragan threatened to dissolve the State Department of Health because its top vaccination official wrote a letter to medical providers explaining that state law allowed them to give COVID-19 vaccinations to minors older than 14 without parental consent. That official, Michelle Fiscus, MD, was fired in July.
Republican Sen. Richard Briggs, MD, a cardiothoracic surgeon who voted against the October legislation affecting COVID-related disciplinary actions, criticized his GOP colleagues’ interference in the medical board’s licensure decisions. “The mission of the board is to protect the health and safety of Tennessee citizens, and this was in complete conflict with that mission,” he said.
The Federation of State Medical Boards similarly condemned the Tennessee lawmakers’ moves. “The FSMB strongly opposes restricting a board’s authority to evaluate the standard of care and assess potential risk for patient harm,” a spokesman said. “Any interference, politically motivated or otherwise, is unhelpful and dangerous.”
But Arthur Caplan, PhD, a professor of bioethics at NYU School of Medicine, doubts that state medical boards are up to the task of policing disinformation spread by physicians. That’s because they ultimately are under the control of elected state officials, who may force the boards to base policy on ideology rather than science.
He said medical board members in Florida and another GOP-controlled state have told him they do not want to pursue disciplinary actions against physicians for COVID-19 misinformation for fear of political backlash.
Michele Heisler, MD, medical director of Physicians for Human Rights, agreed that the Tennessee situation highlights the looming political threat to the independence of state medical boards. She urged other medical organizations, particularly medical specialty boards, to step in.
“As a profession, we need to take a stance against this,” said Heisler, who’s a professor of internal medicine and public health at the University of Michigan. “Our credibility as physicians is at stake.”
A version of this article first appeared on Medscape.com.
AMA, hospital group sue federal government over surprise billing law
which tilts toward using prevailing rates paid for services.
The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.
Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.
Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.
The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.
In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.
AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.
In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”
The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.
“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”
AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”
“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.
AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.
“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.
A version of this article first appeared on Medscape.com.
which tilts toward using prevailing rates paid for services.
The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.
Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.
Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.
The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.
In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.
AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.
In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”
The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.
“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”
AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”
“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.
AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.
“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.
A version of this article first appeared on Medscape.com.
which tilts toward using prevailing rates paid for services.
The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.
Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.
Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.
The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.
In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.
AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.
In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”
The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.
“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”
AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”
“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.
AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.
“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.
A version of this article first appeared on Medscape.com.