Just over a year ago, Congress passed and the President signed into law the MACRA legislation, which will serve as the basis for Medicare physician payment beginning in 2019. At the recent Leadership and Advocacy Summit, it became apparent to me that a “refresher” on seven key acronyms would be useful for surgeons as they gear up to understand and effectively participate in this “brave new world” which is rapidly approaching.

Accordingly, let us start at the beginning. MACRA stands for the Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015. As noted above, this legislation, signed into law by President Obama on April 16, 2015, replaces the flawed sustainable growth rate formula and will be the template utilized to determine Medicare physician payment beginning in 2019. However, it is important to note that it is anticipated that the data to be utilized as the basis for payment in 2019 will likely be collected sometime in 2017.

MACRA provides modest but stable positive updates of 0.5 percent/year for the 5-year period of 2015-2019. Fellows may remember that this provision was included in the legislation as a direct result of objections made by the leadership of the ACS to the original draft legislation, which contained no provision for a positive update. In addition, MACRA provides for the elimination, after 2018, of the current-law penalties associated with the existing Medicare quality programs, including the PQRS (Physician Quality Reporting System), the VBM (Value-Based Modifier) program and the EHR-MU (Electronic Health Record–Meaningful Use) program. That said, and as outlined below, we will not be saying goodbye to these programs completely. Accordingly, surgeons need to remain, or become, familiar with those acronyms and the programs they represent.

MACRA has two payment pathways. Physicians will choose to participate in one or the other. Those choices are: 1) MIPS (Merit-based Incentive Payment System) and 2) APMs (Alternative Payment Models).

Beginning in 2019, the PQRS (Physician Quality Reporting System), the VBM (Value-Based Modifier) program and the EHR-MU (Electronic Health Record–Meaningful Use) program will be combined into MIPS (Merit-based Incentive Payment System). In this program, it is possible for all surgeons to receive an annual positive update based on their individual performance in the four categories of Quality, Resource Use, Electronic Health Record–Meaningful Use, and lastly the newly created category of Clinical Practice Improvement Activities (CPIA).

Individual surgeons’ performance in the four categories will be combined into a composite score. Each individual composite score will then be compared with a performance threshold. The threshold will be set as either the mean or median of the composite performance scores for all MIPS-eligible professionals from a prior performance period. The threshold will reset every year. Those with an individual composite performance score above the threshold will receive a positive payment adjustment while those with an individual composite performance score below the threshold will receive a negative payment adjustment.

The Quality component of the MIPS will consist of quality measures currently used in existing quality performance programs namely, the PQRS (Physician Quality Reporting System), the VBM (Value-Based Modifier program), and EHR-MU (Electronic Health Record–Meaningful Use), as well as measures developed by stakeholders to meet the needs of specialties lacking meaningful measures in the current programs. The RESOURCE USE component of MIPS will include the cost measures used in the current VBM (Value-Based Modifier) program. With regard to the Electronic Health Record–Meaningful Use (EHR-MU) component of MIPS, current EHR-MU requirements will continue to apply but are expected to be modified significantly. ACS continues to advocate for changes to the EHR-MU program to make it easier for surgeons to comply with requirements. Evidence of the effectiveness of our advocacy in this area is found in the success achieved in obtaining a blanket exception for the 2015 reporting period, Stage 2 Meaningful Use rule about which I wrote in the December 2015 and January 2016 editions of this column.

The CPIA (Clinical Practice Improvement Activities) are designed to assess surgeons’ effort toward improving their clinical practice and/or their preparation toward participating in APMs (Alternative Payment Models). The menu of specific, approved activities has yet to be firmly established. ACS provided significant input on the CPIA component of MIPS in our November 2015 response to the request for information issued by the Centers for Medicare & Medicaid Services (CMS) last fall. The MACRA legislation specifies that the CPIA be applicable to all specialties and be attainable for small practices and professionals in rural and underserved areas.

Those Fellows interested in knowing specifically the areas on which CMS requested input in the process of drafting the first proposed rule on MACRA and how ACS responded to same may find the letter sent in response to CMS at https://www.facs.org/~/media/files/advocacy/medicare/cms%20mips%20apm%20rfi%20final.ashx.

The new law takes concerted steps to incentivize and encourage providers to develop and participate in APMs (Alternative Payment Models). As with the CPIA discussed above, the details of APMs are not yet fully clear and are currently being developed. ACS is actively working on behalf of surgeons to develop APMs as part of the policy efforts of the Division of Advocacy and Health Policy. In general, these programs will require quality measures, the inclusion of elements of upside and downside financial risk for providers and use of certified electronic health record technology. For those surgeons who receive a significant share of their revenue from an APM, an annual 5% bonus will be available for each of the years 2019-2024. To qualify for that bonus, surgeons must receive 25% of their Medicare revenue from an APM in the years 2019 and 2020. That threshold requirement subsequently increases to 50% in 2021 and ultimately to 75% beginning in 2023.

As MACRA specifies that providers participate in either MIPS or APMs, surgeons who meet the aforementioned threshold of payment from a qualified APM will be exempted from many of the MIPS reporting requirements and receive the 5% bonus in lieu of the previously described MIPS payment adjustment. Those who participate in APMs but fail to meet the threshold necessary to receive the 5% bonus will receive credit for their participation in the CPIA component of their MIPS composite score but will not receive the 5% incentive.

While it is completely understandable that acronyms add to surgeons’ collective frustration, I am confident that all Fellows can, with relative ease, master the seven acronyms above and thus be well on their way to both understanding and successfully participating in the new Medicare physician payment system.

Until next month …

Dr. Patrick V. Bailey is an ACS Fellow, a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington, D.C.

Just over a year ago, Congress passed and the President signed into law the MACRA legislation, which will serve as the basis for Medicare physician payment beginning in 2019. At the recent Leadership and Advocacy Summit, it became apparent to me that a “refresher” on seven key acronyms would be useful for surgeons as they gear up to understand and effectively participate in this “brave new world” which is rapidly approaching.

Accordingly, let us start at the beginning. MACRA stands for the Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015. As noted above, this legislation, signed into law by President Obama on April 16, 2015, replaces the flawed sustainable growth rate formula and will be the template utilized to determine Medicare physician payment beginning in 2019. However, it is important to note that it is anticipated that the data to be utilized as the basis for payment in 2019 will likely be collected sometime in 2017.

MACRA provides modest but stable positive updates of 0.5 percent/year for the 5-year period of 2015-2019. Fellows may remember that this provision was included in the legislation as a direct result of objections made by the leadership of the ACS to the original draft legislation, which contained no provision for a positive update. In addition, MACRA provides for the elimination, after 2018, of the current-law penalties associated with the existing Medicare quality programs, including the PQRS (Physician Quality Reporting System), the VBM (Value-Based Modifier) program and the EHR-MU (Electronic Health Record–Meaningful Use) program. That said, and as outlined below, we will not be saying goodbye to these programs completely. Accordingly, surgeons need to remain, or become, familiar with those acronyms and the programs they represent.

MACRA has two payment pathways. Physicians will choose to participate in one or the other. Those choices are: 1) MIPS (Merit-based Incentive Payment System) and 2) APMs (Alternative Payment Models).

Beginning in 2019, the PQRS (Physician Quality Reporting System), the VBM (Value-Based Modifier) program and the EHR-MU (Electronic Health Record–Meaningful Use) program will be combined into MIPS (Merit-based Incentive Payment System). In this program, it is possible for all surgeons to receive an annual positive update based on their individual performance in the four categories of Quality, Resource Use, Electronic Health Record–Meaningful Use, and lastly the newly created category of Clinical Practice Improvement Activities (CPIA).

Individual surgeons’ performance in the four categories will be combined into a composite score. Each individual composite score will then be compared with a performance threshold. The threshold will be set as either the mean or median of the composite performance scores for all MIPS-eligible professionals from a prior performance period. The threshold will reset every year. Those with an individual composite performance score above the threshold will receive a positive payment adjustment while those with an individual composite performance score below the threshold will receive a negative payment adjustment.

The Quality component of the MIPS will consist of quality measures currently used in existing quality performance programs namely, the PQRS (Physician Quality Reporting System), the VBM (Value-Based Modifier program), and EHR-MU (Electronic Health Record–Meaningful Use), as well as measures developed by stakeholders to meet the needs of specialties lacking meaningful measures in the current programs. The RESOURCE USE component of MIPS will include the cost measures used in the current VBM (Value-Based Modifier) program. With regard to the Electronic Health Record–Meaningful Use (EHR-MU) component of MIPS, current EHR-MU requirements will continue to apply but are expected to be modified significantly. ACS continues to advocate for changes to the EHR-MU program to make it easier for surgeons to comply with requirements. Evidence of the effectiveness of our advocacy in this area is found in the success achieved in obtaining a blanket exception for the 2015 reporting period, Stage 2 Meaningful Use rule about which I wrote in the December 2015 and January 2016 editions of this column.

The CPIA (Clinical Practice Improvement Activities) are designed to assess surgeons’ effort toward improving their clinical practice and/or their preparation toward participating in APMs (Alternative Payment Models). The menu of specific, approved activities has yet to be firmly established. ACS provided significant input on the CPIA component of MIPS in our November 2015 response to the request for information issued by the Centers for Medicare & Medicaid Services (CMS) last fall. The MACRA legislation specifies that the CPIA be applicable to all specialties and be attainable for small practices and professionals in rural and underserved areas.

Those Fellows interested in knowing specifically the areas on which CMS requested input in the process of drafting the first proposed rule on MACRA and how ACS responded to same may find the letter sent in response to CMS at https://www.facs.org/~/media/files/advocacy/medicare/cms%20mips%20apm%20rfi%20final.ashx.

The new law takes concerted steps to incentivize and encourage providers to develop and participate in APMs (Alternative Payment Models). As with the CPIA discussed above, the details of APMs are not yet fully clear and are currently being developed. ACS is actively working on behalf of surgeons to develop APMs as part of the policy efforts of the Division of Advocacy and Health Policy. In general, these programs will require quality measures, the inclusion of elements of upside and downside financial risk for providers and use of certified electronic health record technology. For those surgeons who receive a significant share of their revenue from an APM, an annual 5% bonus will be available for each of the years 2019-2024. To qualify for that bonus, surgeons must receive 25% of their Medicare revenue from an APM in the years 2019 and 2020. That threshold requirement subsequently increases to 50% in 2021 and ultimately to 75% beginning in 2023.

As MACRA specifies that providers participate in either MIPS or APMs, surgeons who meet the aforementioned threshold of payment from a qualified APM will be exempted from many of the MIPS reporting requirements and receive the 5% bonus in lieu of the previously described MIPS payment adjustment. Those who participate in APMs but fail to meet the threshold necessary to receive the 5% bonus will receive credit for their participation in the CPIA component of their MIPS composite score but will not receive the 5% incentive.

While it is completely understandable that acronyms add to surgeons’ collective frustration, I am confident that all Fellows can, with relative ease, master the seven acronyms above and thus be well on their way to both understanding and successfully participating in the new Medicare physician payment system.

Until next month …

Dr. Patrick V. Bailey is an ACS Fellow, a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington, D.C.

Just over a year ago, Congress passed and the President signed into law the MACRA legislation, which will serve as the basis for Medicare physician payment beginning in 2019. At the recent Leadership and Advocacy Summit, it became apparent to me that a “refresher” on seven key acronyms would be useful for surgeons as they gear up to understand and effectively participate in this “brave new world” which is rapidly approaching.

Accordingly, let us start at the beginning. MACRA stands for the Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015. As noted above, this legislation, signed into law by President Obama on April 16, 2015, replaces the flawed sustainable growth rate formula and will be the template utilized to determine Medicare physician payment beginning in 2019. However, it is important to note that it is anticipated that the data to be utilized as the basis for payment in 2019 will likely be collected sometime in 2017.

MACRA provides modest but stable positive updates of 0.5 percent/year for the 5-year period of 2015-2019. Fellows may remember that this provision was included in the legislation as a direct result of objections made by the leadership of the ACS to the original draft legislation, which contained no provision for a positive update. In addition, MACRA provides for the elimination, after 2018, of the current-law penalties associated with the existing Medicare quality programs, including the PQRS (Physician Quality Reporting System), the VBM (Value-Based Modifier) program and the EHR-MU (Electronic Health Record–Meaningful Use) program. That said, and as outlined below, we will not be saying goodbye to these programs completely. Accordingly, surgeons need to remain, or become, familiar with those acronyms and the programs they represent.

MACRA has two payment pathways. Physicians will choose to participate in one or the other. Those choices are: 1) MIPS (Merit-based Incentive Payment System) and 2) APMs (Alternative Payment Models).

Beginning in 2019, the PQRS (Physician Quality Reporting System), the VBM (Value-Based Modifier) program and the EHR-MU (Electronic Health Record–Meaningful Use) program will be combined into MIPS (Merit-based Incentive Payment System). In this program, it is possible for all surgeons to receive an annual positive update based on their individual performance in the four categories of Quality, Resource Use, Electronic Health Record–Meaningful Use, and lastly the newly created category of Clinical Practice Improvement Activities (CPIA).

Individual surgeons’ performance in the four categories will be combined into a composite score. Each individual composite score will then be compared with a performance threshold. The threshold will be set as either the mean or median of the composite performance scores for all MIPS-eligible professionals from a prior performance period. The threshold will reset every year. Those with an individual composite performance score above the threshold will receive a positive payment adjustment while those with an individual composite performance score below the threshold will receive a negative payment adjustment.

The Quality component of the MIPS will consist of quality measures currently used in existing quality performance programs namely, the PQRS (Physician Quality Reporting System), the VBM (Value-Based Modifier program), and EHR-MU (Electronic Health Record–Meaningful Use), as well as measures developed by stakeholders to meet the needs of specialties lacking meaningful measures in the current programs. The RESOURCE USE component of MIPS will include the cost measures used in the current VBM (Value-Based Modifier) program. With regard to the Electronic Health Record–Meaningful Use (EHR-MU) component of MIPS, current EHR-MU requirements will continue to apply but are expected to be modified significantly. ACS continues to advocate for changes to the EHR-MU program to make it easier for surgeons to comply with requirements. Evidence of the effectiveness of our advocacy in this area is found in the success achieved in obtaining a blanket exception for the 2015 reporting period, Stage 2 Meaningful Use rule about which I wrote in the December 2015 and January 2016 editions of this column.

The CPIA (Clinical Practice Improvement Activities) are designed to assess surgeons’ effort toward improving their clinical practice and/or their preparation toward participating in APMs (Alternative Payment Models). The menu of specific, approved activities has yet to be firmly established. ACS provided significant input on the CPIA component of MIPS in our November 2015 response to the request for information issued by the Centers for Medicare & Medicaid Services (CMS) last fall. The MACRA legislation specifies that the CPIA be applicable to all specialties and be attainable for small practices and professionals in rural and underserved areas.

Those Fellows interested in knowing specifically the areas on which CMS requested input in the process of drafting the first proposed rule on MACRA and how ACS responded to same may find the letter sent in response to CMS at https://www.facs.org/~/media/files/advocacy/medicare/cms%20mips%20apm%20rfi%20final.ashx.

The new law takes concerted steps to incentivize and encourage providers to develop and participate in APMs (Alternative Payment Models). As with the CPIA discussed above, the details of APMs are not yet fully clear and are currently being developed. ACS is actively working on behalf of surgeons to develop APMs as part of the policy efforts of the Division of Advocacy and Health Policy. In general, these programs will require quality measures, the inclusion of elements of upside and downside financial risk for providers and use of certified electronic health record technology. For those surgeons who receive a significant share of their revenue from an APM, an annual 5% bonus will be available for each of the years 2019-2024. To qualify for that bonus, surgeons must receive 25% of their Medicare revenue from an APM in the years 2019 and 2020. That threshold requirement subsequently increases to 50% in 2021 and ultimately to 75% beginning in 2023.

As MACRA specifies that providers participate in either MIPS or APMs, surgeons who meet the aforementioned threshold of payment from a qualified APM will be exempted from many of the MIPS reporting requirements and receive the 5% bonus in lieu of the previously described MIPS payment adjustment. Those who participate in APMs but fail to meet the threshold necessary to receive the 5% bonus will receive credit for their participation in the CPIA component of their MIPS composite score but will not receive the 5% incentive.

While it is completely understandable that acronyms add to surgeons’ collective frustration, I am confident that all Fellows can, with relative ease, master the seven acronyms above and thus be well on their way to both understanding and successfully participating in the new Medicare physician payment system.

Until next month …

Dr. Patrick V. Bailey is an ACS Fellow, a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington, D.C.

The American College of Surgeons (ACS) hosted the fifth annual Leadership & Advocacy Summit, April 9–12, at the JW Marriott in Washington, DC. More than 445 College leaders, residents, and medical students participated in the Leadership portion of the Summit, which featured a full day of sessions on effective leadership building communication and strategic thinking skills for effective leadership in and out of the operating room. The Leadership Summit also provided attendees with ample networking opportunities.

The Leadership Summit began with a well-attended Welcome Reception on Saturday evening. Sunday’s program featured nine presentations on such topics as preparing for difficult conversations, best practices for social networking, improving team emotional intelligence, leading teams through conflict situations, and sharpening strategic thinking skills. Leaders from the Georgia, North Texas, and West Virginia Chapters of the ACS presented their chapter’s success stories from the past year. Leadership Summit attendees also convened over lunch by state/region to identify new areas for collaboration in the coming year.

Details regarding the Leadership Summit will be published in the July Bulletin of the American College of Surgeons at http://bulletin.facs.org/. The sixth annual Leadership & Advocacy Summit will take place May 6−9, 2017 at the Renaissance Washington, DC Downtown Hotel. For more information on the Leadership Summit, contact Donna Tieberg, ACS International Chapter Services Manager, at dtieberg@facs.org.

The American College of Surgeons (ACS) hosted the fifth annual Leadership & Advocacy Summit, April 9–12, at the JW Marriott in Washington, DC. More than 445 College leaders, residents, and medical students participated in the Leadership portion of the Summit, which featured a full day of sessions on effective leadership building communication and strategic thinking skills for effective leadership in and out of the operating room. The Leadership Summit also provided attendees with ample networking opportunities.

The Leadership Summit began with a well-attended Welcome Reception on Saturday evening. Sunday’s program featured nine presentations on such topics as preparing for difficult conversations, best practices for social networking, improving team emotional intelligence, leading teams through conflict situations, and sharpening strategic thinking skills. Leaders from the Georgia, North Texas, and West Virginia Chapters of the ACS presented their chapter’s success stories from the past year. Leadership Summit attendees also convened over lunch by state/region to identify new areas for collaboration in the coming year.

Details regarding the Leadership Summit will be published in the July Bulletin of the American College of Surgeons at http://bulletin.facs.org/. The sixth annual Leadership & Advocacy Summit will take place May 6−9, 2017 at the Renaissance Washington, DC Downtown Hotel. For more information on the Leadership Summit, contact Donna Tieberg, ACS International Chapter Services Manager, at dtieberg@facs.org.

The American College of Surgeons (ACS) hosted the fifth annual Leadership & Advocacy Summit, April 9–12, at the JW Marriott in Washington, DC. More than 445 College leaders, residents, and medical students participated in the Leadership portion of the Summit, which featured a full day of sessions on effective leadership building communication and strategic thinking skills for effective leadership in and out of the operating room. The Leadership Summit also provided attendees with ample networking opportunities.

The Leadership Summit began with a well-attended Welcome Reception on Saturday evening. Sunday’s program featured nine presentations on such topics as preparing for difficult conversations, best practices for social networking, improving team emotional intelligence, leading teams through conflict situations, and sharpening strategic thinking skills. Leaders from the Georgia, North Texas, and West Virginia Chapters of the ACS presented their chapter’s success stories from the past year. Leadership Summit attendees also convened over lunch by state/region to identify new areas for collaboration in the coming year.

Details regarding the Leadership Summit will be published in the July Bulletin of the American College of Surgeons at http://bulletin.facs.org/. The sixth annual Leadership & Advocacy Summit will take place May 6−9, 2017 at the Renaissance Washington, DC Downtown Hotel. For more information on the Leadership Summit, contact Donna Tieberg, ACS International Chapter Services Manager, at dtieberg@facs.org.

Many civilians have expressed interest in taking a bleeding control training course that would empower them to immediately assist victims of active shooter and other intentional mass casualty events at the point of wounding, according to the results of a national poll published in the Journal of the American College of Surgeons (JACS). Furthermore, most civilians support training and equipping police officers to perform severe bleeding control on victims as soon as possible, rather than wait for emergency medical services (EMS) personnel to arrive on the scene. Survey respondents also supported the placement of bleeding control kits in public places where large crowds gather, similar to the way that automatic external defibrillators are now found in airports and shopping malls.

Working to save lives

The Joint Committee to Create a National Policy to Enhance Survivability from Intentional Mass Casualty and Active Shooter Events, convened by the American College of Surgeons, recommends careful consideration of these study results. The committee’s deliberations are known as the Hartford Consensus™. The Hartford Consensus reports have been published in the Bulletin and JACS since the group’s formation in 2013 and promote the group’s core principle that “no one should die from uncontrolled bleeding.”

To that end, the Hartford Consensus calls for providing law enforcement officers with the training and equipment needed to act before EMS personnel arrive, providing EMS professionals with quicker access to the wounded, and training civilian bystanders to act as immediate responders. This element from the Hartford Consensus is at the heart of the “Stop the Bleed” campaign launched by the U.S. Department of Homeland Security through the National Security Council.

“We know that to save life and limb, you need to stop the bleeding very early—within five to 10 minutes—or victims can lose their lives,” said ACS Regent Lenworth M. Jacobs, Jr., MD, MPH, FACS, Chair of the Hartford Consensus and director of the Trauma Institute at Hartford Hospital, CT. “However, until now, there has been no clear indication of how well trained the general public is in bleeding control and how willing they might be to participate as immediate responders until professionals arrive on the scene.”

Public ready and willing to act

Langer Research Associates, New York, NY, conducted a national telephone survey of the general public, November 6−11, 2015, concluding just two days before the terrorist attacks in Paris. A total of 1,051 telephone interviews were conducted—528 via cellphone and 523 via landline. Respondents were asked whether they had ever participated in first aid training, and, if so, when and whether it included bleeding control instruction. Nearly half of all respondents (47 percent) said that they had received first aid training at some point. Of that number, 13 percent had trained in first aid in the last two years and 52 percent had first aid training in the last five years.

Respondents also were asked about their willingness to provide aid to bleeding victims in two different scenarios: a car crash and a mass shooting.

Within the context of the two scenarios, the study authors reported that:

Of the 941 respondents able to provide first aid, 98 percent indicated they would be “very likely” or “somewhat likely” to attempt bleeding control on a family member with a leg wound. Within this subgroup, 62 percent indicated they would apply pressure or compression to the wound, 36 percent would apply a tourniquet, 6 percent would cover or wrap the wound in a bandage, and 2 percent would elevate the injured leg.

When presented with a scenario of trying to stop severe bleeding in a car crash victim who is unknown to them, 92 percent of a random half sample of respondents indicated they would be very likely (61 percent) or somewhat likely (31 percent) to act.

In a mass shooting scenario, 75 percent of the other random half sample responded that they would attempt to give first aid if it seemed safe to act, 16 percent responded that they would wait to see what happens, and 8 percent said they would leave the area. In terms of assisting if the situation seemed safe, 94 percent responded that they would be very likely (62 percent) or somewhat likely (32 percent) to try to help a stranger.

Many respondents reported having major or some concern about several issues related to trying to stop severe bleeding in someone whom they did not know. Specifically, respondents expressed concern about seeing someone bleeding heavily (30 percent), becoming contaminated with a disease (61 percent), endangering personal safety (43 percent), causing a victim additional pain or injury (65 percent), and being responsible for a bad outcome (61 percent). Within the context of rendering assistance in the shooting scenario, 71 percent expressed concern about “putting themselves in physical danger from additional violence.”

Respondents also were asked about their interest in taking a bleeding control class and their support for requiring bleeding control kits in public places. Among the respondents who were physically able to provide first aid, 82 percent said they would be “very interested” or “somewhat interested” in attending a two-hour bleeding control course.

In addition, 93 percent supported the public placement of bleeding control kits (containing gloves, tourniquets, and compression dressings).

The authors also noted strong public approval (91 percent of all surveyed) for training and equipping police officers for severe bleeding control to act as soon as possible before the arrival of EMS personnel, with 65 percent also supporting “faster access of EMS to victims in areas that may not be totally secure.”

“It takes internal fortitude to want to get involved as an immediate responder. We were overwhelmed to learn that the public is prepared to accept this responsibility,” Dr. Jacobs said. “Moving forward, we plan to use these new insights to develop a training program for the public, not just health care professionals, so civilians can learn how to act as immediate responders. We want to steer interested people toward getting the right training and to understand when victims are experiencing the signs of massive bleeding so they can ‘stop the bleed’ and save lives.”

Many civilians have expressed interest in taking a bleeding control training course that would empower them to immediately assist victims of active shooter and other intentional mass casualty events at the point of wounding, according to the results of a national poll published in the Journal of the American College of Surgeons (JACS). Furthermore, most civilians support training and equipping police officers to perform severe bleeding control on victims as soon as possible, rather than wait for emergency medical services (EMS) personnel to arrive on the scene. Survey respondents also supported the placement of bleeding control kits in public places where large crowds gather, similar to the way that automatic external defibrillators are now found in airports and shopping malls.

Working to save lives

The Joint Committee to Create a National Policy to Enhance Survivability from Intentional Mass Casualty and Active Shooter Events, convened by the American College of Surgeons, recommends careful consideration of these study results. The committee’s deliberations are known as the Hartford Consensus™. The Hartford Consensus reports have been published in the Bulletin and JACS since the group’s formation in 2013 and promote the group’s core principle that “no one should die from uncontrolled bleeding.”

To that end, the Hartford Consensus calls for providing law enforcement officers with the training and equipment needed to act before EMS personnel arrive, providing EMS professionals with quicker access to the wounded, and training civilian bystanders to act as immediate responders. This element from the Hartford Consensus is at the heart of the “Stop the Bleed” campaign launched by the U.S. Department of Homeland Security through the National Security Council.

“We know that to save life and limb, you need to stop the bleeding very early—within five to 10 minutes—or victims can lose their lives,” said ACS Regent Lenworth M. Jacobs, Jr., MD, MPH, FACS, Chair of the Hartford Consensus and director of the Trauma Institute at Hartford Hospital, CT. “However, until now, there has been no clear indication of how well trained the general public is in bleeding control and how willing they might be to participate as immediate responders until professionals arrive on the scene.”

Public ready and willing to act

Langer Research Associates, New York, NY, conducted a national telephone survey of the general public, November 6−11, 2015, concluding just two days before the terrorist attacks in Paris. A total of 1,051 telephone interviews were conducted—528 via cellphone and 523 via landline. Respondents were asked whether they had ever participated in first aid training, and, if so, when and whether it included bleeding control instruction. Nearly half of all respondents (47 percent) said that they had received first aid training at some point. Of that number, 13 percent had trained in first aid in the last two years and 52 percent had first aid training in the last five years.

Respondents also were asked about their willingness to provide aid to bleeding victims in two different scenarios: a car crash and a mass shooting.

Within the context of the two scenarios, the study authors reported that:

Of the 941 respondents able to provide first aid, 98 percent indicated they would be “very likely” or “somewhat likely” to attempt bleeding control on a family member with a leg wound. Within this subgroup, 62 percent indicated they would apply pressure or compression to the wound, 36 percent would apply a tourniquet, 6 percent would cover or wrap the wound in a bandage, and 2 percent would elevate the injured leg.

When presented with a scenario of trying to stop severe bleeding in a car crash victim who is unknown to them, 92 percent of a random half sample of respondents indicated they would be very likely (61 percent) or somewhat likely (31 percent) to act.

In a mass shooting scenario, 75 percent of the other random half sample responded that they would attempt to give first aid if it seemed safe to act, 16 percent responded that they would wait to see what happens, and 8 percent said they would leave the area. In terms of assisting if the situation seemed safe, 94 percent responded that they would be very likely (62 percent) or somewhat likely (32 percent) to try to help a stranger.

Many respondents reported having major or some concern about several issues related to trying to stop severe bleeding in someone whom they did not know. Specifically, respondents expressed concern about seeing someone bleeding heavily (30 percent), becoming contaminated with a disease (61 percent), endangering personal safety (43 percent), causing a victim additional pain or injury (65 percent), and being responsible for a bad outcome (61 percent). Within the context of rendering assistance in the shooting scenario, 71 percent expressed concern about “putting themselves in physical danger from additional violence.”

Respondents also were asked about their interest in taking a bleeding control class and their support for requiring bleeding control kits in public places. Among the respondents who were physically able to provide first aid, 82 percent said they would be “very interested” or “somewhat interested” in attending a two-hour bleeding control course.

In addition, 93 percent supported the public placement of bleeding control kits (containing gloves, tourniquets, and compression dressings).

The authors also noted strong public approval (91 percent of all surveyed) for training and equipping police officers for severe bleeding control to act as soon as possible before the arrival of EMS personnel, with 65 percent also supporting “faster access of EMS to victims in areas that may not be totally secure.”

“It takes internal fortitude to want to get involved as an immediate responder. We were overwhelmed to learn that the public is prepared to accept this responsibility,” Dr. Jacobs said. “Moving forward, we plan to use these new insights to develop a training program for the public, not just health care professionals, so civilians can learn how to act as immediate responders. We want to steer interested people toward getting the right training and to understand when victims are experiencing the signs of massive bleeding so they can ‘stop the bleed’ and save lives.”

Many civilians have expressed interest in taking a bleeding control training course that would empower them to immediately assist victims of active shooter and other intentional mass casualty events at the point of wounding, according to the results of a national poll published in the Journal of the American College of Surgeons (JACS). Furthermore, most civilians support training and equipping police officers to perform severe bleeding control on victims as soon as possible, rather than wait for emergency medical services (EMS) personnel to arrive on the scene. Survey respondents also supported the placement of bleeding control kits in public places where large crowds gather, similar to the way that automatic external defibrillators are now found in airports and shopping malls.

Working to save lives

The Joint Committee to Create a National Policy to Enhance Survivability from Intentional Mass Casualty and Active Shooter Events, convened by the American College of Surgeons, recommends careful consideration of these study results. The committee’s deliberations are known as the Hartford Consensus™. The Hartford Consensus reports have been published in the Bulletin and JACS since the group’s formation in 2013 and promote the group’s core principle that “no one should die from uncontrolled bleeding.”

To that end, the Hartford Consensus calls for providing law enforcement officers with the training and equipment needed to act before EMS personnel arrive, providing EMS professionals with quicker access to the wounded, and training civilian bystanders to act as immediate responders. This element from the Hartford Consensus is at the heart of the “Stop the Bleed” campaign launched by the U.S. Department of Homeland Security through the National Security Council.

“We know that to save life and limb, you need to stop the bleeding very early—within five to 10 minutes—or victims can lose their lives,” said ACS Regent Lenworth M. Jacobs, Jr., MD, MPH, FACS, Chair of the Hartford Consensus and director of the Trauma Institute at Hartford Hospital, CT. “However, until now, there has been no clear indication of how well trained the general public is in bleeding control and how willing they might be to participate as immediate responders until professionals arrive on the scene.”

Public ready and willing to act

Langer Research Associates, New York, NY, conducted a national telephone survey of the general public, November 6−11, 2015, concluding just two days before the terrorist attacks in Paris. A total of 1,051 telephone interviews were conducted—528 via cellphone and 523 via landline. Respondents were asked whether they had ever participated in first aid training, and, if so, when and whether it included bleeding control instruction. Nearly half of all respondents (47 percent) said that they had received first aid training at some point. Of that number, 13 percent had trained in first aid in the last two years and 52 percent had first aid training in the last five years.

Respondents also were asked about their willingness to provide aid to bleeding victims in two different scenarios: a car crash and a mass shooting.

Within the context of the two scenarios, the study authors reported that:

Of the 941 respondents able to provide first aid, 98 percent indicated they would be “very likely” or “somewhat likely” to attempt bleeding control on a family member with a leg wound. Within this subgroup, 62 percent indicated they would apply pressure or compression to the wound, 36 percent would apply a tourniquet, 6 percent would cover or wrap the wound in a bandage, and 2 percent would elevate the injured leg.

When presented with a scenario of trying to stop severe bleeding in a car crash victim who is unknown to them, 92 percent of a random half sample of respondents indicated they would be very likely (61 percent) or somewhat likely (31 percent) to act.

In a mass shooting scenario, 75 percent of the other random half sample responded that they would attempt to give first aid if it seemed safe to act, 16 percent responded that they would wait to see what happens, and 8 percent said they would leave the area. In terms of assisting if the situation seemed safe, 94 percent responded that they would be very likely (62 percent) or somewhat likely (32 percent) to try to help a stranger.

Many respondents reported having major or some concern about several issues related to trying to stop severe bleeding in someone whom they did not know. Specifically, respondents expressed concern about seeing someone bleeding heavily (30 percent), becoming contaminated with a disease (61 percent), endangering personal safety (43 percent), causing a victim additional pain or injury (65 percent), and being responsible for a bad outcome (61 percent). Within the context of rendering assistance in the shooting scenario, 71 percent expressed concern about “putting themselves in physical danger from additional violence.”

Respondents also were asked about their interest in taking a bleeding control class and their support for requiring bleeding control kits in public places. Among the respondents who were physically able to provide first aid, 82 percent said they would be “very interested” or “somewhat interested” in attending a two-hour bleeding control course.

In addition, 93 percent supported the public placement of bleeding control kits (containing gloves, tourniquets, and compression dressings).

The authors also noted strong public approval (91 percent of all surveyed) for training and equipping police officers for severe bleeding control to act as soon as possible before the arrival of EMS personnel, with 65 percent also supporting “faster access of EMS to victims in areas that may not be totally secure.”

“It takes internal fortitude to want to get involved as an immediate responder. We were overwhelmed to learn that the public is prepared to accept this responsibility,” Dr. Jacobs said. “Moving forward, we plan to use these new insights to develop a training program for the public, not just health care professionals, so civilians can learn how to act as immediate responders. We want to steer interested people toward getting the right training and to understand when victims are experiencing the signs of massive bleeding so they can ‘stop the bleed’ and save lives.”

Approximately 300 surgeons and surgical residents participated in the advocacy portion of the 2016 American College of Surgeons (ACS) Leadership & Advocacy Summit. The event provided participants with an opportunity to develop their advocacy skills, learn about legislative and health policy priorities, and advocate in meetings with members of Congress and their staffs.

Surgeons asked lawmakers to use their oversight authority to encourage the Centers for Medicare & Medicaid Services to adopt meaningful quality measures, and physician-developed Alternative Payment Models. ACS members also asked their elected officials to support the Responsible Data Transparency Act, legislation that is being developed by Rep. Bill Flores (R-Tex.). The College is committed to maintaining transparency in the Medicare system to promote high-quality patient care. At issue, however, are third-party groups that are evading established, accurate, valid, and transparent pathways to sensitive Medicare data by using Freedom of Information Act requests to obtain raw physician claims data. This legislation would prevent groups from using questionable, non–risk-adjusted methodologies to conduct performance analyses and publish potentially misleading physician performance ratings on public websites.

Other issues discussed at the Capitol Hill meetings include promotion of the Ensuring Access to General Surgery Act of 2016, legislation being developed that would require that a study be conducted to designate general surgery Health Professional Shortage Areas (HPSAs); cancer-related concerns, including education on the importance of Commission on Cancer accreditation; and improved access to trauma care. Details about the ACS Leadership & Advocacy Summit will be published in the May SurgeonsVoice Monthly and the July issue of the Bulletin at http://bulletin.facs.org/.

Approximately 300 surgeons and surgical residents participated in the advocacy portion of the 2016 American College of Surgeons (ACS) Leadership & Advocacy Summit. The event provided participants with an opportunity to develop their advocacy skills, learn about legislative and health policy priorities, and advocate in meetings with members of Congress and their staffs.

Surgeons asked lawmakers to use their oversight authority to encourage the Centers for Medicare & Medicaid Services to adopt meaningful quality measures, and physician-developed Alternative Payment Models. ACS members also asked their elected officials to support the Responsible Data Transparency Act, legislation that is being developed by Rep. Bill Flores (R-Tex.). The College is committed to maintaining transparency in the Medicare system to promote high-quality patient care. At issue, however, are third-party groups that are evading established, accurate, valid, and transparent pathways to sensitive Medicare data by using Freedom of Information Act requests to obtain raw physician claims data. This legislation would prevent groups from using questionable, non–risk-adjusted methodologies to conduct performance analyses and publish potentially misleading physician performance ratings on public websites.

Other issues discussed at the Capitol Hill meetings include promotion of the Ensuring Access to General Surgery Act of 2016, legislation being developed that would require that a study be conducted to designate general surgery Health Professional Shortage Areas (HPSAs); cancer-related concerns, including education on the importance of Commission on Cancer accreditation; and improved access to trauma care. Details about the ACS Leadership & Advocacy Summit will be published in the May SurgeonsVoice Monthly and the July issue of the Bulletin at http://bulletin.facs.org/.

Approximately 300 surgeons and surgical residents participated in the advocacy portion of the 2016 American College of Surgeons (ACS) Leadership & Advocacy Summit. The event provided participants with an opportunity to develop their advocacy skills, learn about legislative and health policy priorities, and advocate in meetings with members of Congress and their staffs.

Surgeons asked lawmakers to use their oversight authority to encourage the Centers for Medicare & Medicaid Services to adopt meaningful quality measures, and physician-developed Alternative Payment Models. ACS members also asked their elected officials to support the Responsible Data Transparency Act, legislation that is being developed by Rep. Bill Flores (R-Tex.). The College is committed to maintaining transparency in the Medicare system to promote high-quality patient care. At issue, however, are third-party groups that are evading established, accurate, valid, and transparent pathways to sensitive Medicare data by using Freedom of Information Act requests to obtain raw physician claims data. This legislation would prevent groups from using questionable, non–risk-adjusted methodologies to conduct performance analyses and publish potentially misleading physician performance ratings on public websites.

Other issues discussed at the Capitol Hill meetings include promotion of the Ensuring Access to General Surgery Act of 2016, legislation being developed that would require that a study be conducted to designate general surgery Health Professional Shortage Areas (HPSAs); cancer-related concerns, including education on the importance of Commission on Cancer accreditation; and improved access to trauma care. Details about the ACS Leadership & Advocacy Summit will be published in the May SurgeonsVoice Monthly and the July issue of the Bulletin at http://bulletin.facs.org/.

When trabectedin was administered to soft tissue sarcoma (STS) patients receiving doxorubicin, neither progression-free nor overall survival significantly improved, investigators found.

In addition, patients who received both drugs were significantly more likely to experience adverse events.

“The combination of trabectedin plus doxorubicin did not show superiority over doxorubicin alone as first-line treatment of advanced STS patients, at least under this schedule. Moreover, the experimental arm was significantly more toxic than the control arm, especially regarding thrombocytopenia, vomiting, liver toxicity, and asthenia,” wrote Dr. Javier Martin-Broto of the Virgen del Rocio Hospital and Biomedicine Institute, Seville (Spain) and his associates (J Clin Oncol. 2016. doi: 10.1200/JCO.2015.65.3329).

Of 115 adult patients with advanced nonresectable or metastatic STS, 59 received doxorubicin only, 55 received both doxorubicin and trabectedin, and one patient was not treated. In the experimental group, doxorubicin was administered before trabectedin. Both the experimental and control groups underwent six cycles of their respective drug regime unless disease progression or unacceptable toxicity was observed.

A Cox proportional hazard regression model revealed that the progression-free survival was not significantly higher among patients receiving trabectedin and doxorubicin compared to patients only receiving doxorubicin (5.7 months vs. 5.5 months; hazard ratio, 1.16; 95% confidence interval, 0.79-1.71; P = .45). Overall survival was also not significantly different between the groups (13.3 months vs. 13.7 months; HR, 1.21; 95% CI, .77-1.92, P = .41).

However, compared with patients who only received doxorubicin, patients who received both trabectedin and doxorubicin experienced significantly more adverse events such as grade 3 or 4 thrombocytopenia (2% vs. 18%, P = .016), grade 3 or 4 liver toxicity (12% vs. 29%, P = .002), AST (0% vs. 8%, P = .007), ALT (0% vs. 19%, P less than .001), and grade 3 or 4 asthenia (4% vs. 25%, P = .002).

jcraig@frontlinemedcom.com

On Twitter @jess_craig94

When trabectedin was administered to soft tissue sarcoma (STS) patients receiving doxorubicin, neither progression-free nor overall survival significantly improved, investigators found.

In addition, patients who received both drugs were significantly more likely to experience adverse events.

“The combination of trabectedin plus doxorubicin did not show superiority over doxorubicin alone as first-line treatment of advanced STS patients, at least under this schedule. Moreover, the experimental arm was significantly more toxic than the control arm, especially regarding thrombocytopenia, vomiting, liver toxicity, and asthenia,” wrote Dr. Javier Martin-Broto of the Virgen del Rocio Hospital and Biomedicine Institute, Seville (Spain) and his associates (J Clin Oncol. 2016. doi: 10.1200/JCO.2015.65.3329).

Of 115 adult patients with advanced nonresectable or metastatic STS, 59 received doxorubicin only, 55 received both doxorubicin and trabectedin, and one patient was not treated. In the experimental group, doxorubicin was administered before trabectedin. Both the experimental and control groups underwent six cycles of their respective drug regime unless disease progression or unacceptable toxicity was observed.

A Cox proportional hazard regression model revealed that the progression-free survival was not significantly higher among patients receiving trabectedin and doxorubicin compared to patients only receiving doxorubicin (5.7 months vs. 5.5 months; hazard ratio, 1.16; 95% confidence interval, 0.79-1.71; P = .45). Overall survival was also not significantly different between the groups (13.3 months vs. 13.7 months; HR, 1.21; 95% CI, .77-1.92, P = .41).

However, compared with patients who only received doxorubicin, patients who received both trabectedin and doxorubicin experienced significantly more adverse events such as grade 3 or 4 thrombocytopenia (2% vs. 18%, P = .016), grade 3 or 4 liver toxicity (12% vs. 29%, P = .002), AST (0% vs. 8%, P = .007), ALT (0% vs. 19%, P less than .001), and grade 3 or 4 asthenia (4% vs. 25%, P = .002).

jcraig@frontlinemedcom.com

On Twitter @jess_craig94

When trabectedin was administered to soft tissue sarcoma (STS) patients receiving doxorubicin, neither progression-free nor overall survival significantly improved, investigators found.

In addition, patients who received both drugs were significantly more likely to experience adverse events.

“The combination of trabectedin plus doxorubicin did not show superiority over doxorubicin alone as first-line treatment of advanced STS patients, at least under this schedule. Moreover, the experimental arm was significantly more toxic than the control arm, especially regarding thrombocytopenia, vomiting, liver toxicity, and asthenia,” wrote Dr. Javier Martin-Broto of the Virgen del Rocio Hospital and Biomedicine Institute, Seville (Spain) and his associates (J Clin Oncol. 2016. doi: 10.1200/JCO.2015.65.3329).

Of 115 adult patients with advanced nonresectable or metastatic STS, 59 received doxorubicin only, 55 received both doxorubicin and trabectedin, and one patient was not treated. In the experimental group, doxorubicin was administered before trabectedin. Both the experimental and control groups underwent six cycles of their respective drug regime unless disease progression or unacceptable toxicity was observed.

A Cox proportional hazard regression model revealed that the progression-free survival was not significantly higher among patients receiving trabectedin and doxorubicin compared to patients only receiving doxorubicin (5.7 months vs. 5.5 months; hazard ratio, 1.16; 95% confidence interval, 0.79-1.71; P = .45). Overall survival was also not significantly different between the groups (13.3 months vs. 13.7 months; HR, 1.21; 95% CI, .77-1.92, P = .41).

However, compared with patients who only received doxorubicin, patients who received both trabectedin and doxorubicin experienced significantly more adverse events such as grade 3 or 4 thrombocytopenia (2% vs. 18%, P = .016), grade 3 or 4 liver toxicity (12% vs. 29%, P = .002), AST (0% vs. 8%, P = .007), ALT (0% vs. 19%, P less than .001), and grade 3 or 4 asthenia (4% vs. 25%, P = .002).

jcraig@frontlinemedcom.com

On Twitter @jess_craig94

A recent study suggests that brain MRI abnormalities are more common in patients with psychogenic nonepileptic events, when compared to the findings in normal persons. When investigators analyzed MRI data from 339 patients discharged from their epilepsy monitoring units, they found brain MRI abnormalities in 33.8% of patients with PNEEs and 57.7% in patients with epilepsy, much higher than would be found in a normal population.  The researchers also discovered that the brain MRI anomalies during epileptic seizures were more likely to occur in the temporal region of the brain, while PNEE anomalies were more frequently multifocal. 

Bolen RD, Koontz EH, Pritchard PB. Prevalence and distribution of MRI abnormalities in patients with psychogenic nonepileptic events. Epilepsy Behav. 2016;59:73-76. 

A recent study suggests that brain MRI abnormalities are more common in patients with psychogenic nonepileptic events, when compared to the findings in normal persons. When investigators analyzed MRI data from 339 patients discharged from their epilepsy monitoring units, they found brain MRI abnormalities in 33.8% of patients with PNEEs and 57.7% in patients with epilepsy, much higher than would be found in a normal population.  The researchers also discovered that the brain MRI anomalies during epileptic seizures were more likely to occur in the temporal region of the brain, while PNEE anomalies were more frequently multifocal. 

Bolen RD, Koontz EH, Pritchard PB. Prevalence and distribution of MRI abnormalities in patients with psychogenic nonepileptic events. Epilepsy Behav. 2016;59:73-76. 

A recent study suggests that brain MRI abnormalities are more common in patients with psychogenic nonepileptic events, when compared to the findings in normal persons. When investigators analyzed MRI data from 339 patients discharged from their epilepsy monitoring units, they found brain MRI abnormalities in 33.8% of patients with PNEEs and 57.7% in patients with epilepsy, much higher than would be found in a normal population.  The researchers also discovered that the brain MRI anomalies during epileptic seizures were more likely to occur in the temporal region of the brain, while PNEE anomalies were more frequently multifocal. 

Bolen RD, Koontz EH, Pritchard PB. Prevalence and distribution of MRI abnormalities in patients with psychogenic nonepileptic events. Epilepsy Behav. 2016;59:73-76. 

Using a smartphone or other personal electronic device (PED) to send text messages produces a “reproducible texting rhythm” that can be detected during video-EEG monitoring, according to Mayo Clinic researchers. In a cohort of 129 patients, this texting rhythm was detected in 27 (20.9%) patients. The rhythm existed in 28% of patients with epilepsy and 16% of those with non-epileptic seizures. The unique pattern was not present in patients when they performed independent tasks or when using a cellphone to make audio calls. The investigators concluded that the reproducible text rhythm “represents a novel technology-specific neurophysiological alteration of brain networks” and proposed that “cortical processing in the contemporary brain is uniquely activated by the use of PEDs.”  

Tatum WO, DiCiaccio B, Yelvington KH. Cortical processing during smartphone text messaging. Epilepsy Behav. 2016;59:117-121. 

Using a smartphone or other personal electronic device (PED) to send text messages produces a “reproducible texting rhythm” that can be detected during video-EEG monitoring, according to Mayo Clinic researchers. In a cohort of 129 patients, this texting rhythm was detected in 27 (20.9%) patients. The rhythm existed in 28% of patients with epilepsy and 16% of those with non-epileptic seizures. The unique pattern was not present in patients when they performed independent tasks or when using a cellphone to make audio calls. The investigators concluded that the reproducible text rhythm “represents a novel technology-specific neurophysiological alteration of brain networks” and proposed that “cortical processing in the contemporary brain is uniquely activated by the use of PEDs.”  

Tatum WO, DiCiaccio B, Yelvington KH. Cortical processing during smartphone text messaging. Epilepsy Behav. 2016;59:117-121. 

Using a smartphone or other personal electronic device (PED) to send text messages produces a “reproducible texting rhythm” that can be detected during video-EEG monitoring, according to Mayo Clinic researchers. In a cohort of 129 patients, this texting rhythm was detected in 27 (20.9%) patients. The rhythm existed in 28% of patients with epilepsy and 16% of those with non-epileptic seizures. The unique pattern was not present in patients when they performed independent tasks or when using a cellphone to make audio calls. The investigators concluded that the reproducible text rhythm “represents a novel technology-specific neurophysiological alteration of brain networks” and proposed that “cortical processing in the contemporary brain is uniquely activated by the use of PEDs.”  

Tatum WO, DiCiaccio B, Yelvington KH. Cortical processing during smartphone text messaging. Epilepsy Behav. 2016;59:117-121. 

A cross-sectional data analysis derived from the Epilepsy Birth Control Registry recently found that among nearly 800 patients who were at risk for unintended pregnancy, 69.7% were using effective contraceptive methods, which included hormonal contraceptives, intrauterine devices, tubal ligation, and vasectomy. Despite the high number of patients with epilepsy using what are generally considered highly effective forms of birth control, the efficacy of these methods in this population "remains to be proven" according to researchers from Columbia University and Beth Israel Deaconess Medical Center. The analysis suggests that there is a need for evidence-based guidelines that demonstrate the efficacy and safety of various contraceptive methods in this special population.

Herzog AG, Mandle HB, Cahill KE, Fowler KM, Hauser WA, Davis AR. Contraceptive practices of women with epilepsy: Findings of the epilepsy birth control registry. Epilepsia. 2016;57(4):630-637. 

A cross-sectional data analysis derived from the Epilepsy Birth Control Registry recently found that among nearly 800 patients who were at risk for unintended pregnancy, 69.7% were using effective contraceptive methods, which included hormonal contraceptives, intrauterine devices, tubal ligation, and vasectomy. Despite the high number of patients with epilepsy using what are generally considered highly effective forms of birth control, the efficacy of these methods in this population "remains to be proven" according to researchers from Columbia University and Beth Israel Deaconess Medical Center. The analysis suggests that there is a need for evidence-based guidelines that demonstrate the efficacy and safety of various contraceptive methods in this special population.

Herzog AG, Mandle HB, Cahill KE, Fowler KM, Hauser WA, Davis AR. Contraceptive practices of women with epilepsy: Findings of the epilepsy birth control registry. Epilepsia. 2016;57(4):630-637. 

A cross-sectional data analysis derived from the Epilepsy Birth Control Registry recently found that among nearly 800 patients who were at risk for unintended pregnancy, 69.7% were using effective contraceptive methods, which included hormonal contraceptives, intrauterine devices, tubal ligation, and vasectomy. Despite the high number of patients with epilepsy using what are generally considered highly effective forms of birth control, the efficacy of these methods in this population "remains to be proven" according to researchers from Columbia University and Beth Israel Deaconess Medical Center. The analysis suggests that there is a need for evidence-based guidelines that demonstrate the efficacy and safety of various contraceptive methods in this special population.

Herzog AG, Mandle HB, Cahill KE, Fowler KM, Hauser WA, Davis AR. Contraceptive practices of women with epilepsy: Findings of the epilepsy birth control registry. Epilepsia. 2016;57(4):630-637. 

The Food and Drug Administration has approved lenvatinib capsules, in combination with everolimus, for the treatment of patients with advanced renal cell carcinoma following one prior antiangiogenic therapy.

Approval was based on prolonged progression-free survival (PFS) in a randomized, phase II, open-label multicenter clinical trial of 153 patients, the FDA said in a written statement.

Patients who received lenvatinib plus everolimus (n = 51) had significantly prolonged PFS, compared with patients who received only everolimus (n = 50) (14.6 months vs. 5.5 months; HR, 0.40; 95% CI, 0.24-0.68; P = .0005) but not compared with patients who received lenvatinib alone (n = 52) (7.4 months; HR, 0.66; 95% CI, 0.30-1.10; P = .12). Of patients receiving the combination of drugs, 71% experienced adverse events, compared with 79% of patients receiving lenvatinib alone and 50% of patients receiving everolimus alone. The most common treatment-related adverse events reported included diarrhea, decreased appetite, and severe fatigue.

The FDA previously granted lenvatinib, marketed as Lenvima by Eisai, a breakthrough therapy designation and priority review.

“This is the only combination regimen to significantly prolong progression-free survival … when compared with a standard of care in patients with advanced renal cell carcinoma,” representatives from Eisai said in a written statement.

Lenvatinib was previously approved for the treatment of recurrent, progressive, radioactive iodine-refractory differentiated thyroid cancer in early 2015. However, in April 2016, the FDA released a safety warning about lenvatinib capsules for oral use.

“Serious tumor-related bleeds, including fatal hemorrhagic events in Lenvima-treated patients, have occurred in clinical trials and been reported in postmarketing experience,” reported the FDA in a written statement.

The recommended lenvatinib dosage for renal cell carcinoma patients is 18 mg/day, lower than the 24 mg/day that was recommended to thyroid cancer patients prior to the FDA’s warning.

jcraig@frontlinemedcom.com

On Twitter @JessCraig_OP

The Food and Drug Administration has approved lenvatinib capsules, in combination with everolimus, for the treatment of patients with advanced renal cell carcinoma following one prior antiangiogenic therapy.

Approval was based on prolonged progression-free survival (PFS) in a randomized, phase II, open-label multicenter clinical trial of 153 patients, the FDA said in a written statement.

Patients who received lenvatinib plus everolimus (n = 51) had significantly prolonged PFS, compared with patients who received only everolimus (n = 50) (14.6 months vs. 5.5 months; HR, 0.40; 95% CI, 0.24-0.68; P = .0005) but not compared with patients who received lenvatinib alone (n = 52) (7.4 months; HR, 0.66; 95% CI, 0.30-1.10; P = .12). Of patients receiving the combination of drugs, 71% experienced adverse events, compared with 79% of patients receiving lenvatinib alone and 50% of patients receiving everolimus alone. The most common treatment-related adverse events reported included diarrhea, decreased appetite, and severe fatigue.

The FDA previously granted lenvatinib, marketed as Lenvima by Eisai, a breakthrough therapy designation and priority review.

“This is the only combination regimen to significantly prolong progression-free survival … when compared with a standard of care in patients with advanced renal cell carcinoma,” representatives from Eisai said in a written statement.

Lenvatinib was previously approved for the treatment of recurrent, progressive, radioactive iodine-refractory differentiated thyroid cancer in early 2015. However, in April 2016, the FDA released a safety warning about lenvatinib capsules for oral use.

“Serious tumor-related bleeds, including fatal hemorrhagic events in Lenvima-treated patients, have occurred in clinical trials and been reported in postmarketing experience,” reported the FDA in a written statement.

The recommended lenvatinib dosage for renal cell carcinoma patients is 18 mg/day, lower than the 24 mg/day that was recommended to thyroid cancer patients prior to the FDA’s warning.

jcraig@frontlinemedcom.com

On Twitter @JessCraig_OP

The Food and Drug Administration has approved lenvatinib capsules, in combination with everolimus, for the treatment of patients with advanced renal cell carcinoma following one prior antiangiogenic therapy.

Approval was based on prolonged progression-free survival (PFS) in a randomized, phase II, open-label multicenter clinical trial of 153 patients, the FDA said in a written statement.

Patients who received lenvatinib plus everolimus (n = 51) had significantly prolonged PFS, compared with patients who received only everolimus (n = 50) (14.6 months vs. 5.5 months; HR, 0.40; 95% CI, 0.24-0.68; P = .0005) but not compared with patients who received lenvatinib alone (n = 52) (7.4 months; HR, 0.66; 95% CI, 0.30-1.10; P = .12). Of patients receiving the combination of drugs, 71% experienced adverse events, compared with 79% of patients receiving lenvatinib alone and 50% of patients receiving everolimus alone. The most common treatment-related adverse events reported included diarrhea, decreased appetite, and severe fatigue.

The FDA previously granted lenvatinib, marketed as Lenvima by Eisai, a breakthrough therapy designation and priority review.

“This is the only combination regimen to significantly prolong progression-free survival … when compared with a standard of care in patients with advanced renal cell carcinoma,” representatives from Eisai said in a written statement.

Lenvatinib was previously approved for the treatment of recurrent, progressive, radioactive iodine-refractory differentiated thyroid cancer in early 2015. However, in April 2016, the FDA released a safety warning about lenvatinib capsules for oral use.

“Serious tumor-related bleeds, including fatal hemorrhagic events in Lenvima-treated patients, have occurred in clinical trials and been reported in postmarketing experience,” reported the FDA in a written statement.

The recommended lenvatinib dosage for renal cell carcinoma patients is 18 mg/day, lower than the 24 mg/day that was recommended to thyroid cancer patients prior to the FDA’s warning.

jcraig@frontlinemedcom.com

On Twitter @JessCraig_OP

The way Dr. Marci L. Bowers sees it, societal acceptance of transgender persons has come a long way, and the future of transgender surgery is bright.

“Who thought that we’d have our decathlon winner Bruce Jenner become Caitlyn?” Dr. Bowers said at the annual scientific meeting of the Society of Gynecologic Surgeons in Indian Wells, Calif. “Who thought that the brothers who created “The Matrix” movies [Larry and Andy Wachowski] would become sisters? All in this past year?”

As the first transgender surgeon to perform transgender surgery in North America, Dr. Bowers knows of what she speaks. In fact, she recently joined the faculty at Mount Sinai Beth Israel Medical Center in New York to help launch what she said will be the first U.S.-based surgical training program for transgender medicine in nearly 40 years.

“An academic institution doing these procedures is really revolutionary,” she said. “I think it’s going to really help how things are taught and described to practitioners.”

She said she also hopes the effort helps stem the “high percentage” of transgender teenagers who attempt or commit suicide. According to 7,261 transgender students in grades 6-12 who responded to the 2009 National School Climate Survey, 61% reported feeling unsafe at school because of their sexual orientation and 40% because of how they expressed their gender; 19% said they have been punched, kicked, or injured with a weapon on at least one occasion within the last year because of their sexual orientation and 13% because of their gender expression; and 53% reported cyberbullying because of their gender identity.

“We need to stop losing these people,” she said. “My kids are now in their early 20s. This generation is asking for honesty in the areas of sexuality and gender identity.”

Dr. Bowers, who graduated from the University of Minnesota Medical School in 1986 and did her ob.gyn. residency at the University of Washington, Seattle, characterized the notion of being “misgendered” as a biologic process. “If you look around nature, there is no single measure anywhere in biology that offers only two choices, besides gender,” said Dr. Bowers, who underwent male to female reassignment surgery at age 39. “So when you think about it, the world is represented by a spectrum; it’s represented by diversity. That’s what transgender is, the inner concept of maleness and femaleness. It can’t be just two choices. This is what’s coming to the surface as this movement takes hold.”

After practicing ob.gyn. in Seattle for 13 years, Dr. Bowers relocated to Trinidad, Colo., where she learned and began to practice transgender surgery under the tutelage of the late Dr. Stanley Biber, who performed more than 4,000 sex reassignment surgeries. After working there for 8 years, Dr. Bowers moved her practice to Burlingame, Calif., where she currently performs about 140 male to female operations each year and has a 3-year waiting list. During each 3-hour operation the testicles are removed, the glans penis becomes the clitoris, the scrotum becomes the labia majora, the urethra becomes the labia minora mucosa, the scrotum/penile skin becomes the vagina, and the Cowper’s glands and prostate are retained. Results are “rather convincing,” she said.

Most patients require a hospital stay of up to 3 days, and the most common complication is wound separation/dehiscence, which occurs in 3%-9% of cases. Out-of-pocket costs average about $25,000 per case, but a growing number of insurers now pay for the procedure.

“A dozen years ago, only one company in the Fortune 500 covered transgender surgery,” she said. “Now in our practice, nearly 90% of insurers do, about 70% of the Fortune 500 companies do, and 12 states mandate coverage for all of their citizens to be covered for transgender surgery. It’s really changed.”

In 2009 the American Medical Association passed a resolution supporting public and private insurance coverage for the treatment of gender identity disorder. According to Dr. Bowers, this came about in part because of a 2009 landmark study conducted by the National Center for Transgender Quality and the Gay and Lesbian Task Force that found that more than half of transgender and gender nonconforming people who were bullied, harassed, or assaulted in school because of their gender identity have attempted suicide. In 2011, ACOG’s Committee on Health Care for Underserved Women published an opinion on health care for transgender individuals. Part of its recommendation was that ob. gyns. “should be prepared to assist or refer transgender individuals for routine treatment and screening as well as hormonal and surgical therapies.” According to guidelines from the World Professional Association for Transgender Health (WPATH), individuals seeking transgender surgery should undergo a psychological evaluation, 1 year of cross-sex hormone therapy, and 1 year of desired gender role, and be at least 18 years of age before undergoing surgery itself.

“Gender identity is established early; this is not something that somebody wakes up with,” said Dr. Bowers, who has appeared on “The Oprah Winfrey Show,” “CBS Sunday Morning,” “Discovery Health,” and CNN, and was named one of Huffington Post’s 50 Transgender Icons. “Yes, they need to have a psychological evaluation. Yes, they need to live in their desired gender role, and yes, they need to be on hormones, but other than that, they rarely regret their decision to move forward medically and surgically. Almost never.”

During a presentation at the annual meeting of the American College of Physicians, Dr. Henry Ng noted that some transgender patients are ambivalent about undergoing gender reassignment surgery. “A lot of them don’t want surgery because it’s not a covered benefit under most health plans, it’s expensive, and it does require a lot of healing time because it’s a very invasive procedure,” said Dr. Ng of the departments of internal medicine and pediatrics at Case Western Reserve University, Cleveland. “Especially for certain procedures like phalloplasty, those procedures have not been developed to a point where we can avoid a lot of complications.”

Dr. Ng, who is also clinical director of the MetroHealth Pride Clinic in Cleveland, noted that general health screening guidelines for transgender patients can be found at www.transhealth.ucsf.edu/protocols. “The good news is that it’s really no different than that versus gender people: cardiovascular health; tobacco use; addressing issues of mood disorders/depression, in part related to the experience of microaggressions and macroaggressions from discrimination, violence, and hate-motivated violence on a day-to-day basis; thyroid disease; respiratory illnesses that may be associated with increased use of tobacco products; sexual health; and vaccinations,” he said. “These are all important to include in a general health screening for transgender people.” A free consultation service known as TransLine offers physicians clinical information about transgender issues and individualized case consultation. For information, visit www.project-health.org/transline.

According to the Human Rights Campaign’s Corporate Quality Index, scores of major employers in the United States, including 3M, Amazon.com, American Express, Boeing, General Motors, Johnson & Johnson, Morgan Stanley, Nike, Procter & Gamble, Starbucks, UnitedHealth Group, Visa, and Xerox, offer at least one transgender-inclusive health care coverage plan. A list of insurers who offer transgender health coverage can be found here. The Human Rights Campaign also notes that seven states that have both bans on insurance exclusions for transgender health care and provide transgender inclusive benefits for state employees: New York, Massachusetts, Connecticut, Rhode Island, California, Oregon, and Washington. The National Center for Transgender Quality notes that since May of 2014, Medicare coverage decisions for transition-related surgeries are “made individually on the basis of medical need and applicable standards of care, similar to other doctor or hospital services under Medicare.”

When a patient realizes that his or her employer has not opted in to cover transgender care as part of its health insurance offerings, “it’s heartbreaking to be the middle man,” Dr. Cecile Unger, a surgeon at the Cleveland Clinic center for female pelvic medicine and reconstructive surgery, said in an interview. “Some patients start calculating how much they need to save weekly or monthly [in order to pay out of pocket]. They figure out where they want to have surgery. We provide them with the exact self-pay numbers. They usually will shop around a bit to see what some of the other providers are offering. Some patients will try to get their names on the books a year-and-a-half or two ahead of time.”

The cost of procedures varies. For example, the price of a vaginoplasty at the Philadelphia Center for Transgender Surgery is $12,600, plus $7,150 in anesthesia, operating room, and hospital stay charges, for a total of $19,750. The center’s cost for female to male surgery at the center are slightly higher. For example, the price of a phalloplasty, scrotoplasty, testicular implants, glansplasty, and transposition of the clitoris is $15,500, plus $5,750 in anesthesia, OR, and hospital charges, for a total of $21,250.

Wound separation and wound-healing problems are the most common complications after gender reassignment surgery, Dr. Unger said, “but within 4-12 weeks usually those issues resolve themselves with a bit of conservative wound care, and don’t require more surgery. Infection is quite rare. Hematoma formation is not common in the first few days after surgery. In female to male procedures, there’s a bit of a risk for stricture of the urethra, which can lead to problems with voiding and fistula formation.”

Discussing realistic expectations with patients preoperatively is key, Dr. Unger said, especially in terms of scarring and cosmesis. “Most of the time you get a great result, but patients should also understand that everybody’s anatomy is different and everybody’s wound healing is different, so [they] have to be flexible and understand that secondary procedures are sometimes necessary to get the perfect outcomes,” she said.

Another procedure Dr. Bowers provides in her practice is functional clitoroplasty for females who have undergone genital mutation, a procedure that has impacted an estimated 140 million women worldwide, especially those in Indonesia. “These women often have never had orgasm in their life because all or part of the clitoris and the labia have been excised,” Dr. Bowers said. “It’s one of the great human tragedies.”

In a procedure that takes about an hour, Dr. Bowers restores refibulation and sensation for women who have been genitally mutilated – at no charge to them. “We 100% of the time find the clitoris when we do these operations,” she said. “We refibulate, we release the suspensory ligament, we anchor the clitoral body down, and that restores function. From the letters I receive, this is a miracle for these patients, to feel orgasm for the first time in your life. Imagine restoring sight to a blind person. It’s that profound.”

Dr. Bowers disclosed that she is a member of WPATH and that she serves on the board of directors of GLAAD and the Transgender Law Center. The meeting was jointly sponsored by the American College of Surgeons.

dbrunk@frontlinemedcom.com

The way Dr. Marci L. Bowers sees it, societal acceptance of transgender persons has come a long way, and the future of transgender surgery is bright.

“Who thought that we’d have our decathlon winner Bruce Jenner become Caitlyn?” Dr. Bowers said at the annual scientific meeting of the Society of Gynecologic Surgeons in Indian Wells, Calif. “Who thought that the brothers who created “The Matrix” movies [Larry and Andy Wachowski] would become sisters? All in this past year?”

As the first transgender surgeon to perform transgender surgery in North America, Dr. Bowers knows of what she speaks. In fact, she recently joined the faculty at Mount Sinai Beth Israel Medical Center in New York to help launch what she said will be the first U.S.-based surgical training program for transgender medicine in nearly 40 years.

“An academic institution doing these procedures is really revolutionary,” she said. “I think it’s going to really help how things are taught and described to practitioners.”

She said she also hopes the effort helps stem the “high percentage” of transgender teenagers who attempt or commit suicide. According to 7,261 transgender students in grades 6-12 who responded to the 2009 National School Climate Survey, 61% reported feeling unsafe at school because of their sexual orientation and 40% because of how they expressed their gender; 19% said they have been punched, kicked, or injured with a weapon on at least one occasion within the last year because of their sexual orientation and 13% because of their gender expression; and 53% reported cyberbullying because of their gender identity.

“We need to stop losing these people,” she said. “My kids are now in their early 20s. This generation is asking for honesty in the areas of sexuality and gender identity.”

Dr. Bowers, who graduated from the University of Minnesota Medical School in 1986 and did her ob.gyn. residency at the University of Washington, Seattle, characterized the notion of being “misgendered” as a biologic process. “If you look around nature, there is no single measure anywhere in biology that offers only two choices, besides gender,” said Dr. Bowers, who underwent male to female reassignment surgery at age 39. “So when you think about it, the world is represented by a spectrum; it’s represented by diversity. That’s what transgender is, the inner concept of maleness and femaleness. It can’t be just two choices. This is what’s coming to the surface as this movement takes hold.”

After practicing ob.gyn. in Seattle for 13 years, Dr. Bowers relocated to Trinidad, Colo., where she learned and began to practice transgender surgery under the tutelage of the late Dr. Stanley Biber, who performed more than 4,000 sex reassignment surgeries. After working there for 8 years, Dr. Bowers moved her practice to Burlingame, Calif., where she currently performs about 140 male to female operations each year and has a 3-year waiting list. During each 3-hour operation the testicles are removed, the glans penis becomes the clitoris, the scrotum becomes the labia majora, the urethra becomes the labia minora mucosa, the scrotum/penile skin becomes the vagina, and the Cowper’s glands and prostate are retained. Results are “rather convincing,” she said.

Most patients require a hospital stay of up to 3 days, and the most common complication is wound separation/dehiscence, which occurs in 3%-9% of cases. Out-of-pocket costs average about $25,000 per case, but a growing number of insurers now pay for the procedure.

“A dozen years ago, only one company in the Fortune 500 covered transgender surgery,” she said. “Now in our practice, nearly 90% of insurers do, about 70% of the Fortune 500 companies do, and 12 states mandate coverage for all of their citizens to be covered for transgender surgery. It’s really changed.”

In 2009 the American Medical Association passed a resolution supporting public and private insurance coverage for the treatment of gender identity disorder. According to Dr. Bowers, this came about in part because of a 2009 landmark study conducted by the National Center for Transgender Quality and the Gay and Lesbian Task Force that found that more than half of transgender and gender nonconforming people who were bullied, harassed, or assaulted in school because of their gender identity have attempted suicide. In 2011, ACOG’s Committee on Health Care for Underserved Women published an opinion on health care for transgender individuals. Part of its recommendation was that ob. gyns. “should be prepared to assist or refer transgender individuals for routine treatment and screening as well as hormonal and surgical therapies.” According to guidelines from the World Professional Association for Transgender Health (WPATH), individuals seeking transgender surgery should undergo a psychological evaluation, 1 year of cross-sex hormone therapy, and 1 year of desired gender role, and be at least 18 years of age before undergoing surgery itself.

“Gender identity is established early; this is not something that somebody wakes up with,” said Dr. Bowers, who has appeared on “The Oprah Winfrey Show,” “CBS Sunday Morning,” “Discovery Health,” and CNN, and was named one of Huffington Post’s 50 Transgender Icons. “Yes, they need to have a psychological evaluation. Yes, they need to live in their desired gender role, and yes, they need to be on hormones, but other than that, they rarely regret their decision to move forward medically and surgically. Almost never.”

During a presentation at the annual meeting of the American College of Physicians, Dr. Henry Ng noted that some transgender patients are ambivalent about undergoing gender reassignment surgery. “A lot of them don’t want surgery because it’s not a covered benefit under most health plans, it’s expensive, and it does require a lot of healing time because it’s a very invasive procedure,” said Dr. Ng of the departments of internal medicine and pediatrics at Case Western Reserve University, Cleveland. “Especially for certain procedures like phalloplasty, those procedures have not been developed to a point where we can avoid a lot of complications.”

Dr. Ng, who is also clinical director of the MetroHealth Pride Clinic in Cleveland, noted that general health screening guidelines for transgender patients can be found at www.transhealth.ucsf.edu/protocols. “The good news is that it’s really no different than that versus gender people: cardiovascular health; tobacco use; addressing issues of mood disorders/depression, in part related to the experience of microaggressions and macroaggressions from discrimination, violence, and hate-motivated violence on a day-to-day basis; thyroid disease; respiratory illnesses that may be associated with increased use of tobacco products; sexual health; and vaccinations,” he said. “These are all important to include in a general health screening for transgender people.” A free consultation service known as TransLine offers physicians clinical information about transgender issues and individualized case consultation. For information, visit www.project-health.org/transline.

According to the Human Rights Campaign’s Corporate Quality Index, scores of major employers in the United States, including 3M, Amazon.com, American Express, Boeing, General Motors, Johnson & Johnson, Morgan Stanley, Nike, Procter & Gamble, Starbucks, UnitedHealth Group, Visa, and Xerox, offer at least one transgender-inclusive health care coverage plan. A list of insurers who offer transgender health coverage can be found here. The Human Rights Campaign also notes that seven states that have both bans on insurance exclusions for transgender health care and provide transgender inclusive benefits for state employees: New York, Massachusetts, Connecticut, Rhode Island, California, Oregon, and Washington. The National Center for Transgender Quality notes that since May of 2014, Medicare coverage decisions for transition-related surgeries are “made individually on the basis of medical need and applicable standards of care, similar to other doctor or hospital services under Medicare.”

When a patient realizes that his or her employer has not opted in to cover transgender care as part of its health insurance offerings, “it’s heartbreaking to be the middle man,” Dr. Cecile Unger, a surgeon at the Cleveland Clinic center for female pelvic medicine and reconstructive surgery, said in an interview. “Some patients start calculating how much they need to save weekly or monthly [in order to pay out of pocket]. They figure out where they want to have surgery. We provide them with the exact self-pay numbers. They usually will shop around a bit to see what some of the other providers are offering. Some patients will try to get their names on the books a year-and-a-half or two ahead of time.”

The cost of procedures varies. For example, the price of a vaginoplasty at the Philadelphia Center for Transgender Surgery is $12,600, plus $7,150 in anesthesia, operating room, and hospital stay charges, for a total of $19,750. The center’s cost for female to male surgery at the center are slightly higher. For example, the price of a phalloplasty, scrotoplasty, testicular implants, glansplasty, and transposition of the clitoris is $15,500, plus $5,750 in anesthesia, OR, and hospital charges, for a total of $21,250.

Wound separation and wound-healing problems are the most common complications after gender reassignment surgery, Dr. Unger said, “but within 4-12 weeks usually those issues resolve themselves with a bit of conservative wound care, and don’t require more surgery. Infection is quite rare. Hematoma formation is not common in the first few days after surgery. In female to male procedures, there’s a bit of a risk for stricture of the urethra, which can lead to problems with voiding and fistula formation.”

Discussing realistic expectations with patients preoperatively is key, Dr. Unger said, especially in terms of scarring and cosmesis. “Most of the time you get a great result, but patients should also understand that everybody’s anatomy is different and everybody’s wound healing is different, so [they] have to be flexible and understand that secondary procedures are sometimes necessary to get the perfect outcomes,” she said.

Another procedure Dr. Bowers provides in her practice is functional clitoroplasty for females who have undergone genital mutation, a procedure that has impacted an estimated 140 million women worldwide, especially those in Indonesia. “These women often have never had orgasm in their life because all or part of the clitoris and the labia have been excised,” Dr. Bowers said. “It’s one of the great human tragedies.”

In a procedure that takes about an hour, Dr. Bowers restores refibulation and sensation for women who have been genitally mutilated – at no charge to them. “We 100% of the time find the clitoris when we do these operations,” she said. “We refibulate, we release the suspensory ligament, we anchor the clitoral body down, and that restores function. From the letters I receive, this is a miracle for these patients, to feel orgasm for the first time in your life. Imagine restoring sight to a blind person. It’s that profound.”

Dr. Bowers disclosed that she is a member of WPATH and that she serves on the board of directors of GLAAD and the Transgender Law Center. The meeting was jointly sponsored by the American College of Surgeons.

dbrunk@frontlinemedcom.com

The way Dr. Marci L. Bowers sees it, societal acceptance of transgender persons has come a long way, and the future of transgender surgery is bright.

“Who thought that we’d have our decathlon winner Bruce Jenner become Caitlyn?” Dr. Bowers said at the annual scientific meeting of the Society of Gynecologic Surgeons in Indian Wells, Calif. “Who thought that the brothers who created “The Matrix” movies [Larry and Andy Wachowski] would become sisters? All in this past year?”

As the first transgender surgeon to perform transgender surgery in North America, Dr. Bowers knows of what she speaks. In fact, she recently joined the faculty at Mount Sinai Beth Israel Medical Center in New York to help launch what she said will be the first U.S.-based surgical training program for transgender medicine in nearly 40 years.

“An academic institution doing these procedures is really revolutionary,” she said. “I think it’s going to really help how things are taught and described to practitioners.”

She said she also hopes the effort helps stem the “high percentage” of transgender teenagers who attempt or commit suicide. According to 7,261 transgender students in grades 6-12 who responded to the 2009 National School Climate Survey, 61% reported feeling unsafe at school because of their sexual orientation and 40% because of how they expressed their gender; 19% said they have been punched, kicked, or injured with a weapon on at least one occasion within the last year because of their sexual orientation and 13% because of their gender expression; and 53% reported cyberbullying because of their gender identity.

“We need to stop losing these people,” she said. “My kids are now in their early 20s. This generation is asking for honesty in the areas of sexuality and gender identity.”

Dr. Bowers, who graduated from the University of Minnesota Medical School in 1986 and did her ob.gyn. residency at the University of Washington, Seattle, characterized the notion of being “misgendered” as a biologic process. “If you look around nature, there is no single measure anywhere in biology that offers only two choices, besides gender,” said Dr. Bowers, who underwent male to female reassignment surgery at age 39. “So when you think about it, the world is represented by a spectrum; it’s represented by diversity. That’s what transgender is, the inner concept of maleness and femaleness. It can’t be just two choices. This is what’s coming to the surface as this movement takes hold.”

After practicing ob.gyn. in Seattle for 13 years, Dr. Bowers relocated to Trinidad, Colo., where she learned and began to practice transgender surgery under the tutelage of the late Dr. Stanley Biber, who performed more than 4,000 sex reassignment surgeries. After working there for 8 years, Dr. Bowers moved her practice to Burlingame, Calif., where she currently performs about 140 male to female operations each year and has a 3-year waiting list. During each 3-hour operation the testicles are removed, the glans penis becomes the clitoris, the scrotum becomes the labia majora, the urethra becomes the labia minora mucosa, the scrotum/penile skin becomes the vagina, and the Cowper’s glands and prostate are retained. Results are “rather convincing,” she said.

Most patients require a hospital stay of up to 3 days, and the most common complication is wound separation/dehiscence, which occurs in 3%-9% of cases. Out-of-pocket costs average about $25,000 per case, but a growing number of insurers now pay for the procedure.

“A dozen years ago, only one company in the Fortune 500 covered transgender surgery,” she said. “Now in our practice, nearly 90% of insurers do, about 70% of the Fortune 500 companies do, and 12 states mandate coverage for all of their citizens to be covered for transgender surgery. It’s really changed.”

In 2009 the American Medical Association passed a resolution supporting public and private insurance coverage for the treatment of gender identity disorder. According to Dr. Bowers, this came about in part because of a 2009 landmark study conducted by the National Center for Transgender Quality and the Gay and Lesbian Task Force that found that more than half of transgender and gender nonconforming people who were bullied, harassed, or assaulted in school because of their gender identity have attempted suicide. In 2011, ACOG’s Committee on Health Care for Underserved Women published an opinion on health care for transgender individuals. Part of its recommendation was that ob. gyns. “should be prepared to assist or refer transgender individuals for routine treatment and screening as well as hormonal and surgical therapies.” According to guidelines from the World Professional Association for Transgender Health (WPATH), individuals seeking transgender surgery should undergo a psychological evaluation, 1 year of cross-sex hormone therapy, and 1 year of desired gender role, and be at least 18 years of age before undergoing surgery itself.

“Gender identity is established early; this is not something that somebody wakes up with,” said Dr. Bowers, who has appeared on “The Oprah Winfrey Show,” “CBS Sunday Morning,” “Discovery Health,” and CNN, and was named one of Huffington Post’s 50 Transgender Icons. “Yes, they need to have a psychological evaluation. Yes, they need to live in their desired gender role, and yes, they need to be on hormones, but other than that, they rarely regret their decision to move forward medically and surgically. Almost never.”

During a presentation at the annual meeting of the American College of Physicians, Dr. Henry Ng noted that some transgender patients are ambivalent about undergoing gender reassignment surgery. “A lot of them don’t want surgery because it’s not a covered benefit under most health plans, it’s expensive, and it does require a lot of healing time because it’s a very invasive procedure,” said Dr. Ng of the departments of internal medicine and pediatrics at Case Western Reserve University, Cleveland. “Especially for certain procedures like phalloplasty, those procedures have not been developed to a point where we can avoid a lot of complications.”

Dr. Ng, who is also clinical director of the MetroHealth Pride Clinic in Cleveland, noted that general health screening guidelines for transgender patients can be found at www.transhealth.ucsf.edu/protocols. “The good news is that it’s really no different than that versus gender people: cardiovascular health; tobacco use; addressing issues of mood disorders/depression, in part related to the experience of microaggressions and macroaggressions from discrimination, violence, and hate-motivated violence on a day-to-day basis; thyroid disease; respiratory illnesses that may be associated with increased use of tobacco products; sexual health; and vaccinations,” he said. “These are all important to include in a general health screening for transgender people.” A free consultation service known as TransLine offers physicians clinical information about transgender issues and individualized case consultation. For information, visit www.project-health.org/transline.

According to the Human Rights Campaign’s Corporate Quality Index, scores of major employers in the United States, including 3M, Amazon.com, American Express, Boeing, General Motors, Johnson & Johnson, Morgan Stanley, Nike, Procter & Gamble, Starbucks, UnitedHealth Group, Visa, and Xerox, offer at least one transgender-inclusive health care coverage plan. A list of insurers who offer transgender health coverage can be found here. The Human Rights Campaign also notes that seven states that have both bans on insurance exclusions for transgender health care and provide transgender inclusive benefits for state employees: New York, Massachusetts, Connecticut, Rhode Island, California, Oregon, and Washington. The National Center for Transgender Quality notes that since May of 2014, Medicare coverage decisions for transition-related surgeries are “made individually on the basis of medical need and applicable standards of care, similar to other doctor or hospital services under Medicare.”

When a patient realizes that his or her employer has not opted in to cover transgender care as part of its health insurance offerings, “it’s heartbreaking to be the middle man,” Dr. Cecile Unger, a surgeon at the Cleveland Clinic center for female pelvic medicine and reconstructive surgery, said in an interview. “Some patients start calculating how much they need to save weekly or monthly [in order to pay out of pocket]. They figure out where they want to have surgery. We provide them with the exact self-pay numbers. They usually will shop around a bit to see what some of the other providers are offering. Some patients will try to get their names on the books a year-and-a-half or two ahead of time.”

The cost of procedures varies. For example, the price of a vaginoplasty at the Philadelphia Center for Transgender Surgery is $12,600, plus $7,150 in anesthesia, operating room, and hospital stay charges, for a total of $19,750. The center’s cost for female to male surgery at the center are slightly higher. For example, the price of a phalloplasty, scrotoplasty, testicular implants, glansplasty, and transposition of the clitoris is $15,500, plus $5,750 in anesthesia, OR, and hospital charges, for a total of $21,250.

Wound separation and wound-healing problems are the most common complications after gender reassignment surgery, Dr. Unger said, “but within 4-12 weeks usually those issues resolve themselves with a bit of conservative wound care, and don’t require more surgery. Infection is quite rare. Hematoma formation is not common in the first few days after surgery. In female to male procedures, there’s a bit of a risk for stricture of the urethra, which can lead to problems with voiding and fistula formation.”

Discussing realistic expectations with patients preoperatively is key, Dr. Unger said, especially in terms of scarring and cosmesis. “Most of the time you get a great result, but patients should also understand that everybody’s anatomy is different and everybody’s wound healing is different, so [they] have to be flexible and understand that secondary procedures are sometimes necessary to get the perfect outcomes,” she said.

Another procedure Dr. Bowers provides in her practice is functional clitoroplasty for females who have undergone genital mutation, a procedure that has impacted an estimated 140 million women worldwide, especially those in Indonesia. “These women often have never had orgasm in their life because all or part of the clitoris and the labia have been excised,” Dr. Bowers said. “It’s one of the great human tragedies.”

In a procedure that takes about an hour, Dr. Bowers restores refibulation and sensation for women who have been genitally mutilated – at no charge to them. “We 100% of the time find the clitoris when we do these operations,” she said. “We refibulate, we release the suspensory ligament, we anchor the clitoral body down, and that restores function. From the letters I receive, this is a miracle for these patients, to feel orgasm for the first time in your life. Imagine restoring sight to a blind person. It’s that profound.”

Dr. Bowers disclosed that she is a member of WPATH and that she serves on the board of directors of GLAAD and the Transgender Law Center. The meeting was jointly sponsored by the American College of Surgeons.

dbrunk@frontlinemedcom.com