Trump administration rule erodes ACA contraceptive mandate

Article Type
Changed

More employers can opt out of providing contraception coverage to their employees under final regulations from the Trump administration that narrow the Affordable Care Act’s contraceptive mandate.

copyright Thinkstock

The two regulations, released Nov. 7, allow an expanded group of employers and insurers to get out of covering contraception methods by objecting on either religious or moral grounds.

The first rule broadens exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. The second rule protects nonprofit organizations and small businesses that have nonreligious moral convictions that oppose services covered by the mandate. The religious and moral exemptions apply to institutions of education, issuers, and individuals, but not to governmental entities.

When first proposed in 2017, Trump administration officials said the new policies would “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions.” The U.S. Department of Health & Human Services estimates that the rules, which take effect in January 2019, will affect no more than 200 employers.

The American College of Obstetricians and Gynecologists expressed concern that the final rules will restrict patient access to meaningful contraceptive methods and will erode decades of progress in increasing women’s reproductive autonomy and restrict patient access to contraception.

“Women, families and our nation all benefit from seamless, affordable access to contraception,” ACOG President Lisa M. Hollier, MD, said in a statement. “Contraception improves women’s health and well-being, reduces unintended pregnancy, enables pregnancy spacing for safer pregnancies and deliveries, and empowers women’s engagement in the workforce and economic self-sufficiency. A woman’s employer should not determine whether or not she has this access.”

Marjorie Dannenfelser, president of Susan B. Anthony List, an anti-abortion group, praised the final rules, calling them needed protections from the burdensome Obama-era ACA abortifacient drug mandate.

“President Trump and HHS Secretary Azar delivered a huge victory for conscience rights and religious liberty in America,” Ms. Dannenfelser said in a statement. “No longer will Catholic nuns who care for the elderly poor be forced by the government to provide abortion-inducing drugs in their health care plans. Not only that, moral objectors such as Susan B. Anthony List, will also no longer have to pay for life-ending drugs that are antithetical to their mission and for which we have argued there is certainly no compelling state interest.”

The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of religious employers, which were deemed exempt. Those religious employers were primarily churches and other houses of worship. After a number of complaints and legal challenges, the Obama administration created a workaround for nonprofit religious employers to opt out of the mandate.

However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.

Under the approved regulations, employers or insurers can stop their coverage of contraceptive services if they have religious beliefs or moral convictions against covering birth control. Exempted entities and individuals also can choose to cover some, but not all, contraceptive services, depending on their specific religious or moral objection, according to an HHS fact sheet.

The agency emphasized that the regulations leave in place government programs that provide free or subsidized contraceptive coverage to low-income women, such as through community health centers, and that the rules do not ban any employer from covering contraceptives.

The regulations become effective 60 days after they are published in the Federal Register.

Publications
Topics
Sections

More employers can opt out of providing contraception coverage to their employees under final regulations from the Trump administration that narrow the Affordable Care Act’s contraceptive mandate.

copyright Thinkstock

The two regulations, released Nov. 7, allow an expanded group of employers and insurers to get out of covering contraception methods by objecting on either religious or moral grounds.

The first rule broadens exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. The second rule protects nonprofit organizations and small businesses that have nonreligious moral convictions that oppose services covered by the mandate. The religious and moral exemptions apply to institutions of education, issuers, and individuals, but not to governmental entities.

When first proposed in 2017, Trump administration officials said the new policies would “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions.” The U.S. Department of Health & Human Services estimates that the rules, which take effect in January 2019, will affect no more than 200 employers.

The American College of Obstetricians and Gynecologists expressed concern that the final rules will restrict patient access to meaningful contraceptive methods and will erode decades of progress in increasing women’s reproductive autonomy and restrict patient access to contraception.

“Women, families and our nation all benefit from seamless, affordable access to contraception,” ACOG President Lisa M. Hollier, MD, said in a statement. “Contraception improves women’s health and well-being, reduces unintended pregnancy, enables pregnancy spacing for safer pregnancies and deliveries, and empowers women’s engagement in the workforce and economic self-sufficiency. A woman’s employer should not determine whether or not she has this access.”

Marjorie Dannenfelser, president of Susan B. Anthony List, an anti-abortion group, praised the final rules, calling them needed protections from the burdensome Obama-era ACA abortifacient drug mandate.

“President Trump and HHS Secretary Azar delivered a huge victory for conscience rights and religious liberty in America,” Ms. Dannenfelser said in a statement. “No longer will Catholic nuns who care for the elderly poor be forced by the government to provide abortion-inducing drugs in their health care plans. Not only that, moral objectors such as Susan B. Anthony List, will also no longer have to pay for life-ending drugs that are antithetical to their mission and for which we have argued there is certainly no compelling state interest.”

The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of religious employers, which were deemed exempt. Those religious employers were primarily churches and other houses of worship. After a number of complaints and legal challenges, the Obama administration created a workaround for nonprofit religious employers to opt out of the mandate.

However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.

Under the approved regulations, employers or insurers can stop their coverage of contraceptive services if they have religious beliefs or moral convictions against covering birth control. Exempted entities and individuals also can choose to cover some, but not all, contraceptive services, depending on their specific religious or moral objection, according to an HHS fact sheet.

The agency emphasized that the regulations leave in place government programs that provide free or subsidized contraceptive coverage to low-income women, such as through community health centers, and that the rules do not ban any employer from covering contraceptives.

The regulations become effective 60 days after they are published in the Federal Register.

More employers can opt out of providing contraception coverage to their employees under final regulations from the Trump administration that narrow the Affordable Care Act’s contraceptive mandate.

copyright Thinkstock

The two regulations, released Nov. 7, allow an expanded group of employers and insurers to get out of covering contraception methods by objecting on either religious or moral grounds.

The first rule broadens exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. The second rule protects nonprofit organizations and small businesses that have nonreligious moral convictions that oppose services covered by the mandate. The religious and moral exemptions apply to institutions of education, issuers, and individuals, but not to governmental entities.

When first proposed in 2017, Trump administration officials said the new policies would “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions.” The U.S. Department of Health & Human Services estimates that the rules, which take effect in January 2019, will affect no more than 200 employers.

The American College of Obstetricians and Gynecologists expressed concern that the final rules will restrict patient access to meaningful contraceptive methods and will erode decades of progress in increasing women’s reproductive autonomy and restrict patient access to contraception.

“Women, families and our nation all benefit from seamless, affordable access to contraception,” ACOG President Lisa M. Hollier, MD, said in a statement. “Contraception improves women’s health and well-being, reduces unintended pregnancy, enables pregnancy spacing for safer pregnancies and deliveries, and empowers women’s engagement in the workforce and economic self-sufficiency. A woman’s employer should not determine whether or not she has this access.”

Marjorie Dannenfelser, president of Susan B. Anthony List, an anti-abortion group, praised the final rules, calling them needed protections from the burdensome Obama-era ACA abortifacient drug mandate.

“President Trump and HHS Secretary Azar delivered a huge victory for conscience rights and religious liberty in America,” Ms. Dannenfelser said in a statement. “No longer will Catholic nuns who care for the elderly poor be forced by the government to provide abortion-inducing drugs in their health care plans. Not only that, moral objectors such as Susan B. Anthony List, will also no longer have to pay for life-ending drugs that are antithetical to their mission and for which we have argued there is certainly no compelling state interest.”

The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of religious employers, which were deemed exempt. Those religious employers were primarily churches and other houses of worship. After a number of complaints and legal challenges, the Obama administration created a workaround for nonprofit religious employers to opt out of the mandate.

However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.

Under the approved regulations, employers or insurers can stop their coverage of contraceptive services if they have religious beliefs or moral convictions against covering birth control. Exempted entities and individuals also can choose to cover some, but not all, contraceptive services, depending on their specific religious or moral objection, according to an HHS fact sheet.

The agency emphasized that the regulations leave in place government programs that provide free or subsidized contraceptive coverage to low-income women, such as through community health centers, and that the rules do not ban any employer from covering contraceptives.

The regulations become effective 60 days after they are published in the Federal Register.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

Cigarette smoking at lowest level ever

Article Type
Changed

 

The prevalence of cigarette smoking among adults was down to 14% in 2017, the lowest level recorded since monitoring began in 1965, according to the Centers for Disease Control and Prevention.

“This new all-time low in cigarette smoking among U.S. adults is a tremendous public health accomplishment, and it demonstrates the importance of continued proven strategies to reduce smoking,” CDC Director Robert Redfield said in a written statement.

In 2017, 19.3% of adults aged 18 years and older – approximately 47.4 million Americans – reported current use of some type of tobacco product, and current use of combustible tobacco was 16.7%, Teresa W. Wang, PhD, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, and her associates reported in the Morbidity and Mortality Weekly Report. Current use was defined as use every day or some days, with an added requirement of at least 100 cigarettes in a lifetime added for cigarette smokers.



Data from the National Health Interview Survey showed that from 2016 to 2017, current use declined for any tobacco product, any combustible tobacco product, cigarettes, smokeless tobacco, and the combination of two or more tobacco products. The most common combination in 2017 was cigarettes and e-cigarettes, which was reported by 30.1% of the 9 million adults who used more than one product, Dr. Wang and her associates said.

Prevalence of current tobacco use was higher among men than women (24.8% vs. 14.2%), and adults aged 25-44 years (22.5%) had the highest level by age, followed by those aged 45-64 years (21.3%), 18-24 years (18.3%), and 65 years or older (11%). Use by race/ethnicity was highest among American Indian/Alaska Natives (29.8%), with the Midwest putting up the highest prevalence by region at 23.5%, they said.



“Although cigarette smoking among U.S. adults has declined considerably, tobacco products have evolved in recent years to include various combustible, noncombustible, and electronic products,” Dr. Wang and her associates wrote. “Implementation of evidence-based tobacco control interventions that address the diversity of tobacco products used by U.S. adults, in coordination with regulation of tobacco product manufacturing, marketing, and sales, can reduce tobacco-related disease and death in the United States.”

SOURCE: Wang TW et al. MMWR. 2018 Nov 9;67[44]:1225-32.

Publications
Topics
Sections

 

The prevalence of cigarette smoking among adults was down to 14% in 2017, the lowest level recorded since monitoring began in 1965, according to the Centers for Disease Control and Prevention.

“This new all-time low in cigarette smoking among U.S. adults is a tremendous public health accomplishment, and it demonstrates the importance of continued proven strategies to reduce smoking,” CDC Director Robert Redfield said in a written statement.

In 2017, 19.3% of adults aged 18 years and older – approximately 47.4 million Americans – reported current use of some type of tobacco product, and current use of combustible tobacco was 16.7%, Teresa W. Wang, PhD, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, and her associates reported in the Morbidity and Mortality Weekly Report. Current use was defined as use every day or some days, with an added requirement of at least 100 cigarettes in a lifetime added for cigarette smokers.



Data from the National Health Interview Survey showed that from 2016 to 2017, current use declined for any tobacco product, any combustible tobacco product, cigarettes, smokeless tobacco, and the combination of two or more tobacco products. The most common combination in 2017 was cigarettes and e-cigarettes, which was reported by 30.1% of the 9 million adults who used more than one product, Dr. Wang and her associates said.

Prevalence of current tobacco use was higher among men than women (24.8% vs. 14.2%), and adults aged 25-44 years (22.5%) had the highest level by age, followed by those aged 45-64 years (21.3%), 18-24 years (18.3%), and 65 years or older (11%). Use by race/ethnicity was highest among American Indian/Alaska Natives (29.8%), with the Midwest putting up the highest prevalence by region at 23.5%, they said.



“Although cigarette smoking among U.S. adults has declined considerably, tobacco products have evolved in recent years to include various combustible, noncombustible, and electronic products,” Dr. Wang and her associates wrote. “Implementation of evidence-based tobacco control interventions that address the diversity of tobacco products used by U.S. adults, in coordination with regulation of tobacco product manufacturing, marketing, and sales, can reduce tobacco-related disease and death in the United States.”

SOURCE: Wang TW et al. MMWR. 2018 Nov 9;67[44]:1225-32.

 

The prevalence of cigarette smoking among adults was down to 14% in 2017, the lowest level recorded since monitoring began in 1965, according to the Centers for Disease Control and Prevention.

“This new all-time low in cigarette smoking among U.S. adults is a tremendous public health accomplishment, and it demonstrates the importance of continued proven strategies to reduce smoking,” CDC Director Robert Redfield said in a written statement.

In 2017, 19.3% of adults aged 18 years and older – approximately 47.4 million Americans – reported current use of some type of tobacco product, and current use of combustible tobacco was 16.7%, Teresa W. Wang, PhD, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, and her associates reported in the Morbidity and Mortality Weekly Report. Current use was defined as use every day or some days, with an added requirement of at least 100 cigarettes in a lifetime added for cigarette smokers.



Data from the National Health Interview Survey showed that from 2016 to 2017, current use declined for any tobacco product, any combustible tobacco product, cigarettes, smokeless tobacco, and the combination of two or more tobacco products. The most common combination in 2017 was cigarettes and e-cigarettes, which was reported by 30.1% of the 9 million adults who used more than one product, Dr. Wang and her associates said.

Prevalence of current tobacco use was higher among men than women (24.8% vs. 14.2%), and adults aged 25-44 years (22.5%) had the highest level by age, followed by those aged 45-64 years (21.3%), 18-24 years (18.3%), and 65 years or older (11%). Use by race/ethnicity was highest among American Indian/Alaska Natives (29.8%), with the Midwest putting up the highest prevalence by region at 23.5%, they said.



“Although cigarette smoking among U.S. adults has declined considerably, tobacco products have evolved in recent years to include various combustible, noncombustible, and electronic products,” Dr. Wang and her associates wrote. “Implementation of evidence-based tobacco control interventions that address the diversity of tobacco products used by U.S. adults, in coordination with regulation of tobacco product manufacturing, marketing, and sales, can reduce tobacco-related disease and death in the United States.”

SOURCE: Wang TW et al. MMWR. 2018 Nov 9;67[44]:1225-32.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM MMWR

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

Open enrollment: Slow first week at HealthCare.gov

Article Type
Changed

 

About 372,000 people selected a health insurance plan during the first week of Affordable Care Act open enrollment for 2019, according to the Centers for Medicare & Medicaid Services. The first week was short, with only 3 days to select coverage.

For Nov. 1-3, the exact number of plans selected was 371,676, which is about 38% less than last year’s first week, which was 4 days long, so the average number of plans selected per day was down by a little less than 18%, CMS data show.



“The final number of plan selections associated with enrollment activity during a reporting period may change due to plan modifications or cancellations,” CMS officials said, adding that the weekly data release “only reports new plan selections and active plan renewals and does not report the number of consumers who have paid premiums to effectuate their enrollment.”

Open enrollment will continue for another 6 weeks, with Dec. 15 being the final day to enroll for 2019 coverage on the 39 state exchanges that use the HealthCare.gov platform.

Publications
Topics
Sections

 

About 372,000 people selected a health insurance plan during the first week of Affordable Care Act open enrollment for 2019, according to the Centers for Medicare & Medicaid Services. The first week was short, with only 3 days to select coverage.

For Nov. 1-3, the exact number of plans selected was 371,676, which is about 38% less than last year’s first week, which was 4 days long, so the average number of plans selected per day was down by a little less than 18%, CMS data show.



“The final number of plan selections associated with enrollment activity during a reporting period may change due to plan modifications or cancellations,” CMS officials said, adding that the weekly data release “only reports new plan selections and active plan renewals and does not report the number of consumers who have paid premiums to effectuate their enrollment.”

Open enrollment will continue for another 6 weeks, with Dec. 15 being the final day to enroll for 2019 coverage on the 39 state exchanges that use the HealthCare.gov platform.

 

About 372,000 people selected a health insurance plan during the first week of Affordable Care Act open enrollment for 2019, according to the Centers for Medicare & Medicaid Services. The first week was short, with only 3 days to select coverage.

For Nov. 1-3, the exact number of plans selected was 371,676, which is about 38% less than last year’s first week, which was 4 days long, so the average number of plans selected per day was down by a little less than 18%, CMS data show.



“The final number of plan selections associated with enrollment activity during a reporting period may change due to plan modifications or cancellations,” CMS officials said, adding that the weekly data release “only reports new plan selections and active plan renewals and does not report the number of consumers who have paid premiums to effectuate their enrollment.”

Open enrollment will continue for another 6 weeks, with Dec. 15 being the final day to enroll for 2019 coverage on the 39 state exchanges that use the HealthCare.gov platform.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

ED clinicians’ confidence in dealing with ICE mixed, survey finds

Article Type
Changed

 

– Most emergency physicians have limited comfort and knowledge about appropriate interactions with Immigration and Customs Enforcement officers in the ED, based on results from a survey conducted at two Chicago hospitals.

Doug Brunk/MDedge News
Dr. Charlotte Roy

“More robust training and education may improve provider comfort and ability to appropriately balance patients’ rights with law enforcement,” one of the study authors, Charlotte Roy, MD, said at the annual meeting of the American College of Emergency Physicians.

Immigration and Customs Enforcement (ICE) is a federal government agency responsible for the detainment and deportation of immigrants whom they deem to be in violation of federal immigration law. Typically, hospitals have fallen into the category of “sensitive locations,” meaning they are avoided by ICE for enforcement actions, said Dr. Roy, a third-year resident in the department of emergency medicine at University of Chicago Hospital. However, “we’ve seen an increase in the apprehension and removal of illegal immigrants by 30% in 2017 across all locations,” she said.

In an effort to assess provider comfort, knowledge, and previous training on the subject, Dr. Roy and her colleagues administered a 15-question multiple-choice survey to 128 emergency residents, fellows, and attendings at John H. Stroger Jr. Hospital of Cook County and University of Chicago Hospital. Most of the 128 survey participants were residents (70), followed by 54 fellows and 4 attendings. One of the two hospital ED programs offered formal training on the topic, yet only 44% of respondents from that program reported that they participated in the training.



Examples of questions included “Do you know in what circumstances you are required to give protected health information of patients to immigration officers?” “Do you feel confident in your knowledge of which areas of the emergency department ICE agents could enter?” and “Are you confident you can get real-time help to answer questions regarding interactions with immigration officers?”

Among all respondents, 52% said that they would not feel comfortable interacting with immigration officers in the ED, 12% felt confident knowing which areas of the ED immigration officers could freely enter, and 11% were familiar with the designation of “sensitive locations” within their hospital. In addition, 23% of respondents knew that immigration status is protected under the Health Insurance Portability and Accountability Act of 1996 as protected health information, 16% knew in which circumstances they were required to convey immigrant status, and 51% knew a warrant or a court order is required for an immigration office to enter a patient’s room.

“Our conclusion based on these survey results is that there is very limited comfort and knowledge amongst ED providers regarding interactions with ICE officers in the ED,” Dr. Roy said. One resource she recommended is the National Immigration Law Center, which publishes a guide, “What to Do If Immigration Comes to Your Workplace.” The study’s primary author was Joseph Palter, MD. The researchers reported having no financial disclosures.

Source: Palter J et al. Ann Emerg Med. 2018 Oct;72;4:S117. doi. 10.1016/j.annemergmed.2018.08.303.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

– Most emergency physicians have limited comfort and knowledge about appropriate interactions with Immigration and Customs Enforcement officers in the ED, based on results from a survey conducted at two Chicago hospitals.

Doug Brunk/MDedge News
Dr. Charlotte Roy

“More robust training and education may improve provider comfort and ability to appropriately balance patients’ rights with law enforcement,” one of the study authors, Charlotte Roy, MD, said at the annual meeting of the American College of Emergency Physicians.

Immigration and Customs Enforcement (ICE) is a federal government agency responsible for the detainment and deportation of immigrants whom they deem to be in violation of federal immigration law. Typically, hospitals have fallen into the category of “sensitive locations,” meaning they are avoided by ICE for enforcement actions, said Dr. Roy, a third-year resident in the department of emergency medicine at University of Chicago Hospital. However, “we’ve seen an increase in the apprehension and removal of illegal immigrants by 30% in 2017 across all locations,” she said.

In an effort to assess provider comfort, knowledge, and previous training on the subject, Dr. Roy and her colleagues administered a 15-question multiple-choice survey to 128 emergency residents, fellows, and attendings at John H. Stroger Jr. Hospital of Cook County and University of Chicago Hospital. Most of the 128 survey participants were residents (70), followed by 54 fellows and 4 attendings. One of the two hospital ED programs offered formal training on the topic, yet only 44% of respondents from that program reported that they participated in the training.



Examples of questions included “Do you know in what circumstances you are required to give protected health information of patients to immigration officers?” “Do you feel confident in your knowledge of which areas of the emergency department ICE agents could enter?” and “Are you confident you can get real-time help to answer questions regarding interactions with immigration officers?”

Among all respondents, 52% said that they would not feel comfortable interacting with immigration officers in the ED, 12% felt confident knowing which areas of the ED immigration officers could freely enter, and 11% were familiar with the designation of “sensitive locations” within their hospital. In addition, 23% of respondents knew that immigration status is protected under the Health Insurance Portability and Accountability Act of 1996 as protected health information, 16% knew in which circumstances they were required to convey immigrant status, and 51% knew a warrant or a court order is required for an immigration office to enter a patient’s room.

“Our conclusion based on these survey results is that there is very limited comfort and knowledge amongst ED providers regarding interactions with ICE officers in the ED,” Dr. Roy said. One resource she recommended is the National Immigration Law Center, which publishes a guide, “What to Do If Immigration Comes to Your Workplace.” The study’s primary author was Joseph Palter, MD. The researchers reported having no financial disclosures.

Source: Palter J et al. Ann Emerg Med. 2018 Oct;72;4:S117. doi. 10.1016/j.annemergmed.2018.08.303.

 

– Most emergency physicians have limited comfort and knowledge about appropriate interactions with Immigration and Customs Enforcement officers in the ED, based on results from a survey conducted at two Chicago hospitals.

Doug Brunk/MDedge News
Dr. Charlotte Roy

“More robust training and education may improve provider comfort and ability to appropriately balance patients’ rights with law enforcement,” one of the study authors, Charlotte Roy, MD, said at the annual meeting of the American College of Emergency Physicians.

Immigration and Customs Enforcement (ICE) is a federal government agency responsible for the detainment and deportation of immigrants whom they deem to be in violation of federal immigration law. Typically, hospitals have fallen into the category of “sensitive locations,” meaning they are avoided by ICE for enforcement actions, said Dr. Roy, a third-year resident in the department of emergency medicine at University of Chicago Hospital. However, “we’ve seen an increase in the apprehension and removal of illegal immigrants by 30% in 2017 across all locations,” she said.

In an effort to assess provider comfort, knowledge, and previous training on the subject, Dr. Roy and her colleagues administered a 15-question multiple-choice survey to 128 emergency residents, fellows, and attendings at John H. Stroger Jr. Hospital of Cook County and University of Chicago Hospital. Most of the 128 survey participants were residents (70), followed by 54 fellows and 4 attendings. One of the two hospital ED programs offered formal training on the topic, yet only 44% of respondents from that program reported that they participated in the training.



Examples of questions included “Do you know in what circumstances you are required to give protected health information of patients to immigration officers?” “Do you feel confident in your knowledge of which areas of the emergency department ICE agents could enter?” and “Are you confident you can get real-time help to answer questions regarding interactions with immigration officers?”

Among all respondents, 52% said that they would not feel comfortable interacting with immigration officers in the ED, 12% felt confident knowing which areas of the ED immigration officers could freely enter, and 11% were familiar with the designation of “sensitive locations” within their hospital. In addition, 23% of respondents knew that immigration status is protected under the Health Insurance Portability and Accountability Act of 1996 as protected health information, 16% knew in which circumstances they were required to convey immigrant status, and 51% knew a warrant or a court order is required for an immigration office to enter a patient’s room.

“Our conclusion based on these survey results is that there is very limited comfort and knowledge amongst ED providers regarding interactions with ICE officers in the ED,” Dr. Roy said. One resource she recommended is the National Immigration Law Center, which publishes a guide, “What to Do If Immigration Comes to Your Workplace.” The study’s primary author was Joseph Palter, MD. The researchers reported having no financial disclosures.

Source: Palter J et al. Ann Emerg Med. 2018 Oct;72;4:S117. doi. 10.1016/j.annemergmed.2018.08.303.

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Article Source

AT ACEP18

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Emergency physicians’ knowledge of how to interact with immigration agencies is highly variable.

Major finding: More than half of respondents (52%) said that they would not feel comfortable interacting with immigration officers in the ED.

Study details: A survey of 128 emergency medicine physicians.

Disclosures: The researchers reported having no financial disclosures.

Source: Palter J et al. Ann Emerg Med. 2018 Oct;72;4:S117. doi. 10.1016/j.annemergmed.2018.08.303.

Disqus Comments
Default
Use ProPublica

Most nonemergent diagnoses can’t be predicted at ED presentation

Article Type
Changed

SAN DIEGO – Symptoms alone are usually not sufficient for either patients or staff to determine whether an ED visit is warranted, based on an analysis of a national health care database presented at the annual meeting of the American College of Emergency Physicians and later published in JAMA Network Open.

The findings have important policy implications, as a large health care insurer recently rolled out a program to deny coverage for ED visits that conclude with a nonemergent diagnosis.

“Nonemergent diagnoses correlate poorly with visit severity and the need for multiple diagnostic tests and hospital care,” Shih-Chuan Chou, MD, of Brigham and Women’s Hospital in Boston, said at the meeting. “Nearly 9 out of 10 ED patients will present with some sort of symptoms that may potentially lead to a nonemergent diagnosis.”

Anthem initiated the decision to deny coverage for nonemergent conditions in 2017. Anthem’s policy is active in six states: Georgia, Indiana, Kentucky, Missouri, New Hampshire, and Ohio. ACEP and the Medical Association of Georgia have filed a federal lawsuit asserting that Anthem Blue Cross/Blue Shield of Georgia is violating the prudent layperson standard, which is a federal law requiring insurance companies to cover the costs of emergency care based on a patient’s symptoms – not their final diagnosis.

In the study reported by Dr. Chou, the impact of the change in reimbursement was applied to ED visit data from the National Hospital Ambulatory Medical Care Survey (NHAMCS-ED).

Of the 29.6 million adult ED visits by commercially insured patients in the NHAMCS-ED database over the study period, 15.7%, or approximately 4.6 million visits, would have been denied reimbursement based on the new Anthem policy. Of these, 24.5% of the visits were initially triaged by the ED staff as urgent or emergent. Another 26% of the visits resulted in two or more diagnostic tests, suggesting that ED staff were concerned that the underlying disease was potentially serious.

From another perspective, 87.9% of patients with a diagnosis that met criteria for reimbursement had symptoms similar to those of patients who would have been denied reimbursement. In other words, according to Dr. Chou, neither patients nor ED staff would likely be able to distinguish on the basis of symptoms alone which patients would ultimately be diagnosed with a disease that was or was not eligible for reimbursement.

“If commercial insurers begin adopting similar policies and retrospectively deny coverage for ED visits using discharge diagnoses, patients will be forced to weigh the odds of foregoing potentially necessary care against the risk of facing a significant financial burden if they guessed wrong,” Dr. Chou said.

Such policies are “likely to disproportionally impact low income populations,” he added, noting that many patient advocacy groups, as well as the American Medical Association, have expressed opposition to Anthem’s approach.

New strategies are needed to reduce reliance on ED visits for acute but nonemergent diseases, Dr. Chou said, but the data argue against denial of reimbursement as a method consistent with delivery of good health care.

Dr. Chou reported no financial relationships relevant to this study.

SOURCE: Chou S-C et al. JAMA Netw Open. 2018 Oct 19. doi: 10.1001/jamanetworkopen.2018.3731.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

SAN DIEGO – Symptoms alone are usually not sufficient for either patients or staff to determine whether an ED visit is warranted, based on an analysis of a national health care database presented at the annual meeting of the American College of Emergency Physicians and later published in JAMA Network Open.

The findings have important policy implications, as a large health care insurer recently rolled out a program to deny coverage for ED visits that conclude with a nonemergent diagnosis.

“Nonemergent diagnoses correlate poorly with visit severity and the need for multiple diagnostic tests and hospital care,” Shih-Chuan Chou, MD, of Brigham and Women’s Hospital in Boston, said at the meeting. “Nearly 9 out of 10 ED patients will present with some sort of symptoms that may potentially lead to a nonemergent diagnosis.”

Anthem initiated the decision to deny coverage for nonemergent conditions in 2017. Anthem’s policy is active in six states: Georgia, Indiana, Kentucky, Missouri, New Hampshire, and Ohio. ACEP and the Medical Association of Georgia have filed a federal lawsuit asserting that Anthem Blue Cross/Blue Shield of Georgia is violating the prudent layperson standard, which is a federal law requiring insurance companies to cover the costs of emergency care based on a patient’s symptoms – not their final diagnosis.

In the study reported by Dr. Chou, the impact of the change in reimbursement was applied to ED visit data from the National Hospital Ambulatory Medical Care Survey (NHAMCS-ED).

Of the 29.6 million adult ED visits by commercially insured patients in the NHAMCS-ED database over the study period, 15.7%, or approximately 4.6 million visits, would have been denied reimbursement based on the new Anthem policy. Of these, 24.5% of the visits were initially triaged by the ED staff as urgent or emergent. Another 26% of the visits resulted in two or more diagnostic tests, suggesting that ED staff were concerned that the underlying disease was potentially serious.

From another perspective, 87.9% of patients with a diagnosis that met criteria for reimbursement had symptoms similar to those of patients who would have been denied reimbursement. In other words, according to Dr. Chou, neither patients nor ED staff would likely be able to distinguish on the basis of symptoms alone which patients would ultimately be diagnosed with a disease that was or was not eligible for reimbursement.

“If commercial insurers begin adopting similar policies and retrospectively deny coverage for ED visits using discharge diagnoses, patients will be forced to weigh the odds of foregoing potentially necessary care against the risk of facing a significant financial burden if they guessed wrong,” Dr. Chou said.

Such policies are “likely to disproportionally impact low income populations,” he added, noting that many patient advocacy groups, as well as the American Medical Association, have expressed opposition to Anthem’s approach.

New strategies are needed to reduce reliance on ED visits for acute but nonemergent diseases, Dr. Chou said, but the data argue against denial of reimbursement as a method consistent with delivery of good health care.

Dr. Chou reported no financial relationships relevant to this study.

SOURCE: Chou S-C et al. JAMA Netw Open. 2018 Oct 19. doi: 10.1001/jamanetworkopen.2018.3731.

SAN DIEGO – Symptoms alone are usually not sufficient for either patients or staff to determine whether an ED visit is warranted, based on an analysis of a national health care database presented at the annual meeting of the American College of Emergency Physicians and later published in JAMA Network Open.

The findings have important policy implications, as a large health care insurer recently rolled out a program to deny coverage for ED visits that conclude with a nonemergent diagnosis.

“Nonemergent diagnoses correlate poorly with visit severity and the need for multiple diagnostic tests and hospital care,” Shih-Chuan Chou, MD, of Brigham and Women’s Hospital in Boston, said at the meeting. “Nearly 9 out of 10 ED patients will present with some sort of symptoms that may potentially lead to a nonemergent diagnosis.”

Anthem initiated the decision to deny coverage for nonemergent conditions in 2017. Anthem’s policy is active in six states: Georgia, Indiana, Kentucky, Missouri, New Hampshire, and Ohio. ACEP and the Medical Association of Georgia have filed a federal lawsuit asserting that Anthem Blue Cross/Blue Shield of Georgia is violating the prudent layperson standard, which is a federal law requiring insurance companies to cover the costs of emergency care based on a patient’s symptoms – not their final diagnosis.

In the study reported by Dr. Chou, the impact of the change in reimbursement was applied to ED visit data from the National Hospital Ambulatory Medical Care Survey (NHAMCS-ED).

Of the 29.6 million adult ED visits by commercially insured patients in the NHAMCS-ED database over the study period, 15.7%, or approximately 4.6 million visits, would have been denied reimbursement based on the new Anthem policy. Of these, 24.5% of the visits were initially triaged by the ED staff as urgent or emergent. Another 26% of the visits resulted in two or more diagnostic tests, suggesting that ED staff were concerned that the underlying disease was potentially serious.

From another perspective, 87.9% of patients with a diagnosis that met criteria for reimbursement had symptoms similar to those of patients who would have been denied reimbursement. In other words, according to Dr. Chou, neither patients nor ED staff would likely be able to distinguish on the basis of symptoms alone which patients would ultimately be diagnosed with a disease that was or was not eligible for reimbursement.

“If commercial insurers begin adopting similar policies and retrospectively deny coverage for ED visits using discharge diagnoses, patients will be forced to weigh the odds of foregoing potentially necessary care against the risk of facing a significant financial burden if they guessed wrong,” Dr. Chou said.

Such policies are “likely to disproportionally impact low income populations,” he added, noting that many patient advocacy groups, as well as the American Medical Association, have expressed opposition to Anthem’s approach.

New strategies are needed to reduce reliance on ED visits for acute but nonemergent diseases, Dr. Chou said, but the data argue against denial of reimbursement as a method consistent with delivery of good health care.

Dr. Chou reported no financial relationships relevant to this study.

SOURCE: Chou S-C et al. JAMA Netw Open. 2018 Oct 19. doi: 10.1001/jamanetworkopen.2018.3731.

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Article Source

REPORTING FROM ACEP18

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

Key clinical point: A program to deny coverage for nonemergent visits to the ED is likely to have an adverse impact on patient care.

Major finding: Of patients with serious diseases eligible for reimbursement, 87.9% also have symptoms associated with nonurgent diseases.

Study details: An analysis of 29.6 million adult ED visits by commercially insured patients in the National Hospital Ambulatory Medical Care Survey.

Disclosures: Dr. Chou reported no financial relationships relevant to this study.

Source: Chou S-C et al. JAMA Netw Open. 2018 Oct 19. doi: 10.1001/jamanetworkopen.2018.3731.

Disqus Comments
Default
Use ProPublica

Marijuana: Know the Rules in Your State

Article Type
Changed
Display Headline
Marijuana: Know the Rules in Your State

In 1992, then-governor of Massachusetts William F. Weld signed a bill into law legalizing the use of marijuana for glaucoma, cancer therapy, and certain asthmatic disorders under a limited Department of Public Health (DPH) research program. In 1996, the legislature gave DPH the power to approve any Massachusetts patient to “possess and use pot” legally for relief of symptoms.1 In my position as Health Policy Coordinator with DPH, those two acts were my introduction to the controversy of medical marijuana.

Since then, the popularity of—or rather, the shift in public sentiment regarding—marijuana (cannabis/cannabinoid) use has changed. There has been significant interest in the use of marijuana as an adjunct to treating chronic and/or debilitating medical conditions. There is also increasing interest in the potential therapeutic uses of marijuana and other cannabinoid compounds.

In recent years, we’ve seen significant momentum on this front. Point in fact, in fiscal year 2017, the National Institutes of Health supported projects on cannabinoid research totaling almost $140 million.2 More than 30 US jurisdictions have passed legislation to legalize marijuana for medical use (while a few have legalized its use, period).3 All of which has prompted quite the debate not only among the public but also among health care providers.

A review of the history of cannabis use is very interesting—specifically, that the use of cannabis as a therapeutic modality predates recorded history. Cannabis was very popular in ancient China, India, and Greece as a medicine to alleviate pain or cure a variety of ailments.4,5 In the early 1900s, cannabis was available OTC and commonly used for a variety of illnesses in the US. The first law regarding marijuana was enacted in 1619 at Jamestown Colony, Virginia; it “ordered” all farmers to grow Indian hempseed.6

But by 1906, cannabis was labeled as a poison in many states, and by the 1920s absolute prohibitions began. The Controlled Substances Act of 1970 outlawed cannabis for any use. Despite that ban, marijuana is the most common illegal drug used in the US today.7

Marijuana, not a completely benign substance, occupies a unique position in our society. On the one hand, it is a recreational compound, used to attain pleasant euphoria and a sense of relaxation. On the other, it has been used as a therapeutic compound, relieving nausea and anorexia from chemotherapy. In the former, it is viewed by many as a dangerous drug that can lead to madness (as depicted in the film Reefer Madness).8 In the latter, its use as an effective analgesic and appetite stimulant has been supported by people who have realized a therapeutic benefit.

The potential medicinal benefits of marijuana and its components have been the subject of research and ongoing heated debates. Decades of anecdotal evidence regarding the effectiveness of marijuana on the aforementioned symptoms have been documented. There are also numerous studies on marijuana as a therapeutic agent for multiple conditions, using the plant itself or extracts derived from it.9-11

Continue to: Perhaps most interesting...

 

 

Perhaps most interesting, emerging data suggest that use and abuse of prescription drugs may be decreasing in states where medical cannabis is legal.12 Two recent studies examining cannabis laws and prescription of opioids found that “medical cannabis laws are associated with significant reductions in opioid prescribing in the Medicare Part D population,” concluding that the potential for marijuana to decrease opioid use in the Medicaid population deserves consideration during policy discussions about marijuana reform and the opioid epidemic.13, 14

The support for policy changes in states that have legalized marijuana for medical use suggests it is gaining greater acceptance in our society. The increase in jurisdictions that have approved marijuana for medical use requires that we, as health care providers, understand the implications for our practice and educate ourselves on the laws and regulations in our respective states.

Recent guidelines from the National Council of State Boards of Nursing (NCSBN) identify six principles of essential knowledge for NPs (that could apply to PAs, as well) who care for patients who qualify to participate in a Medical Marijuana Program (MMP). These include principles of safe and knowledgeable practice for clinicians when qualifying a patient for an MMP.3 Note that I said qualifying a patient and not prescribing marijuana. Federal law still classifies cannabis as a Schedule I controlled substance, thus prohibiting the actual prescription of marijuana, and prohibits pharmacies from dispensing cannabis. Quite a contradiction!

All of that said, it is incumbent upon each of us to understand the complexities of the MMP in our state. Each has its own specifications as to the qualifying conditions or symptoms, as well as the requirements to become an approved provider. And each is as diverse as the opinions on marijuana use.

Without doubt, the debate and dichotomy about medical marijuana will ensue for years. What we as health care providers must do is keep current on the laws and regulations not only in our state, but also at the federal level. As a primer on the status of MMPs and provider approval, I encourage all to review the NCSBN document.3

As always, you can share your thoughts with me via [email protected].

References

1. State House News Service. Marijuana in Massachusetts: where are we, what’s next? Beacon Hill Patch. November 12, 2017. https://patch.com/massachusetts/beaconhill/marijuana-massachusetts-where-are-we-whats-next. Accessed October 12, 2018.
2. National Institute on Drug Abuse. NIDA’s role in providing marijuana for research. April 2018. www.drugabuse.gov/drugs-abuse/marijuana/nidas-role-in-providing-marijuana-research. Accessed October 12, 2018.
3. The National Council of State Boards of Nursing. The NCSBN national nursing guidelines for medical marijuana. 2018;9(suppl 2). www.ncsbn.org/The_NCSBN_National_Nursing_Guidelines_for_Medical_Marijuana_JNR_July_2018.pdf. Accessed October 12, 2018.
4. ProCon.org. Historical timeline: history of marijuana as medicine—2900 BC to present. http://medicalmarijuana.procon.org/view.timeline.php?timelineID=000026. Accessed October 12, 2018.
5. National Commission on Marihuana and Drug Abuse. Marihuana: A Signal of Misunderstanding—First Report. Washington, DC: US Government Printing Office; 1972.
6. Guither P. Why is marijuana illegal? DrugWarRant.com. http://www.drugwarrant.com/articles/why-is-marijuana-illegal. Accessed October 12, 2018.
7. Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. Results from the 2015 National Survey on Drug Use and Health: Detailed Tables. www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2015/NSDUH-DetTabs-2015/NSDUH-DetTabs-2015.pdf. Accessed October 12, 2018.
8. Reefer Madness (1938). https://publicdomainreview.org/collections/reefer-madness-1938. Accessed October 12, 2018.
9. ProCon.org. 60 peer-reviewed studies on medical marijuana: medical studies involving cannabis and cannabis extracts (1990-2014). http://medicalmarijuana.procon.org/view.resource.php?resourceID=000884. Accessed October 12, 2018.
10. Cochrane Library. Cochrane evidence: cannabis. www.cochrane.org/search/site/cannabis. Accessed October 12, 2018.
11. The National Academies of Sciences, Engineering, and Medicine. The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. Washington, DC: The National Academies Press; 2017. https://doi.org/10.17226/24625. Accessed October 12, 2018.
12. Carroon JM, Mischley LK, Sexton M. Cannabis as a substitute for prescription drugs: a cross-sectional study. J Pain Res. 2017;10:989-998.
13. Bradford AC, Bradford WD, Abraham A, Adams GB. Association between US state medical cannabis laws and opioid prescribing in the Medicare Part D population. JAMA Intern Med. 2018;178(5):667-672.
14. Wen H, Hockenberr M. Association of medical and adult-use marijuana laws with opioid prescribing for Medicaid enrollees. JAMA Intern Med. 2018;178(5):673-679.

Article PDF
Author and Disclosure Information

Issue
Clinician Reviews - 28(11)
Publications
Topics
Page Number
e5-e6
Sections
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

In 1992, then-governor of Massachusetts William F. Weld signed a bill into law legalizing the use of marijuana for glaucoma, cancer therapy, and certain asthmatic disorders under a limited Department of Public Health (DPH) research program. In 1996, the legislature gave DPH the power to approve any Massachusetts patient to “possess and use pot” legally for relief of symptoms.1 In my position as Health Policy Coordinator with DPH, those two acts were my introduction to the controversy of medical marijuana.

Since then, the popularity of—or rather, the shift in public sentiment regarding—marijuana (cannabis/cannabinoid) use has changed. There has been significant interest in the use of marijuana as an adjunct to treating chronic and/or debilitating medical conditions. There is also increasing interest in the potential therapeutic uses of marijuana and other cannabinoid compounds.

In recent years, we’ve seen significant momentum on this front. Point in fact, in fiscal year 2017, the National Institutes of Health supported projects on cannabinoid research totaling almost $140 million.2 More than 30 US jurisdictions have passed legislation to legalize marijuana for medical use (while a few have legalized its use, period).3 All of which has prompted quite the debate not only among the public but also among health care providers.

A review of the history of cannabis use is very interesting—specifically, that the use of cannabis as a therapeutic modality predates recorded history. Cannabis was very popular in ancient China, India, and Greece as a medicine to alleviate pain or cure a variety of ailments.4,5 In the early 1900s, cannabis was available OTC and commonly used for a variety of illnesses in the US. The first law regarding marijuana was enacted in 1619 at Jamestown Colony, Virginia; it “ordered” all farmers to grow Indian hempseed.6

But by 1906, cannabis was labeled as a poison in many states, and by the 1920s absolute prohibitions began. The Controlled Substances Act of 1970 outlawed cannabis for any use. Despite that ban, marijuana is the most common illegal drug used in the US today.7

Marijuana, not a completely benign substance, occupies a unique position in our society. On the one hand, it is a recreational compound, used to attain pleasant euphoria and a sense of relaxation. On the other, it has been used as a therapeutic compound, relieving nausea and anorexia from chemotherapy. In the former, it is viewed by many as a dangerous drug that can lead to madness (as depicted in the film Reefer Madness).8 In the latter, its use as an effective analgesic and appetite stimulant has been supported by people who have realized a therapeutic benefit.

The potential medicinal benefits of marijuana and its components have been the subject of research and ongoing heated debates. Decades of anecdotal evidence regarding the effectiveness of marijuana on the aforementioned symptoms have been documented. There are also numerous studies on marijuana as a therapeutic agent for multiple conditions, using the plant itself or extracts derived from it.9-11

Continue to: Perhaps most interesting...

 

 

Perhaps most interesting, emerging data suggest that use and abuse of prescription drugs may be decreasing in states where medical cannabis is legal.12 Two recent studies examining cannabis laws and prescription of opioids found that “medical cannabis laws are associated with significant reductions in opioid prescribing in the Medicare Part D population,” concluding that the potential for marijuana to decrease opioid use in the Medicaid population deserves consideration during policy discussions about marijuana reform and the opioid epidemic.13, 14

The support for policy changes in states that have legalized marijuana for medical use suggests it is gaining greater acceptance in our society. The increase in jurisdictions that have approved marijuana for medical use requires that we, as health care providers, understand the implications for our practice and educate ourselves on the laws and regulations in our respective states.

Recent guidelines from the National Council of State Boards of Nursing (NCSBN) identify six principles of essential knowledge for NPs (that could apply to PAs, as well) who care for patients who qualify to participate in a Medical Marijuana Program (MMP). These include principles of safe and knowledgeable practice for clinicians when qualifying a patient for an MMP.3 Note that I said qualifying a patient and not prescribing marijuana. Federal law still classifies cannabis as a Schedule I controlled substance, thus prohibiting the actual prescription of marijuana, and prohibits pharmacies from dispensing cannabis. Quite a contradiction!

All of that said, it is incumbent upon each of us to understand the complexities of the MMP in our state. Each has its own specifications as to the qualifying conditions or symptoms, as well as the requirements to become an approved provider. And each is as diverse as the opinions on marijuana use.

Without doubt, the debate and dichotomy about medical marijuana will ensue for years. What we as health care providers must do is keep current on the laws and regulations not only in our state, but also at the federal level. As a primer on the status of MMPs and provider approval, I encourage all to review the NCSBN document.3

As always, you can share your thoughts with me via [email protected].

In 1992, then-governor of Massachusetts William F. Weld signed a bill into law legalizing the use of marijuana for glaucoma, cancer therapy, and certain asthmatic disorders under a limited Department of Public Health (DPH) research program. In 1996, the legislature gave DPH the power to approve any Massachusetts patient to “possess and use pot” legally for relief of symptoms.1 In my position as Health Policy Coordinator with DPH, those two acts were my introduction to the controversy of medical marijuana.

Since then, the popularity of—or rather, the shift in public sentiment regarding—marijuana (cannabis/cannabinoid) use has changed. There has been significant interest in the use of marijuana as an adjunct to treating chronic and/or debilitating medical conditions. There is also increasing interest in the potential therapeutic uses of marijuana and other cannabinoid compounds.

In recent years, we’ve seen significant momentum on this front. Point in fact, in fiscal year 2017, the National Institutes of Health supported projects on cannabinoid research totaling almost $140 million.2 More than 30 US jurisdictions have passed legislation to legalize marijuana for medical use (while a few have legalized its use, period).3 All of which has prompted quite the debate not only among the public but also among health care providers.

A review of the history of cannabis use is very interesting—specifically, that the use of cannabis as a therapeutic modality predates recorded history. Cannabis was very popular in ancient China, India, and Greece as a medicine to alleviate pain or cure a variety of ailments.4,5 In the early 1900s, cannabis was available OTC and commonly used for a variety of illnesses in the US. The first law regarding marijuana was enacted in 1619 at Jamestown Colony, Virginia; it “ordered” all farmers to grow Indian hempseed.6

But by 1906, cannabis was labeled as a poison in many states, and by the 1920s absolute prohibitions began. The Controlled Substances Act of 1970 outlawed cannabis for any use. Despite that ban, marijuana is the most common illegal drug used in the US today.7

Marijuana, not a completely benign substance, occupies a unique position in our society. On the one hand, it is a recreational compound, used to attain pleasant euphoria and a sense of relaxation. On the other, it has been used as a therapeutic compound, relieving nausea and anorexia from chemotherapy. In the former, it is viewed by many as a dangerous drug that can lead to madness (as depicted in the film Reefer Madness).8 In the latter, its use as an effective analgesic and appetite stimulant has been supported by people who have realized a therapeutic benefit.

The potential medicinal benefits of marijuana and its components have been the subject of research and ongoing heated debates. Decades of anecdotal evidence regarding the effectiveness of marijuana on the aforementioned symptoms have been documented. There are also numerous studies on marijuana as a therapeutic agent for multiple conditions, using the plant itself or extracts derived from it.9-11

Continue to: Perhaps most interesting...

 

 

Perhaps most interesting, emerging data suggest that use and abuse of prescription drugs may be decreasing in states where medical cannabis is legal.12 Two recent studies examining cannabis laws and prescription of opioids found that “medical cannabis laws are associated with significant reductions in opioid prescribing in the Medicare Part D population,” concluding that the potential for marijuana to decrease opioid use in the Medicaid population deserves consideration during policy discussions about marijuana reform and the opioid epidemic.13, 14

The support for policy changes in states that have legalized marijuana for medical use suggests it is gaining greater acceptance in our society. The increase in jurisdictions that have approved marijuana for medical use requires that we, as health care providers, understand the implications for our practice and educate ourselves on the laws and regulations in our respective states.

Recent guidelines from the National Council of State Boards of Nursing (NCSBN) identify six principles of essential knowledge for NPs (that could apply to PAs, as well) who care for patients who qualify to participate in a Medical Marijuana Program (MMP). These include principles of safe and knowledgeable practice for clinicians when qualifying a patient for an MMP.3 Note that I said qualifying a patient and not prescribing marijuana. Federal law still classifies cannabis as a Schedule I controlled substance, thus prohibiting the actual prescription of marijuana, and prohibits pharmacies from dispensing cannabis. Quite a contradiction!

All of that said, it is incumbent upon each of us to understand the complexities of the MMP in our state. Each has its own specifications as to the qualifying conditions or symptoms, as well as the requirements to become an approved provider. And each is as diverse as the opinions on marijuana use.

Without doubt, the debate and dichotomy about medical marijuana will ensue for years. What we as health care providers must do is keep current on the laws and regulations not only in our state, but also at the federal level. As a primer on the status of MMPs and provider approval, I encourage all to review the NCSBN document.3

As always, you can share your thoughts with me via [email protected].

References

1. State House News Service. Marijuana in Massachusetts: where are we, what’s next? Beacon Hill Patch. November 12, 2017. https://patch.com/massachusetts/beaconhill/marijuana-massachusetts-where-are-we-whats-next. Accessed October 12, 2018.
2. National Institute on Drug Abuse. NIDA’s role in providing marijuana for research. April 2018. www.drugabuse.gov/drugs-abuse/marijuana/nidas-role-in-providing-marijuana-research. Accessed October 12, 2018.
3. The National Council of State Boards of Nursing. The NCSBN national nursing guidelines for medical marijuana. 2018;9(suppl 2). www.ncsbn.org/The_NCSBN_National_Nursing_Guidelines_for_Medical_Marijuana_JNR_July_2018.pdf. Accessed October 12, 2018.
4. ProCon.org. Historical timeline: history of marijuana as medicine—2900 BC to present. http://medicalmarijuana.procon.org/view.timeline.php?timelineID=000026. Accessed October 12, 2018.
5. National Commission on Marihuana and Drug Abuse. Marihuana: A Signal of Misunderstanding—First Report. Washington, DC: US Government Printing Office; 1972.
6. Guither P. Why is marijuana illegal? DrugWarRant.com. http://www.drugwarrant.com/articles/why-is-marijuana-illegal. Accessed October 12, 2018.
7. Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. Results from the 2015 National Survey on Drug Use and Health: Detailed Tables. www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2015/NSDUH-DetTabs-2015/NSDUH-DetTabs-2015.pdf. Accessed October 12, 2018.
8. Reefer Madness (1938). https://publicdomainreview.org/collections/reefer-madness-1938. Accessed October 12, 2018.
9. ProCon.org. 60 peer-reviewed studies on medical marijuana: medical studies involving cannabis and cannabis extracts (1990-2014). http://medicalmarijuana.procon.org/view.resource.php?resourceID=000884. Accessed October 12, 2018.
10. Cochrane Library. Cochrane evidence: cannabis. www.cochrane.org/search/site/cannabis. Accessed October 12, 2018.
11. The National Academies of Sciences, Engineering, and Medicine. The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. Washington, DC: The National Academies Press; 2017. https://doi.org/10.17226/24625. Accessed October 12, 2018.
12. Carroon JM, Mischley LK, Sexton M. Cannabis as a substitute for prescription drugs: a cross-sectional study. J Pain Res. 2017;10:989-998.
13. Bradford AC, Bradford WD, Abraham A, Adams GB. Association between US state medical cannabis laws and opioid prescribing in the Medicare Part D population. JAMA Intern Med. 2018;178(5):667-672.
14. Wen H, Hockenberr M. Association of medical and adult-use marijuana laws with opioid prescribing for Medicaid enrollees. JAMA Intern Med. 2018;178(5):673-679.

References

1. State House News Service. Marijuana in Massachusetts: where are we, what’s next? Beacon Hill Patch. November 12, 2017. https://patch.com/massachusetts/beaconhill/marijuana-massachusetts-where-are-we-whats-next. Accessed October 12, 2018.
2. National Institute on Drug Abuse. NIDA’s role in providing marijuana for research. April 2018. www.drugabuse.gov/drugs-abuse/marijuana/nidas-role-in-providing-marijuana-research. Accessed October 12, 2018.
3. The National Council of State Boards of Nursing. The NCSBN national nursing guidelines for medical marijuana. 2018;9(suppl 2). www.ncsbn.org/The_NCSBN_National_Nursing_Guidelines_for_Medical_Marijuana_JNR_July_2018.pdf. Accessed October 12, 2018.
4. ProCon.org. Historical timeline: history of marijuana as medicine—2900 BC to present. http://medicalmarijuana.procon.org/view.timeline.php?timelineID=000026. Accessed October 12, 2018.
5. National Commission on Marihuana and Drug Abuse. Marihuana: A Signal of Misunderstanding—First Report. Washington, DC: US Government Printing Office; 1972.
6. Guither P. Why is marijuana illegal? DrugWarRant.com. http://www.drugwarrant.com/articles/why-is-marijuana-illegal. Accessed October 12, 2018.
7. Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. Results from the 2015 National Survey on Drug Use and Health: Detailed Tables. www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2015/NSDUH-DetTabs-2015/NSDUH-DetTabs-2015.pdf. Accessed October 12, 2018.
8. Reefer Madness (1938). https://publicdomainreview.org/collections/reefer-madness-1938. Accessed October 12, 2018.
9. ProCon.org. 60 peer-reviewed studies on medical marijuana: medical studies involving cannabis and cannabis extracts (1990-2014). http://medicalmarijuana.procon.org/view.resource.php?resourceID=000884. Accessed October 12, 2018.
10. Cochrane Library. Cochrane evidence: cannabis. www.cochrane.org/search/site/cannabis. Accessed October 12, 2018.
11. The National Academies of Sciences, Engineering, and Medicine. The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. Washington, DC: The National Academies Press; 2017. https://doi.org/10.17226/24625. Accessed October 12, 2018.
12. Carroon JM, Mischley LK, Sexton M. Cannabis as a substitute for prescription drugs: a cross-sectional study. J Pain Res. 2017;10:989-998.
13. Bradford AC, Bradford WD, Abraham A, Adams GB. Association between US state medical cannabis laws and opioid prescribing in the Medicare Part D population. JAMA Intern Med. 2018;178(5):667-672.
14. Wen H, Hockenberr M. Association of medical and adult-use marijuana laws with opioid prescribing for Medicaid enrollees. JAMA Intern Med. 2018;178(5):673-679.

Issue
Clinician Reviews - 28(11)
Issue
Clinician Reviews - 28(11)
Page Number
e5-e6
Page Number
e5-e6
Publications
Publications
Topics
Article Type
Display Headline
Marijuana: Know the Rules in Your State
Display Headline
Marijuana: Know the Rules in Your State
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Article PDF Media

With midterm elections near, PhRMA continues to spend

Article Type
Changed

 

The Pharmaceutical Research and Manufacturers of America (PhRMA) continued to lead the health sector in lobbying spending through the third quarter of 2018, according to the Center for Responsive Politics.

PhRMA’s $21.8 million worth of lobbying through September put it ahead of Blue Cross Blue Shield’s $17.2 million. PhRMA remains on pace to exceed its previous spending high of $27.2 million in 2009, and the health sector as a whole, with a lobbying bill of $421.5 million for three-quarters of 2018, is just slightly ahead of last year’s record of $561.3 million, the center reported on OpenSecrets.org.



PhRMA is third overall in lobbying spending so far this year, behind the U.S. Chamber of Commerce ($69.1 million) and the National Association of Realtors ($53.8 million). Blue Cross Blue Shield is sixth overall, with the American Hospital Association ($17.2 million, seventh) and the American Medical Association ($15.5 million, ninth) also in the top 10, according to the center’s analysis of data from the Senate Office of Public Records.

The pharmaceutical/health product industry leads health-sector lobbying with $216.1 million in spending so far in 2018, followed by hospitals/nursing homes at $73.6 million, health professionals at $68.6 million, and health services/HMOs at $57.5 million.

Publications
Topics
Sections

 

The Pharmaceutical Research and Manufacturers of America (PhRMA) continued to lead the health sector in lobbying spending through the third quarter of 2018, according to the Center for Responsive Politics.

PhRMA’s $21.8 million worth of lobbying through September put it ahead of Blue Cross Blue Shield’s $17.2 million. PhRMA remains on pace to exceed its previous spending high of $27.2 million in 2009, and the health sector as a whole, with a lobbying bill of $421.5 million for three-quarters of 2018, is just slightly ahead of last year’s record of $561.3 million, the center reported on OpenSecrets.org.



PhRMA is third overall in lobbying spending so far this year, behind the U.S. Chamber of Commerce ($69.1 million) and the National Association of Realtors ($53.8 million). Blue Cross Blue Shield is sixth overall, with the American Hospital Association ($17.2 million, seventh) and the American Medical Association ($15.5 million, ninth) also in the top 10, according to the center’s analysis of data from the Senate Office of Public Records.

The pharmaceutical/health product industry leads health-sector lobbying with $216.1 million in spending so far in 2018, followed by hospitals/nursing homes at $73.6 million, health professionals at $68.6 million, and health services/HMOs at $57.5 million.

 

The Pharmaceutical Research and Manufacturers of America (PhRMA) continued to lead the health sector in lobbying spending through the third quarter of 2018, according to the Center for Responsive Politics.

PhRMA’s $21.8 million worth of lobbying through September put it ahead of Blue Cross Blue Shield’s $17.2 million. PhRMA remains on pace to exceed its previous spending high of $27.2 million in 2009, and the health sector as a whole, with a lobbying bill of $421.5 million for three-quarters of 2018, is just slightly ahead of last year’s record of $561.3 million, the center reported on OpenSecrets.org.



PhRMA is third overall in lobbying spending so far this year, behind the U.S. Chamber of Commerce ($69.1 million) and the National Association of Realtors ($53.8 million). Blue Cross Blue Shield is sixth overall, with the American Hospital Association ($17.2 million, seventh) and the American Medical Association ($15.5 million, ninth) also in the top 10, according to the center’s analysis of data from the Senate Office of Public Records.

The pharmaceutical/health product industry leads health-sector lobbying with $216.1 million in spending so far in 2018, followed by hospitals/nursing homes at $73.6 million, health professionals at $68.6 million, and health services/HMOs at $57.5 million.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

VA Reaches Milestone in Digitizing Claims Process

Article Type
Changed
The new electronic claims process creates a more efficient and easier veteran experience.

In a “significant modernization effort,” the VA has removed nearly 8 million paper files from 60 locations in under 22 months. The files are scanned into the electronic claims process system, which means faster claims decisions, the VA says.

According to the VA, it is a milestone in a years-long project to improve the veteran experience and streamline claims processes. The project began in 2013 when the VA began removing paper records from its regional offices to save space and money. It then expanded in 2016 when the VA launched the File Bank Extraction initiative, which removed more than 1.7 million paper claims files. In 2017, the agency began extracting 6.1 million paper records held in the Records Control Division (RCD) in St. Louis.

The records are temporarily stored in a secure facility certified by the National Archives and Records Administration, where they are inventoried, prioritized, and sent to VA vendors for scanning into the VA’s Veterans Benefits Management System.

The VA is negotiating to return the RCD’s leased warehouse space to the General Services Administration, estimating the move will save roughly $1.8 million per year.

Source:
VA achieves major milestone in effort to modernize claims processing [news release]. Washington, DC: U.S. Department of Veteran Affairs Office of Public Affairs and Media Relations; October 23,2018.  https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5131. Accessed October 31, 2018.

Publications
Topics
Sections
The new electronic claims process creates a more efficient and easier veteran experience.
The new electronic claims process creates a more efficient and easier veteran experience.

In a “significant modernization effort,” the VA has removed nearly 8 million paper files from 60 locations in under 22 months. The files are scanned into the electronic claims process system, which means faster claims decisions, the VA says.

According to the VA, it is a milestone in a years-long project to improve the veteran experience and streamline claims processes. The project began in 2013 when the VA began removing paper records from its regional offices to save space and money. It then expanded in 2016 when the VA launched the File Bank Extraction initiative, which removed more than 1.7 million paper claims files. In 2017, the agency began extracting 6.1 million paper records held in the Records Control Division (RCD) in St. Louis.

The records are temporarily stored in a secure facility certified by the National Archives and Records Administration, where they are inventoried, prioritized, and sent to VA vendors for scanning into the VA’s Veterans Benefits Management System.

The VA is negotiating to return the RCD’s leased warehouse space to the General Services Administration, estimating the move will save roughly $1.8 million per year.

Source:
VA achieves major milestone in effort to modernize claims processing [news release]. Washington, DC: U.S. Department of Veteran Affairs Office of Public Affairs and Media Relations; October 23,2018.  https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5131. Accessed October 31, 2018.

In a “significant modernization effort,” the VA has removed nearly 8 million paper files from 60 locations in under 22 months. The files are scanned into the electronic claims process system, which means faster claims decisions, the VA says.

According to the VA, it is a milestone in a years-long project to improve the veteran experience and streamline claims processes. The project began in 2013 when the VA began removing paper records from its regional offices to save space and money. It then expanded in 2016 when the VA launched the File Bank Extraction initiative, which removed more than 1.7 million paper claims files. In 2017, the agency began extracting 6.1 million paper records held in the Records Control Division (RCD) in St. Louis.

The records are temporarily stored in a secure facility certified by the National Archives and Records Administration, where they are inventoried, prioritized, and sent to VA vendors for scanning into the VA’s Veterans Benefits Management System.

The VA is negotiating to return the RCD’s leased warehouse space to the General Services Administration, estimating the move will save roughly $1.8 million per year.

Source:
VA achieves major milestone in effort to modernize claims processing [news release]. Washington, DC: U.S. Department of Veteran Affairs Office of Public Affairs and Media Relations; October 23,2018.  https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5131. Accessed October 31, 2018.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Un-Gate On Date
Use ProPublica
CFC Schedule Remove Status

Kids and guns: Injury costs rose as incidence fell

Article Type
Changed

 

Hospital costs for children with firearm-related injuries rose from 2006 to 2014, while the incidence of emergency department visits declined over the same period, according to the first national study of such visits in children.

Median charges were $2,445 for an ED visit and $44,966 for inpatient management of individuals under 18 years of age for the entire study period, with both increasing over time and all data adjusted to 2018 dollars. The median charge for an ED visit rose from over $2,100 in 2006 to under $2,900 in 2014, while the inpatient median increased from approximately $43,000 to about $59,000. Total charges for firearm-related injuries in children were $2.5 billion during 2006-2014, with a mean of $270 million a year, Faiz Gani, MBBS, and Joseph K. Canner, MHS, said in JAMA Pediatrics.

The overall incidence of ED visits was 11.3/100,000 children under 18 years of age for the study period, with a steady decline seen from 2006, when incidence was about 15 visits/100,000, to 10/100,000 in 2014. The rate had dropped to about 7.5 visits/100,000 in 2013 before increasing in 2014, Dr. Gani and Mr. Canner of Johns Hopkins University, Baltimore, said based on data for 75,086 visits from the Nationwide Emergency Medicine Sample.

A trend observed throughout the course of the study was the higher incidence of ED visits among males, which was consistently more than five times higher than that of females. The highest incidence by age group was 85.9/100,000 for males aged 15-17 years. The most common intent of injury was assault at 49%, with unintentional injury next at 39% and suicide at 2%, the investigators reported.

This “first and largest nationally representative study” demonstrates the “substantial clinical and financial burden associated with firearm-related injuries among pediatric patients. Moving forward, additional resources and funds should be allocated to the study of firearm-related injuries. Only through further understanding of the social, political, and health-related risk factors for these injuries can we develop and implement effective policies to address this public health concern, wrote Dr. Gani and Mr. Canner, who reported no conflicts of interest.

SOURCE: JAMA Pediatr. 2018 Oct 29. doi: 10.1001/jamapediatrics.2018.3091.

Publications
Topics
Sections

 

Hospital costs for children with firearm-related injuries rose from 2006 to 2014, while the incidence of emergency department visits declined over the same period, according to the first national study of such visits in children.

Median charges were $2,445 for an ED visit and $44,966 for inpatient management of individuals under 18 years of age for the entire study period, with both increasing over time and all data adjusted to 2018 dollars. The median charge for an ED visit rose from over $2,100 in 2006 to under $2,900 in 2014, while the inpatient median increased from approximately $43,000 to about $59,000. Total charges for firearm-related injuries in children were $2.5 billion during 2006-2014, with a mean of $270 million a year, Faiz Gani, MBBS, and Joseph K. Canner, MHS, said in JAMA Pediatrics.

The overall incidence of ED visits was 11.3/100,000 children under 18 years of age for the study period, with a steady decline seen from 2006, when incidence was about 15 visits/100,000, to 10/100,000 in 2014. The rate had dropped to about 7.5 visits/100,000 in 2013 before increasing in 2014, Dr. Gani and Mr. Canner of Johns Hopkins University, Baltimore, said based on data for 75,086 visits from the Nationwide Emergency Medicine Sample.

A trend observed throughout the course of the study was the higher incidence of ED visits among males, which was consistently more than five times higher than that of females. The highest incidence by age group was 85.9/100,000 for males aged 15-17 years. The most common intent of injury was assault at 49%, with unintentional injury next at 39% and suicide at 2%, the investigators reported.

This “first and largest nationally representative study” demonstrates the “substantial clinical and financial burden associated with firearm-related injuries among pediatric patients. Moving forward, additional resources and funds should be allocated to the study of firearm-related injuries. Only through further understanding of the social, political, and health-related risk factors for these injuries can we develop and implement effective policies to address this public health concern, wrote Dr. Gani and Mr. Canner, who reported no conflicts of interest.

SOURCE: JAMA Pediatr. 2018 Oct 29. doi: 10.1001/jamapediatrics.2018.3091.

 

Hospital costs for children with firearm-related injuries rose from 2006 to 2014, while the incidence of emergency department visits declined over the same period, according to the first national study of such visits in children.

Median charges were $2,445 for an ED visit and $44,966 for inpatient management of individuals under 18 years of age for the entire study period, with both increasing over time and all data adjusted to 2018 dollars. The median charge for an ED visit rose from over $2,100 in 2006 to under $2,900 in 2014, while the inpatient median increased from approximately $43,000 to about $59,000. Total charges for firearm-related injuries in children were $2.5 billion during 2006-2014, with a mean of $270 million a year, Faiz Gani, MBBS, and Joseph K. Canner, MHS, said in JAMA Pediatrics.

The overall incidence of ED visits was 11.3/100,000 children under 18 years of age for the study period, with a steady decline seen from 2006, when incidence was about 15 visits/100,000, to 10/100,000 in 2014. The rate had dropped to about 7.5 visits/100,000 in 2013 before increasing in 2014, Dr. Gani and Mr. Canner of Johns Hopkins University, Baltimore, said based on data for 75,086 visits from the Nationwide Emergency Medicine Sample.

A trend observed throughout the course of the study was the higher incidence of ED visits among males, which was consistently more than five times higher than that of females. The highest incidence by age group was 85.9/100,000 for males aged 15-17 years. The most common intent of injury was assault at 49%, with unintentional injury next at 39% and suicide at 2%, the investigators reported.

This “first and largest nationally representative study” demonstrates the “substantial clinical and financial burden associated with firearm-related injuries among pediatric patients. Moving forward, additional resources and funds should be allocated to the study of firearm-related injuries. Only through further understanding of the social, political, and health-related risk factors for these injuries can we develop and implement effective policies to address this public health concern, wrote Dr. Gani and Mr. Canner, who reported no conflicts of interest.

SOURCE: JAMA Pediatr. 2018 Oct 29. doi: 10.1001/jamapediatrics.2018.3091.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA PEDIATRICS

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

Endocrine Society raises concerns about FDA’s “safe” classification of bisphenol A in food containers

Article Type
Changed

 

An initial report from the Endocrine Society has raised concerns about bisphenol A use in products such as food and drink containers, toys, and medical devices, citing recent data that show the synthetic compound is linked to reproductive, behavioral, and metabolic disorders.

Dr. Laura N. Vandenberg

Although the Food and Drug Administration classifies bisphenol A (BPA) as safe to use in food containers, there have been hundreds of studies tying BPA to health problems such as “neurological outcomes, abnormal metabolism, reproductive effects as well as growth and development effects,” according to Laura N. Vandenberg, PhD, an Endocrine Society spokesperson, who spoke at a press briefing held on Oct. 23. Dr. Vandenberg explained the FDA’s 2014 position on BPA safety comes from a small subset of publicly available data, but these are not all the data on BPA, as some academic data are still under review.

The Endocrine Society recently held the news conference because they are concerned the FDA has “jumped the gun” before all the research has been published. “Even considering the fact that the data that have been presented by FDA have been interpreted by FDA as suggesting that BPA is safe, scientists still disagree,” Dr. Vandenberg said.

Dr. Heather Patisaul

However, the Endocrine Society noted there is an issue with the current literature, which can be used to interpret and report different results. Heather Patisaul, PhD, cited a joint report from the Food and Agriculture Organization of the United Nations and World Health Organization, as well as a report from the National Toxicology Program (NTP), to illustrate this problem. Both reports expressed concern about BPA safety but took different approaches and a wider viewpoint, and came to different conclusions, she said.

“These two documents both concluded that there was some concern about bisphenol A and behavior, but they identified there was a big problem with trying to pool all this literature together because the experimental protocols were different, the animals were different, the dosing was different,” she said. “It was not a very harmonious literature.”

To combat this issue, the National Institute of Environmental Health Sciences and the FDA have funded the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) study. Dr. Patisaul said CLARITY-BPA is “the most ambitious project that’s ever been done” to study the health effects of a chemical, bringing together scientists from academic institutions, the NTP, and the FDA to help create data for risk assessment.

“The goal was to create this culture of partnership and communication between the agencies that have to make these decisions about safety and the scientists who are producing the data that’s trying to inform those assessments,” Dr. Patisaul said.

Dr. Vandenberg and Dr. Patisaul presented results from the CLARITY-BPA Core Study, which studied the effects of continuous doses of BPA in rats starting from 6 days of pregnancy; after birth, the rat offspring were fed doses of BPA for 1 year and 2 years. A second group of rats in a stop-dose group were fed BPA from early development, where the mothers were fed BPA at day 6 of pregnancy and the offspring fed BPA from birth until puberty (21 days) and followed for 1 year or 2 years. The researchers also examined 2.5 mcg/kg, 25 mcg/kg, 250 mcg/kg, 2,500 mcg/kg, and 25,000 mcg/kg doses of BPA exposure as well as continuous ethinyl estradiol exposure as a positive control.

In the FDA Core Study, there was a significantly increased incidence of mammary adenocarcinoma in the stop dose group and inflammation of the dorsal and lateral lobes of the prostate in the continuous dose group at a dose of 2.5 mcg/kg. In addition, kidney nephropathy and increased body weight in female rats in the continuous group were also seen at the 2.5 mcg/kg dose, Dr. Vandenberg noted.

“I think one of the reasons why FDA is dismissing those low-dose effects is that there’s an expectation with increasing dose, there should be an increase in an effect,” Dr. Vandenberg said.

In the low-dose range, BPA could be acting as a hormone such as estrogen, but also could be acting through other hormone receptors or as a toxicant at the high-dose range, she explained.

Dr. Patisaul also presented results of BPA-related effects on the brain and behavior in the existing literature from the TEDX Low-dose Bisphenol A project, which is a comparison of 391 in vivo and in vitro studies of BPA prior to 2009. The results showed brain and behavior was “heavily impacted” by BPA, as were organ systems such as the heart, which supports the results from the CLARITY-BPA study, Dr. Patisaul noted.

“When you think about reproducibility in the broadest sense, and you look at the effects that the FDA found at low dose, you look at the effects the CLARITY investigators found at low dose, and you go back and look at the existing literature, you see a very clear picture of BPA-produced effects on brain and behavior, female reproductive systems, and the cardiovascular system,” she said.

Dr. Patisaul is a study investigator for CLARITY-BPA.

Publications
Topics
Sections

 

An initial report from the Endocrine Society has raised concerns about bisphenol A use in products such as food and drink containers, toys, and medical devices, citing recent data that show the synthetic compound is linked to reproductive, behavioral, and metabolic disorders.

Dr. Laura N. Vandenberg

Although the Food and Drug Administration classifies bisphenol A (BPA) as safe to use in food containers, there have been hundreds of studies tying BPA to health problems such as “neurological outcomes, abnormal metabolism, reproductive effects as well as growth and development effects,” according to Laura N. Vandenberg, PhD, an Endocrine Society spokesperson, who spoke at a press briefing held on Oct. 23. Dr. Vandenberg explained the FDA’s 2014 position on BPA safety comes from a small subset of publicly available data, but these are not all the data on BPA, as some academic data are still under review.

The Endocrine Society recently held the news conference because they are concerned the FDA has “jumped the gun” before all the research has been published. “Even considering the fact that the data that have been presented by FDA have been interpreted by FDA as suggesting that BPA is safe, scientists still disagree,” Dr. Vandenberg said.

Dr. Heather Patisaul

However, the Endocrine Society noted there is an issue with the current literature, which can be used to interpret and report different results. Heather Patisaul, PhD, cited a joint report from the Food and Agriculture Organization of the United Nations and World Health Organization, as well as a report from the National Toxicology Program (NTP), to illustrate this problem. Both reports expressed concern about BPA safety but took different approaches and a wider viewpoint, and came to different conclusions, she said.

“These two documents both concluded that there was some concern about bisphenol A and behavior, but they identified there was a big problem with trying to pool all this literature together because the experimental protocols were different, the animals were different, the dosing was different,” she said. “It was not a very harmonious literature.”

To combat this issue, the National Institute of Environmental Health Sciences and the FDA have funded the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) study. Dr. Patisaul said CLARITY-BPA is “the most ambitious project that’s ever been done” to study the health effects of a chemical, bringing together scientists from academic institutions, the NTP, and the FDA to help create data for risk assessment.

“The goal was to create this culture of partnership and communication between the agencies that have to make these decisions about safety and the scientists who are producing the data that’s trying to inform those assessments,” Dr. Patisaul said.

Dr. Vandenberg and Dr. Patisaul presented results from the CLARITY-BPA Core Study, which studied the effects of continuous doses of BPA in rats starting from 6 days of pregnancy; after birth, the rat offspring were fed doses of BPA for 1 year and 2 years. A second group of rats in a stop-dose group were fed BPA from early development, where the mothers were fed BPA at day 6 of pregnancy and the offspring fed BPA from birth until puberty (21 days) and followed for 1 year or 2 years. The researchers also examined 2.5 mcg/kg, 25 mcg/kg, 250 mcg/kg, 2,500 mcg/kg, and 25,000 mcg/kg doses of BPA exposure as well as continuous ethinyl estradiol exposure as a positive control.

In the FDA Core Study, there was a significantly increased incidence of mammary adenocarcinoma in the stop dose group and inflammation of the dorsal and lateral lobes of the prostate in the continuous dose group at a dose of 2.5 mcg/kg. In addition, kidney nephropathy and increased body weight in female rats in the continuous group were also seen at the 2.5 mcg/kg dose, Dr. Vandenberg noted.

“I think one of the reasons why FDA is dismissing those low-dose effects is that there’s an expectation with increasing dose, there should be an increase in an effect,” Dr. Vandenberg said.

In the low-dose range, BPA could be acting as a hormone such as estrogen, but also could be acting through other hormone receptors or as a toxicant at the high-dose range, she explained.

Dr. Patisaul also presented results of BPA-related effects on the brain and behavior in the existing literature from the TEDX Low-dose Bisphenol A project, which is a comparison of 391 in vivo and in vitro studies of BPA prior to 2009. The results showed brain and behavior was “heavily impacted” by BPA, as were organ systems such as the heart, which supports the results from the CLARITY-BPA study, Dr. Patisaul noted.

“When you think about reproducibility in the broadest sense, and you look at the effects that the FDA found at low dose, you look at the effects the CLARITY investigators found at low dose, and you go back and look at the existing literature, you see a very clear picture of BPA-produced effects on brain and behavior, female reproductive systems, and the cardiovascular system,” she said.

Dr. Patisaul is a study investigator for CLARITY-BPA.

 

An initial report from the Endocrine Society has raised concerns about bisphenol A use in products such as food and drink containers, toys, and medical devices, citing recent data that show the synthetic compound is linked to reproductive, behavioral, and metabolic disorders.

Dr. Laura N. Vandenberg

Although the Food and Drug Administration classifies bisphenol A (BPA) as safe to use in food containers, there have been hundreds of studies tying BPA to health problems such as “neurological outcomes, abnormal metabolism, reproductive effects as well as growth and development effects,” according to Laura N. Vandenberg, PhD, an Endocrine Society spokesperson, who spoke at a press briefing held on Oct. 23. Dr. Vandenberg explained the FDA’s 2014 position on BPA safety comes from a small subset of publicly available data, but these are not all the data on BPA, as some academic data are still under review.

The Endocrine Society recently held the news conference because they are concerned the FDA has “jumped the gun” before all the research has been published. “Even considering the fact that the data that have been presented by FDA have been interpreted by FDA as suggesting that BPA is safe, scientists still disagree,” Dr. Vandenberg said.

Dr. Heather Patisaul

However, the Endocrine Society noted there is an issue with the current literature, which can be used to interpret and report different results. Heather Patisaul, PhD, cited a joint report from the Food and Agriculture Organization of the United Nations and World Health Organization, as well as a report from the National Toxicology Program (NTP), to illustrate this problem. Both reports expressed concern about BPA safety but took different approaches and a wider viewpoint, and came to different conclusions, she said.

“These two documents both concluded that there was some concern about bisphenol A and behavior, but they identified there was a big problem with trying to pool all this literature together because the experimental protocols were different, the animals were different, the dosing was different,” she said. “It was not a very harmonious literature.”

To combat this issue, the National Institute of Environmental Health Sciences and the FDA have funded the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) study. Dr. Patisaul said CLARITY-BPA is “the most ambitious project that’s ever been done” to study the health effects of a chemical, bringing together scientists from academic institutions, the NTP, and the FDA to help create data for risk assessment.

“The goal was to create this culture of partnership and communication between the agencies that have to make these decisions about safety and the scientists who are producing the data that’s trying to inform those assessments,” Dr. Patisaul said.

Dr. Vandenberg and Dr. Patisaul presented results from the CLARITY-BPA Core Study, which studied the effects of continuous doses of BPA in rats starting from 6 days of pregnancy; after birth, the rat offspring were fed doses of BPA for 1 year and 2 years. A second group of rats in a stop-dose group were fed BPA from early development, where the mothers were fed BPA at day 6 of pregnancy and the offspring fed BPA from birth until puberty (21 days) and followed for 1 year or 2 years. The researchers also examined 2.5 mcg/kg, 25 mcg/kg, 250 mcg/kg, 2,500 mcg/kg, and 25,000 mcg/kg doses of BPA exposure as well as continuous ethinyl estradiol exposure as a positive control.

In the FDA Core Study, there was a significantly increased incidence of mammary adenocarcinoma in the stop dose group and inflammation of the dorsal and lateral lobes of the prostate in the continuous dose group at a dose of 2.5 mcg/kg. In addition, kidney nephropathy and increased body weight in female rats in the continuous group were also seen at the 2.5 mcg/kg dose, Dr. Vandenberg noted.

“I think one of the reasons why FDA is dismissing those low-dose effects is that there’s an expectation with increasing dose, there should be an increase in an effect,” Dr. Vandenberg said.

In the low-dose range, BPA could be acting as a hormone such as estrogen, but also could be acting through other hormone receptors or as a toxicant at the high-dose range, she explained.

Dr. Patisaul also presented results of BPA-related effects on the brain and behavior in the existing literature from the TEDX Low-dose Bisphenol A project, which is a comparison of 391 in vivo and in vitro studies of BPA prior to 2009. The results showed brain and behavior was “heavily impacted” by BPA, as were organ systems such as the heart, which supports the results from the CLARITY-BPA study, Dr. Patisaul noted.

“When you think about reproducibility in the broadest sense, and you look at the effects that the FDA found at low dose, you look at the effects the CLARITY investigators found at low dose, and you go back and look at the existing literature, you see a very clear picture of BPA-produced effects on brain and behavior, female reproductive systems, and the cardiovascular system,” she said.

Dr. Patisaul is a study investigator for CLARITY-BPA.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Despite claims from the Food and Drug Administration, results from the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) Core Study show serious effects in humans of bisphenol A at low doses.

Major finding: Research from CLARITY-BPA has shown brain and behavior, female reproduction, and organ systems such as the heart can be adversely affected by bisphenol A even at low doses.

Study details: An initial report from the CLARITY-BPA Core Study.

Disclosures: Dr. Patisaul is a study investigator for CLARITY-BPA.
 

Disqus Comments
Default
Use ProPublica