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HHS awards more money for innovative care models
The federal government has announced another round of awards to health care organizations that have designed innovative ways to provide better-quality care at a lower cost.
The latest group includes 27 health care organizations, receiving awards of $2 million to $24 million over 3 years.
"The Health Care Innovation Awards support our ongoing work to drive down health care costs while providing high-quality care," Sylvia Mathews Burwell, secretary of the Department of Health & Human Services (HHS), said in a statement. "These awards advance innovative solutions in delivering and improving care from all across our nation."
The awards are funded with up to $1 billion in money authorized by the Affordable Care Act. HHS began seeking awardees in late 2011, soliciting a broad range of proposals. The Centers for Medicare & Medicaid Services Innovation Center ultimately gave out 107 3-year awards in May and June 2012.
HHS started soliciting applicants for a second round of awards last year, this time looking for innovations that would focus on four areas: rapidly reducing costs in the outpatient and postacute setting for patients with Medicare, Medicaid, and/or the Children’s Health Insurance Program; improving care for populations with specialized needs; testing improved financial and clinical models for specific types of providers, including specialists; and models that improve the health of populations – such as a community, or those with specific diseases – through prevention, wellness, and comprehensive care that extends beyond the clinical setting.
The 27 new awardees named on July 9 include:
• $6 million for a care coordination project at the Boston Medical Center that will pair a complex care nurse, a care coordinator, and pediatricians in the community in Boston and Springfield, with the goal of providing a medical home for children with complex conditions.
• $10 million for the Detroit Medical Center, which will establish patient-centered medical home clinics next to emergency departments (EDs) at four inner-city hospitals, in an attempt to make primary care immediately available to patients seeking nonurgent care. The initial focus will be on improving diabetes or asthma, and targeting so-called ED superutilizers, who have 10 or more visits a year.
• $15 million for the University of New Mexico Health Sciences Center, Albuquerque, which will expand its 11-hospital telehealth system to 30 hospitals, to test providing remote emergency neurological consultation using inexpensive audiovisual equipment and software.
HHS does not anticipate making any further innovation awards, according to the agency.
Awardees still have to meet certain criteria to receive their funds. Final award notices will be sent in a few months.
On Twitter @aliciaault
The federal government has announced another round of awards to health care organizations that have designed innovative ways to provide better-quality care at a lower cost.
The latest group includes 27 health care organizations, receiving awards of $2 million to $24 million over 3 years.
"The Health Care Innovation Awards support our ongoing work to drive down health care costs while providing high-quality care," Sylvia Mathews Burwell, secretary of the Department of Health & Human Services (HHS), said in a statement. "These awards advance innovative solutions in delivering and improving care from all across our nation."
The awards are funded with up to $1 billion in money authorized by the Affordable Care Act. HHS began seeking awardees in late 2011, soliciting a broad range of proposals. The Centers for Medicare & Medicaid Services Innovation Center ultimately gave out 107 3-year awards in May and June 2012.
HHS started soliciting applicants for a second round of awards last year, this time looking for innovations that would focus on four areas: rapidly reducing costs in the outpatient and postacute setting for patients with Medicare, Medicaid, and/or the Children’s Health Insurance Program; improving care for populations with specialized needs; testing improved financial and clinical models for specific types of providers, including specialists; and models that improve the health of populations – such as a community, or those with specific diseases – through prevention, wellness, and comprehensive care that extends beyond the clinical setting.
The 27 new awardees named on July 9 include:
• $6 million for a care coordination project at the Boston Medical Center that will pair a complex care nurse, a care coordinator, and pediatricians in the community in Boston and Springfield, with the goal of providing a medical home for children with complex conditions.
• $10 million for the Detroit Medical Center, which will establish patient-centered medical home clinics next to emergency departments (EDs) at four inner-city hospitals, in an attempt to make primary care immediately available to patients seeking nonurgent care. The initial focus will be on improving diabetes or asthma, and targeting so-called ED superutilizers, who have 10 or more visits a year.
• $15 million for the University of New Mexico Health Sciences Center, Albuquerque, which will expand its 11-hospital telehealth system to 30 hospitals, to test providing remote emergency neurological consultation using inexpensive audiovisual equipment and software.
HHS does not anticipate making any further innovation awards, according to the agency.
Awardees still have to meet certain criteria to receive their funds. Final award notices will be sent in a few months.
On Twitter @aliciaault
The federal government has announced another round of awards to health care organizations that have designed innovative ways to provide better-quality care at a lower cost.
The latest group includes 27 health care organizations, receiving awards of $2 million to $24 million over 3 years.
"The Health Care Innovation Awards support our ongoing work to drive down health care costs while providing high-quality care," Sylvia Mathews Burwell, secretary of the Department of Health & Human Services (HHS), said in a statement. "These awards advance innovative solutions in delivering and improving care from all across our nation."
The awards are funded with up to $1 billion in money authorized by the Affordable Care Act. HHS began seeking awardees in late 2011, soliciting a broad range of proposals. The Centers for Medicare & Medicaid Services Innovation Center ultimately gave out 107 3-year awards in May and June 2012.
HHS started soliciting applicants for a second round of awards last year, this time looking for innovations that would focus on four areas: rapidly reducing costs in the outpatient and postacute setting for patients with Medicare, Medicaid, and/or the Children’s Health Insurance Program; improving care for populations with specialized needs; testing improved financial and clinical models for specific types of providers, including specialists; and models that improve the health of populations – such as a community, or those with specific diseases – through prevention, wellness, and comprehensive care that extends beyond the clinical setting.
The 27 new awardees named on July 9 include:
• $6 million for a care coordination project at the Boston Medical Center that will pair a complex care nurse, a care coordinator, and pediatricians in the community in Boston and Springfield, with the goal of providing a medical home for children with complex conditions.
• $10 million for the Detroit Medical Center, which will establish patient-centered medical home clinics next to emergency departments (EDs) at four inner-city hospitals, in an attempt to make primary care immediately available to patients seeking nonurgent care. The initial focus will be on improving diabetes or asthma, and targeting so-called ED superutilizers, who have 10 or more visits a year.
• $15 million for the University of New Mexico Health Sciences Center, Albuquerque, which will expand its 11-hospital telehealth system to 30 hospitals, to test providing remote emergency neurological consultation using inexpensive audiovisual equipment and software.
HHS does not anticipate making any further innovation awards, according to the agency.
Awardees still have to meet certain criteria to receive their funds. Final award notices will be sent in a few months.
On Twitter @aliciaault
New push: OSA screen at Medicare introduction
MINNEAPOLIS – The American Academy of Sleep Medicine is pushing to have a simple sleep apnea questionnaire included in the initial Welcome to Medicare preventive care visit.
Including such a screening tool would help identify obstructive sleep apnea (OSA) when patients first join the Medicare program and thus improve the odds of diagnosing and treating the condition, said Dr. Timothy Morgenthaler, president of the AASM. Getting a handle on OSA could also reduce the potential that the beneficiary will develop related chronic conditions, and that will help Medicare curb expenditures, he said.
An estimated 20% of current Medicare beneficiaries have OSA. That number is expected to grow with the rising obesity rates, he said. Untreated OSA can increase the risk of hypertension, heart disease, type 2 diabetes, and stroke, said Dr. Morgenthaler, who is professor of medicine at the Mayo Clinic in Rochester, Minn.
The AASM has been lobbying Congress to include a validated OSA screen in the initial Medicare visit and found sponsors in Rep. Michael Burgess (R-Tex.) and Rep. Bobby Rush (D-Ill.). In May, the two congressmen introduced a bill (H.R. 4695) that would do just that.
"This important legislation addresses the barriers that prevent new Medicare beneficiaries from receiving what we know to be required sleep apnea services," Dr. Morgenthaler said at the annual meeting of the Associated Professional Sleep Societies.
Rep. Erik Paulsen (R-Minn.), who recently signed on to the bill as a cosponsor, told AASM attendees that adding an OSA screen to the initial Medicare visit would help increase detection of disease, raise patient awareness, and "improve health care quality and reduce costs to the Medicare program," over the long term.
The AASM is asking its members to back the legislation and educate local lawmakers and patients through the group’s Seniors Sleep Campaign. The association also wants to make it easier for board-certified sleep medicine specialists to care for Medicare patients from start to finish, including durable medical equipment such as continuous positive airway pressure devices.
Currently, antikickback laws prevent sleep specialists and sleep centers from directly providing therapeutic durable medical equipment to Medicare patients, said Dr. Morgenthaler.
The AASM has developed model language for an exception to that statute, which it hopes legislators or regulators will approve, he said.
Eliminating the current fragmented system of care would eliminate waste, simplify the work flow, and improve the quality of care and reduce costs, said Dr. Morgenthaler.
Dr. Krishna Sundar, FCCP, comments: This is a bold definitive step from AASM to highlight benefit of early recognition of obstructive sleep apnea.
Given the high prevalence of OSA and how it interfaces with a variety of chronic problems, this push to screen Medicare recipients underscores the need for understanding of the impact that treating sleep-disordered breathing affords in this population by reducing health care costs and morbidity from chronic disease.
Dr. Krishna Sundar, FCCP, comments: This is a bold definitive step from AASM to highlight benefit of early recognition of obstructive sleep apnea.
Given the high prevalence of OSA and how it interfaces with a variety of chronic problems, this push to screen Medicare recipients underscores the need for understanding of the impact that treating sleep-disordered breathing affords in this population by reducing health care costs and morbidity from chronic disease.
Dr. Krishna Sundar, FCCP, comments: This is a bold definitive step from AASM to highlight benefit of early recognition of obstructive sleep apnea.
Given the high prevalence of OSA and how it interfaces with a variety of chronic problems, this push to screen Medicare recipients underscores the need for understanding of the impact that treating sleep-disordered breathing affords in this population by reducing health care costs and morbidity from chronic disease.
MINNEAPOLIS – The American Academy of Sleep Medicine is pushing to have a simple sleep apnea questionnaire included in the initial Welcome to Medicare preventive care visit.
Including such a screening tool would help identify obstructive sleep apnea (OSA) when patients first join the Medicare program and thus improve the odds of diagnosing and treating the condition, said Dr. Timothy Morgenthaler, president of the AASM. Getting a handle on OSA could also reduce the potential that the beneficiary will develop related chronic conditions, and that will help Medicare curb expenditures, he said.
An estimated 20% of current Medicare beneficiaries have OSA. That number is expected to grow with the rising obesity rates, he said. Untreated OSA can increase the risk of hypertension, heart disease, type 2 diabetes, and stroke, said Dr. Morgenthaler, who is professor of medicine at the Mayo Clinic in Rochester, Minn.
The AASM has been lobbying Congress to include a validated OSA screen in the initial Medicare visit and found sponsors in Rep. Michael Burgess (R-Tex.) and Rep. Bobby Rush (D-Ill.). In May, the two congressmen introduced a bill (H.R. 4695) that would do just that.
"This important legislation addresses the barriers that prevent new Medicare beneficiaries from receiving what we know to be required sleep apnea services," Dr. Morgenthaler said at the annual meeting of the Associated Professional Sleep Societies.
Rep. Erik Paulsen (R-Minn.), who recently signed on to the bill as a cosponsor, told AASM attendees that adding an OSA screen to the initial Medicare visit would help increase detection of disease, raise patient awareness, and "improve health care quality and reduce costs to the Medicare program," over the long term.
The AASM is asking its members to back the legislation and educate local lawmakers and patients through the group’s Seniors Sleep Campaign. The association also wants to make it easier for board-certified sleep medicine specialists to care for Medicare patients from start to finish, including durable medical equipment such as continuous positive airway pressure devices.
Currently, antikickback laws prevent sleep specialists and sleep centers from directly providing therapeutic durable medical equipment to Medicare patients, said Dr. Morgenthaler.
The AASM has developed model language for an exception to that statute, which it hopes legislators or regulators will approve, he said.
Eliminating the current fragmented system of care would eliminate waste, simplify the work flow, and improve the quality of care and reduce costs, said Dr. Morgenthaler.
MINNEAPOLIS – The American Academy of Sleep Medicine is pushing to have a simple sleep apnea questionnaire included in the initial Welcome to Medicare preventive care visit.
Including such a screening tool would help identify obstructive sleep apnea (OSA) when patients first join the Medicare program and thus improve the odds of diagnosing and treating the condition, said Dr. Timothy Morgenthaler, president of the AASM. Getting a handle on OSA could also reduce the potential that the beneficiary will develop related chronic conditions, and that will help Medicare curb expenditures, he said.
An estimated 20% of current Medicare beneficiaries have OSA. That number is expected to grow with the rising obesity rates, he said. Untreated OSA can increase the risk of hypertension, heart disease, type 2 diabetes, and stroke, said Dr. Morgenthaler, who is professor of medicine at the Mayo Clinic in Rochester, Minn.
The AASM has been lobbying Congress to include a validated OSA screen in the initial Medicare visit and found sponsors in Rep. Michael Burgess (R-Tex.) and Rep. Bobby Rush (D-Ill.). In May, the two congressmen introduced a bill (H.R. 4695) that would do just that.
"This important legislation addresses the barriers that prevent new Medicare beneficiaries from receiving what we know to be required sleep apnea services," Dr. Morgenthaler said at the annual meeting of the Associated Professional Sleep Societies.
Rep. Erik Paulsen (R-Minn.), who recently signed on to the bill as a cosponsor, told AASM attendees that adding an OSA screen to the initial Medicare visit would help increase detection of disease, raise patient awareness, and "improve health care quality and reduce costs to the Medicare program," over the long term.
The AASM is asking its members to back the legislation and educate local lawmakers and patients through the group’s Seniors Sleep Campaign. The association also wants to make it easier for board-certified sleep medicine specialists to care for Medicare patients from start to finish, including durable medical equipment such as continuous positive airway pressure devices.
Currently, antikickback laws prevent sleep specialists and sleep centers from directly providing therapeutic durable medical equipment to Medicare patients, said Dr. Morgenthaler.
The AASM has developed model language for an exception to that statute, which it hopes legislators or regulators will approve, he said.
Eliminating the current fragmented system of care would eliminate waste, simplify the work flow, and improve the quality of care and reduce costs, said Dr. Morgenthaler.
FROM THE ANNUAL MEETING OF THE ASSOCIATED PROFESSIONAL SLEEP SOCIETIES
FDA Approves Blood Test for Membranous Glomerulonephritis
The Food and Drug Administration has approved a noninvasive test to determine whether a chronic kidney disease is caused by an autoimmune disease or another cause such as infection.
The EUROIMMUN Anti- PLA2R IFA blood test detects an antibody that is specific to primary membranous glomerulonephritis (pMGN). MGN, a chronic kidney disease, damages the glomeruli; it can lead to kidney failure and transplant. Symptoms include swelling, hypercholesterolemia, hypertension, and an increased predisposition to blood clots.
The condition mostly affects white men. It occurs in 2 of every 10,000 people and is more common after age 40, according to the National Library of Medicine. Risk factors include cancers, especially lung and colon cancer; exposure to toxins, including gold and mercury; infections, including hepatitis B, malaria, syphilis, and endocarditis; certain medications, including penicillamine, trimethadione, and skin-lightening creams; and systemic lupus erythematosus, rheumatoid arthritis, Graves’ disease, and other autoimmune disorders.
"Treatment of MGN depends on the underlying cause of the disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "This test can help patients get a timely diagnosis for their MGN and aid with earlier treatment."
Test manufacturer EUROIMMUN US submitted data that compared 275 blood samples from patients with presumed pMGN, with 285 samples from patients diagnosed with other kidney diseases including secondary MGN (sMGN) and autoimmune diseases. The test detected pMGN in 77% of the presumed pMGN samples, and gave a false-positive result in less than 1% of the other samples.
The diagnostic test helped distinguish pMGN from sMGN in most of the patients.
The FDA said that the test should not be used alone to diagnose pMGN, but that patients’ symptoms and other laboratory test results should also be considered. A kidney biopsy is required for confirmation, according to the FDA.
On Twitter @aliciaault
The Food and Drug Administration has approved a noninvasive test to determine whether a chronic kidney disease is caused by an autoimmune disease or another cause such as infection.
The EUROIMMUN Anti- PLA2R IFA blood test detects an antibody that is specific to primary membranous glomerulonephritis (pMGN). MGN, a chronic kidney disease, damages the glomeruli; it can lead to kidney failure and transplant. Symptoms include swelling, hypercholesterolemia, hypertension, and an increased predisposition to blood clots.
The condition mostly affects white men. It occurs in 2 of every 10,000 people and is more common after age 40, according to the National Library of Medicine. Risk factors include cancers, especially lung and colon cancer; exposure to toxins, including gold and mercury; infections, including hepatitis B, malaria, syphilis, and endocarditis; certain medications, including penicillamine, trimethadione, and skin-lightening creams; and systemic lupus erythematosus, rheumatoid arthritis, Graves’ disease, and other autoimmune disorders.
"Treatment of MGN depends on the underlying cause of the disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "This test can help patients get a timely diagnosis for their MGN and aid with earlier treatment."
Test manufacturer EUROIMMUN US submitted data that compared 275 blood samples from patients with presumed pMGN, with 285 samples from patients diagnosed with other kidney diseases including secondary MGN (sMGN) and autoimmune diseases. The test detected pMGN in 77% of the presumed pMGN samples, and gave a false-positive result in less than 1% of the other samples.
The diagnostic test helped distinguish pMGN from sMGN in most of the patients.
The FDA said that the test should not be used alone to diagnose pMGN, but that patients’ symptoms and other laboratory test results should also be considered. A kidney biopsy is required for confirmation, according to the FDA.
On Twitter @aliciaault
The Food and Drug Administration has approved a noninvasive test to determine whether a chronic kidney disease is caused by an autoimmune disease or another cause such as infection.
The EUROIMMUN Anti- PLA2R IFA blood test detects an antibody that is specific to primary membranous glomerulonephritis (pMGN). MGN, a chronic kidney disease, damages the glomeruli; it can lead to kidney failure and transplant. Symptoms include swelling, hypercholesterolemia, hypertension, and an increased predisposition to blood clots.
The condition mostly affects white men. It occurs in 2 of every 10,000 people and is more common after age 40, according to the National Library of Medicine. Risk factors include cancers, especially lung and colon cancer; exposure to toxins, including gold and mercury; infections, including hepatitis B, malaria, syphilis, and endocarditis; certain medications, including penicillamine, trimethadione, and skin-lightening creams; and systemic lupus erythematosus, rheumatoid arthritis, Graves’ disease, and other autoimmune disorders.
"Treatment of MGN depends on the underlying cause of the disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "This test can help patients get a timely diagnosis for their MGN and aid with earlier treatment."
Test manufacturer EUROIMMUN US submitted data that compared 275 blood samples from patients with presumed pMGN, with 285 samples from patients diagnosed with other kidney diseases including secondary MGN (sMGN) and autoimmune diseases. The test detected pMGN in 77% of the presumed pMGN samples, and gave a false-positive result in less than 1% of the other samples.
The diagnostic test helped distinguish pMGN from sMGN in most of the patients.
The FDA said that the test should not be used alone to diagnose pMGN, but that patients’ symptoms and other laboratory test results should also be considered. A kidney biopsy is required for confirmation, according to the FDA.
On Twitter @aliciaault
Medicare’s 2015 outpatient proposal continues focus on bundled pay
The Centers for Medicare and Medicaid Services’ proposed rule on outpatient department and ambulatory surgery center payment for 2015 expands the agency’s focus on bundling pay for device-related procedures, largely in cardiology, neurology, oncology, and gynecology.
The Hospital Outpatient Prospective Payment System (OPPS) rule also continues the same payment rate for outpatient drug delivery such as chemotherapy. That payment rate has been a source of disappointment for oncologists. The American Society of Clinical Oncology has said in the past that, with the additional impact of budget sequestration, the actual payment for delivering chemotherapy drugs falls by 28%.
The agency is proposing again in 2015 to continue paying average sales price plus 6% for non–pass through drugs and biologicals that are administered under Part B of Medicare.
Proposed on July 3, the rule will be published on July 14. It covers payment for 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals. It also applies to 5,300 ambulatory surgery centers (ASCs) that participate in Medicare.
Overall, the government is proposing to increase payments to outpatient departments by 2%. The CMS expects to pay out some $57 billion for outpatient services in 2015. Payments to ASCs will increase just over 1% to $4 billion in 2015.
The agency is proposing to expand its Comprehensive Ambulatory Payment Classification (APC) policy, which was first discussed in its 2014 rule. The idea is to give a single Medicare payment and require a single beneficiary copayment for the entire hospital stay for a group of 28 procedures, including pacemaker insertion, implantation of neurostimulators, and stereotactic radiosurgery. It also would cover implantable cardioverter defibrillators.
The single, bundled payments would begin in 2015.
The proposed rule also contains several adjustments to both the Hospital Outpatient Quality Reporting Program and the ASC Quality Reporting Program. On the hospital side, the CMS is proposing to remove three quality measures, stating that performance has been uniformly high among reporting facilities. Those measures are aspirin at arrival (cardiac care), timing of prophylaxis antibiotics, and prophylactic antibiotic selection for surgical patients. The agency is proposing to add a claims-based measure – facility 7-day risk-standardized hospital visit rate after outpatient colonoscopy – for 2017 and beyond.
For ASCs, the agency is proposing to continue its effort to align measures with the hospital program. In 2015, ASCs will be required to report on the 7-day risk-standardized visit rate after outpatient colonoscopy measure.
The CMS is accepting comments on the proposed rule until Sept. 2, 2014. A final rule will be issued by Nov. 1.
On Twitter @aliciaault
The Centers for Medicare and Medicaid Services’ proposed rule on outpatient department and ambulatory surgery center payment for 2015 expands the agency’s focus on bundling pay for device-related procedures, largely in cardiology, neurology, oncology, and gynecology.
The Hospital Outpatient Prospective Payment System (OPPS) rule also continues the same payment rate for outpatient drug delivery such as chemotherapy. That payment rate has been a source of disappointment for oncologists. The American Society of Clinical Oncology has said in the past that, with the additional impact of budget sequestration, the actual payment for delivering chemotherapy drugs falls by 28%.
The agency is proposing again in 2015 to continue paying average sales price plus 6% for non–pass through drugs and biologicals that are administered under Part B of Medicare.
Proposed on July 3, the rule will be published on July 14. It covers payment for 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals. It also applies to 5,300 ambulatory surgery centers (ASCs) that participate in Medicare.
Overall, the government is proposing to increase payments to outpatient departments by 2%. The CMS expects to pay out some $57 billion for outpatient services in 2015. Payments to ASCs will increase just over 1% to $4 billion in 2015.
The agency is proposing to expand its Comprehensive Ambulatory Payment Classification (APC) policy, which was first discussed in its 2014 rule. The idea is to give a single Medicare payment and require a single beneficiary copayment for the entire hospital stay for a group of 28 procedures, including pacemaker insertion, implantation of neurostimulators, and stereotactic radiosurgery. It also would cover implantable cardioverter defibrillators.
The single, bundled payments would begin in 2015.
The proposed rule also contains several adjustments to both the Hospital Outpatient Quality Reporting Program and the ASC Quality Reporting Program. On the hospital side, the CMS is proposing to remove three quality measures, stating that performance has been uniformly high among reporting facilities. Those measures are aspirin at arrival (cardiac care), timing of prophylaxis antibiotics, and prophylactic antibiotic selection for surgical patients. The agency is proposing to add a claims-based measure – facility 7-day risk-standardized hospital visit rate after outpatient colonoscopy – for 2017 and beyond.
For ASCs, the agency is proposing to continue its effort to align measures with the hospital program. In 2015, ASCs will be required to report on the 7-day risk-standardized visit rate after outpatient colonoscopy measure.
The CMS is accepting comments on the proposed rule until Sept. 2, 2014. A final rule will be issued by Nov. 1.
On Twitter @aliciaault
The Centers for Medicare and Medicaid Services’ proposed rule on outpatient department and ambulatory surgery center payment for 2015 expands the agency’s focus on bundling pay for device-related procedures, largely in cardiology, neurology, oncology, and gynecology.
The Hospital Outpatient Prospective Payment System (OPPS) rule also continues the same payment rate for outpatient drug delivery such as chemotherapy. That payment rate has been a source of disappointment for oncologists. The American Society of Clinical Oncology has said in the past that, with the additional impact of budget sequestration, the actual payment for delivering chemotherapy drugs falls by 28%.
The agency is proposing again in 2015 to continue paying average sales price plus 6% for non–pass through drugs and biologicals that are administered under Part B of Medicare.
Proposed on July 3, the rule will be published on July 14. It covers payment for 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals. It also applies to 5,300 ambulatory surgery centers (ASCs) that participate in Medicare.
Overall, the government is proposing to increase payments to outpatient departments by 2%. The CMS expects to pay out some $57 billion for outpatient services in 2015. Payments to ASCs will increase just over 1% to $4 billion in 2015.
The agency is proposing to expand its Comprehensive Ambulatory Payment Classification (APC) policy, which was first discussed in its 2014 rule. The idea is to give a single Medicare payment and require a single beneficiary copayment for the entire hospital stay for a group of 28 procedures, including pacemaker insertion, implantation of neurostimulators, and stereotactic radiosurgery. It also would cover implantable cardioverter defibrillators.
The single, bundled payments would begin in 2015.
The proposed rule also contains several adjustments to both the Hospital Outpatient Quality Reporting Program and the ASC Quality Reporting Program. On the hospital side, the CMS is proposing to remove three quality measures, stating that performance has been uniformly high among reporting facilities. Those measures are aspirin at arrival (cardiac care), timing of prophylaxis antibiotics, and prophylactic antibiotic selection for surgical patients. The agency is proposing to add a claims-based measure – facility 7-day risk-standardized hospital visit rate after outpatient colonoscopy – for 2017 and beyond.
For ASCs, the agency is proposing to continue its effort to align measures with the hospital program. In 2015, ASCs will be required to report on the 7-day risk-standardized visit rate after outpatient colonoscopy measure.
The CMS is accepting comments on the proposed rule until Sept. 2, 2014. A final rule will be issued by Nov. 1.
On Twitter @aliciaault
Individualized program improves sleep in preschoolers
MINNEAPOLIS – Tailoring an intervention to the particular needs of a child and his or her family can markedly improve the child’s ability to go to sleep and stay asleep, a pilot study shows.
The trial was successful enough that the National Institute of Child Health and Development has given the lead researcher, Michelle M. Garrison, Ph.D., of the Seattle Children’s Research Institute, funding to enroll 500 children in a randomized, controlled trial to validate the intervention.
Dr. Garrison undertook the pilot in part to see what would help sleep-deprived and frustrated parents, and pediatricians, who might not have a ready solution for a preschooler who persistently won’t go to bed or won’t stay in bed.
To recruit children for the study, Dr. Garrison sent the CSHQ (Children’s Sleep Habits Questionnaire) to parents of all children aged 2.5-5 years who had been seen at local pediatric clinics. If parents were interested, they returned the survey. If the children met the eligibility criteria for having a behavioral sleep problem, they were included. Not every parent agreed that their child had an issue, which created an initial hurdle for making the intervention work, said Dr. Garrison.
The program started with a home visit, in which parents received education and a kit that included a binder with educational handouts, the book
Take Charge of Your Child's Sleep (New York: Marlowe and Co., 2005), a bedtime routine chart with cards that can be individualized to the child, laminated passes that allow the child to step outside the routine occasionally, and a clock that glows green when it is okay to get out of bed in the morning.
Parents received three follow-up phone calls for education, to set goals, and to engage in preemptive problem solving. Parents were coached on setting bedtime routines, creating a consistent bedtime, eliminating screen time in the hour or two before bed, setting limits, and working on night waking.
The pilot enrolled 36 children with a mean age of about 4 years. Forty-four percent were female and 72% were white, 19% were Asian, 8% were black, and 6% were Hispanic. The race and ethnicity categories were not mutually exclusive, said Dr. Garrison. A total of 22% of children had been adopted after 1 year of age. The mean age of the parents was 38 years. Only 11% of children lived in a one-adult home, and 11% lived in a multigenerational home.
Sleep habits and issues were assessed at baseline and at 3 months through 7-day diaries, actigraphy, and several sleep scales. The researchers were able to perform actigraphy on only 15 children, but there was good concordance between those measures and the diaries, said Dr. Garrison.
Overall, on average, children slept an additional 36 minutes a night. According to the diaries, 14% slept 10-30 minutes more, a third slept 30-60 minutes more, and 25% slept an additional hour. The actigraphy showed that 14% of children gained 10-30 minutes sleep, 36% gained 30-60 minutes, and 7% gained more than an hour. The average onset latency decreased by 10 minutes.
Dr. Garrison said the intervention could be tailored to children and parents with varying needs. For instance, adopted and nonadopted children did equally well with the program. She and her colleagues also worked with co-sleepers. She split them into "reactive" co-sleepers – that is, parents who felt like they had no choice – and "lifestyle" co-sleepers, who saw it as a way to bond. Reactive co-sleepers were coached on getting children to sleep in their own beds. Lifestyle parents were taught how to get children to get to sleep first, before the adults joined them in bed. There was a significant increase in sleep duration in those children of lifestyle co-sleepers, said Dr. Garrison.
Overall, there were no differences observed by age, sex, or comorbid conditions such as asthma.
The things that seemed to help the most included the number of contacts with the families, the tailored bedtime routine, and anticipatory problem solving around bedtime consistency. Parents who were the most skeptical about the benefits of sleep benefited the most from the program, said Dr. Garrison.
She will now take her methods into a larger trial that is being funded by the NICHD and has begun enrolling children. It will include 500 children and families will get monthly phone follow-ups for 9 months. Children will be analyzed for 3 years, in part to see if improving sleep has any impact on body mass index, learning, and cognitive function, she said.
The study was funded by the Sleep Research Society Foundation’s J. Christian Gillin, M.D., Research Grant; the Institution of Translational Health Sciences; and Seattle Children’s Research Institute. Dr. Garrison reported no conflicts.
On Twitter @aliciaault
MINNEAPOLIS – Tailoring an intervention to the particular needs of a child and his or her family can markedly improve the child’s ability to go to sleep and stay asleep, a pilot study shows.
The trial was successful enough that the National Institute of Child Health and Development has given the lead researcher, Michelle M. Garrison, Ph.D., of the Seattle Children’s Research Institute, funding to enroll 500 children in a randomized, controlled trial to validate the intervention.
Dr. Garrison undertook the pilot in part to see what would help sleep-deprived and frustrated parents, and pediatricians, who might not have a ready solution for a preschooler who persistently won’t go to bed or won’t stay in bed.
To recruit children for the study, Dr. Garrison sent the CSHQ (Children’s Sleep Habits Questionnaire) to parents of all children aged 2.5-5 years who had been seen at local pediatric clinics. If parents were interested, they returned the survey. If the children met the eligibility criteria for having a behavioral sleep problem, they were included. Not every parent agreed that their child had an issue, which created an initial hurdle for making the intervention work, said Dr. Garrison.
The program started with a home visit, in which parents received education and a kit that included a binder with educational handouts, the book
Take Charge of Your Child's Sleep (New York: Marlowe and Co., 2005), a bedtime routine chart with cards that can be individualized to the child, laminated passes that allow the child to step outside the routine occasionally, and a clock that glows green when it is okay to get out of bed in the morning.
Parents received three follow-up phone calls for education, to set goals, and to engage in preemptive problem solving. Parents were coached on setting bedtime routines, creating a consistent bedtime, eliminating screen time in the hour or two before bed, setting limits, and working on night waking.
The pilot enrolled 36 children with a mean age of about 4 years. Forty-four percent were female and 72% were white, 19% were Asian, 8% were black, and 6% were Hispanic. The race and ethnicity categories were not mutually exclusive, said Dr. Garrison. A total of 22% of children had been adopted after 1 year of age. The mean age of the parents was 38 years. Only 11% of children lived in a one-adult home, and 11% lived in a multigenerational home.
Sleep habits and issues were assessed at baseline and at 3 months through 7-day diaries, actigraphy, and several sleep scales. The researchers were able to perform actigraphy on only 15 children, but there was good concordance between those measures and the diaries, said Dr. Garrison.
Overall, on average, children slept an additional 36 minutes a night. According to the diaries, 14% slept 10-30 minutes more, a third slept 30-60 minutes more, and 25% slept an additional hour. The actigraphy showed that 14% of children gained 10-30 minutes sleep, 36% gained 30-60 minutes, and 7% gained more than an hour. The average onset latency decreased by 10 minutes.
Dr. Garrison said the intervention could be tailored to children and parents with varying needs. For instance, adopted and nonadopted children did equally well with the program. She and her colleagues also worked with co-sleepers. She split them into "reactive" co-sleepers – that is, parents who felt like they had no choice – and "lifestyle" co-sleepers, who saw it as a way to bond. Reactive co-sleepers were coached on getting children to sleep in their own beds. Lifestyle parents were taught how to get children to get to sleep first, before the adults joined them in bed. There was a significant increase in sleep duration in those children of lifestyle co-sleepers, said Dr. Garrison.
Overall, there were no differences observed by age, sex, or comorbid conditions such as asthma.
The things that seemed to help the most included the number of contacts with the families, the tailored bedtime routine, and anticipatory problem solving around bedtime consistency. Parents who were the most skeptical about the benefits of sleep benefited the most from the program, said Dr. Garrison.
She will now take her methods into a larger trial that is being funded by the NICHD and has begun enrolling children. It will include 500 children and families will get monthly phone follow-ups for 9 months. Children will be analyzed for 3 years, in part to see if improving sleep has any impact on body mass index, learning, and cognitive function, she said.
The study was funded by the Sleep Research Society Foundation’s J. Christian Gillin, M.D., Research Grant; the Institution of Translational Health Sciences; and Seattle Children’s Research Institute. Dr. Garrison reported no conflicts.
On Twitter @aliciaault
MINNEAPOLIS – Tailoring an intervention to the particular needs of a child and his or her family can markedly improve the child’s ability to go to sleep and stay asleep, a pilot study shows.
The trial was successful enough that the National Institute of Child Health and Development has given the lead researcher, Michelle M. Garrison, Ph.D., of the Seattle Children’s Research Institute, funding to enroll 500 children in a randomized, controlled trial to validate the intervention.
Dr. Garrison undertook the pilot in part to see what would help sleep-deprived and frustrated parents, and pediatricians, who might not have a ready solution for a preschooler who persistently won’t go to bed or won’t stay in bed.
To recruit children for the study, Dr. Garrison sent the CSHQ (Children’s Sleep Habits Questionnaire) to parents of all children aged 2.5-5 years who had been seen at local pediatric clinics. If parents were interested, they returned the survey. If the children met the eligibility criteria for having a behavioral sleep problem, they were included. Not every parent agreed that their child had an issue, which created an initial hurdle for making the intervention work, said Dr. Garrison.
The program started with a home visit, in which parents received education and a kit that included a binder with educational handouts, the book
Take Charge of Your Child's Sleep (New York: Marlowe and Co., 2005), a bedtime routine chart with cards that can be individualized to the child, laminated passes that allow the child to step outside the routine occasionally, and a clock that glows green when it is okay to get out of bed in the morning.
Parents received three follow-up phone calls for education, to set goals, and to engage in preemptive problem solving. Parents were coached on setting bedtime routines, creating a consistent bedtime, eliminating screen time in the hour or two before bed, setting limits, and working on night waking.
The pilot enrolled 36 children with a mean age of about 4 years. Forty-four percent were female and 72% were white, 19% were Asian, 8% were black, and 6% were Hispanic. The race and ethnicity categories were not mutually exclusive, said Dr. Garrison. A total of 22% of children had been adopted after 1 year of age. The mean age of the parents was 38 years. Only 11% of children lived in a one-adult home, and 11% lived in a multigenerational home.
Sleep habits and issues were assessed at baseline and at 3 months through 7-day diaries, actigraphy, and several sleep scales. The researchers were able to perform actigraphy on only 15 children, but there was good concordance between those measures and the diaries, said Dr. Garrison.
Overall, on average, children slept an additional 36 minutes a night. According to the diaries, 14% slept 10-30 minutes more, a third slept 30-60 minutes more, and 25% slept an additional hour. The actigraphy showed that 14% of children gained 10-30 minutes sleep, 36% gained 30-60 minutes, and 7% gained more than an hour. The average onset latency decreased by 10 minutes.
Dr. Garrison said the intervention could be tailored to children and parents with varying needs. For instance, adopted and nonadopted children did equally well with the program. She and her colleagues also worked with co-sleepers. She split them into "reactive" co-sleepers – that is, parents who felt like they had no choice – and "lifestyle" co-sleepers, who saw it as a way to bond. Reactive co-sleepers were coached on getting children to sleep in their own beds. Lifestyle parents were taught how to get children to get to sleep first, before the adults joined them in bed. There was a significant increase in sleep duration in those children of lifestyle co-sleepers, said Dr. Garrison.
Overall, there were no differences observed by age, sex, or comorbid conditions such as asthma.
The things that seemed to help the most included the number of contacts with the families, the tailored bedtime routine, and anticipatory problem solving around bedtime consistency. Parents who were the most skeptical about the benefits of sleep benefited the most from the program, said Dr. Garrison.
She will now take her methods into a larger trial that is being funded by the NICHD and has begun enrolling children. It will include 500 children and families will get monthly phone follow-ups for 9 months. Children will be analyzed for 3 years, in part to see if improving sleep has any impact on body mass index, learning, and cognitive function, she said.
The study was funded by the Sleep Research Society Foundation’s J. Christian Gillin, M.D., Research Grant; the Institution of Translational Health Sciences; and Seattle Children’s Research Institute. Dr. Garrison reported no conflicts.
On Twitter @aliciaault
FROM SLEEP 2014
Key clinical point: A focused, individualized program can help recalcitrant preschoolers get to sleep and stay asleep.
Major finding: In a pilot study with 36 children, they slept an additional 36 minutes a night with the program.
Data source: The Sleep Health in Preschoolers intervention program, which was conducted in children aged 2.5-5 years over 3 months.
Disclosures: The study was funded by the Sleep Research Society Foundation’s J. Christian Gillin, M.D., Research Grant; the Institution of Translational Health Sciences; and Seattle Children’s Research Institute. Dr. Garrison reported no conflicts.
FDA approves Restylane Silk for plumper lips, smoother mouth
The Food and Drug Administration has approved a new formulation of Restylane, known as Restylane Silk.
The new product was approved for submucosal lip augmentation and correction of perioral rhytids in patients aged 21 years and older. Restylane Silk is a clear, injectable gel composed of a non–animal-based formulation of hyaluronic acid, and it includes 0.3% lidocaine. The lidocaine was added to reduce the discomfort associated with the injectable, according to the manufacturer, Medicis, which is a division of Valeant Pharmaceuticals.
Restylane was first approved by the FDA in 2005 for mid-to-deep dermal implantation to treat moderate to severe facial wrinkles and nasolabial folds. An indication for submucosal lip augmentation was approved in 2011.
The Silk formulation is injected once or twice, as needed, over a 2-week period, and the effect lasts about 6 months, according to the FDA.
Restylane Silk is contraindicated in patients with a history of hypersensitivity or anaphylaxis, or a history of hypersensitivity to lidocaine, or gram-positive bacteria such as Streptococcus. It should not be used in patients with a bleeding disorder.
Safety and effectiveness were gauged in a 221-patient study. Restylane Silk was evaluated in patients with light and dark skin; 52 patients had Fitzpatrick skin types IV and V. The incidence of adverse events in these 52 patients was similar to that in the overall study population, but the safety in patients with Fitzpatrick skin type VI has not been established, said the FDA.
Side effects include bruising, redness, swelling, pain, tenderness, and itching. There were 12 severe events in six study patients; 10 were lip swelling. There were five serious adverse events in three patients.
Valeant said that 98% of study patients reported improvement in their lip fullness 14 days after injection, and 76% still had lip improvement after 6 months.
On Twitter @aliciaault
The Food and Drug Administration has approved a new formulation of Restylane, known as Restylane Silk.
The new product was approved for submucosal lip augmentation and correction of perioral rhytids in patients aged 21 years and older. Restylane Silk is a clear, injectable gel composed of a non–animal-based formulation of hyaluronic acid, and it includes 0.3% lidocaine. The lidocaine was added to reduce the discomfort associated with the injectable, according to the manufacturer, Medicis, which is a division of Valeant Pharmaceuticals.
Restylane was first approved by the FDA in 2005 for mid-to-deep dermal implantation to treat moderate to severe facial wrinkles and nasolabial folds. An indication for submucosal lip augmentation was approved in 2011.
The Silk formulation is injected once or twice, as needed, over a 2-week period, and the effect lasts about 6 months, according to the FDA.
Restylane Silk is contraindicated in patients with a history of hypersensitivity or anaphylaxis, or a history of hypersensitivity to lidocaine, or gram-positive bacteria such as Streptococcus. It should not be used in patients with a bleeding disorder.
Safety and effectiveness were gauged in a 221-patient study. Restylane Silk was evaluated in patients with light and dark skin; 52 patients had Fitzpatrick skin types IV and V. The incidence of adverse events in these 52 patients was similar to that in the overall study population, but the safety in patients with Fitzpatrick skin type VI has not been established, said the FDA.
Side effects include bruising, redness, swelling, pain, tenderness, and itching. There were 12 severe events in six study patients; 10 were lip swelling. There were five serious adverse events in three patients.
Valeant said that 98% of study patients reported improvement in their lip fullness 14 days after injection, and 76% still had lip improvement after 6 months.
On Twitter @aliciaault
The Food and Drug Administration has approved a new formulation of Restylane, known as Restylane Silk.
The new product was approved for submucosal lip augmentation and correction of perioral rhytids in patients aged 21 years and older. Restylane Silk is a clear, injectable gel composed of a non–animal-based formulation of hyaluronic acid, and it includes 0.3% lidocaine. The lidocaine was added to reduce the discomfort associated with the injectable, according to the manufacturer, Medicis, which is a division of Valeant Pharmaceuticals.
Restylane was first approved by the FDA in 2005 for mid-to-deep dermal implantation to treat moderate to severe facial wrinkles and nasolabial folds. An indication for submucosal lip augmentation was approved in 2011.
The Silk formulation is injected once or twice, as needed, over a 2-week period, and the effect lasts about 6 months, according to the FDA.
Restylane Silk is contraindicated in patients with a history of hypersensitivity or anaphylaxis, or a history of hypersensitivity to lidocaine, or gram-positive bacteria such as Streptococcus. It should not be used in patients with a bleeding disorder.
Safety and effectiveness were gauged in a 221-patient study. Restylane Silk was evaluated in patients with light and dark skin; 52 patients had Fitzpatrick skin types IV and V. The incidence of adverse events in these 52 patients was similar to that in the overall study population, but the safety in patients with Fitzpatrick skin type VI has not been established, said the FDA.
Side effects include bruising, redness, swelling, pain, tenderness, and itching. There were 12 severe events in six study patients; 10 were lip swelling. There were five serious adverse events in three patients.
Valeant said that 98% of study patients reported improvement in their lip fullness 14 days after injection, and 76% still had lip improvement after 6 months.
On Twitter @aliciaault
Supreme Court: Companies can deny contraceptive coverage
WASHINGTON – For-profit companies cannot be compelled to provide insurance coverage for contraception if doing so violates the religious beliefs of the company’s owners, the Supreme Court ruled June 30.
Dissenting justices said that it had the potential to allow employers to use their religious beliefs as a way to object to providing coverage for vaccinations, blood transfusions, and other procedures, and that it could open the door to deny employment to certain individuals or groups.
The Court ruled 5-4 in the cases of Burwell v. Hobby Lobby Stores Inc. and Conestoga Wood Specialties Corp. v. Burwell.
Justice Samuel Alito, reading the opinion for the majority, said that the Religious Freedom Restoration Act (RFRA) of 1993 protected the rights of not just individuals, but also of individuals who run closely held for-profit corporations.
The terms of that law "make it perfectly clear that Congress did not discriminate in this way against men and women who wish to run their businesses as for-profit corporations in the manner required by their religious beliefs," according to the opinion signed by Justice Alito, Justice Anthony P. Kennedy, Justice Antonin Scalia, and Justice Clarence Thomas, and Chief Justice John P. Roberts.
The plaintiffs in the cases said that being required by the Affordable Care Act to provide insurance coverage for contraception violated their religious beliefs. In particular, Hobby Lobby and Conestoga Wood both objected to four specific types of contraception that they said interfere with conception and thus constitute abortion: the Ella morning-after pill, the Plan B morning-after pill, and hormonal and copper intrauterine devices (IUDs).
The majority opinion said that by requiring companies that did not comply to pay fines, the government was placing an undue burden on these employers. Justice Alito noted that Hobby Lobby would have to either give up its religious tenets or pay up to $1.3 million a day in fines*.
"If these consequences don’t amount to a heavy burden, I’m not sure what would," he said.
The majority also said that since the government already makes exceptions to the contraception requirement for religious organizations and nonprofit religiously affiliated groups, that it could have made the same allowances for for-profit companies. The government also could have offered to pay for the contraceptives that companies refuse to cover, they said.
Justice Ruth Bader Ginsburg, who read the dissenting opinion, called the majority’s opinion "a decision of startling breadth." If allowed to stand, it could raise what she called "a host of ‘me, too’ questions," such as whether an employer could opt out of coverage for antidepressants, vaccinations, or medications derived from pigs, "based on the employer’s sincerely held religious beliefs opposing those medical practices."
Joined by Justice Stephen G. Breyer, Justice Elena Kagan, and Justice Sonia Sotomayor, she also said that while the ruling might seem to be limited to access to the four contraceptives in the cases, it was likely that companies would seek to deny coverage for all available contraceptive technologies.
The dissenters also said that they doubted that Congress intended for the RFRA to be used to allow a company to stand in between a woman and her physician. Any decision to use a contraceptive "will be the woman’s autonomous choice, informed by the physician she consults," they wrote.
Many physicians’ and women’s health organizations called it a dangerous precedent.
The American College of Obstetricians and Gynecologists President John C. Jennings said in a statement that the group was “profoundly disappointed” in the decision, as it “inappropriately allows employers to interfere in women’s health care decisions.” Dr. Jennings also said that contraceptives should not be treated differently than other health care services for women. “The value of family planning – including contraception – has been clearly demonstrated,” he said. “The ability of a woman to time and space her children reduces infant, child, and maternal morbidity and mortality, and can lead to more optimal health outcomes for mother and for baby.”
Contraception also helps prevent unintended pregnancy, he said, adding, “This is absolutely essential in America, where nearly one half of all pregnancies are unintended.”
In a statement, Dr.Reid Blackwelder, president of the American Academy of Family Physicians, said, "With this decision, the court has moved health care decisions out of the exam room, where patients can consult with their physicians — and where such decisions should be made — and put them into the hands of business owners who base decisions on personal beliefs rather than [on] medical science." Dr. Blackwelder added, "Personal or institutional beliefs should not put Americans’ health and lives at risk, simply because employers control the insurance available to their workers. Unfortunately, the Supreme Court decision opens the gate for just such consequences."
Dr. James M. Perrin, president of the American Academy of Pediatrics, said, "For pediatricians, the science is clear: contraception is a safe, effective tool to prevent unintended pregnancy in young women of any reproductive age. Today, we are disappointed that justice did not side with science."
Some physician groups expressed their support for the decision.
The American Association of Pro-Life Obstetricians and Gynecologists called the ruling a "tremendous victory for all Americans and their freedom of conscience." The group added that it was "hopeful that this recognition of conscientious objection will help to strengthen the rights of physicians to continue to refuse to participate in any medical procedure or to prescribe any drug that is designed and purposed to kill a living human being."
The Christian Medical Association also applauded the decision. In a statement, Dr. David Stevens, CEO, said, "We are very thankful that the Supreme Court acted to protect family businesses from government coercion and fines for simply honoring the tenets of their faith," and called it a "much-needed victory for faith freedoms."
In a joint press briefing, representatives from Planned Parenthood, NARAL, the American Civil Liberties Union, and the National Women’s Law Center said that they would work with Congress to try to reverse the Supreme Court ruling through legislation. The AAP will do the same, said Dr. Perrin.
Some Senate Democrats have said they will prepare legislation to address the case immediately. Sen. Patty Murray (D-Wash.), who filed a friend of the court brief on behalf of 18 Senators that sided with the government’s case, said in a statement that, "Since the Supreme Court decided it will not protect women’s access to health care, I will. In the coming days I will work with my colleagues and the Administration to protect this access, regardless of who signs your paycheck."
Senate Republican leader Mitch McConnell (R-Ky.), however, said that the decision was a validation of religious freedom. "Obamacare is the single worst piece of legislation to pass in the last 50 years, and I was glad to see the Supreme Court agree that this particular Obamacare mandate violates the Religious Freedom Restoration Act," Sen. McConnell said, in a statement.
On Twitter @aliciaault
*Clarification, 7/2/2014: An earlier version of this article did not include the intact quote from the majority opinion.
*This story was updated 7/2/2014.
WASHINGTON – For-profit companies cannot be compelled to provide insurance coverage for contraception if doing so violates the religious beliefs of the company’s owners, the Supreme Court ruled June 30.
Dissenting justices said that it had the potential to allow employers to use their religious beliefs as a way to object to providing coverage for vaccinations, blood transfusions, and other procedures, and that it could open the door to deny employment to certain individuals or groups.
The Court ruled 5-4 in the cases of Burwell v. Hobby Lobby Stores Inc. and Conestoga Wood Specialties Corp. v. Burwell.
Justice Samuel Alito, reading the opinion for the majority, said that the Religious Freedom Restoration Act (RFRA) of 1993 protected the rights of not just individuals, but also of individuals who run closely held for-profit corporations.
The terms of that law "make it perfectly clear that Congress did not discriminate in this way against men and women who wish to run their businesses as for-profit corporations in the manner required by their religious beliefs," according to the opinion signed by Justice Alito, Justice Anthony P. Kennedy, Justice Antonin Scalia, and Justice Clarence Thomas, and Chief Justice John P. Roberts.
The plaintiffs in the cases said that being required by the Affordable Care Act to provide insurance coverage for contraception violated their religious beliefs. In particular, Hobby Lobby and Conestoga Wood both objected to four specific types of contraception that they said interfere with conception and thus constitute abortion: the Ella morning-after pill, the Plan B morning-after pill, and hormonal and copper intrauterine devices (IUDs).
The majority opinion said that by requiring companies that did not comply to pay fines, the government was placing an undue burden on these employers. Justice Alito noted that Hobby Lobby would have to either give up its religious tenets or pay up to $1.3 million a day in fines*.
"If these consequences don’t amount to a heavy burden, I’m not sure what would," he said.
The majority also said that since the government already makes exceptions to the contraception requirement for religious organizations and nonprofit religiously affiliated groups, that it could have made the same allowances for for-profit companies. The government also could have offered to pay for the contraceptives that companies refuse to cover, they said.
Justice Ruth Bader Ginsburg, who read the dissenting opinion, called the majority’s opinion "a decision of startling breadth." If allowed to stand, it could raise what she called "a host of ‘me, too’ questions," such as whether an employer could opt out of coverage for antidepressants, vaccinations, or medications derived from pigs, "based on the employer’s sincerely held religious beliefs opposing those medical practices."
Joined by Justice Stephen G. Breyer, Justice Elena Kagan, and Justice Sonia Sotomayor, she also said that while the ruling might seem to be limited to access to the four contraceptives in the cases, it was likely that companies would seek to deny coverage for all available contraceptive technologies.
The dissenters also said that they doubted that Congress intended for the RFRA to be used to allow a company to stand in between a woman and her physician. Any decision to use a contraceptive "will be the woman’s autonomous choice, informed by the physician she consults," they wrote.
Many physicians’ and women’s health organizations called it a dangerous precedent.
The American College of Obstetricians and Gynecologists President John C. Jennings said in a statement that the group was “profoundly disappointed” in the decision, as it “inappropriately allows employers to interfere in women’s health care decisions.” Dr. Jennings also said that contraceptives should not be treated differently than other health care services for women. “The value of family planning – including contraception – has been clearly demonstrated,” he said. “The ability of a woman to time and space her children reduces infant, child, and maternal morbidity and mortality, and can lead to more optimal health outcomes for mother and for baby.”
Contraception also helps prevent unintended pregnancy, he said, adding, “This is absolutely essential in America, where nearly one half of all pregnancies are unintended.”
In a statement, Dr.Reid Blackwelder, president of the American Academy of Family Physicians, said, "With this decision, the court has moved health care decisions out of the exam room, where patients can consult with their physicians — and where such decisions should be made — and put them into the hands of business owners who base decisions on personal beliefs rather than [on] medical science." Dr. Blackwelder added, "Personal or institutional beliefs should not put Americans’ health and lives at risk, simply because employers control the insurance available to their workers. Unfortunately, the Supreme Court decision opens the gate for just such consequences."
Dr. James M. Perrin, president of the American Academy of Pediatrics, said, "For pediatricians, the science is clear: contraception is a safe, effective tool to prevent unintended pregnancy in young women of any reproductive age. Today, we are disappointed that justice did not side with science."
Some physician groups expressed their support for the decision.
The American Association of Pro-Life Obstetricians and Gynecologists called the ruling a "tremendous victory for all Americans and their freedom of conscience." The group added that it was "hopeful that this recognition of conscientious objection will help to strengthen the rights of physicians to continue to refuse to participate in any medical procedure or to prescribe any drug that is designed and purposed to kill a living human being."
The Christian Medical Association also applauded the decision. In a statement, Dr. David Stevens, CEO, said, "We are very thankful that the Supreme Court acted to protect family businesses from government coercion and fines for simply honoring the tenets of their faith," and called it a "much-needed victory for faith freedoms."
In a joint press briefing, representatives from Planned Parenthood, NARAL, the American Civil Liberties Union, and the National Women’s Law Center said that they would work with Congress to try to reverse the Supreme Court ruling through legislation. The AAP will do the same, said Dr. Perrin.
Some Senate Democrats have said they will prepare legislation to address the case immediately. Sen. Patty Murray (D-Wash.), who filed a friend of the court brief on behalf of 18 Senators that sided with the government’s case, said in a statement that, "Since the Supreme Court decided it will not protect women’s access to health care, I will. In the coming days I will work with my colleagues and the Administration to protect this access, regardless of who signs your paycheck."
Senate Republican leader Mitch McConnell (R-Ky.), however, said that the decision was a validation of religious freedom. "Obamacare is the single worst piece of legislation to pass in the last 50 years, and I was glad to see the Supreme Court agree that this particular Obamacare mandate violates the Religious Freedom Restoration Act," Sen. McConnell said, in a statement.
On Twitter @aliciaault
*Clarification, 7/2/2014: An earlier version of this article did not include the intact quote from the majority opinion.
*This story was updated 7/2/2014.
WASHINGTON – For-profit companies cannot be compelled to provide insurance coverage for contraception if doing so violates the religious beliefs of the company’s owners, the Supreme Court ruled June 30.
Dissenting justices said that it had the potential to allow employers to use their religious beliefs as a way to object to providing coverage for vaccinations, blood transfusions, and other procedures, and that it could open the door to deny employment to certain individuals or groups.
The Court ruled 5-4 in the cases of Burwell v. Hobby Lobby Stores Inc. and Conestoga Wood Specialties Corp. v. Burwell.
Justice Samuel Alito, reading the opinion for the majority, said that the Religious Freedom Restoration Act (RFRA) of 1993 protected the rights of not just individuals, but also of individuals who run closely held for-profit corporations.
The terms of that law "make it perfectly clear that Congress did not discriminate in this way against men and women who wish to run their businesses as for-profit corporations in the manner required by their religious beliefs," according to the opinion signed by Justice Alito, Justice Anthony P. Kennedy, Justice Antonin Scalia, and Justice Clarence Thomas, and Chief Justice John P. Roberts.
The plaintiffs in the cases said that being required by the Affordable Care Act to provide insurance coverage for contraception violated their religious beliefs. In particular, Hobby Lobby and Conestoga Wood both objected to four specific types of contraception that they said interfere with conception and thus constitute abortion: the Ella morning-after pill, the Plan B morning-after pill, and hormonal and copper intrauterine devices (IUDs).
The majority opinion said that by requiring companies that did not comply to pay fines, the government was placing an undue burden on these employers. Justice Alito noted that Hobby Lobby would have to either give up its religious tenets or pay up to $1.3 million a day in fines*.
"If these consequences don’t amount to a heavy burden, I’m not sure what would," he said.
The majority also said that since the government already makes exceptions to the contraception requirement for religious organizations and nonprofit religiously affiliated groups, that it could have made the same allowances for for-profit companies. The government also could have offered to pay for the contraceptives that companies refuse to cover, they said.
Justice Ruth Bader Ginsburg, who read the dissenting opinion, called the majority’s opinion "a decision of startling breadth." If allowed to stand, it could raise what she called "a host of ‘me, too’ questions," such as whether an employer could opt out of coverage for antidepressants, vaccinations, or medications derived from pigs, "based on the employer’s sincerely held religious beliefs opposing those medical practices."
Joined by Justice Stephen G. Breyer, Justice Elena Kagan, and Justice Sonia Sotomayor, she also said that while the ruling might seem to be limited to access to the four contraceptives in the cases, it was likely that companies would seek to deny coverage for all available contraceptive technologies.
The dissenters also said that they doubted that Congress intended for the RFRA to be used to allow a company to stand in between a woman and her physician. Any decision to use a contraceptive "will be the woman’s autonomous choice, informed by the physician she consults," they wrote.
Many physicians’ and women’s health organizations called it a dangerous precedent.
The American College of Obstetricians and Gynecologists President John C. Jennings said in a statement that the group was “profoundly disappointed” in the decision, as it “inappropriately allows employers to interfere in women’s health care decisions.” Dr. Jennings also said that contraceptives should not be treated differently than other health care services for women. “The value of family planning – including contraception – has been clearly demonstrated,” he said. “The ability of a woman to time and space her children reduces infant, child, and maternal morbidity and mortality, and can lead to more optimal health outcomes for mother and for baby.”
Contraception also helps prevent unintended pregnancy, he said, adding, “This is absolutely essential in America, where nearly one half of all pregnancies are unintended.”
In a statement, Dr.Reid Blackwelder, president of the American Academy of Family Physicians, said, "With this decision, the court has moved health care decisions out of the exam room, where patients can consult with their physicians — and where such decisions should be made — and put them into the hands of business owners who base decisions on personal beliefs rather than [on] medical science." Dr. Blackwelder added, "Personal or institutional beliefs should not put Americans’ health and lives at risk, simply because employers control the insurance available to their workers. Unfortunately, the Supreme Court decision opens the gate for just such consequences."
Dr. James M. Perrin, president of the American Academy of Pediatrics, said, "For pediatricians, the science is clear: contraception is a safe, effective tool to prevent unintended pregnancy in young women of any reproductive age. Today, we are disappointed that justice did not side with science."
Some physician groups expressed their support for the decision.
The American Association of Pro-Life Obstetricians and Gynecologists called the ruling a "tremendous victory for all Americans and their freedom of conscience." The group added that it was "hopeful that this recognition of conscientious objection will help to strengthen the rights of physicians to continue to refuse to participate in any medical procedure or to prescribe any drug that is designed and purposed to kill a living human being."
The Christian Medical Association also applauded the decision. In a statement, Dr. David Stevens, CEO, said, "We are very thankful that the Supreme Court acted to protect family businesses from government coercion and fines for simply honoring the tenets of their faith," and called it a "much-needed victory for faith freedoms."
In a joint press briefing, representatives from Planned Parenthood, NARAL, the American Civil Liberties Union, and the National Women’s Law Center said that they would work with Congress to try to reverse the Supreme Court ruling through legislation. The AAP will do the same, said Dr. Perrin.
Some Senate Democrats have said they will prepare legislation to address the case immediately. Sen. Patty Murray (D-Wash.), who filed a friend of the court brief on behalf of 18 Senators that sided with the government’s case, said in a statement that, "Since the Supreme Court decided it will not protect women’s access to health care, I will. In the coming days I will work with my colleagues and the Administration to protect this access, regardless of who signs your paycheck."
Senate Republican leader Mitch McConnell (R-Ky.), however, said that the decision was a validation of religious freedom. "Obamacare is the single worst piece of legislation to pass in the last 50 years, and I was glad to see the Supreme Court agree that this particular Obamacare mandate violates the Religious Freedom Restoration Act," Sen. McConnell said, in a statement.
On Twitter @aliciaault
*Clarification, 7/2/2014: An earlier version of this article did not include the intact quote from the majority opinion.
*This story was updated 7/2/2014.
AT THE U.S. SUPREME COURT
Supreme Court strikes down abortion clinic buffer zones
WASHINGTON – A Massachusetts law that established a 35-foot protest-free buffer zone around abortion clinics is unconstitutional, the Supreme Court ruled June 26.
The buffer zone represents a "dramatic intrusion on First Amendment rights," said Chief Justice John Roberts Jr., in reading the opinion from the bench.
The Justices were unanimous that the law was a First Amendment violation, but varied on how they formulated their opinions. Chief Justice Roberts Jr. was joined by Justice Ruth Bader Ginsburg, Justice Stephen G. Breyer, Justice Sonia Sotomayor and Justice Elena Kagan. Justice Antonin Scalia was joined by Justice Anthony M. Kennedy and Justice Clarence Thomas, who all agreed that the law was unconstitutional on its face, and that there were no acceptable alternatives to barring protesters from the clinics. Justice Samuel A. Alito Jr. agreed in a separate concurring opinion.
The 2007 law prohibited most people – with the exception of employees and their agents, patients, and people passing by the clinics – from standing within 35 feet of an abortion clinic. Those buffer zones were delineated by painted lines.
In McCullen v. Coakley, Eleanor McCullen said that the law violated her First Amendment right to talk with women going into the clinics, in an effort to counsel them and persuade them not to have an abortion.
The Chief Justice and his five colleagues agreed and said that though the buffer zones had helped the state maintain public safety and preserve access to the clinics, it had done so at the expense of the First Amendment. Ms. McCullen and her colleagues are not "protesters," the Justices said. Instead, "they seek not merely to express their opposition to abortion, but to engage in personal, caring, consensual conversations with women about various alternatives."
And, they said, "It is not enough for Massachusetts simply to say that other approaches have not worked."
Pro-life groups praised the ruling. "The Massachusetts law impermissibly discriminated against and censored pro-life Americans," said Dr. Charmaine Yoest, president and chief executive officer of Americans United for Life, in a statement. "The pro-abortion position could be represented in the zone, while the pro-life view point was strictly prohibited under threat of criminal sanctions."
The Pro-Life Action League issued a statement following the decision that, "The pro-life movement scored a huge victory at the Supreme Court today."
Pro-choice groups, however, said they were disappointed. Ilyse Hogue, president of NARAL Pro-Choice America, noted that there has been a long history of violence against women who patronize clinics, and physicians and other clinic workers, with 8 murders and 17 attempted murders since 1991.
"Let’s be clear: Today’s decision puts women and health care providers at greater risk," Ms. Hogue said in a statement.
Megan Amundson, executive director of NARAL Pro-Choice Massachusetts, said that the ruling "turns back the clock to when women were too intimidated to seek medical care," adding that "women’s health will suffer because of it."
Planned Parenthood echoed that position. "This decision shows a troubling level of disregard for American women, who should be able to make carefully considered, private medical decisions without running a gauntlet of harassing and threatening protesters," Cecile Richards, president of Planned Parenthood Federation of America, said in a statement.
"We are taking a close look at this ruling, as well as patient protection laws around the country, to ensure that women can continue to make their own health care decisions without fear of harassment or intimidation," she said.
On Twitter @aliciaault
WASHINGTON – A Massachusetts law that established a 35-foot protest-free buffer zone around abortion clinics is unconstitutional, the Supreme Court ruled June 26.
The buffer zone represents a "dramatic intrusion on First Amendment rights," said Chief Justice John Roberts Jr., in reading the opinion from the bench.
The Justices were unanimous that the law was a First Amendment violation, but varied on how they formulated their opinions. Chief Justice Roberts Jr. was joined by Justice Ruth Bader Ginsburg, Justice Stephen G. Breyer, Justice Sonia Sotomayor and Justice Elena Kagan. Justice Antonin Scalia was joined by Justice Anthony M. Kennedy and Justice Clarence Thomas, who all agreed that the law was unconstitutional on its face, and that there were no acceptable alternatives to barring protesters from the clinics. Justice Samuel A. Alito Jr. agreed in a separate concurring opinion.
The 2007 law prohibited most people – with the exception of employees and their agents, patients, and people passing by the clinics – from standing within 35 feet of an abortion clinic. Those buffer zones were delineated by painted lines.
In McCullen v. Coakley, Eleanor McCullen said that the law violated her First Amendment right to talk with women going into the clinics, in an effort to counsel them and persuade them not to have an abortion.
The Chief Justice and his five colleagues agreed and said that though the buffer zones had helped the state maintain public safety and preserve access to the clinics, it had done so at the expense of the First Amendment. Ms. McCullen and her colleagues are not "protesters," the Justices said. Instead, "they seek not merely to express their opposition to abortion, but to engage in personal, caring, consensual conversations with women about various alternatives."
And, they said, "It is not enough for Massachusetts simply to say that other approaches have not worked."
Pro-life groups praised the ruling. "The Massachusetts law impermissibly discriminated against and censored pro-life Americans," said Dr. Charmaine Yoest, president and chief executive officer of Americans United for Life, in a statement. "The pro-abortion position could be represented in the zone, while the pro-life view point was strictly prohibited under threat of criminal sanctions."
The Pro-Life Action League issued a statement following the decision that, "The pro-life movement scored a huge victory at the Supreme Court today."
Pro-choice groups, however, said they were disappointed. Ilyse Hogue, president of NARAL Pro-Choice America, noted that there has been a long history of violence against women who patronize clinics, and physicians and other clinic workers, with 8 murders and 17 attempted murders since 1991.
"Let’s be clear: Today’s decision puts women and health care providers at greater risk," Ms. Hogue said in a statement.
Megan Amundson, executive director of NARAL Pro-Choice Massachusetts, said that the ruling "turns back the clock to when women were too intimidated to seek medical care," adding that "women’s health will suffer because of it."
Planned Parenthood echoed that position. "This decision shows a troubling level of disregard for American women, who should be able to make carefully considered, private medical decisions without running a gauntlet of harassing and threatening protesters," Cecile Richards, president of Planned Parenthood Federation of America, said in a statement.
"We are taking a close look at this ruling, as well as patient protection laws around the country, to ensure that women can continue to make their own health care decisions without fear of harassment or intimidation," she said.
On Twitter @aliciaault
WASHINGTON – A Massachusetts law that established a 35-foot protest-free buffer zone around abortion clinics is unconstitutional, the Supreme Court ruled June 26.
The buffer zone represents a "dramatic intrusion on First Amendment rights," said Chief Justice John Roberts Jr., in reading the opinion from the bench.
The Justices were unanimous that the law was a First Amendment violation, but varied on how they formulated their opinions. Chief Justice Roberts Jr. was joined by Justice Ruth Bader Ginsburg, Justice Stephen G. Breyer, Justice Sonia Sotomayor and Justice Elena Kagan. Justice Antonin Scalia was joined by Justice Anthony M. Kennedy and Justice Clarence Thomas, who all agreed that the law was unconstitutional on its face, and that there were no acceptable alternatives to barring protesters from the clinics. Justice Samuel A. Alito Jr. agreed in a separate concurring opinion.
The 2007 law prohibited most people – with the exception of employees and their agents, patients, and people passing by the clinics – from standing within 35 feet of an abortion clinic. Those buffer zones were delineated by painted lines.
In McCullen v. Coakley, Eleanor McCullen said that the law violated her First Amendment right to talk with women going into the clinics, in an effort to counsel them and persuade them not to have an abortion.
The Chief Justice and his five colleagues agreed and said that though the buffer zones had helped the state maintain public safety and preserve access to the clinics, it had done so at the expense of the First Amendment. Ms. McCullen and her colleagues are not "protesters," the Justices said. Instead, "they seek not merely to express their opposition to abortion, but to engage in personal, caring, consensual conversations with women about various alternatives."
And, they said, "It is not enough for Massachusetts simply to say that other approaches have not worked."
Pro-life groups praised the ruling. "The Massachusetts law impermissibly discriminated against and censored pro-life Americans," said Dr. Charmaine Yoest, president and chief executive officer of Americans United for Life, in a statement. "The pro-abortion position could be represented in the zone, while the pro-life view point was strictly prohibited under threat of criminal sanctions."
The Pro-Life Action League issued a statement following the decision that, "The pro-life movement scored a huge victory at the Supreme Court today."
Pro-choice groups, however, said they were disappointed. Ilyse Hogue, president of NARAL Pro-Choice America, noted that there has been a long history of violence against women who patronize clinics, and physicians and other clinic workers, with 8 murders and 17 attempted murders since 1991.
"Let’s be clear: Today’s decision puts women and health care providers at greater risk," Ms. Hogue said in a statement.
Megan Amundson, executive director of NARAL Pro-Choice Massachusetts, said that the ruling "turns back the clock to when women were too intimidated to seek medical care," adding that "women’s health will suffer because of it."
Planned Parenthood echoed that position. "This decision shows a troubling level of disregard for American women, who should be able to make carefully considered, private medical decisions without running a gauntlet of harassing and threatening protesters," Cecile Richards, president of Planned Parenthood Federation of America, said in a statement.
"We are taking a close look at this ruling, as well as patient protection laws around the country, to ensure that women can continue to make their own health care decisions without fear of harassment or intimidation," she said.
On Twitter @aliciaault
AT THE U.S. SUPREME COURT
OTC topical acne meds can cause severe reactions
The Food and Drug Administration says that some over-the-counter acne products can cause severe hypersensitivity or allergic reactions and is warning consumers to discontinue use immediately and seek emergency medical attention if they experience such symptoms.
The reactions seem to be on the upswing, according to the agency’s review of reports from 1969 to early 2013.
The agency said in safety announcement that it has not determined whether the reactions are being triggered by the active ingredients in the products – benzoyl peroxide or salicylic acid – or by the inactive ingredients or a combination of the inactive and active ingredients.
The products include Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and private label store brands, and are sold as gels, lotions, face washes, solutions, cleansing pads, toners, and face scrubs, among other products, according to the agency.
The FDA has received reports stating that – within minutes to a day or longer of use – consumers have had hypersensitivity reactions that include throat tightness, difficulty breathing, or swelling of the eyes, face, lips, or tongue. Hives and itching are also indications of an allergic reaction.
From 1969 to January 2013, the agency identified 131 cases of hypersensitivity reactions, with the majority reported in 2012-2013. A total of 86% (113) of the cases were in women, and the reactions were reported in people aged 11-78 years.
There were no deaths, but 58 of the consumers were hospitalized. A total of 38 of the 131 cases (29%) were categorized as anaphylactic reactions, and the remainder were categorized as nonanaphylactic hypersensitivity. Almost half of the consumers said they had discontinued use after the reaction, the majority of whom reported some degree of recovery after discontinuing product use, with final outcomes unavailable for the rest. Four of the patients who used the product again reported a recurrence of the reaction.
The agency is encouraging manufacturers to add directions on testing for hypersensitivity to the labels of all OTC topical acne products. Some labels already include those instructions, which direct users to apply a small amount to one or two small affected areas of the skin for 3 days. If there is no reaction – topical or otherwise – then the product can be used according to the directions.
Consumers are also being urged to avoid using a product if they have previously experienced a hypersensitivity reaction with its use.
The FDA says that physicians should be aware that some topical prescription acne drug products also contain warnings about allergic reactions, including anaphylaxis.
Physicians can report adverse events involving OTC topical acne products to the FDA MedWatch program.
On Twitter @aliciaault
The Food and Drug Administration says that some over-the-counter acne products can cause severe hypersensitivity or allergic reactions and is warning consumers to discontinue use immediately and seek emergency medical attention if they experience such symptoms.
The reactions seem to be on the upswing, according to the agency’s review of reports from 1969 to early 2013.
The agency said in safety announcement that it has not determined whether the reactions are being triggered by the active ingredients in the products – benzoyl peroxide or salicylic acid – or by the inactive ingredients or a combination of the inactive and active ingredients.
The products include Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and private label store brands, and are sold as gels, lotions, face washes, solutions, cleansing pads, toners, and face scrubs, among other products, according to the agency.
The FDA has received reports stating that – within minutes to a day or longer of use – consumers have had hypersensitivity reactions that include throat tightness, difficulty breathing, or swelling of the eyes, face, lips, or tongue. Hives and itching are also indications of an allergic reaction.
From 1969 to January 2013, the agency identified 131 cases of hypersensitivity reactions, with the majority reported in 2012-2013. A total of 86% (113) of the cases were in women, and the reactions were reported in people aged 11-78 years.
There were no deaths, but 58 of the consumers were hospitalized. A total of 38 of the 131 cases (29%) were categorized as anaphylactic reactions, and the remainder were categorized as nonanaphylactic hypersensitivity. Almost half of the consumers said they had discontinued use after the reaction, the majority of whom reported some degree of recovery after discontinuing product use, with final outcomes unavailable for the rest. Four of the patients who used the product again reported a recurrence of the reaction.
The agency is encouraging manufacturers to add directions on testing for hypersensitivity to the labels of all OTC topical acne products. Some labels already include those instructions, which direct users to apply a small amount to one or two small affected areas of the skin for 3 days. If there is no reaction – topical or otherwise – then the product can be used according to the directions.
Consumers are also being urged to avoid using a product if they have previously experienced a hypersensitivity reaction with its use.
The FDA says that physicians should be aware that some topical prescription acne drug products also contain warnings about allergic reactions, including anaphylaxis.
Physicians can report adverse events involving OTC topical acne products to the FDA MedWatch program.
On Twitter @aliciaault
The Food and Drug Administration says that some over-the-counter acne products can cause severe hypersensitivity or allergic reactions and is warning consumers to discontinue use immediately and seek emergency medical attention if they experience such symptoms.
The reactions seem to be on the upswing, according to the agency’s review of reports from 1969 to early 2013.
The agency said in safety announcement that it has not determined whether the reactions are being triggered by the active ingredients in the products – benzoyl peroxide or salicylic acid – or by the inactive ingredients or a combination of the inactive and active ingredients.
The products include Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and private label store brands, and are sold as gels, lotions, face washes, solutions, cleansing pads, toners, and face scrubs, among other products, according to the agency.
The FDA has received reports stating that – within minutes to a day or longer of use – consumers have had hypersensitivity reactions that include throat tightness, difficulty breathing, or swelling of the eyes, face, lips, or tongue. Hives and itching are also indications of an allergic reaction.
From 1969 to January 2013, the agency identified 131 cases of hypersensitivity reactions, with the majority reported in 2012-2013. A total of 86% (113) of the cases were in women, and the reactions were reported in people aged 11-78 years.
There were no deaths, but 58 of the consumers were hospitalized. A total of 38 of the 131 cases (29%) were categorized as anaphylactic reactions, and the remainder were categorized as nonanaphylactic hypersensitivity. Almost half of the consumers said they had discontinued use after the reaction, the majority of whom reported some degree of recovery after discontinuing product use, with final outcomes unavailable for the rest. Four of the patients who used the product again reported a recurrence of the reaction.
The agency is encouraging manufacturers to add directions on testing for hypersensitivity to the labels of all OTC topical acne products. Some labels already include those instructions, which direct users to apply a small amount to one or two small affected areas of the skin for 3 days. If there is no reaction – topical or otherwise – then the product can be used according to the directions.
Consumers are also being urged to avoid using a product if they have previously experienced a hypersensitivity reaction with its use.
The FDA says that physicians should be aware that some topical prescription acne drug products also contain warnings about allergic reactions, including anaphylaxis.
Physicians can report adverse events involving OTC topical acne products to the FDA MedWatch program.
On Twitter @aliciaault
Maintenance of certification took center stage at AMA Congress of Delegates
CHICAGO – The American Medical Association should continue to work with the American Board of Medical Specialties to address physicians’ concerns about Maintenance of Certification – that was the consensus at the annual meeting of the AMA House of Delegates.
The AMA’s delegates defeated a resolution that asked the organization to put a moratorium on MOC until it was proven to improve the quality of care and patient outcomes. However, they did agree to a new policy that directs the AMA to:
• Explore with independent entities the feasibility of conducting a study to evaluate the effect MOC requirements and Maintenance of Licensure principles have on workforce, practice costs, patient outcomes, patient safety, and patient access.
• Work with the American Board of Medical Specialties and its 24 member boards to collect data on why physicians choose to maintain or discontinue their board certification.
• Work with the ABMS and the Federation of State Medical Boards to study whether MOC and the principles of Maintenance of Licensure are important factors to physicians when deciding whether to retire and whether they have a direct effect on workforce.
• Oppose making MOC mandatory as a condition of medical licensure, and encourage physicians to strive constantly to improve their care of patients by the means they find most effective.
The new policy applies to both the ABMS MOC process and the Osteopathic Continuous Certification (OCC) process.
Physicians have increasingly voiced their concerns about MOC. Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif., launched a petition drive to overhaul the American Board of Internal Medicine’s MOC process. The petition has more than 17,000 signatures.
The ABIM says that it is listening to physicians and is making changes in the process, but also recently said that more than 150,000 physicians had participated in its MOC process – making the May 1 deadline to be listed on the ABIM website as having met the MOC criteria.
But anger is still bubbling up, and was expressed at the AMA’s meeting.
"Practicing physicians on the front lines are increasingly burdened, hassled, and confused by the onerous and expensive process of Maintenance of Certification and Maintenance of Licensure," said Dr. James A. Goodyear, a delegate from Pennsylvania.
Dr. Goodyear introduced the resolution to seek a moratorium on the MOC.
But Dr. Darlyne Menscer, a member of the AMA Council on Medical Education, told the delegates that such a moratorium would put a wedge in the close working relationship the AMA has had with the ABMS. "This is more prescriptive than we can commit to as a council, although we definitely do hear the concerns of the House," added Dr. Menscer.
The AMA has been discussing the concerns about MOC with the ABMS, most recently holding a meeting in Chicago in early June.
Dr. Joshua Cohen, a delegate from the American Academy of Neurology, and a member of the AMA Foundation’s Board of Directors, who attended that meeting, also argued against a moratorium. "It would make it impossible for the AMA to improve the process going forward," said Dr. Cohen.
Dr. Chuck Wilson, a pediatrician and delegate from the North Carolina delegation, also opposed any major change in direction for the AMA. He noted that if the AMA was seen as opposed to MOC, it might not be viewed well. "We all want it to be less onerous," said Dr. Wilson. But, he noted, "the Council on Medical Education is working in that direction. Let’s give them a chance to be successful."
In a statement after the HOD meeting, the AMA said that it "continues to ensure the MOC process does not disrupt physician practice or reduce the capacity of the overall physician workforce." Concerns about MOC "center around the need for relevance to the daily practice of physicians and the better integration into physician practices to optimally support learning and improvement."
On Twitter @aliciaault
CHICAGO – The American Medical Association should continue to work with the American Board of Medical Specialties to address physicians’ concerns about Maintenance of Certification – that was the consensus at the annual meeting of the AMA House of Delegates.
The AMA’s delegates defeated a resolution that asked the organization to put a moratorium on MOC until it was proven to improve the quality of care and patient outcomes. However, they did agree to a new policy that directs the AMA to:
• Explore with independent entities the feasibility of conducting a study to evaluate the effect MOC requirements and Maintenance of Licensure principles have on workforce, practice costs, patient outcomes, patient safety, and patient access.
• Work with the American Board of Medical Specialties and its 24 member boards to collect data on why physicians choose to maintain or discontinue their board certification.
• Work with the ABMS and the Federation of State Medical Boards to study whether MOC and the principles of Maintenance of Licensure are important factors to physicians when deciding whether to retire and whether they have a direct effect on workforce.
• Oppose making MOC mandatory as a condition of medical licensure, and encourage physicians to strive constantly to improve their care of patients by the means they find most effective.
The new policy applies to both the ABMS MOC process and the Osteopathic Continuous Certification (OCC) process.
Physicians have increasingly voiced their concerns about MOC. Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif., launched a petition drive to overhaul the American Board of Internal Medicine’s MOC process. The petition has more than 17,000 signatures.
The ABIM says that it is listening to physicians and is making changes in the process, but also recently said that more than 150,000 physicians had participated in its MOC process – making the May 1 deadline to be listed on the ABIM website as having met the MOC criteria.
But anger is still bubbling up, and was expressed at the AMA’s meeting.
"Practicing physicians on the front lines are increasingly burdened, hassled, and confused by the onerous and expensive process of Maintenance of Certification and Maintenance of Licensure," said Dr. James A. Goodyear, a delegate from Pennsylvania.
Dr. Goodyear introduced the resolution to seek a moratorium on the MOC.
But Dr. Darlyne Menscer, a member of the AMA Council on Medical Education, told the delegates that such a moratorium would put a wedge in the close working relationship the AMA has had with the ABMS. "This is more prescriptive than we can commit to as a council, although we definitely do hear the concerns of the House," added Dr. Menscer.
The AMA has been discussing the concerns about MOC with the ABMS, most recently holding a meeting in Chicago in early June.
Dr. Joshua Cohen, a delegate from the American Academy of Neurology, and a member of the AMA Foundation’s Board of Directors, who attended that meeting, also argued against a moratorium. "It would make it impossible for the AMA to improve the process going forward," said Dr. Cohen.
Dr. Chuck Wilson, a pediatrician and delegate from the North Carolina delegation, also opposed any major change in direction for the AMA. He noted that if the AMA was seen as opposed to MOC, it might not be viewed well. "We all want it to be less onerous," said Dr. Wilson. But, he noted, "the Council on Medical Education is working in that direction. Let’s give them a chance to be successful."
In a statement after the HOD meeting, the AMA said that it "continues to ensure the MOC process does not disrupt physician practice or reduce the capacity of the overall physician workforce." Concerns about MOC "center around the need for relevance to the daily practice of physicians and the better integration into physician practices to optimally support learning and improvement."
On Twitter @aliciaault
CHICAGO – The American Medical Association should continue to work with the American Board of Medical Specialties to address physicians’ concerns about Maintenance of Certification – that was the consensus at the annual meeting of the AMA House of Delegates.
The AMA’s delegates defeated a resolution that asked the organization to put a moratorium on MOC until it was proven to improve the quality of care and patient outcomes. However, they did agree to a new policy that directs the AMA to:
• Explore with independent entities the feasibility of conducting a study to evaluate the effect MOC requirements and Maintenance of Licensure principles have on workforce, practice costs, patient outcomes, patient safety, and patient access.
• Work with the American Board of Medical Specialties and its 24 member boards to collect data on why physicians choose to maintain or discontinue their board certification.
• Work with the ABMS and the Federation of State Medical Boards to study whether MOC and the principles of Maintenance of Licensure are important factors to physicians when deciding whether to retire and whether they have a direct effect on workforce.
• Oppose making MOC mandatory as a condition of medical licensure, and encourage physicians to strive constantly to improve their care of patients by the means they find most effective.
The new policy applies to both the ABMS MOC process and the Osteopathic Continuous Certification (OCC) process.
Physicians have increasingly voiced their concerns about MOC. Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif., launched a petition drive to overhaul the American Board of Internal Medicine’s MOC process. The petition has more than 17,000 signatures.
The ABIM says that it is listening to physicians and is making changes in the process, but also recently said that more than 150,000 physicians had participated in its MOC process – making the May 1 deadline to be listed on the ABIM website as having met the MOC criteria.
But anger is still bubbling up, and was expressed at the AMA’s meeting.
"Practicing physicians on the front lines are increasingly burdened, hassled, and confused by the onerous and expensive process of Maintenance of Certification and Maintenance of Licensure," said Dr. James A. Goodyear, a delegate from Pennsylvania.
Dr. Goodyear introduced the resolution to seek a moratorium on the MOC.
But Dr. Darlyne Menscer, a member of the AMA Council on Medical Education, told the delegates that such a moratorium would put a wedge in the close working relationship the AMA has had with the ABMS. "This is more prescriptive than we can commit to as a council, although we definitely do hear the concerns of the House," added Dr. Menscer.
The AMA has been discussing the concerns about MOC with the ABMS, most recently holding a meeting in Chicago in early June.
Dr. Joshua Cohen, a delegate from the American Academy of Neurology, and a member of the AMA Foundation’s Board of Directors, who attended that meeting, also argued against a moratorium. "It would make it impossible for the AMA to improve the process going forward," said Dr. Cohen.
Dr. Chuck Wilson, a pediatrician and delegate from the North Carolina delegation, also opposed any major change in direction for the AMA. He noted that if the AMA was seen as opposed to MOC, it might not be viewed well. "We all want it to be less onerous," said Dr. Wilson. But, he noted, "the Council on Medical Education is working in that direction. Let’s give them a chance to be successful."
In a statement after the HOD meeting, the AMA said that it "continues to ensure the MOC process does not disrupt physician practice or reduce the capacity of the overall physician workforce." Concerns about MOC "center around the need for relevance to the daily practice of physicians and the better integration into physician practices to optimally support learning and improvement."
On Twitter @aliciaault
AT THE AMA HOD MEETING
