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Children with poor lung function develop ACOS
Children with poor lung function will be more likely to develop asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome (ACOS), suggesting that prevention of this disease should be attempted in early life, a study shows.
While other research has found that patients with poor lung function in early life have poor lung function as adults, this was the first study to investigate the relationship between childhood lung function and ACOS in adult life, according to Dinh S. Bui of the University of Melbourne, and his colleagues.
The study, published in the American Journal of Respiratory and Critical Care Medicine, used multinomial regression models to investigate associations between childhood lung parameters at age 7 years and asthma, COPD, and ACOS at age 45 years (Am J Respir Crit Care Med. 2017 Feb 1. doi: 10.1164/rccm.201606-1272OC).
“We found that ACOS participants showed evidence of persistently lower FEV1 [forced expiratory volume in 1 second] and FEV1/FVC [forced vital capacity] from childhood. This suggests that poorer childhood lung function tracked to early adult life, leading to impaired maximally attained lung function,” the researchers said.
“The study highlights that low childhood lung function is a risk factor for COPD (and ACOS) independent of smoking,” they noted.
The 1,355 study participants who had postbronchodilator (post-BD) lung function available were categorized into the following four mutually exclusive groups at age 45 years based on their asthma and COPD status: having neither asthma nor COPD (unaffected) (n = 959); having asthma alone (n = 269); having COPD alone (n = 59); having ACOS (n = 68).
Once adjusted for the sampling weights, the prevalence of current asthma alone was 13.5%, COPD alone was 4.1%, and ACOS was 2.9%. The researchers defined COPD at age 45 years as post-BD FEV1/FVC less than the Global Lung Initiative lower limit of normal. Because the associations between childhood lung function and both ACOS and COPD alone were nonlinear, the patients were grouped into quartiles based on their characteristics, such as their percent predicted FEV1 and percent predicted FEV1/FVC at 7 years, the investigators said.
Patients in the lowest quartile for FEV1 percent predicted at 7 years were 2.93 times more likely to have ACOS, compared with patients in the other quartiles for FEV1 percent predicted. Patients in the lowest quartile for FEV1/FVC percent predicted at 7 years were 16.3 times more likely to have ACOS and 5.76 times more likely to have COPD alone, compared with patients in the higher quartiles.
The researchers found large variation in childhood lung function among patients in the lowest quartiles for FEV1 and FEV1/FVC. To account for this, they conducted a sensitivity analysis, which excluded those with less than 80% predicted FEV1 and FEV1/FVC (n = 76 and 13, respectively).The associations between lung function measures and diseases in adulthood for patients in the lowest quartiles differed slightly following this adjustment. The sensitivity analysis showed that patients in the lowest quartile for FEV1 had an odds ratio of 2.4 for ACOS and that those patients in the lowest quartile for FEV1/FVC had an odds ratio of 5.2 for COPD alone and 15.1 for ACOS.
A sensitivity analysis that excluded patients with remitted asthma from the unaffected group showed childhood FEV1 was more strongly associated with ACOS for patients in the lowest quartile, compared with patients in the highest quartile (OR: 7.0, 95% CI: 2.7-18.3). This same analysis found that patients from the lowest quartile and second quartile for childhood FEV1/FVC were 6.8 and 3.9 times more likely to have COPD, respectively, compared with patients in the other quartiles. This sensitivity analysis also found that patients in the first quartile for FEV1/FVC were 19.1 times more likely to have ACOS, and patients in the second quartile for FEV1/FVC were 5.3 times more likely to have ACOS.
The researchers analyzed data from the Tasmanian Longitudinal Health Study, which began in 1968 when Tasmanian children born in 1961 and attending school in Tasmania were studied with respiratory health surveys and prebronchodilator (pre-BD) spirometry measurements. The most recent survey started in 2002. Survey respondents who had participated in past follow-up studies and/or reported symptoms of asthma or cough were invited to participate in a more detailed laboratory study from 2006 to 2008. That study included completing a questionnaire, pre-BD and post-BD spirometry, and skin prick testing. The predicted and percent predicted values for spirometry were derived from the Global Lung Initiative reference equations.
The final multinomial model was adjusted for various factors including childhood asthma, maternal smoking, and paternal smoking during childhood.
History of active smoking was significantly more frequent in patients with ACOS (73.5%) and COPD alone (73%) than in the unaffected (57%) groups. Childhood asthma, maternal asthma and atopy were more prevalent in the ACOS and asthma alone groups. ACOS and COPD participants had a higher prevalence of maternal smoking during childhood.
Individuals with ACOS had the lowest pre-BD FEV1 (percent predicted values) over time. Those with COPD alone or ACOS had significantly lower pre-BD FEV1/FVC (percent predicted values) at all time points, when patients were assessed, compared with unaffected participants. “Participants with COPD alone had significantly higher FVC at 7 and 13 years, while ACOS participants had significantly lower FVC at 45 years,” the researchers said.
“There was no evidence of effect modification by childhood lung infections, childhood asthma, maternal asthma, maternal smoking, or paternal smoking during childhood on the associations between childhood lung and the disease groups,” they noted.
The study was limited by its “relatively small sample sizes for the ACOS and COPD alone groups” and the absence of post-BD spirometry at 7 years, they added.
The researchers concluded that “screening of lung function in school-aged children may provide an opportunity to detect children likely to have ongoing poorer lung health, such as those with lung function below the lower limit of normal,” and that “[multifaceted] intervention strategies could then be implemented to reduce the burden of COPD and ACOS in adulthood.”
“I suspect that genetics may play a big role in the results, and there is increasing interest in learning how genetics are involved in COPD. A better understanding of the risk factors for lower lung function in children may also provide targets of intervention. The groups with ACOS and COPD have higher rates of maternal smoking, and while this study determined that the association between childhood low lung function and development of COPD and ACOS is independent of maternal smoking, maternal smoking still seems like a good area to target,” she said in an interview.
It would also be interesting to further study the first quartile of patients, she added. “The clinical disease for this quartile of patients covers a wide range of severities. I would be interested in dividing this group up further and learning the outcomes of their lung function and development of COPD and ACOS.”
Using inhaled corticosteroids and other medications for maintenance control, reducing and monitoring impairment, educating patients and patients’ guardians on triggers, avoiding triggers, and having an action plan for changing therapy based on symptoms or measured flows are ways to aggressively treat such conditions, said Dr. Gartman, assistant professor of medicine at Brown University, Providence, R.I*. He cited avoiding exposure to smoke, environmental pollutants, and living near highways, for those with low childhood function, as interventions that might prevent people with low lung function from later developing COPD.
Dr. Gartman added that differences between the availability of medication for children with asthma today and at the time of the study may mean there are differences between the children with low lung function in the study and those children who have low function today. A population of children with low lung function now may be experiencing relatively less asthma and more chronic lung disorders brought on by prematurity or cystic fibrosis, he noted. “As such, identification of poor function in today’s young children may carry with it a significantly different set of interventions and challenges,” Dr. Gartman said.
While asthma in children is better controlled now than it was at the time of the study, because the researchers did not provide any information about the asthma control of the study participants, “it [is] hard for me to say if better asthma drugs in those children would have made a difference in long-term outcomes of COPD and ACOS as an adult,” Dr. Swaminathan noted.
“The best thing we currently can do for children with low lung function is try and determine the underlying cause and treat any active diseases [such as asthma] that we can. This study reminds us of the need to keep searching for causes of low lung function that may be reversible,” she said.
The investigators recommended future research to understand the risk factors for lower lung function in children. They called for studies that address “the risk factors over adulthood that interact with lower lung function to increase the risk of rapid lung function decline.”
The study was supported by a National Health and Medical Research Council of Australia research grant, the University of Melbourne, Clifford Craig Medical Research Trust of Tasmania, the Victorian, Queensland & Tasmanian Asthma Foundations, The Royal Hobart Hospital, Helen MacPherson Smith Trust, GlaxoSmithKline, and John L Hopper. Five authors were supported by the research grant; the others reported no conflicts. Dr. Swaminathan and Dr. Gartman had no disclosures.
*This story was updated March 16, 2017, with Dr. Gartman's full affiliation.
Children with poor lung function will be more likely to develop asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome (ACOS), suggesting that prevention of this disease should be attempted in early life, a study shows.
While other research has found that patients with poor lung function in early life have poor lung function as adults, this was the first study to investigate the relationship between childhood lung function and ACOS in adult life, according to Dinh S. Bui of the University of Melbourne, and his colleagues.
The study, published in the American Journal of Respiratory and Critical Care Medicine, used multinomial regression models to investigate associations between childhood lung parameters at age 7 years and asthma, COPD, and ACOS at age 45 years (Am J Respir Crit Care Med. 2017 Feb 1. doi: 10.1164/rccm.201606-1272OC).
“We found that ACOS participants showed evidence of persistently lower FEV1 [forced expiratory volume in 1 second] and FEV1/FVC [forced vital capacity] from childhood. This suggests that poorer childhood lung function tracked to early adult life, leading to impaired maximally attained lung function,” the researchers said.
“The study highlights that low childhood lung function is a risk factor for COPD (and ACOS) independent of smoking,” they noted.
The 1,355 study participants who had postbronchodilator (post-BD) lung function available were categorized into the following four mutually exclusive groups at age 45 years based on their asthma and COPD status: having neither asthma nor COPD (unaffected) (n = 959); having asthma alone (n = 269); having COPD alone (n = 59); having ACOS (n = 68).
Once adjusted for the sampling weights, the prevalence of current asthma alone was 13.5%, COPD alone was 4.1%, and ACOS was 2.9%. The researchers defined COPD at age 45 years as post-BD FEV1/FVC less than the Global Lung Initiative lower limit of normal. Because the associations between childhood lung function and both ACOS and COPD alone were nonlinear, the patients were grouped into quartiles based on their characteristics, such as their percent predicted FEV1 and percent predicted FEV1/FVC at 7 years, the investigators said.
Patients in the lowest quartile for FEV1 percent predicted at 7 years were 2.93 times more likely to have ACOS, compared with patients in the other quartiles for FEV1 percent predicted. Patients in the lowest quartile for FEV1/FVC percent predicted at 7 years were 16.3 times more likely to have ACOS and 5.76 times more likely to have COPD alone, compared with patients in the higher quartiles.
The researchers found large variation in childhood lung function among patients in the lowest quartiles for FEV1 and FEV1/FVC. To account for this, they conducted a sensitivity analysis, which excluded those with less than 80% predicted FEV1 and FEV1/FVC (n = 76 and 13, respectively).The associations between lung function measures and diseases in adulthood for patients in the lowest quartiles differed slightly following this adjustment. The sensitivity analysis showed that patients in the lowest quartile for FEV1 had an odds ratio of 2.4 for ACOS and that those patients in the lowest quartile for FEV1/FVC had an odds ratio of 5.2 for COPD alone and 15.1 for ACOS.
A sensitivity analysis that excluded patients with remitted asthma from the unaffected group showed childhood FEV1 was more strongly associated with ACOS for patients in the lowest quartile, compared with patients in the highest quartile (OR: 7.0, 95% CI: 2.7-18.3). This same analysis found that patients from the lowest quartile and second quartile for childhood FEV1/FVC were 6.8 and 3.9 times more likely to have COPD, respectively, compared with patients in the other quartiles. This sensitivity analysis also found that patients in the first quartile for FEV1/FVC were 19.1 times more likely to have ACOS, and patients in the second quartile for FEV1/FVC were 5.3 times more likely to have ACOS.
The researchers analyzed data from the Tasmanian Longitudinal Health Study, which began in 1968 when Tasmanian children born in 1961 and attending school in Tasmania were studied with respiratory health surveys and prebronchodilator (pre-BD) spirometry measurements. The most recent survey started in 2002. Survey respondents who had participated in past follow-up studies and/or reported symptoms of asthma or cough were invited to participate in a more detailed laboratory study from 2006 to 2008. That study included completing a questionnaire, pre-BD and post-BD spirometry, and skin prick testing. The predicted and percent predicted values for spirometry were derived from the Global Lung Initiative reference equations.
The final multinomial model was adjusted for various factors including childhood asthma, maternal smoking, and paternal smoking during childhood.
History of active smoking was significantly more frequent in patients with ACOS (73.5%) and COPD alone (73%) than in the unaffected (57%) groups. Childhood asthma, maternal asthma and atopy were more prevalent in the ACOS and asthma alone groups. ACOS and COPD participants had a higher prevalence of maternal smoking during childhood.
Individuals with ACOS had the lowest pre-BD FEV1 (percent predicted values) over time. Those with COPD alone or ACOS had significantly lower pre-BD FEV1/FVC (percent predicted values) at all time points, when patients were assessed, compared with unaffected participants. “Participants with COPD alone had significantly higher FVC at 7 and 13 years, while ACOS participants had significantly lower FVC at 45 years,” the researchers said.
“There was no evidence of effect modification by childhood lung infections, childhood asthma, maternal asthma, maternal smoking, or paternal smoking during childhood on the associations between childhood lung and the disease groups,” they noted.
The study was limited by its “relatively small sample sizes for the ACOS and COPD alone groups” and the absence of post-BD spirometry at 7 years, they added.
The researchers concluded that “screening of lung function in school-aged children may provide an opportunity to detect children likely to have ongoing poorer lung health, such as those with lung function below the lower limit of normal,” and that “[multifaceted] intervention strategies could then be implemented to reduce the burden of COPD and ACOS in adulthood.”
“I suspect that genetics may play a big role in the results, and there is increasing interest in learning how genetics are involved in COPD. A better understanding of the risk factors for lower lung function in children may also provide targets of intervention. The groups with ACOS and COPD have higher rates of maternal smoking, and while this study determined that the association between childhood low lung function and development of COPD and ACOS is independent of maternal smoking, maternal smoking still seems like a good area to target,” she said in an interview.
It would also be interesting to further study the first quartile of patients, she added. “The clinical disease for this quartile of patients covers a wide range of severities. I would be interested in dividing this group up further and learning the outcomes of their lung function and development of COPD and ACOS.”
Using inhaled corticosteroids and other medications for maintenance control, reducing and monitoring impairment, educating patients and patients’ guardians on triggers, avoiding triggers, and having an action plan for changing therapy based on symptoms or measured flows are ways to aggressively treat such conditions, said Dr. Gartman, assistant professor of medicine at Brown University, Providence, R.I*. He cited avoiding exposure to smoke, environmental pollutants, and living near highways, for those with low childhood function, as interventions that might prevent people with low lung function from later developing COPD.
Dr. Gartman added that differences between the availability of medication for children with asthma today and at the time of the study may mean there are differences between the children with low lung function in the study and those children who have low function today. A population of children with low lung function now may be experiencing relatively less asthma and more chronic lung disorders brought on by prematurity or cystic fibrosis, he noted. “As such, identification of poor function in today’s young children may carry with it a significantly different set of interventions and challenges,” Dr. Gartman said.
While asthma in children is better controlled now than it was at the time of the study, because the researchers did not provide any information about the asthma control of the study participants, “it [is] hard for me to say if better asthma drugs in those children would have made a difference in long-term outcomes of COPD and ACOS as an adult,” Dr. Swaminathan noted.
“The best thing we currently can do for children with low lung function is try and determine the underlying cause and treat any active diseases [such as asthma] that we can. This study reminds us of the need to keep searching for causes of low lung function that may be reversible,” she said.
The investigators recommended future research to understand the risk factors for lower lung function in children. They called for studies that address “the risk factors over adulthood that interact with lower lung function to increase the risk of rapid lung function decline.”
The study was supported by a National Health and Medical Research Council of Australia research grant, the University of Melbourne, Clifford Craig Medical Research Trust of Tasmania, the Victorian, Queensland & Tasmanian Asthma Foundations, The Royal Hobart Hospital, Helen MacPherson Smith Trust, GlaxoSmithKline, and John L Hopper. Five authors were supported by the research grant; the others reported no conflicts. Dr. Swaminathan and Dr. Gartman had no disclosures.
*This story was updated March 16, 2017, with Dr. Gartman's full affiliation.
Children with poor lung function will be more likely to develop asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome (ACOS), suggesting that prevention of this disease should be attempted in early life, a study shows.
While other research has found that patients with poor lung function in early life have poor lung function as adults, this was the first study to investigate the relationship between childhood lung function and ACOS in adult life, according to Dinh S. Bui of the University of Melbourne, and his colleagues.
The study, published in the American Journal of Respiratory and Critical Care Medicine, used multinomial regression models to investigate associations between childhood lung parameters at age 7 years and asthma, COPD, and ACOS at age 45 years (Am J Respir Crit Care Med. 2017 Feb 1. doi: 10.1164/rccm.201606-1272OC).
“We found that ACOS participants showed evidence of persistently lower FEV1 [forced expiratory volume in 1 second] and FEV1/FVC [forced vital capacity] from childhood. This suggests that poorer childhood lung function tracked to early adult life, leading to impaired maximally attained lung function,” the researchers said.
“The study highlights that low childhood lung function is a risk factor for COPD (and ACOS) independent of smoking,” they noted.
The 1,355 study participants who had postbronchodilator (post-BD) lung function available were categorized into the following four mutually exclusive groups at age 45 years based on their asthma and COPD status: having neither asthma nor COPD (unaffected) (n = 959); having asthma alone (n = 269); having COPD alone (n = 59); having ACOS (n = 68).
Once adjusted for the sampling weights, the prevalence of current asthma alone was 13.5%, COPD alone was 4.1%, and ACOS was 2.9%. The researchers defined COPD at age 45 years as post-BD FEV1/FVC less than the Global Lung Initiative lower limit of normal. Because the associations between childhood lung function and both ACOS and COPD alone were nonlinear, the patients were grouped into quartiles based on their characteristics, such as their percent predicted FEV1 and percent predicted FEV1/FVC at 7 years, the investigators said.
Patients in the lowest quartile for FEV1 percent predicted at 7 years were 2.93 times more likely to have ACOS, compared with patients in the other quartiles for FEV1 percent predicted. Patients in the lowest quartile for FEV1/FVC percent predicted at 7 years were 16.3 times more likely to have ACOS and 5.76 times more likely to have COPD alone, compared with patients in the higher quartiles.
The researchers found large variation in childhood lung function among patients in the lowest quartiles for FEV1 and FEV1/FVC. To account for this, they conducted a sensitivity analysis, which excluded those with less than 80% predicted FEV1 and FEV1/FVC (n = 76 and 13, respectively).The associations between lung function measures and diseases in adulthood for patients in the lowest quartiles differed slightly following this adjustment. The sensitivity analysis showed that patients in the lowest quartile for FEV1 had an odds ratio of 2.4 for ACOS and that those patients in the lowest quartile for FEV1/FVC had an odds ratio of 5.2 for COPD alone and 15.1 for ACOS.
A sensitivity analysis that excluded patients with remitted asthma from the unaffected group showed childhood FEV1 was more strongly associated with ACOS for patients in the lowest quartile, compared with patients in the highest quartile (OR: 7.0, 95% CI: 2.7-18.3). This same analysis found that patients from the lowest quartile and second quartile for childhood FEV1/FVC were 6.8 and 3.9 times more likely to have COPD, respectively, compared with patients in the other quartiles. This sensitivity analysis also found that patients in the first quartile for FEV1/FVC were 19.1 times more likely to have ACOS, and patients in the second quartile for FEV1/FVC were 5.3 times more likely to have ACOS.
The researchers analyzed data from the Tasmanian Longitudinal Health Study, which began in 1968 when Tasmanian children born in 1961 and attending school in Tasmania were studied with respiratory health surveys and prebronchodilator (pre-BD) spirometry measurements. The most recent survey started in 2002. Survey respondents who had participated in past follow-up studies and/or reported symptoms of asthma or cough were invited to participate in a more detailed laboratory study from 2006 to 2008. That study included completing a questionnaire, pre-BD and post-BD spirometry, and skin prick testing. The predicted and percent predicted values for spirometry were derived from the Global Lung Initiative reference equations.
The final multinomial model was adjusted for various factors including childhood asthma, maternal smoking, and paternal smoking during childhood.
History of active smoking was significantly more frequent in patients with ACOS (73.5%) and COPD alone (73%) than in the unaffected (57%) groups. Childhood asthma, maternal asthma and atopy were more prevalent in the ACOS and asthma alone groups. ACOS and COPD participants had a higher prevalence of maternal smoking during childhood.
Individuals with ACOS had the lowest pre-BD FEV1 (percent predicted values) over time. Those with COPD alone or ACOS had significantly lower pre-BD FEV1/FVC (percent predicted values) at all time points, when patients were assessed, compared with unaffected participants. “Participants with COPD alone had significantly higher FVC at 7 and 13 years, while ACOS participants had significantly lower FVC at 45 years,” the researchers said.
“There was no evidence of effect modification by childhood lung infections, childhood asthma, maternal asthma, maternal smoking, or paternal smoking during childhood on the associations between childhood lung and the disease groups,” they noted.
The study was limited by its “relatively small sample sizes for the ACOS and COPD alone groups” and the absence of post-BD spirometry at 7 years, they added.
The researchers concluded that “screening of lung function in school-aged children may provide an opportunity to detect children likely to have ongoing poorer lung health, such as those with lung function below the lower limit of normal,” and that “[multifaceted] intervention strategies could then be implemented to reduce the burden of COPD and ACOS in adulthood.”
“I suspect that genetics may play a big role in the results, and there is increasing interest in learning how genetics are involved in COPD. A better understanding of the risk factors for lower lung function in children may also provide targets of intervention. The groups with ACOS and COPD have higher rates of maternal smoking, and while this study determined that the association between childhood low lung function and development of COPD and ACOS is independent of maternal smoking, maternal smoking still seems like a good area to target,” she said in an interview.
It would also be interesting to further study the first quartile of patients, she added. “The clinical disease for this quartile of patients covers a wide range of severities. I would be interested in dividing this group up further and learning the outcomes of their lung function and development of COPD and ACOS.”
Using inhaled corticosteroids and other medications for maintenance control, reducing and monitoring impairment, educating patients and patients’ guardians on triggers, avoiding triggers, and having an action plan for changing therapy based on symptoms or measured flows are ways to aggressively treat such conditions, said Dr. Gartman, assistant professor of medicine at Brown University, Providence, R.I*. He cited avoiding exposure to smoke, environmental pollutants, and living near highways, for those with low childhood function, as interventions that might prevent people with low lung function from later developing COPD.
Dr. Gartman added that differences between the availability of medication for children with asthma today and at the time of the study may mean there are differences between the children with low lung function in the study and those children who have low function today. A population of children with low lung function now may be experiencing relatively less asthma and more chronic lung disorders brought on by prematurity or cystic fibrosis, he noted. “As such, identification of poor function in today’s young children may carry with it a significantly different set of interventions and challenges,” Dr. Gartman said.
While asthma in children is better controlled now than it was at the time of the study, because the researchers did not provide any information about the asthma control of the study participants, “it [is] hard for me to say if better asthma drugs in those children would have made a difference in long-term outcomes of COPD and ACOS as an adult,” Dr. Swaminathan noted.
“The best thing we currently can do for children with low lung function is try and determine the underlying cause and treat any active diseases [such as asthma] that we can. This study reminds us of the need to keep searching for causes of low lung function that may be reversible,” she said.
The investigators recommended future research to understand the risk factors for lower lung function in children. They called for studies that address “the risk factors over adulthood that interact with lower lung function to increase the risk of rapid lung function decline.”
The study was supported by a National Health and Medical Research Council of Australia research grant, the University of Melbourne, Clifford Craig Medical Research Trust of Tasmania, the Victorian, Queensland & Tasmanian Asthma Foundations, The Royal Hobart Hospital, Helen MacPherson Smith Trust, GlaxoSmithKline, and John L Hopper. Five authors were supported by the research grant; the others reported no conflicts. Dr. Swaminathan and Dr. Gartman had no disclosures.
*This story was updated March 16, 2017, with Dr. Gartman's full affiliation.
FROM AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
Decision support tool appears to safely reduce CSF use
ORLANDO – A decision support tool safely reduces use of colony-stimulating factors (CSFs) in patients undergoing chemotherapy for lung cancer, suggests a retrospective claims-based cohort study of nearly 3,500 patients across the country.
The rate of CSF use fell among patients treated in the nine states that implemented the tool – a library of chemotherapy regimens and their expected FN risk that uses preauthorization and an algorithm to promote risk-appropriate, guideline-adherent use – but it remained unchanged in the 39 states and the District of Columbia, where usual practice continued, investigators reported at a symposium on quality care sponsored by the American Society of Clinical Oncology and simultaneously published (J Oncol Pract. 2017 March 4. doi: 10.1200/JOP.2017.020867). The adjusted difference was nearly 9%.
“Decision support programs like the one highlighted here could be one way, definitely not the only way, of achieving guideline-adherent CSF use and reducing practice variation across the country,” commented coinvestigator Abiy Agiro, PhD, associate director of payer and provider research at HealthCore, a subsidiary of Anthem, in Wilmington, Delaware.
“Such efforts could also have unintended consequences, so it’s important to study relevant patient outcomes,” he added. “In this case, although it appears that the incidence of febrile neutropenia rising does not seem to relate with the program, the study does not establish the safety of CSF use reduction in lung cancer patients receiving chemotherapy. So, we should take the results with that caveat.”
Parsing the findings
Although the United States makes up just 4% of the world’s population, it uses nearly 80% of CSFs sold by a leading manufacturer, according to invited discussant Thomas J. Smith, MD, a professor of oncology and palliative medicine at Johns Hopkins University in Baltimore.
“When we rewrote the ASCO [American Society of Clinical Oncology] guidelines on CSF use in 2015, there were some specific indications: dose-intense chemo for adjuvant breast cancer and uroepithelial cancer and ... when the risk of febrile neutropenia is about 20% and dose reduction is not an appropriate strategy. We were quick to point out that most regimens have a risk of febrile neutropenia much less than that,” he noted.
Dr. Agiro and his colleagues’ findings are valid, real, and reproducible, Dr. Smith maintained. However, it is unclear to what extent the observed levels of CSF use represented overuse.
“In lung cancer, there are very few regimens that have a febrile neutropenia rate close to 20%,” he elaborated. “What we don’t know is how much of this [use] was actually justified. I would suspect it is 10% or 15%, rather than 40%.”
CSF use, as guided by the new tool, “might not support increased dose density [of chemotherapy], but I would challenge anybody in the audience to show me data in normal solid tumor patients that [show that] dose density maintained by CSFs makes a difference in overall survival,” he said.
Questions yet to be addressed include the difficulty and cost of using the decision support tool and the possible negative impact on practices’ finances, according to Dr. Smith.
“When ESAs [erythropoiesis-stimulating agents] came off being used so much, some of my friends’ practices took a 15% to 20% drop in their revenue, and this is an important source of revenue for a lot of practices,” he explained. “So, I hope that when we take this revenue away, that we are cognizant of that and realize that it’s just another stress on practices, many of which are under significant stress already.”
Study details
An estimated 26% of uses of CSFs in patients with lung cancer are not in accordance with the ASCO practice guidelines, according to Dr. Agiro. “Such variations from recommendations are sometimes the reason why different stakeholders take actions” to improve care, such as ASCO’s Quality Oncology Practice Initiative (QOPI) and the American Board of Internal Medicine’s Choosing Wisely initiative (J Oncol Pract. 2015;11:338-43).
The decision support tool evaluated in the study uses preauthorization before delivery of care and, therefore, differs from point-of-care interventions, he noted.
“The tool allows access to a library of chemotherapy regimens and their associated, expected febrile neutropenia risk based on the myelotoxicity of the planned regimens as indicated in published trials. The tool is accessible online and provides real-time recommendations that are tailored based on disease- and patient-specific factors for either the use of CSF or not,” he elaborated.
According to the tool’s algorithm, use is recommended for patients who are given a regimen with a high risk of febrile neutropenia (greater than 20%) and is not recommended for those given a low-risk regimen (less than 10%). It is tailored according to the presence of additional risk factors for the intermediate-risk group.
Oncologists use the tool only for patients starting a new chemotherapy and only in the first cycle, when the risk of febrile neutropenia is highest, according to Dr. Agiro. “Once the approval is given in the first cycle, it remains in effect for the next 6 months, so they don’t have to use it again and again in additional cycles,” he explained.
The decision support tool was implemented in nine states starting in July 2014. In the study, which was funded by Anthem, the investigators analyzed administrative claims data from commercially insured adult patients starting chemotherapy for lung cancer, assessing changes in outcomes between a preimplementation period (April 2013 to Dec. 2013) and a postimplementation period (July 2014 to March 2015).
Analyses were based on 1,857 patients in the states that implemented the tool and 1,610 patients in the states that did not.
The percentage of patients receiving CSFs in the 6 months after starting chemotherapy fell in states that implemented the decision support tool (from 48.4% to 35.6%) but remained stable in states that did not (43.2% and 44.4%), Dr. Agiro reported. The adjusted difference in differences was –8.7% (P less than .001).
Meanwhile, the percentage of patients admitted for febrile neutropenia or experiencing this outcome while hospitalized increased in both states implementing the tool (from 2.8% to 4.3%) and those not implementing it (from 3.1% to 5.1%). Although the magnitude of increase was smaller in the former (+1.5% vs. +2.0%), the difference was not significant. Findings were essentially the same among the subset of patients aged 65 years and older.
“It’s important to study both intended and unintended consequences of such interventions,” Dr. Agiro noted. “Our study goes beyond financial considerations by looking at unintended outcomes: in this case, focusing on the incidence of febrile neutropenia, an outcome that is of prime interest to patients and oncologists and payers alike.”
The study may have missed some cases of febrile neutropenia, he acknowledged. “Also, there are other important outcomes of concern. For example, were there any delays in chemotherapy administration or immune recovery that could have been triggered by the implementation of the decision support program?”
The impact, both intended and unintended, on practices warrants evaluation as well, he further noted. “An important question could be, ‘Does it take less time to use this decision support tool compared to the time taken with normal care processes?’ ”
Dr. Agiro disclosed that he is employed by, has stock or other ownership interests in, and receives research funding from Anthem.
ORLANDO – A decision support tool safely reduces use of colony-stimulating factors (CSFs) in patients undergoing chemotherapy for lung cancer, suggests a retrospective claims-based cohort study of nearly 3,500 patients across the country.
The rate of CSF use fell among patients treated in the nine states that implemented the tool – a library of chemotherapy regimens and their expected FN risk that uses preauthorization and an algorithm to promote risk-appropriate, guideline-adherent use – but it remained unchanged in the 39 states and the District of Columbia, where usual practice continued, investigators reported at a symposium on quality care sponsored by the American Society of Clinical Oncology and simultaneously published (J Oncol Pract. 2017 March 4. doi: 10.1200/JOP.2017.020867). The adjusted difference was nearly 9%.
“Decision support programs like the one highlighted here could be one way, definitely not the only way, of achieving guideline-adherent CSF use and reducing practice variation across the country,” commented coinvestigator Abiy Agiro, PhD, associate director of payer and provider research at HealthCore, a subsidiary of Anthem, in Wilmington, Delaware.
“Such efforts could also have unintended consequences, so it’s important to study relevant patient outcomes,” he added. “In this case, although it appears that the incidence of febrile neutropenia rising does not seem to relate with the program, the study does not establish the safety of CSF use reduction in lung cancer patients receiving chemotherapy. So, we should take the results with that caveat.”
Parsing the findings
Although the United States makes up just 4% of the world’s population, it uses nearly 80% of CSFs sold by a leading manufacturer, according to invited discussant Thomas J. Smith, MD, a professor of oncology and palliative medicine at Johns Hopkins University in Baltimore.
“When we rewrote the ASCO [American Society of Clinical Oncology] guidelines on CSF use in 2015, there were some specific indications: dose-intense chemo for adjuvant breast cancer and uroepithelial cancer and ... when the risk of febrile neutropenia is about 20% and dose reduction is not an appropriate strategy. We were quick to point out that most regimens have a risk of febrile neutropenia much less than that,” he noted.
Dr. Agiro and his colleagues’ findings are valid, real, and reproducible, Dr. Smith maintained. However, it is unclear to what extent the observed levels of CSF use represented overuse.
“In lung cancer, there are very few regimens that have a febrile neutropenia rate close to 20%,” he elaborated. “What we don’t know is how much of this [use] was actually justified. I would suspect it is 10% or 15%, rather than 40%.”
CSF use, as guided by the new tool, “might not support increased dose density [of chemotherapy], but I would challenge anybody in the audience to show me data in normal solid tumor patients that [show that] dose density maintained by CSFs makes a difference in overall survival,” he said.
Questions yet to be addressed include the difficulty and cost of using the decision support tool and the possible negative impact on practices’ finances, according to Dr. Smith.
“When ESAs [erythropoiesis-stimulating agents] came off being used so much, some of my friends’ practices took a 15% to 20% drop in their revenue, and this is an important source of revenue for a lot of practices,” he explained. “So, I hope that when we take this revenue away, that we are cognizant of that and realize that it’s just another stress on practices, many of which are under significant stress already.”
Study details
An estimated 26% of uses of CSFs in patients with lung cancer are not in accordance with the ASCO practice guidelines, according to Dr. Agiro. “Such variations from recommendations are sometimes the reason why different stakeholders take actions” to improve care, such as ASCO’s Quality Oncology Practice Initiative (QOPI) and the American Board of Internal Medicine’s Choosing Wisely initiative (J Oncol Pract. 2015;11:338-43).
The decision support tool evaluated in the study uses preauthorization before delivery of care and, therefore, differs from point-of-care interventions, he noted.
“The tool allows access to a library of chemotherapy regimens and their associated, expected febrile neutropenia risk based on the myelotoxicity of the planned regimens as indicated in published trials. The tool is accessible online and provides real-time recommendations that are tailored based on disease- and patient-specific factors for either the use of CSF or not,” he elaborated.
According to the tool’s algorithm, use is recommended for patients who are given a regimen with a high risk of febrile neutropenia (greater than 20%) and is not recommended for those given a low-risk regimen (less than 10%). It is tailored according to the presence of additional risk factors for the intermediate-risk group.
Oncologists use the tool only for patients starting a new chemotherapy and only in the first cycle, when the risk of febrile neutropenia is highest, according to Dr. Agiro. “Once the approval is given in the first cycle, it remains in effect for the next 6 months, so they don’t have to use it again and again in additional cycles,” he explained.
The decision support tool was implemented in nine states starting in July 2014. In the study, which was funded by Anthem, the investigators analyzed administrative claims data from commercially insured adult patients starting chemotherapy for lung cancer, assessing changes in outcomes between a preimplementation period (April 2013 to Dec. 2013) and a postimplementation period (July 2014 to March 2015).
Analyses were based on 1,857 patients in the states that implemented the tool and 1,610 patients in the states that did not.
The percentage of patients receiving CSFs in the 6 months after starting chemotherapy fell in states that implemented the decision support tool (from 48.4% to 35.6%) but remained stable in states that did not (43.2% and 44.4%), Dr. Agiro reported. The adjusted difference in differences was –8.7% (P less than .001).
Meanwhile, the percentage of patients admitted for febrile neutropenia or experiencing this outcome while hospitalized increased in both states implementing the tool (from 2.8% to 4.3%) and those not implementing it (from 3.1% to 5.1%). Although the magnitude of increase was smaller in the former (+1.5% vs. +2.0%), the difference was not significant. Findings were essentially the same among the subset of patients aged 65 years and older.
“It’s important to study both intended and unintended consequences of such interventions,” Dr. Agiro noted. “Our study goes beyond financial considerations by looking at unintended outcomes: in this case, focusing on the incidence of febrile neutropenia, an outcome that is of prime interest to patients and oncologists and payers alike.”
The study may have missed some cases of febrile neutropenia, he acknowledged. “Also, there are other important outcomes of concern. For example, were there any delays in chemotherapy administration or immune recovery that could have been triggered by the implementation of the decision support program?”
The impact, both intended and unintended, on practices warrants evaluation as well, he further noted. “An important question could be, ‘Does it take less time to use this decision support tool compared to the time taken with normal care processes?’ ”
Dr. Agiro disclosed that he is employed by, has stock or other ownership interests in, and receives research funding from Anthem.
ORLANDO – A decision support tool safely reduces use of colony-stimulating factors (CSFs) in patients undergoing chemotherapy for lung cancer, suggests a retrospective claims-based cohort study of nearly 3,500 patients across the country.
The rate of CSF use fell among patients treated in the nine states that implemented the tool – a library of chemotherapy regimens and their expected FN risk that uses preauthorization and an algorithm to promote risk-appropriate, guideline-adherent use – but it remained unchanged in the 39 states and the District of Columbia, where usual practice continued, investigators reported at a symposium on quality care sponsored by the American Society of Clinical Oncology and simultaneously published (J Oncol Pract. 2017 March 4. doi: 10.1200/JOP.2017.020867). The adjusted difference was nearly 9%.
“Decision support programs like the one highlighted here could be one way, definitely not the only way, of achieving guideline-adherent CSF use and reducing practice variation across the country,” commented coinvestigator Abiy Agiro, PhD, associate director of payer and provider research at HealthCore, a subsidiary of Anthem, in Wilmington, Delaware.
“Such efforts could also have unintended consequences, so it’s important to study relevant patient outcomes,” he added. “In this case, although it appears that the incidence of febrile neutropenia rising does not seem to relate with the program, the study does not establish the safety of CSF use reduction in lung cancer patients receiving chemotherapy. So, we should take the results with that caveat.”
Parsing the findings
Although the United States makes up just 4% of the world’s population, it uses nearly 80% of CSFs sold by a leading manufacturer, according to invited discussant Thomas J. Smith, MD, a professor of oncology and palliative medicine at Johns Hopkins University in Baltimore.
“When we rewrote the ASCO [American Society of Clinical Oncology] guidelines on CSF use in 2015, there were some specific indications: dose-intense chemo for adjuvant breast cancer and uroepithelial cancer and ... when the risk of febrile neutropenia is about 20% and dose reduction is not an appropriate strategy. We were quick to point out that most regimens have a risk of febrile neutropenia much less than that,” he noted.
Dr. Agiro and his colleagues’ findings are valid, real, and reproducible, Dr. Smith maintained. However, it is unclear to what extent the observed levels of CSF use represented overuse.
“In lung cancer, there are very few regimens that have a febrile neutropenia rate close to 20%,” he elaborated. “What we don’t know is how much of this [use] was actually justified. I would suspect it is 10% or 15%, rather than 40%.”
CSF use, as guided by the new tool, “might not support increased dose density [of chemotherapy], but I would challenge anybody in the audience to show me data in normal solid tumor patients that [show that] dose density maintained by CSFs makes a difference in overall survival,” he said.
Questions yet to be addressed include the difficulty and cost of using the decision support tool and the possible negative impact on practices’ finances, according to Dr. Smith.
“When ESAs [erythropoiesis-stimulating agents] came off being used so much, some of my friends’ practices took a 15% to 20% drop in their revenue, and this is an important source of revenue for a lot of practices,” he explained. “So, I hope that when we take this revenue away, that we are cognizant of that and realize that it’s just another stress on practices, many of which are under significant stress already.”
Study details
An estimated 26% of uses of CSFs in patients with lung cancer are not in accordance with the ASCO practice guidelines, according to Dr. Agiro. “Such variations from recommendations are sometimes the reason why different stakeholders take actions” to improve care, such as ASCO’s Quality Oncology Practice Initiative (QOPI) and the American Board of Internal Medicine’s Choosing Wisely initiative (J Oncol Pract. 2015;11:338-43).
The decision support tool evaluated in the study uses preauthorization before delivery of care and, therefore, differs from point-of-care interventions, he noted.
“The tool allows access to a library of chemotherapy regimens and their associated, expected febrile neutropenia risk based on the myelotoxicity of the planned regimens as indicated in published trials. The tool is accessible online and provides real-time recommendations that are tailored based on disease- and patient-specific factors for either the use of CSF or not,” he elaborated.
According to the tool’s algorithm, use is recommended for patients who are given a regimen with a high risk of febrile neutropenia (greater than 20%) and is not recommended for those given a low-risk regimen (less than 10%). It is tailored according to the presence of additional risk factors for the intermediate-risk group.
Oncologists use the tool only for patients starting a new chemotherapy and only in the first cycle, when the risk of febrile neutropenia is highest, according to Dr. Agiro. “Once the approval is given in the first cycle, it remains in effect for the next 6 months, so they don’t have to use it again and again in additional cycles,” he explained.
The decision support tool was implemented in nine states starting in July 2014. In the study, which was funded by Anthem, the investigators analyzed administrative claims data from commercially insured adult patients starting chemotherapy for lung cancer, assessing changes in outcomes between a preimplementation period (April 2013 to Dec. 2013) and a postimplementation period (July 2014 to March 2015).
Analyses were based on 1,857 patients in the states that implemented the tool and 1,610 patients in the states that did not.
The percentage of patients receiving CSFs in the 6 months after starting chemotherapy fell in states that implemented the decision support tool (from 48.4% to 35.6%) but remained stable in states that did not (43.2% and 44.4%), Dr. Agiro reported. The adjusted difference in differences was –8.7% (P less than .001).
Meanwhile, the percentage of patients admitted for febrile neutropenia or experiencing this outcome while hospitalized increased in both states implementing the tool (from 2.8% to 4.3%) and those not implementing it (from 3.1% to 5.1%). Although the magnitude of increase was smaller in the former (+1.5% vs. +2.0%), the difference was not significant. Findings were essentially the same among the subset of patients aged 65 years and older.
“It’s important to study both intended and unintended consequences of such interventions,” Dr. Agiro noted. “Our study goes beyond financial considerations by looking at unintended outcomes: in this case, focusing on the incidence of febrile neutropenia, an outcome that is of prime interest to patients and oncologists and payers alike.”
The study may have missed some cases of febrile neutropenia, he acknowledged. “Also, there are other important outcomes of concern. For example, were there any delays in chemotherapy administration or immune recovery that could have been triggered by the implementation of the decision support program?”
The impact, both intended and unintended, on practices warrants evaluation as well, he further noted. “An important question could be, ‘Does it take less time to use this decision support tool compared to the time taken with normal care processes?’ ”
Dr. Agiro disclosed that he is employed by, has stock or other ownership interests in, and receives research funding from Anthem.
AT THE QUALITY CARE SYMPOSIUM
Key clinical point:
Major finding: The percentage of patients receiving CSFs fell in states that used the tool, versus those that did not (difference in differences, –8.7%), but changes in admissions for febrile neutropenia did not differ significantly.
Data source: A retrospective cohort study of 3,467 patients from 48 states starting chemotherapy for lung cancer.
Disclosures: Dr. Agiro disclosed that he is employed by, has stock or other ownership interests in, and receives research funding from Anthem. The study was funded by Anthem.
Senate confirms Verma as CMS administrator
The Senate confirmed Seema Verma as administrator of the Centers for Medicare & Medicaid Services on March 13 by a largely party line vote of 55-43.
Ms. Verma’s confirmation comes as Republicans begin their efforts to repeal and replace the Affordable Care Act. During the March 13 debate, Senate Finance Committee Chairman Orrin Hatch (R-Utah) reiterated his support for Ms. Verma, saying she will be a needed leader during the transition from the ACA.
Senate Finance Committee Ranking Member Ron Wyden (D-Ore.) continued to criticize Ms. Verma during the debate, stressing that she has presented no clear vision of her plans as the next CMS administrator.
“Ms. Verma gave the Finance Committee and the public virtually nothing to go by in terms of how she’d approach this job,” Sen. Wyden said during floor debate. “If confirmed, she’d be one of the top officials to implement Trumpcare, a bill that would raid Medicaid, slash Medicare, and kick millions of Americans off their health care... So I’m unable to support this nomination.”
A relative unknown before her nomination, Ms. Verma spent 20 years designing policy projects involving Medicaid, including HIP, the nation’s first consumer-directed Medicaid program under Indiana Governor Mitch Daniels and then-Gov. Mike Pence’s HIP 2.0 waiver proposal.
Prior to consulting, Ms. Verma served as vice president of planning for the Health and Hospital Corporation of Marion County (Ind.) and as a director with the Association of State and Territorial Health Officials in Washington.
During her confirmation hearing, senators raised concerns about Ms. Verma’s past consulting agreements with states while working for Hewlett Packard, a company that had financial interests in the health programs she designed. But Ms. Verma argued that she never negotiated on behalf of Hewlett Packard, and that the work she conducted for the states did not overlap with work she completed for Hewlett Packard. Her company sought an ethics opinion to ensure the arrangement was not problematic, she said.
The Association for Community Affiliated Plans (ACAP) pledged to work with Ms. Verma as the Trump administration works toward changing how Medicaid is financed and administered. ACAP represents nonprofit safety net health plans in 28 states that serve patients enrolled in Medicaid, Medicare, the Children’s Health Insurance Program, marketplaces, and other publicly supported health programs.
“Flexibility is one of the great things about the Medicaid program today – this very flexibility is what has allowed the changes Ms. Verma helped to effect in Indiana,” ACAP CEO Margaret A. Murray said in a statement. “We look forward to working with Ms. Verma on pathways to refine the program while maintaining its guarantee of coverage for all eligible individuals, improving transparency and actuarial soundness in rate-setting, and assuring access to needed care and services.”
[email protected]
On Twitter @legal_med
The Senate confirmed Seema Verma as administrator of the Centers for Medicare & Medicaid Services on March 13 by a largely party line vote of 55-43.
Ms. Verma’s confirmation comes as Republicans begin their efforts to repeal and replace the Affordable Care Act. During the March 13 debate, Senate Finance Committee Chairman Orrin Hatch (R-Utah) reiterated his support for Ms. Verma, saying she will be a needed leader during the transition from the ACA.
Senate Finance Committee Ranking Member Ron Wyden (D-Ore.) continued to criticize Ms. Verma during the debate, stressing that she has presented no clear vision of her plans as the next CMS administrator.
“Ms. Verma gave the Finance Committee and the public virtually nothing to go by in terms of how she’d approach this job,” Sen. Wyden said during floor debate. “If confirmed, she’d be one of the top officials to implement Trumpcare, a bill that would raid Medicaid, slash Medicare, and kick millions of Americans off their health care... So I’m unable to support this nomination.”
A relative unknown before her nomination, Ms. Verma spent 20 years designing policy projects involving Medicaid, including HIP, the nation’s first consumer-directed Medicaid program under Indiana Governor Mitch Daniels and then-Gov. Mike Pence’s HIP 2.0 waiver proposal.
Prior to consulting, Ms. Verma served as vice president of planning for the Health and Hospital Corporation of Marion County (Ind.) and as a director with the Association of State and Territorial Health Officials in Washington.
During her confirmation hearing, senators raised concerns about Ms. Verma’s past consulting agreements with states while working for Hewlett Packard, a company that had financial interests in the health programs she designed. But Ms. Verma argued that she never negotiated on behalf of Hewlett Packard, and that the work she conducted for the states did not overlap with work she completed for Hewlett Packard. Her company sought an ethics opinion to ensure the arrangement was not problematic, she said.
The Association for Community Affiliated Plans (ACAP) pledged to work with Ms. Verma as the Trump administration works toward changing how Medicaid is financed and administered. ACAP represents nonprofit safety net health plans in 28 states that serve patients enrolled in Medicaid, Medicare, the Children’s Health Insurance Program, marketplaces, and other publicly supported health programs.
“Flexibility is one of the great things about the Medicaid program today – this very flexibility is what has allowed the changes Ms. Verma helped to effect in Indiana,” ACAP CEO Margaret A. Murray said in a statement. “We look forward to working with Ms. Verma on pathways to refine the program while maintaining its guarantee of coverage for all eligible individuals, improving transparency and actuarial soundness in rate-setting, and assuring access to needed care and services.”
[email protected]
On Twitter @legal_med
The Senate confirmed Seema Verma as administrator of the Centers for Medicare & Medicaid Services on March 13 by a largely party line vote of 55-43.
Ms. Verma’s confirmation comes as Republicans begin their efforts to repeal and replace the Affordable Care Act. During the March 13 debate, Senate Finance Committee Chairman Orrin Hatch (R-Utah) reiterated his support for Ms. Verma, saying she will be a needed leader during the transition from the ACA.
Senate Finance Committee Ranking Member Ron Wyden (D-Ore.) continued to criticize Ms. Verma during the debate, stressing that she has presented no clear vision of her plans as the next CMS administrator.
“Ms. Verma gave the Finance Committee and the public virtually nothing to go by in terms of how she’d approach this job,” Sen. Wyden said during floor debate. “If confirmed, she’d be one of the top officials to implement Trumpcare, a bill that would raid Medicaid, slash Medicare, and kick millions of Americans off their health care... So I’m unable to support this nomination.”
A relative unknown before her nomination, Ms. Verma spent 20 years designing policy projects involving Medicaid, including HIP, the nation’s first consumer-directed Medicaid program under Indiana Governor Mitch Daniels and then-Gov. Mike Pence’s HIP 2.0 waiver proposal.
Prior to consulting, Ms. Verma served as vice president of planning for the Health and Hospital Corporation of Marion County (Ind.) and as a director with the Association of State and Territorial Health Officials in Washington.
During her confirmation hearing, senators raised concerns about Ms. Verma’s past consulting agreements with states while working for Hewlett Packard, a company that had financial interests in the health programs she designed. But Ms. Verma argued that she never negotiated on behalf of Hewlett Packard, and that the work she conducted for the states did not overlap with work she completed for Hewlett Packard. Her company sought an ethics opinion to ensure the arrangement was not problematic, she said.
The Association for Community Affiliated Plans (ACAP) pledged to work with Ms. Verma as the Trump administration works toward changing how Medicaid is financed and administered. ACAP represents nonprofit safety net health plans in 28 states that serve patients enrolled in Medicaid, Medicare, the Children’s Health Insurance Program, marketplaces, and other publicly supported health programs.
“Flexibility is one of the great things about the Medicaid program today – this very flexibility is what has allowed the changes Ms. Verma helped to effect in Indiana,” ACAP CEO Margaret A. Murray said in a statement. “We look forward to working with Ms. Verma on pathways to refine the program while maintaining its guarantee of coverage for all eligible individuals, improving transparency and actuarial soundness in rate-setting, and assuring access to needed care and services.”
[email protected]
On Twitter @legal_med
More pushback from docs after CBO scores GOP health care plan
Physician groups continue to push back against a Republican plan to repeal and replace the Affordable Care Act following a Congressional Budget Office analysis that showed up to 24 million patients would not be insured under the plan.
According to the CBO analysis, 14 million more patients would become uninsured in the first year of the American Health Care Act than under current law, with most dropping coverage because of the repeal of the ACA’s individual health insurance mandate.
By 2020, an additional 7 million patients would lose coverage largely because of the bill’s rollback of expansion in favor of a per capita allotment to states to cover their Medicaid population.
“In 2026, an estimated 52 million would be uninsured, compared with 28 million who would lack insurance that year under current law,” according to the CBO analysis.
American Medical Association President Andrew Gurman, MD, called the uptick in uninsured “unacceptable.”
“While the Affordable Care Act was an imperfect law, it was a significant improvement on the status quo at the time, and the AMA believes we need continued progress to expand coverage for the uninsured. Unfortunately, the current proposal – as the CBO analysis shows – would result in the most vulnerable population losing their coverage,” Dr. Gurman said in a statement.
Likewise, the American Osteopathic Association voiced its objections to the GOP proposal.
“The AOA urges Congress to halt any further progression of the American Health Care Act as written and take a more comprehensive approach that addresses such systemic issues while providing stability for the insurance marketplace and the millions of Americans who rely on it for coverage,” President Boyd Buser, DO, said in a statement.
According to the CBO analysis, the individual health insurance market “would probably be stable in most areas under either current law or the legislation.” However, there could be large premium increases for some patients, based on age group.
Tom Price, MD, secretary of the Department of Health & Human Services, criticized the CBO projections.
“The CBO report’s coverage numbers defy logic,” he said in a statement. “They project that zeroing out the individual mandate – allowing Americans to choose whether to have insurance – will result in 14 million Americans opting out of coverage in 1 year. For there to be the reductions in coverage they project in just the first year, they assume 5 million Americans on Medicaid will drop off of health insurance for which they pay very little, and another 9 million will stop participating in the individual and employer markets. These types of assumptions do not translate to the real world, and they do not accurately estimate the effects of this bill.”
Rep. Kevin Brady (R-Texas), chairman of the House Ways & Means Committee, also disputed the increase in the uninsured population.
“The American Health Care Act is a dramatic departure from Obamacare, which forced Americans to buy expensive, one-size-fits-all health insurance,” Chairman Brady said in a statement. “Our legislation gives individuals and families the freedom to access health care options that are tailored to the needs, not Washington’s.”
Rep. Brady and Dr. Price also pointed out that the AHCA is just the first step of a three-step process, which will include a review of ACA regulations as well as passage of further legislation aimed at providing high quality care at lower costs. However, those cannot be scored by CBO as those details have yet to be released, the GOP leaders pointed out.
The CBO analysis predicts that premiums for those buying insurance in the individual marketplace would increase of 15%-20% from 2018 to 2019, but starting in 2020, average premiums are expected to decrease from states using federal government funds to help offset costs from high users of health care and more younger people coming into the health insurance market.
“By 2026, average premiums for single policyholders in the nongroup market under the legislation would be roughly 10% lower than under current law,” according to the analysis, although since the law allows for higher premiums for older individuals, the congressional budget watchdog sees the provisions of the AHCA as “substantially reducing premiums for young adults and substantially raising premiums for older people.”
The CBO estimates that enacting this legislation would reduce federal deficits by $337 billion over the 2017-2026 period, mainly from reductions in Medicaid spending and the elimination of the current premium subsidies, though the deficit reduction is somewhat offset by the refundable premium tax credits that replace the ACA’s subsidies.
Physician groups continue to push back against a Republican plan to repeal and replace the Affordable Care Act following a Congressional Budget Office analysis that showed up to 24 million patients would not be insured under the plan.
According to the CBO analysis, 14 million more patients would become uninsured in the first year of the American Health Care Act than under current law, with most dropping coverage because of the repeal of the ACA’s individual health insurance mandate.
By 2020, an additional 7 million patients would lose coverage largely because of the bill’s rollback of expansion in favor of a per capita allotment to states to cover their Medicaid population.
“In 2026, an estimated 52 million would be uninsured, compared with 28 million who would lack insurance that year under current law,” according to the CBO analysis.
American Medical Association President Andrew Gurman, MD, called the uptick in uninsured “unacceptable.”
“While the Affordable Care Act was an imperfect law, it was a significant improvement on the status quo at the time, and the AMA believes we need continued progress to expand coverage for the uninsured. Unfortunately, the current proposal – as the CBO analysis shows – would result in the most vulnerable population losing their coverage,” Dr. Gurman said in a statement.
Likewise, the American Osteopathic Association voiced its objections to the GOP proposal.
“The AOA urges Congress to halt any further progression of the American Health Care Act as written and take a more comprehensive approach that addresses such systemic issues while providing stability for the insurance marketplace and the millions of Americans who rely on it for coverage,” President Boyd Buser, DO, said in a statement.
According to the CBO analysis, the individual health insurance market “would probably be stable in most areas under either current law or the legislation.” However, there could be large premium increases for some patients, based on age group.
Tom Price, MD, secretary of the Department of Health & Human Services, criticized the CBO projections.
“The CBO report’s coverage numbers defy logic,” he said in a statement. “They project that zeroing out the individual mandate – allowing Americans to choose whether to have insurance – will result in 14 million Americans opting out of coverage in 1 year. For there to be the reductions in coverage they project in just the first year, they assume 5 million Americans on Medicaid will drop off of health insurance for which they pay very little, and another 9 million will stop participating in the individual and employer markets. These types of assumptions do not translate to the real world, and they do not accurately estimate the effects of this bill.”
Rep. Kevin Brady (R-Texas), chairman of the House Ways & Means Committee, also disputed the increase in the uninsured population.
“The American Health Care Act is a dramatic departure from Obamacare, which forced Americans to buy expensive, one-size-fits-all health insurance,” Chairman Brady said in a statement. “Our legislation gives individuals and families the freedom to access health care options that are tailored to the needs, not Washington’s.”
Rep. Brady and Dr. Price also pointed out that the AHCA is just the first step of a three-step process, which will include a review of ACA regulations as well as passage of further legislation aimed at providing high quality care at lower costs. However, those cannot be scored by CBO as those details have yet to be released, the GOP leaders pointed out.
The CBO analysis predicts that premiums for those buying insurance in the individual marketplace would increase of 15%-20% from 2018 to 2019, but starting in 2020, average premiums are expected to decrease from states using federal government funds to help offset costs from high users of health care and more younger people coming into the health insurance market.
“By 2026, average premiums for single policyholders in the nongroup market under the legislation would be roughly 10% lower than under current law,” according to the analysis, although since the law allows for higher premiums for older individuals, the congressional budget watchdog sees the provisions of the AHCA as “substantially reducing premiums for young adults and substantially raising premiums for older people.”
The CBO estimates that enacting this legislation would reduce federal deficits by $337 billion over the 2017-2026 period, mainly from reductions in Medicaid spending and the elimination of the current premium subsidies, though the deficit reduction is somewhat offset by the refundable premium tax credits that replace the ACA’s subsidies.
Physician groups continue to push back against a Republican plan to repeal and replace the Affordable Care Act following a Congressional Budget Office analysis that showed up to 24 million patients would not be insured under the plan.
According to the CBO analysis, 14 million more patients would become uninsured in the first year of the American Health Care Act than under current law, with most dropping coverage because of the repeal of the ACA’s individual health insurance mandate.
By 2020, an additional 7 million patients would lose coverage largely because of the bill’s rollback of expansion in favor of a per capita allotment to states to cover their Medicaid population.
“In 2026, an estimated 52 million would be uninsured, compared with 28 million who would lack insurance that year under current law,” according to the CBO analysis.
American Medical Association President Andrew Gurman, MD, called the uptick in uninsured “unacceptable.”
“While the Affordable Care Act was an imperfect law, it was a significant improvement on the status quo at the time, and the AMA believes we need continued progress to expand coverage for the uninsured. Unfortunately, the current proposal – as the CBO analysis shows – would result in the most vulnerable population losing their coverage,” Dr. Gurman said in a statement.
Likewise, the American Osteopathic Association voiced its objections to the GOP proposal.
“The AOA urges Congress to halt any further progression of the American Health Care Act as written and take a more comprehensive approach that addresses such systemic issues while providing stability for the insurance marketplace and the millions of Americans who rely on it for coverage,” President Boyd Buser, DO, said in a statement.
According to the CBO analysis, the individual health insurance market “would probably be stable in most areas under either current law or the legislation.” However, there could be large premium increases for some patients, based on age group.
Tom Price, MD, secretary of the Department of Health & Human Services, criticized the CBO projections.
“The CBO report’s coverage numbers defy logic,” he said in a statement. “They project that zeroing out the individual mandate – allowing Americans to choose whether to have insurance – will result in 14 million Americans opting out of coverage in 1 year. For there to be the reductions in coverage they project in just the first year, they assume 5 million Americans on Medicaid will drop off of health insurance for which they pay very little, and another 9 million will stop participating in the individual and employer markets. These types of assumptions do not translate to the real world, and they do not accurately estimate the effects of this bill.”
Rep. Kevin Brady (R-Texas), chairman of the House Ways & Means Committee, also disputed the increase in the uninsured population.
“The American Health Care Act is a dramatic departure from Obamacare, which forced Americans to buy expensive, one-size-fits-all health insurance,” Chairman Brady said in a statement. “Our legislation gives individuals and families the freedom to access health care options that are tailored to the needs, not Washington’s.”
Rep. Brady and Dr. Price also pointed out that the AHCA is just the first step of a three-step process, which will include a review of ACA regulations as well as passage of further legislation aimed at providing high quality care at lower costs. However, those cannot be scored by CBO as those details have yet to be released, the GOP leaders pointed out.
The CBO analysis predicts that premiums for those buying insurance in the individual marketplace would increase of 15%-20% from 2018 to 2019, but starting in 2020, average premiums are expected to decrease from states using federal government funds to help offset costs from high users of health care and more younger people coming into the health insurance market.
“By 2026, average premiums for single policyholders in the nongroup market under the legislation would be roughly 10% lower than under current law,” according to the analysis, although since the law allows for higher premiums for older individuals, the congressional budget watchdog sees the provisions of the AHCA as “substantially reducing premiums for young adults and substantially raising premiums for older people.”
The CBO estimates that enacting this legislation would reduce federal deficits by $337 billion over the 2017-2026 period, mainly from reductions in Medicaid spending and the elimination of the current premium subsidies, though the deficit reduction is somewhat offset by the refundable premium tax credits that replace the ACA’s subsidies.
Hospitals rarely offer cessation therapy to smokers with MI
according to a poster presented at the annual meeting of the American College of Cardiology.
“Inpatient smoking cessation therapy coupled with outpatient follow-up can significantly improve long-term smoking cessation rates, but little is known about how often smoking cessation therapies are used among hospitalized patients,” wrote Dr Quinn R. Pack and coauthors from the Baystate Medical Center in Springfield, and Massachusetts General Hospital.
The nicotine patch was the most common therapy; 20.4% of patients received it with an average daily dose of 19.8 mg, while 2.2% of patients received bupropion, 0.4% received varenicline, 0.3% received nicotine gum, 0.2% received nicotine inhaler therapy, and just 0.04% received nicotine lozenge therapy. Nearly one in ten patients received professional counseling (9.6%).
Smoking cessation was more commonly given to patients with lung disease, depression, alcohol use or who were younger but the researchers noted significant variations in the use of smoking cessation therapies across hospitals. While the median treatment rate was 26.2%, it ranged from as low as 11.4% to a high of 51.1%.
Given the variation across hospitals, the authors said they plan to identify the strategies and practices that the high-performing hospitals use to provide smoking cessation therapies.
“Smoking cessation is the single most effective behavior change that patients can make after a hospitalization for coronary heart disease to prevent recurrent events,” the authors wrote. “Given that hospitalization is usually a teachable moment with high patient motivation to quit smoking, there appears to be a large opportunity for improvement in the care of smokers hospitalized with CHD.”
The authors noted that their data were limited to smoking cessation options provided during hospitalization; the researchers said they did not assess whether those therapies helped MI patients quit smoking, or whether there were patients who declined the therapies offered.
No conflict of interest disclosures were provided with the data.
according to a poster presented at the annual meeting of the American College of Cardiology.
“Inpatient smoking cessation therapy coupled with outpatient follow-up can significantly improve long-term smoking cessation rates, but little is known about how often smoking cessation therapies are used among hospitalized patients,” wrote Dr Quinn R. Pack and coauthors from the Baystate Medical Center in Springfield, and Massachusetts General Hospital.
The nicotine patch was the most common therapy; 20.4% of patients received it with an average daily dose of 19.8 mg, while 2.2% of patients received bupropion, 0.4% received varenicline, 0.3% received nicotine gum, 0.2% received nicotine inhaler therapy, and just 0.04% received nicotine lozenge therapy. Nearly one in ten patients received professional counseling (9.6%).
Smoking cessation was more commonly given to patients with lung disease, depression, alcohol use or who were younger but the researchers noted significant variations in the use of smoking cessation therapies across hospitals. While the median treatment rate was 26.2%, it ranged from as low as 11.4% to a high of 51.1%.
Given the variation across hospitals, the authors said they plan to identify the strategies and practices that the high-performing hospitals use to provide smoking cessation therapies.
“Smoking cessation is the single most effective behavior change that patients can make after a hospitalization for coronary heart disease to prevent recurrent events,” the authors wrote. “Given that hospitalization is usually a teachable moment with high patient motivation to quit smoking, there appears to be a large opportunity for improvement in the care of smokers hospitalized with CHD.”
The authors noted that their data were limited to smoking cessation options provided during hospitalization; the researchers said they did not assess whether those therapies helped MI patients quit smoking, or whether there were patients who declined the therapies offered.
No conflict of interest disclosures were provided with the data.
according to a poster presented at the annual meeting of the American College of Cardiology.
“Inpatient smoking cessation therapy coupled with outpatient follow-up can significantly improve long-term smoking cessation rates, but little is known about how often smoking cessation therapies are used among hospitalized patients,” wrote Dr Quinn R. Pack and coauthors from the Baystate Medical Center in Springfield, and Massachusetts General Hospital.
The nicotine patch was the most common therapy; 20.4% of patients received it with an average daily dose of 19.8 mg, while 2.2% of patients received bupropion, 0.4% received varenicline, 0.3% received nicotine gum, 0.2% received nicotine inhaler therapy, and just 0.04% received nicotine lozenge therapy. Nearly one in ten patients received professional counseling (9.6%).
Smoking cessation was more commonly given to patients with lung disease, depression, alcohol use or who were younger but the researchers noted significant variations in the use of smoking cessation therapies across hospitals. While the median treatment rate was 26.2%, it ranged from as low as 11.4% to a high of 51.1%.
Given the variation across hospitals, the authors said they plan to identify the strategies and practices that the high-performing hospitals use to provide smoking cessation therapies.
“Smoking cessation is the single most effective behavior change that patients can make after a hospitalization for coronary heart disease to prevent recurrent events,” the authors wrote. “Given that hospitalization is usually a teachable moment with high patient motivation to quit smoking, there appears to be a large opportunity for improvement in the care of smokers hospitalized with CHD.”
The authors noted that their data were limited to smoking cessation options provided during hospitalization; the researchers said they did not assess whether those therapies helped MI patients quit smoking, or whether there were patients who declined the therapies offered.
No conflict of interest disclosures were provided with the data.
FROM ACC 17
Key clinical point: Less than one-third of smokers hospitalized for myocardial infarction receive any kind of smoking cessation therapy during their stay in hospital.
Major finding: Only 29.9% of current smokers hospitalized for MI were given at least one kind of smoking cessation therapy while in hospital.
Data source: Cohort study of billing and ICD-9 data from 36,675 current smokers hospitalized for myocardial infarction.
Disclosures: No disclosures were available.
Lung cancer pathways reduce cost of care without compromising outcomes
ORLANDO – Implementation of clinical pathways aimed at improving appropriate, evidence-based care for patients with metastatic non–small-cell lung cancer (NSCLC) reduces costs without negatively affecting survival, the Dana-Farber Cancer Institute’s experience suggests.
“At Dana-Farber ... we have looked toward pathways as a potential tool to help manage complexity and resource utilization,” senior author David M. Jackman, MD, explained at a symposium on quality care sponsored by the American Society of Clinical Oncology. “We see pathways as a patient-centered platform that provides real-time decision-making support across the continuum of cancer care. We think that these should be based on preemptive decision making, reflect current standards of care, incorporate feedback from which we can learn from our practice patterns, and support clinical research.”
After the customized Dana-Farber Lung Pathways were implemented in 2014, the cost of outpatient care per patient in the first year after diagnosis fell by about $17,000, or 25%, primarily driven by reduced use of antineoplastic agents, according to data reported at the symposium and simultaneously published (J Oncol Pract. 2017 Mar 4. doi: 10.1200/JOP.2017.021741). Meanwhile, median survival remained at about 11 months, even trending slightly upward.
“Frankly, I’d like to think that we were delivering reasonable and expert care prior to 2014, so I did not anticipate that we were going to see a major change in terms of improvement in survival. But it is important for us to make sure that as we implemented Pathways, there was certainly no decrease in such care,”said Dr. Jackman, medical director of Clinical Pathways at Dana-Farber and an assistant professor of medicine, Harvard Medical School, Boston.
He and his colleagues plan to expand Pathways to cover the full spectrum of cancer care at their center, encompassing medical, radiation, and surgical oncology, he said.
“We also think that pathways can have a major impact on things like symptom management and survivorship care,” he added. “And as we work to embed all of our trials within our Pathways system, and as we push to have our trials in our satellites and in our network affiliates, we hope that this combination of activity can help move us from being not just a good care network, but also a research network.”
The pathways will still have to address some of the thornier issues related to the value of care, Dr. Jackman acknowledged “It’s incredibly easy for us to look at two equivalent therapies in terms of toxicity and efficacy and pick the cheaper one. The harder conversations are to come, that is, what if something is x dollars more expensive and only improves things by a small number of months, is it really worth it?
“Finally, we hope that pathways can be an area for innovation, not used solely to manage costs and to make decisions based on yesteryear, but also to help us move forward and to be the watering hole where everybody comes, as we build out our system that is looking granularly at genomics in order to help match patients with trial opportunities, and for researchers, to help them find specific patients for their trials,” he said. “Pathways can potentially be the nexus where everyone comes and where doctors are informed in real time about opportunities for their patients.”
More evidence of benefit
The Dana-Farber study adds to others showing that the benefits of pathways are real and reproducible, according to invited discussant Thomas J. Smith, MD, professor of oncology and palliative medicine at Johns Hopkins Medicine in Baltimore.
“More importantly, I think, for patients, who are getting hit with these bills and might have a 20% copay, it’s going to reduce their copays and for all the right reasons,” Dr. Smith concluded.
Pathways development
In developing the pathways, Dana-Farber began with lung cancer in part because the center sees a high volume of patients with the disease. In addition, decision making for this malignancy is complex, and there was considerable variation in oncologists’ practices.
“Our platform exists as an independent web-based system that currently lives outside of our EMR. Physicians can access this in real time, in the clinic room with the patient if they so choose,” Dr. Jackman explained. “From our EMR, we are flagged every time a provider orders a new start [of therapy], whether it’s IV chemo, oral chemo, or hormonal therapy. From our vendor, we receive granular treatment decision information made within the pathways system – information about the provider and site, information about the patients, their disease, and the line of therapy, as well as other important factors that drive decision making. Finally, from our clinical trials system interface, we can confirm trial enrollment data.”
Oncologists are free to leave the suggested pathway if their clinical judgment favors an alternate course, according to Dr. Jackman.
“We always want our physicians to feel comfortable treating the patients in front of them however they see best fit. If that means an off-pathway therapy, we want them to have the freedom to do that,” he said. “But we think one of the major tools of the pathways is to help capture the reasons why. So if they think it’s warranted and appropriate, go ahead, go off pathway, but tell us why you are doing it so we can learn from it.”
Using Pathways has not proved burdensome, according to Dr. Jackman. Navigating through the system requires about a minute or two, and use is required only when a patient is starting a new therapy, which typically occurs less than once per half-day clinic session.
Study details
In the study, he and colleagues compared costs of care in the first year after diagnosis of stage IV NSCLC between 160 patients treated at Dana-Farber in 2012 (before Pathways implementation) and 210 patients treated there in 2014 (after Pathways implementation).
“It should be noted that because we are a free-standing outpatient cancer center, all of the costs that we were able to gather are intramural and therefore related only to outpatient activities,” he pointed out.
The total annual costs of care per patient, adjusted for potential confounders (age, sex, race, distance to the institute, clinical trial enrollment, and EGFR and ALK status) fell by $17,085 after implementation of Pathways, from $69,122 to $52,037 (P = .01), he reported.
The largest source of cost savings by far, accounting for 73% of the total, was reduced use of antineoplastic agents (chemotherapy, biologics, and other anticancer agents). Cost for this component fell from $44,237 per patient to $31,846 (P less than .01).
“The majority of this savings came through a reduction in the use of what we considered unwarranted use of combination chemotherapy,” Dr. Jackman said. “In the first-line setting, we specifically went after the regimen of carboplatin, pemetrexed, and bevacizumab; based on our interpretation of the PointBreak study, we felt that that regimen did not bring additional efficacy but did essentially double drug costs. In going after that, we reduced not only use of that but also the subsequent use of pemetrexed plus bevacizumab maintenance. In the second-line setting, with the implementation of Pathways, we saw a decrease in the use of inappropriate platinum-based doublet therapy in those patients who had previously progressed on a platinum-based doublet.”
Median overall survival did not decrease and in fact increased slightly, from 10.7 months before Pathways implementation to 11.2 months afterward (P = .08). Corresponding 1-year rates of survival were 52% and 64%.
“We stand on the shoulders of those who came before us, who have also shown savings associated with implementation of pathways,” concluded Dr. Jackman. “But we hope that we add our voice and our data to this argument that pathways, I think, are a reasonable tool as we try to manage complexity and resource utilization. In addition, we do so without impinging upon clinical outcomes.”
The study was limited by its inclusion of only outpatient costs at Dana-Farber, he acknowledged. “You and we would be very interested in being able to know whether our Pathways implementation affected ED [emergency department] visits or hospitalizations. To that end, we are working with some of our regional payers to try to transparently share data around outcomes, costs, and usage, so that we can learn more in this regard.”
Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.
ORLANDO – Implementation of clinical pathways aimed at improving appropriate, evidence-based care for patients with metastatic non–small-cell lung cancer (NSCLC) reduces costs without negatively affecting survival, the Dana-Farber Cancer Institute’s experience suggests.
“At Dana-Farber ... we have looked toward pathways as a potential tool to help manage complexity and resource utilization,” senior author David M. Jackman, MD, explained at a symposium on quality care sponsored by the American Society of Clinical Oncology. “We see pathways as a patient-centered platform that provides real-time decision-making support across the continuum of cancer care. We think that these should be based on preemptive decision making, reflect current standards of care, incorporate feedback from which we can learn from our practice patterns, and support clinical research.”
After the customized Dana-Farber Lung Pathways were implemented in 2014, the cost of outpatient care per patient in the first year after diagnosis fell by about $17,000, or 25%, primarily driven by reduced use of antineoplastic agents, according to data reported at the symposium and simultaneously published (J Oncol Pract. 2017 Mar 4. doi: 10.1200/JOP.2017.021741). Meanwhile, median survival remained at about 11 months, even trending slightly upward.
“Frankly, I’d like to think that we were delivering reasonable and expert care prior to 2014, so I did not anticipate that we were going to see a major change in terms of improvement in survival. But it is important for us to make sure that as we implemented Pathways, there was certainly no decrease in such care,”said Dr. Jackman, medical director of Clinical Pathways at Dana-Farber and an assistant professor of medicine, Harvard Medical School, Boston.
He and his colleagues plan to expand Pathways to cover the full spectrum of cancer care at their center, encompassing medical, radiation, and surgical oncology, he said.
“We also think that pathways can have a major impact on things like symptom management and survivorship care,” he added. “And as we work to embed all of our trials within our Pathways system, and as we push to have our trials in our satellites and in our network affiliates, we hope that this combination of activity can help move us from being not just a good care network, but also a research network.”
The pathways will still have to address some of the thornier issues related to the value of care, Dr. Jackman acknowledged “It’s incredibly easy for us to look at two equivalent therapies in terms of toxicity and efficacy and pick the cheaper one. The harder conversations are to come, that is, what if something is x dollars more expensive and only improves things by a small number of months, is it really worth it?
“Finally, we hope that pathways can be an area for innovation, not used solely to manage costs and to make decisions based on yesteryear, but also to help us move forward and to be the watering hole where everybody comes, as we build out our system that is looking granularly at genomics in order to help match patients with trial opportunities, and for researchers, to help them find specific patients for their trials,” he said. “Pathways can potentially be the nexus where everyone comes and where doctors are informed in real time about opportunities for their patients.”
More evidence of benefit
The Dana-Farber study adds to others showing that the benefits of pathways are real and reproducible, according to invited discussant Thomas J. Smith, MD, professor of oncology and palliative medicine at Johns Hopkins Medicine in Baltimore.
“More importantly, I think, for patients, who are getting hit with these bills and might have a 20% copay, it’s going to reduce their copays and for all the right reasons,” Dr. Smith concluded.
Pathways development
In developing the pathways, Dana-Farber began with lung cancer in part because the center sees a high volume of patients with the disease. In addition, decision making for this malignancy is complex, and there was considerable variation in oncologists’ practices.
“Our platform exists as an independent web-based system that currently lives outside of our EMR. Physicians can access this in real time, in the clinic room with the patient if they so choose,” Dr. Jackman explained. “From our EMR, we are flagged every time a provider orders a new start [of therapy], whether it’s IV chemo, oral chemo, or hormonal therapy. From our vendor, we receive granular treatment decision information made within the pathways system – information about the provider and site, information about the patients, their disease, and the line of therapy, as well as other important factors that drive decision making. Finally, from our clinical trials system interface, we can confirm trial enrollment data.”
Oncologists are free to leave the suggested pathway if their clinical judgment favors an alternate course, according to Dr. Jackman.
“We always want our physicians to feel comfortable treating the patients in front of them however they see best fit. If that means an off-pathway therapy, we want them to have the freedom to do that,” he said. “But we think one of the major tools of the pathways is to help capture the reasons why. So if they think it’s warranted and appropriate, go ahead, go off pathway, but tell us why you are doing it so we can learn from it.”
Using Pathways has not proved burdensome, according to Dr. Jackman. Navigating through the system requires about a minute or two, and use is required only when a patient is starting a new therapy, which typically occurs less than once per half-day clinic session.
Study details
In the study, he and colleagues compared costs of care in the first year after diagnosis of stage IV NSCLC between 160 patients treated at Dana-Farber in 2012 (before Pathways implementation) and 210 patients treated there in 2014 (after Pathways implementation).
“It should be noted that because we are a free-standing outpatient cancer center, all of the costs that we were able to gather are intramural and therefore related only to outpatient activities,” he pointed out.
The total annual costs of care per patient, adjusted for potential confounders (age, sex, race, distance to the institute, clinical trial enrollment, and EGFR and ALK status) fell by $17,085 after implementation of Pathways, from $69,122 to $52,037 (P = .01), he reported.
The largest source of cost savings by far, accounting for 73% of the total, was reduced use of antineoplastic agents (chemotherapy, biologics, and other anticancer agents). Cost for this component fell from $44,237 per patient to $31,846 (P less than .01).
“The majority of this savings came through a reduction in the use of what we considered unwarranted use of combination chemotherapy,” Dr. Jackman said. “In the first-line setting, we specifically went after the regimen of carboplatin, pemetrexed, and bevacizumab; based on our interpretation of the PointBreak study, we felt that that regimen did not bring additional efficacy but did essentially double drug costs. In going after that, we reduced not only use of that but also the subsequent use of pemetrexed plus bevacizumab maintenance. In the second-line setting, with the implementation of Pathways, we saw a decrease in the use of inappropriate platinum-based doublet therapy in those patients who had previously progressed on a platinum-based doublet.”
Median overall survival did not decrease and in fact increased slightly, from 10.7 months before Pathways implementation to 11.2 months afterward (P = .08). Corresponding 1-year rates of survival were 52% and 64%.
“We stand on the shoulders of those who came before us, who have also shown savings associated with implementation of pathways,” concluded Dr. Jackman. “But we hope that we add our voice and our data to this argument that pathways, I think, are a reasonable tool as we try to manage complexity and resource utilization. In addition, we do so without impinging upon clinical outcomes.”
The study was limited by its inclusion of only outpatient costs at Dana-Farber, he acknowledged. “You and we would be very interested in being able to know whether our Pathways implementation affected ED [emergency department] visits or hospitalizations. To that end, we are working with some of our regional payers to try to transparently share data around outcomes, costs, and usage, so that we can learn more in this regard.”
Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.
ORLANDO – Implementation of clinical pathways aimed at improving appropriate, evidence-based care for patients with metastatic non–small-cell lung cancer (NSCLC) reduces costs without negatively affecting survival, the Dana-Farber Cancer Institute’s experience suggests.
“At Dana-Farber ... we have looked toward pathways as a potential tool to help manage complexity and resource utilization,” senior author David M. Jackman, MD, explained at a symposium on quality care sponsored by the American Society of Clinical Oncology. “We see pathways as a patient-centered platform that provides real-time decision-making support across the continuum of cancer care. We think that these should be based on preemptive decision making, reflect current standards of care, incorporate feedback from which we can learn from our practice patterns, and support clinical research.”
After the customized Dana-Farber Lung Pathways were implemented in 2014, the cost of outpatient care per patient in the first year after diagnosis fell by about $17,000, or 25%, primarily driven by reduced use of antineoplastic agents, according to data reported at the symposium and simultaneously published (J Oncol Pract. 2017 Mar 4. doi: 10.1200/JOP.2017.021741). Meanwhile, median survival remained at about 11 months, even trending slightly upward.
“Frankly, I’d like to think that we were delivering reasonable and expert care prior to 2014, so I did not anticipate that we were going to see a major change in terms of improvement in survival. But it is important for us to make sure that as we implemented Pathways, there was certainly no decrease in such care,”said Dr. Jackman, medical director of Clinical Pathways at Dana-Farber and an assistant professor of medicine, Harvard Medical School, Boston.
He and his colleagues plan to expand Pathways to cover the full spectrum of cancer care at their center, encompassing medical, radiation, and surgical oncology, he said.
“We also think that pathways can have a major impact on things like symptom management and survivorship care,” he added. “And as we work to embed all of our trials within our Pathways system, and as we push to have our trials in our satellites and in our network affiliates, we hope that this combination of activity can help move us from being not just a good care network, but also a research network.”
The pathways will still have to address some of the thornier issues related to the value of care, Dr. Jackman acknowledged “It’s incredibly easy for us to look at two equivalent therapies in terms of toxicity and efficacy and pick the cheaper one. The harder conversations are to come, that is, what if something is x dollars more expensive and only improves things by a small number of months, is it really worth it?
“Finally, we hope that pathways can be an area for innovation, not used solely to manage costs and to make decisions based on yesteryear, but also to help us move forward and to be the watering hole where everybody comes, as we build out our system that is looking granularly at genomics in order to help match patients with trial opportunities, and for researchers, to help them find specific patients for their trials,” he said. “Pathways can potentially be the nexus where everyone comes and where doctors are informed in real time about opportunities for their patients.”
More evidence of benefit
The Dana-Farber study adds to others showing that the benefits of pathways are real and reproducible, according to invited discussant Thomas J. Smith, MD, professor of oncology and palliative medicine at Johns Hopkins Medicine in Baltimore.
“More importantly, I think, for patients, who are getting hit with these bills and might have a 20% copay, it’s going to reduce their copays and for all the right reasons,” Dr. Smith concluded.
Pathways development
In developing the pathways, Dana-Farber began with lung cancer in part because the center sees a high volume of patients with the disease. In addition, decision making for this malignancy is complex, and there was considerable variation in oncologists’ practices.
“Our platform exists as an independent web-based system that currently lives outside of our EMR. Physicians can access this in real time, in the clinic room with the patient if they so choose,” Dr. Jackman explained. “From our EMR, we are flagged every time a provider orders a new start [of therapy], whether it’s IV chemo, oral chemo, or hormonal therapy. From our vendor, we receive granular treatment decision information made within the pathways system – information about the provider and site, information about the patients, their disease, and the line of therapy, as well as other important factors that drive decision making. Finally, from our clinical trials system interface, we can confirm trial enrollment data.”
Oncologists are free to leave the suggested pathway if their clinical judgment favors an alternate course, according to Dr. Jackman.
“We always want our physicians to feel comfortable treating the patients in front of them however they see best fit. If that means an off-pathway therapy, we want them to have the freedom to do that,” he said. “But we think one of the major tools of the pathways is to help capture the reasons why. So if they think it’s warranted and appropriate, go ahead, go off pathway, but tell us why you are doing it so we can learn from it.”
Using Pathways has not proved burdensome, according to Dr. Jackman. Navigating through the system requires about a minute or two, and use is required only when a patient is starting a new therapy, which typically occurs less than once per half-day clinic session.
Study details
In the study, he and colleagues compared costs of care in the first year after diagnosis of stage IV NSCLC between 160 patients treated at Dana-Farber in 2012 (before Pathways implementation) and 210 patients treated there in 2014 (after Pathways implementation).
“It should be noted that because we are a free-standing outpatient cancer center, all of the costs that we were able to gather are intramural and therefore related only to outpatient activities,” he pointed out.
The total annual costs of care per patient, adjusted for potential confounders (age, sex, race, distance to the institute, clinical trial enrollment, and EGFR and ALK status) fell by $17,085 after implementation of Pathways, from $69,122 to $52,037 (P = .01), he reported.
The largest source of cost savings by far, accounting for 73% of the total, was reduced use of antineoplastic agents (chemotherapy, biologics, and other anticancer agents). Cost for this component fell from $44,237 per patient to $31,846 (P less than .01).
“The majority of this savings came through a reduction in the use of what we considered unwarranted use of combination chemotherapy,” Dr. Jackman said. “In the first-line setting, we specifically went after the regimen of carboplatin, pemetrexed, and bevacizumab; based on our interpretation of the PointBreak study, we felt that that regimen did not bring additional efficacy but did essentially double drug costs. In going after that, we reduced not only use of that but also the subsequent use of pemetrexed plus bevacizumab maintenance. In the second-line setting, with the implementation of Pathways, we saw a decrease in the use of inappropriate platinum-based doublet therapy in those patients who had previously progressed on a platinum-based doublet.”
Median overall survival did not decrease and in fact increased slightly, from 10.7 months before Pathways implementation to 11.2 months afterward (P = .08). Corresponding 1-year rates of survival were 52% and 64%.
“We stand on the shoulders of those who came before us, who have also shown savings associated with implementation of pathways,” concluded Dr. Jackman. “But we hope that we add our voice and our data to this argument that pathways, I think, are a reasonable tool as we try to manage complexity and resource utilization. In addition, we do so without impinging upon clinical outcomes.”
The study was limited by its inclusion of only outpatient costs at Dana-Farber, he acknowledged. “You and we would be very interested in being able to know whether our Pathways implementation affected ED [emergency department] visits or hospitalizations. To that end, we are working with some of our regional payers to try to transparently share data around outcomes, costs, and usage, so that we can learn more in this regard.”
Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.
AT THE QUALITY CARE SYMPOSIUM
Key clinical point:
Major finding: The annual cost of outpatient care per patient fell by $17,085, mainly because of reduced use of antineoplastic agents, whereas median survival remained at about 11 months.
Data source: A cohort study among patients with newly diagnosed metastatic NSCLC, comparing 160 treated before and 210 treated after pathways implementation.
Disclosures: Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.
GOP health plan clears first hurdle as opposition lines up
The Republican plan to replace the Affordable Care Act cleared the first legislative hurdle when two house committees passed language that would repeal revenue provisions of the Affordable Care Act and lay the foundation for replacing the health care reform law.
The House Ways and Means Committee–approved legislation would eliminate the individual mandate in favor of allowing insurance companies to penalize individuals by up to 30% of premiums for lapses in coverage and would repeal taxes on high-cost health plans (Cadillac tax), over-the-counter and prescription medications, health savings accounts, tanning, investment, and on health insurers.
The language passed with a party-line vote March 9 with 23 Republicans voting for and 16 Democrats voting against after nearly 18 hours of debate and amendments.
The House Energy and Commerce Committee, after 27 hours of debate that started March 8, also passed its language along party lines with 31 Republicans voting for and 23 Democrats voting against. Their bill would end Medicaid expansion and reset the program’s funding to a per capita allotment based on population indicators, along with block grants, to provide states more flexibility to better manage its population.
A key concern raised in both committee debates was the brief window between the public unveiling of the legislation and the committees’ efforts, especially the lack of financial impact analysis or “score” from the Congressional Budget Office. Democrats efforts in both committees to hold action for a CBO score were voted down on across party lines.
In both committees, Democrats introduced a wide range of amendments, including guarantees there would be no impact from the reduction of Medicaid expansion and on funding to support coverage for mental health, women, children, seniors, and veterans, all of which were voted down. Ways and Means members also offered an amendment to require President Trump to release his income tax filings.
Rep. Frank Pallone (D-N.J.), lead Democrat in the Energy and Commerce Committee, voiced his colleagues’ objections to the bill and the process.
The bill “would rip health care away from millions of Americans, raise costs for working families and seniors, and lead to the rationing of care for 76 million Americans who receive Medicaid. … This has not been a transparent process. We did not go through regular order. The bill was posted less than 2 days before markup. No hearings were held, and we don’t have a CBO score,” Rep. Pallone said during committee debate.
A CBO score of the budget and coverage impacts of the Republican health care proposal could come as early as March 13.
The pace of action in the House even drew criticism from some in the GOP. Sen. Tom Cotton (R-Ark.) took to Twitter with a stern warning to the House.
“House health-care bill can’t pass w/o major changes,” Sen. Cotton tweeted. “To my friends in House: pause, start over. Get it right, don’t get it fast.”
He followed up with two more tweets: “GOP shouldn’t act like Dems did in O’care. No excuse to release bill Mon night, start voting Wed. With no budget estimate!” He added: “What matters in long run is better, more affordable health care for Americans, NOT house leaders’ arbitrary legislative calendar.”
Four Republican senators – Rob Portman (Ohio), Shelley Moore Capito (W.Va.), Cory Gardner (Colo.), and Lisa Murkowski (Alaska) – also expressed concerns regarding how Medicaid will be changed under the repeal/replace effort and vowed not to support any plan “that does not include stability for Medicaid expansion populations or flexibility for states.”
Republicans hold a slim 52-seat majority in the Senate and need only 50 votes to pass any legislation that uses the budget reconciliation process. If those four senators voted with Democrats, who are expected to vote as a party against the repeal effort, the current House Republican legislation would not clear the Senate.
Physicians’ groups also have voiced their opposition. American Medical Association President Andrew Gurman, MD, said in a statement that it is “not legislation we can support. The replacement bill, as written, would reverse the coverage gains of the ACA, causing many Americans to lose the health coverage they have come to depend on.” He added that the proposed changes to Medicaid “would limit states’ ability to respond to changes in service demands and threaten coverage for people with low incomes.”
Likewise, a joint statement issued by the American Academy of Family Physicians, American Academy of Pediatricians, American College of Physicians, American Congress of Obstetricians and Gynecologists and the American Osteopathic Association, expressed concern that the proposal “will likely result in less access to coverage and higher costs for millions of patients.”
The Republican plan to replace the Affordable Care Act cleared the first legislative hurdle when two house committees passed language that would repeal revenue provisions of the Affordable Care Act and lay the foundation for replacing the health care reform law.
The House Ways and Means Committee–approved legislation would eliminate the individual mandate in favor of allowing insurance companies to penalize individuals by up to 30% of premiums for lapses in coverage and would repeal taxes on high-cost health plans (Cadillac tax), over-the-counter and prescription medications, health savings accounts, tanning, investment, and on health insurers.
The language passed with a party-line vote March 9 with 23 Republicans voting for and 16 Democrats voting against after nearly 18 hours of debate and amendments.
The House Energy and Commerce Committee, after 27 hours of debate that started March 8, also passed its language along party lines with 31 Republicans voting for and 23 Democrats voting against. Their bill would end Medicaid expansion and reset the program’s funding to a per capita allotment based on population indicators, along with block grants, to provide states more flexibility to better manage its population.
A key concern raised in both committee debates was the brief window between the public unveiling of the legislation and the committees’ efforts, especially the lack of financial impact analysis or “score” from the Congressional Budget Office. Democrats efforts in both committees to hold action for a CBO score were voted down on across party lines.
In both committees, Democrats introduced a wide range of amendments, including guarantees there would be no impact from the reduction of Medicaid expansion and on funding to support coverage for mental health, women, children, seniors, and veterans, all of which were voted down. Ways and Means members also offered an amendment to require President Trump to release his income tax filings.
Rep. Frank Pallone (D-N.J.), lead Democrat in the Energy and Commerce Committee, voiced his colleagues’ objections to the bill and the process.
The bill “would rip health care away from millions of Americans, raise costs for working families and seniors, and lead to the rationing of care for 76 million Americans who receive Medicaid. … This has not been a transparent process. We did not go through regular order. The bill was posted less than 2 days before markup. No hearings were held, and we don’t have a CBO score,” Rep. Pallone said during committee debate.
A CBO score of the budget and coverage impacts of the Republican health care proposal could come as early as March 13.
The pace of action in the House even drew criticism from some in the GOP. Sen. Tom Cotton (R-Ark.) took to Twitter with a stern warning to the House.
“House health-care bill can’t pass w/o major changes,” Sen. Cotton tweeted. “To my friends in House: pause, start over. Get it right, don’t get it fast.”
He followed up with two more tweets: “GOP shouldn’t act like Dems did in O’care. No excuse to release bill Mon night, start voting Wed. With no budget estimate!” He added: “What matters in long run is better, more affordable health care for Americans, NOT house leaders’ arbitrary legislative calendar.”
Four Republican senators – Rob Portman (Ohio), Shelley Moore Capito (W.Va.), Cory Gardner (Colo.), and Lisa Murkowski (Alaska) – also expressed concerns regarding how Medicaid will be changed under the repeal/replace effort and vowed not to support any plan “that does not include stability for Medicaid expansion populations or flexibility for states.”
Republicans hold a slim 52-seat majority in the Senate and need only 50 votes to pass any legislation that uses the budget reconciliation process. If those four senators voted with Democrats, who are expected to vote as a party against the repeal effort, the current House Republican legislation would not clear the Senate.
Physicians’ groups also have voiced their opposition. American Medical Association President Andrew Gurman, MD, said in a statement that it is “not legislation we can support. The replacement bill, as written, would reverse the coverage gains of the ACA, causing many Americans to lose the health coverage they have come to depend on.” He added that the proposed changes to Medicaid “would limit states’ ability to respond to changes in service demands and threaten coverage for people with low incomes.”
Likewise, a joint statement issued by the American Academy of Family Physicians, American Academy of Pediatricians, American College of Physicians, American Congress of Obstetricians and Gynecologists and the American Osteopathic Association, expressed concern that the proposal “will likely result in less access to coverage and higher costs for millions of patients.”
The Republican plan to replace the Affordable Care Act cleared the first legislative hurdle when two house committees passed language that would repeal revenue provisions of the Affordable Care Act and lay the foundation for replacing the health care reform law.
The House Ways and Means Committee–approved legislation would eliminate the individual mandate in favor of allowing insurance companies to penalize individuals by up to 30% of premiums for lapses in coverage and would repeal taxes on high-cost health plans (Cadillac tax), over-the-counter and prescription medications, health savings accounts, tanning, investment, and on health insurers.
The language passed with a party-line vote March 9 with 23 Republicans voting for and 16 Democrats voting against after nearly 18 hours of debate and amendments.
The House Energy and Commerce Committee, after 27 hours of debate that started March 8, also passed its language along party lines with 31 Republicans voting for and 23 Democrats voting against. Their bill would end Medicaid expansion and reset the program’s funding to a per capita allotment based on population indicators, along with block grants, to provide states more flexibility to better manage its population.
A key concern raised in both committee debates was the brief window between the public unveiling of the legislation and the committees’ efforts, especially the lack of financial impact analysis or “score” from the Congressional Budget Office. Democrats efforts in both committees to hold action for a CBO score were voted down on across party lines.
In both committees, Democrats introduced a wide range of amendments, including guarantees there would be no impact from the reduction of Medicaid expansion and on funding to support coverage for mental health, women, children, seniors, and veterans, all of which were voted down. Ways and Means members also offered an amendment to require President Trump to release his income tax filings.
Rep. Frank Pallone (D-N.J.), lead Democrat in the Energy and Commerce Committee, voiced his colleagues’ objections to the bill and the process.
The bill “would rip health care away from millions of Americans, raise costs for working families and seniors, and lead to the rationing of care for 76 million Americans who receive Medicaid. … This has not been a transparent process. We did not go through regular order. The bill was posted less than 2 days before markup. No hearings were held, and we don’t have a CBO score,” Rep. Pallone said during committee debate.
A CBO score of the budget and coverage impacts of the Republican health care proposal could come as early as March 13.
The pace of action in the House even drew criticism from some in the GOP. Sen. Tom Cotton (R-Ark.) took to Twitter with a stern warning to the House.
“House health-care bill can’t pass w/o major changes,” Sen. Cotton tweeted. “To my friends in House: pause, start over. Get it right, don’t get it fast.”
He followed up with two more tweets: “GOP shouldn’t act like Dems did in O’care. No excuse to release bill Mon night, start voting Wed. With no budget estimate!” He added: “What matters in long run is better, more affordable health care for Americans, NOT house leaders’ arbitrary legislative calendar.”
Four Republican senators – Rob Portman (Ohio), Shelley Moore Capito (W.Va.), Cory Gardner (Colo.), and Lisa Murkowski (Alaska) – also expressed concerns regarding how Medicaid will be changed under the repeal/replace effort and vowed not to support any plan “that does not include stability for Medicaid expansion populations or flexibility for states.”
Republicans hold a slim 52-seat majority in the Senate and need only 50 votes to pass any legislation that uses the budget reconciliation process. If those four senators voted with Democrats, who are expected to vote as a party against the repeal effort, the current House Republican legislation would not clear the Senate.
Physicians’ groups also have voiced their opposition. American Medical Association President Andrew Gurman, MD, said in a statement that it is “not legislation we can support. The replacement bill, as written, would reverse the coverage gains of the ACA, causing many Americans to lose the health coverage they have come to depend on.” He added that the proposed changes to Medicaid “would limit states’ ability to respond to changes in service demands and threaten coverage for people with low incomes.”
Likewise, a joint statement issued by the American Academy of Family Physicians, American Academy of Pediatricians, American College of Physicians, American Congress of Obstetricians and Gynecologists and the American Osteopathic Association, expressed concern that the proposal “will likely result in less access to coverage and higher costs for millions of patients.”
FDA approves first dedicated bifurcation device to treat coronary bifurcation lesions
Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.
In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.
Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.
Read more on Tryton Side Branch Stent on Tryton’s website.
Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.
In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.
Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.
Read more on Tryton Side Branch Stent on Tryton’s website.
Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.
In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.
Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.
Read more on Tryton Side Branch Stent on Tryton’s website.
Malpractice bill would impose $250,000 damages cap
New legislation approved by the House Judiciary Committee could mean legal relief for health providers in the form of capped damages and a tighter time frame for lawsuits.
The House Judiciary Committee passed the Protecting Access to Care Act of 2017 (H.R. 1215) on Feb. 28 by a vote of 18-17. The bill, modeled after California’s Medical Injury Compensation Reform Act (MICRA), would limit noneconomic damages in medical malpractice cases to $250,000, restrict contingency fees charged by attorneys, and enforce a 3-year statute of limitations for liability lawsuits from the date of alleged injury. The bill also includes a “fair share” rule in which defendants are liable only for the damages in direct proportion to their percentage of responsibility.
The bill is the first significant medical professional liability reform legislation to be approved by the committee since 2011, said Brian K. Atchinson, president and CEO of PIAA, a national trade association for medical liability insurers.
“Unlike previous federal bills, the bill is focused solely on health care professionals and entities, includes detailed flexibility for states for all its reforms, and is linked with the expenditure of federal dollars to address states’ rights concerns,” Mr. Atchinson said in a statement. “H.R. 1215 will help ensure fair and timely compensation to injured patients, improve access to patient care, and promote affordable and accessible medical liability insurance coverage.”
The proposed statute would apply to any patient who receives medical care provided via a federal program, such as Medicare or Medicaid, or via a subsidy or tax benefit, such as coverage purchased under the Affordable Care Act or a future* replacement. Medical care paid by employer health plans would fall under the legislation’s umbrella since insurance premiums receive federal tax exemptions. The bill would not preempt state medical malpractice laws that impose damage caps, whether higher or lower than $250,000, nor would the legislation affect the availability of economic damages, according to bill language.
As part of the H.R. 1215, courts could limit how much attorneys receive from a patient’s ultimate award. Specifically, courts would have the power to restrict payments from a plaintiff’s damage recovery to an attorney who claims a financial stake in the outcome by virtue of a contingent fee.
“The Protecting Access to Care Act will help keep the rising costs of health care from being passed along to the American people,” Rep. Goodlatte said in a statement. “The Congressional Budget Office estimates that the reforms contained in the bill would lower health care costs by tens of billions of dollars.”
Public Citizen, a consumer rights group, criticized the legislation as misleading to consumers and harmful to patients.
“Proposals to shield providers from liability are nothing but a giveaway to industry,” Lisa Gilbert, director of Public Citizen’s Congress Watch, said in a statement. “Members supporting this bill would further harm those who are suffering from doctors’ mistakes and abandon the GOP’s supposedly unwavering commitment to state’s rights.”
“There are so many moving parts to this bill, I think the likelihood of its being passed as is is low,” said Dr. Segal, founder of Medical Justice, a company that works to deter frivolous medical malpractice lawsuits. “The biggest challenge will be whether the Republicans have to get eight Democratic senators to join the bill. To make it more palatable, something will need to give. Such provisions on tort reform are likely to be the first items offered for sacrifice.”
[email protected]
On Twitter @legal_med
New legislation approved by the House Judiciary Committee could mean legal relief for health providers in the form of capped damages and a tighter time frame for lawsuits.
The House Judiciary Committee passed the Protecting Access to Care Act of 2017 (H.R. 1215) on Feb. 28 by a vote of 18-17. The bill, modeled after California’s Medical Injury Compensation Reform Act (MICRA), would limit noneconomic damages in medical malpractice cases to $250,000, restrict contingency fees charged by attorneys, and enforce a 3-year statute of limitations for liability lawsuits from the date of alleged injury. The bill also includes a “fair share” rule in which defendants are liable only for the damages in direct proportion to their percentage of responsibility.
The bill is the first significant medical professional liability reform legislation to be approved by the committee since 2011, said Brian K. Atchinson, president and CEO of PIAA, a national trade association for medical liability insurers.
“Unlike previous federal bills, the bill is focused solely on health care professionals and entities, includes detailed flexibility for states for all its reforms, and is linked with the expenditure of federal dollars to address states’ rights concerns,” Mr. Atchinson said in a statement. “H.R. 1215 will help ensure fair and timely compensation to injured patients, improve access to patient care, and promote affordable and accessible medical liability insurance coverage.”
The proposed statute would apply to any patient who receives medical care provided via a federal program, such as Medicare or Medicaid, or via a subsidy or tax benefit, such as coverage purchased under the Affordable Care Act or a future* replacement. Medical care paid by employer health plans would fall under the legislation’s umbrella since insurance premiums receive federal tax exemptions. The bill would not preempt state medical malpractice laws that impose damage caps, whether higher or lower than $250,000, nor would the legislation affect the availability of economic damages, according to bill language.
As part of the H.R. 1215, courts could limit how much attorneys receive from a patient’s ultimate award. Specifically, courts would have the power to restrict payments from a plaintiff’s damage recovery to an attorney who claims a financial stake in the outcome by virtue of a contingent fee.
“The Protecting Access to Care Act will help keep the rising costs of health care from being passed along to the American people,” Rep. Goodlatte said in a statement. “The Congressional Budget Office estimates that the reforms contained in the bill would lower health care costs by tens of billions of dollars.”
Public Citizen, a consumer rights group, criticized the legislation as misleading to consumers and harmful to patients.
“Proposals to shield providers from liability are nothing but a giveaway to industry,” Lisa Gilbert, director of Public Citizen’s Congress Watch, said in a statement. “Members supporting this bill would further harm those who are suffering from doctors’ mistakes and abandon the GOP’s supposedly unwavering commitment to state’s rights.”
“There are so many moving parts to this bill, I think the likelihood of its being passed as is is low,” said Dr. Segal, founder of Medical Justice, a company that works to deter frivolous medical malpractice lawsuits. “The biggest challenge will be whether the Republicans have to get eight Democratic senators to join the bill. To make it more palatable, something will need to give. Such provisions on tort reform are likely to be the first items offered for sacrifice.”
[email protected]
On Twitter @legal_med
New legislation approved by the House Judiciary Committee could mean legal relief for health providers in the form of capped damages and a tighter time frame for lawsuits.
The House Judiciary Committee passed the Protecting Access to Care Act of 2017 (H.R. 1215) on Feb. 28 by a vote of 18-17. The bill, modeled after California’s Medical Injury Compensation Reform Act (MICRA), would limit noneconomic damages in medical malpractice cases to $250,000, restrict contingency fees charged by attorneys, and enforce a 3-year statute of limitations for liability lawsuits from the date of alleged injury. The bill also includes a “fair share” rule in which defendants are liable only for the damages in direct proportion to their percentage of responsibility.
The bill is the first significant medical professional liability reform legislation to be approved by the committee since 2011, said Brian K. Atchinson, president and CEO of PIAA, a national trade association for medical liability insurers.
“Unlike previous federal bills, the bill is focused solely on health care professionals and entities, includes detailed flexibility for states for all its reforms, and is linked with the expenditure of federal dollars to address states’ rights concerns,” Mr. Atchinson said in a statement. “H.R. 1215 will help ensure fair and timely compensation to injured patients, improve access to patient care, and promote affordable and accessible medical liability insurance coverage.”
The proposed statute would apply to any patient who receives medical care provided via a federal program, such as Medicare or Medicaid, or via a subsidy or tax benefit, such as coverage purchased under the Affordable Care Act or a future* replacement. Medical care paid by employer health plans would fall under the legislation’s umbrella since insurance premiums receive federal tax exemptions. The bill would not preempt state medical malpractice laws that impose damage caps, whether higher or lower than $250,000, nor would the legislation affect the availability of economic damages, according to bill language.
As part of the H.R. 1215, courts could limit how much attorneys receive from a patient’s ultimate award. Specifically, courts would have the power to restrict payments from a plaintiff’s damage recovery to an attorney who claims a financial stake in the outcome by virtue of a contingent fee.
“The Protecting Access to Care Act will help keep the rising costs of health care from being passed along to the American people,” Rep. Goodlatte said in a statement. “The Congressional Budget Office estimates that the reforms contained in the bill would lower health care costs by tens of billions of dollars.”
Public Citizen, a consumer rights group, criticized the legislation as misleading to consumers and harmful to patients.
“Proposals to shield providers from liability are nothing but a giveaway to industry,” Lisa Gilbert, director of Public Citizen’s Congress Watch, said in a statement. “Members supporting this bill would further harm those who are suffering from doctors’ mistakes and abandon the GOP’s supposedly unwavering commitment to state’s rights.”
“There are so many moving parts to this bill, I think the likelihood of its being passed as is is low,” said Dr. Segal, founder of Medical Justice, a company that works to deter frivolous medical malpractice lawsuits. “The biggest challenge will be whether the Republicans have to get eight Democratic senators to join the bill. To make it more palatable, something will need to give. Such provisions on tort reform are likely to be the first items offered for sacrifice.”
[email protected]
On Twitter @legal_med
TAVR can be performed safely within 30 days of PCI
WASHINGTON – The risk of adverse events from a transcatheter aortic valve replacement (TAVR) does not appear to be significantly increased in those who have undergone a recent percutaneous intervention (PCI), according to a matched retrospective analysis.
“PCI prior to TAVR in patients with severe aortic stenosis and significant coronary artery disease appears to be feasible and safe,” reported Ashwat S. Dhillon, MD, a cardiology fellow at the University of Southern California, Los Angeles, at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The conclusion that PCI can be performed safely prior to TAVR was drawn from a series of 286 patients treated with TAVR over a nearly 5-year period. Within this group, 29 patients underwent PCI for CAD within 30 days prior to TAVR. They were matched in a 1:1 fashion based on age, sex, history of prior myocardial infarction, and left ventricular ejection fraction to patients undergoing PCI without subsequent TAVR.
The primary endpoint of the analysis was a composite of major in-hospital adverse cardiovascular events (MACE) that included MI and stroke. In addition, the two groups were compared for mortality and readmission rates 30 days after TAVR.
Most of the patients (69%) were male, and the mean age was 77 years. About 20% had a prior MI, roughly 30% had a prior coronary artery bypass graft procedure, and approximately 30% had a prior PCI. There were numerical differences in the rates of hypertension, chronic kidney disease, and diabetes when the two groups were compared, but none were statistically significant.
The procedural details of the PCI were also similar, according to Dr. Dhillon. Although there was a significantly greater proportion of patients treated for lesions in the left circumflex artery in the group that did not undergo TAVR (31.03% vs. 3.45%; P = .02), there were no significant differences in procedures performed in other arteries. There were also no significant differences in the average number of stents and the average total stent length for those who underwent TAVR relative to those who did not.
The rate of in-hospital MI was 14% in both groups. No patient in either group had a stroke. At 30 days, mortality was 3% in each group. Although 30-day readmissions were higher in the group that underwent both PCI and TAVR than those who underwent PCI alone (10% vs. 0%), the difference did not reach significance.
Data evaluating the safety of performing PCI and TAVR procedures in close proximity is needed because “a significant proportion of patients with severe aortic stenosis have coexisting and significant CAD,” Dr. Dhillon explained. Although he suggested that a larger pool of data is needed to confirm the preliminary findings of this study, he suggested that these data are reassuring.
WASHINGTON – The risk of adverse events from a transcatheter aortic valve replacement (TAVR) does not appear to be significantly increased in those who have undergone a recent percutaneous intervention (PCI), according to a matched retrospective analysis.
“PCI prior to TAVR in patients with severe aortic stenosis and significant coronary artery disease appears to be feasible and safe,” reported Ashwat S. Dhillon, MD, a cardiology fellow at the University of Southern California, Los Angeles, at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The conclusion that PCI can be performed safely prior to TAVR was drawn from a series of 286 patients treated with TAVR over a nearly 5-year period. Within this group, 29 patients underwent PCI for CAD within 30 days prior to TAVR. They were matched in a 1:1 fashion based on age, sex, history of prior myocardial infarction, and left ventricular ejection fraction to patients undergoing PCI without subsequent TAVR.
The primary endpoint of the analysis was a composite of major in-hospital adverse cardiovascular events (MACE) that included MI and stroke. In addition, the two groups were compared for mortality and readmission rates 30 days after TAVR.
Most of the patients (69%) were male, and the mean age was 77 years. About 20% had a prior MI, roughly 30% had a prior coronary artery bypass graft procedure, and approximately 30% had a prior PCI. There were numerical differences in the rates of hypertension, chronic kidney disease, and diabetes when the two groups were compared, but none were statistically significant.
The procedural details of the PCI were also similar, according to Dr. Dhillon. Although there was a significantly greater proportion of patients treated for lesions in the left circumflex artery in the group that did not undergo TAVR (31.03% vs. 3.45%; P = .02), there were no significant differences in procedures performed in other arteries. There were also no significant differences in the average number of stents and the average total stent length for those who underwent TAVR relative to those who did not.
The rate of in-hospital MI was 14% in both groups. No patient in either group had a stroke. At 30 days, mortality was 3% in each group. Although 30-day readmissions were higher in the group that underwent both PCI and TAVR than those who underwent PCI alone (10% vs. 0%), the difference did not reach significance.
Data evaluating the safety of performing PCI and TAVR procedures in close proximity is needed because “a significant proportion of patients with severe aortic stenosis have coexisting and significant CAD,” Dr. Dhillon explained. Although he suggested that a larger pool of data is needed to confirm the preliminary findings of this study, he suggested that these data are reassuring.
WASHINGTON – The risk of adverse events from a transcatheter aortic valve replacement (TAVR) does not appear to be significantly increased in those who have undergone a recent percutaneous intervention (PCI), according to a matched retrospective analysis.
“PCI prior to TAVR in patients with severe aortic stenosis and significant coronary artery disease appears to be feasible and safe,” reported Ashwat S. Dhillon, MD, a cardiology fellow at the University of Southern California, Los Angeles, at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The conclusion that PCI can be performed safely prior to TAVR was drawn from a series of 286 patients treated with TAVR over a nearly 5-year period. Within this group, 29 patients underwent PCI for CAD within 30 days prior to TAVR. They were matched in a 1:1 fashion based on age, sex, history of prior myocardial infarction, and left ventricular ejection fraction to patients undergoing PCI without subsequent TAVR.
The primary endpoint of the analysis was a composite of major in-hospital adverse cardiovascular events (MACE) that included MI and stroke. In addition, the two groups were compared for mortality and readmission rates 30 days after TAVR.
Most of the patients (69%) were male, and the mean age was 77 years. About 20% had a prior MI, roughly 30% had a prior coronary artery bypass graft procedure, and approximately 30% had a prior PCI. There were numerical differences in the rates of hypertension, chronic kidney disease, and diabetes when the two groups were compared, but none were statistically significant.
The procedural details of the PCI were also similar, according to Dr. Dhillon. Although there was a significantly greater proportion of patients treated for lesions in the left circumflex artery in the group that did not undergo TAVR (31.03% vs. 3.45%; P = .02), there were no significant differences in procedures performed in other arteries. There were also no significant differences in the average number of stents and the average total stent length for those who underwent TAVR relative to those who did not.
The rate of in-hospital MI was 14% in both groups. No patient in either group had a stroke. At 30 days, mortality was 3% in each group. Although 30-day readmissions were higher in the group that underwent both PCI and TAVR than those who underwent PCI alone (10% vs. 0%), the difference did not reach significance.
Data evaluating the safety of performing PCI and TAVR procedures in close proximity is needed because “a significant proportion of patients with severe aortic stenosis have coexisting and significant CAD,” Dr. Dhillon explained. Although he suggested that a larger pool of data is needed to confirm the preliminary findings of this study, he suggested that these data are reassuring.
AT CRT 2017
Key clinical point: Adverse outcomes from transcatheter aortic valve replacement are not increased in patients who had a recent percutaneous intervention.
Major finding: Rates of in-hospital MI (14%), stroke (0%), and 30-day mortality (3%) were exactly the same for those with or without prior PCI.
Data source: A nonrandomized, retrospective, matched analysis.
Disclosures: Dr. Dhillon reported no financial relationships to disclose.