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Senate panel considers bill to overturn state restrictions on abortion
WASHINGTON – Senate Democrats are pushing a bill to overturn most state restrictions on abortion services.
The Women's Health Protection Act (S. 1696) was introduced last November by Sen. Richard Blumenthal (D-Conn.) and was the subject of a Judiciary Committee hearing July 15. At press time, the bill had 35 cosponsors – 34 Democrats and Sen. Bernie Sanders (I-Vt.).
The American Congress of Obstetricians and Gynecologists submitted written testimony in support of the bill. Dr. Hal Lawrence III, executive vice president and CEO, said that many state laws "put physicians in the terrible predicament of either adhering to medical ethics by providing high-quality care that’s in the best interest of their patients, or facing legal punishments which may include fines, loss of licensure, and even jail time."
Among those he cited were laws that restrict the use of or prescribe potentially outdated clinical protocols for medication abortions, laws that prohibit the use of telemedicine to assist in medication abortions, laws that require abortion providers to have admitting privileges at local hospitals, and laws that require tests and procedures that are not medically necessary.
S. 1696 would overturn such state laws, and also ones that specify office setup, equipment, staffing, and hospital transfer arrangements; require medically unnecessary visits before an abortion; or limit training for abortion services.
The law also would declare illegal any restrictions on when an abortion provider could choose to perform the procedure.
Pro-life organizations and physicians said the proposed legislation would actually strip away protections for women.
"This bill would not protect the rights of patients because it would remove the rights of states to regulate the practice of medicine," said Dr. Monique Chireau, a board member of Americans United for Life who is also with the department of obstetrics and gynecology at Duke University, Durham, N.C. She also said that it "would endanger freedom of conscience."
The bill "seeks to strip away from elected lawmakers the ability to provide even the most minimal protections for unborn children, at any stage of their prenatal development," said Carol Tobias, president of the National Right to Life Committee. She said the proposed legislation was "sweeping and extreme" and that "calling the bill the ‘Abortion Without Limits Until Birth Act’ would be more in line with truth-in-advertising standards."
Dr. Willie Parker, who provides abortion services at the Jackson (Miss.) Women’s Health Organization, said that a state law in Mississippi – if it stands – will effectively shut the clinic because it restricts the provision of abortion to ob.gyns. with local hospital admitting privileges. He flies from Chicago to provide the services, and is a plaintiff in a suit challenging the Mississippi law.
Abortion services should be provided because the state has high teen and unintended pregnancy rates, high infant mortality rates, high maternal mortality rates, and a high poverty rate, he said. "We know that when women have access to abortion, contraception, and medically accurate sex education, they thrive," he said. "It should be the same for all women, no matter where they live."
It’s unclear whether the Senate will take up the bill. There is a companion bill in the House, H.R. 3471, which was introduced by Rep. Judy Chu (D-Calif.) and was cosponsored by 124 Democrats at press time.
On Twitter @aliciaault
WASHINGTON – Senate Democrats are pushing a bill to overturn most state restrictions on abortion services.
The Women's Health Protection Act (S. 1696) was introduced last November by Sen. Richard Blumenthal (D-Conn.) and was the subject of a Judiciary Committee hearing July 15. At press time, the bill had 35 cosponsors – 34 Democrats and Sen. Bernie Sanders (I-Vt.).
The American Congress of Obstetricians and Gynecologists submitted written testimony in support of the bill. Dr. Hal Lawrence III, executive vice president and CEO, said that many state laws "put physicians in the terrible predicament of either adhering to medical ethics by providing high-quality care that’s in the best interest of their patients, or facing legal punishments which may include fines, loss of licensure, and even jail time."
Among those he cited were laws that restrict the use of or prescribe potentially outdated clinical protocols for medication abortions, laws that prohibit the use of telemedicine to assist in medication abortions, laws that require abortion providers to have admitting privileges at local hospitals, and laws that require tests and procedures that are not medically necessary.
S. 1696 would overturn such state laws, and also ones that specify office setup, equipment, staffing, and hospital transfer arrangements; require medically unnecessary visits before an abortion; or limit training for abortion services.
The law also would declare illegal any restrictions on when an abortion provider could choose to perform the procedure.
Pro-life organizations and physicians said the proposed legislation would actually strip away protections for women.
"This bill would not protect the rights of patients because it would remove the rights of states to regulate the practice of medicine," said Dr. Monique Chireau, a board member of Americans United for Life who is also with the department of obstetrics and gynecology at Duke University, Durham, N.C. She also said that it "would endanger freedom of conscience."
The bill "seeks to strip away from elected lawmakers the ability to provide even the most minimal protections for unborn children, at any stage of their prenatal development," said Carol Tobias, president of the National Right to Life Committee. She said the proposed legislation was "sweeping and extreme" and that "calling the bill the ‘Abortion Without Limits Until Birth Act’ would be more in line with truth-in-advertising standards."
Dr. Willie Parker, who provides abortion services at the Jackson (Miss.) Women’s Health Organization, said that a state law in Mississippi – if it stands – will effectively shut the clinic because it restricts the provision of abortion to ob.gyns. with local hospital admitting privileges. He flies from Chicago to provide the services, and is a plaintiff in a suit challenging the Mississippi law.
Abortion services should be provided because the state has high teen and unintended pregnancy rates, high infant mortality rates, high maternal mortality rates, and a high poverty rate, he said. "We know that when women have access to abortion, contraception, and medically accurate sex education, they thrive," he said. "It should be the same for all women, no matter where they live."
It’s unclear whether the Senate will take up the bill. There is a companion bill in the House, H.R. 3471, which was introduced by Rep. Judy Chu (D-Calif.) and was cosponsored by 124 Democrats at press time.
On Twitter @aliciaault
WASHINGTON – Senate Democrats are pushing a bill to overturn most state restrictions on abortion services.
The Women's Health Protection Act (S. 1696) was introduced last November by Sen. Richard Blumenthal (D-Conn.) and was the subject of a Judiciary Committee hearing July 15. At press time, the bill had 35 cosponsors – 34 Democrats and Sen. Bernie Sanders (I-Vt.).
The American Congress of Obstetricians and Gynecologists submitted written testimony in support of the bill. Dr. Hal Lawrence III, executive vice president and CEO, said that many state laws "put physicians in the terrible predicament of either adhering to medical ethics by providing high-quality care that’s in the best interest of their patients, or facing legal punishments which may include fines, loss of licensure, and even jail time."
Among those he cited were laws that restrict the use of or prescribe potentially outdated clinical protocols for medication abortions, laws that prohibit the use of telemedicine to assist in medication abortions, laws that require abortion providers to have admitting privileges at local hospitals, and laws that require tests and procedures that are not medically necessary.
S. 1696 would overturn such state laws, and also ones that specify office setup, equipment, staffing, and hospital transfer arrangements; require medically unnecessary visits before an abortion; or limit training for abortion services.
The law also would declare illegal any restrictions on when an abortion provider could choose to perform the procedure.
Pro-life organizations and physicians said the proposed legislation would actually strip away protections for women.
"This bill would not protect the rights of patients because it would remove the rights of states to regulate the practice of medicine," said Dr. Monique Chireau, a board member of Americans United for Life who is also with the department of obstetrics and gynecology at Duke University, Durham, N.C. She also said that it "would endanger freedom of conscience."
The bill "seeks to strip away from elected lawmakers the ability to provide even the most minimal protections for unborn children, at any stage of their prenatal development," said Carol Tobias, president of the National Right to Life Committee. She said the proposed legislation was "sweeping and extreme" and that "calling the bill the ‘Abortion Without Limits Until Birth Act’ would be more in line with truth-in-advertising standards."
Dr. Willie Parker, who provides abortion services at the Jackson (Miss.) Women’s Health Organization, said that a state law in Mississippi – if it stands – will effectively shut the clinic because it restricts the provision of abortion to ob.gyns. with local hospital admitting privileges. He flies from Chicago to provide the services, and is a plaintiff in a suit challenging the Mississippi law.
Abortion services should be provided because the state has high teen and unintended pregnancy rates, high infant mortality rates, high maternal mortality rates, and a high poverty rate, he said. "We know that when women have access to abortion, contraception, and medically accurate sex education, they thrive," he said. "It should be the same for all women, no matter where they live."
It’s unclear whether the Senate will take up the bill. There is a companion bill in the House, H.R. 3471, which was introduced by Rep. Judy Chu (D-Calif.) and was cosponsored by 124 Democrats at press time.
On Twitter @aliciaault
AT A SENATE COMMITTEE HEARING
Physician groups take closer look at telemedicine
Medical societies are joining the call for better support for telemedicine, stating that when appropriately used, it can help address physician shortages and improve quality of care.
The American Medical Association’s policy-making body – the House of Delegates – approved a set of guiding principles at its annual meeting in June, including the following:
• A physician should have a valid face-to-face relationship with the patient before telemedicine services are provided, except in the instance of on-call or cross-coverage situations.
• Those who deliver telemedicine services must abide by state practice and licensure laws and should be licensed in the state where the patient receives services.
• Delivery of services should be consistent with in-person services in scope and standards and follow evidence-based practice guidelines.
• Services should be documented, including providing a visit summary to the patient and a copy of the record sent to a primary or referring physician.
"We believe that a patient-physician relationship must be established to ensure proper diagnoses and appropriate follow-up care," AMA President Robert M. Wah said in a statement. "This new policy establishes a foundation for physicians to utilize telemedicine to help maintain an ongoing relationship with their patients, and as a means to enhance follow-up care, better coordinate care and manage chronic conditions."
The AMA delegates also called for a study of the issues associated with the state-based licensure and the portability of state licensure for telemedicine services.
The Federation of State Medical Boards (FSMB) has drafted model legislation that would expedite licensing in multiple states in an effort to address the concerns of medical practices that straddle state lines.
Currently, according to the American Telemedicine Association, some states restrict the practice of telemedicine across state borders, while others have varying license requirements. The FSMB is hoping to complete a final draft of the model legislation within a few months; it will then work to convince state legislatures to adopt the model.
The American Academy of Neurology also seeks a streamlined licensing process, according to a recent position paper.
The AAN weighed in on telemedicine partly because neurologists are increasingly including the service as part of their practices, most often in emergency stroke care and other acute neurologic conditions. It also is being employed more often for treatment of chronic conditions, including migraines and epilepsy, according to the paper.
The policy also calls for clear liability policies. "The decision to administer or not administer thrombolysis for acute stroke is a prominent source of malpractice claims for neurologists, and telemedicine physicians managing acute stroke patients may be exposed to complex liability issues," the AAN said in the statement. Both physicians and patients need to be protected, it noted.
The organization also called for reimbursement that’s on par with traditional services.
The American Academy of Family Physicians recently said in a letter to members of the House Energy & Commerce Subcommittee on Health that, while it agrees with removing barriers to delivering telemedicine across state lines, it opposes a federal license. It is backing the FSMB process.
Payment Issues
More private insurers are starting to cover telemedicine, with 21 states and Washington, D.C., requiring coverage of the service and reimbursement on par with in-person visits, according to the American Telemedicine Association: Arizona, California, Colorado, Georgia, Hawaii, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, Montana, New Hampshire, New Mexico, Oklahoma, Oregon, Tennessee, Texas, Vermont, Virginia.
Five states – Massachusetts, Michigan, North Dakota, Pennsylvania, and South Dakota – do not allow out-of-state physician-to-physician consultations.
Licensure requirements vary. Maryland, New York, Virginia, and Washington, D.C., have licensure reciprocity for bordering states.
Ten states – Alabama, Louisiana, Minnesota, Montana, Nevada, New Mexico, Ohio, Oregon, Tennessee, and Texas – allow physicians to practice with a conditional license or a specific telemedicine license.
Medicaid coverage varies on a state-by-state basis but is better than Medicare in many states, according to the ATA. Medicare only pays for telemedicine services if a beneficiary lives in a rural Health Professional Shortage area; several additional requirements must be met:
• The service must be furnished via an interactive telecommunications system, which is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.
• The practitioner furnishing the service must meet the telehealth requirements, as well as the usual Medicare requirements.
• The individual receiving the services must be in an eligible "originating" site.
Medicare then pays a fee to the originating site and a separate fee to the distant site practitioner.
Family physicians’ offices are "ideally suited" to be originating sites for the delivery of telemedicine, according to the AAFP, but the current originating site fee ($24.63) doesn’t begin to cover the investment needed to ensure that telemedicine equipment is in compliance with the Health Insurance Portability and Accountability Act (HIPAA). The originating site also should be defined broadly, so that the patient’s home can be considered one of the eligible telemedicine sites, according to the academy.
The Telehealth Enhancement Act of 2013 (H.R. 3306) would expand the definition to include all critical access and sole community hospitals and home-based video services for hospice care, home dialysis, and homebound beneficiaries. The AAFP said that it supports the bill, which was introduced by Rep. Gregg Harper (R-Miss.), Rep. Mike Thompson (D-Calif.), Rep. Devin Nunes (R-Calif.), and Rep. Peter Welch (D-Vt.). The bill has no companion in the Senate, and no hearings have been scheduled.
For 2015, Medicare proposed to expand the types of services it will cover. Barring any changes in the final rule for the 2015 physician fee schedule, Medicare will cover several psychotherapy services, including psychoanalysis (CPT code 90845), family psychotherapy without the patient present (90846), and family psychotherapy with patient present (90847).
The agency also proposes to cover prolonged service in the office or other outpatient setting requiring direct patient contact beyond the usual service (99354 and 99355), and the HCPCS codes G0438 (annual wellness visit; includes a personalized prevention plan of service, initial visit), and G0439, the subsequent annual wellness visit.
Other requests for coverage have been declined by Medicare, including various types of echocardiography interpretation, psychological testing, colposcopy, brief visit to monitor or change medications for mental illness, and urgent dermatologic conditions and wound care.
On Twitter @aliciaault
Medical societies are joining the call for better support for telemedicine, stating that when appropriately used, it can help address physician shortages and improve quality of care.
The American Medical Association’s policy-making body – the House of Delegates – approved a set of guiding principles at its annual meeting in June, including the following:
• A physician should have a valid face-to-face relationship with the patient before telemedicine services are provided, except in the instance of on-call or cross-coverage situations.
• Those who deliver telemedicine services must abide by state practice and licensure laws and should be licensed in the state where the patient receives services.
• Delivery of services should be consistent with in-person services in scope and standards and follow evidence-based practice guidelines.
• Services should be documented, including providing a visit summary to the patient and a copy of the record sent to a primary or referring physician.
"We believe that a patient-physician relationship must be established to ensure proper diagnoses and appropriate follow-up care," AMA President Robert M. Wah said in a statement. "This new policy establishes a foundation for physicians to utilize telemedicine to help maintain an ongoing relationship with their patients, and as a means to enhance follow-up care, better coordinate care and manage chronic conditions."
The AMA delegates also called for a study of the issues associated with the state-based licensure and the portability of state licensure for telemedicine services.
The Federation of State Medical Boards (FSMB) has drafted model legislation that would expedite licensing in multiple states in an effort to address the concerns of medical practices that straddle state lines.
Currently, according to the American Telemedicine Association, some states restrict the practice of telemedicine across state borders, while others have varying license requirements. The FSMB is hoping to complete a final draft of the model legislation within a few months; it will then work to convince state legislatures to adopt the model.
The American Academy of Neurology also seeks a streamlined licensing process, according to a recent position paper.
The AAN weighed in on telemedicine partly because neurologists are increasingly including the service as part of their practices, most often in emergency stroke care and other acute neurologic conditions. It also is being employed more often for treatment of chronic conditions, including migraines and epilepsy, according to the paper.
The policy also calls for clear liability policies. "The decision to administer or not administer thrombolysis for acute stroke is a prominent source of malpractice claims for neurologists, and telemedicine physicians managing acute stroke patients may be exposed to complex liability issues," the AAN said in the statement. Both physicians and patients need to be protected, it noted.
The organization also called for reimbursement that’s on par with traditional services.
The American Academy of Family Physicians recently said in a letter to members of the House Energy & Commerce Subcommittee on Health that, while it agrees with removing barriers to delivering telemedicine across state lines, it opposes a federal license. It is backing the FSMB process.
Payment Issues
More private insurers are starting to cover telemedicine, with 21 states and Washington, D.C., requiring coverage of the service and reimbursement on par with in-person visits, according to the American Telemedicine Association: Arizona, California, Colorado, Georgia, Hawaii, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, Montana, New Hampshire, New Mexico, Oklahoma, Oregon, Tennessee, Texas, Vermont, Virginia.
Five states – Massachusetts, Michigan, North Dakota, Pennsylvania, and South Dakota – do not allow out-of-state physician-to-physician consultations.
Licensure requirements vary. Maryland, New York, Virginia, and Washington, D.C., have licensure reciprocity for bordering states.
Ten states – Alabama, Louisiana, Minnesota, Montana, Nevada, New Mexico, Ohio, Oregon, Tennessee, and Texas – allow physicians to practice with a conditional license or a specific telemedicine license.
Medicaid coverage varies on a state-by-state basis but is better than Medicare in many states, according to the ATA. Medicare only pays for telemedicine services if a beneficiary lives in a rural Health Professional Shortage area; several additional requirements must be met:
• The service must be furnished via an interactive telecommunications system, which is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.
• The practitioner furnishing the service must meet the telehealth requirements, as well as the usual Medicare requirements.
• The individual receiving the services must be in an eligible "originating" site.
Medicare then pays a fee to the originating site and a separate fee to the distant site practitioner.
Family physicians’ offices are "ideally suited" to be originating sites for the delivery of telemedicine, according to the AAFP, but the current originating site fee ($24.63) doesn’t begin to cover the investment needed to ensure that telemedicine equipment is in compliance with the Health Insurance Portability and Accountability Act (HIPAA). The originating site also should be defined broadly, so that the patient’s home can be considered one of the eligible telemedicine sites, according to the academy.
The Telehealth Enhancement Act of 2013 (H.R. 3306) would expand the definition to include all critical access and sole community hospitals and home-based video services for hospice care, home dialysis, and homebound beneficiaries. The AAFP said that it supports the bill, which was introduced by Rep. Gregg Harper (R-Miss.), Rep. Mike Thompson (D-Calif.), Rep. Devin Nunes (R-Calif.), and Rep. Peter Welch (D-Vt.). The bill has no companion in the Senate, and no hearings have been scheduled.
For 2015, Medicare proposed to expand the types of services it will cover. Barring any changes in the final rule for the 2015 physician fee schedule, Medicare will cover several psychotherapy services, including psychoanalysis (CPT code 90845), family psychotherapy without the patient present (90846), and family psychotherapy with patient present (90847).
The agency also proposes to cover prolonged service in the office or other outpatient setting requiring direct patient contact beyond the usual service (99354 and 99355), and the HCPCS codes G0438 (annual wellness visit; includes a personalized prevention plan of service, initial visit), and G0439, the subsequent annual wellness visit.
Other requests for coverage have been declined by Medicare, including various types of echocardiography interpretation, psychological testing, colposcopy, brief visit to monitor or change medications for mental illness, and urgent dermatologic conditions and wound care.
On Twitter @aliciaault
Medical societies are joining the call for better support for telemedicine, stating that when appropriately used, it can help address physician shortages and improve quality of care.
The American Medical Association’s policy-making body – the House of Delegates – approved a set of guiding principles at its annual meeting in June, including the following:
• A physician should have a valid face-to-face relationship with the patient before telemedicine services are provided, except in the instance of on-call or cross-coverage situations.
• Those who deliver telemedicine services must abide by state practice and licensure laws and should be licensed in the state where the patient receives services.
• Delivery of services should be consistent with in-person services in scope and standards and follow evidence-based practice guidelines.
• Services should be documented, including providing a visit summary to the patient and a copy of the record sent to a primary or referring physician.
"We believe that a patient-physician relationship must be established to ensure proper diagnoses and appropriate follow-up care," AMA President Robert M. Wah said in a statement. "This new policy establishes a foundation for physicians to utilize telemedicine to help maintain an ongoing relationship with their patients, and as a means to enhance follow-up care, better coordinate care and manage chronic conditions."
The AMA delegates also called for a study of the issues associated with the state-based licensure and the portability of state licensure for telemedicine services.
The Federation of State Medical Boards (FSMB) has drafted model legislation that would expedite licensing in multiple states in an effort to address the concerns of medical practices that straddle state lines.
Currently, according to the American Telemedicine Association, some states restrict the practice of telemedicine across state borders, while others have varying license requirements. The FSMB is hoping to complete a final draft of the model legislation within a few months; it will then work to convince state legislatures to adopt the model.
The American Academy of Neurology also seeks a streamlined licensing process, according to a recent position paper.
The AAN weighed in on telemedicine partly because neurologists are increasingly including the service as part of their practices, most often in emergency stroke care and other acute neurologic conditions. It also is being employed more often for treatment of chronic conditions, including migraines and epilepsy, according to the paper.
The policy also calls for clear liability policies. "The decision to administer or not administer thrombolysis for acute stroke is a prominent source of malpractice claims for neurologists, and telemedicine physicians managing acute stroke patients may be exposed to complex liability issues," the AAN said in the statement. Both physicians and patients need to be protected, it noted.
The organization also called for reimbursement that’s on par with traditional services.
The American Academy of Family Physicians recently said in a letter to members of the House Energy & Commerce Subcommittee on Health that, while it agrees with removing barriers to delivering telemedicine across state lines, it opposes a federal license. It is backing the FSMB process.
Payment Issues
More private insurers are starting to cover telemedicine, with 21 states and Washington, D.C., requiring coverage of the service and reimbursement on par with in-person visits, according to the American Telemedicine Association: Arizona, California, Colorado, Georgia, Hawaii, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, Montana, New Hampshire, New Mexico, Oklahoma, Oregon, Tennessee, Texas, Vermont, Virginia.
Five states – Massachusetts, Michigan, North Dakota, Pennsylvania, and South Dakota – do not allow out-of-state physician-to-physician consultations.
Licensure requirements vary. Maryland, New York, Virginia, and Washington, D.C., have licensure reciprocity for bordering states.
Ten states – Alabama, Louisiana, Minnesota, Montana, Nevada, New Mexico, Ohio, Oregon, Tennessee, and Texas – allow physicians to practice with a conditional license or a specific telemedicine license.
Medicaid coverage varies on a state-by-state basis but is better than Medicare in many states, according to the ATA. Medicare only pays for telemedicine services if a beneficiary lives in a rural Health Professional Shortage area; several additional requirements must be met:
• The service must be furnished via an interactive telecommunications system, which is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.
• The practitioner furnishing the service must meet the telehealth requirements, as well as the usual Medicare requirements.
• The individual receiving the services must be in an eligible "originating" site.
Medicare then pays a fee to the originating site and a separate fee to the distant site practitioner.
Family physicians’ offices are "ideally suited" to be originating sites for the delivery of telemedicine, according to the AAFP, but the current originating site fee ($24.63) doesn’t begin to cover the investment needed to ensure that telemedicine equipment is in compliance with the Health Insurance Portability and Accountability Act (HIPAA). The originating site also should be defined broadly, so that the patient’s home can be considered one of the eligible telemedicine sites, according to the academy.
The Telehealth Enhancement Act of 2013 (H.R. 3306) would expand the definition to include all critical access and sole community hospitals and home-based video services for hospice care, home dialysis, and homebound beneficiaries. The AAFP said that it supports the bill, which was introduced by Rep. Gregg Harper (R-Miss.), Rep. Mike Thompson (D-Calif.), Rep. Devin Nunes (R-Calif.), and Rep. Peter Welch (D-Vt.). The bill has no companion in the Senate, and no hearings have been scheduled.
For 2015, Medicare proposed to expand the types of services it will cover. Barring any changes in the final rule for the 2015 physician fee schedule, Medicare will cover several psychotherapy services, including psychoanalysis (CPT code 90845), family psychotherapy without the patient present (90846), and family psychotherapy with patient present (90847).
The agency also proposes to cover prolonged service in the office or other outpatient setting requiring direct patient contact beyond the usual service (99354 and 99355), and the HCPCS codes G0438 (annual wellness visit; includes a personalized prevention plan of service, initial visit), and G0439, the subsequent annual wellness visit.
Other requests for coverage have been declined by Medicare, including various types of echocardiography interpretation, psychological testing, colposcopy, brief visit to monitor or change medications for mental illness, and urgent dermatologic conditions and wound care.
On Twitter @aliciaault
House committee says yes to sunscreen ingredient bill
The House Energy & Commerce Committee has approved a bill that aims to speed up Food and Drug Administration approval of new sunscreen ingredients and eliminate the backlog that has kept some ingredients off the market for a decade.
The Sunscreen Innovation Act (H.R. 4250) was approved by the committee on a voice vote. An amendment to establish timeframes for how quickly the FDA must initially review applications and provide final decisions was added by one of the bill’s main sponsors, Rep. Ed Whitfield (R-Ky.).
"We thought it was essential we try to resolve and speed up this approval process while at same time still protecting the health of the American people," said Rep. Whitfield at the meeting convened to vote on the legislation. He said that the timeframes in his amendment had been agreed upon by the FDA, the Public Access to SunScreens (PASS) Coalition, and various manufacturers and consumer advocates.
The bill now would require the FDA to notify the manufacturer within 60 days of submission whether its application was acceptable, or whether more data were needed. It would then allow a public comment period for 45 days. Overall, the FDA would have 300 days to review a new sunscreen ingredient. If the agency deemed it not approvable, it would be required to hold an advisory committee meeting within that 300-day period.
At a June meeting on the legislation, Energy & Commerce Committee chairman Fred Upton (R-Mich.) noted that there had not been a new sunscreen ingredient approved in the United States in 20 years.
Before the full committee vote, Rep. Bob Latta (R-Ohio) said that eight new ingredients had been awaiting review at the FDA for a dozen years and that many of those products were produced in the United States but shipped overseas "because of the regulatory inaction by the FDA." The bill will help eliminate that backlog and bring sunscreens available in foreign markets to America, said Rep. Latta.
The legislation also is "extremely important as melanoma is a prevalent form of cancer in this country," he said, noting a 400% increase in the last several decades. He also noted that Ohio ranks in top 10 states for melanoma deaths in the United States.
"Americans should have access to the best products to protect themselves from this terrible disease," he said.
The bill now awaits the approval of the full House, and then must be approved by the Senate.
The House Energy & Commerce Committee has approved a bill that aims to speed up Food and Drug Administration approval of new sunscreen ingredients and eliminate the backlog that has kept some ingredients off the market for a decade.
The Sunscreen Innovation Act (H.R. 4250) was approved by the committee on a voice vote. An amendment to establish timeframes for how quickly the FDA must initially review applications and provide final decisions was added by one of the bill’s main sponsors, Rep. Ed Whitfield (R-Ky.).
"We thought it was essential we try to resolve and speed up this approval process while at same time still protecting the health of the American people," said Rep. Whitfield at the meeting convened to vote on the legislation. He said that the timeframes in his amendment had been agreed upon by the FDA, the Public Access to SunScreens (PASS) Coalition, and various manufacturers and consumer advocates.
The bill now would require the FDA to notify the manufacturer within 60 days of submission whether its application was acceptable, or whether more data were needed. It would then allow a public comment period for 45 days. Overall, the FDA would have 300 days to review a new sunscreen ingredient. If the agency deemed it not approvable, it would be required to hold an advisory committee meeting within that 300-day period.
At a June meeting on the legislation, Energy & Commerce Committee chairman Fred Upton (R-Mich.) noted that there had not been a new sunscreen ingredient approved in the United States in 20 years.
Before the full committee vote, Rep. Bob Latta (R-Ohio) said that eight new ingredients had been awaiting review at the FDA for a dozen years and that many of those products were produced in the United States but shipped overseas "because of the regulatory inaction by the FDA." The bill will help eliminate that backlog and bring sunscreens available in foreign markets to America, said Rep. Latta.
The legislation also is "extremely important as melanoma is a prevalent form of cancer in this country," he said, noting a 400% increase in the last several decades. He also noted that Ohio ranks in top 10 states for melanoma deaths in the United States.
"Americans should have access to the best products to protect themselves from this terrible disease," he said.
The bill now awaits the approval of the full House, and then must be approved by the Senate.
The House Energy & Commerce Committee has approved a bill that aims to speed up Food and Drug Administration approval of new sunscreen ingredients and eliminate the backlog that has kept some ingredients off the market for a decade.
The Sunscreen Innovation Act (H.R. 4250) was approved by the committee on a voice vote. An amendment to establish timeframes for how quickly the FDA must initially review applications and provide final decisions was added by one of the bill’s main sponsors, Rep. Ed Whitfield (R-Ky.).
"We thought it was essential we try to resolve and speed up this approval process while at same time still protecting the health of the American people," said Rep. Whitfield at the meeting convened to vote on the legislation. He said that the timeframes in his amendment had been agreed upon by the FDA, the Public Access to SunScreens (PASS) Coalition, and various manufacturers and consumer advocates.
The bill now would require the FDA to notify the manufacturer within 60 days of submission whether its application was acceptable, or whether more data were needed. It would then allow a public comment period for 45 days. Overall, the FDA would have 300 days to review a new sunscreen ingredient. If the agency deemed it not approvable, it would be required to hold an advisory committee meeting within that 300-day period.
At a June meeting on the legislation, Energy & Commerce Committee chairman Fred Upton (R-Mich.) noted that there had not been a new sunscreen ingredient approved in the United States in 20 years.
Before the full committee vote, Rep. Bob Latta (R-Ohio) said that eight new ingredients had been awaiting review at the FDA for a dozen years and that many of those products were produced in the United States but shipped overseas "because of the regulatory inaction by the FDA." The bill will help eliminate that backlog and bring sunscreens available in foreign markets to America, said Rep. Latta.
The legislation also is "extremely important as melanoma is a prevalent form of cancer in this country," he said, noting a 400% increase in the last several decades. He also noted that Ohio ranks in top 10 states for melanoma deaths in the United States.
"Americans should have access to the best products to protect themselves from this terrible disease," he said.
The bill now awaits the approval of the full House, and then must be approved by the Senate.
HHS awards more money for innovative care models
The federal government has announced another round of awards to health care organizations that have designed innovative ways to provide better-quality care at a lower cost.
The latest group includes 27 health care organizations, receiving awards of $2 million to $24 million over 3 years.
"The Health Care Innovation Awards support our ongoing work to drive down health care costs while providing high-quality care," Sylvia Mathews Burwell, secretary of the Department of Health & Human Services (HHS), said in a statement. "These awards advance innovative solutions in delivering and improving care from all across our nation."
The awards are funded with up to $1 billion in money authorized by the Affordable Care Act. HHS began seeking awardees in late 2011, soliciting a broad range of proposals. The Centers for Medicare & Medicaid Services Innovation Center ultimately gave out 107 3-year awards in May and June 2012.
HHS started soliciting applicants for a second round of awards last year, this time looking for innovations that would focus on four areas: rapidly reducing costs in the outpatient and postacute setting for patients with Medicare, Medicaid, and/or the Children’s Health Insurance Program; improving care for populations with specialized needs; testing improved financial and clinical models for specific types of providers, including specialists; and models that improve the health of populations – such as a community, or those with specific diseases – through prevention, wellness, and comprehensive care that extends beyond the clinical setting.
The 27 new awardees named on July 9 include:
• $6 million for a care coordination project at the Boston Medical Center that will pair a complex care nurse, a care coordinator, and pediatricians in the community in Boston and Springfield, with the goal of providing a medical home for children with complex conditions.
• $10 million for the Detroit Medical Center, which will establish patient-centered medical home clinics next to emergency departments (EDs) at four inner-city hospitals, in an attempt to make primary care immediately available to patients seeking nonurgent care. The initial focus will be on improving diabetes or asthma, and targeting so-called ED superutilizers, who have 10 or more visits a year.
• $15 million for the University of New Mexico Health Sciences Center, Albuquerque, which will expand its 11-hospital telehealth system to 30 hospitals, to test providing remote emergency neurological consultation using inexpensive audiovisual equipment and software.
HHS does not anticipate making any further innovation awards, according to the agency.
Awardees still have to meet certain criteria to receive their funds. Final award notices will be sent in a few months.
On Twitter @aliciaault
The federal government has announced another round of awards to health care organizations that have designed innovative ways to provide better-quality care at a lower cost.
The latest group includes 27 health care organizations, receiving awards of $2 million to $24 million over 3 years.
"The Health Care Innovation Awards support our ongoing work to drive down health care costs while providing high-quality care," Sylvia Mathews Burwell, secretary of the Department of Health & Human Services (HHS), said in a statement. "These awards advance innovative solutions in delivering and improving care from all across our nation."
The awards are funded with up to $1 billion in money authorized by the Affordable Care Act. HHS began seeking awardees in late 2011, soliciting a broad range of proposals. The Centers for Medicare & Medicaid Services Innovation Center ultimately gave out 107 3-year awards in May and June 2012.
HHS started soliciting applicants for a second round of awards last year, this time looking for innovations that would focus on four areas: rapidly reducing costs in the outpatient and postacute setting for patients with Medicare, Medicaid, and/or the Children’s Health Insurance Program; improving care for populations with specialized needs; testing improved financial and clinical models for specific types of providers, including specialists; and models that improve the health of populations – such as a community, or those with specific diseases – through prevention, wellness, and comprehensive care that extends beyond the clinical setting.
The 27 new awardees named on July 9 include:
• $6 million for a care coordination project at the Boston Medical Center that will pair a complex care nurse, a care coordinator, and pediatricians in the community in Boston and Springfield, with the goal of providing a medical home for children with complex conditions.
• $10 million for the Detroit Medical Center, which will establish patient-centered medical home clinics next to emergency departments (EDs) at four inner-city hospitals, in an attempt to make primary care immediately available to patients seeking nonurgent care. The initial focus will be on improving diabetes or asthma, and targeting so-called ED superutilizers, who have 10 or more visits a year.
• $15 million for the University of New Mexico Health Sciences Center, Albuquerque, which will expand its 11-hospital telehealth system to 30 hospitals, to test providing remote emergency neurological consultation using inexpensive audiovisual equipment and software.
HHS does not anticipate making any further innovation awards, according to the agency.
Awardees still have to meet certain criteria to receive their funds. Final award notices will be sent in a few months.
On Twitter @aliciaault
The federal government has announced another round of awards to health care organizations that have designed innovative ways to provide better-quality care at a lower cost.
The latest group includes 27 health care organizations, receiving awards of $2 million to $24 million over 3 years.
"The Health Care Innovation Awards support our ongoing work to drive down health care costs while providing high-quality care," Sylvia Mathews Burwell, secretary of the Department of Health & Human Services (HHS), said in a statement. "These awards advance innovative solutions in delivering and improving care from all across our nation."
The awards are funded with up to $1 billion in money authorized by the Affordable Care Act. HHS began seeking awardees in late 2011, soliciting a broad range of proposals. The Centers for Medicare & Medicaid Services Innovation Center ultimately gave out 107 3-year awards in May and June 2012.
HHS started soliciting applicants for a second round of awards last year, this time looking for innovations that would focus on four areas: rapidly reducing costs in the outpatient and postacute setting for patients with Medicare, Medicaid, and/or the Children’s Health Insurance Program; improving care for populations with specialized needs; testing improved financial and clinical models for specific types of providers, including specialists; and models that improve the health of populations – such as a community, or those with specific diseases – through prevention, wellness, and comprehensive care that extends beyond the clinical setting.
The 27 new awardees named on July 9 include:
• $6 million for a care coordination project at the Boston Medical Center that will pair a complex care nurse, a care coordinator, and pediatricians in the community in Boston and Springfield, with the goal of providing a medical home for children with complex conditions.
• $10 million for the Detroit Medical Center, which will establish patient-centered medical home clinics next to emergency departments (EDs) at four inner-city hospitals, in an attempt to make primary care immediately available to patients seeking nonurgent care. The initial focus will be on improving diabetes or asthma, and targeting so-called ED superutilizers, who have 10 or more visits a year.
• $15 million for the University of New Mexico Health Sciences Center, Albuquerque, which will expand its 11-hospital telehealth system to 30 hospitals, to test providing remote emergency neurological consultation using inexpensive audiovisual equipment and software.
HHS does not anticipate making any further innovation awards, according to the agency.
Awardees still have to meet certain criteria to receive their funds. Final award notices will be sent in a few months.
On Twitter @aliciaault
New push: OSA screen at Medicare introduction
MINNEAPOLIS – The American Academy of Sleep Medicine is pushing to have a simple sleep apnea questionnaire included in the initial Welcome to Medicare preventive care visit.
Including such a screening tool would help identify obstructive sleep apnea (OSA) when patients first join the Medicare program and thus improve the odds of diagnosing and treating the condition, said Dr. Timothy Morgenthaler, president of the AASM. Getting a handle on OSA could also reduce the potential that the beneficiary will develop related chronic conditions, and that will help Medicare curb expenditures, he said.
An estimated 20% of current Medicare beneficiaries have OSA. That number is expected to grow with the rising obesity rates, he said. Untreated OSA can increase the risk of hypertension, heart disease, type 2 diabetes, and stroke, said Dr. Morgenthaler, who is professor of medicine at the Mayo Clinic in Rochester, Minn.
The AASM has been lobbying Congress to include a validated OSA screen in the initial Medicare visit and found sponsors in Rep. Michael Burgess (R-Tex.) and Rep. Bobby Rush (D-Ill.). In May, the two congressmen introduced a bill (H.R. 4695) that would do just that.
"This important legislation addresses the barriers that prevent new Medicare beneficiaries from receiving what we know to be required sleep apnea services," Dr. Morgenthaler said at the annual meeting of the Associated Professional Sleep Societies.
Rep. Erik Paulsen (R-Minn.), who recently signed on to the bill as a cosponsor, told AASM attendees that adding an OSA screen to the initial Medicare visit would help increase detection of disease, raise patient awareness, and "improve health care quality and reduce costs to the Medicare program," over the long term.
The AASM is asking its members to back the legislation and educate local lawmakers and patients through the group’s Seniors Sleep Campaign. The association also wants to make it easier for board-certified sleep medicine specialists to care for Medicare patients from start to finish, including durable medical equipment such as continuous positive airway pressure devices.
Currently, antikickback laws prevent sleep specialists and sleep centers from directly providing therapeutic durable medical equipment to Medicare patients, said Dr. Morgenthaler.
The AASM has developed model language for an exception to that statute, which it hopes legislators or regulators will approve, he said.
Eliminating the current fragmented system of care would eliminate waste, simplify the work flow, and improve the quality of care and reduce costs, said Dr. Morgenthaler.
Dr. Krishna Sundar, FCCP, comments: This is a bold definitive step from AASM to highlight benefit of early recognition of obstructive sleep apnea.
Given the high prevalence of OSA and how it interfaces with a variety of chronic problems, this push to screen Medicare recipients underscores the need for understanding of the impact that treating sleep-disordered breathing affords in this population by reducing health care costs and morbidity from chronic disease.
Dr. Krishna Sundar, FCCP, comments: This is a bold definitive step from AASM to highlight benefit of early recognition of obstructive sleep apnea.
Given the high prevalence of OSA and how it interfaces with a variety of chronic problems, this push to screen Medicare recipients underscores the need for understanding of the impact that treating sleep-disordered breathing affords in this population by reducing health care costs and morbidity from chronic disease.
Dr. Krishna Sundar, FCCP, comments: This is a bold definitive step from AASM to highlight benefit of early recognition of obstructive sleep apnea.
Given the high prevalence of OSA and how it interfaces with a variety of chronic problems, this push to screen Medicare recipients underscores the need for understanding of the impact that treating sleep-disordered breathing affords in this population by reducing health care costs and morbidity from chronic disease.
MINNEAPOLIS – The American Academy of Sleep Medicine is pushing to have a simple sleep apnea questionnaire included in the initial Welcome to Medicare preventive care visit.
Including such a screening tool would help identify obstructive sleep apnea (OSA) when patients first join the Medicare program and thus improve the odds of diagnosing and treating the condition, said Dr. Timothy Morgenthaler, president of the AASM. Getting a handle on OSA could also reduce the potential that the beneficiary will develop related chronic conditions, and that will help Medicare curb expenditures, he said.
An estimated 20% of current Medicare beneficiaries have OSA. That number is expected to grow with the rising obesity rates, he said. Untreated OSA can increase the risk of hypertension, heart disease, type 2 diabetes, and stroke, said Dr. Morgenthaler, who is professor of medicine at the Mayo Clinic in Rochester, Minn.
The AASM has been lobbying Congress to include a validated OSA screen in the initial Medicare visit and found sponsors in Rep. Michael Burgess (R-Tex.) and Rep. Bobby Rush (D-Ill.). In May, the two congressmen introduced a bill (H.R. 4695) that would do just that.
"This important legislation addresses the barriers that prevent new Medicare beneficiaries from receiving what we know to be required sleep apnea services," Dr. Morgenthaler said at the annual meeting of the Associated Professional Sleep Societies.
Rep. Erik Paulsen (R-Minn.), who recently signed on to the bill as a cosponsor, told AASM attendees that adding an OSA screen to the initial Medicare visit would help increase detection of disease, raise patient awareness, and "improve health care quality and reduce costs to the Medicare program," over the long term.
The AASM is asking its members to back the legislation and educate local lawmakers and patients through the group’s Seniors Sleep Campaign. The association also wants to make it easier for board-certified sleep medicine specialists to care for Medicare patients from start to finish, including durable medical equipment such as continuous positive airway pressure devices.
Currently, antikickback laws prevent sleep specialists and sleep centers from directly providing therapeutic durable medical equipment to Medicare patients, said Dr. Morgenthaler.
The AASM has developed model language for an exception to that statute, which it hopes legislators or regulators will approve, he said.
Eliminating the current fragmented system of care would eliminate waste, simplify the work flow, and improve the quality of care and reduce costs, said Dr. Morgenthaler.
MINNEAPOLIS – The American Academy of Sleep Medicine is pushing to have a simple sleep apnea questionnaire included in the initial Welcome to Medicare preventive care visit.
Including such a screening tool would help identify obstructive sleep apnea (OSA) when patients first join the Medicare program and thus improve the odds of diagnosing and treating the condition, said Dr. Timothy Morgenthaler, president of the AASM. Getting a handle on OSA could also reduce the potential that the beneficiary will develop related chronic conditions, and that will help Medicare curb expenditures, he said.
An estimated 20% of current Medicare beneficiaries have OSA. That number is expected to grow with the rising obesity rates, he said. Untreated OSA can increase the risk of hypertension, heart disease, type 2 diabetes, and stroke, said Dr. Morgenthaler, who is professor of medicine at the Mayo Clinic in Rochester, Minn.
The AASM has been lobbying Congress to include a validated OSA screen in the initial Medicare visit and found sponsors in Rep. Michael Burgess (R-Tex.) and Rep. Bobby Rush (D-Ill.). In May, the two congressmen introduced a bill (H.R. 4695) that would do just that.
"This important legislation addresses the barriers that prevent new Medicare beneficiaries from receiving what we know to be required sleep apnea services," Dr. Morgenthaler said at the annual meeting of the Associated Professional Sleep Societies.
Rep. Erik Paulsen (R-Minn.), who recently signed on to the bill as a cosponsor, told AASM attendees that adding an OSA screen to the initial Medicare visit would help increase detection of disease, raise patient awareness, and "improve health care quality and reduce costs to the Medicare program," over the long term.
The AASM is asking its members to back the legislation and educate local lawmakers and patients through the group’s Seniors Sleep Campaign. The association also wants to make it easier for board-certified sleep medicine specialists to care for Medicare patients from start to finish, including durable medical equipment such as continuous positive airway pressure devices.
Currently, antikickback laws prevent sleep specialists and sleep centers from directly providing therapeutic durable medical equipment to Medicare patients, said Dr. Morgenthaler.
The AASM has developed model language for an exception to that statute, which it hopes legislators or regulators will approve, he said.
Eliminating the current fragmented system of care would eliminate waste, simplify the work flow, and improve the quality of care and reduce costs, said Dr. Morgenthaler.
FROM THE ANNUAL MEETING OF THE ASSOCIATED PROFESSIONAL SLEEP SOCIETIES
FDA Approves Blood Test for Membranous Glomerulonephritis
The Food and Drug Administration has approved a noninvasive test to determine whether a chronic kidney disease is caused by an autoimmune disease or another cause such as infection.
The EUROIMMUN Anti- PLA2R IFA blood test detects an antibody that is specific to primary membranous glomerulonephritis (pMGN). MGN, a chronic kidney disease, damages the glomeruli; it can lead to kidney failure and transplant. Symptoms include swelling, hypercholesterolemia, hypertension, and an increased predisposition to blood clots.
The condition mostly affects white men. It occurs in 2 of every 10,000 people and is more common after age 40, according to the National Library of Medicine. Risk factors include cancers, especially lung and colon cancer; exposure to toxins, including gold and mercury; infections, including hepatitis B, malaria, syphilis, and endocarditis; certain medications, including penicillamine, trimethadione, and skin-lightening creams; and systemic lupus erythematosus, rheumatoid arthritis, Graves’ disease, and other autoimmune disorders.
"Treatment of MGN depends on the underlying cause of the disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "This test can help patients get a timely diagnosis for their MGN and aid with earlier treatment."
Test manufacturer EUROIMMUN US submitted data that compared 275 blood samples from patients with presumed pMGN, with 285 samples from patients diagnosed with other kidney diseases including secondary MGN (sMGN) and autoimmune diseases. The test detected pMGN in 77% of the presumed pMGN samples, and gave a false-positive result in less than 1% of the other samples.
The diagnostic test helped distinguish pMGN from sMGN in most of the patients.
The FDA said that the test should not be used alone to diagnose pMGN, but that patients’ symptoms and other laboratory test results should also be considered. A kidney biopsy is required for confirmation, according to the FDA.
On Twitter @aliciaault
The Food and Drug Administration has approved a noninvasive test to determine whether a chronic kidney disease is caused by an autoimmune disease or another cause such as infection.
The EUROIMMUN Anti- PLA2R IFA blood test detects an antibody that is specific to primary membranous glomerulonephritis (pMGN). MGN, a chronic kidney disease, damages the glomeruli; it can lead to kidney failure and transplant. Symptoms include swelling, hypercholesterolemia, hypertension, and an increased predisposition to blood clots.
The condition mostly affects white men. It occurs in 2 of every 10,000 people and is more common after age 40, according to the National Library of Medicine. Risk factors include cancers, especially lung and colon cancer; exposure to toxins, including gold and mercury; infections, including hepatitis B, malaria, syphilis, and endocarditis; certain medications, including penicillamine, trimethadione, and skin-lightening creams; and systemic lupus erythematosus, rheumatoid arthritis, Graves’ disease, and other autoimmune disorders.
"Treatment of MGN depends on the underlying cause of the disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "This test can help patients get a timely diagnosis for their MGN and aid with earlier treatment."
Test manufacturer EUROIMMUN US submitted data that compared 275 blood samples from patients with presumed pMGN, with 285 samples from patients diagnosed with other kidney diseases including secondary MGN (sMGN) and autoimmune diseases. The test detected pMGN in 77% of the presumed pMGN samples, and gave a false-positive result in less than 1% of the other samples.
The diagnostic test helped distinguish pMGN from sMGN in most of the patients.
The FDA said that the test should not be used alone to diagnose pMGN, but that patients’ symptoms and other laboratory test results should also be considered. A kidney biopsy is required for confirmation, according to the FDA.
On Twitter @aliciaault
The Food and Drug Administration has approved a noninvasive test to determine whether a chronic kidney disease is caused by an autoimmune disease or another cause such as infection.
The EUROIMMUN Anti- PLA2R IFA blood test detects an antibody that is specific to primary membranous glomerulonephritis (pMGN). MGN, a chronic kidney disease, damages the glomeruli; it can lead to kidney failure and transplant. Symptoms include swelling, hypercholesterolemia, hypertension, and an increased predisposition to blood clots.
The condition mostly affects white men. It occurs in 2 of every 10,000 people and is more common after age 40, according to the National Library of Medicine. Risk factors include cancers, especially lung and colon cancer; exposure to toxins, including gold and mercury; infections, including hepatitis B, malaria, syphilis, and endocarditis; certain medications, including penicillamine, trimethadione, and skin-lightening creams; and systemic lupus erythematosus, rheumatoid arthritis, Graves’ disease, and other autoimmune disorders.
"Treatment of MGN depends on the underlying cause of the disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "This test can help patients get a timely diagnosis for their MGN and aid with earlier treatment."
Test manufacturer EUROIMMUN US submitted data that compared 275 blood samples from patients with presumed pMGN, with 285 samples from patients diagnosed with other kidney diseases including secondary MGN (sMGN) and autoimmune diseases. The test detected pMGN in 77% of the presumed pMGN samples, and gave a false-positive result in less than 1% of the other samples.
The diagnostic test helped distinguish pMGN from sMGN in most of the patients.
The FDA said that the test should not be used alone to diagnose pMGN, but that patients’ symptoms and other laboratory test results should also be considered. A kidney biopsy is required for confirmation, according to the FDA.
On Twitter @aliciaault
Medicare’s 2015 outpatient proposal continues focus on bundled pay
The Centers for Medicare and Medicaid Services’ proposed rule on outpatient department and ambulatory surgery center payment for 2015 expands the agency’s focus on bundling pay for device-related procedures, largely in cardiology, neurology, oncology, and gynecology.
The Hospital Outpatient Prospective Payment System (OPPS) rule also continues the same payment rate for outpatient drug delivery such as chemotherapy. That payment rate has been a source of disappointment for oncologists. The American Society of Clinical Oncology has said in the past that, with the additional impact of budget sequestration, the actual payment for delivering chemotherapy drugs falls by 28%.
The agency is proposing again in 2015 to continue paying average sales price plus 6% for non–pass through drugs and biologicals that are administered under Part B of Medicare.
Proposed on July 3, the rule will be published on July 14. It covers payment for 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals. It also applies to 5,300 ambulatory surgery centers (ASCs) that participate in Medicare.
Overall, the government is proposing to increase payments to outpatient departments by 2%. The CMS expects to pay out some $57 billion for outpatient services in 2015. Payments to ASCs will increase just over 1% to $4 billion in 2015.
The agency is proposing to expand its Comprehensive Ambulatory Payment Classification (APC) policy, which was first discussed in its 2014 rule. The idea is to give a single Medicare payment and require a single beneficiary copayment for the entire hospital stay for a group of 28 procedures, including pacemaker insertion, implantation of neurostimulators, and stereotactic radiosurgery. It also would cover implantable cardioverter defibrillators.
The single, bundled payments would begin in 2015.
The proposed rule also contains several adjustments to both the Hospital Outpatient Quality Reporting Program and the ASC Quality Reporting Program. On the hospital side, the CMS is proposing to remove three quality measures, stating that performance has been uniformly high among reporting facilities. Those measures are aspirin at arrival (cardiac care), timing of prophylaxis antibiotics, and prophylactic antibiotic selection for surgical patients. The agency is proposing to add a claims-based measure – facility 7-day risk-standardized hospital visit rate after outpatient colonoscopy – for 2017 and beyond.
For ASCs, the agency is proposing to continue its effort to align measures with the hospital program. In 2015, ASCs will be required to report on the 7-day risk-standardized visit rate after outpatient colonoscopy measure.
The CMS is accepting comments on the proposed rule until Sept. 2, 2014. A final rule will be issued by Nov. 1.
On Twitter @aliciaault
The Centers for Medicare and Medicaid Services’ proposed rule on outpatient department and ambulatory surgery center payment for 2015 expands the agency’s focus on bundling pay for device-related procedures, largely in cardiology, neurology, oncology, and gynecology.
The Hospital Outpatient Prospective Payment System (OPPS) rule also continues the same payment rate for outpatient drug delivery such as chemotherapy. That payment rate has been a source of disappointment for oncologists. The American Society of Clinical Oncology has said in the past that, with the additional impact of budget sequestration, the actual payment for delivering chemotherapy drugs falls by 28%.
The agency is proposing again in 2015 to continue paying average sales price plus 6% for non–pass through drugs and biologicals that are administered under Part B of Medicare.
Proposed on July 3, the rule will be published on July 14. It covers payment for 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals. It also applies to 5,300 ambulatory surgery centers (ASCs) that participate in Medicare.
Overall, the government is proposing to increase payments to outpatient departments by 2%. The CMS expects to pay out some $57 billion for outpatient services in 2015. Payments to ASCs will increase just over 1% to $4 billion in 2015.
The agency is proposing to expand its Comprehensive Ambulatory Payment Classification (APC) policy, which was first discussed in its 2014 rule. The idea is to give a single Medicare payment and require a single beneficiary copayment for the entire hospital stay for a group of 28 procedures, including pacemaker insertion, implantation of neurostimulators, and stereotactic radiosurgery. It also would cover implantable cardioverter defibrillators.
The single, bundled payments would begin in 2015.
The proposed rule also contains several adjustments to both the Hospital Outpatient Quality Reporting Program and the ASC Quality Reporting Program. On the hospital side, the CMS is proposing to remove three quality measures, stating that performance has been uniformly high among reporting facilities. Those measures are aspirin at arrival (cardiac care), timing of prophylaxis antibiotics, and prophylactic antibiotic selection for surgical patients. The agency is proposing to add a claims-based measure – facility 7-day risk-standardized hospital visit rate after outpatient colonoscopy – for 2017 and beyond.
For ASCs, the agency is proposing to continue its effort to align measures with the hospital program. In 2015, ASCs will be required to report on the 7-day risk-standardized visit rate after outpatient colonoscopy measure.
The CMS is accepting comments on the proposed rule until Sept. 2, 2014. A final rule will be issued by Nov. 1.
On Twitter @aliciaault
The Centers for Medicare and Medicaid Services’ proposed rule on outpatient department and ambulatory surgery center payment for 2015 expands the agency’s focus on bundling pay for device-related procedures, largely in cardiology, neurology, oncology, and gynecology.
The Hospital Outpatient Prospective Payment System (OPPS) rule also continues the same payment rate for outpatient drug delivery such as chemotherapy. That payment rate has been a source of disappointment for oncologists. The American Society of Clinical Oncology has said in the past that, with the additional impact of budget sequestration, the actual payment for delivering chemotherapy drugs falls by 28%.
The agency is proposing again in 2015 to continue paying average sales price plus 6% for non–pass through drugs and biologicals that are administered under Part B of Medicare.
Proposed on July 3, the rule will be published on July 14. It covers payment for 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals. It also applies to 5,300 ambulatory surgery centers (ASCs) that participate in Medicare.
Overall, the government is proposing to increase payments to outpatient departments by 2%. The CMS expects to pay out some $57 billion for outpatient services in 2015. Payments to ASCs will increase just over 1% to $4 billion in 2015.
The agency is proposing to expand its Comprehensive Ambulatory Payment Classification (APC) policy, which was first discussed in its 2014 rule. The idea is to give a single Medicare payment and require a single beneficiary copayment for the entire hospital stay for a group of 28 procedures, including pacemaker insertion, implantation of neurostimulators, and stereotactic radiosurgery. It also would cover implantable cardioverter defibrillators.
The single, bundled payments would begin in 2015.
The proposed rule also contains several adjustments to both the Hospital Outpatient Quality Reporting Program and the ASC Quality Reporting Program. On the hospital side, the CMS is proposing to remove three quality measures, stating that performance has been uniformly high among reporting facilities. Those measures are aspirin at arrival (cardiac care), timing of prophylaxis antibiotics, and prophylactic antibiotic selection for surgical patients. The agency is proposing to add a claims-based measure – facility 7-day risk-standardized hospital visit rate after outpatient colonoscopy – for 2017 and beyond.
For ASCs, the agency is proposing to continue its effort to align measures with the hospital program. In 2015, ASCs will be required to report on the 7-day risk-standardized visit rate after outpatient colonoscopy measure.
The CMS is accepting comments on the proposed rule until Sept. 2, 2014. A final rule will be issued by Nov. 1.
On Twitter @aliciaault
Individualized program improves sleep in preschoolers
MINNEAPOLIS – Tailoring an intervention to the particular needs of a child and his or her family can markedly improve the child’s ability to go to sleep and stay asleep, a pilot study shows.
The trial was successful enough that the National Institute of Child Health and Development has given the lead researcher, Michelle M. Garrison, Ph.D., of the Seattle Children’s Research Institute, funding to enroll 500 children in a randomized, controlled trial to validate the intervention.
Dr. Garrison undertook the pilot in part to see what would help sleep-deprived and frustrated parents, and pediatricians, who might not have a ready solution for a preschooler who persistently won’t go to bed or won’t stay in bed.
To recruit children for the study, Dr. Garrison sent the CSHQ (Children’s Sleep Habits Questionnaire) to parents of all children aged 2.5-5 years who had been seen at local pediatric clinics. If parents were interested, they returned the survey. If the children met the eligibility criteria for having a behavioral sleep problem, they were included. Not every parent agreed that their child had an issue, which created an initial hurdle for making the intervention work, said Dr. Garrison.
The program started with a home visit, in which parents received education and a kit that included a binder with educational handouts, the book
Take Charge of Your Child's Sleep (New York: Marlowe and Co., 2005), a bedtime routine chart with cards that can be individualized to the child, laminated passes that allow the child to step outside the routine occasionally, and a clock that glows green when it is okay to get out of bed in the morning.
Parents received three follow-up phone calls for education, to set goals, and to engage in preemptive problem solving. Parents were coached on setting bedtime routines, creating a consistent bedtime, eliminating screen time in the hour or two before bed, setting limits, and working on night waking.
The pilot enrolled 36 children with a mean age of about 4 years. Forty-four percent were female and 72% were white, 19% were Asian, 8% were black, and 6% were Hispanic. The race and ethnicity categories were not mutually exclusive, said Dr. Garrison. A total of 22% of children had been adopted after 1 year of age. The mean age of the parents was 38 years. Only 11% of children lived in a one-adult home, and 11% lived in a multigenerational home.
Sleep habits and issues were assessed at baseline and at 3 months through 7-day diaries, actigraphy, and several sleep scales. The researchers were able to perform actigraphy on only 15 children, but there was good concordance between those measures and the diaries, said Dr. Garrison.
Overall, on average, children slept an additional 36 minutes a night. According to the diaries, 14% slept 10-30 minutes more, a third slept 30-60 minutes more, and 25% slept an additional hour. The actigraphy showed that 14% of children gained 10-30 minutes sleep, 36% gained 30-60 minutes, and 7% gained more than an hour. The average onset latency decreased by 10 minutes.
Dr. Garrison said the intervention could be tailored to children and parents with varying needs. For instance, adopted and nonadopted children did equally well with the program. She and her colleagues also worked with co-sleepers. She split them into "reactive" co-sleepers – that is, parents who felt like they had no choice – and "lifestyle" co-sleepers, who saw it as a way to bond. Reactive co-sleepers were coached on getting children to sleep in their own beds. Lifestyle parents were taught how to get children to get to sleep first, before the adults joined them in bed. There was a significant increase in sleep duration in those children of lifestyle co-sleepers, said Dr. Garrison.
Overall, there were no differences observed by age, sex, or comorbid conditions such as asthma.
The things that seemed to help the most included the number of contacts with the families, the tailored bedtime routine, and anticipatory problem solving around bedtime consistency. Parents who were the most skeptical about the benefits of sleep benefited the most from the program, said Dr. Garrison.
She will now take her methods into a larger trial that is being funded by the NICHD and has begun enrolling children. It will include 500 children and families will get monthly phone follow-ups for 9 months. Children will be analyzed for 3 years, in part to see if improving sleep has any impact on body mass index, learning, and cognitive function, she said.
The study was funded by the Sleep Research Society Foundation’s J. Christian Gillin, M.D., Research Grant; the Institution of Translational Health Sciences; and Seattle Children’s Research Institute. Dr. Garrison reported no conflicts.
On Twitter @aliciaault
MINNEAPOLIS – Tailoring an intervention to the particular needs of a child and his or her family can markedly improve the child’s ability to go to sleep and stay asleep, a pilot study shows.
The trial was successful enough that the National Institute of Child Health and Development has given the lead researcher, Michelle M. Garrison, Ph.D., of the Seattle Children’s Research Institute, funding to enroll 500 children in a randomized, controlled trial to validate the intervention.
Dr. Garrison undertook the pilot in part to see what would help sleep-deprived and frustrated parents, and pediatricians, who might not have a ready solution for a preschooler who persistently won’t go to bed or won’t stay in bed.
To recruit children for the study, Dr. Garrison sent the CSHQ (Children’s Sleep Habits Questionnaire) to parents of all children aged 2.5-5 years who had been seen at local pediatric clinics. If parents were interested, they returned the survey. If the children met the eligibility criteria for having a behavioral sleep problem, they were included. Not every parent agreed that their child had an issue, which created an initial hurdle for making the intervention work, said Dr. Garrison.
The program started with a home visit, in which parents received education and a kit that included a binder with educational handouts, the book
Take Charge of Your Child's Sleep (New York: Marlowe and Co., 2005), a bedtime routine chart with cards that can be individualized to the child, laminated passes that allow the child to step outside the routine occasionally, and a clock that glows green when it is okay to get out of bed in the morning.
Parents received three follow-up phone calls for education, to set goals, and to engage in preemptive problem solving. Parents were coached on setting bedtime routines, creating a consistent bedtime, eliminating screen time in the hour or two before bed, setting limits, and working on night waking.
The pilot enrolled 36 children with a mean age of about 4 years. Forty-four percent were female and 72% were white, 19% were Asian, 8% were black, and 6% were Hispanic. The race and ethnicity categories were not mutually exclusive, said Dr. Garrison. A total of 22% of children had been adopted after 1 year of age. The mean age of the parents was 38 years. Only 11% of children lived in a one-adult home, and 11% lived in a multigenerational home.
Sleep habits and issues were assessed at baseline and at 3 months through 7-day diaries, actigraphy, and several sleep scales. The researchers were able to perform actigraphy on only 15 children, but there was good concordance between those measures and the diaries, said Dr. Garrison.
Overall, on average, children slept an additional 36 minutes a night. According to the diaries, 14% slept 10-30 minutes more, a third slept 30-60 minutes more, and 25% slept an additional hour. The actigraphy showed that 14% of children gained 10-30 minutes sleep, 36% gained 30-60 minutes, and 7% gained more than an hour. The average onset latency decreased by 10 minutes.
Dr. Garrison said the intervention could be tailored to children and parents with varying needs. For instance, adopted and nonadopted children did equally well with the program. She and her colleagues also worked with co-sleepers. She split them into "reactive" co-sleepers – that is, parents who felt like they had no choice – and "lifestyle" co-sleepers, who saw it as a way to bond. Reactive co-sleepers were coached on getting children to sleep in their own beds. Lifestyle parents were taught how to get children to get to sleep first, before the adults joined them in bed. There was a significant increase in sleep duration in those children of lifestyle co-sleepers, said Dr. Garrison.
Overall, there were no differences observed by age, sex, or comorbid conditions such as asthma.
The things that seemed to help the most included the number of contacts with the families, the tailored bedtime routine, and anticipatory problem solving around bedtime consistency. Parents who were the most skeptical about the benefits of sleep benefited the most from the program, said Dr. Garrison.
She will now take her methods into a larger trial that is being funded by the NICHD and has begun enrolling children. It will include 500 children and families will get monthly phone follow-ups for 9 months. Children will be analyzed for 3 years, in part to see if improving sleep has any impact on body mass index, learning, and cognitive function, she said.
The study was funded by the Sleep Research Society Foundation’s J. Christian Gillin, M.D., Research Grant; the Institution of Translational Health Sciences; and Seattle Children’s Research Institute. Dr. Garrison reported no conflicts.
On Twitter @aliciaault
MINNEAPOLIS – Tailoring an intervention to the particular needs of a child and his or her family can markedly improve the child’s ability to go to sleep and stay asleep, a pilot study shows.
The trial was successful enough that the National Institute of Child Health and Development has given the lead researcher, Michelle M. Garrison, Ph.D., of the Seattle Children’s Research Institute, funding to enroll 500 children in a randomized, controlled trial to validate the intervention.
Dr. Garrison undertook the pilot in part to see what would help sleep-deprived and frustrated parents, and pediatricians, who might not have a ready solution for a preschooler who persistently won’t go to bed or won’t stay in bed.
To recruit children for the study, Dr. Garrison sent the CSHQ (Children’s Sleep Habits Questionnaire) to parents of all children aged 2.5-5 years who had been seen at local pediatric clinics. If parents were interested, they returned the survey. If the children met the eligibility criteria for having a behavioral sleep problem, they were included. Not every parent agreed that their child had an issue, which created an initial hurdle for making the intervention work, said Dr. Garrison.
The program started with a home visit, in which parents received education and a kit that included a binder with educational handouts, the book
Take Charge of Your Child's Sleep (New York: Marlowe and Co., 2005), a bedtime routine chart with cards that can be individualized to the child, laminated passes that allow the child to step outside the routine occasionally, and a clock that glows green when it is okay to get out of bed in the morning.
Parents received three follow-up phone calls for education, to set goals, and to engage in preemptive problem solving. Parents were coached on setting bedtime routines, creating a consistent bedtime, eliminating screen time in the hour or two before bed, setting limits, and working on night waking.
The pilot enrolled 36 children with a mean age of about 4 years. Forty-four percent were female and 72% were white, 19% were Asian, 8% were black, and 6% were Hispanic. The race and ethnicity categories were not mutually exclusive, said Dr. Garrison. A total of 22% of children had been adopted after 1 year of age. The mean age of the parents was 38 years. Only 11% of children lived in a one-adult home, and 11% lived in a multigenerational home.
Sleep habits and issues were assessed at baseline and at 3 months through 7-day diaries, actigraphy, and several sleep scales. The researchers were able to perform actigraphy on only 15 children, but there was good concordance between those measures and the diaries, said Dr. Garrison.
Overall, on average, children slept an additional 36 minutes a night. According to the diaries, 14% slept 10-30 minutes more, a third slept 30-60 minutes more, and 25% slept an additional hour. The actigraphy showed that 14% of children gained 10-30 minutes sleep, 36% gained 30-60 minutes, and 7% gained more than an hour. The average onset latency decreased by 10 minutes.
Dr. Garrison said the intervention could be tailored to children and parents with varying needs. For instance, adopted and nonadopted children did equally well with the program. She and her colleagues also worked with co-sleepers. She split them into "reactive" co-sleepers – that is, parents who felt like they had no choice – and "lifestyle" co-sleepers, who saw it as a way to bond. Reactive co-sleepers were coached on getting children to sleep in their own beds. Lifestyle parents were taught how to get children to get to sleep first, before the adults joined them in bed. There was a significant increase in sleep duration in those children of lifestyle co-sleepers, said Dr. Garrison.
Overall, there were no differences observed by age, sex, or comorbid conditions such as asthma.
The things that seemed to help the most included the number of contacts with the families, the tailored bedtime routine, and anticipatory problem solving around bedtime consistency. Parents who were the most skeptical about the benefits of sleep benefited the most from the program, said Dr. Garrison.
She will now take her methods into a larger trial that is being funded by the NICHD and has begun enrolling children. It will include 500 children and families will get monthly phone follow-ups for 9 months. Children will be analyzed for 3 years, in part to see if improving sleep has any impact on body mass index, learning, and cognitive function, she said.
The study was funded by the Sleep Research Society Foundation’s J. Christian Gillin, M.D., Research Grant; the Institution of Translational Health Sciences; and Seattle Children’s Research Institute. Dr. Garrison reported no conflicts.
On Twitter @aliciaault
FROM SLEEP 2014
Key clinical point: A focused, individualized program can help recalcitrant preschoolers get to sleep and stay asleep.
Major finding: In a pilot study with 36 children, they slept an additional 36 minutes a night with the program.
Data source: The Sleep Health in Preschoolers intervention program, which was conducted in children aged 2.5-5 years over 3 months.
Disclosures: The study was funded by the Sleep Research Society Foundation’s J. Christian Gillin, M.D., Research Grant; the Institution of Translational Health Sciences; and Seattle Children’s Research Institute. Dr. Garrison reported no conflicts.
FDA approves Restylane Silk for plumper lips, smoother mouth
The Food and Drug Administration has approved a new formulation of Restylane, known as Restylane Silk.
The new product was approved for submucosal lip augmentation and correction of perioral rhytids in patients aged 21 years and older. Restylane Silk is a clear, injectable gel composed of a non–animal-based formulation of hyaluronic acid, and it includes 0.3% lidocaine. The lidocaine was added to reduce the discomfort associated with the injectable, according to the manufacturer, Medicis, which is a division of Valeant Pharmaceuticals.
Restylane was first approved by the FDA in 2005 for mid-to-deep dermal implantation to treat moderate to severe facial wrinkles and nasolabial folds. An indication for submucosal lip augmentation was approved in 2011.
The Silk formulation is injected once or twice, as needed, over a 2-week period, and the effect lasts about 6 months, according to the FDA.
Restylane Silk is contraindicated in patients with a history of hypersensitivity or anaphylaxis, or a history of hypersensitivity to lidocaine, or gram-positive bacteria such as Streptococcus. It should not be used in patients with a bleeding disorder.
Safety and effectiveness were gauged in a 221-patient study. Restylane Silk was evaluated in patients with light and dark skin; 52 patients had Fitzpatrick skin types IV and V. The incidence of adverse events in these 52 patients was similar to that in the overall study population, but the safety in patients with Fitzpatrick skin type VI has not been established, said the FDA.
Side effects include bruising, redness, swelling, pain, tenderness, and itching. There were 12 severe events in six study patients; 10 were lip swelling. There were five serious adverse events in three patients.
Valeant said that 98% of study patients reported improvement in their lip fullness 14 days after injection, and 76% still had lip improvement after 6 months.
On Twitter @aliciaault
The Food and Drug Administration has approved a new formulation of Restylane, known as Restylane Silk.
The new product was approved for submucosal lip augmentation and correction of perioral rhytids in patients aged 21 years and older. Restylane Silk is a clear, injectable gel composed of a non–animal-based formulation of hyaluronic acid, and it includes 0.3% lidocaine. The lidocaine was added to reduce the discomfort associated with the injectable, according to the manufacturer, Medicis, which is a division of Valeant Pharmaceuticals.
Restylane was first approved by the FDA in 2005 for mid-to-deep dermal implantation to treat moderate to severe facial wrinkles and nasolabial folds. An indication for submucosal lip augmentation was approved in 2011.
The Silk formulation is injected once or twice, as needed, over a 2-week period, and the effect lasts about 6 months, according to the FDA.
Restylane Silk is contraindicated in patients with a history of hypersensitivity or anaphylaxis, or a history of hypersensitivity to lidocaine, or gram-positive bacteria such as Streptococcus. It should not be used in patients with a bleeding disorder.
Safety and effectiveness were gauged in a 221-patient study. Restylane Silk was evaluated in patients with light and dark skin; 52 patients had Fitzpatrick skin types IV and V. The incidence of adverse events in these 52 patients was similar to that in the overall study population, but the safety in patients with Fitzpatrick skin type VI has not been established, said the FDA.
Side effects include bruising, redness, swelling, pain, tenderness, and itching. There were 12 severe events in six study patients; 10 were lip swelling. There were five serious adverse events in three patients.
Valeant said that 98% of study patients reported improvement in their lip fullness 14 days after injection, and 76% still had lip improvement after 6 months.
On Twitter @aliciaault
The Food and Drug Administration has approved a new formulation of Restylane, known as Restylane Silk.
The new product was approved for submucosal lip augmentation and correction of perioral rhytids in patients aged 21 years and older. Restylane Silk is a clear, injectable gel composed of a non–animal-based formulation of hyaluronic acid, and it includes 0.3% lidocaine. The lidocaine was added to reduce the discomfort associated with the injectable, according to the manufacturer, Medicis, which is a division of Valeant Pharmaceuticals.
Restylane was first approved by the FDA in 2005 for mid-to-deep dermal implantation to treat moderate to severe facial wrinkles and nasolabial folds. An indication for submucosal lip augmentation was approved in 2011.
The Silk formulation is injected once or twice, as needed, over a 2-week period, and the effect lasts about 6 months, according to the FDA.
Restylane Silk is contraindicated in patients with a history of hypersensitivity or anaphylaxis, or a history of hypersensitivity to lidocaine, or gram-positive bacteria such as Streptococcus. It should not be used in patients with a bleeding disorder.
Safety and effectiveness were gauged in a 221-patient study. Restylane Silk was evaluated in patients with light and dark skin; 52 patients had Fitzpatrick skin types IV and V. The incidence of adverse events in these 52 patients was similar to that in the overall study population, but the safety in patients with Fitzpatrick skin type VI has not been established, said the FDA.
Side effects include bruising, redness, swelling, pain, tenderness, and itching. There were 12 severe events in six study patients; 10 were lip swelling. There were five serious adverse events in three patients.
Valeant said that 98% of study patients reported improvement in their lip fullness 14 days after injection, and 76% still had lip improvement after 6 months.
On Twitter @aliciaault
Supreme Court: Companies can deny contraceptive coverage
WASHINGTON – For-profit companies cannot be compelled to provide insurance coverage for contraception if doing so violates the religious beliefs of the company’s owners, the Supreme Court ruled June 30.
Dissenting justices said that it had the potential to allow employers to use their religious beliefs as a way to object to providing coverage for vaccinations, blood transfusions, and other procedures, and that it could open the door to deny employment to certain individuals or groups.
The Court ruled 5-4 in the cases of Burwell v. Hobby Lobby Stores Inc. and Conestoga Wood Specialties Corp. v. Burwell.
Justice Samuel Alito, reading the opinion for the majority, said that the Religious Freedom Restoration Act (RFRA) of 1993 protected the rights of not just individuals, but also of individuals who run closely held for-profit corporations.
The terms of that law "make it perfectly clear that Congress did not discriminate in this way against men and women who wish to run their businesses as for-profit corporations in the manner required by their religious beliefs," according to the opinion signed by Justice Alito, Justice Anthony P. Kennedy, Justice Antonin Scalia, and Justice Clarence Thomas, and Chief Justice John P. Roberts.
The plaintiffs in the cases said that being required by the Affordable Care Act to provide insurance coverage for contraception violated their religious beliefs. In particular, Hobby Lobby and Conestoga Wood both objected to four specific types of contraception that they said interfere with conception and thus constitute abortion: the Ella morning-after pill, the Plan B morning-after pill, and hormonal and copper intrauterine devices (IUDs).
The majority opinion said that by requiring companies that did not comply to pay fines, the government was placing an undue burden on these employers. Justice Alito noted that Hobby Lobby would have to either give up its religious tenets or pay up to $1.3 million a day in fines*.
"If these consequences don’t amount to a heavy burden, I’m not sure what would," he said.
The majority also said that since the government already makes exceptions to the contraception requirement for religious organizations and nonprofit religiously affiliated groups, that it could have made the same allowances for for-profit companies. The government also could have offered to pay for the contraceptives that companies refuse to cover, they said.
Justice Ruth Bader Ginsburg, who read the dissenting opinion, called the majority’s opinion "a decision of startling breadth." If allowed to stand, it could raise what she called "a host of ‘me, too’ questions," such as whether an employer could opt out of coverage for antidepressants, vaccinations, or medications derived from pigs, "based on the employer’s sincerely held religious beliefs opposing those medical practices."
Joined by Justice Stephen G. Breyer, Justice Elena Kagan, and Justice Sonia Sotomayor, she also said that while the ruling might seem to be limited to access to the four contraceptives in the cases, it was likely that companies would seek to deny coverage for all available contraceptive technologies.
The dissenters also said that they doubted that Congress intended for the RFRA to be used to allow a company to stand in between a woman and her physician. Any decision to use a contraceptive "will be the woman’s autonomous choice, informed by the physician she consults," they wrote.
Many physicians’ and women’s health organizations called it a dangerous precedent.
The American College of Obstetricians and Gynecologists President John C. Jennings said in a statement that the group was “profoundly disappointed” in the decision, as it “inappropriately allows employers to interfere in women’s health care decisions.” Dr. Jennings also said that contraceptives should not be treated differently than other health care services for women. “The value of family planning – including contraception – has been clearly demonstrated,” he said. “The ability of a woman to time and space her children reduces infant, child, and maternal morbidity and mortality, and can lead to more optimal health outcomes for mother and for baby.”
Contraception also helps prevent unintended pregnancy, he said, adding, “This is absolutely essential in America, where nearly one half of all pregnancies are unintended.”
In a statement, Dr.Reid Blackwelder, president of the American Academy of Family Physicians, said, "With this decision, the court has moved health care decisions out of the exam room, where patients can consult with their physicians — and where such decisions should be made — and put them into the hands of business owners who base decisions on personal beliefs rather than [on] medical science." Dr. Blackwelder added, "Personal or institutional beliefs should not put Americans’ health and lives at risk, simply because employers control the insurance available to their workers. Unfortunately, the Supreme Court decision opens the gate for just such consequences."
Dr. James M. Perrin, president of the American Academy of Pediatrics, said, "For pediatricians, the science is clear: contraception is a safe, effective tool to prevent unintended pregnancy in young women of any reproductive age. Today, we are disappointed that justice did not side with science."
Some physician groups expressed their support for the decision.
The American Association of Pro-Life Obstetricians and Gynecologists called the ruling a "tremendous victory for all Americans and their freedom of conscience." The group added that it was "hopeful that this recognition of conscientious objection will help to strengthen the rights of physicians to continue to refuse to participate in any medical procedure or to prescribe any drug that is designed and purposed to kill a living human being."
The Christian Medical Association also applauded the decision. In a statement, Dr. David Stevens, CEO, said, "We are very thankful that the Supreme Court acted to protect family businesses from government coercion and fines for simply honoring the tenets of their faith," and called it a "much-needed victory for faith freedoms."
In a joint press briefing, representatives from Planned Parenthood, NARAL, the American Civil Liberties Union, and the National Women’s Law Center said that they would work with Congress to try to reverse the Supreme Court ruling through legislation. The AAP will do the same, said Dr. Perrin.
Some Senate Democrats have said they will prepare legislation to address the case immediately. Sen. Patty Murray (D-Wash.), who filed a friend of the court brief on behalf of 18 Senators that sided with the government’s case, said in a statement that, "Since the Supreme Court decided it will not protect women’s access to health care, I will. In the coming days I will work with my colleagues and the Administration to protect this access, regardless of who signs your paycheck."
Senate Republican leader Mitch McConnell (R-Ky.), however, said that the decision was a validation of religious freedom. "Obamacare is the single worst piece of legislation to pass in the last 50 years, and I was glad to see the Supreme Court agree that this particular Obamacare mandate violates the Religious Freedom Restoration Act," Sen. McConnell said, in a statement.
On Twitter @aliciaault
*Clarification, 7/2/2014: An earlier version of this article did not include the intact quote from the majority opinion.
*This story was updated 7/2/2014.
WASHINGTON – For-profit companies cannot be compelled to provide insurance coverage for contraception if doing so violates the religious beliefs of the company’s owners, the Supreme Court ruled June 30.
Dissenting justices said that it had the potential to allow employers to use their religious beliefs as a way to object to providing coverage for vaccinations, blood transfusions, and other procedures, and that it could open the door to deny employment to certain individuals or groups.
The Court ruled 5-4 in the cases of Burwell v. Hobby Lobby Stores Inc. and Conestoga Wood Specialties Corp. v. Burwell.
Justice Samuel Alito, reading the opinion for the majority, said that the Religious Freedom Restoration Act (RFRA) of 1993 protected the rights of not just individuals, but also of individuals who run closely held for-profit corporations.
The terms of that law "make it perfectly clear that Congress did not discriminate in this way against men and women who wish to run their businesses as for-profit corporations in the manner required by their religious beliefs," according to the opinion signed by Justice Alito, Justice Anthony P. Kennedy, Justice Antonin Scalia, and Justice Clarence Thomas, and Chief Justice John P. Roberts.
The plaintiffs in the cases said that being required by the Affordable Care Act to provide insurance coverage for contraception violated their religious beliefs. In particular, Hobby Lobby and Conestoga Wood both objected to four specific types of contraception that they said interfere with conception and thus constitute abortion: the Ella morning-after pill, the Plan B morning-after pill, and hormonal and copper intrauterine devices (IUDs).
The majority opinion said that by requiring companies that did not comply to pay fines, the government was placing an undue burden on these employers. Justice Alito noted that Hobby Lobby would have to either give up its religious tenets or pay up to $1.3 million a day in fines*.
"If these consequences don’t amount to a heavy burden, I’m not sure what would," he said.
The majority also said that since the government already makes exceptions to the contraception requirement for religious organizations and nonprofit religiously affiliated groups, that it could have made the same allowances for for-profit companies. The government also could have offered to pay for the contraceptives that companies refuse to cover, they said.
Justice Ruth Bader Ginsburg, who read the dissenting opinion, called the majority’s opinion "a decision of startling breadth." If allowed to stand, it could raise what she called "a host of ‘me, too’ questions," such as whether an employer could opt out of coverage for antidepressants, vaccinations, or medications derived from pigs, "based on the employer’s sincerely held religious beliefs opposing those medical practices."
Joined by Justice Stephen G. Breyer, Justice Elena Kagan, and Justice Sonia Sotomayor, she also said that while the ruling might seem to be limited to access to the four contraceptives in the cases, it was likely that companies would seek to deny coverage for all available contraceptive technologies.
The dissenters also said that they doubted that Congress intended for the RFRA to be used to allow a company to stand in between a woman and her physician. Any decision to use a contraceptive "will be the woman’s autonomous choice, informed by the physician she consults," they wrote.
Many physicians’ and women’s health organizations called it a dangerous precedent.
The American College of Obstetricians and Gynecologists President John C. Jennings said in a statement that the group was “profoundly disappointed” in the decision, as it “inappropriately allows employers to interfere in women’s health care decisions.” Dr. Jennings also said that contraceptives should not be treated differently than other health care services for women. “The value of family planning – including contraception – has been clearly demonstrated,” he said. “The ability of a woman to time and space her children reduces infant, child, and maternal morbidity and mortality, and can lead to more optimal health outcomes for mother and for baby.”
Contraception also helps prevent unintended pregnancy, he said, adding, “This is absolutely essential in America, where nearly one half of all pregnancies are unintended.”
In a statement, Dr.Reid Blackwelder, president of the American Academy of Family Physicians, said, "With this decision, the court has moved health care decisions out of the exam room, where patients can consult with their physicians — and where such decisions should be made — and put them into the hands of business owners who base decisions on personal beliefs rather than [on] medical science." Dr. Blackwelder added, "Personal or institutional beliefs should not put Americans’ health and lives at risk, simply because employers control the insurance available to their workers. Unfortunately, the Supreme Court decision opens the gate for just such consequences."
Dr. James M. Perrin, president of the American Academy of Pediatrics, said, "For pediatricians, the science is clear: contraception is a safe, effective tool to prevent unintended pregnancy in young women of any reproductive age. Today, we are disappointed that justice did not side with science."
Some physician groups expressed their support for the decision.
The American Association of Pro-Life Obstetricians and Gynecologists called the ruling a "tremendous victory for all Americans and their freedom of conscience." The group added that it was "hopeful that this recognition of conscientious objection will help to strengthen the rights of physicians to continue to refuse to participate in any medical procedure or to prescribe any drug that is designed and purposed to kill a living human being."
The Christian Medical Association also applauded the decision. In a statement, Dr. David Stevens, CEO, said, "We are very thankful that the Supreme Court acted to protect family businesses from government coercion and fines for simply honoring the tenets of their faith," and called it a "much-needed victory for faith freedoms."
In a joint press briefing, representatives from Planned Parenthood, NARAL, the American Civil Liberties Union, and the National Women’s Law Center said that they would work with Congress to try to reverse the Supreme Court ruling through legislation. The AAP will do the same, said Dr. Perrin.
Some Senate Democrats have said they will prepare legislation to address the case immediately. Sen. Patty Murray (D-Wash.), who filed a friend of the court brief on behalf of 18 Senators that sided with the government’s case, said in a statement that, "Since the Supreme Court decided it will not protect women’s access to health care, I will. In the coming days I will work with my colleagues and the Administration to protect this access, regardless of who signs your paycheck."
Senate Republican leader Mitch McConnell (R-Ky.), however, said that the decision was a validation of religious freedom. "Obamacare is the single worst piece of legislation to pass in the last 50 years, and I was glad to see the Supreme Court agree that this particular Obamacare mandate violates the Religious Freedom Restoration Act," Sen. McConnell said, in a statement.
On Twitter @aliciaault
*Clarification, 7/2/2014: An earlier version of this article did not include the intact quote from the majority opinion.
*This story was updated 7/2/2014.
WASHINGTON – For-profit companies cannot be compelled to provide insurance coverage for contraception if doing so violates the religious beliefs of the company’s owners, the Supreme Court ruled June 30.
Dissenting justices said that it had the potential to allow employers to use their religious beliefs as a way to object to providing coverage for vaccinations, blood transfusions, and other procedures, and that it could open the door to deny employment to certain individuals or groups.
The Court ruled 5-4 in the cases of Burwell v. Hobby Lobby Stores Inc. and Conestoga Wood Specialties Corp. v. Burwell.
Justice Samuel Alito, reading the opinion for the majority, said that the Religious Freedom Restoration Act (RFRA) of 1993 protected the rights of not just individuals, but also of individuals who run closely held for-profit corporations.
The terms of that law "make it perfectly clear that Congress did not discriminate in this way against men and women who wish to run their businesses as for-profit corporations in the manner required by their religious beliefs," according to the opinion signed by Justice Alito, Justice Anthony P. Kennedy, Justice Antonin Scalia, and Justice Clarence Thomas, and Chief Justice John P. Roberts.
The plaintiffs in the cases said that being required by the Affordable Care Act to provide insurance coverage for contraception violated their religious beliefs. In particular, Hobby Lobby and Conestoga Wood both objected to four specific types of contraception that they said interfere with conception and thus constitute abortion: the Ella morning-after pill, the Plan B morning-after pill, and hormonal and copper intrauterine devices (IUDs).
The majority opinion said that by requiring companies that did not comply to pay fines, the government was placing an undue burden on these employers. Justice Alito noted that Hobby Lobby would have to either give up its religious tenets or pay up to $1.3 million a day in fines*.
"If these consequences don’t amount to a heavy burden, I’m not sure what would," he said.
The majority also said that since the government already makes exceptions to the contraception requirement for religious organizations and nonprofit religiously affiliated groups, that it could have made the same allowances for for-profit companies. The government also could have offered to pay for the contraceptives that companies refuse to cover, they said.
Justice Ruth Bader Ginsburg, who read the dissenting opinion, called the majority’s opinion "a decision of startling breadth." If allowed to stand, it could raise what she called "a host of ‘me, too’ questions," such as whether an employer could opt out of coverage for antidepressants, vaccinations, or medications derived from pigs, "based on the employer’s sincerely held religious beliefs opposing those medical practices."
Joined by Justice Stephen G. Breyer, Justice Elena Kagan, and Justice Sonia Sotomayor, she also said that while the ruling might seem to be limited to access to the four contraceptives in the cases, it was likely that companies would seek to deny coverage for all available contraceptive technologies.
The dissenters also said that they doubted that Congress intended for the RFRA to be used to allow a company to stand in between a woman and her physician. Any decision to use a contraceptive "will be the woman’s autonomous choice, informed by the physician she consults," they wrote.
Many physicians’ and women’s health organizations called it a dangerous precedent.
The American College of Obstetricians and Gynecologists President John C. Jennings said in a statement that the group was “profoundly disappointed” in the decision, as it “inappropriately allows employers to interfere in women’s health care decisions.” Dr. Jennings also said that contraceptives should not be treated differently than other health care services for women. “The value of family planning – including contraception – has been clearly demonstrated,” he said. “The ability of a woman to time and space her children reduces infant, child, and maternal morbidity and mortality, and can lead to more optimal health outcomes for mother and for baby.”
Contraception also helps prevent unintended pregnancy, he said, adding, “This is absolutely essential in America, where nearly one half of all pregnancies are unintended.”
In a statement, Dr.Reid Blackwelder, president of the American Academy of Family Physicians, said, "With this decision, the court has moved health care decisions out of the exam room, where patients can consult with their physicians — and where such decisions should be made — and put them into the hands of business owners who base decisions on personal beliefs rather than [on] medical science." Dr. Blackwelder added, "Personal or institutional beliefs should not put Americans’ health and lives at risk, simply because employers control the insurance available to their workers. Unfortunately, the Supreme Court decision opens the gate for just such consequences."
Dr. James M. Perrin, president of the American Academy of Pediatrics, said, "For pediatricians, the science is clear: contraception is a safe, effective tool to prevent unintended pregnancy in young women of any reproductive age. Today, we are disappointed that justice did not side with science."
Some physician groups expressed their support for the decision.
The American Association of Pro-Life Obstetricians and Gynecologists called the ruling a "tremendous victory for all Americans and their freedom of conscience." The group added that it was "hopeful that this recognition of conscientious objection will help to strengthen the rights of physicians to continue to refuse to participate in any medical procedure or to prescribe any drug that is designed and purposed to kill a living human being."
The Christian Medical Association also applauded the decision. In a statement, Dr. David Stevens, CEO, said, "We are very thankful that the Supreme Court acted to protect family businesses from government coercion and fines for simply honoring the tenets of their faith," and called it a "much-needed victory for faith freedoms."
In a joint press briefing, representatives from Planned Parenthood, NARAL, the American Civil Liberties Union, and the National Women’s Law Center said that they would work with Congress to try to reverse the Supreme Court ruling through legislation. The AAP will do the same, said Dr. Perrin.
Some Senate Democrats have said they will prepare legislation to address the case immediately. Sen. Patty Murray (D-Wash.), who filed a friend of the court brief on behalf of 18 Senators that sided with the government’s case, said in a statement that, "Since the Supreme Court decided it will not protect women’s access to health care, I will. In the coming days I will work with my colleagues and the Administration to protect this access, regardless of who signs your paycheck."
Senate Republican leader Mitch McConnell (R-Ky.), however, said that the decision was a validation of religious freedom. "Obamacare is the single worst piece of legislation to pass in the last 50 years, and I was glad to see the Supreme Court agree that this particular Obamacare mandate violates the Religious Freedom Restoration Act," Sen. McConnell said, in a statement.
On Twitter @aliciaault
*Clarification, 7/2/2014: An earlier version of this article did not include the intact quote from the majority opinion.
*This story was updated 7/2/2014.
AT THE U.S. SUPREME COURT
