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TRAAP trial looks at tranexamic acid to prevent postpartum hemorrhage after vaginal delivery
DALLAS – An intravenous drug administered to women along with oxytocin after vaginal delivery did not reduce the risk of a large-volume hemorrhage, but it did significantly affect some other markers of postpartum blood loss.
The TRAAP trial failed to achieve its primary endpoint – reduction of postpartum hemorrhage of at least 500 ml, Loïc Sentilhes, MD, reported at the meeting sponsored by the Society for Maternal-Fetal Medicine. But tranexamic acid’s success in the prespecified secondary endpoints suggests there still may be a place for the drug in obstetrics, said Dr. Sentilhes of the University Hospital of Bordeaux, France.
TRAAP randomized 4,079 women in labor for a planned vaginal birth to either 1 g of tranexamic acid or placebo. The interventions were added to existing IV fluids within 2 minutes after vaginal birth, after the women had also received routine oxytocin.
The study’s primary outcome was the incidence of postpartum hemorrhage, defined as a blood loss of 500 ml or more. There were a number of prespecified secondary outcomes, including clinically significant blood loss, need for additional uterotonics, severe hemorrhage (more than 1,000 mL), estimated total blood loss, transfusion, and changes in hemoglobin and hematocrit.
The study also looked at these outcomes in prespecified subgroups: women who had an episiotomy, who had an operative delivery, and who had a history of prior postpartum hemorrhage.
Women in the study were a mean age of 30 years; about half were primiparous, and 5% were attempting a vaginal birth after cesarean section. Of the women, 4% had experienced a prior postpartum hemorrhage. Labor was induced in 20%, and about 60% needed labor augmentation.
An operative vaginal delivery was necessary for 17%. Forms of assistance included forceps (55%) and vacuum extraction (45%). About a quarter had an episiotomy, and 8% had a macrosomic neonate of more than 4,000 g.
The primary endpoint of at least 500 ml blood loss occurred in 8.1% of the active group and 9.8% of the placebo group – a nonsignificant difference (relative risk, 0.83; P = .07).
Of the secondary endpoints, only two – clinically significant bleeding and need for additional uterotonics – were significantly better in the tranexamic acid group. The drug reduced the risk of clinically significant bleeding by 26% (RR, 0.74; P = .004) and the need for additional uterotonics by 25% (RR, 0.75; P = .006).
While the primary endpoint was not realized in the overall patient group, tranexamic acid achieved barely significant risk reductions of 34% in the risk of hemorrhage among women who had an operative delivery (RR, 0.66; P = .0498) and 27% among those who had an episiotomy (RR, 0.73; P = .049).
It was no better than placebo in women with a history of postpartum hemorrhage.
Those who received the drug were twice as likely to experience nausea and vomiting after delivery as did those who received placebo. But tranexamic acid exerted no lingering prothrombotic effects at 3 months after delivery, with no signals in deep vein thrombosis, no pulmonary embolism, and no clots in the ovarian or superficial veins.
The TRAAP trial was funded by the French Ministry of Health under its clinical research hospital program. Dr. Sentilhes had no financial disclosures.
SOURCE: Sentilhes L et al. Am J Obstet Gynecol. 2018;218:S1.
DALLAS – An intravenous drug administered to women along with oxytocin after vaginal delivery did not reduce the risk of a large-volume hemorrhage, but it did significantly affect some other markers of postpartum blood loss.
The TRAAP trial failed to achieve its primary endpoint – reduction of postpartum hemorrhage of at least 500 ml, Loïc Sentilhes, MD, reported at the meeting sponsored by the Society for Maternal-Fetal Medicine. But tranexamic acid’s success in the prespecified secondary endpoints suggests there still may be a place for the drug in obstetrics, said Dr. Sentilhes of the University Hospital of Bordeaux, France.
TRAAP randomized 4,079 women in labor for a planned vaginal birth to either 1 g of tranexamic acid or placebo. The interventions were added to existing IV fluids within 2 minutes after vaginal birth, after the women had also received routine oxytocin.
The study’s primary outcome was the incidence of postpartum hemorrhage, defined as a blood loss of 500 ml or more. There were a number of prespecified secondary outcomes, including clinically significant blood loss, need for additional uterotonics, severe hemorrhage (more than 1,000 mL), estimated total blood loss, transfusion, and changes in hemoglobin and hematocrit.
The study also looked at these outcomes in prespecified subgroups: women who had an episiotomy, who had an operative delivery, and who had a history of prior postpartum hemorrhage.
Women in the study were a mean age of 30 years; about half were primiparous, and 5% were attempting a vaginal birth after cesarean section. Of the women, 4% had experienced a prior postpartum hemorrhage. Labor was induced in 20%, and about 60% needed labor augmentation.
An operative vaginal delivery was necessary for 17%. Forms of assistance included forceps (55%) and vacuum extraction (45%). About a quarter had an episiotomy, and 8% had a macrosomic neonate of more than 4,000 g.
The primary endpoint of at least 500 ml blood loss occurred in 8.1% of the active group and 9.8% of the placebo group – a nonsignificant difference (relative risk, 0.83; P = .07).
Of the secondary endpoints, only two – clinically significant bleeding and need for additional uterotonics – were significantly better in the tranexamic acid group. The drug reduced the risk of clinically significant bleeding by 26% (RR, 0.74; P = .004) and the need for additional uterotonics by 25% (RR, 0.75; P = .006).
While the primary endpoint was not realized in the overall patient group, tranexamic acid achieved barely significant risk reductions of 34% in the risk of hemorrhage among women who had an operative delivery (RR, 0.66; P = .0498) and 27% among those who had an episiotomy (RR, 0.73; P = .049).
It was no better than placebo in women with a history of postpartum hemorrhage.
Those who received the drug were twice as likely to experience nausea and vomiting after delivery as did those who received placebo. But tranexamic acid exerted no lingering prothrombotic effects at 3 months after delivery, with no signals in deep vein thrombosis, no pulmonary embolism, and no clots in the ovarian or superficial veins.
The TRAAP trial was funded by the French Ministry of Health under its clinical research hospital program. Dr. Sentilhes had no financial disclosures.
SOURCE: Sentilhes L et al. Am J Obstet Gynecol. 2018;218:S1.
DALLAS – An intravenous drug administered to women along with oxytocin after vaginal delivery did not reduce the risk of a large-volume hemorrhage, but it did significantly affect some other markers of postpartum blood loss.
The TRAAP trial failed to achieve its primary endpoint – reduction of postpartum hemorrhage of at least 500 ml, Loïc Sentilhes, MD, reported at the meeting sponsored by the Society for Maternal-Fetal Medicine. But tranexamic acid’s success in the prespecified secondary endpoints suggests there still may be a place for the drug in obstetrics, said Dr. Sentilhes of the University Hospital of Bordeaux, France.
TRAAP randomized 4,079 women in labor for a planned vaginal birth to either 1 g of tranexamic acid or placebo. The interventions were added to existing IV fluids within 2 minutes after vaginal birth, after the women had also received routine oxytocin.
The study’s primary outcome was the incidence of postpartum hemorrhage, defined as a blood loss of 500 ml or more. There were a number of prespecified secondary outcomes, including clinically significant blood loss, need for additional uterotonics, severe hemorrhage (more than 1,000 mL), estimated total blood loss, transfusion, and changes in hemoglobin and hematocrit.
The study also looked at these outcomes in prespecified subgroups: women who had an episiotomy, who had an operative delivery, and who had a history of prior postpartum hemorrhage.
Women in the study were a mean age of 30 years; about half were primiparous, and 5% were attempting a vaginal birth after cesarean section. Of the women, 4% had experienced a prior postpartum hemorrhage. Labor was induced in 20%, and about 60% needed labor augmentation.
An operative vaginal delivery was necessary for 17%. Forms of assistance included forceps (55%) and vacuum extraction (45%). About a quarter had an episiotomy, and 8% had a macrosomic neonate of more than 4,000 g.
The primary endpoint of at least 500 ml blood loss occurred in 8.1% of the active group and 9.8% of the placebo group – a nonsignificant difference (relative risk, 0.83; P = .07).
Of the secondary endpoints, only two – clinically significant bleeding and need for additional uterotonics – were significantly better in the tranexamic acid group. The drug reduced the risk of clinically significant bleeding by 26% (RR, 0.74; P = .004) and the need for additional uterotonics by 25% (RR, 0.75; P = .006).
While the primary endpoint was not realized in the overall patient group, tranexamic acid achieved barely significant risk reductions of 34% in the risk of hemorrhage among women who had an operative delivery (RR, 0.66; P = .0498) and 27% among those who had an episiotomy (RR, 0.73; P = .049).
It was no better than placebo in women with a history of postpartum hemorrhage.
Those who received the drug were twice as likely to experience nausea and vomiting after delivery as did those who received placebo. But tranexamic acid exerted no lingering prothrombotic effects at 3 months after delivery, with no signals in deep vein thrombosis, no pulmonary embolism, and no clots in the ovarian or superficial veins.
The TRAAP trial was funded by the French Ministry of Health under its clinical research hospital program. Dr. Sentilhes had no financial disclosures.
SOURCE: Sentilhes L et al. Am J Obstet Gynecol. 2018;218:S1.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: Tranexamic acid didn’t significantly reduce the risk of a postpartum hemorrhage of 500 ml or more.
Major finding: Hemorrhage occurred in 8.1% of the active group and 9.8% of the placebo group – a nonsignificant difference (relative risk, 0.83; P = .07).
Study details: The randomized, placebo-controlled study comprised 4,079 women.
Disclosures: The TRAAP trial was funded by the French Ministry of Health under its clinical research hospital program. Dr. Sentilhes had no financial disclosures.
Source: Sentilhes L et al. Am J Obstet Gynecol. 2018;218:S1.
FIRST trial analysis shows more benefit for lenalidomide
Lenalidomide with low-dose dexamethasone showed a significant overall survival benefit, compared with melphalan with prednisone and thalidomide, for patients with transplant-ineligible newly diagnosed multiple myeloma, according to the final analysis of the phase 3 FIRST trial.
The prespecified final analysis evaluated overall survival (OS) at a follow-up of 60 months or longer, according to the study, which was published in Blood. The FIRST study included 1,623 patients randomized to receive lenalidomide with low-dose dexamethasone continuously until disease progression (Rd continuous), lenalidomide plus low-dose dexamethasone for 18 cycles instead of continuously (Rd18), or melphalan plus prednisone and thalidomide (MPT). Patients with high-risk cytogenetics were distributed evenly across the three treatment arms.
The Rd continuous cohort also experienced significantly longer PFS, compared with the MPT arm (HR, 0.69, 95% CI, 0.59-0.79, P less than .00001).
“Taken together, these findings suggest that Rd affords a clinical advantage in subsequent lines of therapy and highlight the importance of using Rd continuous and not MPT as first-line treatment of transplant-ineligible patients with [newly-diagnosed multiple myeloma],” the researchers wrote.
The OS benefit was similar for patients who received Rd continuous (59.1 months) and Rd18 (62.3 months). The researchers suggested that the similar survival could be due to a combination of factors, including the impact of subsequent lines of treatment and the older age of the patient population.
However, the benefit for Rd18 was not seen in the PFS analysis. Patients in the Rd18 group had a median PFS similar to that of patients in the MPT group (21 months vs. 21.9 months), both of which were shorter than the Rd continuous group (26 months).
The 4-year PFS more than doubled among patients in the Rd continuous arm (32.6%), compared with patients in both the Rd18 group (14.3%) and the MPT group (13.6%).
Patients in the Rd continuous group also experienced a decreased risk for progression or death, compared with patients in the Rd18 group (HR, 0.70, 95% CI, 0.60-0.81).
The researchers noted that no new safety concerns were observed in the final analysis. Second primary malignancies, including hematologic and solid tumors, were found in 36% of patients in the Rd continuous group, 38% of patients in the Rd18 group, and 46% of patients in the MPT group.
Celgene Corporation sponsored the study. Dr. Facon and his coauthors reported financial ties to various pharmaceutical companies, including Celgene.
SOURCE: Facon T et al. Blood. 2018 Jan 18;131(3):301-10.
Lenalidomide with low-dose dexamethasone showed a significant overall survival benefit, compared with melphalan with prednisone and thalidomide, for patients with transplant-ineligible newly diagnosed multiple myeloma, according to the final analysis of the phase 3 FIRST trial.
The prespecified final analysis evaluated overall survival (OS) at a follow-up of 60 months or longer, according to the study, which was published in Blood. The FIRST study included 1,623 patients randomized to receive lenalidomide with low-dose dexamethasone continuously until disease progression (Rd continuous), lenalidomide plus low-dose dexamethasone for 18 cycles instead of continuously (Rd18), or melphalan plus prednisone and thalidomide (MPT). Patients with high-risk cytogenetics were distributed evenly across the three treatment arms.
The Rd continuous cohort also experienced significantly longer PFS, compared with the MPT arm (HR, 0.69, 95% CI, 0.59-0.79, P less than .00001).
“Taken together, these findings suggest that Rd affords a clinical advantage in subsequent lines of therapy and highlight the importance of using Rd continuous and not MPT as first-line treatment of transplant-ineligible patients with [newly-diagnosed multiple myeloma],” the researchers wrote.
The OS benefit was similar for patients who received Rd continuous (59.1 months) and Rd18 (62.3 months). The researchers suggested that the similar survival could be due to a combination of factors, including the impact of subsequent lines of treatment and the older age of the patient population.
However, the benefit for Rd18 was not seen in the PFS analysis. Patients in the Rd18 group had a median PFS similar to that of patients in the MPT group (21 months vs. 21.9 months), both of which were shorter than the Rd continuous group (26 months).
The 4-year PFS more than doubled among patients in the Rd continuous arm (32.6%), compared with patients in both the Rd18 group (14.3%) and the MPT group (13.6%).
Patients in the Rd continuous group also experienced a decreased risk for progression or death, compared with patients in the Rd18 group (HR, 0.70, 95% CI, 0.60-0.81).
The researchers noted that no new safety concerns were observed in the final analysis. Second primary malignancies, including hematologic and solid tumors, were found in 36% of patients in the Rd continuous group, 38% of patients in the Rd18 group, and 46% of patients in the MPT group.
Celgene Corporation sponsored the study. Dr. Facon and his coauthors reported financial ties to various pharmaceutical companies, including Celgene.
SOURCE: Facon T et al. Blood. 2018 Jan 18;131(3):301-10.
Lenalidomide with low-dose dexamethasone showed a significant overall survival benefit, compared with melphalan with prednisone and thalidomide, for patients with transplant-ineligible newly diagnosed multiple myeloma, according to the final analysis of the phase 3 FIRST trial.
The prespecified final analysis evaluated overall survival (OS) at a follow-up of 60 months or longer, according to the study, which was published in Blood. The FIRST study included 1,623 patients randomized to receive lenalidomide with low-dose dexamethasone continuously until disease progression (Rd continuous), lenalidomide plus low-dose dexamethasone for 18 cycles instead of continuously (Rd18), or melphalan plus prednisone and thalidomide (MPT). Patients with high-risk cytogenetics were distributed evenly across the three treatment arms.
The Rd continuous cohort also experienced significantly longer PFS, compared with the MPT arm (HR, 0.69, 95% CI, 0.59-0.79, P less than .00001).
“Taken together, these findings suggest that Rd affords a clinical advantage in subsequent lines of therapy and highlight the importance of using Rd continuous and not MPT as first-line treatment of transplant-ineligible patients with [newly-diagnosed multiple myeloma],” the researchers wrote.
The OS benefit was similar for patients who received Rd continuous (59.1 months) and Rd18 (62.3 months). The researchers suggested that the similar survival could be due to a combination of factors, including the impact of subsequent lines of treatment and the older age of the patient population.
However, the benefit for Rd18 was not seen in the PFS analysis. Patients in the Rd18 group had a median PFS similar to that of patients in the MPT group (21 months vs. 21.9 months), both of which were shorter than the Rd continuous group (26 months).
The 4-year PFS more than doubled among patients in the Rd continuous arm (32.6%), compared with patients in both the Rd18 group (14.3%) and the MPT group (13.6%).
Patients in the Rd continuous group also experienced a decreased risk for progression or death, compared with patients in the Rd18 group (HR, 0.70, 95% CI, 0.60-0.81).
The researchers noted that no new safety concerns were observed in the final analysis. Second primary malignancies, including hematologic and solid tumors, were found in 36% of patients in the Rd continuous group, 38% of patients in the Rd18 group, and 46% of patients in the MPT group.
Celgene Corporation sponsored the study. Dr. Facon and his coauthors reported financial ties to various pharmaceutical companies, including Celgene.
SOURCE: Facon T et al. Blood. 2018 Jan 18;131(3):301-10.
FROM BLOOD
Key clinical point:
Major finding: Continuously administered lenalidomide with dexamethasone regimen improved PFS (HR, 0.69) and OS (HR, 0.78), compared with melphalan, prednisone, and thalidomide.
Study details: Final analysis of the phase 3 FIRST trial.
Disclosures: Celgene Corporation sponsored the study. Dr. Facon and his coauthors reported financial ties to various pharmaceutical companies, including Celgene.
Source: Facon T et al. Blood. 2018 Jan 18;131(3):301-10.
OSA patients report sleeping better with dronabinol
in a new study.
A paper published in the January edition of Sleep presents data from a phase 2, blinded, randomized controlled trial of the nonselective cannabinoid 1 and cannabinoid 2 receptor agonist, dronabinol, in 73 adults with moderate or severe obstructive sleep apnea (OSA). No approved drug treatments for OSA exist, and this study provides results “from the largest and longest randomized controlled trial to date of any putative drug treatment for OSA,” the researchers wrote.
Patients were randomized to 2.5 mg dronabinol or 10 mg dronabinol daily for up to 6 weeks, or placebo. At the end of treatment, researchers saw significant increases in the apnea-hypopnea index among the patients on placebo, while those who received dronabinol showed decreases in the number of apnea and hypopnea events per hour. Patients given the 2.5-mg dose of dronabinol had a mean decrease of 10.7 events per hour, and those on the 10-mg dose had a mean decrease of 12.9 events per hour compared with placebo.
The difference between the placebo and treatment arms was significant for both dosages, and the apnea-hypopnea index decreases were similar between the two dosages of dronabinol.
These effects were largely due to reductions in apnea events; the largest reduction was seen in the REM apnea index in patients treated with the 10-mg dose of dronabinol. However, there were few effects on the expression of hypopneas, except in the higher-dose group.
After adjustment for age, race, ethnicity, and baseline apnea-hypopnea index, the increases seen in the placebo group were no longer significant, but the decreases from baseline seen in the treatment arms were greater.
Dronabinol treatment was also associated with significant decreases, compared with placebo, in non-REM apnea-hypopnea index and REM apnea-hypopnea index.
Patients’ self-reported daytime sleepiness, measured by the Epworth Sleepiness Scale, remained similar compared with baseline in those who received placebo and the 2.5-mg/day dose of dronabinol, but decreased significantly by a mean of −2.3 points compared with placebo in those on the higher dose of dronabinol.
There were no significant changes from baseline in objective sleepiness, as measured by the maintenance of wakefulness test, in any of the study groups. Researchers also saw no significant changes in sleep architecture, oxygenation, or the duration of supine sleep in any of the study groups, although the patients on the higher dose of dronabinol showed a slight increase in REM sleep and those on placebo showed a slight decrease.
Younger patients and those with a greater preponderance of REM-related apnea/hypopnea, and shorter average event duration were both more likely to respond to treatment, but apart from these factors there were no other influences on likelihood of patients responding to dronabinol.
David W. Carley, PhD, of the University of Illinois at Chicago, and his coauthors noted that there was a great need for pharmacological treatments for obstructive sleep apnea because positive airway pressure – while effective – has poor long-term adherence rates.
“Based on a series of animal investigations, we proposed that drugs which dampen afferent vagal feedback to the medulla may be effective in stabilizing respiratory pattern generation and increasing activation of upper airway dilating muscles during sleep,” they wrote.
One patient experienced diarrhea and vomiting that required admission to hospital, and which was judged as possibly related to the study medication. There were six other withdrawals due to adverse events including dizziness and vision changes, vertigo, ECG arrhythmias, and headache with dizziness and vomiting. Overall, nearly 90% of patients reported at least one adverse event, but the rates did not differ significantly between the treatment and placebo arms.
The researchers noted that significantly higher satisfaction scores were seen among patients receiving the higher dose of dronabinol.
“All of these observations argue that dronabinol, at doses from 2.5 to 10 mg/day, is safe for use by medically stable patients with moderate or severe OSA,” the authors wrote. “Participants also tolerated and adhered well to daily self-administration of dronabinol.”
The National Institutes of Health, National Heart, Lung, and Blood Institute, and National Center for Advancing Translational Sciences funded the study. One author declared grants from the National Institutes of Health for the study, and patents related to treatment of sleep-related breathing disorders by cannabinoid drugs. He also holds stock in RespireRx Pharmaceuticals, which holds an exclusive license to these and other related patents.
SOURCE: Carley D, et al. Sleep. 2018 Jan 1. doi: 10.1093/sleep/zsx184
This study has found a small overall effect on the apnea-hypopnea index with treatment, but a strong beneficial effect on subjective sleepiness. In addition, participants who received the higher dose of the drug showed significant satisfaction with their therapy. It is therefore intriguing that there was no impact on objective wakefulness or sleep architecture with this treatment.
This suggests that perhaps sleepiness and subjective wellbeing may be improved without necessarily seeing major improvements in the apnea-hypopnea index, which calls into question our use of this index as a primary end-point.
Sigrid C. Veasey, MD, is with the Center for Sleep and Circadian Neurobiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia. These comments are taken from an accompanying (Sleep 2018 Jan 1. doi: 10.1093/sleep/zsy014). No conflicts of interest were declared.
This study has found a small overall effect on the apnea-hypopnea index with treatment, but a strong beneficial effect on subjective sleepiness. In addition, participants who received the higher dose of the drug showed significant satisfaction with their therapy. It is therefore intriguing that there was no impact on objective wakefulness or sleep architecture with this treatment.
This suggests that perhaps sleepiness and subjective wellbeing may be improved without necessarily seeing major improvements in the apnea-hypopnea index, which calls into question our use of this index as a primary end-point.
Sigrid C. Veasey, MD, is with the Center for Sleep and Circadian Neurobiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia. These comments are taken from an accompanying (Sleep 2018 Jan 1. doi: 10.1093/sleep/zsy014). No conflicts of interest were declared.
This study has found a small overall effect on the apnea-hypopnea index with treatment, but a strong beneficial effect on subjective sleepiness. In addition, participants who received the higher dose of the drug showed significant satisfaction with their therapy. It is therefore intriguing that there was no impact on objective wakefulness or sleep architecture with this treatment.
This suggests that perhaps sleepiness and subjective wellbeing may be improved without necessarily seeing major improvements in the apnea-hypopnea index, which calls into question our use of this index as a primary end-point.
Sigrid C. Veasey, MD, is with the Center for Sleep and Circadian Neurobiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia. These comments are taken from an accompanying (Sleep 2018 Jan 1. doi: 10.1093/sleep/zsy014). No conflicts of interest were declared.
in a new study.
A paper published in the January edition of Sleep presents data from a phase 2, blinded, randomized controlled trial of the nonselective cannabinoid 1 and cannabinoid 2 receptor agonist, dronabinol, in 73 adults with moderate or severe obstructive sleep apnea (OSA). No approved drug treatments for OSA exist, and this study provides results “from the largest and longest randomized controlled trial to date of any putative drug treatment for OSA,” the researchers wrote.
Patients were randomized to 2.5 mg dronabinol or 10 mg dronabinol daily for up to 6 weeks, or placebo. At the end of treatment, researchers saw significant increases in the apnea-hypopnea index among the patients on placebo, while those who received dronabinol showed decreases in the number of apnea and hypopnea events per hour. Patients given the 2.5-mg dose of dronabinol had a mean decrease of 10.7 events per hour, and those on the 10-mg dose had a mean decrease of 12.9 events per hour compared with placebo.
The difference between the placebo and treatment arms was significant for both dosages, and the apnea-hypopnea index decreases were similar between the two dosages of dronabinol.
These effects were largely due to reductions in apnea events; the largest reduction was seen in the REM apnea index in patients treated with the 10-mg dose of dronabinol. However, there were few effects on the expression of hypopneas, except in the higher-dose group.
After adjustment for age, race, ethnicity, and baseline apnea-hypopnea index, the increases seen in the placebo group were no longer significant, but the decreases from baseline seen in the treatment arms were greater.
Dronabinol treatment was also associated with significant decreases, compared with placebo, in non-REM apnea-hypopnea index and REM apnea-hypopnea index.
Patients’ self-reported daytime sleepiness, measured by the Epworth Sleepiness Scale, remained similar compared with baseline in those who received placebo and the 2.5-mg/day dose of dronabinol, but decreased significantly by a mean of −2.3 points compared with placebo in those on the higher dose of dronabinol.
There were no significant changes from baseline in objective sleepiness, as measured by the maintenance of wakefulness test, in any of the study groups. Researchers also saw no significant changes in sleep architecture, oxygenation, or the duration of supine sleep in any of the study groups, although the patients on the higher dose of dronabinol showed a slight increase in REM sleep and those on placebo showed a slight decrease.
Younger patients and those with a greater preponderance of REM-related apnea/hypopnea, and shorter average event duration were both more likely to respond to treatment, but apart from these factors there were no other influences on likelihood of patients responding to dronabinol.
David W. Carley, PhD, of the University of Illinois at Chicago, and his coauthors noted that there was a great need for pharmacological treatments for obstructive sleep apnea because positive airway pressure – while effective – has poor long-term adherence rates.
“Based on a series of animal investigations, we proposed that drugs which dampen afferent vagal feedback to the medulla may be effective in stabilizing respiratory pattern generation and increasing activation of upper airway dilating muscles during sleep,” they wrote.
One patient experienced diarrhea and vomiting that required admission to hospital, and which was judged as possibly related to the study medication. There were six other withdrawals due to adverse events including dizziness and vision changes, vertigo, ECG arrhythmias, and headache with dizziness and vomiting. Overall, nearly 90% of patients reported at least one adverse event, but the rates did not differ significantly between the treatment and placebo arms.
The researchers noted that significantly higher satisfaction scores were seen among patients receiving the higher dose of dronabinol.
“All of these observations argue that dronabinol, at doses from 2.5 to 10 mg/day, is safe for use by medically stable patients with moderate or severe OSA,” the authors wrote. “Participants also tolerated and adhered well to daily self-administration of dronabinol.”
The National Institutes of Health, National Heart, Lung, and Blood Institute, and National Center for Advancing Translational Sciences funded the study. One author declared grants from the National Institutes of Health for the study, and patents related to treatment of sleep-related breathing disorders by cannabinoid drugs. He also holds stock in RespireRx Pharmaceuticals, which holds an exclusive license to these and other related patents.
SOURCE: Carley D, et al. Sleep. 2018 Jan 1. doi: 10.1093/sleep/zsx184
in a new study.
A paper published in the January edition of Sleep presents data from a phase 2, blinded, randomized controlled trial of the nonselective cannabinoid 1 and cannabinoid 2 receptor agonist, dronabinol, in 73 adults with moderate or severe obstructive sleep apnea (OSA). No approved drug treatments for OSA exist, and this study provides results “from the largest and longest randomized controlled trial to date of any putative drug treatment for OSA,” the researchers wrote.
Patients were randomized to 2.5 mg dronabinol or 10 mg dronabinol daily for up to 6 weeks, or placebo. At the end of treatment, researchers saw significant increases in the apnea-hypopnea index among the patients on placebo, while those who received dronabinol showed decreases in the number of apnea and hypopnea events per hour. Patients given the 2.5-mg dose of dronabinol had a mean decrease of 10.7 events per hour, and those on the 10-mg dose had a mean decrease of 12.9 events per hour compared with placebo.
The difference between the placebo and treatment arms was significant for both dosages, and the apnea-hypopnea index decreases were similar between the two dosages of dronabinol.
These effects were largely due to reductions in apnea events; the largest reduction was seen in the REM apnea index in patients treated with the 10-mg dose of dronabinol. However, there were few effects on the expression of hypopneas, except in the higher-dose group.
After adjustment for age, race, ethnicity, and baseline apnea-hypopnea index, the increases seen in the placebo group were no longer significant, but the decreases from baseline seen in the treatment arms were greater.
Dronabinol treatment was also associated with significant decreases, compared with placebo, in non-REM apnea-hypopnea index and REM apnea-hypopnea index.
Patients’ self-reported daytime sleepiness, measured by the Epworth Sleepiness Scale, remained similar compared with baseline in those who received placebo and the 2.5-mg/day dose of dronabinol, but decreased significantly by a mean of −2.3 points compared with placebo in those on the higher dose of dronabinol.
There were no significant changes from baseline in objective sleepiness, as measured by the maintenance of wakefulness test, in any of the study groups. Researchers also saw no significant changes in sleep architecture, oxygenation, or the duration of supine sleep in any of the study groups, although the patients on the higher dose of dronabinol showed a slight increase in REM sleep and those on placebo showed a slight decrease.
Younger patients and those with a greater preponderance of REM-related apnea/hypopnea, and shorter average event duration were both more likely to respond to treatment, but apart from these factors there were no other influences on likelihood of patients responding to dronabinol.
David W. Carley, PhD, of the University of Illinois at Chicago, and his coauthors noted that there was a great need for pharmacological treatments for obstructive sleep apnea because positive airway pressure – while effective – has poor long-term adherence rates.
“Based on a series of animal investigations, we proposed that drugs which dampen afferent vagal feedback to the medulla may be effective in stabilizing respiratory pattern generation and increasing activation of upper airway dilating muscles during sleep,” they wrote.
One patient experienced diarrhea and vomiting that required admission to hospital, and which was judged as possibly related to the study medication. There were six other withdrawals due to adverse events including dizziness and vision changes, vertigo, ECG arrhythmias, and headache with dizziness and vomiting. Overall, nearly 90% of patients reported at least one adverse event, but the rates did not differ significantly between the treatment and placebo arms.
The researchers noted that significantly higher satisfaction scores were seen among patients receiving the higher dose of dronabinol.
“All of these observations argue that dronabinol, at doses from 2.5 to 10 mg/day, is safe for use by medically stable patients with moderate or severe OSA,” the authors wrote. “Participants also tolerated and adhered well to daily self-administration of dronabinol.”
The National Institutes of Health, National Heart, Lung, and Blood Institute, and National Center for Advancing Translational Sciences funded the study. One author declared grants from the National Institutes of Health for the study, and patents related to treatment of sleep-related breathing disorders by cannabinoid drugs. He also holds stock in RespireRx Pharmaceuticals, which holds an exclusive license to these and other related patents.
SOURCE: Carley D, et al. Sleep. 2018 Jan 1. doi: 10.1093/sleep/zsx184
FROM SLEEP
Key clinical point: A cannabinoid receptor agonist may significantly reduce apnea and hypopnea events in patients with obstructive sleep apnea.
Major finding: Patients who received either low dose or high-dose dronabinol showed significant decreases in apnea and hypopnea events compared to those on placebo.
Data source: Randomized controlled, blinded phase II trial in 73 patients with obstructive sleep apnea.
Disclosures: The National Institutes of Health, National Heart Lung and Blood Institute, and National Center for Advancing Translational Sciences funded the study. One author declared grants from the National Institutes of Health for the study, and patents related to treatment of sleep-related breathing disorders by cannabinoid drugs. He also holds stock in RespireRx Pharmaceuticals, which holds an exclusive license to these and other related patents.
Source: Carley D, et al. Sleep. 2018 Jan 1. doi: 10.1093/sleep/zsx184.
Status asthmaticus risk upped fourfold with IV labetalol for preeclampsia
DALLAS – A maternal death occurred at Columbia University Medical Center after a patient with asthma was given intravenous labetalol, prompting a study that found an elevated risk of status asthmaticus associated with intravenous (IV) labetalol administration but not with the uterotonic carboprost.
“Overall, 71.4% of status asthmaticus cases occurred among women receiving IV labetalol,” said Whitney A. Booker, MD, speaking about the findings at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The risk of status asthmaticus didn’t reach statistical significance when women with asthma who experienced postpartum hemorrhage were given carboprost, compared with other uterotonics (3.1 vs. 1.0 per 1,000 patients; P = .56).
“Some regularly used medications in obstetrics can trigger bronchospasm,” said Dr. Booker; the American College of Obstetricians and Gynecologists lists both carboprost and labetalol as contraindicated for use in patients with asthma because of the potential for bronchospasm with each medication.
However, she said, data on the actual risk of bronchospasm when these medications are used in obstetric patients is limited.
The retrospective cohort study constructed by Dr. Booker and her colleagues at Columbia University Medical Center’s department of obstetrics and gynecology tapped 10 years’ worth of data from a large inpatient drug utilization database.
Dr. Booker, a maternal-fetal medicine fellow, said that patients were included if they were admitted for delivery and had a diagnosis of preeclampsia or postpartum hemorrhage. Of the 5.7 million hospitalizations from 2006 to 2015, 2.5% were for postpartum hemorrhage, and 4.2% for preeclampsia.
Of the patients with hemorrhage, 5,633 had a prior history of asthma, as did 12,486 of the patients with preeclampsia. In both groups, a little more than a third of patients were younger than 25 years, and about a quarter were black. Half were on Medicaid, and most were in urban areas and cared for in a teaching hospital.
The first outcome that Dr. Booker and her colleagues looked at was how practice patterns for postpartum hemorrhage varied according to whether patients had asthma; to do so, they looked at receipt of carboprost, misoprostol, and methylergonovine. A similar analysis was performed for the second outcome addressing patients with preeclampsia, in which investigators examined the use of both IV and oral labetalol, hydralazine, and nifedipine. For this and the hemorrhage outcome, the investigators performed multivariable analysis, with receipt of carboprost and IV labetalol as the outcomes of interest.
Finally, the investigators assessed the risk of status asthmaticus by comparing receipt of either carboprost (for postpartum hemorrhage) or IV labetalol (for preeclampsia) with receipt of the other medications to treat these conditions.
They found that overall, 11.4% of patients with asthma and 18% of patients without asthma received carboprost to treat postpartum hemorrhage, which makes for an adjusted risk model of 0.68 (95% confidence interval, 0.62-0.74) for receipt of carboprost for patients with asthma versus those without.
However, the pattern was different for IV labetalol: 18.5% of patients with asthma and preeclampsia received labetalol, compared with 16.7% of those without asthma. After statistical adjustment, patients with asthma had a risk ratio of 0.93 (95% CI, 0.90-0.97) for receiving IV labetalol for preeclampsia.
The analysis showed that pregnant patients with asthma were less likely to be given carboprost than labetalol, although the actual risk of status asthmaticus was higher when patients with asthma received labetalol than when they received carboprost.
“Given similar theoretical risks, obstetric providers currently administer carboprost differently than labetalol. ... Obstetricians should proceed with caution prior to giving labetalol to patients with underlying asthma,” said Dr. Booker.
During the discussion after the presentation, one attendee suggested that a next step might be to examine claims databases in conjunction with the findings of Dr. Booker’s current work in order to see whether there’s an association between asthma medication prescription fills – a surrogate for disease severity – and the risk of bronchospasm. Dr. Booker agreed that this might be a promising line of inquiry.
Dr. Booker and her colleagues reported that they had no conflicts of interest. The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
SOURCE: Booker W et al. Am J Obstet Gynecol. 2018 Jan;218:S51.
I teach my residents and fellows the “rule of thirds”: One-third of asthma patients get worse during pregnancy; one-third get better; one-third stay the same.” Asthma during pregnancy remains a challenging problem, with physicians striving to treat two complicated patients (mother and child) safely and effectively. We learn now that the use of labetalol, a beta-blocker, to treat preeclampsia in pregnant asthma patients may be associated with an increased incidence of status asthmaticus. Until we learn more about these occurrences, we should use great caution in treating pregnant asthma patients with labetalol and other beta-blockers
I teach my residents and fellows the “rule of thirds”: One-third of asthma patients get worse during pregnancy; one-third get better; one-third stay the same.” Asthma during pregnancy remains a challenging problem, with physicians striving to treat two complicated patients (mother and child) safely and effectively. We learn now that the use of labetalol, a beta-blocker, to treat preeclampsia in pregnant asthma patients may be associated with an increased incidence of status asthmaticus. Until we learn more about these occurrences, we should use great caution in treating pregnant asthma patients with labetalol and other beta-blockers
I teach my residents and fellows the “rule of thirds”: One-third of asthma patients get worse during pregnancy; one-third get better; one-third stay the same.” Asthma during pregnancy remains a challenging problem, with physicians striving to treat two complicated patients (mother and child) safely and effectively. We learn now that the use of labetalol, a beta-blocker, to treat preeclampsia in pregnant asthma patients may be associated with an increased incidence of status asthmaticus. Until we learn more about these occurrences, we should use great caution in treating pregnant asthma patients with labetalol and other beta-blockers
DALLAS – A maternal death occurred at Columbia University Medical Center after a patient with asthma was given intravenous labetalol, prompting a study that found an elevated risk of status asthmaticus associated with intravenous (IV) labetalol administration but not with the uterotonic carboprost.
“Overall, 71.4% of status asthmaticus cases occurred among women receiving IV labetalol,” said Whitney A. Booker, MD, speaking about the findings at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The risk of status asthmaticus didn’t reach statistical significance when women with asthma who experienced postpartum hemorrhage were given carboprost, compared with other uterotonics (3.1 vs. 1.0 per 1,000 patients; P = .56).
“Some regularly used medications in obstetrics can trigger bronchospasm,” said Dr. Booker; the American College of Obstetricians and Gynecologists lists both carboprost and labetalol as contraindicated for use in patients with asthma because of the potential for bronchospasm with each medication.
However, she said, data on the actual risk of bronchospasm when these medications are used in obstetric patients is limited.
The retrospective cohort study constructed by Dr. Booker and her colleagues at Columbia University Medical Center’s department of obstetrics and gynecology tapped 10 years’ worth of data from a large inpatient drug utilization database.
Dr. Booker, a maternal-fetal medicine fellow, said that patients were included if they were admitted for delivery and had a diagnosis of preeclampsia or postpartum hemorrhage. Of the 5.7 million hospitalizations from 2006 to 2015, 2.5% were for postpartum hemorrhage, and 4.2% for preeclampsia.
Of the patients with hemorrhage, 5,633 had a prior history of asthma, as did 12,486 of the patients with preeclampsia. In both groups, a little more than a third of patients were younger than 25 years, and about a quarter were black. Half were on Medicaid, and most were in urban areas and cared for in a teaching hospital.
The first outcome that Dr. Booker and her colleagues looked at was how practice patterns for postpartum hemorrhage varied according to whether patients had asthma; to do so, they looked at receipt of carboprost, misoprostol, and methylergonovine. A similar analysis was performed for the second outcome addressing patients with preeclampsia, in which investigators examined the use of both IV and oral labetalol, hydralazine, and nifedipine. For this and the hemorrhage outcome, the investigators performed multivariable analysis, with receipt of carboprost and IV labetalol as the outcomes of interest.
Finally, the investigators assessed the risk of status asthmaticus by comparing receipt of either carboprost (for postpartum hemorrhage) or IV labetalol (for preeclampsia) with receipt of the other medications to treat these conditions.
They found that overall, 11.4% of patients with asthma and 18% of patients without asthma received carboprost to treat postpartum hemorrhage, which makes for an adjusted risk model of 0.68 (95% confidence interval, 0.62-0.74) for receipt of carboprost for patients with asthma versus those without.
However, the pattern was different for IV labetalol: 18.5% of patients with asthma and preeclampsia received labetalol, compared with 16.7% of those without asthma. After statistical adjustment, patients with asthma had a risk ratio of 0.93 (95% CI, 0.90-0.97) for receiving IV labetalol for preeclampsia.
The analysis showed that pregnant patients with asthma were less likely to be given carboprost than labetalol, although the actual risk of status asthmaticus was higher when patients with asthma received labetalol than when they received carboprost.
“Given similar theoretical risks, obstetric providers currently administer carboprost differently than labetalol. ... Obstetricians should proceed with caution prior to giving labetalol to patients with underlying asthma,” said Dr. Booker.
During the discussion after the presentation, one attendee suggested that a next step might be to examine claims databases in conjunction with the findings of Dr. Booker’s current work in order to see whether there’s an association between asthma medication prescription fills – a surrogate for disease severity – and the risk of bronchospasm. Dr. Booker agreed that this might be a promising line of inquiry.
Dr. Booker and her colleagues reported that they had no conflicts of interest. The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
SOURCE: Booker W et al. Am J Obstet Gynecol. 2018 Jan;218:S51.
DALLAS – A maternal death occurred at Columbia University Medical Center after a patient with asthma was given intravenous labetalol, prompting a study that found an elevated risk of status asthmaticus associated with intravenous (IV) labetalol administration but not with the uterotonic carboprost.
“Overall, 71.4% of status asthmaticus cases occurred among women receiving IV labetalol,” said Whitney A. Booker, MD, speaking about the findings at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The risk of status asthmaticus didn’t reach statistical significance when women with asthma who experienced postpartum hemorrhage were given carboprost, compared with other uterotonics (3.1 vs. 1.0 per 1,000 patients; P = .56).
“Some regularly used medications in obstetrics can trigger bronchospasm,” said Dr. Booker; the American College of Obstetricians and Gynecologists lists both carboprost and labetalol as contraindicated for use in patients with asthma because of the potential for bronchospasm with each medication.
However, she said, data on the actual risk of bronchospasm when these medications are used in obstetric patients is limited.
The retrospective cohort study constructed by Dr. Booker and her colleagues at Columbia University Medical Center’s department of obstetrics and gynecology tapped 10 years’ worth of data from a large inpatient drug utilization database.
Dr. Booker, a maternal-fetal medicine fellow, said that patients were included if they were admitted for delivery and had a diagnosis of preeclampsia or postpartum hemorrhage. Of the 5.7 million hospitalizations from 2006 to 2015, 2.5% were for postpartum hemorrhage, and 4.2% for preeclampsia.
Of the patients with hemorrhage, 5,633 had a prior history of asthma, as did 12,486 of the patients with preeclampsia. In both groups, a little more than a third of patients were younger than 25 years, and about a quarter were black. Half were on Medicaid, and most were in urban areas and cared for in a teaching hospital.
The first outcome that Dr. Booker and her colleagues looked at was how practice patterns for postpartum hemorrhage varied according to whether patients had asthma; to do so, they looked at receipt of carboprost, misoprostol, and methylergonovine. A similar analysis was performed for the second outcome addressing patients with preeclampsia, in which investigators examined the use of both IV and oral labetalol, hydralazine, and nifedipine. For this and the hemorrhage outcome, the investigators performed multivariable analysis, with receipt of carboprost and IV labetalol as the outcomes of interest.
Finally, the investigators assessed the risk of status asthmaticus by comparing receipt of either carboprost (for postpartum hemorrhage) or IV labetalol (for preeclampsia) with receipt of the other medications to treat these conditions.
They found that overall, 11.4% of patients with asthma and 18% of patients without asthma received carboprost to treat postpartum hemorrhage, which makes for an adjusted risk model of 0.68 (95% confidence interval, 0.62-0.74) for receipt of carboprost for patients with asthma versus those without.
However, the pattern was different for IV labetalol: 18.5% of patients with asthma and preeclampsia received labetalol, compared with 16.7% of those without asthma. After statistical adjustment, patients with asthma had a risk ratio of 0.93 (95% CI, 0.90-0.97) for receiving IV labetalol for preeclampsia.
The analysis showed that pregnant patients with asthma were less likely to be given carboprost than labetalol, although the actual risk of status asthmaticus was higher when patients with asthma received labetalol than when they received carboprost.
“Given similar theoretical risks, obstetric providers currently administer carboprost differently than labetalol. ... Obstetricians should proceed with caution prior to giving labetalol to patients with underlying asthma,” said Dr. Booker.
During the discussion after the presentation, one attendee suggested that a next step might be to examine claims databases in conjunction with the findings of Dr. Booker’s current work in order to see whether there’s an association between asthma medication prescription fills – a surrogate for disease severity – and the risk of bronchospasm. Dr. Booker agreed that this might be a promising line of inquiry.
Dr. Booker and her colleagues reported that they had no conflicts of interest. The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
SOURCE: Booker W et al. Am J Obstet Gynecol. 2018 Jan;218:S51.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: IV labetalol receipt meant a fourfold increase in risk of status asthmaticus for women with preeclampsia and asthma.
Major finding: Status asthmaticus occurred in 6.5 per 1,000 patients given IV labetalol, and 1.7 per 1,000 given a different antihypertensive.
Study details: Retrospective review of 10 years’ data from a national inpatient database, which gathered data on 18,149 women with asthma and either preeclampsia or postpartum hemorrhage.
Disclosures: The study was sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The study authors had no conflicts of interest.
Source: Booker W et al. Am J Obstet Gynecol. 2018 Jan;218:S51.
Study: Half of doctors sued by age 55
By age 55, nearly half of physicians have been sued for malpractice, with general surgeons and obstetricians-gynecologists facing the highest lawsuit risks, according to data from the America Medical Association.
Investigators with the AMA surveyed 3,500 postresidency physicians who were not employed by the federal government. Findings show that the probability of getting sued increases with age, and that male doctors are more likely to be sued than female physicians. For example, only 8% of doctors under 40 have been sued, compared to nearly half of physicians over age 54, the study found. In addition, nearly 40% of male physicians have been sued over the course of their careers, compared with 23% of female doctors.
Employed physicians were no more or less likely than were physician-owners to have been sued. In addition, while solo practitioners had more claims filed against them than did doctors in single-specialty groups, the estimate was not statistically significant.
In a second report, an analysis showed the average expense incurred during a medical liability claim is $54,165 – a 65% increase since 2006. For the study, the AMA analyzed data from PIAA, a trade association for the medical professional liability insurance industry, and evaluated payments, expenses, and claim disposition within a sample of 90,473 medical liability claims that closed between 2006 and 2015.
Only 7% of claims were decided by a trial verdict with the vast majority (88%) won by the defendant health care provider. In about 25% of claims, a payment was paid to the plaintiff. The average indemnity payment to a plaintiff was $365,503 and the median payment was $200,000.
The new research paints a bleak picture of physicians’ experiences with medical liability claims and the associated cost burdens on the health system, AMA President David O. Barbe, MD, said in a statement.
“Even though the vast majority of claims are dropped, dismissed, or withdrawn, the heavy cost associated with a litigious climate takes a significant financial toll on our health care system when the nation is working to reduce unnecessary health care costs,” Dr. Barbe said.
By age 55, nearly half of physicians have been sued for malpractice, with general surgeons and obstetricians-gynecologists facing the highest lawsuit risks, according to data from the America Medical Association.
Investigators with the AMA surveyed 3,500 postresidency physicians who were not employed by the federal government. Findings show that the probability of getting sued increases with age, and that male doctors are more likely to be sued than female physicians. For example, only 8% of doctors under 40 have been sued, compared to nearly half of physicians over age 54, the study found. In addition, nearly 40% of male physicians have been sued over the course of their careers, compared with 23% of female doctors.
Employed physicians were no more or less likely than were physician-owners to have been sued. In addition, while solo practitioners had more claims filed against them than did doctors in single-specialty groups, the estimate was not statistically significant.
In a second report, an analysis showed the average expense incurred during a medical liability claim is $54,165 – a 65% increase since 2006. For the study, the AMA analyzed data from PIAA, a trade association for the medical professional liability insurance industry, and evaluated payments, expenses, and claim disposition within a sample of 90,473 medical liability claims that closed between 2006 and 2015.
Only 7% of claims were decided by a trial verdict with the vast majority (88%) won by the defendant health care provider. In about 25% of claims, a payment was paid to the plaintiff. The average indemnity payment to a plaintiff was $365,503 and the median payment was $200,000.
The new research paints a bleak picture of physicians’ experiences with medical liability claims and the associated cost burdens on the health system, AMA President David O. Barbe, MD, said in a statement.
“Even though the vast majority of claims are dropped, dismissed, or withdrawn, the heavy cost associated with a litigious climate takes a significant financial toll on our health care system when the nation is working to reduce unnecessary health care costs,” Dr. Barbe said.
By age 55, nearly half of physicians have been sued for malpractice, with general surgeons and obstetricians-gynecologists facing the highest lawsuit risks, according to data from the America Medical Association.
Investigators with the AMA surveyed 3,500 postresidency physicians who were not employed by the federal government. Findings show that the probability of getting sued increases with age, and that male doctors are more likely to be sued than female physicians. For example, only 8% of doctors under 40 have been sued, compared to nearly half of physicians over age 54, the study found. In addition, nearly 40% of male physicians have been sued over the course of their careers, compared with 23% of female doctors.
Employed physicians were no more or less likely than were physician-owners to have been sued. In addition, while solo practitioners had more claims filed against them than did doctors in single-specialty groups, the estimate was not statistically significant.
In a second report, an analysis showed the average expense incurred during a medical liability claim is $54,165 – a 65% increase since 2006. For the study, the AMA analyzed data from PIAA, a trade association for the medical professional liability insurance industry, and evaluated payments, expenses, and claim disposition within a sample of 90,473 medical liability claims that closed between 2006 and 2015.
Only 7% of claims were decided by a trial verdict with the vast majority (88%) won by the defendant health care provider. In about 25% of claims, a payment was paid to the plaintiff. The average indemnity payment to a plaintiff was $365,503 and the median payment was $200,000.
The new research paints a bleak picture of physicians’ experiences with medical liability claims and the associated cost burdens on the health system, AMA President David O. Barbe, MD, said in a statement.
“Even though the vast majority of claims are dropped, dismissed, or withdrawn, the heavy cost associated with a litigious climate takes a significant financial toll on our health care system when the nation is working to reduce unnecessary health care costs,” Dr. Barbe said.
Classifying Headache Types from Children’s Drawings
Diplopia, commonly known as double vision, was depicted in a significantly higher percentage of drawings by children (aged 6-18 years) with pseudotumor cerebri than drawings by children with migraine, a recent study found. In all other respects, headache drawings by both groups of children were similar. In this study, children attending university hospital pediatric neurology clinics were asked to draw a picture of how their headache feels. Headache drawings of 21 children (16 females) with pseudotumor were compared with those of 518 children with migraine. Researchers found:
- Pseudotumor drawings depicted a variety of symptoms including pounding pain (n=11), pressure-like pain (n=3), photophobia (n=3), dizziness (n=1), and recumbency (n=1).
- Severe pain indicators included hammers, bombs, an anvil, and vise grip.
- Positive visual phenomena included scintillations, scotomata, or blurring (n=8).
- Negative visual phenomena included field defects (n=2).
Pseudotumor drawings were similar to migraine drawings except that 6 of 21 pseudotumor drawings (28.6%) depicted diplopia, whereas only 3 of 518 migraine drawings (0.6%) depicted diplopia.
Evidence of diplopia in children's headache drawings helps to differentiate pseudotumor cerebri from migraine. 2018;79:40-44. Pediatr Neurol. doi:10.1016/j.pediatrneurol.2017.10.020.
Diplopia, commonly known as double vision, was depicted in a significantly higher percentage of drawings by children (aged 6-18 years) with pseudotumor cerebri than drawings by children with migraine, a recent study found. In all other respects, headache drawings by both groups of children were similar. In this study, children attending university hospital pediatric neurology clinics were asked to draw a picture of how their headache feels. Headache drawings of 21 children (16 females) with pseudotumor were compared with those of 518 children with migraine. Researchers found:
- Pseudotumor drawings depicted a variety of symptoms including pounding pain (n=11), pressure-like pain (n=3), photophobia (n=3), dizziness (n=1), and recumbency (n=1).
- Severe pain indicators included hammers, bombs, an anvil, and vise grip.
- Positive visual phenomena included scintillations, scotomata, or blurring (n=8).
- Negative visual phenomena included field defects (n=2).
Pseudotumor drawings were similar to migraine drawings except that 6 of 21 pseudotumor drawings (28.6%) depicted diplopia, whereas only 3 of 518 migraine drawings (0.6%) depicted diplopia.
Evidence of diplopia in children's headache drawings helps to differentiate pseudotumor cerebri from migraine. 2018;79:40-44. Pediatr Neurol. doi:10.1016/j.pediatrneurol.2017.10.020.
Diplopia, commonly known as double vision, was depicted in a significantly higher percentage of drawings by children (aged 6-18 years) with pseudotumor cerebri than drawings by children with migraine, a recent study found. In all other respects, headache drawings by both groups of children were similar. In this study, children attending university hospital pediatric neurology clinics were asked to draw a picture of how their headache feels. Headache drawings of 21 children (16 females) with pseudotumor were compared with those of 518 children with migraine. Researchers found:
- Pseudotumor drawings depicted a variety of symptoms including pounding pain (n=11), pressure-like pain (n=3), photophobia (n=3), dizziness (n=1), and recumbency (n=1).
- Severe pain indicators included hammers, bombs, an anvil, and vise grip.
- Positive visual phenomena included scintillations, scotomata, or blurring (n=8).
- Negative visual phenomena included field defects (n=2).
Pseudotumor drawings were similar to migraine drawings except that 6 of 21 pseudotumor drawings (28.6%) depicted diplopia, whereas only 3 of 518 migraine drawings (0.6%) depicted diplopia.
Evidence of diplopia in children's headache drawings helps to differentiate pseudotumor cerebri from migraine. 2018;79:40-44. Pediatr Neurol. doi:10.1016/j.pediatrneurol.2017.10.020.
Levetiracetam increased time between seizures for infants with epilepsy
, a multicenter, prospective, observational study has shown.
“Our findings suggest that levetiracetam has superior effectiveness compared with phenobarbital as initial monotherapy for nonsyndromic epilepsy in infants,” wrote Zachary Grinspan, MD, director of the pediatric epilepsy program at Cornell University, New York, and his colleagues. “We estimate that for every 100 infants with epilepsy treated with levetiracetam instead of phenobarbital, 44 infants would be free from monotherapy failure instead of 16.”
To evaluate the effectiveness of levetiracetam vs. phenobarbital, Dr. Grinspan and his colleagues developed the Early Life Epilepsy Study, a multicenter, prospective, observational investigation of 155 children with nonsyndromic epilepsy. Patient information for this study was obtained from medical records and was collected from March 1, 2012, through April 30, 2015. All of the patients in the study were observed in the first 3 years of life.
Of the 155 children included in the analysis for this study, 117 were treated with levetiracetam and 38 with phenobarbital. There were some differences between the groups. Children treated with levetiracetam were, on average, 2 months older at seizure onset than were those in the phenobarbital group (5.2 months vs. 3.0 months; P less than .001). Infants treated with levetiracetam also tended to begin treatment further from the time of their first seizure and exhibited less developmental delay at the time of epilepsy diagnosis. There were some other differences of possible clinical importance (developmental structural brain abnormalities, head circumference) that did not reach statistical significance.
Freedom from monotherapy failure was greater in the levetiracetam group (47 [40.2%] vs. 6 [15.8%]; P = .01; odds ratio, 3.6; 95% confidence interval, 1.5-10). Overall, the researchers concluded that levetiracetam was superior to phenobarbital for nonsyndromic epilepsy in pediatric patients (OR, 4.2; 95% CI, 1.1-16; number needed to treat, 3.5 [95% CI, 1.7-60]).
Outcome information was missing for more infants treated with levetiracetam than for those treated with phenobarbital, which could have skewed the analyses, Dr. Grinspan and his associates said. The nature of nonsyndromic epilepsy also makes it difficult to study because of the intricate genetic interactions that can influence the disorder.
Although this study provides information that could potentially benefit infantile epilepsy patients, the investigators said that more work must be done on the topic.
“A prospective clinical trial is needed. Levetiracetam and phenobarbital are both commonly used for infantile-onset epilepsy, indicating community equipoise regarding their relative effectiveness,” they wrote. “However, the effect size in our analysis was surprisingly large (number needed to treat, 3.5), suggesting that a change in practice could meaningfully improve outcomes.”
The investigators reported receiving grants and fees and consulting with a range of institutions, and the complete list can be found on the JAMA Pediatrics website. This study was funded by the Pediatric Epilepsy Research Foundation.
SOURCE: Grinspan Z et al. JAMA Pediatr. 2018 Feb 12. doi: 10.1001/jamapediatrics.2017.5211.
, a multicenter, prospective, observational study has shown.
“Our findings suggest that levetiracetam has superior effectiveness compared with phenobarbital as initial monotherapy for nonsyndromic epilepsy in infants,” wrote Zachary Grinspan, MD, director of the pediatric epilepsy program at Cornell University, New York, and his colleagues. “We estimate that for every 100 infants with epilepsy treated with levetiracetam instead of phenobarbital, 44 infants would be free from monotherapy failure instead of 16.”
To evaluate the effectiveness of levetiracetam vs. phenobarbital, Dr. Grinspan and his colleagues developed the Early Life Epilepsy Study, a multicenter, prospective, observational investigation of 155 children with nonsyndromic epilepsy. Patient information for this study was obtained from medical records and was collected from March 1, 2012, through April 30, 2015. All of the patients in the study were observed in the first 3 years of life.
Of the 155 children included in the analysis for this study, 117 were treated with levetiracetam and 38 with phenobarbital. There were some differences between the groups. Children treated with levetiracetam were, on average, 2 months older at seizure onset than were those in the phenobarbital group (5.2 months vs. 3.0 months; P less than .001). Infants treated with levetiracetam also tended to begin treatment further from the time of their first seizure and exhibited less developmental delay at the time of epilepsy diagnosis. There were some other differences of possible clinical importance (developmental structural brain abnormalities, head circumference) that did not reach statistical significance.
Freedom from monotherapy failure was greater in the levetiracetam group (47 [40.2%] vs. 6 [15.8%]; P = .01; odds ratio, 3.6; 95% confidence interval, 1.5-10). Overall, the researchers concluded that levetiracetam was superior to phenobarbital for nonsyndromic epilepsy in pediatric patients (OR, 4.2; 95% CI, 1.1-16; number needed to treat, 3.5 [95% CI, 1.7-60]).
Outcome information was missing for more infants treated with levetiracetam than for those treated with phenobarbital, which could have skewed the analyses, Dr. Grinspan and his associates said. The nature of nonsyndromic epilepsy also makes it difficult to study because of the intricate genetic interactions that can influence the disorder.
Although this study provides information that could potentially benefit infantile epilepsy patients, the investigators said that more work must be done on the topic.
“A prospective clinical trial is needed. Levetiracetam and phenobarbital are both commonly used for infantile-onset epilepsy, indicating community equipoise regarding their relative effectiveness,” they wrote. “However, the effect size in our analysis was surprisingly large (number needed to treat, 3.5), suggesting that a change in practice could meaningfully improve outcomes.”
The investigators reported receiving grants and fees and consulting with a range of institutions, and the complete list can be found on the JAMA Pediatrics website. This study was funded by the Pediatric Epilepsy Research Foundation.
SOURCE: Grinspan Z et al. JAMA Pediatr. 2018 Feb 12. doi: 10.1001/jamapediatrics.2017.5211.
, a multicenter, prospective, observational study has shown.
“Our findings suggest that levetiracetam has superior effectiveness compared with phenobarbital as initial monotherapy for nonsyndromic epilepsy in infants,” wrote Zachary Grinspan, MD, director of the pediatric epilepsy program at Cornell University, New York, and his colleagues. “We estimate that for every 100 infants with epilepsy treated with levetiracetam instead of phenobarbital, 44 infants would be free from monotherapy failure instead of 16.”
To evaluate the effectiveness of levetiracetam vs. phenobarbital, Dr. Grinspan and his colleagues developed the Early Life Epilepsy Study, a multicenter, prospective, observational investigation of 155 children with nonsyndromic epilepsy. Patient information for this study was obtained from medical records and was collected from March 1, 2012, through April 30, 2015. All of the patients in the study were observed in the first 3 years of life.
Of the 155 children included in the analysis for this study, 117 were treated with levetiracetam and 38 with phenobarbital. There were some differences between the groups. Children treated with levetiracetam were, on average, 2 months older at seizure onset than were those in the phenobarbital group (5.2 months vs. 3.0 months; P less than .001). Infants treated with levetiracetam also tended to begin treatment further from the time of their first seizure and exhibited less developmental delay at the time of epilepsy diagnosis. There were some other differences of possible clinical importance (developmental structural brain abnormalities, head circumference) that did not reach statistical significance.
Freedom from monotherapy failure was greater in the levetiracetam group (47 [40.2%] vs. 6 [15.8%]; P = .01; odds ratio, 3.6; 95% confidence interval, 1.5-10). Overall, the researchers concluded that levetiracetam was superior to phenobarbital for nonsyndromic epilepsy in pediatric patients (OR, 4.2; 95% CI, 1.1-16; number needed to treat, 3.5 [95% CI, 1.7-60]).
Outcome information was missing for more infants treated with levetiracetam than for those treated with phenobarbital, which could have skewed the analyses, Dr. Grinspan and his associates said. The nature of nonsyndromic epilepsy also makes it difficult to study because of the intricate genetic interactions that can influence the disorder.
Although this study provides information that could potentially benefit infantile epilepsy patients, the investigators said that more work must be done on the topic.
“A prospective clinical trial is needed. Levetiracetam and phenobarbital are both commonly used for infantile-onset epilepsy, indicating community equipoise regarding their relative effectiveness,” they wrote. “However, the effect size in our analysis was surprisingly large (number needed to treat, 3.5), suggesting that a change in practice could meaningfully improve outcomes.”
The investigators reported receiving grants and fees and consulting with a range of institutions, and the complete list can be found on the JAMA Pediatrics website. This study was funded by the Pediatric Epilepsy Research Foundation.
SOURCE: Grinspan Z et al. JAMA Pediatr. 2018 Feb 12. doi: 10.1001/jamapediatrics.2017.5211.
FROM JAMA PEDIATRICS
Key clinical point: Levetiracetam gave infants with nonsyndromic epilepsy greater freedom from seizure.
Major finding: Freedom from monotherapy failure was greater with levetiracetam than with phenobarbital (40.2% vs. 15.8%).
Study details: A multicenter, prospective, observational study of 155 children with nonsyndromic epilepsy.
Disclosures: The investigators reported receiving grants and fees and consulting with a range of institutions, and the complete list can be found on the JAMA Pediatrics website. This study was funded by the Pediatric Epilepsy Research Foundation.
Source: Grinspan Z et al. JAMA Pediatr. 2018 Feb 12. doi: 10.1001/jamapediatrics.2017.5211.
Rivaroxaban versus warfarin in mild acute ischemic stroke secondary to atrial fibrillation
Clinical question: Is rivaroxaban as effective and safe as warfarin immediately following minor acute ischemic stroke from atrial fibrillation?
Background: There is uncertainty regarding the best approach to anticoagulation acutely after ischemic stroke secondary to atrial fibrillation. To reduce the risk of intracranial hemorrhage, many physicians start aspirin immediately and delay initiating warfarin until days to weeks later. With their more predictable and rapid anticoagulant effect with potentially lower risk of intracranial hemorrhage, direct oral anticoagulants such as rivaroxaban are an attractive possible alternative to warfarin in the acute setting. 
Study design: Multicenter, randomized, open-label superiority trial with blinded outcome assessment.
Setting: Fourteen academic hospitals in South Korea.
Synopsis: One hundred eighty-three patients with mild acute (within 5 days) ischemic stroke secondary to nonvalvular atrial fibrillation were randomized to immediately initiate either rivaroxaban or warfarin. The primary outcome (composite of new ischemic lesion or new intracranial hemorrhage on MRI at 4 weeks) occurred at similar frequency between groups (49.5% versus 54.5%, P = .49). Rates of adverse events were comparable in each group. Median hospitalization length was shorter in those randomized to rivaroxaban (4.0 versus 6.0 days, P less than .001). Limitations include a radiographic primary outcome that captured many asymptomatic lesions, homogenous study population, and lack of a delayed anticoagulation group.
Bottom line: In patients with mild acute stroke from nonvalvular atrial fibrillation, rivaroxaban and warfarin demonstrated comparable efficacy and safety. More study is needed to determine the optimal anticoagulation strategy in acute stroke.
Citation: Hong K-S et al. Rivaroxaban vs. warfarin sodium in the ultra-early period after atrial fibrillation-related mild ischemic stroke: A randomized clinical trial. JAMA Neurol. 2017; 74(10):1206-15.
Dr. Kanjee is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.
Clinical question: Is rivaroxaban as effective and safe as warfarin immediately following minor acute ischemic stroke from atrial fibrillation?
Background: There is uncertainty regarding the best approach to anticoagulation acutely after ischemic stroke secondary to atrial fibrillation. To reduce the risk of intracranial hemorrhage, many physicians start aspirin immediately and delay initiating warfarin until days to weeks later. With their more predictable and rapid anticoagulant effect with potentially lower risk of intracranial hemorrhage, direct oral anticoagulants such as rivaroxaban are an attractive possible alternative to warfarin in the acute setting.
Study design: Multicenter, randomized, open-label superiority trial with blinded outcome assessment.
Setting: Fourteen academic hospitals in South Korea.
Synopsis: One hundred eighty-three patients with mild acute (within 5 days) ischemic stroke secondary to nonvalvular atrial fibrillation were randomized to immediately initiate either rivaroxaban or warfarin. The primary outcome (composite of new ischemic lesion or new intracranial hemorrhage on MRI at 4 weeks) occurred at similar frequency between groups (49.5% versus 54.5%, P = .49). Rates of adverse events were comparable in each group. Median hospitalization length was shorter in those randomized to rivaroxaban (4.0 versus 6.0 days, P less than .001). Limitations include a radiographic primary outcome that captured many asymptomatic lesions, homogenous study population, and lack of a delayed anticoagulation group.
Bottom line: In patients with mild acute stroke from nonvalvular atrial fibrillation, rivaroxaban and warfarin demonstrated comparable efficacy and safety. More study is needed to determine the optimal anticoagulation strategy in acute stroke.
Citation: Hong K-S et al. Rivaroxaban vs. warfarin sodium in the ultra-early period after atrial fibrillation-related mild ischemic stroke: A randomized clinical trial. JAMA Neurol. 2017; 74(10):1206-15.
Dr. Kanjee is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.
Clinical question: Is rivaroxaban as effective and safe as warfarin immediately following minor acute ischemic stroke from atrial fibrillation?
Background: There is uncertainty regarding the best approach to anticoagulation acutely after ischemic stroke secondary to atrial fibrillation. To reduce the risk of intracranial hemorrhage, many physicians start aspirin immediately and delay initiating warfarin until days to weeks later. With their more predictable and rapid anticoagulant effect with potentially lower risk of intracranial hemorrhage, direct oral anticoagulants such as rivaroxaban are an attractive possible alternative to warfarin in the acute setting.
Study design: Multicenter, randomized, open-label superiority trial with blinded outcome assessment.
Setting: Fourteen academic hospitals in South Korea.
Synopsis: One hundred eighty-three patients with mild acute (within 5 days) ischemic stroke secondary to nonvalvular atrial fibrillation were randomized to immediately initiate either rivaroxaban or warfarin. The primary outcome (composite of new ischemic lesion or new intracranial hemorrhage on MRI at 4 weeks) occurred at similar frequency between groups (49.5% versus 54.5%, P = .49). Rates of adverse events were comparable in each group. Median hospitalization length was shorter in those randomized to rivaroxaban (4.0 versus 6.0 days, P less than .001). Limitations include a radiographic primary outcome that captured many asymptomatic lesions, homogenous study population, and lack of a delayed anticoagulation group.
Bottom line: In patients with mild acute stroke from nonvalvular atrial fibrillation, rivaroxaban and warfarin demonstrated comparable efficacy and safety. More study is needed to determine the optimal anticoagulation strategy in acute stroke.
Citation: Hong K-S et al. Rivaroxaban vs. warfarin sodium in the ultra-early period after atrial fibrillation-related mild ischemic stroke: A randomized clinical trial. JAMA Neurol. 2017; 74(10):1206-15.
Dr. Kanjee is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.
Webinar on Medicare Reimbursement is Thursday; Still Time to Avoid ’17 Penalties
The SVS Patient Safety Organization and the SVS Quality and Performance Measures Committee (QPMC) will hold a webinar at 8 p.m. Eastern Standard Time, Thursday, Feb. 15. It will help unravel the new Quality Payment Program (QPP) under Medicare, including what surgeons still can do for 2017 to avoid reimbursement penalties. Learn more here and register here.
The SVS Patient Safety Organization and the SVS Quality and Performance Measures Committee (QPMC) will hold a webinar at 8 p.m. Eastern Standard Time, Thursday, Feb. 15. It will help unravel the new Quality Payment Program (QPP) under Medicare, including what surgeons still can do for 2017 to avoid reimbursement penalties. Learn more here and register here.
The SVS Patient Safety Organization and the SVS Quality and Performance Measures Committee (QPMC) will hold a webinar at 8 p.m. Eastern Standard Time, Thursday, Feb. 15. It will help unravel the new Quality Payment Program (QPP) under Medicare, including what surgeons still can do for 2017 to avoid reimbursement penalties. Learn more here and register here.
Rheumatologists target prior authorization, Stark Law as barriers to competition
Onerous prior authorization rules, Stark Law, and other issues are creating barriers to health care choice and competition, the American College of Rheumatology recently told the Department of Health & Human Services.
The agency recently issued an informal request for information seeking “input from the public on the extent to which existing state and federal laws, regulations, guidance, requirements, and policies limit choice and competition across all health care markets, and the identification of actions that states or the federal government could take to support the development and operations of a health care system that provides high-quality care at affordable prices for the American people.”
“We believe this is a waste of valuable resources that results in delays in care and does not add value to health care delivery,” the ACR said in its Jan. 25 reply to the request for information. The ACR offered a series of recommendations to make the use of prior authorization by the Centers for Medicare & Medicaid Services more efficient.
Among the requested changes are:
• CMS should require all Medicare Advantage and Part D prescription drug plans to publicly disclose in a searchable electronic format to both patients and physicians all drugs and medical services that are subject to coverage restrictions (prior authorization, step therapy, formulary restrictions, quantity limits), and provide this information to vendors to be displayed in electronic health records.
• CMS should ensure that all utilization management requirements are based on accurate and up-to-date, publicly available clinical criteria and never cost alone.
• CMS should ensure that any “peer-to-peer” reviews utilize physicians from the same specialty/subspecialty as the ordering physician.
• CMS should restrict prior authorization requirements to “outlier” providers whose prescribing or ordering patterns differ significantly from their peers after adjusting for patient mix.
• CMS should not allow Part B services to be subject to prior authorization requirements because this would increase physician time spent on administrative tasks and reduce availability for patient care.
In addition, the ACR expressed concern about the consolidated pharmacy benefit managers market, noting that two PBMs cover more than 170 million Americans, and urged the HHS to “consider policies that require PBMs to be more transparent about their payment practices, including transparency around the true cost of prescription drugs.”
In the area of the Stark Law, the ACR called for the HHS to waive the prohibitions “for physicians seeking to develop and operate alternative payment models (APMs) as was provided to accountable care organizations in the Affordable Care Act. We also recommend removing the ‘volume or value’ prohibition in Stark policy so that physician practices can incentivize physicians to abide by best practices and succeed in new value-based alternative payment models.”
The ACR asked the CMS not to alter policy on assigning unique J-codes to biosimilars, as the unique codes allow for better monitoring of effectiveness and ensure adequate pharmacovigilance.
The physician organization also called for the removal of antitrust exemptions to insurance companies to give “the federal government the ability to intervene in places where insurance monopolies exist or develop.”
One request made – the removal of Part B drug payments from being adjusted by scoring in the Merit-based Incentive Payment System in the Quality Payment Program created by MACRA – was addressed in legislation passed by Congress and signed into law Feb. 9 by President Trump that provided short-term funding for the government and funding and other policy changes in the health care space, among other issues.
Onerous prior authorization rules, Stark Law, and other issues are creating barriers to health care choice and competition, the American College of Rheumatology recently told the Department of Health & Human Services.
The agency recently issued an informal request for information seeking “input from the public on the extent to which existing state and federal laws, regulations, guidance, requirements, and policies limit choice and competition across all health care markets, and the identification of actions that states or the federal government could take to support the development and operations of a health care system that provides high-quality care at affordable prices for the American people.”
“We believe this is a waste of valuable resources that results in delays in care and does not add value to health care delivery,” the ACR said in its Jan. 25 reply to the request for information. The ACR offered a series of recommendations to make the use of prior authorization by the Centers for Medicare & Medicaid Services more efficient.
Among the requested changes are:
• CMS should require all Medicare Advantage and Part D prescription drug plans to publicly disclose in a searchable electronic format to both patients and physicians all drugs and medical services that are subject to coverage restrictions (prior authorization, step therapy, formulary restrictions, quantity limits), and provide this information to vendors to be displayed in electronic health records.
• CMS should ensure that all utilization management requirements are based on accurate and up-to-date, publicly available clinical criteria and never cost alone.
• CMS should ensure that any “peer-to-peer” reviews utilize physicians from the same specialty/subspecialty as the ordering physician.
• CMS should restrict prior authorization requirements to “outlier” providers whose prescribing or ordering patterns differ significantly from their peers after adjusting for patient mix.
• CMS should not allow Part B services to be subject to prior authorization requirements because this would increase physician time spent on administrative tasks and reduce availability for patient care.
In addition, the ACR expressed concern about the consolidated pharmacy benefit managers market, noting that two PBMs cover more than 170 million Americans, and urged the HHS to “consider policies that require PBMs to be more transparent about their payment practices, including transparency around the true cost of prescription drugs.”
In the area of the Stark Law, the ACR called for the HHS to waive the prohibitions “for physicians seeking to develop and operate alternative payment models (APMs) as was provided to accountable care organizations in the Affordable Care Act. We also recommend removing the ‘volume or value’ prohibition in Stark policy so that physician practices can incentivize physicians to abide by best practices and succeed in new value-based alternative payment models.”
The ACR asked the CMS not to alter policy on assigning unique J-codes to biosimilars, as the unique codes allow for better monitoring of effectiveness and ensure adequate pharmacovigilance.
The physician organization also called for the removal of antitrust exemptions to insurance companies to give “the federal government the ability to intervene in places where insurance monopolies exist or develop.”
One request made – the removal of Part B drug payments from being adjusted by scoring in the Merit-based Incentive Payment System in the Quality Payment Program created by MACRA – was addressed in legislation passed by Congress and signed into law Feb. 9 by President Trump that provided short-term funding for the government and funding and other policy changes in the health care space, among other issues.
Onerous prior authorization rules, Stark Law, and other issues are creating barriers to health care choice and competition, the American College of Rheumatology recently told the Department of Health & Human Services.
The agency recently issued an informal request for information seeking “input from the public on the extent to which existing state and federal laws, regulations, guidance, requirements, and policies limit choice and competition across all health care markets, and the identification of actions that states or the federal government could take to support the development and operations of a health care system that provides high-quality care at affordable prices for the American people.”
“We believe this is a waste of valuable resources that results in delays in care and does not add value to health care delivery,” the ACR said in its Jan. 25 reply to the request for information. The ACR offered a series of recommendations to make the use of prior authorization by the Centers for Medicare & Medicaid Services more efficient.
Among the requested changes are:
• CMS should require all Medicare Advantage and Part D prescription drug plans to publicly disclose in a searchable electronic format to both patients and physicians all drugs and medical services that are subject to coverage restrictions (prior authorization, step therapy, formulary restrictions, quantity limits), and provide this information to vendors to be displayed in electronic health records.
• CMS should ensure that all utilization management requirements are based on accurate and up-to-date, publicly available clinical criteria and never cost alone.
• CMS should ensure that any “peer-to-peer” reviews utilize physicians from the same specialty/subspecialty as the ordering physician.
• CMS should restrict prior authorization requirements to “outlier” providers whose prescribing or ordering patterns differ significantly from their peers after adjusting for patient mix.
• CMS should not allow Part B services to be subject to prior authorization requirements because this would increase physician time spent on administrative tasks and reduce availability for patient care.
In addition, the ACR expressed concern about the consolidated pharmacy benefit managers market, noting that two PBMs cover more than 170 million Americans, and urged the HHS to “consider policies that require PBMs to be more transparent about their payment practices, including transparency around the true cost of prescription drugs.”
In the area of the Stark Law, the ACR called for the HHS to waive the prohibitions “for physicians seeking to develop and operate alternative payment models (APMs) as was provided to accountable care organizations in the Affordable Care Act. We also recommend removing the ‘volume or value’ prohibition in Stark policy so that physician practices can incentivize physicians to abide by best practices and succeed in new value-based alternative payment models.”
The ACR asked the CMS not to alter policy on assigning unique J-codes to biosimilars, as the unique codes allow for better monitoring of effectiveness and ensure adequate pharmacovigilance.
The physician organization also called for the removal of antitrust exemptions to insurance companies to give “the federal government the ability to intervene in places where insurance monopolies exist or develop.”
One request made – the removal of Part B drug payments from being adjusted by scoring in the Merit-based Incentive Payment System in the Quality Payment Program created by MACRA – was addressed in legislation passed by Congress and signed into law Feb. 9 by President Trump that provided short-term funding for the government and funding and other policy changes in the health care space, among other issues.