Medicare’s 2015 outpatient proposal continues focus on bundled pay

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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.

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On Twitter @aliciaault

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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.

[email protected]

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.

[email protected]

On Twitter @aliciaault

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Individualized program improves sleep in preschoolers

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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.

©Mykola Velychko/Fotolia.com
On average, the participants of the study gained an additional 36 minutes of sleep a night.

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.

[email protected]

On Twitter @aliciaault

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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.

©Mykola Velychko/Fotolia.com
On average, the participants of the study gained an additional 36 minutes of sleep a night.

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.

[email protected]

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.

©Mykola Velychko/Fotolia.com
On average, the participants of the study gained an additional 36 minutes of sleep a night.

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.

[email protected]

On Twitter @aliciaault

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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

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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.

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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.

[email protected]

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.

[email protected]

On Twitter @aliciaault

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Supreme Court: Companies can deny contraceptive coverage

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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.

Alicia Ault/Frontline Medical News
The Supreme Court decision in the Hobby Lobby/Conestoga Woodworking case could impact the physician/patient relationship, some critics contend.

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.

[email protected]

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.

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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.

Alicia Ault/Frontline Medical News
The Supreme Court decision in the Hobby Lobby/Conestoga Woodworking case could impact the physician/patient relationship, some critics contend.

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.

[email protected]

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.

Alicia Ault/Frontline Medical News
The Supreme Court decision in the Hobby Lobby/Conestoga Woodworking case could impact the physician/patient relationship, some critics contend.

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.

[email protected]

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.

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Supreme Court strikes down abortion clinic buffer zones

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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.

Alicia Ault/Frontline Medical News
The buffer zone represents a "dramatic intrusion on First Amendment rights," said Chief Justice John Roberts Jr.

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.

[email protected]

On Twitter @aliciaault

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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.

Alicia Ault/Frontline Medical News
The buffer zone represents a "dramatic intrusion on First Amendment rights," said Chief Justice John Roberts Jr.

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.

[email protected]

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.

Alicia Ault/Frontline Medical News
The buffer zone represents a "dramatic intrusion on First Amendment rights," said Chief Justice John Roberts Jr.

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.

[email protected]

On Twitter @aliciaault

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OTC topical acne meds can cause severe reactions

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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.

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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.

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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.

[email protected]

On Twitter @aliciaault

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Maintenance of certification took center stage at AMA Congress of Delegates

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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:

Alicia Ault/Frontline Medical News
The AMA's delegates defeated a resolution to put a moratorium on MOC until it was proven to improve quality of care and patient outcomes.

• 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."

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On Twitter @aliciaault

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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:

Alicia Ault/Frontline Medical News
The AMA's delegates defeated a resolution to put a moratorium on MOC until it was proven to improve quality of care and patient outcomes.

• 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."

[email protected]

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:

Alicia Ault/Frontline Medical News
The AMA's delegates defeated a resolution to put a moratorium on MOC until it was proven to improve quality of care and patient outcomes.

• 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."

[email protected]

On Twitter @aliciaault

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House subcommittee OKs sunscreen ingredient proposal

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The Health subcommittee of the House Energy & Commerce Committee unanimously advanced a proposal to make it easier for manufacturers to get new sunscreen ingredients approved by the Food and Drug Administration.

The subcommittee approved the legislation, the Sunscreen Innovation Act (H.R. 4250) on June 19. It has now been referred to the full Energy & Commerce Committee for approval.

One of the bill’s cosponsors, Rep. Ed Whitfield (R-Ky.) said that too many potentially innovative ingredients were languishing at the FDA, including at least one that had been there for a decade. "The American public is being denied effective sunscreen products that have been used safely overseas for years," said Rep. Whitfield, at a mark-up of the legislation.

He said that two outside advocacy groups – the Public Access To SunScreens (PASS) Coalition, a partnership of health organizations, sunscreen ingredient companies, and citizens, and the Environmental Working Group – had been instrumental in crafting the legislation and making sure there was an agreement that would satisfy manufacturers and also protect the public’s health.

Energy & Commerce Committee Chairman Fred Upton (R-Mich.) said in a statement submitted for the record that "it is unacceptable that the FDA has not approved a new sunscreen ingredient in nearly 2 decades." He said this was especially a problem given that there is now "a much better understanding of the deadly consequences of excessive sun exposure."

The Sunscreen Innovation Act would overhaul the reviews and approval process, said Rep. Upton.

Members of the committee are still hashing out some issues on the legislation, including timeframes for FDA review of pending and new applications. Rep. Henry Waxman (D-Calif.) said that the review process had led to "unacceptable backlogs" and unnecessary delays, but, he added, "I will not support a bill that sets FDA up for failure by imposing unrealistic timeframes for action."

The full Energy & Commerce Committee has not yet scheduled a date for taking up the bill.

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The Health subcommittee of the House Energy & Commerce Committee unanimously advanced a proposal to make it easier for manufacturers to get new sunscreen ingredients approved by the Food and Drug Administration.

The subcommittee approved the legislation, the Sunscreen Innovation Act (H.R. 4250) on June 19. It has now been referred to the full Energy & Commerce Committee for approval.

One of the bill’s cosponsors, Rep. Ed Whitfield (R-Ky.) said that too many potentially innovative ingredients were languishing at the FDA, including at least one that had been there for a decade. "The American public is being denied effective sunscreen products that have been used safely overseas for years," said Rep. Whitfield, at a mark-up of the legislation.

He said that two outside advocacy groups – the Public Access To SunScreens (PASS) Coalition, a partnership of health organizations, sunscreen ingredient companies, and citizens, and the Environmental Working Group – had been instrumental in crafting the legislation and making sure there was an agreement that would satisfy manufacturers and also protect the public’s health.

Energy & Commerce Committee Chairman Fred Upton (R-Mich.) said in a statement submitted for the record that "it is unacceptable that the FDA has not approved a new sunscreen ingredient in nearly 2 decades." He said this was especially a problem given that there is now "a much better understanding of the deadly consequences of excessive sun exposure."

The Sunscreen Innovation Act would overhaul the reviews and approval process, said Rep. Upton.

Members of the committee are still hashing out some issues on the legislation, including timeframes for FDA review of pending and new applications. Rep. Henry Waxman (D-Calif.) said that the review process had led to "unacceptable backlogs" and unnecessary delays, but, he added, "I will not support a bill that sets FDA up for failure by imposing unrealistic timeframes for action."

The full Energy & Commerce Committee has not yet scheduled a date for taking up the bill.

[email protected]

On Twitter @aliciaault

The Health subcommittee of the House Energy & Commerce Committee unanimously advanced a proposal to make it easier for manufacturers to get new sunscreen ingredients approved by the Food and Drug Administration.

The subcommittee approved the legislation, the Sunscreen Innovation Act (H.R. 4250) on June 19. It has now been referred to the full Energy & Commerce Committee for approval.

One of the bill’s cosponsors, Rep. Ed Whitfield (R-Ky.) said that too many potentially innovative ingredients were languishing at the FDA, including at least one that had been there for a decade. "The American public is being denied effective sunscreen products that have been used safely overseas for years," said Rep. Whitfield, at a mark-up of the legislation.

He said that two outside advocacy groups – the Public Access To SunScreens (PASS) Coalition, a partnership of health organizations, sunscreen ingredient companies, and citizens, and the Environmental Working Group – had been instrumental in crafting the legislation and making sure there was an agreement that would satisfy manufacturers and also protect the public’s health.

Energy & Commerce Committee Chairman Fred Upton (R-Mich.) said in a statement submitted for the record that "it is unacceptable that the FDA has not approved a new sunscreen ingredient in nearly 2 decades." He said this was especially a problem given that there is now "a much better understanding of the deadly consequences of excessive sun exposure."

The Sunscreen Innovation Act would overhaul the reviews and approval process, said Rep. Upton.

Members of the committee are still hashing out some issues on the legislation, including timeframes for FDA review of pending and new applications. Rep. Henry Waxman (D-Calif.) said that the review process had led to "unacceptable backlogs" and unnecessary delays, but, he added, "I will not support a bill that sets FDA up for failure by imposing unrealistic timeframes for action."

The full Energy & Commerce Committee has not yet scheduled a date for taking up the bill.

[email protected]

On Twitter @aliciaault

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AMA defers action on Medicaid pay parity

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CHICAGO – The American Medical Association House of Delegates voted to defer taking action on Medicaid payment policy so that the primary care societies can continue an almost-year-long lobbying effort to convince Congress to extend a Medicaid pay increase.

The pay increase, established under the Affordable Care Act, brings Medicaid pay up to the same level as Medicare reimbursement for eligible primary care physicians. Currently, family physicians, general internists, pediatricians, and subspecialists in those categories are eligible for the pay increase if they are board certified or can show that at least 60% of the codes they submitted to Medicaid in 2012 were for primary care services. The increase expires on Dec. 31.

Alicia Ault/Frontline Medical News
Dr. Reid Blackwelder

At least a year ago, the American Academy of Family Physicians, the American College of Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Osteopathic Association struck an agreement to urge Congress to extend the pay increase for at least 2 years, and to add ob.gyns. to the list of eligible specialists, Dr. Reid Blackwelder, president of the AAFP, said at the House of Delegates meeting.

He offered a resolution to the House to include ob.gyns. as eligible, but the amendment led to some confusion.

The AMA Council on Medical Service was already recommending that the AMA advocate for both an extension of the payments and to add ob.gyns. to the eligibility list, as AMA policy recognizes them as a primary care specialty.

Initially, an amendment had been offered suggesting that ob.gyns. would have to meet different requirements to get the increased pay. That upset some delegates. But Dr. Blackwelder said that his amendment would "use the same accepted threshold methodology" as for internists, pediatricians, and family physicians.

Even so, many delegates said they were not in favor of the resolution. Dr. Lisa Egbert, an ob.gyn. on the Council on Medical Service, said that for one, current legislation did not give her specialty an opportunity to receive the pay increase. The Council report gave clear directions on how the AMA could lobby Congress to change that, she said.

Dr. Yul Ejnes

As debate began again the next day, delegates from the AAFP and the ACP retreated from their amendment, and instead asked that it, along with any AMA action on the pay parity issue, be deferred. They noted the ongoing joint effort by the AAFP, ACP, AAP, and ACOG to help persuade Congress that pay parity needed to be extended.

The four societies sent a letter to Senate Finance Committee leaders Ron Wyden (D-Ore.) and Orrin Hatch (R-Utah) and House Energy & Commerce Committee leaders Fred Upton (R-Mich.) and Henry Waxman (D-Calif.) on May 21, seeking the 2-year extension and also to add ob.gyns.

On June 10, it was resent to the same legislators with 16 additional signatories including other osteopathic organizations, the Society of Hospital Medicine, and the Children’s Hospital Association.

Dr. Yul Ejnes, an ACP delegate and a previous ACP board chairman, urged the AMA delegates to defer action. Otherwise, "it would be injurious to [our] effort, as well as to our AMA, if this body came out with different policy that contradicted what the four organizations are trying to do," said Dr. Ejnes.

AAFP Board Chair Jeffrey Cain agreed. "It would be injurious to the AMA’s reputation to come out against the four groups representing primary care on Capitol Hill," he said.

The delegates voted 223-174 to put off action, referring the amendments and the Council’s report for study by the AMA’s Board of Trustees.

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CHICAGO – The American Medical Association House of Delegates voted to defer taking action on Medicaid payment policy so that the primary care societies can continue an almost-year-long lobbying effort to convince Congress to extend a Medicaid pay increase.

The pay increase, established under the Affordable Care Act, brings Medicaid pay up to the same level as Medicare reimbursement for eligible primary care physicians. Currently, family physicians, general internists, pediatricians, and subspecialists in those categories are eligible for the pay increase if they are board certified or can show that at least 60% of the codes they submitted to Medicaid in 2012 were for primary care services. The increase expires on Dec. 31.

Alicia Ault/Frontline Medical News
Dr. Reid Blackwelder

At least a year ago, the American Academy of Family Physicians, the American College of Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Osteopathic Association struck an agreement to urge Congress to extend the pay increase for at least 2 years, and to add ob.gyns. to the list of eligible specialists, Dr. Reid Blackwelder, president of the AAFP, said at the House of Delegates meeting.

He offered a resolution to the House to include ob.gyns. as eligible, but the amendment led to some confusion.

The AMA Council on Medical Service was already recommending that the AMA advocate for both an extension of the payments and to add ob.gyns. to the eligibility list, as AMA policy recognizes them as a primary care specialty.

Initially, an amendment had been offered suggesting that ob.gyns. would have to meet different requirements to get the increased pay. That upset some delegates. But Dr. Blackwelder said that his amendment would "use the same accepted threshold methodology" as for internists, pediatricians, and family physicians.

Even so, many delegates said they were not in favor of the resolution. Dr. Lisa Egbert, an ob.gyn. on the Council on Medical Service, said that for one, current legislation did not give her specialty an opportunity to receive the pay increase. The Council report gave clear directions on how the AMA could lobby Congress to change that, she said.

Dr. Yul Ejnes

As debate began again the next day, delegates from the AAFP and the ACP retreated from their amendment, and instead asked that it, along with any AMA action on the pay parity issue, be deferred. They noted the ongoing joint effort by the AAFP, ACP, AAP, and ACOG to help persuade Congress that pay parity needed to be extended.

The four societies sent a letter to Senate Finance Committee leaders Ron Wyden (D-Ore.) and Orrin Hatch (R-Utah) and House Energy & Commerce Committee leaders Fred Upton (R-Mich.) and Henry Waxman (D-Calif.) on May 21, seeking the 2-year extension and also to add ob.gyns.

On June 10, it was resent to the same legislators with 16 additional signatories including other osteopathic organizations, the Society of Hospital Medicine, and the Children’s Hospital Association.

Dr. Yul Ejnes, an ACP delegate and a previous ACP board chairman, urged the AMA delegates to defer action. Otherwise, "it would be injurious to [our] effort, as well as to our AMA, if this body came out with different policy that contradicted what the four organizations are trying to do," said Dr. Ejnes.

AAFP Board Chair Jeffrey Cain agreed. "It would be injurious to the AMA’s reputation to come out against the four groups representing primary care on Capitol Hill," he said.

The delegates voted 223-174 to put off action, referring the amendments and the Council’s report for study by the AMA’s Board of Trustees.

[email protected]

On Twitter @aliciaault

CHICAGO – The American Medical Association House of Delegates voted to defer taking action on Medicaid payment policy so that the primary care societies can continue an almost-year-long lobbying effort to convince Congress to extend a Medicaid pay increase.

The pay increase, established under the Affordable Care Act, brings Medicaid pay up to the same level as Medicare reimbursement for eligible primary care physicians. Currently, family physicians, general internists, pediatricians, and subspecialists in those categories are eligible for the pay increase if they are board certified or can show that at least 60% of the codes they submitted to Medicaid in 2012 were for primary care services. The increase expires on Dec. 31.

Alicia Ault/Frontline Medical News
Dr. Reid Blackwelder

At least a year ago, the American Academy of Family Physicians, the American College of Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Osteopathic Association struck an agreement to urge Congress to extend the pay increase for at least 2 years, and to add ob.gyns. to the list of eligible specialists, Dr. Reid Blackwelder, president of the AAFP, said at the House of Delegates meeting.

He offered a resolution to the House to include ob.gyns. as eligible, but the amendment led to some confusion.

The AMA Council on Medical Service was already recommending that the AMA advocate for both an extension of the payments and to add ob.gyns. to the eligibility list, as AMA policy recognizes them as a primary care specialty.

Initially, an amendment had been offered suggesting that ob.gyns. would have to meet different requirements to get the increased pay. That upset some delegates. But Dr. Blackwelder said that his amendment would "use the same accepted threshold methodology" as for internists, pediatricians, and family physicians.

Even so, many delegates said they were not in favor of the resolution. Dr. Lisa Egbert, an ob.gyn. on the Council on Medical Service, said that for one, current legislation did not give her specialty an opportunity to receive the pay increase. The Council report gave clear directions on how the AMA could lobby Congress to change that, she said.

Dr. Yul Ejnes

As debate began again the next day, delegates from the AAFP and the ACP retreated from their amendment, and instead asked that it, along with any AMA action on the pay parity issue, be deferred. They noted the ongoing joint effort by the AAFP, ACP, AAP, and ACOG to help persuade Congress that pay parity needed to be extended.

The four societies sent a letter to Senate Finance Committee leaders Ron Wyden (D-Ore.) and Orrin Hatch (R-Utah) and House Energy & Commerce Committee leaders Fred Upton (R-Mich.) and Henry Waxman (D-Calif.) on May 21, seeking the 2-year extension and also to add ob.gyns.

On June 10, it was resent to the same legislators with 16 additional signatories including other osteopathic organizations, the Society of Hospital Medicine, and the Children’s Hospital Association.

Dr. Yul Ejnes, an ACP delegate and a previous ACP board chairman, urged the AMA delegates to defer action. Otherwise, "it would be injurious to [our] effort, as well as to our AMA, if this body came out with different policy that contradicted what the four organizations are trying to do," said Dr. Ejnes.

AAFP Board Chair Jeffrey Cain agreed. "It would be injurious to the AMA’s reputation to come out against the four groups representing primary care on Capitol Hill," he said.

The delegates voted 223-174 to put off action, referring the amendments and the Council’s report for study by the AMA’s Board of Trustees.

[email protected]

On Twitter @aliciaault

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AAP launching initiative to address toxic stress

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WASHINGTON – The American Academy of Pediatrics is starting a new initiative that aims to help physicians, researchers, educators, legislators, and parents address the impact of toxic stress on children.

The Center on Healthy, Resilient Children will collect and disseminate the latest scientific evidence on brain health and development and ways to prevent toxic stress. It will also help pediatricians and others identify children who have experienced adversity and then steer them to appropriate supports.

Alicia Ault/Frontline Medical News
Dr. Robert Block

Toxic stress is defined as strong, frequent, and/or prolonged adversity such as physical or emotional abuse, chronic neglect, caregiver substance abuse or mental illness, exposure to violence, and the accumulated burden of economic hardship, according to the Harvard University Center on the Developing Child.

Children in those situations who do not have adequate adult support can develop a prolonged activation of the stress response system, which can disrupt the brain’s development and increase the risk for stress-related disease and cognitive impairment, even into adulthood.

In 2012, the AAP outlined a call to action on toxic stress (Pediatrics 2012;129:e224-e231). The Center is a way to disseminate the policy and translate it into practice, said Dr. V. Fan Tait, AAP associate executive director, and director of its department of Child Health and Wellness. It will coordinate the work of all the AAP sections and committees, and reach out to government agencies and private organizations to help find the gaps, develop tools to address poverty, link with scientists, and encourage, also, said Dr. Tait, a pediatric neurologist.

"There needs to be a change in the climate, in our own communities, in our states, and in the way our nation approaches the antecedents of health issues and the antecedents of child wellbeing issues, which are all intimately connected," said Dr. Robert Block, a past president of the AAP who will serve as the medical director of the new center.

Intervening early will help foster an overall healthier society, he said.

"All adults once were children. Who we are, who the adults are, are heavily influenced by what happens in childhood," said Dr. Block, a professor of pediatrics at the University of Oklahoma.

To address toxic stress, pediatricians can first examine ecology of a child’s environment – that is, ask about family life or screen children who might be at high risk of adversity, he said.

There is no perfect screen right now, said Dr. Andrew Garner, chair of the AAP Early Brain and Child Development Leadership Work Group. Instead of focusing on the child’s behavior or dysfunction, pediatricians can "look upstream," said Dr. Garner of the department of pediatrics at Case Western Reserve University, Cleveland, and lead author of the toxic stress paper in Pediatrics.

Even if there is no specific intervention to offer, "We can always demystify, we can always destigmatize, and we can always provide support," Dr. Garner said.

Clinicians also need tools to help teach children the skills to adapt to stress "in a healthy manner as opposed to a maladaptive manner," he said. The goal is not to "put kids in a bubble," but to "actively build resilience."

The resiliency center will also promote the patient-centered medical home as a model to help pediatricians link to other health providers or resources that can aid their patients and families, said Dr. James Perrin, AAP president.

It is clear that the fee-for-service model won’t be the ideal for comprehensively addressing toxic stress, said Dr. Perrin.

Seeking payment for the additional effort may be in the cards, Dr. Tait added.

The center can help give pediatricians what they need to disrupt the handing down of behavioral and health care woes from generation to generation, said Dr. Perrin. "It’s an epic journey, it’s a critically important journey for all of us, and it begins today," he said.

[email protected]

On Twitter @aliciaault

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WASHINGTON – The American Academy of Pediatrics is starting a new initiative that aims to help physicians, researchers, educators, legislators, and parents address the impact of toxic stress on children.

The Center on Healthy, Resilient Children will collect and disseminate the latest scientific evidence on brain health and development and ways to prevent toxic stress. It will also help pediatricians and others identify children who have experienced adversity and then steer them to appropriate supports.

Alicia Ault/Frontline Medical News
Dr. Robert Block

Toxic stress is defined as strong, frequent, and/or prolonged adversity such as physical or emotional abuse, chronic neglect, caregiver substance abuse or mental illness, exposure to violence, and the accumulated burden of economic hardship, according to the Harvard University Center on the Developing Child.

Children in those situations who do not have adequate adult support can develop a prolonged activation of the stress response system, which can disrupt the brain’s development and increase the risk for stress-related disease and cognitive impairment, even into adulthood.

In 2012, the AAP outlined a call to action on toxic stress (Pediatrics 2012;129:e224-e231). The Center is a way to disseminate the policy and translate it into practice, said Dr. V. Fan Tait, AAP associate executive director, and director of its department of Child Health and Wellness. It will coordinate the work of all the AAP sections and committees, and reach out to government agencies and private organizations to help find the gaps, develop tools to address poverty, link with scientists, and encourage, also, said Dr. Tait, a pediatric neurologist.

"There needs to be a change in the climate, in our own communities, in our states, and in the way our nation approaches the antecedents of health issues and the antecedents of child wellbeing issues, which are all intimately connected," said Dr. Robert Block, a past president of the AAP who will serve as the medical director of the new center.

Intervening early will help foster an overall healthier society, he said.

"All adults once were children. Who we are, who the adults are, are heavily influenced by what happens in childhood," said Dr. Block, a professor of pediatrics at the University of Oklahoma.

To address toxic stress, pediatricians can first examine ecology of a child’s environment – that is, ask about family life or screen children who might be at high risk of adversity, he said.

There is no perfect screen right now, said Dr. Andrew Garner, chair of the AAP Early Brain and Child Development Leadership Work Group. Instead of focusing on the child’s behavior or dysfunction, pediatricians can "look upstream," said Dr. Garner of the department of pediatrics at Case Western Reserve University, Cleveland, and lead author of the toxic stress paper in Pediatrics.

Even if there is no specific intervention to offer, "We can always demystify, we can always destigmatize, and we can always provide support," Dr. Garner said.

Clinicians also need tools to help teach children the skills to adapt to stress "in a healthy manner as opposed to a maladaptive manner," he said. The goal is not to "put kids in a bubble," but to "actively build resilience."

The resiliency center will also promote the patient-centered medical home as a model to help pediatricians link to other health providers or resources that can aid their patients and families, said Dr. James Perrin, AAP president.

It is clear that the fee-for-service model won’t be the ideal for comprehensively addressing toxic stress, said Dr. Perrin.

Seeking payment for the additional effort may be in the cards, Dr. Tait added.

The center can help give pediatricians what they need to disrupt the handing down of behavioral and health care woes from generation to generation, said Dr. Perrin. "It’s an epic journey, it’s a critically important journey for all of us, and it begins today," he said.

[email protected]

On Twitter @aliciaault

WASHINGTON – The American Academy of Pediatrics is starting a new initiative that aims to help physicians, researchers, educators, legislators, and parents address the impact of toxic stress on children.

The Center on Healthy, Resilient Children will collect and disseminate the latest scientific evidence on brain health and development and ways to prevent toxic stress. It will also help pediatricians and others identify children who have experienced adversity and then steer them to appropriate supports.

Alicia Ault/Frontline Medical News
Dr. Robert Block

Toxic stress is defined as strong, frequent, and/or prolonged adversity such as physical or emotional abuse, chronic neglect, caregiver substance abuse or mental illness, exposure to violence, and the accumulated burden of economic hardship, according to the Harvard University Center on the Developing Child.

Children in those situations who do not have adequate adult support can develop a prolonged activation of the stress response system, which can disrupt the brain’s development and increase the risk for stress-related disease and cognitive impairment, even into adulthood.

In 2012, the AAP outlined a call to action on toxic stress (Pediatrics 2012;129:e224-e231). The Center is a way to disseminate the policy and translate it into practice, said Dr. V. Fan Tait, AAP associate executive director, and director of its department of Child Health and Wellness. It will coordinate the work of all the AAP sections and committees, and reach out to government agencies and private organizations to help find the gaps, develop tools to address poverty, link with scientists, and encourage, also, said Dr. Tait, a pediatric neurologist.

"There needs to be a change in the climate, in our own communities, in our states, and in the way our nation approaches the antecedents of health issues and the antecedents of child wellbeing issues, which are all intimately connected," said Dr. Robert Block, a past president of the AAP who will serve as the medical director of the new center.

Intervening early will help foster an overall healthier society, he said.

"All adults once were children. Who we are, who the adults are, are heavily influenced by what happens in childhood," said Dr. Block, a professor of pediatrics at the University of Oklahoma.

To address toxic stress, pediatricians can first examine ecology of a child’s environment – that is, ask about family life or screen children who might be at high risk of adversity, he said.

There is no perfect screen right now, said Dr. Andrew Garner, chair of the AAP Early Brain and Child Development Leadership Work Group. Instead of focusing on the child’s behavior or dysfunction, pediatricians can "look upstream," said Dr. Garner of the department of pediatrics at Case Western Reserve University, Cleveland, and lead author of the toxic stress paper in Pediatrics.

Even if there is no specific intervention to offer, "We can always demystify, we can always destigmatize, and we can always provide support," Dr. Garner said.

Clinicians also need tools to help teach children the skills to adapt to stress "in a healthy manner as opposed to a maladaptive manner," he said. The goal is not to "put kids in a bubble," but to "actively build resilience."

The resiliency center will also promote the patient-centered medical home as a model to help pediatricians link to other health providers or resources that can aid their patients and families, said Dr. James Perrin, AAP president.

It is clear that the fee-for-service model won’t be the ideal for comprehensively addressing toxic stress, said Dr. Perrin.

Seeking payment for the additional effort may be in the cards, Dr. Tait added.

The center can help give pediatricians what they need to disrupt the handing down of behavioral and health care woes from generation to generation, said Dr. Perrin. "It’s an epic journey, it’s a critically important journey for all of us, and it begins today," he said.

[email protected]

On Twitter @aliciaault

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