What's new with potential treatment options such as tildrakizumab? Given the roles obesity and metabolic disease play in psoriatic arthritis, how does weight loss affect treatment response? Alexis Ogdie, MD, director of the psoriatic arthritis clinic at the University of Pennsylvania in Philadelphia, talks about the latest developments in psoriatic arthritis research.

What's new with potential treatment options such as tildrakizumab? Given the roles obesity and metabolic disease play in psoriatic arthritis, how does weight loss affect treatment response? Alexis Ogdie, MD, director of the psoriatic arthritis clinic at the University of Pennsylvania in Philadelphia, talks about the latest developments in psoriatic arthritis research.

What's new with potential treatment options such as tildrakizumab? Given the roles obesity and metabolic disease play in psoriatic arthritis, how does weight loss affect treatment response? Alexis Ogdie, MD, director of the psoriatic arthritis clinic at the University of Pennsylvania in Philadelphia, talks about the latest developments in psoriatic arthritis research.

Isotretinoin use may increase vulnerability to psychiatric conditions, but available evidence does not support a causal relationship, on the basis of data from a retrospective study of 17,829 psychiatric adverse events reported to the Food and Drug Administration over 2 decades.

“Although one study highlighted consistent reporting of depression and suicide in patients taking isotretinoin in the United States from 1982 to 2000, few studies have examined reports of psychiatric adverse events at the national level since 2000,” wrote Sean Singer of Harvard University, Boston, and his colleagues.

In a study published in JAMA Dermatology, the researchers reviewed data from the FDA’s Adverse Event Reporting System between 1997 and 2017.

A total of 17,829 psychiatric adverse events in which isotretinoin was the primary suspect drug were reported during the study period. The researchers classified the events into 12 categories; the most common were depressive disorders (42%), emotional lability (17%), and anxiety (14%). The number of reported psychiatric adverse events was similar between men and women (8,936 and 8,362 events, respectively).

The researchers also identified 2,278 reports of suicidal ideation, 602 reports of attempted suicide, and 368 reports of completed suicide.

In addition, the researchers examined data from the iPLEDGE program and found completed suicide rates of 8.4 per 100,000 patients in 2009 and 5.6 per 100,000 patients in 2010. However, these rates were lower than national suicide rates in the general population of 11.8 per 100,000 people in 2009 and 12.1 per 100,000 people in 2010.

Patient age was available for 13,553 adverse event reports, and patients aged 10-19 years accounted for 53% of the reports overall and 58% of completed suicides for which age was reported.

The high number of psychiatric adverse events in the youngest age group “could reflect more isotretinoin prescriptions in this age group or may suggest that teenagers are particularly vulnerable to psychiatric adverse events while taking isotretinoin,” the researchers said.

The findings were limited by several factors, including the reliance on proper clinician reports to the Adverse Event Reporting System database and the separation of some psychiatric terms into categories that may reflect symptoms of other psychiatric diagnoses, the researchers said.

However, “Our data showed high numbers of reports of emotional lability, anxiety disorders, insomnia, self-injurious behavior, and psychotic disorders with isotretinoin as the primary suspect drug,” they noted.

“Although no causal link has been established between isotretinoin and psychiatric adverse events, it is important to recognize that there are data that suggest patients using this drug may be vulnerable to a number of psychiatric conditions” and that monthly iPLEDGE visits are an opportunity to screen patients for these conditions, they said.

They also stressed that “the risk of psychiatric adverse events in patients taking isotretinoin must be considered in the context of a known increased risk of suicidal ideation in patients with acne independent of isotretinoin therapy.”

Mr. Singer had no financial conflicts to disclose. Study coauthor John S. Barbieri, MD, disclosed partial salary support from Pfizer and grand support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and Arash Mostaghimi, MD, disclosed personal fees from Pfizer.

SOURCE: Singer S et al. JAMA Dermatol. 2019. Jul 3. doi: 10.1001/jamadermatol.2019.1416.

Isotretinoin use may increase vulnerability to psychiatric conditions, but available evidence does not support a causal relationship, on the basis of data from a retrospective study of 17,829 psychiatric adverse events reported to the Food and Drug Administration over 2 decades.

“Although one study highlighted consistent reporting of depression and suicide in patients taking isotretinoin in the United States from 1982 to 2000, few studies have examined reports of psychiatric adverse events at the national level since 2000,” wrote Sean Singer of Harvard University, Boston, and his colleagues.

In a study published in JAMA Dermatology, the researchers reviewed data from the FDA’s Adverse Event Reporting System between 1997 and 2017.

A total of 17,829 psychiatric adverse events in which isotretinoin was the primary suspect drug were reported during the study period. The researchers classified the events into 12 categories; the most common were depressive disorders (42%), emotional lability (17%), and anxiety (14%). The number of reported psychiatric adverse events was similar between men and women (8,936 and 8,362 events, respectively).

The researchers also identified 2,278 reports of suicidal ideation, 602 reports of attempted suicide, and 368 reports of completed suicide.

In addition, the researchers examined data from the iPLEDGE program and found completed suicide rates of 8.4 per 100,000 patients in 2009 and 5.6 per 100,000 patients in 2010. However, these rates were lower than national suicide rates in the general population of 11.8 per 100,000 people in 2009 and 12.1 per 100,000 people in 2010.

Patient age was available for 13,553 adverse event reports, and patients aged 10-19 years accounted for 53% of the reports overall and 58% of completed suicides for which age was reported.

The high number of psychiatric adverse events in the youngest age group “could reflect more isotretinoin prescriptions in this age group or may suggest that teenagers are particularly vulnerable to psychiatric adverse events while taking isotretinoin,” the researchers said.

The findings were limited by several factors, including the reliance on proper clinician reports to the Adverse Event Reporting System database and the separation of some psychiatric terms into categories that may reflect symptoms of other psychiatric diagnoses, the researchers said.

However, “Our data showed high numbers of reports of emotional lability, anxiety disorders, insomnia, self-injurious behavior, and psychotic disorders with isotretinoin as the primary suspect drug,” they noted.

“Although no causal link has been established between isotretinoin and psychiatric adverse events, it is important to recognize that there are data that suggest patients using this drug may be vulnerable to a number of psychiatric conditions” and that monthly iPLEDGE visits are an opportunity to screen patients for these conditions, they said.

They also stressed that “the risk of psychiatric adverse events in patients taking isotretinoin must be considered in the context of a known increased risk of suicidal ideation in patients with acne independent of isotretinoin therapy.”

Mr. Singer had no financial conflicts to disclose. Study coauthor John S. Barbieri, MD, disclosed partial salary support from Pfizer and grand support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and Arash Mostaghimi, MD, disclosed personal fees from Pfizer.

SOURCE: Singer S et al. JAMA Dermatol. 2019. Jul 3. doi: 10.1001/jamadermatol.2019.1416.

Isotretinoin use may increase vulnerability to psychiatric conditions, but available evidence does not support a causal relationship, on the basis of data from a retrospective study of 17,829 psychiatric adverse events reported to the Food and Drug Administration over 2 decades.

“Although one study highlighted consistent reporting of depression and suicide in patients taking isotretinoin in the United States from 1982 to 2000, few studies have examined reports of psychiatric adverse events at the national level since 2000,” wrote Sean Singer of Harvard University, Boston, and his colleagues.

In a study published in JAMA Dermatology, the researchers reviewed data from the FDA’s Adverse Event Reporting System between 1997 and 2017.

A total of 17,829 psychiatric adverse events in which isotretinoin was the primary suspect drug were reported during the study period. The researchers classified the events into 12 categories; the most common were depressive disorders (42%), emotional lability (17%), and anxiety (14%). The number of reported psychiatric adverse events was similar between men and women (8,936 and 8,362 events, respectively).

The researchers also identified 2,278 reports of suicidal ideation, 602 reports of attempted suicide, and 368 reports of completed suicide.

In addition, the researchers examined data from the iPLEDGE program and found completed suicide rates of 8.4 per 100,000 patients in 2009 and 5.6 per 100,000 patients in 2010. However, these rates were lower than national suicide rates in the general population of 11.8 per 100,000 people in 2009 and 12.1 per 100,000 people in 2010.

Patient age was available for 13,553 adverse event reports, and patients aged 10-19 years accounted for 53% of the reports overall and 58% of completed suicides for which age was reported.

The high number of psychiatric adverse events in the youngest age group “could reflect more isotretinoin prescriptions in this age group or may suggest that teenagers are particularly vulnerable to psychiatric adverse events while taking isotretinoin,” the researchers said.

The findings were limited by several factors, including the reliance on proper clinician reports to the Adverse Event Reporting System database and the separation of some psychiatric terms into categories that may reflect symptoms of other psychiatric diagnoses, the researchers said.

However, “Our data showed high numbers of reports of emotional lability, anxiety disorders, insomnia, self-injurious behavior, and psychotic disorders with isotretinoin as the primary suspect drug,” they noted.

“Although no causal link has been established between isotretinoin and psychiatric adverse events, it is important to recognize that there are data that suggest patients using this drug may be vulnerable to a number of psychiatric conditions” and that monthly iPLEDGE visits are an opportunity to screen patients for these conditions, they said.

They also stressed that “the risk of psychiatric adverse events in patients taking isotretinoin must be considered in the context of a known increased risk of suicidal ideation in patients with acne independent of isotretinoin therapy.”

Mr. Singer had no financial conflicts to disclose. Study coauthor John S. Barbieri, MD, disclosed partial salary support from Pfizer and grand support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and Arash Mostaghimi, MD, disclosed personal fees from Pfizer.

SOURCE: Singer S et al. JAMA Dermatol. 2019. Jul 3. doi: 10.1001/jamadermatol.2019.1416.

MILAN – Health-related quality of life improved for patients with moderate to severe genital psoriasis while they received ixekizumab, according to data presented at the World Congress of Dermatology.

After 12 weeks of ixekizumab administration, nearly half of patients who received ixekizumab in the randomized, double-blind, placebo-controlled trial achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, compared with fewer than 5% of those receiving placebo. At the end of one year, 46.7% of the original ixekizumab group and 50.8% of those who transitioned to ixekizumab from placebo via an open-label extension arm achieved a DLQI of 0 or 1. A DLQI score of 0 or 1 on a 30-point scale indicated that psoriasis had no effect on health-related quality of life.

Among patients with plaque psoriasis, genital involvement is common – present in over 60% at some point during the disease course, Lyn Guenther, MD, of Guenther Dermatology Research Centre, London, Ont., and her colleagues wrote in the poster accompanying the presentation. Sexual health and overall quality of life can be negatively affected by genital psoriasis, they added.

In the study, adult patients were included if they had chronic plaque psoriasis present in genital and nongenital areas. For overall psoriasis and genital involvement, the Static Physician’s Global Assessment (sPGA) was 3 or greater, and total body surface area involvement was at least 1%. Also, patients had to have failed or been intolerant to at least one topical therapy for genital psoriasis.

Patients were excluded if they had genital pustules or vesicles, significant uncontrolled medical or psychiatric comorbidities, recent infection, or prior interleukin-17 antagonist treatment.

In all, patients received ixekizumab 160 mg (75 patients) or placebo (74) subcutaneously every 2 weeks during the initial 12-week study period. For the open-label extension arm, 74 patients in the active arm and 65 patients in the placebo arm went on to receive 80 mg of ixekizumab every 4 weeks, with a step-up option to every other week dosing depending on clinical response.

Patients were given the Short Form Health Survey (SF-36) at baseline and at week 12 and week 52; investigators recorded the mean change for baseline for both the physical and mental component.

Participants also completed the DLQI, which was administered nine times over the 52-week study period.

From baseline, SF-36 scores climbed in both the physical and mental domains for those on ixekizumab, wrote Dr. Guenther and her coinvestigators, with “improvements in all SF-36 domains” for those on ixekizumab at 12 weeks, which continued through week 52. For patients who transitioned to ixekizumab from placebo, “improvements in all SF-36 domains were achieved at week 52,” they wrote.

The mean change from baseline on the SF-36 for the ixekizumab population was 3.5 on the physical domain and 4.8 on the mental component. For the placebo-ixekizumab group, scores improved by a mean 4.5 on the physical domain and 4.9 on the mental domain. Those who stayed on ixekizumab saw some decline in SF-36 scores, with a physical component improvement of 2.5 and mental component improvement of 3.6 at 52 weeks.

Ixekizumab (Taltz), a monoclonal antibody targeting interleukin-17A, is approved for moderate to severe plaque psoriasis, and active psoriatic arthritis..

“Ixekizumab provided clinically meaningful and persistent improvements in HRQoL in patients with moderate to severe genital psoriasis,” wrote Dr. Guenther and her colleagues.

Dr. Guenther and two coauthors reported receiving remuneration from several pharmaceutical companies, including Eli Lilly, which funded the study. Four coauthors are employees and shareholders of Eli Lilly.

[email protected]

MILAN – Health-related quality of life improved for patients with moderate to severe genital psoriasis while they received ixekizumab, according to data presented at the World Congress of Dermatology.

After 12 weeks of ixekizumab administration, nearly half of patients who received ixekizumab in the randomized, double-blind, placebo-controlled trial achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, compared with fewer than 5% of those receiving placebo. At the end of one year, 46.7% of the original ixekizumab group and 50.8% of those who transitioned to ixekizumab from placebo via an open-label extension arm achieved a DLQI of 0 or 1. A DLQI score of 0 or 1 on a 30-point scale indicated that psoriasis had no effect on health-related quality of life.

Among patients with plaque psoriasis, genital involvement is common – present in over 60% at some point during the disease course, Lyn Guenther, MD, of Guenther Dermatology Research Centre, London, Ont., and her colleagues wrote in the poster accompanying the presentation. Sexual health and overall quality of life can be negatively affected by genital psoriasis, they added.

In the study, adult patients were included if they had chronic plaque psoriasis present in genital and nongenital areas. For overall psoriasis and genital involvement, the Static Physician’s Global Assessment (sPGA) was 3 or greater, and total body surface area involvement was at least 1%. Also, patients had to have failed or been intolerant to at least one topical therapy for genital psoriasis.

Patients were excluded if they had genital pustules or vesicles, significant uncontrolled medical or psychiatric comorbidities, recent infection, or prior interleukin-17 antagonist treatment.

In all, patients received ixekizumab 160 mg (75 patients) or placebo (74) subcutaneously every 2 weeks during the initial 12-week study period. For the open-label extension arm, 74 patients in the active arm and 65 patients in the placebo arm went on to receive 80 mg of ixekizumab every 4 weeks, with a step-up option to every other week dosing depending on clinical response.

Patients were given the Short Form Health Survey (SF-36) at baseline and at week 12 and week 52; investigators recorded the mean change for baseline for both the physical and mental component.

Participants also completed the DLQI, which was administered nine times over the 52-week study period.

From baseline, SF-36 scores climbed in both the physical and mental domains for those on ixekizumab, wrote Dr. Guenther and her coinvestigators, with “improvements in all SF-36 domains” for those on ixekizumab at 12 weeks, which continued through week 52. For patients who transitioned to ixekizumab from placebo, “improvements in all SF-36 domains were achieved at week 52,” they wrote.

The mean change from baseline on the SF-36 for the ixekizumab population was 3.5 on the physical domain and 4.8 on the mental component. For the placebo-ixekizumab group, scores improved by a mean 4.5 on the physical domain and 4.9 on the mental domain. Those who stayed on ixekizumab saw some decline in SF-36 scores, with a physical component improvement of 2.5 and mental component improvement of 3.6 at 52 weeks.

Ixekizumab (Taltz), a monoclonal antibody targeting interleukin-17A, is approved for moderate to severe plaque psoriasis, and active psoriatic arthritis..

“Ixekizumab provided clinically meaningful and persistent improvements in HRQoL in patients with moderate to severe genital psoriasis,” wrote Dr. Guenther and her colleagues.

Dr. Guenther and two coauthors reported receiving remuneration from several pharmaceutical companies, including Eli Lilly, which funded the study. Four coauthors are employees and shareholders of Eli Lilly.

[email protected]

MILAN – Health-related quality of life improved for patients with moderate to severe genital psoriasis while they received ixekizumab, according to data presented at the World Congress of Dermatology.

After 12 weeks of ixekizumab administration, nearly half of patients who received ixekizumab in the randomized, double-blind, placebo-controlled trial achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, compared with fewer than 5% of those receiving placebo. At the end of one year, 46.7% of the original ixekizumab group and 50.8% of those who transitioned to ixekizumab from placebo via an open-label extension arm achieved a DLQI of 0 or 1. A DLQI score of 0 or 1 on a 30-point scale indicated that psoriasis had no effect on health-related quality of life.

Among patients with plaque psoriasis, genital involvement is common – present in over 60% at some point during the disease course, Lyn Guenther, MD, of Guenther Dermatology Research Centre, London, Ont., and her colleagues wrote in the poster accompanying the presentation. Sexual health and overall quality of life can be negatively affected by genital psoriasis, they added.

In the study, adult patients were included if they had chronic plaque psoriasis present in genital and nongenital areas. For overall psoriasis and genital involvement, the Static Physician’s Global Assessment (sPGA) was 3 or greater, and total body surface area involvement was at least 1%. Also, patients had to have failed or been intolerant to at least one topical therapy for genital psoriasis.

Patients were excluded if they had genital pustules or vesicles, significant uncontrolled medical or psychiatric comorbidities, recent infection, or prior interleukin-17 antagonist treatment.

In all, patients received ixekizumab 160 mg (75 patients) or placebo (74) subcutaneously every 2 weeks during the initial 12-week study period. For the open-label extension arm, 74 patients in the active arm and 65 patients in the placebo arm went on to receive 80 mg of ixekizumab every 4 weeks, with a step-up option to every other week dosing depending on clinical response.

Patients were given the Short Form Health Survey (SF-36) at baseline and at week 12 and week 52; investigators recorded the mean change for baseline for both the physical and mental component.

Participants also completed the DLQI, which was administered nine times over the 52-week study period.

From baseline, SF-36 scores climbed in both the physical and mental domains for those on ixekizumab, wrote Dr. Guenther and her coinvestigators, with “improvements in all SF-36 domains” for those on ixekizumab at 12 weeks, which continued through week 52. For patients who transitioned to ixekizumab from placebo, “improvements in all SF-36 domains were achieved at week 52,” they wrote.

The mean change from baseline on the SF-36 for the ixekizumab population was 3.5 on the physical domain and 4.8 on the mental component. For the placebo-ixekizumab group, scores improved by a mean 4.5 on the physical domain and 4.9 on the mental domain. Those who stayed on ixekizumab saw some decline in SF-36 scores, with a physical component improvement of 2.5 and mental component improvement of 3.6 at 52 weeks.

Ixekizumab (Taltz), a monoclonal antibody targeting interleukin-17A, is approved for moderate to severe plaque psoriasis, and active psoriatic arthritis..

“Ixekizumab provided clinically meaningful and persistent improvements in HRQoL in patients with moderate to severe genital psoriasis,” wrote Dr. Guenther and her colleagues.

Dr. Guenther and two coauthors reported receiving remuneration from several pharmaceutical companies, including Eli Lilly, which funded the study. Four coauthors are employees and shareholders of Eli Lilly.

[email protected]

The tyrosine kinase inhibitor dasatinib was found to transiently inhibit CAR T-cell function in mice, suggesting applicability as an on-off control for CAR T-cell therapy, investigators report.

“In this study, we focused our efforts on evaluating dasatinib as a control drug for CAR T cells,” wrote Katrin Mestermann, PhD, of the University of Würzburg in Germany and colleagues in Science Translational Medicine.

The researchers explored the pharmacological effects of dasatinib on CAR T-cell function using a mouse xenograft model. In this model, dasatinib was administered every 6 hours to sustain serum levels above a mandatory threshold to ensure human pharmacokinetic equivalence.

The team observed that dasatinib interferes with several cellular mechanisms that effect CAR T-cell activity, including inhibition of protein phosphorylation and cytokine secretion, among others.

Short-term administration of dasatinib was shown to not alter antilymphoma activity of CD19-CAR T cells, according to data from in vivo experiments.

In addition, upon cessation of dasatinib, CAR T-cell antitumor activity was rapidly restored, based on in vitro experiment data.

Dr. Mestermann and her colleagues also noted that the dose of dasatinib was titratable to attain either partial or complete inhibition of CAR T-cell activity. These effects could be maintained for several days without altering T-cell survival.

“A short treatment course of dasatinib, administered early after CAR T-cell infusion, protects a proportion of mice from otherwise fatal cytokine release syndrome,” the researchers wrote.

Cytokine release syndrome is the most frequently seen acute toxicity linked to CAR T-cell therapy, they explained.

“Further studies are warranted to determine whether dasatinib is also effective in clinical situations with established cytokine release syndrome,” they concluded.

The study was funded by the Cluster Biotechnologie Bayern and Free State of Bavaria, the German Cancer Aid, and the University of Würzburg. The authors reported financial affiliations with Amgen, Bristol-Myers Squibb, Celgene, Janssen, Novartis, Takeda, and others.

SOURCE: Mestermann K et al. Sci Transl Med. 2019 Jul 3. doi: 10.1126/scitranslmed.aau5907.

The tyrosine kinase inhibitor dasatinib was found to transiently inhibit CAR T-cell function in mice, suggesting applicability as an on-off control for CAR T-cell therapy, investigators report.

“In this study, we focused our efforts on evaluating dasatinib as a control drug for CAR T cells,” wrote Katrin Mestermann, PhD, of the University of Würzburg in Germany and colleagues in Science Translational Medicine.

The researchers explored the pharmacological effects of dasatinib on CAR T-cell function using a mouse xenograft model. In this model, dasatinib was administered every 6 hours to sustain serum levels above a mandatory threshold to ensure human pharmacokinetic equivalence.

The team observed that dasatinib interferes with several cellular mechanisms that effect CAR T-cell activity, including inhibition of protein phosphorylation and cytokine secretion, among others.

Short-term administration of dasatinib was shown to not alter antilymphoma activity of CD19-CAR T cells, according to data from in vivo experiments.

In addition, upon cessation of dasatinib, CAR T-cell antitumor activity was rapidly restored, based on in vitro experiment data.

Dr. Mestermann and her colleagues also noted that the dose of dasatinib was titratable to attain either partial or complete inhibition of CAR T-cell activity. These effects could be maintained for several days without altering T-cell survival.

“A short treatment course of dasatinib, administered early after CAR T-cell infusion, protects a proportion of mice from otherwise fatal cytokine release syndrome,” the researchers wrote.

Cytokine release syndrome is the most frequently seen acute toxicity linked to CAR T-cell therapy, they explained.

“Further studies are warranted to determine whether dasatinib is also effective in clinical situations with established cytokine release syndrome,” they concluded.

The study was funded by the Cluster Biotechnologie Bayern and Free State of Bavaria, the German Cancer Aid, and the University of Würzburg. The authors reported financial affiliations with Amgen, Bristol-Myers Squibb, Celgene, Janssen, Novartis, Takeda, and others.

SOURCE: Mestermann K et al. Sci Transl Med. 2019 Jul 3. doi: 10.1126/scitranslmed.aau5907.

The tyrosine kinase inhibitor dasatinib was found to transiently inhibit CAR T-cell function in mice, suggesting applicability as an on-off control for CAR T-cell therapy, investigators report.

“In this study, we focused our efforts on evaluating dasatinib as a control drug for CAR T cells,” wrote Katrin Mestermann, PhD, of the University of Würzburg in Germany and colleagues in Science Translational Medicine.

The researchers explored the pharmacological effects of dasatinib on CAR T-cell function using a mouse xenograft model. In this model, dasatinib was administered every 6 hours to sustain serum levels above a mandatory threshold to ensure human pharmacokinetic equivalence.

The team observed that dasatinib interferes with several cellular mechanisms that effect CAR T-cell activity, including inhibition of protein phosphorylation and cytokine secretion, among others.

Short-term administration of dasatinib was shown to not alter antilymphoma activity of CD19-CAR T cells, according to data from in vivo experiments.

In addition, upon cessation of dasatinib, CAR T-cell antitumor activity was rapidly restored, based on in vitro experiment data.

Dr. Mestermann and her colleagues also noted that the dose of dasatinib was titratable to attain either partial or complete inhibition of CAR T-cell activity. These effects could be maintained for several days without altering T-cell survival.

“A short treatment course of dasatinib, administered early after CAR T-cell infusion, protects a proportion of mice from otherwise fatal cytokine release syndrome,” the researchers wrote.

Cytokine release syndrome is the most frequently seen acute toxicity linked to CAR T-cell therapy, they explained.

“Further studies are warranted to determine whether dasatinib is also effective in clinical situations with established cytokine release syndrome,” they concluded.

The study was funded by the Cluster Biotechnologie Bayern and Free State of Bavaria, the German Cancer Aid, and the University of Würzburg. The authors reported financial affiliations with Amgen, Bristol-Myers Squibb, Celgene, Janssen, Novartis, Takeda, and others.

SOURCE: Mestermann K et al. Sci Transl Med. 2019 Jul 3. doi: 10.1126/scitranslmed.aau5907.

AMSTERDAM – Rituximab maintenance therapy did not significantly prolong disease-free survival among patients with diffuse large B-cell lymphoma in complete remission after induction chemotherapy, investigators in the HOVON-Nordic trial collaboration found.

Among 380 patients with diffuse large B-cell lymphoma (DLBCL) in complete remission following induction chemotherapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), the median disease-free survival (DFS) after a median follow-up of 79.9 months had not been reached for patients randomized to either rituximab maintenance therapy or observation alone, reported Pieternella J. Lugtenburg, MD, PhD, from Erasmus Medical Center in Rotterdam, the Netherlands.

“In patients with diffuse large B-cell lymphoma in first complete remission after R-CHOP induction therapy, rituximab maintenance therapy does not prolong disease-free survival, and we could not identify a clinical subgroup that benefited,” she said at the annual congress of the European Hematology Association.

The randomized, phase 3 HOVON-Nordic LG trial compared R-CHOP-14 with rituximab delivered on day 1 for four cycles in one arm, and on days 1 and 8 in the comparison arm (R2-CHOP). Patients were assessed for response after four cycles, and those with progressive disease were taken off the study. The remaining patients continued on their assigned regimen for an additional four cycles and second assessment, and those who had complete responses then underwent a second randomization to rituximab maintenance or observation. Patients randomized to maintenance could receive up to 12 8-week cycles.

The second randomization was stratified by age (18-65 vs. 66-80 years), age-adjusted International Prognostic Index score, and R-CHOP regimen (one or two infusions per cycle in the first randomization).

The induction phase found no significant benefit for the additional rituximab infusion for the primary endpoint of progression-free survival, with 3-year PFS rates of 74% for R-CHOP and 71% for R2-CHOP. Respective 5-year PFS rates were 68% and 62%.

There were no differences between the arms by any of the stratification factors, and no difference in overall survival.

Dr. Lugtenburg presented results of the maintenance phase, which included all patients in complete remission at least 4 weeks after the last cycle of R-CHOP-14 who did not have rituximab-related adverse events or active infections.

A total of 195 patients were randomized to observation, and 185 to maintenance. Of this latter group, 149 patients received all 12 cycles, with a median duration of exposure of 22.5 months.

As noted, DFS, the primary endpoint for the maintenance phase, was not significantly different between the arms, with 136 events in the maintenance arm versus 134 in the observation arm. A total of 21 patients assigned to maintenance died, and 22 patients assigned to observation died during follow-up.

The respective 5-year DFS rates were 79% and 74%, a difference that was not statistically significant.

There were no significant differences between the arms in either time to relapse or death, and no difference in overall survival.

In the question-and-answer section following her talk, Marek Trnený, MD, from Charles University in Prague, pointed out that, in the NHL 13 study, which looked at rituximab maintenance for patients with DLBCL or follicular lymphoma in first remission, there was an apparent clinical benefit with rituximab maintenance for men with low International Prognostic Index scores, and asked whether Dr. Lugtenburg and colleagues had seen similar trends.

“We knew about this finding, and we really didn’t see any differences between males and females, not only in terms of efficacy, but also in terms of toxicity, they had actually the same rates of toxicity,” she said.

In NHL 13, women had a significantly higher incidence of grade 3-4 adverse events, compared with men.

The study was sponsored by HOVON, the HematoOncology Foundation for Adults in the Netherlands, with additional support from Roche. Dr. Lugtenburg reported consultancy for and research funding from Roche and others. Dr. Trnený reported advisory board activity, research support, and honoraria from Roche and others.

SOURCE: Lugtenburg PJ et al. EHA 2019, Abstract S1559.

AMSTERDAM – Rituximab maintenance therapy did not significantly prolong disease-free survival among patients with diffuse large B-cell lymphoma in complete remission after induction chemotherapy, investigators in the HOVON-Nordic trial collaboration found.

Among 380 patients with diffuse large B-cell lymphoma (DLBCL) in complete remission following induction chemotherapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), the median disease-free survival (DFS) after a median follow-up of 79.9 months had not been reached for patients randomized to either rituximab maintenance therapy or observation alone, reported Pieternella J. Lugtenburg, MD, PhD, from Erasmus Medical Center in Rotterdam, the Netherlands.

“In patients with diffuse large B-cell lymphoma in first complete remission after R-CHOP induction therapy, rituximab maintenance therapy does not prolong disease-free survival, and we could not identify a clinical subgroup that benefited,” she said at the annual congress of the European Hematology Association.

The randomized, phase 3 HOVON-Nordic LG trial compared R-CHOP-14 with rituximab delivered on day 1 for four cycles in one arm, and on days 1 and 8 in the comparison arm (R2-CHOP). Patients were assessed for response after four cycles, and those with progressive disease were taken off the study. The remaining patients continued on their assigned regimen for an additional four cycles and second assessment, and those who had complete responses then underwent a second randomization to rituximab maintenance or observation. Patients randomized to maintenance could receive up to 12 8-week cycles.

The second randomization was stratified by age (18-65 vs. 66-80 years), age-adjusted International Prognostic Index score, and R-CHOP regimen (one or two infusions per cycle in the first randomization).

The induction phase found no significant benefit for the additional rituximab infusion for the primary endpoint of progression-free survival, with 3-year PFS rates of 74% for R-CHOP and 71% for R2-CHOP. Respective 5-year PFS rates were 68% and 62%.

There were no differences between the arms by any of the stratification factors, and no difference in overall survival.

Dr. Lugtenburg presented results of the maintenance phase, which included all patients in complete remission at least 4 weeks after the last cycle of R-CHOP-14 who did not have rituximab-related adverse events or active infections.

A total of 195 patients were randomized to observation, and 185 to maintenance. Of this latter group, 149 patients received all 12 cycles, with a median duration of exposure of 22.5 months.

As noted, DFS, the primary endpoint for the maintenance phase, was not significantly different between the arms, with 136 events in the maintenance arm versus 134 in the observation arm. A total of 21 patients assigned to maintenance died, and 22 patients assigned to observation died during follow-up.

The respective 5-year DFS rates were 79% and 74%, a difference that was not statistically significant.

There were no significant differences between the arms in either time to relapse or death, and no difference in overall survival.

In the question-and-answer section following her talk, Marek Trnený, MD, from Charles University in Prague, pointed out that, in the NHL 13 study, which looked at rituximab maintenance for patients with DLBCL or follicular lymphoma in first remission, there was an apparent clinical benefit with rituximab maintenance for men with low International Prognostic Index scores, and asked whether Dr. Lugtenburg and colleagues had seen similar trends.

“We knew about this finding, and we really didn’t see any differences between males and females, not only in terms of efficacy, but also in terms of toxicity, they had actually the same rates of toxicity,” she said.

In NHL 13, women had a significantly higher incidence of grade 3-4 adverse events, compared with men.

The study was sponsored by HOVON, the HematoOncology Foundation for Adults in the Netherlands, with additional support from Roche. Dr. Lugtenburg reported consultancy for and research funding from Roche and others. Dr. Trnený reported advisory board activity, research support, and honoraria from Roche and others.

SOURCE: Lugtenburg PJ et al. EHA 2019, Abstract S1559.

AMSTERDAM – Rituximab maintenance therapy did not significantly prolong disease-free survival among patients with diffuse large B-cell lymphoma in complete remission after induction chemotherapy, investigators in the HOVON-Nordic trial collaboration found.

Among 380 patients with diffuse large B-cell lymphoma (DLBCL) in complete remission following induction chemotherapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), the median disease-free survival (DFS) after a median follow-up of 79.9 months had not been reached for patients randomized to either rituximab maintenance therapy or observation alone, reported Pieternella J. Lugtenburg, MD, PhD, from Erasmus Medical Center in Rotterdam, the Netherlands.

“In patients with diffuse large B-cell lymphoma in first complete remission after R-CHOP induction therapy, rituximab maintenance therapy does not prolong disease-free survival, and we could not identify a clinical subgroup that benefited,” she said at the annual congress of the European Hematology Association.

The randomized, phase 3 HOVON-Nordic LG trial compared R-CHOP-14 with rituximab delivered on day 1 for four cycles in one arm, and on days 1 and 8 in the comparison arm (R2-CHOP). Patients were assessed for response after four cycles, and those with progressive disease were taken off the study. The remaining patients continued on their assigned regimen for an additional four cycles and second assessment, and those who had complete responses then underwent a second randomization to rituximab maintenance or observation. Patients randomized to maintenance could receive up to 12 8-week cycles.

The second randomization was stratified by age (18-65 vs. 66-80 years), age-adjusted International Prognostic Index score, and R-CHOP regimen (one or two infusions per cycle in the first randomization).

The induction phase found no significant benefit for the additional rituximab infusion for the primary endpoint of progression-free survival, with 3-year PFS rates of 74% for R-CHOP and 71% for R2-CHOP. Respective 5-year PFS rates were 68% and 62%.

There were no differences between the arms by any of the stratification factors, and no difference in overall survival.

Dr. Lugtenburg presented results of the maintenance phase, which included all patients in complete remission at least 4 weeks after the last cycle of R-CHOP-14 who did not have rituximab-related adverse events or active infections.

A total of 195 patients were randomized to observation, and 185 to maintenance. Of this latter group, 149 patients received all 12 cycles, with a median duration of exposure of 22.5 months.

As noted, DFS, the primary endpoint for the maintenance phase, was not significantly different between the arms, with 136 events in the maintenance arm versus 134 in the observation arm. A total of 21 patients assigned to maintenance died, and 22 patients assigned to observation died during follow-up.

The respective 5-year DFS rates were 79% and 74%, a difference that was not statistically significant.

There were no significant differences between the arms in either time to relapse or death, and no difference in overall survival.

In the question-and-answer section following her talk, Marek Trnený, MD, from Charles University in Prague, pointed out that, in the NHL 13 study, which looked at rituximab maintenance for patients with DLBCL or follicular lymphoma in first remission, there was an apparent clinical benefit with rituximab maintenance for men with low International Prognostic Index scores, and asked whether Dr. Lugtenburg and colleagues had seen similar trends.

“We knew about this finding, and we really didn’t see any differences between males and females, not only in terms of efficacy, but also in terms of toxicity, they had actually the same rates of toxicity,” she said.

In NHL 13, women had a significantly higher incidence of grade 3-4 adverse events, compared with men.

The study was sponsored by HOVON, the HematoOncology Foundation for Adults in the Netherlands, with additional support from Roche. Dr. Lugtenburg reported consultancy for and research funding from Roche and others. Dr. Trnený reported advisory board activity, research support, and honoraria from Roche and others.

SOURCE: Lugtenburg PJ et al. EHA 2019, Abstract S1559.

Radiation therapy could be safe as a bridging strategy for axicabtagene ciloleucel chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed/refractory diffuse large B-cell lymphoma, according to results from a case series.

“Effective bridging strategies may be needed to provide patients with aggressive disease access to CAR T therapy,” wrote Austin J. Sim MD, JD, of Moffitt Cancer Center in Tampa and colleagues. The findings were reported in the International Journal of Radiation Oncology, Biology, Physics.

The study included a total of 12 patients planned to receive bridging treatment with radiation prior to axicabtagene ciloleucel infusion. The cohort consisted of patients with highly aggressive disease, including six with double-hit lymphoma and six with disease 10 cm or greater in diameter.

Study participants received a radiation dose between 2 and 4 Gy per fraction to a median of 20 Gy (range, 6-36.5 Gy) and half of the participants received 20 Gy in 5 fractions or 30 Gy in 10 fractions. Of the 12 patients, 7 were administered concomitant chemotherapy.

“One patient who underwent apheresis and radiation therapy ultimately did not proceed with CAR T infusion, but was still included in our analysis,” the researchers noted.

After analysis, the researchers reported that, during bridging radiation therapy, no patients had significant toxicities or in-field disease progression of disease prior to CAR T infusion.

Post CAR T infusion, 27% of patients experienced neurotoxicity or severe cytokine release syndrome.

At 30 days, the objective response rate was 81.8%, with 27% attaining complete response. At final follow-up, the best response rate was 81.8%, with complete response achieved in 45% of patients.

The researchers acknowledged that a key limitation of the study was the retrospective design. As a result, radiation dosing was not uniform and the optimal dose and fractionation remains unclear.

In addition, Dr. Sim and colleagues advised that caution should be taken if irradiation is initiated before T-cell apheresis, and if so, blood counts should be monitored closely.

“Future investigation is warranted to optimize the use of bridging radiation before CAR T therapy,” they concluded.

No funding sources were reported. The authors reported financial affiliations with Atara Biotherapeutics, AstraZeneca, Celgene, GlaxoSmithKline, Novartis, Precision Biosciences, and several others.

SOURCE: Sim AJ et al. Int J Radiat Oncol Biol Phys. 2019 Jun 5. doi: 10.1016/j.ijrobp.2019.05.065.

Radiation therapy could be safe as a bridging strategy for axicabtagene ciloleucel chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed/refractory diffuse large B-cell lymphoma, according to results from a case series.

“Effective bridging strategies may be needed to provide patients with aggressive disease access to CAR T therapy,” wrote Austin J. Sim MD, JD, of Moffitt Cancer Center in Tampa and colleagues. The findings were reported in the International Journal of Radiation Oncology, Biology, Physics.

The study included a total of 12 patients planned to receive bridging treatment with radiation prior to axicabtagene ciloleucel infusion. The cohort consisted of patients with highly aggressive disease, including six with double-hit lymphoma and six with disease 10 cm or greater in diameter.

Study participants received a radiation dose between 2 and 4 Gy per fraction to a median of 20 Gy (range, 6-36.5 Gy) and half of the participants received 20 Gy in 5 fractions or 30 Gy in 10 fractions. Of the 12 patients, 7 were administered concomitant chemotherapy.

“One patient who underwent apheresis and radiation therapy ultimately did not proceed with CAR T infusion, but was still included in our analysis,” the researchers noted.

After analysis, the researchers reported that, during bridging radiation therapy, no patients had significant toxicities or in-field disease progression of disease prior to CAR T infusion.

Post CAR T infusion, 27% of patients experienced neurotoxicity or severe cytokine release syndrome.

At 30 days, the objective response rate was 81.8%, with 27% attaining complete response. At final follow-up, the best response rate was 81.8%, with complete response achieved in 45% of patients.

The researchers acknowledged that a key limitation of the study was the retrospective design. As a result, radiation dosing was not uniform and the optimal dose and fractionation remains unclear.

In addition, Dr. Sim and colleagues advised that caution should be taken if irradiation is initiated before T-cell apheresis, and if so, blood counts should be monitored closely.

“Future investigation is warranted to optimize the use of bridging radiation before CAR T therapy,” they concluded.

No funding sources were reported. The authors reported financial affiliations with Atara Biotherapeutics, AstraZeneca, Celgene, GlaxoSmithKline, Novartis, Precision Biosciences, and several others.

SOURCE: Sim AJ et al. Int J Radiat Oncol Biol Phys. 2019 Jun 5. doi: 10.1016/j.ijrobp.2019.05.065.

Radiation therapy could be safe as a bridging strategy for axicabtagene ciloleucel chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed/refractory diffuse large B-cell lymphoma, according to results from a case series.

“Effective bridging strategies may be needed to provide patients with aggressive disease access to CAR T therapy,” wrote Austin J. Sim MD, JD, of Moffitt Cancer Center in Tampa and colleagues. The findings were reported in the International Journal of Radiation Oncology, Biology, Physics.

The study included a total of 12 patients planned to receive bridging treatment with radiation prior to axicabtagene ciloleucel infusion. The cohort consisted of patients with highly aggressive disease, including six with double-hit lymphoma and six with disease 10 cm or greater in diameter.

Study participants received a radiation dose between 2 and 4 Gy per fraction to a median of 20 Gy (range, 6-36.5 Gy) and half of the participants received 20 Gy in 5 fractions or 30 Gy in 10 fractions. Of the 12 patients, 7 were administered concomitant chemotherapy.

“One patient who underwent apheresis and radiation therapy ultimately did not proceed with CAR T infusion, but was still included in our analysis,” the researchers noted.

After analysis, the researchers reported that, during bridging radiation therapy, no patients had significant toxicities or in-field disease progression of disease prior to CAR T infusion.

Post CAR T infusion, 27% of patients experienced neurotoxicity or severe cytokine release syndrome.

At 30 days, the objective response rate was 81.8%, with 27% attaining complete response. At final follow-up, the best response rate was 81.8%, with complete response achieved in 45% of patients.

The researchers acknowledged that a key limitation of the study was the retrospective design. As a result, radiation dosing was not uniform and the optimal dose and fractionation remains unclear.

In addition, Dr. Sim and colleagues advised that caution should be taken if irradiation is initiated before T-cell apheresis, and if so, blood counts should be monitored closely.

“Future investigation is warranted to optimize the use of bridging radiation before CAR T therapy,” they concluded.

No funding sources were reported. The authors reported financial affiliations with Atara Biotherapeutics, AstraZeneca, Celgene, GlaxoSmithKline, Novartis, Precision Biosciences, and several others.

SOURCE: Sim AJ et al. Int J Radiat Oncol Biol Phys. 2019 Jun 5. doi: 10.1016/j.ijrobp.2019.05.065.

Combination polatuzumab vedotin and immunochemotherapy showed manageable safety and positive clinical outcomes in patients with previously untreated diffuse large B-cell lymphoma, according to preliminary results from a phase 1b-2 trial.

Polatuzumab vedotin has already shown single-agent activity in relapsed/refractory diffuse large B-cell lymphoma, Hervé Tilly, MD, PhD, of the University of Rouen (France), and colleagues wrote in Lancet Oncology. “We explored the combination of polatuzumab vedotin with either rituximab, cyclophosphamide, doxorubicin, and prednisone [R-CHP] or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone [G-CHP].”

With respect to polatuzumab vedotin dosing, the maximum investigated dose was 1.8 mg/kg. The novel agent was infused on day 2 of cycles 1 and 2 and subsequently on day 1 of each cycle thereafter for a total of 6-8 cycles, with each cycle lasting of 21 days.

The primary outcomes of this ongoing study were treatment safety and tolerability, as well as the establishment of recommended phase 2 dosing. Secondary endpoints included overall response rate, complete response=, among others.

A total of 82 patients were included in final analysis, 25 in the phase 1b dose escalation phase and 57 in the expansion phase.

After analysis, Dr. Tilly and his colleagues reported two dose-limiting toxicities: One patient experienced a grade 4 pulmonary embolism (1.8 mg/kg plus R-CHP) and another had grade 4 febrile neutropenia and grade 3 thrombocytopenia (1.4 mg/kg plus G-CHP).

At a median follow-up of 21.5 months, the overall response rate was 89% in study participants, including 77% of patients who achieved a complete response and 12% who had a partial response.

The recommended phase 2 dose of polatuzumab vedotin was 1.8 mg/kg. At this dose, the most common grade 3 or higher toxicities were neutropenia (30%), febrile neutropenia (18%), and thrombocytopenia (9%).

The researchers acknowledged a key limitation of the study was the nonrandomized design. As a result, dose and regimen comparisons could not be made.

The study was funded by F. Hoffmann-La Roche and Genentech. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Celgene, Gilead, Janssen, Merck, Pfizer, and others.

SOURCE: Tilly H et al. Lancet Oncol. 2019 May 14. doi: 10.1016/S1470-2045(19)30091-9.

Combination polatuzumab vedotin and immunochemotherapy showed manageable safety and positive clinical outcomes in patients with previously untreated diffuse large B-cell lymphoma, according to preliminary results from a phase 1b-2 trial.

Polatuzumab vedotin has already shown single-agent activity in relapsed/refractory diffuse large B-cell lymphoma, Hervé Tilly, MD, PhD, of the University of Rouen (France), and colleagues wrote in Lancet Oncology. “We explored the combination of polatuzumab vedotin with either rituximab, cyclophosphamide, doxorubicin, and prednisone [R-CHP] or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone [G-CHP].”

With respect to polatuzumab vedotin dosing, the maximum investigated dose was 1.8 mg/kg. The novel agent was infused on day 2 of cycles 1 and 2 and subsequently on day 1 of each cycle thereafter for a total of 6-8 cycles, with each cycle lasting of 21 days.

The primary outcomes of this ongoing study were treatment safety and tolerability, as well as the establishment of recommended phase 2 dosing. Secondary endpoints included overall response rate, complete response=, among others.

A total of 82 patients were included in final analysis, 25 in the phase 1b dose escalation phase and 57 in the expansion phase.

After analysis, Dr. Tilly and his colleagues reported two dose-limiting toxicities: One patient experienced a grade 4 pulmonary embolism (1.8 mg/kg plus R-CHP) and another had grade 4 febrile neutropenia and grade 3 thrombocytopenia (1.4 mg/kg plus G-CHP).

At a median follow-up of 21.5 months, the overall response rate was 89% in study participants, including 77% of patients who achieved a complete response and 12% who had a partial response.

The recommended phase 2 dose of polatuzumab vedotin was 1.8 mg/kg. At this dose, the most common grade 3 or higher toxicities were neutropenia (30%), febrile neutropenia (18%), and thrombocytopenia (9%).

The researchers acknowledged a key limitation of the study was the nonrandomized design. As a result, dose and regimen comparisons could not be made.

The study was funded by F. Hoffmann-La Roche and Genentech. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Celgene, Gilead, Janssen, Merck, Pfizer, and others.

SOURCE: Tilly H et al. Lancet Oncol. 2019 May 14. doi: 10.1016/S1470-2045(19)30091-9.

Combination polatuzumab vedotin and immunochemotherapy showed manageable safety and positive clinical outcomes in patients with previously untreated diffuse large B-cell lymphoma, according to preliminary results from a phase 1b-2 trial.

Polatuzumab vedotin has already shown single-agent activity in relapsed/refractory diffuse large B-cell lymphoma, Hervé Tilly, MD, PhD, of the University of Rouen (France), and colleagues wrote in Lancet Oncology. “We explored the combination of polatuzumab vedotin with either rituximab, cyclophosphamide, doxorubicin, and prednisone [R-CHP] or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone [G-CHP].”

With respect to polatuzumab vedotin dosing, the maximum investigated dose was 1.8 mg/kg. The novel agent was infused on day 2 of cycles 1 and 2 and subsequently on day 1 of each cycle thereafter for a total of 6-8 cycles, with each cycle lasting of 21 days.

The primary outcomes of this ongoing study were treatment safety and tolerability, as well as the establishment of recommended phase 2 dosing. Secondary endpoints included overall response rate, complete response=, among others.

A total of 82 patients were included in final analysis, 25 in the phase 1b dose escalation phase and 57 in the expansion phase.

After analysis, Dr. Tilly and his colleagues reported two dose-limiting toxicities: One patient experienced a grade 4 pulmonary embolism (1.8 mg/kg plus R-CHP) and another had grade 4 febrile neutropenia and grade 3 thrombocytopenia (1.4 mg/kg plus G-CHP).

At a median follow-up of 21.5 months, the overall response rate was 89% in study participants, including 77% of patients who achieved a complete response and 12% who had a partial response.

The recommended phase 2 dose of polatuzumab vedotin was 1.8 mg/kg. At this dose, the most common grade 3 or higher toxicities were neutropenia (30%), febrile neutropenia (18%), and thrombocytopenia (9%).

The researchers acknowledged a key limitation of the study was the nonrandomized design. As a result, dose and regimen comparisons could not be made.

The study was funded by F. Hoffmann-La Roche and Genentech. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Celgene, Gilead, Janssen, Merck, Pfizer, and others.

SOURCE: Tilly H et al. Lancet Oncol. 2019 May 14. doi: 10.1016/S1470-2045(19)30091-9.

Annual influenza vaccination rates and documentation of vaccination status appear to be suboptimal among patients with newly diagnosed diffuse large B-cell lymphoma, based on a retrospective analysis of data in the state of Georgia.

The researchers reviewed medical records of patients with a new diagnosis of diffuse large B-cell lymphoma at three Georgia hospitals. Documentation related to vaccine administration, refusal, and patient counseling was collected between Feb. 1, 2015, and Oct. 31, 2017, Andres Chang, MD, PhD, of Emory University, Atlanta, and colleagues wrote. The findings were published in Clinical Lymphoma, Myeloma & Leukemia.

Vaccination status within 1 year of diagnosis was documented for 61 of 107 patients. Among the 61 patients with documentation of influenza vaccination status, 35 (57%) were vaccinated. No reason was documented for vaccine refusal, and there was no follow-up documentation on vaccine counseling by nursing staff, physicians, or advanced practice providers in any of these admitted patients.

Nearly all documentation of influenza vaccination status came from the nursing staff. Only 4 of the 61 patients had documentation provided by primary oncologists or advanced practice providers, and those patients also had documentation from the outpatient nursing staff who subsequently administered the influenza vaccine.

“Routine outpatient vaccination screening and strategies for sharing and linking patient vaccination status between providers in different health care systems at the state and national levels could improve vaccination documentation in patients with lymphoma and provide opportunities to improve compliance,” the researchers wrote.

A key limitation of the study was the lack of adequate documentation, they explained. As a result, the reported vaccination rates were not more rigorously evaluated.

The study was funded by the Winship Cancer Institute and the National Institutes of Health. The authors reported financial affiliations with AbbVie, Acerta Pharma, Celgene, Gilead, Janssen, Pharmacyclics, and others.

SOURCE: Chang A et al. Clin Lymphoma Myeloma Leuk. 2019 Jan 2. doi: 10.1016/j.clml.2018.12.018.

Annual influenza vaccination rates and documentation of vaccination status appear to be suboptimal among patients with newly diagnosed diffuse large B-cell lymphoma, based on a retrospective analysis of data in the state of Georgia.

The researchers reviewed medical records of patients with a new diagnosis of diffuse large B-cell lymphoma at three Georgia hospitals. Documentation related to vaccine administration, refusal, and patient counseling was collected between Feb. 1, 2015, and Oct. 31, 2017, Andres Chang, MD, PhD, of Emory University, Atlanta, and colleagues wrote. The findings were published in Clinical Lymphoma, Myeloma & Leukemia.

Vaccination status within 1 year of diagnosis was documented for 61 of 107 patients. Among the 61 patients with documentation of influenza vaccination status, 35 (57%) were vaccinated. No reason was documented for vaccine refusal, and there was no follow-up documentation on vaccine counseling by nursing staff, physicians, or advanced practice providers in any of these admitted patients.

Nearly all documentation of influenza vaccination status came from the nursing staff. Only 4 of the 61 patients had documentation provided by primary oncologists or advanced practice providers, and those patients also had documentation from the outpatient nursing staff who subsequently administered the influenza vaccine.

“Routine outpatient vaccination screening and strategies for sharing and linking patient vaccination status between providers in different health care systems at the state and national levels could improve vaccination documentation in patients with lymphoma and provide opportunities to improve compliance,” the researchers wrote.

A key limitation of the study was the lack of adequate documentation, they explained. As a result, the reported vaccination rates were not more rigorously evaluated.

The study was funded by the Winship Cancer Institute and the National Institutes of Health. The authors reported financial affiliations with AbbVie, Acerta Pharma, Celgene, Gilead, Janssen, Pharmacyclics, and others.

SOURCE: Chang A et al. Clin Lymphoma Myeloma Leuk. 2019 Jan 2. doi: 10.1016/j.clml.2018.12.018.

Annual influenza vaccination rates and documentation of vaccination status appear to be suboptimal among patients with newly diagnosed diffuse large B-cell lymphoma, based on a retrospective analysis of data in the state of Georgia.

The researchers reviewed medical records of patients with a new diagnosis of diffuse large B-cell lymphoma at three Georgia hospitals. Documentation related to vaccine administration, refusal, and patient counseling was collected between Feb. 1, 2015, and Oct. 31, 2017, Andres Chang, MD, PhD, of Emory University, Atlanta, and colleagues wrote. The findings were published in Clinical Lymphoma, Myeloma & Leukemia.

Vaccination status within 1 year of diagnosis was documented for 61 of 107 patients. Among the 61 patients with documentation of influenza vaccination status, 35 (57%) were vaccinated. No reason was documented for vaccine refusal, and there was no follow-up documentation on vaccine counseling by nursing staff, physicians, or advanced practice providers in any of these admitted patients.

Nearly all documentation of influenza vaccination status came from the nursing staff. Only 4 of the 61 patients had documentation provided by primary oncologists or advanced practice providers, and those patients also had documentation from the outpatient nursing staff who subsequently administered the influenza vaccine.

“Routine outpatient vaccination screening and strategies for sharing and linking patient vaccination status between providers in different health care systems at the state and national levels could improve vaccination documentation in patients with lymphoma and provide opportunities to improve compliance,” the researchers wrote.

A key limitation of the study was the lack of adequate documentation, they explained. As a result, the reported vaccination rates were not more rigorously evaluated.

The study was funded by the Winship Cancer Institute and the National Institutes of Health. The authors reported financial affiliations with AbbVie, Acerta Pharma, Celgene, Gilead, Janssen, Pharmacyclics, and others.

SOURCE: Chang A et al. Clin Lymphoma Myeloma Leuk. 2019 Jan 2. doi: 10.1016/j.clml.2018.12.018.

The Affordable Care Act (ACA) was enacted on March 23, 2010. Controversies, complaints, and detractors have and continue to abound. But the ACA’s landmark women’s health gains are unmistakable. Contraceptive coverage, maternity coverage, Medicaid coverage of low-income women, coverage for individuals with preexisting conditions, and gender-neutral premiums are now a part of the fabric of our society. For most.

Many physicians and patients—many lawmakers, too—do not remember the serious problems people had with their insurance companies before the ACA. Maternity coverage was usually a free-standing rider to an insurance policy, making it very expensive. Insurance plans did not have to, and often did not, cover contraceptives, and none did without copays or deductibles. Women were routinely denied coverage if they had ever had a cesarean delivery, had once been the victim of domestic violence, or had any one of many common conditions, like diabetes. The many exclusionary conditions are so common, in fact, that one study estimated that around 52 million adults in the United States (27% of those younger than age 65 years) have preexisting conditions that would potentially make them uninsurable without the ACA’s protections.¹

Before the ACA, it also was common for women with insurance policies to find their coverage rescinded, often with no explanation, even though they paid their premiums every month. And women with serious medical conditions often saw their coverage ended midway through their course of treatment. That placed their ObGyns in a terrible situation, too.

The insurance industry as a whole was running rough-shod over its customers, and making a lot of money by creatively and routinely denying coverage and payment for care. People were often insured, but not covered. The ACA halted many of these practices, and required insurers to meet high medical loss ratios, guaranteeing that 80% of the premiums’ for individual and small market insurers (and 85% for large insurers) are returned to patients in care payments or even in checks. In fact, nearly $4 billion in premiums have been rebated to insured individuals over the last 7 years under the ACA.²

The commitment of the American College of Obstetricians and Gynecologists (ACOG) to women’s health and to our members’ ability to provide the best care has centered on preserving the critical gains of the ACA for women, improving them when we can, and making sure politicians don’t turn back the clock on women’s health. We have been busy.

In this article, we will look at what has happened to these landmark gains and promises of improved women’s health, specifically preexisting condition protections and contraceptive coverage, under a new Administration. What happens when good health care policy and political enmity collide?

Preexisting coverage protections

The 1996 Health Insurance Portability and Accountability Act (HIPAA) defines a preexisting condition exclusionas a “limitation or exclusion of benefits relating to a condition based on the fact that the condition was present before the date of enrollment for the coverage, whether or not any medical advice, diagnosis, care, or treatment was recommended or received before that date.” HIPPA prohibited employer-sponsored health plans from discriminating against individuals through denying them coverage or charging them more based on their or their family members’ health problems. The ACA expanded protections to prohibit the insurance practice of denying coverage altogether to an individual with a preexisting condition.³

Continue to: Under Congress...

Under Congress

Republicans held the majority in both chambers of the 115th Congress (2017–2018), and hoped to use their majority status to get an ACA repeal bill to the Republican President’s desk for speedy enactment. It was not easy, and they were not successful. Four major bills—the American Health Care Act, the Better Care Reconciliation Act, the Health Care Freedom Act, and the Graham-Cassidy Amendment—never made it over the finish line, with some not even making it to a vote. The Health Care Freedom Act was voted down in the Senate 51-49 when Senator John McCain came back from brain surgery to cast his famous thumbs-down vote.⁴ These bills all would have repealed or hobbled guaranteed issue, community rating, and essential health benefits of the ACA. Of all the legislative attempts to undermine the ACA, only the 2017 Tax Cuts and Jobs Act (TCJA) was signed into law, repealing the ACA individual mandate.

Handling by the courts

The TCJA gave ACA opponents their opening in court. Twenty Republican state attorneys general and governors brought suit in February 2018 (Texas v Azar), arguing that because the ACA relies on the mandate, and the mandate has been repealed, the rest of the ACA also should be struck down. A federal district judge agreed, on December 15, 2018, declaring the entire ACA unconstitutional.⁵

That decision has been limited in its practical effect so far, and maybe it was not altogether unexpected. What was unexpected was that the US Department of Justice (DOJ) refused to defend a federal law, in this case, the ACA. In June 2018, the DOJ declined to defend the individual mandate, as well as guaranteed issue, community rating, the ban on preexisting condition exclusions, and discrimination based on health status in the ACA. The DOJ at that time, however, did not agree with the plaintiffs that without the mandate the entire ACA should be struck down. It said, “There is no reason why the ACA’s particular expansion of Medicaid hinges on the individual mandate.” Later, after the December 15 ruling, the DOJ changed its position and agreed with the judge, in a two-sentence letter to the court, that the ACA should be stricken altogether—shortly after which 3 career DOJ attorneys resigned.⁶

A legal expert observed: “The DOJ’s decision not to defend the ACA breaks with the Department’s long-standing bipartisan commitment to defend federal laws if reasonable arguments can be made in their defense. Decisions not to defend federal law are exceedingly rare. It seems even rarer to change the government’s position mid-appeal in such a high-profile lawsuit that risks disrupting the entire health care system and health insurance coverage for millions of Americans.”⁷

Regulatory tactics

What a policy maker cannot do by law, he or she can try to accomplish by regulation. The Administration is using 3 regulatory routes to undercut the ACA preexisting coverage protections and market stability.

Route 1: Short-Term Limited Duration (STLD) plans. These plans were created in the ACA to provide bridge coverage for up to 3 months for individuals in between health insurance plans. These plans do not have to comply with ACA patient protections, can deny coverage for preexisting conditions, and do not cover maternity care. In 2018, the Administration moved to allow these plans to be marketed broadly and renewed for up to 3 years. Because these plans provide less coverage and often come with high deductibles, they can be marketed with lower premiums, skimming off healthier younger people who do not expect to need much care, as well as lower-income families. This destabilizes the market and leaves people insured but not covered, exactly the situation before the ACA. Seven public health and medical groups sued to challenge the Administration’s STLD regulation; the lawsuit is presently pending.

Continue to: Route 2: Association Health Plans (AHPs)...

Route 2: Association Health Plans (AHPs). The Administration also has allowed the sale of AHPs, marketed to small employers and self-employed individuals. These plans also do not have to comply with ACA consumer protections. They often do not cover maternity care or other essential benefits, and can charge women higher premiums for the same insurance. This regulation, too, resulted in litigation and a federal judge enjoined the rule, but the case is now on appeal.

Route 3: ACA Section 1332 waivers. These waivers were created in the ACA to encourage state innovation to increase access to health coverage, under certain guardrails: states must ensure coverage is at least as comprehensive as the Essential Health Benefits; cost sharing protections must be at least as affordable as under the ACA; the plan must cover at least a comparable number of its residents; and the plan must not increase the federal deficit.

The Adminstration has come under fire for approving 1332 waiver plans that do not meet these guardrails, and allow insurers to exclude coverage for individuals with preexisting conditions, as well as skirt other important ACA patient protections. In response, Seema Verma, Administrator of the Centers for Medicare & Medicaid Services, promised as recently as April 23, that the Administration will not allow any weakening of the ACA preexisting coverage guarantee.⁸ So far, however, we do not know what action this means, and not surprisingly, House Democrats, now in the majority, are waiting to see those assurances come true. Consistent polling shows that a large majority of Americans, across political parties, think preexisting coverage protections are very important.⁹

Already, the House passed HR986, to repeal the Administration’s changes to the 1332 waiver rules. The bill won only 4 Republican votes in the House and now waits a Senate vote.

The House is ready to vote on HR1010, which returns the STLD rules to the original ACA version. The Congressional Budget Office has determined that this bill will reduce the federal deficit by $8.9 billion over 10 years, in part by reestablishing a large risk pool. Lower ACA premiums would mean lower federal subsidies and small federal outlays.

Contraceptive coverage

Since 2012, the ACA has required non-grandfathered individual and group health plans to cover, with no copays or deductibles, women’s preventive services, as determined by the Health Resources and Services Administration (HRSA). HRSA asked the National Academy of Medicine (the Institute of Medicine [IOM] at the time) to develop these coverage guidelines based on clinical and scientific relevance. The IOM relied heavily on ACOG’s testimony and women’s health guidelines. The guidelines are updated every 5 years, based on extensive review by the Women’s Preventive Services Initiative, led by ACOG. By law and regulation, covered services include:

• well-woman visits
• contraceptive methods and counseling, including all methods approved for women by the FDA
• breast and cervical cancer screening
• counseling for sexually transmitted infections
• counseling and screening for HIV
• screening for gestational diabetes
• breastfeeding support, supplies, and counseling
• screening and counseling for interpersonal and domestic violence.

Continue to: The previous administration offered a narrow exemption...

The previous administration offered a narrow exemption—an accommodation—for churches, religious orders, and integrated auxiliaries (organizations with financial support primarily from churches). That accommodation was expanded in the Supreme Court’s decision in Hobby Lobby, for closely held for-profit organizations that had religious objections to covering some or all contraceptives. Under the accommodation, the entity’s insurer or third-party administrator was responsible for providing contraceptive services to the entity’s plan participants and beneficiaries.

In October 2017, the Trump administration acted to greatly expand the ability of any employer, college or university, individual, or insurer to opt out of the ACA’s contraceptive coverage requirement. You will read more about this later.

ACOG’s business case for contraception

Early in the Trump Administration, the White House released a statement saying, “Ensuring affordable, accessible, and quality healthcare is critical to improving women’s health and ensuring that it fits their priorities at any stage of life.”¹⁰ ACOG could not agree more, and we encouraged the President to accomplish this important goal by protecting the landmark women’s health gains of the ACA. Our call to the President and the US Congress was: “Don’t turn back the clock on women’s health.”

We made a business case for continued contraceptive coverage:

Contraception reduces unintended pregnancies and saves federal dollars.

• Approximately 45% of US pregnancies are unintended.¹¹
• No-copay coverage of contraception has contributed to a dramatic decline in the unintended pregnancy rate in the United States, now at a 30-year low.¹²
• When cost is not a barrier, women choose more effective forms of contraception, such as intrauterine devices and implants.¹³
• Unintended pregnancies cost approximately $12.5 billion in government expenditures in 2008.¹⁴
• Private health plans spend as much as $4.6 billion annually in costs related to unintended pregnancies.¹⁵

Contraception means healthier women and healthier families.

• Under the ACA, the uninsured rate among women ages 18 to 64 almost halved, decreasing from 19.3% to 10.8%.¹⁶
• More than 55 million women gained access to preventive services, including contraception, without a copay or a deductible.¹⁶
• Women with unintended pregnancies are more likely to delay prenatal care. Infants are at greater risk of birth defects, low birth weight, and poor mental and physical functioning in early childhood.¹⁷

Increased access to contraception helps families and improves economic security.

• Women saved $1.4 billion in out-of-pocket costs for contraception in 1 year.¹⁸
• Before the ACA, women were spending between 30% and 44% of their total out-of-pocket health costs just on birth control.¹⁹
• The ability to plan a pregnancy increases engagement of women in the workforce and improves economic stability for women and their families.²⁰

Administration expands religious exemptions to contraception coverage

Still, on October 6, 2017, the Trump Administration moved to curtail women’s access to and coverage of contraception with the Religious Exemptions and Accommodations for Coverage of Certain Preventive Services under the Affordable Care Act and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. In November 2018, the Administration published a revised rule, to take effect in January 2019.²¹ The rule immediately was taken to court by more than a dozen states and, 1 month later, was subject to an injunction by the US Court of Appeals for the Ninth Circuit, blocking the rules from going into effect in those states.

Continue to: The rule vastly expands the Obama Administration’s religious accommodation...

The rule vastly expands the Obama Administration’s religious accommodation to include “nonprofit organizations, small businesses, and individuals that have nonreligious moral convictions opposing services covered by the contraceptive mandate.” The covered entities include²¹:

• churches, integrated auxiliaries, and religious orders with religious objections
• nonprofit organizations with religious or moral objections
• for-profit entities that are not publicly traded, with religious or moral objections
• for-profit entities that are publicly traded, with religious objections
• other nongovernmental employers with religious objections
• nongovernmental institutions of higher education with religious or moral objections
• individuals with religious or moral objections, with employer sponsored or individual market coverage, where the plan sponsor and/or issuer (as applicable) are willing to offer them a plan omitting contraceptive coverage to which they object
• issuers with religious or moral objections, to the extent they provide coverage to a plan sponsor or individual that is also exempt.

The Administration says women losing coverage can get contraceptives through Title X clinics or other government programs. Of course, many women losing coverage are employed, and earn above the low income (100% of the federal poverty level) eligibility requirement for Title X assistance. To address that, the Administration, through its proposed Title X regulations, broadens the definition of “low income” in that program to include women who lose their contraceptive coverage through the employer-base health insurance plan. This move further limits the ability of the Title X program to adequately care for already-qualified individuals.

The Administration’s rule also relied on major inaccuracies, which ACOG corrected.²² First, ACOG pointed out that, in fact, FDA-approved contraceptive methods are not abortifacients, countering the Administration’s contention that contraception is an abortifacient, and that contraceptives cause abortions or miscarriages. Every FDA-approved contraceptive acts before implantation, does not interfere with a pregnancy, and is not effective after a fertilized egg has implanted successfully in the uterus.²³ No credible research supports the false statement that birth control causes miscarriages.²⁴

Second, ACOG offered data proving that increased access to contraception is not associated with increased unsafe sexual behavior or increased sexual activity.^25,26 The facts are that:

• The percentage of teens who are having sex has declined significantly, by 14% for female and 22% for male teenagers, over the past 25 years.²⁷
• More women are using contraception the first time they have sex. Young women who do not use birth control at first sexual intercourse are twice as likely to become teen mothers.²⁸
• Increased access to and use of contraception has contributed to a dramatic decline in rates of adolescent pregnancy.²⁹
• School-based health centers that provide access to contraceptives are proven to increase use of contraceptives by already sexually active students, not to increase onset of sexual activity.^30,31

Third, ACOG made clear the benefits to women’s health from contraception. ACOG asserted: As with any medication, certain types of contraception may be contraindicated for patients with certain medical conditions, including high blood pressure, lupus, or a history of breast cancer.^32,33 For these and many other reasons, access to the full range of FDA-approved contraception, with no cost sharing or other barriers, is critical to women’s health. Regarding VTE, the risk among oral contraceptive users is very low. In fact, it is much lower than the risk of VTE during pregnancy or in the immediate postpartum period.³⁴

Continue to: Regarding breast cancer: there is no proven increased risk...

Regarding breast cancer: there is no proven increased risk of breast cancer among contraceptive users, particularly among those younger than age 40. For women older than 40, health care providers must consider both the risks of becoming pregnant at advanced reproductive age and the risks of continuing contraception use until menopause.³⁵

ACOG has 2 clear messages for politicians

ACOG has remained steadfast in its opposition to the Administration’s proposals to block access to contraception. ACOG expressed its strong opposition to political interference in medical care, saying “Every woman, regardless of her insurer, employer, state of residence, or income, should have affordable, seamless access to the right form of contraception for her, free from interference from her employer or politicians.”²²

ACOG’s voice has been joined by 5 other major medical associations—American Academy of Family Physicians, American Academy of Pediatrics, American Psychiatric Association, American Academy of Pediatrics, and American Osteopathic Association—together representing more than 560,000 physicians and medical students, in urging the Administration to immediately withdraw its proposals. This broad coalition unequivocally stated³⁶:

Contraception is an integral part of preventive care and a medical necessity for women during approximately 30 years of their lives. Access to no-copay contraception leads to healthier women and families. Changes to our healthcare system come with very high stakes – impacting tens of millions of our patients. Access to contraception allows women to achieve, lead and reach their full potentials, becoming key drivers of our Nation’s economic success. These rules would create a new standard whereby employers can deny their employees coverage, based on their own moral objections. This interferes in the personal health care decisions of our patients, and inappropriately inserts a patient’s employer into the physician-patient relationship. In addition, these rules open the door to moral exemptions for other essential health care, including vaccinations.

These are challenging days for women’s health policy and legislation federally, and in many states. ACOG has two clear messages for politicians: Don’t turn back the clock on women’s health, and stay out of our exam rooms.

The Affordable Care Act (ACA) was enacted on March 23, 2010. Controversies, complaints, and detractors have and continue to abound. But the ACA’s landmark women’s health gains are unmistakable. Contraceptive coverage, maternity coverage, Medicaid coverage of low-income women, coverage for individuals with preexisting conditions, and gender-neutral premiums are now a part of the fabric of our society. For most.

Many physicians and patients—many lawmakers, too—do not remember the serious problems people had with their insurance companies before the ACA. Maternity coverage was usually a free-standing rider to an insurance policy, making it very expensive. Insurance plans did not have to, and often did not, cover contraceptives, and none did without copays or deductibles. Women were routinely denied coverage if they had ever had a cesarean delivery, had once been the victim of domestic violence, or had any one of many common conditions, like diabetes. The many exclusionary conditions are so common, in fact, that one study estimated that around 52 million adults in the United States (27% of those younger than age 65 years) have preexisting conditions that would potentially make them uninsurable without the ACA’s protections.¹

Before the ACA, it also was common for women with insurance policies to find their coverage rescinded, often with no explanation, even though they paid their premiums every month. And women with serious medical conditions often saw their coverage ended midway through their course of treatment. That placed their ObGyns in a terrible situation, too.

The insurance industry as a whole was running rough-shod over its customers, and making a lot of money by creatively and routinely denying coverage and payment for care. People were often insured, but not covered. The ACA halted many of these practices, and required insurers to meet high medical loss ratios, guaranteeing that 80% of the premiums’ for individual and small market insurers (and 85% for large insurers) are returned to patients in care payments or even in checks. In fact, nearly $4 billion in premiums have been rebated to insured individuals over the last 7 years under the ACA.²

The commitment of the American College of Obstetricians and Gynecologists (ACOG) to women’s health and to our members’ ability to provide the best care has centered on preserving the critical gains of the ACA for women, improving them when we can, and making sure politicians don’t turn back the clock on women’s health. We have been busy.

In this article, we will look at what has happened to these landmark gains and promises of improved women’s health, specifically preexisting condition protections and contraceptive coverage, under a new Administration. What happens when good health care policy and political enmity collide?

Preexisting coverage protections

The 1996 Health Insurance Portability and Accountability Act (HIPAA) defines a preexisting condition exclusionas a “limitation or exclusion of benefits relating to a condition based on the fact that the condition was present before the date of enrollment for the coverage, whether or not any medical advice, diagnosis, care, or treatment was recommended or received before that date.” HIPPA prohibited employer-sponsored health plans from discriminating against individuals through denying them coverage or charging them more based on their or their family members’ health problems. The ACA expanded protections to prohibit the insurance practice of denying coverage altogether to an individual with a preexisting condition.³

Continue to: Under Congress...

Under Congress

Republicans held the majority in both chambers of the 115th Congress (2017–2018), and hoped to use their majority status to get an ACA repeal bill to the Republican President’s desk for speedy enactment. It was not easy, and they were not successful. Four major bills—the American Health Care Act, the Better Care Reconciliation Act, the Health Care Freedom Act, and the Graham-Cassidy Amendment—never made it over the finish line, with some not even making it to a vote. The Health Care Freedom Act was voted down in the Senate 51-49 when Senator John McCain came back from brain surgery to cast his famous thumbs-down vote.⁴ These bills all would have repealed or hobbled guaranteed issue, community rating, and essential health benefits of the ACA. Of all the legislative attempts to undermine the ACA, only the 2017 Tax Cuts and Jobs Act (TCJA) was signed into law, repealing the ACA individual mandate.

Handling by the courts

The TCJA gave ACA opponents their opening in court. Twenty Republican state attorneys general and governors brought suit in February 2018 (Texas v Azar), arguing that because the ACA relies on the mandate, and the mandate has been repealed, the rest of the ACA also should be struck down. A federal district judge agreed, on December 15, 2018, declaring the entire ACA unconstitutional.⁵

That decision has been limited in its practical effect so far, and maybe it was not altogether unexpected. What was unexpected was that the US Department of Justice (DOJ) refused to defend a federal law, in this case, the ACA. In June 2018, the DOJ declined to defend the individual mandate, as well as guaranteed issue, community rating, the ban on preexisting condition exclusions, and discrimination based on health status in the ACA. The DOJ at that time, however, did not agree with the plaintiffs that without the mandate the entire ACA should be struck down. It said, “There is no reason why the ACA’s particular expansion of Medicaid hinges on the individual mandate.” Later, after the December 15 ruling, the DOJ changed its position and agreed with the judge, in a two-sentence letter to the court, that the ACA should be stricken altogether—shortly after which 3 career DOJ attorneys resigned.⁶

A legal expert observed: “The DOJ’s decision not to defend the ACA breaks with the Department’s long-standing bipartisan commitment to defend federal laws if reasonable arguments can be made in their defense. Decisions not to defend federal law are exceedingly rare. It seems even rarer to change the government’s position mid-appeal in such a high-profile lawsuit that risks disrupting the entire health care system and health insurance coverage for millions of Americans.”⁷

Regulatory tactics

What a policy maker cannot do by law, he or she can try to accomplish by regulation. The Administration is using 3 regulatory routes to undercut the ACA preexisting coverage protections and market stability.

Route 1: Short-Term Limited Duration (STLD) plans. These plans were created in the ACA to provide bridge coverage for up to 3 months for individuals in between health insurance plans. These plans do not have to comply with ACA patient protections, can deny coverage for preexisting conditions, and do not cover maternity care. In 2018, the Administration moved to allow these plans to be marketed broadly and renewed for up to 3 years. Because these plans provide less coverage and often come with high deductibles, they can be marketed with lower premiums, skimming off healthier younger people who do not expect to need much care, as well as lower-income families. This destabilizes the market and leaves people insured but not covered, exactly the situation before the ACA. Seven public health and medical groups sued to challenge the Administration’s STLD regulation; the lawsuit is presently pending.

Continue to: Route 2: Association Health Plans (AHPs)...

Route 2: Association Health Plans (AHPs). The Administration also has allowed the sale of AHPs, marketed to small employers and self-employed individuals. These plans also do not have to comply with ACA consumer protections. They often do not cover maternity care or other essential benefits, and can charge women higher premiums for the same insurance. This regulation, too, resulted in litigation and a federal judge enjoined the rule, but the case is now on appeal.

Route 3: ACA Section 1332 waivers. These waivers were created in the ACA to encourage state innovation to increase access to health coverage, under certain guardrails: states must ensure coverage is at least as comprehensive as the Essential Health Benefits; cost sharing protections must be at least as affordable as under the ACA; the plan must cover at least a comparable number of its residents; and the plan must not increase the federal deficit.

The Adminstration has come under fire for approving 1332 waiver plans that do not meet these guardrails, and allow insurers to exclude coverage for individuals with preexisting conditions, as well as skirt other important ACA patient protections. In response, Seema Verma, Administrator of the Centers for Medicare & Medicaid Services, promised as recently as April 23, that the Administration will not allow any weakening of the ACA preexisting coverage guarantee.⁸ So far, however, we do not know what action this means, and not surprisingly, House Democrats, now in the majority, are waiting to see those assurances come true. Consistent polling shows that a large majority of Americans, across political parties, think preexisting coverage protections are very important.⁹

Already, the House passed HR986, to repeal the Administration’s changes to the 1332 waiver rules. The bill won only 4 Republican votes in the House and now waits a Senate vote.

The House is ready to vote on HR1010, which returns the STLD rules to the original ACA version. The Congressional Budget Office has determined that this bill will reduce the federal deficit by $8.9 billion over 10 years, in part by reestablishing a large risk pool. Lower ACA premiums would mean lower federal subsidies and small federal outlays.

Contraceptive coverage

Since 2012, the ACA has required non-grandfathered individual and group health plans to cover, with no copays or deductibles, women’s preventive services, as determined by the Health Resources and Services Administration (HRSA). HRSA asked the National Academy of Medicine (the Institute of Medicine [IOM] at the time) to develop these coverage guidelines based on clinical and scientific relevance. The IOM relied heavily on ACOG’s testimony and women’s health guidelines. The guidelines are updated every 5 years, based on extensive review by the Women’s Preventive Services Initiative, led by ACOG. By law and regulation, covered services include:

• well-woman visits
• contraceptive methods and counseling, including all methods approved for women by the FDA
• breast and cervical cancer screening
• counseling for sexually transmitted infections
• counseling and screening for HIV
• screening for gestational diabetes
• breastfeeding support, supplies, and counseling
• screening and counseling for interpersonal and domestic violence.

Continue to: The previous administration offered a narrow exemption...

The previous administration offered a narrow exemption—an accommodation—for churches, religious orders, and integrated auxiliaries (organizations with financial support primarily from churches). That accommodation was expanded in the Supreme Court’s decision in Hobby Lobby, for closely held for-profit organizations that had religious objections to covering some or all contraceptives. Under the accommodation, the entity’s insurer or third-party administrator was responsible for providing contraceptive services to the entity’s plan participants and beneficiaries.

In October 2017, the Trump administration acted to greatly expand the ability of any employer, college or university, individual, or insurer to opt out of the ACA’s contraceptive coverage requirement. You will read more about this later.

ACOG’s business case for contraception

Early in the Trump Administration, the White House released a statement saying, “Ensuring affordable, accessible, and quality healthcare is critical to improving women’s health and ensuring that it fits their priorities at any stage of life.”¹⁰ ACOG could not agree more, and we encouraged the President to accomplish this important goal by protecting the landmark women’s health gains of the ACA. Our call to the President and the US Congress was: “Don’t turn back the clock on women’s health.”

We made a business case for continued contraceptive coverage:

Contraception reduces unintended pregnancies and saves federal dollars.

• Approximately 45% of US pregnancies are unintended.¹¹
• No-copay coverage of contraception has contributed to a dramatic decline in the unintended pregnancy rate in the United States, now at a 30-year low.¹²
• When cost is not a barrier, women choose more effective forms of contraception, such as intrauterine devices and implants.¹³
• Unintended pregnancies cost approximately $12.5 billion in government expenditures in 2008.¹⁴
• Private health plans spend as much as $4.6 billion annually in costs related to unintended pregnancies.¹⁵

Contraception means healthier women and healthier families.

• Under the ACA, the uninsured rate among women ages 18 to 64 almost halved, decreasing from 19.3% to 10.8%.¹⁶
• More than 55 million women gained access to preventive services, including contraception, without a copay or a deductible.¹⁶
• Women with unintended pregnancies are more likely to delay prenatal care. Infants are at greater risk of birth defects, low birth weight, and poor mental and physical functioning in early childhood.¹⁷

Increased access to contraception helps families and improves economic security.

• Women saved $1.4 billion in out-of-pocket costs for contraception in 1 year.¹⁸
• Before the ACA, women were spending between 30% and 44% of their total out-of-pocket health costs just on birth control.¹⁹
• The ability to plan a pregnancy increases engagement of women in the workforce and improves economic stability for women and their families.²⁰

Administration expands religious exemptions to contraception coverage

Still, on October 6, 2017, the Trump Administration moved to curtail women’s access to and coverage of contraception with the Religious Exemptions and Accommodations for Coverage of Certain Preventive Services under the Affordable Care Act and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. In November 2018, the Administration published a revised rule, to take effect in January 2019.²¹ The rule immediately was taken to court by more than a dozen states and, 1 month later, was subject to an injunction by the US Court of Appeals for the Ninth Circuit, blocking the rules from going into effect in those states.

Continue to: The rule vastly expands the Obama Administration’s religious accommodation...

The rule vastly expands the Obama Administration’s religious accommodation to include “nonprofit organizations, small businesses, and individuals that have nonreligious moral convictions opposing services covered by the contraceptive mandate.” The covered entities include²¹:

• churches, integrated auxiliaries, and religious orders with religious objections
• nonprofit organizations with religious or moral objections
• for-profit entities that are not publicly traded, with religious or moral objections
• for-profit entities that are publicly traded, with religious objections
• other nongovernmental employers with religious objections
• nongovernmental institutions of higher education with religious or moral objections
• individuals with religious or moral objections, with employer sponsored or individual market coverage, where the plan sponsor and/or issuer (as applicable) are willing to offer them a plan omitting contraceptive coverage to which they object
• issuers with religious or moral objections, to the extent they provide coverage to a plan sponsor or individual that is also exempt.

The Administration says women losing coverage can get contraceptives through Title X clinics or other government programs. Of course, many women losing coverage are employed, and earn above the low income (100% of the federal poverty level) eligibility requirement for Title X assistance. To address that, the Administration, through its proposed Title X regulations, broadens the definition of “low income” in that program to include women who lose their contraceptive coverage through the employer-base health insurance plan. This move further limits the ability of the Title X program to adequately care for already-qualified individuals.

The Administration’s rule also relied on major inaccuracies, which ACOG corrected.²² First, ACOG pointed out that, in fact, FDA-approved contraceptive methods are not abortifacients, countering the Administration’s contention that contraception is an abortifacient, and that contraceptives cause abortions or miscarriages. Every FDA-approved contraceptive acts before implantation, does not interfere with a pregnancy, and is not effective after a fertilized egg has implanted successfully in the uterus.²³ No credible research supports the false statement that birth control causes miscarriages.²⁴

Second, ACOG offered data proving that increased access to contraception is not associated with increased unsafe sexual behavior or increased sexual activity.^25,26 The facts are that:

• The percentage of teens who are having sex has declined significantly, by 14% for female and 22% for male teenagers, over the past 25 years.²⁷
• More women are using contraception the first time they have sex. Young women who do not use birth control at first sexual intercourse are twice as likely to become teen mothers.²⁸
• Increased access to and use of contraception has contributed to a dramatic decline in rates of adolescent pregnancy.²⁹
• School-based health centers that provide access to contraceptives are proven to increase use of contraceptives by already sexually active students, not to increase onset of sexual activity.^30,31

Third, ACOG made clear the benefits to women’s health from contraception. ACOG asserted: As with any medication, certain types of contraception may be contraindicated for patients with certain medical conditions, including high blood pressure, lupus, or a history of breast cancer.^32,33 For these and many other reasons, access to the full range of FDA-approved contraception, with no cost sharing or other barriers, is critical to women’s health. Regarding VTE, the risk among oral contraceptive users is very low. In fact, it is much lower than the risk of VTE during pregnancy or in the immediate postpartum period.³⁴

Continue to: Regarding breast cancer: there is no proven increased risk...

Regarding breast cancer: there is no proven increased risk of breast cancer among contraceptive users, particularly among those younger than age 40. For women older than 40, health care providers must consider both the risks of becoming pregnant at advanced reproductive age and the risks of continuing contraception use until menopause.³⁵

ACOG has 2 clear messages for politicians

ACOG has remained steadfast in its opposition to the Administration’s proposals to block access to contraception. ACOG expressed its strong opposition to political interference in medical care, saying “Every woman, regardless of her insurer, employer, state of residence, or income, should have affordable, seamless access to the right form of contraception for her, free from interference from her employer or politicians.”²²

ACOG’s voice has been joined by 5 other major medical associations—American Academy of Family Physicians, American Academy of Pediatrics, American Psychiatric Association, American Academy of Pediatrics, and American Osteopathic Association—together representing more than 560,000 physicians and medical students, in urging the Administration to immediately withdraw its proposals. This broad coalition unequivocally stated³⁶:

Contraception is an integral part of preventive care and a medical necessity for women during approximately 30 years of their lives. Access to no-copay contraception leads to healthier women and families. Changes to our healthcare system come with very high stakes – impacting tens of millions of our patients. Access to contraception allows women to achieve, lead and reach their full potentials, becoming key drivers of our Nation’s economic success. These rules would create a new standard whereby employers can deny their employees coverage, based on their own moral objections. This interferes in the personal health care decisions of our patients, and inappropriately inserts a patient’s employer into the physician-patient relationship. In addition, these rules open the door to moral exemptions for other essential health care, including vaccinations.

These are challenging days for women’s health policy and legislation federally, and in many states. ACOG has two clear messages for politicians: Don’t turn back the clock on women’s health, and stay out of our exam rooms.

The Affordable Care Act (ACA) was enacted on March 23, 2010. Controversies, complaints, and detractors have and continue to abound. But the ACA’s landmark women’s health gains are unmistakable. Contraceptive coverage, maternity coverage, Medicaid coverage of low-income women, coverage for individuals with preexisting conditions, and gender-neutral premiums are now a part of the fabric of our society. For most.

Many physicians and patients—many lawmakers, too—do not remember the serious problems people had with their insurance companies before the ACA. Maternity coverage was usually a free-standing rider to an insurance policy, making it very expensive. Insurance plans did not have to, and often did not, cover contraceptives, and none did without copays or deductibles. Women were routinely denied coverage if they had ever had a cesarean delivery, had once been the victim of domestic violence, or had any one of many common conditions, like diabetes. The many exclusionary conditions are so common, in fact, that one study estimated that around 52 million adults in the United States (27% of those younger than age 65 years) have preexisting conditions that would potentially make them uninsurable without the ACA’s protections.¹

Before the ACA, it also was common for women with insurance policies to find their coverage rescinded, often with no explanation, even though they paid their premiums every month. And women with serious medical conditions often saw their coverage ended midway through their course of treatment. That placed their ObGyns in a terrible situation, too.

The insurance industry as a whole was running rough-shod over its customers, and making a lot of money by creatively and routinely denying coverage and payment for care. People were often insured, but not covered. The ACA halted many of these practices, and required insurers to meet high medical loss ratios, guaranteeing that 80% of the premiums’ for individual and small market insurers (and 85% for large insurers) are returned to patients in care payments or even in checks. In fact, nearly $4 billion in premiums have been rebated to insured individuals over the last 7 years under the ACA.²

The commitment of the American College of Obstetricians and Gynecologists (ACOG) to women’s health and to our members’ ability to provide the best care has centered on preserving the critical gains of the ACA for women, improving them when we can, and making sure politicians don’t turn back the clock on women’s health. We have been busy.

In this article, we will look at what has happened to these landmark gains and promises of improved women’s health, specifically preexisting condition protections and contraceptive coverage, under a new Administration. What happens when good health care policy and political enmity collide?

Preexisting coverage protections

The 1996 Health Insurance Portability and Accountability Act (HIPAA) defines a preexisting condition exclusionas a “limitation or exclusion of benefits relating to a condition based on the fact that the condition was present before the date of enrollment for the coverage, whether or not any medical advice, diagnosis, care, or treatment was recommended or received before that date.” HIPPA prohibited employer-sponsored health plans from discriminating against individuals through denying them coverage or charging them more based on their or their family members’ health problems. The ACA expanded protections to prohibit the insurance practice of denying coverage altogether to an individual with a preexisting condition.³

Continue to: Under Congress...

Under Congress

Republicans held the majority in both chambers of the 115th Congress (2017–2018), and hoped to use their majority status to get an ACA repeal bill to the Republican President’s desk for speedy enactment. It was not easy, and they were not successful. Four major bills—the American Health Care Act, the Better Care Reconciliation Act, the Health Care Freedom Act, and the Graham-Cassidy Amendment—never made it over the finish line, with some not even making it to a vote. The Health Care Freedom Act was voted down in the Senate 51-49 when Senator John McCain came back from brain surgery to cast his famous thumbs-down vote.⁴ These bills all would have repealed or hobbled guaranteed issue, community rating, and essential health benefits of the ACA. Of all the legislative attempts to undermine the ACA, only the 2017 Tax Cuts and Jobs Act (TCJA) was signed into law, repealing the ACA individual mandate.

Handling by the courts

The TCJA gave ACA opponents their opening in court. Twenty Republican state attorneys general and governors brought suit in February 2018 (Texas v Azar), arguing that because the ACA relies on the mandate, and the mandate has been repealed, the rest of the ACA also should be struck down. A federal district judge agreed, on December 15, 2018, declaring the entire ACA unconstitutional.⁵

That decision has been limited in its practical effect so far, and maybe it was not altogether unexpected. What was unexpected was that the US Department of Justice (DOJ) refused to defend a federal law, in this case, the ACA. In June 2018, the DOJ declined to defend the individual mandate, as well as guaranteed issue, community rating, the ban on preexisting condition exclusions, and discrimination based on health status in the ACA. The DOJ at that time, however, did not agree with the plaintiffs that without the mandate the entire ACA should be struck down. It said, “There is no reason why the ACA’s particular expansion of Medicaid hinges on the individual mandate.” Later, after the December 15 ruling, the DOJ changed its position and agreed with the judge, in a two-sentence letter to the court, that the ACA should be stricken altogether—shortly after which 3 career DOJ attorneys resigned.⁶

A legal expert observed: “The DOJ’s decision not to defend the ACA breaks with the Department’s long-standing bipartisan commitment to defend federal laws if reasonable arguments can be made in their defense. Decisions not to defend federal law are exceedingly rare. It seems even rarer to change the government’s position mid-appeal in such a high-profile lawsuit that risks disrupting the entire health care system and health insurance coverage for millions of Americans.”⁷

Regulatory tactics

What a policy maker cannot do by law, he or she can try to accomplish by regulation. The Administration is using 3 regulatory routes to undercut the ACA preexisting coverage protections and market stability.

Route 1: Short-Term Limited Duration (STLD) plans. These plans were created in the ACA to provide bridge coverage for up to 3 months for individuals in between health insurance plans. These plans do not have to comply with ACA patient protections, can deny coverage for preexisting conditions, and do not cover maternity care. In 2018, the Administration moved to allow these plans to be marketed broadly and renewed for up to 3 years. Because these plans provide less coverage and often come with high deductibles, they can be marketed with lower premiums, skimming off healthier younger people who do not expect to need much care, as well as lower-income families. This destabilizes the market and leaves people insured but not covered, exactly the situation before the ACA. Seven public health and medical groups sued to challenge the Administration’s STLD regulation; the lawsuit is presently pending.

Continue to: Route 2: Association Health Plans (AHPs)...

Route 2: Association Health Plans (AHPs). The Administration also has allowed the sale of AHPs, marketed to small employers and self-employed individuals. These plans also do not have to comply with ACA consumer protections. They often do not cover maternity care or other essential benefits, and can charge women higher premiums for the same insurance. This regulation, too, resulted in litigation and a federal judge enjoined the rule, but the case is now on appeal.

Route 3: ACA Section 1332 waivers. These waivers were created in the ACA to encourage state innovation to increase access to health coverage, under certain guardrails: states must ensure coverage is at least as comprehensive as the Essential Health Benefits; cost sharing protections must be at least as affordable as under the ACA; the plan must cover at least a comparable number of its residents; and the plan must not increase the federal deficit.

The Adminstration has come under fire for approving 1332 waiver plans that do not meet these guardrails, and allow insurers to exclude coverage for individuals with preexisting conditions, as well as skirt other important ACA patient protections. In response, Seema Verma, Administrator of the Centers for Medicare & Medicaid Services, promised as recently as April 23, that the Administration will not allow any weakening of the ACA preexisting coverage guarantee.⁸ So far, however, we do not know what action this means, and not surprisingly, House Democrats, now in the majority, are waiting to see those assurances come true. Consistent polling shows that a large majority of Americans, across political parties, think preexisting coverage protections are very important.⁹

Already, the House passed HR986, to repeal the Administration’s changes to the 1332 waiver rules. The bill won only 4 Republican votes in the House and now waits a Senate vote.

The House is ready to vote on HR1010, which returns the STLD rules to the original ACA version. The Congressional Budget Office has determined that this bill will reduce the federal deficit by $8.9 billion over 10 years, in part by reestablishing a large risk pool. Lower ACA premiums would mean lower federal subsidies and small federal outlays.

Contraceptive coverage

Since 2012, the ACA has required non-grandfathered individual and group health plans to cover, with no copays or deductibles, women’s preventive services, as determined by the Health Resources and Services Administration (HRSA). HRSA asked the National Academy of Medicine (the Institute of Medicine [IOM] at the time) to develop these coverage guidelines based on clinical and scientific relevance. The IOM relied heavily on ACOG’s testimony and women’s health guidelines. The guidelines are updated every 5 years, based on extensive review by the Women’s Preventive Services Initiative, led by ACOG. By law and regulation, covered services include:

• well-woman visits
• contraceptive methods and counseling, including all methods approved for women by the FDA
• breast and cervical cancer screening
• counseling for sexually transmitted infections
• counseling and screening for HIV
• screening for gestational diabetes
• breastfeeding support, supplies, and counseling
• screening and counseling for interpersonal and domestic violence.

Continue to: The previous administration offered a narrow exemption...

The previous administration offered a narrow exemption—an accommodation—for churches, religious orders, and integrated auxiliaries (organizations with financial support primarily from churches). That accommodation was expanded in the Supreme Court’s decision in Hobby Lobby, for closely held for-profit organizations that had religious objections to covering some or all contraceptives. Under the accommodation, the entity’s insurer or third-party administrator was responsible for providing contraceptive services to the entity’s plan participants and beneficiaries.

In October 2017, the Trump administration acted to greatly expand the ability of any employer, college or university, individual, or insurer to opt out of the ACA’s contraceptive coverage requirement. You will read more about this later.

ACOG’s business case for contraception

Early in the Trump Administration, the White House released a statement saying, “Ensuring affordable, accessible, and quality healthcare is critical to improving women’s health and ensuring that it fits their priorities at any stage of life.”¹⁰ ACOG could not agree more, and we encouraged the President to accomplish this important goal by protecting the landmark women’s health gains of the ACA. Our call to the President and the US Congress was: “Don’t turn back the clock on women’s health.”

We made a business case for continued contraceptive coverage:

Contraception reduces unintended pregnancies and saves federal dollars.

• Approximately 45% of US pregnancies are unintended.¹¹
• No-copay coverage of contraception has contributed to a dramatic decline in the unintended pregnancy rate in the United States, now at a 30-year low.¹²
• When cost is not a barrier, women choose more effective forms of contraception, such as intrauterine devices and implants.¹³
• Unintended pregnancies cost approximately $12.5 billion in government expenditures in 2008.¹⁴
• Private health plans spend as much as $4.6 billion annually in costs related to unintended pregnancies.¹⁵

Contraception means healthier women and healthier families.

• Under the ACA, the uninsured rate among women ages 18 to 64 almost halved, decreasing from 19.3% to 10.8%.¹⁶
• More than 55 million women gained access to preventive services, including contraception, without a copay or a deductible.¹⁶
• Women with unintended pregnancies are more likely to delay prenatal care. Infants are at greater risk of birth defects, low birth weight, and poor mental and physical functioning in early childhood.¹⁷

Increased access to contraception helps families and improves economic security.

• Women saved $1.4 billion in out-of-pocket costs for contraception in 1 year.¹⁸
• Before the ACA, women were spending between 30% and 44% of their total out-of-pocket health costs just on birth control.¹⁹
• The ability to plan a pregnancy increases engagement of women in the workforce and improves economic stability for women and their families.²⁰

Administration expands religious exemptions to contraception coverage

Still, on October 6, 2017, the Trump Administration moved to curtail women’s access to and coverage of contraception with the Religious Exemptions and Accommodations for Coverage of Certain Preventive Services under the Affordable Care Act and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. In November 2018, the Administration published a revised rule, to take effect in January 2019.²¹ The rule immediately was taken to court by more than a dozen states and, 1 month later, was subject to an injunction by the US Court of Appeals for the Ninth Circuit, blocking the rules from going into effect in those states.

Continue to: The rule vastly expands the Obama Administration’s religious accommodation...

The rule vastly expands the Obama Administration’s religious accommodation to include “nonprofit organizations, small businesses, and individuals that have nonreligious moral convictions opposing services covered by the contraceptive mandate.” The covered entities include²¹:

• churches, integrated auxiliaries, and religious orders with religious objections
• nonprofit organizations with religious or moral objections
• for-profit entities that are not publicly traded, with religious or moral objections
• for-profit entities that are publicly traded, with religious objections
• other nongovernmental employers with religious objections
• nongovernmental institutions of higher education with religious or moral objections
• individuals with religious or moral objections, with employer sponsored or individual market coverage, where the plan sponsor and/or issuer (as applicable) are willing to offer them a plan omitting contraceptive coverage to which they object
• issuers with religious or moral objections, to the extent they provide coverage to a plan sponsor or individual that is also exempt.

The Administration says women losing coverage can get contraceptives through Title X clinics or other government programs. Of course, many women losing coverage are employed, and earn above the low income (100% of the federal poverty level) eligibility requirement for Title X assistance. To address that, the Administration, through its proposed Title X regulations, broadens the definition of “low income” in that program to include women who lose their contraceptive coverage through the employer-base health insurance plan. This move further limits the ability of the Title X program to adequately care for already-qualified individuals.

The Administration’s rule also relied on major inaccuracies, which ACOG corrected.²² First, ACOG pointed out that, in fact, FDA-approved contraceptive methods are not abortifacients, countering the Administration’s contention that contraception is an abortifacient, and that contraceptives cause abortions or miscarriages. Every FDA-approved contraceptive acts before implantation, does not interfere with a pregnancy, and is not effective after a fertilized egg has implanted successfully in the uterus.²³ No credible research supports the false statement that birth control causes miscarriages.²⁴

Second, ACOG offered data proving that increased access to contraception is not associated with increased unsafe sexual behavior or increased sexual activity.^25,26 The facts are that:

• The percentage of teens who are having sex has declined significantly, by 14% for female and 22% for male teenagers, over the past 25 years.²⁷
• More women are using contraception the first time they have sex. Young women who do not use birth control at first sexual intercourse are twice as likely to become teen mothers.²⁸
• Increased access to and use of contraception has contributed to a dramatic decline in rates of adolescent pregnancy.²⁹
• School-based health centers that provide access to contraceptives are proven to increase use of contraceptives by already sexually active students, not to increase onset of sexual activity.^30,31

Third, ACOG made clear the benefits to women’s health from contraception. ACOG asserted: As with any medication, certain types of contraception may be contraindicated for patients with certain medical conditions, including high blood pressure, lupus, or a history of breast cancer.^32,33 For these and many other reasons, access to the full range of FDA-approved contraception, with no cost sharing or other barriers, is critical to women’s health. Regarding VTE, the risk among oral contraceptive users is very low. In fact, it is much lower than the risk of VTE during pregnancy or in the immediate postpartum period.³⁴

Continue to: Regarding breast cancer: there is no proven increased risk...

Regarding breast cancer: there is no proven increased risk of breast cancer among contraceptive users, particularly among those younger than age 40. For women older than 40, health care providers must consider both the risks of becoming pregnant at advanced reproductive age and the risks of continuing contraception use until menopause.³⁵

ACOG has 2 clear messages for politicians

ACOG has remained steadfast in its opposition to the Administration’s proposals to block access to contraception. ACOG expressed its strong opposition to political interference in medical care, saying “Every woman, regardless of her insurer, employer, state of residence, or income, should have affordable, seamless access to the right form of contraception for her, free from interference from her employer or politicians.”²²

ACOG’s voice has been joined by 5 other major medical associations—American Academy of Family Physicians, American Academy of Pediatrics, American Psychiatric Association, American Academy of Pediatrics, and American Osteopathic Association—together representing more than 560,000 physicians and medical students, in urging the Administration to immediately withdraw its proposals. This broad coalition unequivocally stated³⁶:

Contraception is an integral part of preventive care and a medical necessity for women during approximately 30 years of their lives. Access to no-copay contraception leads to healthier women and families. Changes to our healthcare system come with very high stakes – impacting tens of millions of our patients. Access to contraception allows women to achieve, lead and reach their full potentials, becoming key drivers of our Nation’s economic success. These rules would create a new standard whereby employers can deny their employees coverage, based on their own moral objections. This interferes in the personal health care decisions of our patients, and inappropriately inserts a patient’s employer into the physician-patient relationship. In addition, these rules open the door to moral exemptions for other essential health care, including vaccinations.

These are challenging days for women’s health policy and legislation federally, and in many states. ACOG has two clear messages for politicians: Don’t turn back the clock on women’s health, and stay out of our exam rooms.