ACS Surgery News

The bisphosphonate zolendronate didn't improve survival in patients with chemoresistant breast cancer, according to results from the phase III NATAN trial.

In an interview at the San Antonio Breast Cancer Symposium, Dr. Gunter von Minckwitz discusses the trial's results and clinical implications, and whether a role remains for bisphosphonates in postmenopausal patients.

The bisphosphonate zolendronate didn't improve survival in patients with chemoresistant breast cancer, according to results from the phase III NATAN trial.

In an interview at the San Antonio Breast Cancer Symposium, Dr. Gunter von Minckwitz discusses the trial's results and clinical implications, and whether a role remains for bisphosphonates in postmenopausal patients.

The bisphosphonate zolendronate didn't improve survival in patients with chemoresistant breast cancer, according to results from the phase III NATAN trial.

In an interview at the San Antonio Breast Cancer Symposium, Dr. Gunter von Minckwitz discusses the trial's results and clinical implications, and whether a role remains for bisphosphonates in postmenopausal patients.

Changes designed to make it easier for consumers to buy insurance through the health insurance exchanges address some concerns raised by physicians.

In a rule issued Dec. 12, the Health and Human Services department formalized a requirement that insurers give consumers until Dec. 23 to choose a health insurance plan and until midnight Dec. 31 to pay for it, in order to be considered covered on Jan. 1. State exchanges can set their own rules about Jan. 1 coverage dates, and in some cases, already have, Chiquita Brooks-Lasure, policy director for the HHS center for consumer information and insurance oversight, said during a press briefing.

Some states may elect to allow payment later than Dec. 31, she said. The HHS is asking insurers to consider accepting payment after Jan. 1 and retroactively cover services. Ms. Brooks-Lasure said that Aetna has already said it will accept payment until Jan. 8.

Insurers are also being asked to accept partial payment for the first month’s premium. Payment flexibility "will reduce the risk that patients will start the year without coverage," said Bob Doherty, senior vice president for governmental affairs and public policy at the American College of Physicians.

The agency is also "strongly encouraging" insurers to consider out-of-network providers as in network and to pay for prescription refills even if the drug is not covered under its plan – at least for the month of January.

The request has precedents, Michael Hash, director of the HHS office of health reform, said during the briefing. "This transition opportunity is quite common in the insurance world."

Mr. Doherty said the ACP hopes that "the insurance industry does its part to help ease the transition, especially by allowing patients who are in a course of treatment to keep seeing their doctors even when they are not in the plan’s network and to continue to get the drugs prescribed for them if not on the plan’s formulary."

Physician groups have asked that such a transition period be considered. At a White House meeting on Nov. 26, they expressed concern that patients in the midst of expensive or specialized treatment might experience a major disruption in care if forced to give up a particular physician or therapy when switching to a new plan.

Mr. Hash said insurers were open to accommodating new enrollees. He said the HHS and insurance companies are working together to "make sure that everyone seeking coverage effective Jan. 1 gets coverage."

The HHS also announced on Dec. 12 that the almost 86,000 individuals in the federal high-risk pool, known as the Pre-Existing Condition Insurance Plan (PCIP), have had their coverage extended to Jan. 31. Those policies had been set to expire Dec. 31.

The program has had its share of financial troubles, and in February, the HHS temporarily stopped enrolling new patients. House Republicans charged that the PCIP had been mismanaged and sought to give it more money. That never happened. On the call with reporters, Ms. Brooks Lasure said the program had spent only $4.74 billion of the $5 billion allotted to it under the Affordable Care Act (ACA), and thus, could afford to pay for the additional month.

The American Cancer Society Cancer Action Network (ACSCAN) applauded the PCIP extension. "Extending coverage under PCIP gives patients valuable additional time to select the marketplace plan that best meets their unique needs," ACSCAN president Chris Hansen said in a statement.

House Republicans, however, portrayed the PCIP policy change as "another delay" in ACA implementation. "The administration has known for many months that this law was not ready for prime time, and Americans who depend on high-risk pools would have been better served by the administration admitting their failures sooner and working with the Congress to protect these and other Americans being harmed by the health care law," House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said in a statement.

[email protected]

On Twitter @aliciaault

Changes designed to make it easier for consumers to buy insurance through the health insurance exchanges address some concerns raised by physicians.

In a rule issued Dec. 12, the Health and Human Services department formalized a requirement that insurers give consumers until Dec. 23 to choose a health insurance plan and until midnight Dec. 31 to pay for it, in order to be considered covered on Jan. 1. State exchanges can set their own rules about Jan. 1 coverage dates, and in some cases, already have, Chiquita Brooks-Lasure, policy director for the HHS center for consumer information and insurance oversight, said during a press briefing.

Some states may elect to allow payment later than Dec. 31, she said. The HHS is asking insurers to consider accepting payment after Jan. 1 and retroactively cover services. Ms. Brooks-Lasure said that Aetna has already said it will accept payment until Jan. 8.

Insurers are also being asked to accept partial payment for the first month’s premium. Payment flexibility "will reduce the risk that patients will start the year without coverage," said Bob Doherty, senior vice president for governmental affairs and public policy at the American College of Physicians.

The agency is also "strongly encouraging" insurers to consider out-of-network providers as in network and to pay for prescription refills even if the drug is not covered under its plan – at least for the month of January.

The request has precedents, Michael Hash, director of the HHS office of health reform, said during the briefing. "This transition opportunity is quite common in the insurance world."

Mr. Doherty said the ACP hopes that "the insurance industry does its part to help ease the transition, especially by allowing patients who are in a course of treatment to keep seeing their doctors even when they are not in the plan’s network and to continue to get the drugs prescribed for them if not on the plan’s formulary."

Physician groups have asked that such a transition period be considered. At a White House meeting on Nov. 26, they expressed concern that patients in the midst of expensive or specialized treatment might experience a major disruption in care if forced to give up a particular physician or therapy when switching to a new plan.

Mr. Hash said insurers were open to accommodating new enrollees. He said the HHS and insurance companies are working together to "make sure that everyone seeking coverage effective Jan. 1 gets coverage."

The HHS also announced on Dec. 12 that the almost 86,000 individuals in the federal high-risk pool, known as the Pre-Existing Condition Insurance Plan (PCIP), have had their coverage extended to Jan. 31. Those policies had been set to expire Dec. 31.

The program has had its share of financial troubles, and in February, the HHS temporarily stopped enrolling new patients. House Republicans charged that the PCIP had been mismanaged and sought to give it more money. That never happened. On the call with reporters, Ms. Brooks Lasure said the program had spent only $4.74 billion of the $5 billion allotted to it under the Affordable Care Act (ACA), and thus, could afford to pay for the additional month.

The American Cancer Society Cancer Action Network (ACSCAN) applauded the PCIP extension. "Extending coverage under PCIP gives patients valuable additional time to select the marketplace plan that best meets their unique needs," ACSCAN president Chris Hansen said in a statement.

House Republicans, however, portrayed the PCIP policy change as "another delay" in ACA implementation. "The administration has known for many months that this law was not ready for prime time, and Americans who depend on high-risk pools would have been better served by the administration admitting their failures sooner and working with the Congress to protect these and other Americans being harmed by the health care law," House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said in a statement.

[email protected]

On Twitter @aliciaault

Changes designed to make it easier for consumers to buy insurance through the health insurance exchanges address some concerns raised by physicians.

In a rule issued Dec. 12, the Health and Human Services department formalized a requirement that insurers give consumers until Dec. 23 to choose a health insurance plan and until midnight Dec. 31 to pay for it, in order to be considered covered on Jan. 1. State exchanges can set their own rules about Jan. 1 coverage dates, and in some cases, already have, Chiquita Brooks-Lasure, policy director for the HHS center for consumer information and insurance oversight, said during a press briefing.

Some states may elect to allow payment later than Dec. 31, she said. The HHS is asking insurers to consider accepting payment after Jan. 1 and retroactively cover services. Ms. Brooks-Lasure said that Aetna has already said it will accept payment until Jan. 8.

Insurers are also being asked to accept partial payment for the first month’s premium. Payment flexibility "will reduce the risk that patients will start the year without coverage," said Bob Doherty, senior vice president for governmental affairs and public policy at the American College of Physicians.

The agency is also "strongly encouraging" insurers to consider out-of-network providers as in network and to pay for prescription refills even if the drug is not covered under its plan – at least for the month of January.

The request has precedents, Michael Hash, director of the HHS office of health reform, said during the briefing. "This transition opportunity is quite common in the insurance world."

Mr. Doherty said the ACP hopes that "the insurance industry does its part to help ease the transition, especially by allowing patients who are in a course of treatment to keep seeing their doctors even when they are not in the plan’s network and to continue to get the drugs prescribed for them if not on the plan’s formulary."

Physician groups have asked that such a transition period be considered. At a White House meeting on Nov. 26, they expressed concern that patients in the midst of expensive or specialized treatment might experience a major disruption in care if forced to give up a particular physician or therapy when switching to a new plan.

Mr. Hash said insurers were open to accommodating new enrollees. He said the HHS and insurance companies are working together to "make sure that everyone seeking coverage effective Jan. 1 gets coverage."

The HHS also announced on Dec. 12 that the almost 86,000 individuals in the federal high-risk pool, known as the Pre-Existing Condition Insurance Plan (PCIP), have had their coverage extended to Jan. 31. Those policies had been set to expire Dec. 31.

The program has had its share of financial troubles, and in February, the HHS temporarily stopped enrolling new patients. House Republicans charged that the PCIP had been mismanaged and sought to give it more money. That never happened. On the call with reporters, Ms. Brooks Lasure said the program had spent only $4.74 billion of the $5 billion allotted to it under the Affordable Care Act (ACA), and thus, could afford to pay for the additional month.

The American Cancer Society Cancer Action Network (ACSCAN) applauded the PCIP extension. "Extending coverage under PCIP gives patients valuable additional time to select the marketplace plan that best meets their unique needs," ACSCAN president Chris Hansen said in a statement.

House Republicans, however, portrayed the PCIP policy change as "another delay" in ACA implementation. "The administration has known for many months that this law was not ready for prime time, and Americans who depend on high-risk pools would have been better served by the administration admitting their failures sooner and working with the Congress to protect these and other Americans being harmed by the health care law," House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said in a statement.

[email protected]

On Twitter @aliciaault

WASHINGTON – The medical understanding of shock and trauma resuscitation has evolved over many decades. But cutting-edge research is revolutionizing the understanding of the mechanisms of trauma and will eventually have a profound impact on treatment models, according to Dr. Ronald V. Maier.

Dr. Maier, an ACS Fellow and the Jane and Donald D. Trunkey Professor and vice-chair of the department of surgery at the University of Washington, Seattle, delivered the Scudder Oration on Trauma during the American College of Surgeons Clinical Congress. He discussed the development of treatment models for trauma resuscitation in the 20th century, beginning with Cannon’s toxins theory of shock (Cannon WB. Traumatic Shock. New York: D. Appleton & Co; 1923), and continuing into the 1930s with Blalock’s pioneering work in developing the homeostasis theory of trauma treatment (Arch. Surg.1934;29:837-57) .

Many advancements in the theory of trauma came out of experiences on the battlefields of World War I, World War II, the Korean War, and the Vietnam War, he said.

The progression of ideas about treatment also evolved, beginning with a minimalist approach developed during World War I to the more interventionist models involving blood transfusion developed during the Korean War era, leading to a focus on crystalloid resuscitation and oxygen deficit that became prominent during the Vietnam War.

Dr. Maier traced the progression of interventionist strategies, each supplanted by new models based on improved understanding of the mechanism of trauma and a growing realization that many of the earlier approaches amounted to overtreatment with limited improvement in survival rates.

The recent paradigm is summed up as hypotensive resuscitation, meaning damage control and supporting blood pressure without reaching normotension, taking account of the natural coagulation process that occurs in the body in response to trauma.

"The goal is to recognize that if we try to chase interventions until they’ve completely corrected the system they impact, we will end up overtreating and having all the harmful effects of the treatment," Dr. Maier said.

Dr. Maier discussed the emerging "genomic storm" model of the mechanisms of trauma that zeros in on patterns of genetic expression. "In the overall genomic response of injured patients, there is a major change in the genomic activity. After a major injury, [the expression of] 80% of the genes change significantly." Damage to the immune system is evident, especially as reflected in down regulation of T-cell pathways and responses.

Dr. Maier’s research efforts have yielded new insight into the nature of that genomic shift. "What we were able to show is that in the patients who develop major complications vs. those who do not develop complications after severe injury, there is a limited number of genes that have a marked difference in reactivity." Sixty-four genes have been identified as having a bearing on the risk of complications.

The path to recovery involves a return of those patterns to a pre-trauma state. And the pursuit of a treatment model from this new understanding of the trauma mechanism means finding a way of predicting which patients will achieve that pre-trauma pattern and which will need intervention to prevent complicated outcomes.

The next step in this line of research will involve close scrutiny of individual responses to interventions, with a focus on timing and amounts. The details of the human body’s natural response to trauma are largely unknown, so this research will be expensive and time consuming, but according to Dr. Maier, necessary if progress is to be made in treatment models.

Dr. Maier described the emerging paradigm of trauma resuscitation in terms of chaos theory. Chaos theory in the context of trauma means that for the highly complex biological system that is the human body, small early perturbations can create significant changes in outcome. An example would be a small blood transfusion early in the treatment process of a trauma patient could have a profoundly positive impact on outcomes.

Dr. Maier argued that future treatment models will involve giving patients the correct treatment at the correct time and in the correct amounts based on the particular characteristics of the patient and the injury as determined by an understanding of their genetic response pattern and timing. "We have just been funded to develop a bedside test where, with a half cc of blood, we can test the 64 genes, and hopefully, by trending the responses ... we can predict patients who are going to have numerous, severe complications vs. those patients who will not," he said.

Despite the advances that have been made, Dr. Maier acknowledged the remaining challenges in transforming trauma resuscitation. "The holy grail is to be able to identify what patient needs what therapy. That is what we are still aspiring to find, and we have not achieved it yet."

Dr. Maier stated that he had no disclosures.

[email protected]

WASHINGTON – The medical understanding of shock and trauma resuscitation has evolved over many decades. But cutting-edge research is revolutionizing the understanding of the mechanisms of trauma and will eventually have a profound impact on treatment models, according to Dr. Ronald V. Maier.

Dr. Maier, an ACS Fellow and the Jane and Donald D. Trunkey Professor and vice-chair of the department of surgery at the University of Washington, Seattle, delivered the Scudder Oration on Trauma during the American College of Surgeons Clinical Congress. He discussed the development of treatment models for trauma resuscitation in the 20th century, beginning with Cannon’s toxins theory of shock (Cannon WB. Traumatic Shock. New York: D. Appleton & Co; 1923), and continuing into the 1930s with Blalock’s pioneering work in developing the homeostasis theory of trauma treatment (Arch. Surg.1934;29:837-57) .

Many advancements in the theory of trauma came out of experiences on the battlefields of World War I, World War II, the Korean War, and the Vietnam War, he said.

The progression of ideas about treatment also evolved, beginning with a minimalist approach developed during World War I to the more interventionist models involving blood transfusion developed during the Korean War era, leading to a focus on crystalloid resuscitation and oxygen deficit that became prominent during the Vietnam War.

Dr. Maier traced the progression of interventionist strategies, each supplanted by new models based on improved understanding of the mechanism of trauma and a growing realization that many of the earlier approaches amounted to overtreatment with limited improvement in survival rates.

The recent paradigm is summed up as hypotensive resuscitation, meaning damage control and supporting blood pressure without reaching normotension, taking account of the natural coagulation process that occurs in the body in response to trauma.

"The goal is to recognize that if we try to chase interventions until they’ve completely corrected the system they impact, we will end up overtreating and having all the harmful effects of the treatment," Dr. Maier said.

Dr. Maier discussed the emerging "genomic storm" model of the mechanisms of trauma that zeros in on patterns of genetic expression. "In the overall genomic response of injured patients, there is a major change in the genomic activity. After a major injury, [the expression of] 80% of the genes change significantly." Damage to the immune system is evident, especially as reflected in down regulation of T-cell pathways and responses.

Dr. Maier’s research efforts have yielded new insight into the nature of that genomic shift. "What we were able to show is that in the patients who develop major complications vs. those who do not develop complications after severe injury, there is a limited number of genes that have a marked difference in reactivity." Sixty-four genes have been identified as having a bearing on the risk of complications.

The path to recovery involves a return of those patterns to a pre-trauma state. And the pursuit of a treatment model from this new understanding of the trauma mechanism means finding a way of predicting which patients will achieve that pre-trauma pattern and which will need intervention to prevent complicated outcomes.

The next step in this line of research will involve close scrutiny of individual responses to interventions, with a focus on timing and amounts. The details of the human body’s natural response to trauma are largely unknown, so this research will be expensive and time consuming, but according to Dr. Maier, necessary if progress is to be made in treatment models.

Dr. Maier described the emerging paradigm of trauma resuscitation in terms of chaos theory. Chaos theory in the context of trauma means that for the highly complex biological system that is the human body, small early perturbations can create significant changes in outcome. An example would be a small blood transfusion early in the treatment process of a trauma patient could have a profoundly positive impact on outcomes.

Dr. Maier argued that future treatment models will involve giving patients the correct treatment at the correct time and in the correct amounts based on the particular characteristics of the patient and the injury as determined by an understanding of their genetic response pattern and timing. "We have just been funded to develop a bedside test where, with a half cc of blood, we can test the 64 genes, and hopefully, by trending the responses ... we can predict patients who are going to have numerous, severe complications vs. those patients who will not," he said.

Despite the advances that have been made, Dr. Maier acknowledged the remaining challenges in transforming trauma resuscitation. "The holy grail is to be able to identify what patient needs what therapy. That is what we are still aspiring to find, and we have not achieved it yet."

Dr. Maier stated that he had no disclosures.

[email protected]

WASHINGTON – The medical understanding of shock and trauma resuscitation has evolved over many decades. But cutting-edge research is revolutionizing the understanding of the mechanisms of trauma and will eventually have a profound impact on treatment models, according to Dr. Ronald V. Maier.

Dr. Maier, an ACS Fellow and the Jane and Donald D. Trunkey Professor and vice-chair of the department of surgery at the University of Washington, Seattle, delivered the Scudder Oration on Trauma during the American College of Surgeons Clinical Congress. He discussed the development of treatment models for trauma resuscitation in the 20th century, beginning with Cannon’s toxins theory of shock (Cannon WB. Traumatic Shock. New York: D. Appleton & Co; 1923), and continuing into the 1930s with Blalock’s pioneering work in developing the homeostasis theory of trauma treatment (Arch. Surg.1934;29:837-57) .

Many advancements in the theory of trauma came out of experiences on the battlefields of World War I, World War II, the Korean War, and the Vietnam War, he said.

The progression of ideas about treatment also evolved, beginning with a minimalist approach developed during World War I to the more interventionist models involving blood transfusion developed during the Korean War era, leading to a focus on crystalloid resuscitation and oxygen deficit that became prominent during the Vietnam War.

Dr. Maier traced the progression of interventionist strategies, each supplanted by new models based on improved understanding of the mechanism of trauma and a growing realization that many of the earlier approaches amounted to overtreatment with limited improvement in survival rates.

The recent paradigm is summed up as hypotensive resuscitation, meaning damage control and supporting blood pressure without reaching normotension, taking account of the natural coagulation process that occurs in the body in response to trauma.

"The goal is to recognize that if we try to chase interventions until they’ve completely corrected the system they impact, we will end up overtreating and having all the harmful effects of the treatment," Dr. Maier said.

Dr. Maier discussed the emerging "genomic storm" model of the mechanisms of trauma that zeros in on patterns of genetic expression. "In the overall genomic response of injured patients, there is a major change in the genomic activity. After a major injury, [the expression of] 80% of the genes change significantly." Damage to the immune system is evident, especially as reflected in down regulation of T-cell pathways and responses.

Dr. Maier’s research efforts have yielded new insight into the nature of that genomic shift. "What we were able to show is that in the patients who develop major complications vs. those who do not develop complications after severe injury, there is a limited number of genes that have a marked difference in reactivity." Sixty-four genes have been identified as having a bearing on the risk of complications.

The path to recovery involves a return of those patterns to a pre-trauma state. And the pursuit of a treatment model from this new understanding of the trauma mechanism means finding a way of predicting which patients will achieve that pre-trauma pattern and which will need intervention to prevent complicated outcomes.

The next step in this line of research will involve close scrutiny of individual responses to interventions, with a focus on timing and amounts. The details of the human body’s natural response to trauma are largely unknown, so this research will be expensive and time consuming, but according to Dr. Maier, necessary if progress is to be made in treatment models.

Dr. Maier described the emerging paradigm of trauma resuscitation in terms of chaos theory. Chaos theory in the context of trauma means that for the highly complex biological system that is the human body, small early perturbations can create significant changes in outcome. An example would be a small blood transfusion early in the treatment process of a trauma patient could have a profoundly positive impact on outcomes.

Dr. Maier argued that future treatment models will involve giving patients the correct treatment at the correct time and in the correct amounts based on the particular characteristics of the patient and the injury as determined by an understanding of their genetic response pattern and timing. "We have just been funded to develop a bedside test where, with a half cc of blood, we can test the 64 genes, and hopefully, by trending the responses ... we can predict patients who are going to have numerous, severe complications vs. those patients who will not," he said.

Despite the advances that have been made, Dr. Maier acknowledged the remaining challenges in transforming trauma resuscitation. "The holy grail is to be able to identify what patient needs what therapy. That is what we are still aspiring to find, and we have not achieved it yet."

Dr. Maier stated that he had no disclosures.

[email protected]

WASHINGTON – The political violence that plagued Northern Ireland for nearly 40 years has subsided, and the memories of those dark days in Belfast have begun to fade. But for Roy A. J. Spence, OBE, J.D., M.D., LL.D., FRCS, those years of treating trauma patients in the emergency room of the Royal Victoria Hospital in that city served as an important opportunity for learning and service.

Dr. Spence worked with a team of surgeons and other staff to treat thousands of victims of bombings, shootings, torture, kneecapping, and assault that happened in the context of clashes between two sides of a sectarian conflict and the British Army. Dr. Spence, who delivered the I.S. Ravdin Lecture in the Basic and Surgical Sciences during the annual clinical congress of the American College of Surgeons, discussed his experiences and lessons learned.

During the worst period of The Troubles, as the conflict is called, emergency room surgeons were treating what were essentially combat injuries in an urban hospital setting. The great majority of the injuries in Belfast occurred within 1 mile of the Royal Victoria Hospital and the Belfast City Hospital, "some at the door of the hospital, some within the hospital, and we even had one patient shot in a bed in the hospital," he said. One victim was killed in the presence of Dr. Spence in the ER.

Dr. Spence, now professor and head of the department of surgery, imaging, and perioperative medicine at Queen’s University of Belfast, stated that despite the at times overwhelming numbers of injured that flooded into the ER, 90% of patients were delivered to the ER within 30 minutes and 50% within 15 minutes. The staff developed systems to speed patients through the ER to treatment and surgery if needed. In 1972 alone, 20,000 individuals were injured in various ways, and most of these injuries occurred in Belfast.

In addition to a streamlined admission process, the surgeons developed their protocol based on lessons learned over the years.

"We had disaster plans, but, in truth, we almost never had a rehearsal. The rehearsals were for real. The rehearsals were occurring day by day."

It became clear in the early years of the conflict that, in most cases, patients were best served if the doctors stayed at the hospital to receive patients instead of rushing to the scene of a bombing or shooting. "We were almost a nuisance if we went to the scene, because there was often continuing gunfire, there were secondary explosions, and sometimes the bodies themselves were booby-trapped."

In addition, the system of handling large numbers of injured patients worked best if there was a senior surgeon and senior nurse at the door to triage patients. Those with minor injuries were taken to a separate room for treatment.

It was also important that one senior surgeon took charge of the situation and led the team. Surgeons discovered that in these crisis situations, x-raying patients could turn into a bottleneck in the treatment process, leading to dangerous delays, so at times surgery proceeded without imaging to save a patient’s life.

Dr. Spence said that the Royal Victoria distinguished itself in treating patients in the midst of a civil war by upholding the highest standards of care, documenting cases thoroughly, and treating all patients with the same level of care. Although the duty surgeons lived in the community, knew many of the victims, were aware of which group had carried out an attack, and even had family members killed in the conflict, Dr. Spence asserted that they maintained their professional standards and did not allow politics to deter them from their duties as physicians.

In the peak years of violence, the early 1970s to the early 1980s, two types of injuries – gunshot wounds to the head and kneecapping trauma – led to innovative treatment plans. The hospital established the standard of care for gunshot wounds to the head in that era, and also pioneered the use of vascular shunts to treat blast-injured limbs. The vascular shunt in particular was considered invaluable by Dr. Spence. This procedure reduced the number of amputations in cases of limb trauma from one-third to less than 10% and "allowed a very unhurried fracture reduction and external fixation."

Dr. Spence noted that general surgeons were valued in the ER because of their capacity to deal with a wide variety of injuries and because of the potentially fatal delays caused by waiting for a specialist. Although specialists were definitely needed and utilized in complex cases, most patients were treated by general surgeons. "I come from a generation that could do chest and abdominal surgery and amputations," said Dr. Spence.

Staff doctors were on call every other night and worked very long hours, a situation no longer allowed in U.K. hospitals. Surgeons worked "until the work was done" to care for all the injured and to maintain continuity of care. "There could be 100 injured people in the ER. You couldn’t just walk out at half past five."

In conclusion, Dr. Spence noted that the extended crisis of violence and trauma resulted in a close-knit "band of brothers, and occasionally, sisters" who worked in trying circumstances as colleagues. Many of those colleagues have left surgery or have died relatively young, and Dr. Spence intended his lecture to be a tribute to their service, dedication, and sacrifice in troubled times.

[email protected]

WASHINGTON – The political violence that plagued Northern Ireland for nearly 40 years has subsided, and the memories of those dark days in Belfast have begun to fade. But for Roy A. J. Spence, OBE, J.D., M.D., LL.D., FRCS, those years of treating trauma patients in the emergency room of the Royal Victoria Hospital in that city served as an important opportunity for learning and service.

Dr. Spence worked with a team of surgeons and other staff to treat thousands of victims of bombings, shootings, torture, kneecapping, and assault that happened in the context of clashes between two sides of a sectarian conflict and the British Army. Dr. Spence, who delivered the I.S. Ravdin Lecture in the Basic and Surgical Sciences during the annual clinical congress of the American College of Surgeons, discussed his experiences and lessons learned.

During the worst period of The Troubles, as the conflict is called, emergency room surgeons were treating what were essentially combat injuries in an urban hospital setting. The great majority of the injuries in Belfast occurred within 1 mile of the Royal Victoria Hospital and the Belfast City Hospital, "some at the door of the hospital, some within the hospital, and we even had one patient shot in a bed in the hospital," he said. One victim was killed in the presence of Dr. Spence in the ER.

Dr. Spence, now professor and head of the department of surgery, imaging, and perioperative medicine at Queen’s University of Belfast, stated that despite the at times overwhelming numbers of injured that flooded into the ER, 90% of patients were delivered to the ER within 30 minutes and 50% within 15 minutes. The staff developed systems to speed patients through the ER to treatment and surgery if needed. In 1972 alone, 20,000 individuals were injured in various ways, and most of these injuries occurred in Belfast.

In addition to a streamlined admission process, the surgeons developed their protocol based on lessons learned over the years.

"We had disaster plans, but, in truth, we almost never had a rehearsal. The rehearsals were for real. The rehearsals were occurring day by day."

It became clear in the early years of the conflict that, in most cases, patients were best served if the doctors stayed at the hospital to receive patients instead of rushing to the scene of a bombing or shooting. "We were almost a nuisance if we went to the scene, because there was often continuing gunfire, there were secondary explosions, and sometimes the bodies themselves were booby-trapped."

In addition, the system of handling large numbers of injured patients worked best if there was a senior surgeon and senior nurse at the door to triage patients. Those with minor injuries were taken to a separate room for treatment.

It was also important that one senior surgeon took charge of the situation and led the team. Surgeons discovered that in these crisis situations, x-raying patients could turn into a bottleneck in the treatment process, leading to dangerous delays, so at times surgery proceeded without imaging to save a patient’s life.

Dr. Spence said that the Royal Victoria distinguished itself in treating patients in the midst of a civil war by upholding the highest standards of care, documenting cases thoroughly, and treating all patients with the same level of care. Although the duty surgeons lived in the community, knew many of the victims, were aware of which group had carried out an attack, and even had family members killed in the conflict, Dr. Spence asserted that they maintained their professional standards and did not allow politics to deter them from their duties as physicians.

In the peak years of violence, the early 1970s to the early 1980s, two types of injuries – gunshot wounds to the head and kneecapping trauma – led to innovative treatment plans. The hospital established the standard of care for gunshot wounds to the head in that era, and also pioneered the use of vascular shunts to treat blast-injured limbs. The vascular shunt in particular was considered invaluable by Dr. Spence. This procedure reduced the number of amputations in cases of limb trauma from one-third to less than 10% and "allowed a very unhurried fracture reduction and external fixation."

Dr. Spence noted that general surgeons were valued in the ER because of their capacity to deal with a wide variety of injuries and because of the potentially fatal delays caused by waiting for a specialist. Although specialists were definitely needed and utilized in complex cases, most patients were treated by general surgeons. "I come from a generation that could do chest and abdominal surgery and amputations," said Dr. Spence.

Staff doctors were on call every other night and worked very long hours, a situation no longer allowed in U.K. hospitals. Surgeons worked "until the work was done" to care for all the injured and to maintain continuity of care. "There could be 100 injured people in the ER. You couldn’t just walk out at half past five."

In conclusion, Dr. Spence noted that the extended crisis of violence and trauma resulted in a close-knit "band of brothers, and occasionally, sisters" who worked in trying circumstances as colleagues. Many of those colleagues have left surgery or have died relatively young, and Dr. Spence intended his lecture to be a tribute to their service, dedication, and sacrifice in troubled times.

[email protected]

WASHINGTON – The political violence that plagued Northern Ireland for nearly 40 years has subsided, and the memories of those dark days in Belfast have begun to fade. But for Roy A. J. Spence, OBE, J.D., M.D., LL.D., FRCS, those years of treating trauma patients in the emergency room of the Royal Victoria Hospital in that city served as an important opportunity for learning and service.

Dr. Spence worked with a team of surgeons and other staff to treat thousands of victims of bombings, shootings, torture, kneecapping, and assault that happened in the context of clashes between two sides of a sectarian conflict and the British Army. Dr. Spence, who delivered the I.S. Ravdin Lecture in the Basic and Surgical Sciences during the annual clinical congress of the American College of Surgeons, discussed his experiences and lessons learned.

During the worst period of The Troubles, as the conflict is called, emergency room surgeons were treating what were essentially combat injuries in an urban hospital setting. The great majority of the injuries in Belfast occurred within 1 mile of the Royal Victoria Hospital and the Belfast City Hospital, "some at the door of the hospital, some within the hospital, and we even had one patient shot in a bed in the hospital," he said. One victim was killed in the presence of Dr. Spence in the ER.

Dr. Spence, now professor and head of the department of surgery, imaging, and perioperative medicine at Queen’s University of Belfast, stated that despite the at times overwhelming numbers of injured that flooded into the ER, 90% of patients were delivered to the ER within 30 minutes and 50% within 15 minutes. The staff developed systems to speed patients through the ER to treatment and surgery if needed. In 1972 alone, 20,000 individuals were injured in various ways, and most of these injuries occurred in Belfast.

In addition to a streamlined admission process, the surgeons developed their protocol based on lessons learned over the years.

"We had disaster plans, but, in truth, we almost never had a rehearsal. The rehearsals were for real. The rehearsals were occurring day by day."

It became clear in the early years of the conflict that, in most cases, patients were best served if the doctors stayed at the hospital to receive patients instead of rushing to the scene of a bombing or shooting. "We were almost a nuisance if we went to the scene, because there was often continuing gunfire, there were secondary explosions, and sometimes the bodies themselves were booby-trapped."

In addition, the system of handling large numbers of injured patients worked best if there was a senior surgeon and senior nurse at the door to triage patients. Those with minor injuries were taken to a separate room for treatment.

It was also important that one senior surgeon took charge of the situation and led the team. Surgeons discovered that in these crisis situations, x-raying patients could turn into a bottleneck in the treatment process, leading to dangerous delays, so at times surgery proceeded without imaging to save a patient’s life.

Dr. Spence said that the Royal Victoria distinguished itself in treating patients in the midst of a civil war by upholding the highest standards of care, documenting cases thoroughly, and treating all patients with the same level of care. Although the duty surgeons lived in the community, knew many of the victims, were aware of which group had carried out an attack, and even had family members killed in the conflict, Dr. Spence asserted that they maintained their professional standards and did not allow politics to deter them from their duties as physicians.

In the peak years of violence, the early 1970s to the early 1980s, two types of injuries – gunshot wounds to the head and kneecapping trauma – led to innovative treatment plans. The hospital established the standard of care for gunshot wounds to the head in that era, and also pioneered the use of vascular shunts to treat blast-injured limbs. The vascular shunt in particular was considered invaluable by Dr. Spence. This procedure reduced the number of amputations in cases of limb trauma from one-third to less than 10% and "allowed a very unhurried fracture reduction and external fixation."

Dr. Spence noted that general surgeons were valued in the ER because of their capacity to deal with a wide variety of injuries and because of the potentially fatal delays caused by waiting for a specialist. Although specialists were definitely needed and utilized in complex cases, most patients were treated by general surgeons. "I come from a generation that could do chest and abdominal surgery and amputations," said Dr. Spence.

Staff doctors were on call every other night and worked very long hours, a situation no longer allowed in U.K. hospitals. Surgeons worked "until the work was done" to care for all the injured and to maintain continuity of care. "There could be 100 injured people in the ER. You couldn’t just walk out at half past five."

In conclusion, Dr. Spence noted that the extended crisis of violence and trauma resulted in a close-knit "band of brothers, and occasionally, sisters" who worked in trying circumstances as colleagues. Many of those colleagues have left surgery or have died relatively young, and Dr. Spence intended his lecture to be a tribute to their service, dedication, and sacrifice in troubled times.

[email protected]

WASHINGTON – Years of research have taught us that when it comes to heath care delivery, there is no relationship between cost and quality, according to Dr. Glenn D. Steele, the president and CEO of Geisinger Health System. Dr. Steele delivered the 2013 Commission on Cancer Oncology Lecture at the annual clinical congress of the American College of Surgeons.

Geisinger Health System, based in Danville, Pa., is a renowned leader in transforming health care delivery through innovative multi-institution collaboration and an emphasis on consistent use of best practices and evidence-based medicine, he said. The goal over the past decade has been to reengineer complex medical care to improve quality and reduce costs. Dr. Steele asserted that these two goals are not mutually exclusive.

"We now believe that if you look at a patient cohort – whether it is hospital based or whether it’s ambulatory care – for folks with three, four, or five chronic diseases, you find that the population with the highest costs has also the least-quality health care ... more often than not, high cost equals a less-than-optimal outcome," he said.

At the heart of the reengineering concept is the recognition that many patients in conventional treatment situations end up with what Dr. Steele referred to as "unjustified variation" in the execution of the treatment. A noted study by Little et al. showed that only half of patients treated for lung cancer, for example, receive the recommended care (Ann. Thorac. Surg. 2005;80:2051-6). The Geisinger Health System tackled the problem of unwarranted variation in treatment and "road tested" a wide range of innovations involving standardization of treatment, electronic data gathering and tracking, and institutional culture change.

The ProvenCare model was developed to incorporate all the initiatives that had been researched and tested at Geisinger, and the model was first applied in 2005 to coronary artery bypass grafting (CABG). This application of ProvenCare showed that "an improvement model that embeds evidence-based medicine into the workflow, applies the principles of reliability science (standardization, error proofing, and failure mode redesign) to the care redesign process, employs effective data feedback strategies, and engages patients in their care results in the right care delivered 100% of the time with better patient outcomes" (CA: A Cancer Journal for Clinicians 2011;61:382-96). The model has since been applied to hip replacement surgery, percutaneous coronary intervention, and cataract surgery.

Dr. Steele gave an update on a recent ProvenCare project, a model for treatment of resectable non–small cell lung cancer. The project is a collaboration between Geisinger and the American College of Surgeons Commission on Cancer. The initial survey of lung cancer care revealed substantial room for improvement. The ProvenCare goals initially were to standardize care; build in redundancy to make sure all tasks are done; bundle related tasks; build teams, feedback protocols, and training models; move toward a multi-institutional collaboration; and achieve widespread change in institutional practices, protocol, and culture of care. The project involved an 18-month period of training and testing in the participating institutions.

Engagement of patients and a "very well-articulated set of expectations" were a critical part of the ProvenCare model. The challenge involved achieving 100% compliance across the many institutions

Geisinger has created an insurance company that has some role in controlling costs. Dr. Steele estimated that many resources spent in health care are wasted. "If we could figure out how to extract much of that 25%-30% of needless cost, we can redistribute it. ... Some of that redistribution would go to our bottom line and allow us to grow programs and make our balance sheet comfortable. ... Some of that value would go back to our insurance company and to the middle-size and small businesses that are buying our insurance premiums." This is where cost savings are reducing the cost of premiums and "giving some of that value back to consumers."

Dr. Steele said, "In most industries where you have reengineered whatever it is you are doing, you’ve got better outcomes on both the quality side and the cost side, and you are in heavy-duty competition in the consolidating market. What do you do? You lower your price. And you maintain your contribution margin. And you run your competition out of business. We don’t think that way in health care. But my bet is, in 5 years, we will think that way."

Ultimately, the drive to lower costs goes hand in hand with improving quality of care, he said. "If you believe that, and you are a professional driven to help your patients, you are much more enthusiastic about reengineering than simply working to keep costs down."

[email protected]

WASHINGTON – Years of research have taught us that when it comes to heath care delivery, there is no relationship between cost and quality, according to Dr. Glenn D. Steele, the president and CEO of Geisinger Health System. Dr. Steele delivered the 2013 Commission on Cancer Oncology Lecture at the annual clinical congress of the American College of Surgeons.

Geisinger Health System, based in Danville, Pa., is a renowned leader in transforming health care delivery through innovative multi-institution collaboration and an emphasis on consistent use of best practices and evidence-based medicine, he said. The goal over the past decade has been to reengineer complex medical care to improve quality and reduce costs. Dr. Steele asserted that these two goals are not mutually exclusive.

"We now believe that if you look at a patient cohort – whether it is hospital based or whether it’s ambulatory care – for folks with three, four, or five chronic diseases, you find that the population with the highest costs has also the least-quality health care ... more often than not, high cost equals a less-than-optimal outcome," he said.

At the heart of the reengineering concept is the recognition that many patients in conventional treatment situations end up with what Dr. Steele referred to as "unjustified variation" in the execution of the treatment. A noted study by Little et al. showed that only half of patients treated for lung cancer, for example, receive the recommended care (Ann. Thorac. Surg. 2005;80:2051-6). The Geisinger Health System tackled the problem of unwarranted variation in treatment and "road tested" a wide range of innovations involving standardization of treatment, electronic data gathering and tracking, and institutional culture change.

The ProvenCare model was developed to incorporate all the initiatives that had been researched and tested at Geisinger, and the model was first applied in 2005 to coronary artery bypass grafting (CABG). This application of ProvenCare showed that "an improvement model that embeds evidence-based medicine into the workflow, applies the principles of reliability science (standardization, error proofing, and failure mode redesign) to the care redesign process, employs effective data feedback strategies, and engages patients in their care results in the right care delivered 100% of the time with better patient outcomes" (CA: A Cancer Journal for Clinicians 2011;61:382-96). The model has since been applied to hip replacement surgery, percutaneous coronary intervention, and cataract surgery.

Dr. Steele gave an update on a recent ProvenCare project, a model for treatment of resectable non–small cell lung cancer. The project is a collaboration between Geisinger and the American College of Surgeons Commission on Cancer. The initial survey of lung cancer care revealed substantial room for improvement. The ProvenCare goals initially were to standardize care; build in redundancy to make sure all tasks are done; bundle related tasks; build teams, feedback protocols, and training models; move toward a multi-institutional collaboration; and achieve widespread change in institutional practices, protocol, and culture of care. The project involved an 18-month period of training and testing in the participating institutions.

Engagement of patients and a "very well-articulated set of expectations" were a critical part of the ProvenCare model. The challenge involved achieving 100% compliance across the many institutions

Geisinger has created an insurance company that has some role in controlling costs. Dr. Steele estimated that many resources spent in health care are wasted. "If we could figure out how to extract much of that 25%-30% of needless cost, we can redistribute it. ... Some of that redistribution would go to our bottom line and allow us to grow programs and make our balance sheet comfortable. ... Some of that value would go back to our insurance company and to the middle-size and small businesses that are buying our insurance premiums." This is where cost savings are reducing the cost of premiums and "giving some of that value back to consumers."

Dr. Steele said, "In most industries where you have reengineered whatever it is you are doing, you’ve got better outcomes on both the quality side and the cost side, and you are in heavy-duty competition in the consolidating market. What do you do? You lower your price. And you maintain your contribution margin. And you run your competition out of business. We don’t think that way in health care. But my bet is, in 5 years, we will think that way."

Ultimately, the drive to lower costs goes hand in hand with improving quality of care, he said. "If you believe that, and you are a professional driven to help your patients, you are much more enthusiastic about reengineering than simply working to keep costs down."

[email protected]

WASHINGTON – Years of research have taught us that when it comes to heath care delivery, there is no relationship between cost and quality, according to Dr. Glenn D. Steele, the president and CEO of Geisinger Health System. Dr. Steele delivered the 2013 Commission on Cancer Oncology Lecture at the annual clinical congress of the American College of Surgeons.

Geisinger Health System, based in Danville, Pa., is a renowned leader in transforming health care delivery through innovative multi-institution collaboration and an emphasis on consistent use of best practices and evidence-based medicine, he said. The goal over the past decade has been to reengineer complex medical care to improve quality and reduce costs. Dr. Steele asserted that these two goals are not mutually exclusive.

"We now believe that if you look at a patient cohort – whether it is hospital based or whether it’s ambulatory care – for folks with three, four, or five chronic diseases, you find that the population with the highest costs has also the least-quality health care ... more often than not, high cost equals a less-than-optimal outcome," he said.

At the heart of the reengineering concept is the recognition that many patients in conventional treatment situations end up with what Dr. Steele referred to as "unjustified variation" in the execution of the treatment. A noted study by Little et al. showed that only half of patients treated for lung cancer, for example, receive the recommended care (Ann. Thorac. Surg. 2005;80:2051-6). The Geisinger Health System tackled the problem of unwarranted variation in treatment and "road tested" a wide range of innovations involving standardization of treatment, electronic data gathering and tracking, and institutional culture change.

The ProvenCare model was developed to incorporate all the initiatives that had been researched and tested at Geisinger, and the model was first applied in 2005 to coronary artery bypass grafting (CABG). This application of ProvenCare showed that "an improvement model that embeds evidence-based medicine into the workflow, applies the principles of reliability science (standardization, error proofing, and failure mode redesign) to the care redesign process, employs effective data feedback strategies, and engages patients in their care results in the right care delivered 100% of the time with better patient outcomes" (CA: A Cancer Journal for Clinicians 2011;61:382-96). The model has since been applied to hip replacement surgery, percutaneous coronary intervention, and cataract surgery.

Dr. Steele gave an update on a recent ProvenCare project, a model for treatment of resectable non–small cell lung cancer. The project is a collaboration between Geisinger and the American College of Surgeons Commission on Cancer. The initial survey of lung cancer care revealed substantial room for improvement. The ProvenCare goals initially were to standardize care; build in redundancy to make sure all tasks are done; bundle related tasks; build teams, feedback protocols, and training models; move toward a multi-institutional collaboration; and achieve widespread change in institutional practices, protocol, and culture of care. The project involved an 18-month period of training and testing in the participating institutions.

Engagement of patients and a "very well-articulated set of expectations" were a critical part of the ProvenCare model. The challenge involved achieving 100% compliance across the many institutions

Geisinger has created an insurance company that has some role in controlling costs. Dr. Steele estimated that many resources spent in health care are wasted. "If we could figure out how to extract much of that 25%-30% of needless cost, we can redistribute it. ... Some of that redistribution would go to our bottom line and allow us to grow programs and make our balance sheet comfortable. ... Some of that value would go back to our insurance company and to the middle-size and small businesses that are buying our insurance premiums." This is where cost savings are reducing the cost of premiums and "giving some of that value back to consumers."

Dr. Steele said, "In most industries where you have reengineered whatever it is you are doing, you’ve got better outcomes on both the quality side and the cost side, and you are in heavy-duty competition in the consolidating market. What do you do? You lower your price. And you maintain your contribution margin. And you run your competition out of business. We don’t think that way in health care. But my bet is, in 5 years, we will think that way."

Ultimately, the drive to lower costs goes hand in hand with improving quality of care, he said. "If you believe that, and you are a professional driven to help your patients, you are much more enthusiastic about reengineering than simply working to keep costs down."

[email protected]

WASHINGTON – Technological innovation is transforming surgery at a rapid pace. The question, according to Dr. Mark Talamini, is how can surgeons prepare for and participate in that transformation.

Dr. Talamini delivered the Excelsior Surgical Society/Edward D. Churchill Lecture at the annual clinical congress of the American College of Surgeons. He discussed his own early interest in medical technology, the trends in technological change, and the complex issues that face surgeons in maintaining currency in training and working to develop new devices.

The most profound change in surgery in recent decades has been the insertion of high-tech devices between the surgeon and the patient. There is now most commonly a physical distance between the patient’s body and the surgeon’s hands, and "the majority of surgical procedures involve the surgeon looking at a screen." Surgical tasks of dissecting, controlling bleeding, and suturing in particular have been all but transformed by devices.

The drive to introduce new surgical devices has come up against the stringent approval process of the Food and Drug Administration and has led to public criticism of that process. Dr. Talamini, who chairs the surgery department at the State University of New York at Stony Brook, and who has worked with the FDA for more than 10 years in various capacities, argued that there must be a correct balance between innovation and regulation. "We’ve got to have both. We cannot just have instruments released to the public without understanding what the issues are regarding safety and effectiveness. For the FDA, that is the mantra: safety and effectiveness." He added, "They have a tough task to figure out the balance between getting new things to the market to benefit patients and yet maintaining overall public safety."

Dr. Talamini asserted that the growing number and complexity of surgical instruments mean that surgeons may be falling behind in their skills without realizing it. He illustrated his point by posing specific questions about the use of some recently introduced instruments and polling the audience on correct use. In response to the many wrong answers, he asserted that "we don’t know as much as we think we do about surgical technology."

To address this problem of maintaining currency and training on innovative devices, Dr. Talamini mentioned the Fundamental Use of Surgical Energy (FUSE) program created by the Society of American Gastrointestinal and Endoscopic Surgeons. FUSE is a web-based educational and testing program for all operating room participants, including surgeons.

Dr. Talamini is particularly proud of the Center for the Future of Surgery located at the University of California, San Diego, which he was instrumental in developing. This center has a research suite for doctors and scientists to collaborate on innovative devices; training suites for the latest in surgical, robotic, laparoscopic, and microscopic techniques; and simulated operating rooms and emergency departments.

Dr. Talamini reflected on the complex relationship between innovative surgeons and device development and manufacturing companies. He cautioned the audience to consider some principles when engaging in technology development with industry. First, there would be no technological innovation without collaboration between the medical device industry and surgeons. But development and training cannot be simply a means of selling equipment. Education and sales must be clearly differentiated. In addition, disclosure and transparency are fundamental to maintaining public trust.

Finally, Dr. Talamini argued that conflict of interest in this area cannot be eliminated, but it must be managed to foster innovation.

Dr. Talamini had no disclosures.

[email protected]

WASHINGTON – Technological innovation is transforming surgery at a rapid pace. The question, according to Dr. Mark Talamini, is how can surgeons prepare for and participate in that transformation.

Dr. Talamini delivered the Excelsior Surgical Society/Edward D. Churchill Lecture at the annual clinical congress of the American College of Surgeons. He discussed his own early interest in medical technology, the trends in technological change, and the complex issues that face surgeons in maintaining currency in training and working to develop new devices.

The most profound change in surgery in recent decades has been the insertion of high-tech devices between the surgeon and the patient. There is now most commonly a physical distance between the patient’s body and the surgeon’s hands, and "the majority of surgical procedures involve the surgeon looking at a screen." Surgical tasks of dissecting, controlling bleeding, and suturing in particular have been all but transformed by devices.

The drive to introduce new surgical devices has come up against the stringent approval process of the Food and Drug Administration and has led to public criticism of that process. Dr. Talamini, who chairs the surgery department at the State University of New York at Stony Brook, and who has worked with the FDA for more than 10 years in various capacities, argued that there must be a correct balance between innovation and regulation. "We’ve got to have both. We cannot just have instruments released to the public without understanding what the issues are regarding safety and effectiveness. For the FDA, that is the mantra: safety and effectiveness." He added, "They have a tough task to figure out the balance between getting new things to the market to benefit patients and yet maintaining overall public safety."

Dr. Talamini asserted that the growing number and complexity of surgical instruments mean that surgeons may be falling behind in their skills without realizing it. He illustrated his point by posing specific questions about the use of some recently introduced instruments and polling the audience on correct use. In response to the many wrong answers, he asserted that "we don’t know as much as we think we do about surgical technology."

To address this problem of maintaining currency and training on innovative devices, Dr. Talamini mentioned the Fundamental Use of Surgical Energy (FUSE) program created by the Society of American Gastrointestinal and Endoscopic Surgeons. FUSE is a web-based educational and testing program for all operating room participants, including surgeons.

Dr. Talamini is particularly proud of the Center for the Future of Surgery located at the University of California, San Diego, which he was instrumental in developing. This center has a research suite for doctors and scientists to collaborate on innovative devices; training suites for the latest in surgical, robotic, laparoscopic, and microscopic techniques; and simulated operating rooms and emergency departments.

Dr. Talamini reflected on the complex relationship between innovative surgeons and device development and manufacturing companies. He cautioned the audience to consider some principles when engaging in technology development with industry. First, there would be no technological innovation without collaboration between the medical device industry and surgeons. But development and training cannot be simply a means of selling equipment. Education and sales must be clearly differentiated. In addition, disclosure and transparency are fundamental to maintaining public trust.

Finally, Dr. Talamini argued that conflict of interest in this area cannot be eliminated, but it must be managed to foster innovation.

Dr. Talamini had no disclosures.

[email protected]

WASHINGTON – Technological innovation is transforming surgery at a rapid pace. The question, according to Dr. Mark Talamini, is how can surgeons prepare for and participate in that transformation.

Dr. Talamini delivered the Excelsior Surgical Society/Edward D. Churchill Lecture at the annual clinical congress of the American College of Surgeons. He discussed his own early interest in medical technology, the trends in technological change, and the complex issues that face surgeons in maintaining currency in training and working to develop new devices.

The most profound change in surgery in recent decades has been the insertion of high-tech devices between the surgeon and the patient. There is now most commonly a physical distance between the patient’s body and the surgeon’s hands, and "the majority of surgical procedures involve the surgeon looking at a screen." Surgical tasks of dissecting, controlling bleeding, and suturing in particular have been all but transformed by devices.

The drive to introduce new surgical devices has come up against the stringent approval process of the Food and Drug Administration and has led to public criticism of that process. Dr. Talamini, who chairs the surgery department at the State University of New York at Stony Brook, and who has worked with the FDA for more than 10 years in various capacities, argued that there must be a correct balance between innovation and regulation. "We’ve got to have both. We cannot just have instruments released to the public without understanding what the issues are regarding safety and effectiveness. For the FDA, that is the mantra: safety and effectiveness." He added, "They have a tough task to figure out the balance between getting new things to the market to benefit patients and yet maintaining overall public safety."

Dr. Talamini asserted that the growing number and complexity of surgical instruments mean that surgeons may be falling behind in their skills without realizing it. He illustrated his point by posing specific questions about the use of some recently introduced instruments and polling the audience on correct use. In response to the many wrong answers, he asserted that "we don’t know as much as we think we do about surgical technology."

To address this problem of maintaining currency and training on innovative devices, Dr. Talamini mentioned the Fundamental Use of Surgical Energy (FUSE) program created by the Society of American Gastrointestinal and Endoscopic Surgeons. FUSE is a web-based educational and testing program for all operating room participants, including surgeons.

Dr. Talamini is particularly proud of the Center for the Future of Surgery located at the University of California, San Diego, which he was instrumental in developing. This center has a research suite for doctors and scientists to collaborate on innovative devices; training suites for the latest in surgical, robotic, laparoscopic, and microscopic techniques; and simulated operating rooms and emergency departments.

Dr. Talamini reflected on the complex relationship between innovative surgeons and device development and manufacturing companies. He cautioned the audience to consider some principles when engaging in technology development with industry. First, there would be no technological innovation without collaboration between the medical device industry and surgeons. But development and training cannot be simply a means of selling equipment. Education and sales must be clearly differentiated. In addition, disclosure and transparency are fundamental to maintaining public trust.

Finally, Dr. Talamini argued that conflict of interest in this area cannot be eliminated, but it must be managed to foster innovation.

Dr. Talamini had no disclosures.

[email protected]

Most evidence supports the effectiveness of platelet-rich plasma therapy for elbow tendinitis and anterior cruciate ligament reconstruction, raising the possibility that insurance companies might one day cover the procedure for those problems, according to a literature review in the Journal of the American Academy of Orthopaedic Surgeons.

"The clinical evidence suggests that local injection of PRP [platelet-rich plasma] containing [white blood cells] may be beneficial to patients with chronic elbow epicondylitis refractory to standard nonsurgical treatment. However, the results of PRP treatment of other chronic tendinopathies are not as clear," concluded lead author Dr. Wellington Hsu, an orthopedic surgeon at Northwestern University in Chicago, and his coauthors, also orthopedic surgeons. They also determined that "although no significant difference in clinical outcomes has been found, preliminary clinical evidence suggests that PRP may be beneficial during the ligamentization and maturation processes of [anterior cruciate ligament] graft healing as well as that of the patellar tendon graft harvest sites."

However, for rotator cuff and Achilles tendon repairs, "the results of clinical studies are equivocal, and further study is needed before definitive conclusions can be drawn and recommendations can be made." Similarly, "further study is required before conclusions can be made regarding the efficacy of PRP in the management of osteochondral lesions and knee osteoarthritis," they wrote.

"Limited clinical evidence exists demonstrating any beneficial effects from the use of PRP in bone-healing applications. The available evidence indicates that PRP is not efficacious either alone or as an adjunct to local bone graft[s]," the authors wrote. The review included more than 60 PRP studies and publications (J. Am. Acad. Orthop. Surg. 2013;21:739-48).

PRP is created by spinning down a patient’s blood sample to isolate and concentrate platelets; the resulting solution is then injected into their joint spaces, tendon sheaths, or other areas. It’s rich in growth factors and other substances thought to aid tissue healing and regeneration.

PRP was first used in the 1950s for dermatology and oromaxillofacial conditions; "interest in PRP jumped way ahead of the research" during the last 5 years partly because celebrity athletes have been using it to recover from injuries. "The hype around PRP definitely came before the science," which is why insurance companies don’t cover it, Dr. Hsu said in a statement.

Instead, patients sometimes pay more than $1,000 for just one of several injections during a typical treatment course. As evidence builds for some indications, "insurance companies hopefully will consider coverage," he said.

Success varies depending on the preparation method and composition. With more than 40 commercial PRP systems on the market, both preparation method and composition vary from one study to the next, as do protocols. In addition, "the dose-response curve is not linear, and a saturation effect has been described in which an inhibitory cascade ensues once a sufficiently high concentration of platelets is reached," the authors wrote.

"Because platelets can exert the greatest influence on healing during or immediately after the inflammatory phase of injury, some authors have postulated that the timing of the administration of PRP has a greater impact on healing than does the number of platelets," they wrote.

Valued at $45 million in 2009, the PRP market is expected to grow to $126 million by 2016.

Dr. Hsu and most of the other seven authors reported financial ties to companies that make PRP equipment or products, including Medtronic Sofamor Danek, Stryker, Terumo Medical, Zimmer, Baxter, Biomet, ThermoGenesis, BioParadox, Smith & Nephew, and DePuy.

[email protected]

Most evidence supports the effectiveness of platelet-rich plasma therapy for elbow tendinitis and anterior cruciate ligament reconstruction, raising the possibility that insurance companies might one day cover the procedure for those problems, according to a literature review in the Journal of the American Academy of Orthopaedic Surgeons.

"The clinical evidence suggests that local injection of PRP [platelet-rich plasma] containing [white blood cells] may be beneficial to patients with chronic elbow epicondylitis refractory to standard nonsurgical treatment. However, the results of PRP treatment of other chronic tendinopathies are not as clear," concluded lead author Dr. Wellington Hsu, an orthopedic surgeon at Northwestern University in Chicago, and his coauthors, also orthopedic surgeons. They also determined that "although no significant difference in clinical outcomes has been found, preliminary clinical evidence suggests that PRP may be beneficial during the ligamentization and maturation processes of [anterior cruciate ligament] graft healing as well as that of the patellar tendon graft harvest sites."

However, for rotator cuff and Achilles tendon repairs, "the results of clinical studies are equivocal, and further study is needed before definitive conclusions can be drawn and recommendations can be made." Similarly, "further study is required before conclusions can be made regarding the efficacy of PRP in the management of osteochondral lesions and knee osteoarthritis," they wrote.

"Limited clinical evidence exists demonstrating any beneficial effects from the use of PRP in bone-healing applications. The available evidence indicates that PRP is not efficacious either alone or as an adjunct to local bone graft[s]," the authors wrote. The review included more than 60 PRP studies and publications (J. Am. Acad. Orthop. Surg. 2013;21:739-48).

PRP is created by spinning down a patient’s blood sample to isolate and concentrate platelets; the resulting solution is then injected into their joint spaces, tendon sheaths, or other areas. It’s rich in growth factors and other substances thought to aid tissue healing and regeneration.

PRP was first used in the 1950s for dermatology and oromaxillofacial conditions; "interest in PRP jumped way ahead of the research" during the last 5 years partly because celebrity athletes have been using it to recover from injuries. "The hype around PRP definitely came before the science," which is why insurance companies don’t cover it, Dr. Hsu said in a statement.

Instead, patients sometimes pay more than $1,000 for just one of several injections during a typical treatment course. As evidence builds for some indications, "insurance companies hopefully will consider coverage," he said.

Success varies depending on the preparation method and composition. With more than 40 commercial PRP systems on the market, both preparation method and composition vary from one study to the next, as do protocols. In addition, "the dose-response curve is not linear, and a saturation effect has been described in which an inhibitory cascade ensues once a sufficiently high concentration of platelets is reached," the authors wrote.

"Because platelets can exert the greatest influence on healing during or immediately after the inflammatory phase of injury, some authors have postulated that the timing of the administration of PRP has a greater impact on healing than does the number of platelets," they wrote.

Valued at $45 million in 2009, the PRP market is expected to grow to $126 million by 2016.

Dr. Hsu and most of the other seven authors reported financial ties to companies that make PRP equipment or products, including Medtronic Sofamor Danek, Stryker, Terumo Medical, Zimmer, Baxter, Biomet, ThermoGenesis, BioParadox, Smith & Nephew, and DePuy.

[email protected]

Most evidence supports the effectiveness of platelet-rich plasma therapy for elbow tendinitis and anterior cruciate ligament reconstruction, raising the possibility that insurance companies might one day cover the procedure for those problems, according to a literature review in the Journal of the American Academy of Orthopaedic Surgeons.

"The clinical evidence suggests that local injection of PRP [platelet-rich plasma] containing [white blood cells] may be beneficial to patients with chronic elbow epicondylitis refractory to standard nonsurgical treatment. However, the results of PRP treatment of other chronic tendinopathies are not as clear," concluded lead author Dr. Wellington Hsu, an orthopedic surgeon at Northwestern University in Chicago, and his coauthors, also orthopedic surgeons. They also determined that "although no significant difference in clinical outcomes has been found, preliminary clinical evidence suggests that PRP may be beneficial during the ligamentization and maturation processes of [anterior cruciate ligament] graft healing as well as that of the patellar tendon graft harvest sites."

However, for rotator cuff and Achilles tendon repairs, "the results of clinical studies are equivocal, and further study is needed before definitive conclusions can be drawn and recommendations can be made." Similarly, "further study is required before conclusions can be made regarding the efficacy of PRP in the management of osteochondral lesions and knee osteoarthritis," they wrote.

"Limited clinical evidence exists demonstrating any beneficial effects from the use of PRP in bone-healing applications. The available evidence indicates that PRP is not efficacious either alone or as an adjunct to local bone graft[s]," the authors wrote. The review included more than 60 PRP studies and publications (J. Am. Acad. Orthop. Surg. 2013;21:739-48).

PRP is created by spinning down a patient’s blood sample to isolate and concentrate platelets; the resulting solution is then injected into their joint spaces, tendon sheaths, or other areas. It’s rich in growth factors and other substances thought to aid tissue healing and regeneration.

PRP was first used in the 1950s for dermatology and oromaxillofacial conditions; "interest in PRP jumped way ahead of the research" during the last 5 years partly because celebrity athletes have been using it to recover from injuries. "The hype around PRP definitely came before the science," which is why insurance companies don’t cover it, Dr. Hsu said in a statement.

Instead, patients sometimes pay more than $1,000 for just one of several injections during a typical treatment course. As evidence builds for some indications, "insurance companies hopefully will consider coverage," he said.

Success varies depending on the preparation method and composition. With more than 40 commercial PRP systems on the market, both preparation method and composition vary from one study to the next, as do protocols. In addition, "the dose-response curve is not linear, and a saturation effect has been described in which an inhibitory cascade ensues once a sufficiently high concentration of platelets is reached," the authors wrote.

"Because platelets can exert the greatest influence on healing during or immediately after the inflammatory phase of injury, some authors have postulated that the timing of the administration of PRP has a greater impact on healing than does the number of platelets," they wrote.

Valued at $45 million in 2009, the PRP market is expected to grow to $126 million by 2016.

Dr. Hsu and most of the other seven authors reported financial ties to companies that make PRP equipment or products, including Medtronic Sofamor Danek, Stryker, Terumo Medical, Zimmer, Baxter, Biomet, ThermoGenesis, BioParadox, Smith & Nephew, and DePuy.

[email protected]

Endoscopic esophageal ultrasound understages many early-stage esophageal cancers, possibly leading to undertreatment for many patients, a study has shown.

A review of more than 100 patients with esophageal cancer found that the procedure correctly staged tumor depth in just 39% of pT1a tumors and 51% of pT1b tumors, Dr. Edward Bergeron and his colleagues reported online Dec. 5 in the Journal of Thoracic and Cardiovascular Surgery (2013 [doi:10.1016/j.jtcvs.2013.10.003]).

"Esophageal ultrasound has [been] shown to be inadequate for the definitive evaluation of lymph nodes in early-stage esophageal cancers," wrote Dr. Bergeron and his coauthors. "As a result, [it] should have a limited role beyond the initial staging examination to rule out more advanced lesions that would require neoadjuvant therapy before surgery."

Dr. Bergeron of the University of Michigan, Ann Arbor, and his team conducted a retrospective study of 107 patients who underwent esophagectomy for early esophageal cancers. The patients’ mean age was 66 years. The majority of the tumors (91%) were in the distal esophagus. Most (83%) were adenocarcinomas, and 63% showed signs of Barrett’s metaplasia.

For those with visible lesions, the average tumor size was 9 mm. More than half of the tumors (55%) were confined to the mucosa; 33% were pT1b with submucosal involvement.

Esophageal ultrasound understaged tumor depth in 32% of the pT1a tumors and 49% of the pT1b tumors. Ultrasound overstaged 29% of the pT1a and 51% of the pT1b tumors.

"In particular, three tumors on esophageal ultrasound invaded into but not through the muscularis mucosa," the authors wrote. "Two of these tumors were staged as pT2 [adenocarcinomas], and one of these tumors was staged as a pT3 squamous cell carcinoma on histology."

The sensitivity of esophageal ultrasound for detecting cT1a tumor invasion was 42%; the specificity was 81%.

Of the 1,083 lymph nodes harvested, 14 from nine patients showed metastatic disease. All of these patients had adenocarcinomas that were understaged by esophageal ultrasound, with no evidence of lymph node involvement.

Among these, disease had spread to the muscularis mucosa in one, to the submucosa in six, and to the muscularis propria in two.

"Thus, eight of the nine patients with positive pathologic lymph nodes had tumor invasion into the submucosal level or further," the authors wrote.

In addition, they noted, two of the nine patients also had multiple metastatic nodes, which led to reclassification as pN2 disease. One of these had tumor invasion into the submucosa and one into the muscularis propria.

"It is notable that 48 patients with pathologic T1a-1p disease had no evidence of lymph node spread," the authors wrote.

Esophageal ultrasound understaged 10% (9/90) of patients with lymph node metastases who had been preoperatively staged as cN0. In addition, 17 patients proved to be node negative after ultrasound staged them as having nodes suspicious of metastasis.

All patients underwent esophagectomy. The median blood loss was 250 mL. One patient needed a splenectomy after an intraoperative injury. The median length of stay was 8 days. One patient died after an unexplained respiratory arrest on postoperative day 2.

None of the authors declared any relevant financial conflicts.

Endoscopic esophageal ultrasound understages many early-stage esophageal cancers, possibly leading to undertreatment for many patients, a study has shown.

A review of more than 100 patients with esophageal cancer found that the procedure correctly staged tumor depth in just 39% of pT1a tumors and 51% of pT1b tumors, Dr. Edward Bergeron and his colleagues reported online Dec. 5 in the Journal of Thoracic and Cardiovascular Surgery (2013 [doi:10.1016/j.jtcvs.2013.10.003]).

"Esophageal ultrasound has [been] shown to be inadequate for the definitive evaluation of lymph nodes in early-stage esophageal cancers," wrote Dr. Bergeron and his coauthors. "As a result, [it] should have a limited role beyond the initial staging examination to rule out more advanced lesions that would require neoadjuvant therapy before surgery."

Dr. Bergeron of the University of Michigan, Ann Arbor, and his team conducted a retrospective study of 107 patients who underwent esophagectomy for early esophageal cancers. The patients’ mean age was 66 years. The majority of the tumors (91%) were in the distal esophagus. Most (83%) were adenocarcinomas, and 63% showed signs of Barrett’s metaplasia.

For those with visible lesions, the average tumor size was 9 mm. More than half of the tumors (55%) were confined to the mucosa; 33% were pT1b with submucosal involvement.

Esophageal ultrasound understaged tumor depth in 32% of the pT1a tumors and 49% of the pT1b tumors. Ultrasound overstaged 29% of the pT1a and 51% of the pT1b tumors.

"In particular, three tumors on esophageal ultrasound invaded into but not through the muscularis mucosa," the authors wrote. "Two of these tumors were staged as pT2 [adenocarcinomas], and one of these tumors was staged as a pT3 squamous cell carcinoma on histology."

The sensitivity of esophageal ultrasound for detecting cT1a tumor invasion was 42%; the specificity was 81%.

Of the 1,083 lymph nodes harvested, 14 from nine patients showed metastatic disease. All of these patients had adenocarcinomas that were understaged by esophageal ultrasound, with no evidence of lymph node involvement.

Among these, disease had spread to the muscularis mucosa in one, to the submucosa in six, and to the muscularis propria in two.

"Thus, eight of the nine patients with positive pathologic lymph nodes had tumor invasion into the submucosal level or further," the authors wrote.

In addition, they noted, two of the nine patients also had multiple metastatic nodes, which led to reclassification as pN2 disease. One of these had tumor invasion into the submucosa and one into the muscularis propria.

"It is notable that 48 patients with pathologic T1a-1p disease had no evidence of lymph node spread," the authors wrote.

Esophageal ultrasound understaged 10% (9/90) of patients with lymph node metastases who had been preoperatively staged as cN0. In addition, 17 patients proved to be node negative after ultrasound staged them as having nodes suspicious of metastasis.

All patients underwent esophagectomy. The median blood loss was 250 mL. One patient needed a splenectomy after an intraoperative injury. The median length of stay was 8 days. One patient died after an unexplained respiratory arrest on postoperative day 2.

None of the authors declared any relevant financial conflicts.

Endoscopic esophageal ultrasound understages many early-stage esophageal cancers, possibly leading to undertreatment for many patients, a study has shown.

A review of more than 100 patients with esophageal cancer found that the procedure correctly staged tumor depth in just 39% of pT1a tumors and 51% of pT1b tumors, Dr. Edward Bergeron and his colleagues reported online Dec. 5 in the Journal of Thoracic and Cardiovascular Surgery (2013 [doi:10.1016/j.jtcvs.2013.10.003]).

"Esophageal ultrasound has [been] shown to be inadequate for the definitive evaluation of lymph nodes in early-stage esophageal cancers," wrote Dr. Bergeron and his coauthors. "As a result, [it] should have a limited role beyond the initial staging examination to rule out more advanced lesions that would require neoadjuvant therapy before surgery."

Dr. Bergeron of the University of Michigan, Ann Arbor, and his team conducted a retrospective study of 107 patients who underwent esophagectomy for early esophageal cancers. The patients’ mean age was 66 years. The majority of the tumors (91%) were in the distal esophagus. Most (83%) were adenocarcinomas, and 63% showed signs of Barrett’s metaplasia.

For those with visible lesions, the average tumor size was 9 mm. More than half of the tumors (55%) were confined to the mucosa; 33% were pT1b with submucosal involvement.

Esophageal ultrasound understaged tumor depth in 32% of the pT1a tumors and 49% of the pT1b tumors. Ultrasound overstaged 29% of the pT1a and 51% of the pT1b tumors.

"In particular, three tumors on esophageal ultrasound invaded into but not through the muscularis mucosa," the authors wrote. "Two of these tumors were staged as pT2 [adenocarcinomas], and one of these tumors was staged as a pT3 squamous cell carcinoma on histology."

The sensitivity of esophageal ultrasound for detecting cT1a tumor invasion was 42%; the specificity was 81%.

Of the 1,083 lymph nodes harvested, 14 from nine patients showed metastatic disease. All of these patients had adenocarcinomas that were understaged by esophageal ultrasound, with no evidence of lymph node involvement.

Among these, disease had spread to the muscularis mucosa in one, to the submucosa in six, and to the muscularis propria in two.

"Thus, eight of the nine patients with positive pathologic lymph nodes had tumor invasion into the submucosal level or further," the authors wrote.

In addition, they noted, two of the nine patients also had multiple metastatic nodes, which led to reclassification as pN2 disease. One of these had tumor invasion into the submucosa and one into the muscularis propria.

"It is notable that 48 patients with pathologic T1a-1p disease had no evidence of lymph node spread," the authors wrote.

Esophageal ultrasound understaged 10% (9/90) of patients with lymph node metastases who had been preoperatively staged as cN0. In addition, 17 patients proved to be node negative after ultrasound staged them as having nodes suspicious of metastasis.

All patients underwent esophagectomy. The median blood loss was 250 mL. One patient needed a splenectomy after an intraoperative injury. The median length of stay was 8 days. One patient died after an unexplained respiratory arrest on postoperative day 2.

None of the authors declared any relevant financial conflicts.

SAN ANTONIO – In patients with metastatic breast cancer who responded favorably to initial chemotherapy, radiotherapy and surgical removal of primary tumors failed to enhance overall survival, a new study has shown.

In an interview at the San Antonio Breast Cancer Symposium, study investigator Dr. Rajendra Badwe offers his perspectives on loco-regional treatment vs. chemotherapy alone, and he discusses why surgical removal of primary tumors might be linked to later spread of metastatic disease.

SAN ANTONIO – In patients with metastatic breast cancer who responded favorably to initial chemotherapy, radiotherapy and surgical removal of primary tumors failed to enhance overall survival, a new study has shown.

In an interview at the San Antonio Breast Cancer Symposium, study investigator Dr. Rajendra Badwe offers his perspectives on loco-regional treatment vs. chemotherapy alone, and he discusses why surgical removal of primary tumors might be linked to later spread of metastatic disease.

SAN ANTONIO – In patients with metastatic breast cancer who responded favorably to initial chemotherapy, radiotherapy and surgical removal of primary tumors failed to enhance overall survival, a new study has shown.

In an interview at the San Antonio Breast Cancer Symposium, study investigator Dr. Rajendra Badwe offers his perspectives on loco-regional treatment vs. chemotherapy alone, and he discusses why surgical removal of primary tumors might be linked to later spread of metastatic disease.

WASHINGTON – Congress has moved the ball forward on permanently replacing the Medicare Sustainable Growth Rate formula, but with time short for a fix by year’s end the House has voted to approve a temporary 3-month reprieve from the 20% cut due to take effect Jan. 1.

In a 332-94 vote, with eight abstentions, the House on Dec. 12 approved the Bipartisan Budget Act of 2013, a wide-ranging budget agreement that includes the 3-month patch. The bill also would increase physician pay by 0.5% through March.

The Congressional Budget Office estimated that the temporary fix would cost $3.3 billion in 2014 and a total of $7.3 billion through 2023. The fix would be paid for by cutting Medicaid payments for hospital-based charity care and to long-term care hospitals.

It also would extend the 2% sequestration cuts for Medicare providers by 2 years, from 2021 to 2023.

The Senate has yet to consider the budget package including the SGR patch; it is expected to do so before its holiday recess. President Obama has said that he supports the deal.

The agreement, brokered by House Budget Committee Chairman Paul Ryan (R-Wisc.) and Senate Budget Committee Chairman Patty Murray (D-Wash.), adds about $63 billion in discretionary federal spending over 2 years and makes targeted cuts and fee hikes to bring about overall deficit reduction of about $23 billion.

Although physician groups aren’t thrilled about the continuation of the Medicare cuts under sequestration, most favor the temporary SGR reprieve and the restoration of some funding to federal health programs.

Dr. Ardis Dee Hoven, president of the American Medical Association, said that the continuation of the sequester cuts in Medicare is "frustrating" and poses the risk of destabilizing physician practices. "The concept of the sequester is probably not the best way to rein in spending," she said.

Dr. Clifford A. Hudis, president of the American Society of Clinical Oncology, praised the agreement for providing funds that could restore cuts in medical research and cancer care at the National Institutes of Health. He expressed disappointment, however, that the bill does not reverse cuts to Medicare, including reductions in the payments for physician-administered drugs under Medicare Part B.

"Oncologists are doing everything possible to continue providing care for Medicare patients, but this reduction has forced many in private practice to send patients to hospitals for chemotherapy because they cannot afford to administer these drugs in their office," Dr. Hudis said in a statement.

Physician organizations viewed the patch as necessary while Congress continues to work on a permanent SGR fix. Both the House and Senate took steps toward that goal on Dec. 12.

The House Ways and Means Committee voted 39-0 to approve its replacement proposal, which essentially adds on to the bill approved by the House Energy and Commerce Committee in July.

"This may not be the final step, it’s a very important step forward," said Rep. Kevin Brady (R-Tex.), chairman of the Ways and Means Health Subcommittee.

The House did not address how to pay for the permanent replacement. House Ways and Means Chairman Dave Camp (R-Mich.) noted that the Congressional Budget Office has estimated that it will cost $116 billion over 10 years to repeal the SGR, which is "more than half the cost 2 years ago." Even though that is the lowest estimate ever, "I am of no illusion that finding pay-fors will be an easy task," he said.

The Senate Finance Committee also did not include a way to pay for repeal in its proposal.

The bill had widespread bipartisan support in the committee, but some Senators raised concerns about the lack of a funding mechanism. Sen. Pat Roberts (R-Kan.) said that he wouldn’t support the bill until he could see how it would be funded.

Sen. Orrin Hatch (R- Utah), the committee’s top-ranking Republican, said that the offsets would be worked out once the bill had cleared the initial policymaking phase.

"This bill will be offset, period, or it’s not going to go through both houses," he said. "This bill will be paid for."

The panel agreed to add a provision aimed at expanding access to community mental health services. The amendment, offered by Sen. Debbie Stabenow (D-Mich.) and Sen. Roy Blunt (R-Mo.), would create pilot programs in 10 states to ensure that community behavioral health clinics offer a full range of mental health services, including 24-hour crisis care, substance abuse treatment, and expanded support for families.

Physician groups praised the continued congressional action.

The AMA "strongly commends members of the House Ways and Means Committee and the Senate Finance Committee for the tremendous progress they have made toward repealing Medicare’s failed Sustainable Growth Rate (SGR) formula and creating a stronger Medicare program," Dr. Hoven said in a statement. "The AMA will continue to work collaboratively with Congress so that a bipartisan agreement can be signed into law early next year to repeal the failed SGR payment formula."

The American College of Physicians said that it, too, would work to ensure that a bill moves through Congress and gets to the White House for approval soon.

"The bills reported today ... will help ensure that Medicare patients continue to have access to their physicians," said Dr. Charles Cutler, chairman of the ACP Board of Regents. "Their efforts will work to stabilize payments, provide multiple pathways for physicians to qualify for positive updates and to participate in alternative payment models, create positive incentives for patient-centered medical homes, provide assistance to small practices, and needed funding for development of quality measures."

The American College of Cardiology said in a statement that the proposals accomplished two of its highest priorities: eliminating the SGR and including provisions that will emphasize quality of care, including "provisions that emphasize the importance of clinical data registries, quality measure development, and appropriate use criteria to promote evidence-based care."

"We caution that our final support rests upon the caveat that paying for this legislation must not cause harm to patients and the physicians who care for them," Dr. John Gordon Harold, ACC president, said in the statement.

Legislators from the Finance Committee and the Ways and Means Committee celebrated their votes in a joint statement. In the statement, Sen. Hatch also issued a word of caution.

"Now that this legislation moves out of Committee and onto the floor, we need to continue to work together to ensure that this smart policy becomes law and ensure that it doesn’t add one dime to our nation’s debt."

[email protected]

[email protected]

WASHINGTON – Congress has moved the ball forward on permanently replacing the Medicare Sustainable Growth Rate formula, but with time short for a fix by year’s end the House has voted to approve a temporary 3-month reprieve from the 20% cut due to take effect Jan. 1.

In a 332-94 vote, with eight abstentions, the House on Dec. 12 approved the Bipartisan Budget Act of 2013, a wide-ranging budget agreement that includes the 3-month patch. The bill also would increase physician pay by 0.5% through March.

The Congressional Budget Office estimated that the temporary fix would cost $3.3 billion in 2014 and a total of $7.3 billion through 2023. The fix would be paid for by cutting Medicaid payments for hospital-based charity care and to long-term care hospitals.

It also would extend the 2% sequestration cuts for Medicare providers by 2 years, from 2021 to 2023.

The Senate has yet to consider the budget package including the SGR patch; it is expected to do so before its holiday recess. President Obama has said that he supports the deal.

The agreement, brokered by House Budget Committee Chairman Paul Ryan (R-Wisc.) and Senate Budget Committee Chairman Patty Murray (D-Wash.), adds about $63 billion in discretionary federal spending over 2 years and makes targeted cuts and fee hikes to bring about overall deficit reduction of about $23 billion.

Although physician groups aren’t thrilled about the continuation of the Medicare cuts under sequestration, most favor the temporary SGR reprieve and the restoration of some funding to federal health programs.

Dr. Ardis Dee Hoven, president of the American Medical Association, said that the continuation of the sequester cuts in Medicare is "frustrating" and poses the risk of destabilizing physician practices. "The concept of the sequester is probably not the best way to rein in spending," she said.

Dr. Clifford A. Hudis, president of the American Society of Clinical Oncology, praised the agreement for providing funds that could restore cuts in medical research and cancer care at the National Institutes of Health. He expressed disappointment, however, that the bill does not reverse cuts to Medicare, including reductions in the payments for physician-administered drugs under Medicare Part B.

"Oncologists are doing everything possible to continue providing care for Medicare patients, but this reduction has forced many in private practice to send patients to hospitals for chemotherapy because they cannot afford to administer these drugs in their office," Dr. Hudis said in a statement.

Physician organizations viewed the patch as necessary while Congress continues to work on a permanent SGR fix. Both the House and Senate took steps toward that goal on Dec. 12.

The House Ways and Means Committee voted 39-0 to approve its replacement proposal, which essentially adds on to the bill approved by the House Energy and Commerce Committee in July.

"This may not be the final step, it’s a very important step forward," said Rep. Kevin Brady (R-Tex.), chairman of the Ways and Means Health Subcommittee.

The House did not address how to pay for the permanent replacement. House Ways and Means Chairman Dave Camp (R-Mich.) noted that the Congressional Budget Office has estimated that it will cost $116 billion over 10 years to repeal the SGR, which is "more than half the cost 2 years ago." Even though that is the lowest estimate ever, "I am of no illusion that finding pay-fors will be an easy task," he said.

The Senate Finance Committee also did not include a way to pay for repeal in its proposal.

The bill had widespread bipartisan support in the committee, but some Senators raised concerns about the lack of a funding mechanism. Sen. Pat Roberts (R-Kan.) said that he wouldn’t support the bill until he could see how it would be funded.

Sen. Orrin Hatch (R- Utah), the committee’s top-ranking Republican, said that the offsets would be worked out once the bill had cleared the initial policymaking phase.

"This bill will be offset, period, or it’s not going to go through both houses," he said. "This bill will be paid for."

The panel agreed to add a provision aimed at expanding access to community mental health services. The amendment, offered by Sen. Debbie Stabenow (D-Mich.) and Sen. Roy Blunt (R-Mo.), would create pilot programs in 10 states to ensure that community behavioral health clinics offer a full range of mental health services, including 24-hour crisis care, substance abuse treatment, and expanded support for families.

Physician groups praised the continued congressional action.

The AMA "strongly commends members of the House Ways and Means Committee and the Senate Finance Committee for the tremendous progress they have made toward repealing Medicare’s failed Sustainable Growth Rate (SGR) formula and creating a stronger Medicare program," Dr. Hoven said in a statement. "The AMA will continue to work collaboratively with Congress so that a bipartisan agreement can be signed into law early next year to repeal the failed SGR payment formula."

The American College of Physicians said that it, too, would work to ensure that a bill moves through Congress and gets to the White House for approval soon.

"The bills reported today ... will help ensure that Medicare patients continue to have access to their physicians," said Dr. Charles Cutler, chairman of the ACP Board of Regents. "Their efforts will work to stabilize payments, provide multiple pathways for physicians to qualify for positive updates and to participate in alternative payment models, create positive incentives for patient-centered medical homes, provide assistance to small practices, and needed funding for development of quality measures."

The American College of Cardiology said in a statement that the proposals accomplished two of its highest priorities: eliminating the SGR and including provisions that will emphasize quality of care, including "provisions that emphasize the importance of clinical data registries, quality measure development, and appropriate use criteria to promote evidence-based care."

"We caution that our final support rests upon the caveat that paying for this legislation must not cause harm to patients and the physicians who care for them," Dr. John Gordon Harold, ACC president, said in the statement.

Legislators from the Finance Committee and the Ways and Means Committee celebrated their votes in a joint statement. In the statement, Sen. Hatch also issued a word of caution.

"Now that this legislation moves out of Committee and onto the floor, we need to continue to work together to ensure that this smart policy becomes law and ensure that it doesn’t add one dime to our nation’s debt."

[email protected]

[email protected]

WASHINGTON – Congress has moved the ball forward on permanently replacing the Medicare Sustainable Growth Rate formula, but with time short for a fix by year’s end the House has voted to approve a temporary 3-month reprieve from the 20% cut due to take effect Jan. 1.

In a 332-94 vote, with eight abstentions, the House on Dec. 12 approved the Bipartisan Budget Act of 2013, a wide-ranging budget agreement that includes the 3-month patch. The bill also would increase physician pay by 0.5% through March.

The Congressional Budget Office estimated that the temporary fix would cost $3.3 billion in 2014 and a total of $7.3 billion through 2023. The fix would be paid for by cutting Medicaid payments for hospital-based charity care and to long-term care hospitals.

It also would extend the 2% sequestration cuts for Medicare providers by 2 years, from 2021 to 2023.

The Senate has yet to consider the budget package including the SGR patch; it is expected to do so before its holiday recess. President Obama has said that he supports the deal.

The agreement, brokered by House Budget Committee Chairman Paul Ryan (R-Wisc.) and Senate Budget Committee Chairman Patty Murray (D-Wash.), adds about $63 billion in discretionary federal spending over 2 years and makes targeted cuts and fee hikes to bring about overall deficit reduction of about $23 billion.

Although physician groups aren’t thrilled about the continuation of the Medicare cuts under sequestration, most favor the temporary SGR reprieve and the restoration of some funding to federal health programs.

Dr. Ardis Dee Hoven, president of the American Medical Association, said that the continuation of the sequester cuts in Medicare is "frustrating" and poses the risk of destabilizing physician practices. "The concept of the sequester is probably not the best way to rein in spending," she said.

Dr. Clifford A. Hudis, president of the American Society of Clinical Oncology, praised the agreement for providing funds that could restore cuts in medical research and cancer care at the National Institutes of Health. He expressed disappointment, however, that the bill does not reverse cuts to Medicare, including reductions in the payments for physician-administered drugs under Medicare Part B.

"Oncologists are doing everything possible to continue providing care for Medicare patients, but this reduction has forced many in private practice to send patients to hospitals for chemotherapy because they cannot afford to administer these drugs in their office," Dr. Hudis said in a statement.

Physician organizations viewed the patch as necessary while Congress continues to work on a permanent SGR fix. Both the House and Senate took steps toward that goal on Dec. 12.

The House Ways and Means Committee voted 39-0 to approve its replacement proposal, which essentially adds on to the bill approved by the House Energy and Commerce Committee in July.

"This may not be the final step, it’s a very important step forward," said Rep. Kevin Brady (R-Tex.), chairman of the Ways and Means Health Subcommittee.

The House did not address how to pay for the permanent replacement. House Ways and Means Chairman Dave Camp (R-Mich.) noted that the Congressional Budget Office has estimated that it will cost $116 billion over 10 years to repeal the SGR, which is "more than half the cost 2 years ago." Even though that is the lowest estimate ever, "I am of no illusion that finding pay-fors will be an easy task," he said.

The Senate Finance Committee also did not include a way to pay for repeal in its proposal.

The bill had widespread bipartisan support in the committee, but some Senators raised concerns about the lack of a funding mechanism. Sen. Pat Roberts (R-Kan.) said that he wouldn’t support the bill until he could see how it would be funded.

Sen. Orrin Hatch (R- Utah), the committee’s top-ranking Republican, said that the offsets would be worked out once the bill had cleared the initial policymaking phase.

"This bill will be offset, period, or it’s not going to go through both houses," he said. "This bill will be paid for."

The panel agreed to add a provision aimed at expanding access to community mental health services. The amendment, offered by Sen. Debbie Stabenow (D-Mich.) and Sen. Roy Blunt (R-Mo.), would create pilot programs in 10 states to ensure that community behavioral health clinics offer a full range of mental health services, including 24-hour crisis care, substance abuse treatment, and expanded support for families.

Physician groups praised the continued congressional action.

The AMA "strongly commends members of the House Ways and Means Committee and the Senate Finance Committee for the tremendous progress they have made toward repealing Medicare’s failed Sustainable Growth Rate (SGR) formula and creating a stronger Medicare program," Dr. Hoven said in a statement. "The AMA will continue to work collaboratively with Congress so that a bipartisan agreement can be signed into law early next year to repeal the failed SGR payment formula."

The American College of Physicians said that it, too, would work to ensure that a bill moves through Congress and gets to the White House for approval soon.

"The bills reported today ... will help ensure that Medicare patients continue to have access to their physicians," said Dr. Charles Cutler, chairman of the ACP Board of Regents. "Their efforts will work to stabilize payments, provide multiple pathways for physicians to qualify for positive updates and to participate in alternative payment models, create positive incentives for patient-centered medical homes, provide assistance to small practices, and needed funding for development of quality measures."

The American College of Cardiology said in a statement that the proposals accomplished two of its highest priorities: eliminating the SGR and including provisions that will emphasize quality of care, including "provisions that emphasize the importance of clinical data registries, quality measure development, and appropriate use criteria to promote evidence-based care."

"We caution that our final support rests upon the caveat that paying for this legislation must not cause harm to patients and the physicians who care for them," Dr. John Gordon Harold, ACC president, said in the statement.

Legislators from the Finance Committee and the Ways and Means Committee celebrated their votes in a joint statement. In the statement, Sen. Hatch also issued a word of caution.

"Now that this legislation moves out of Committee and onto the floor, we need to continue to work together to ensure that this smart policy becomes law and ensure that it doesn’t add one dime to our nation’s debt."

[email protected]

[email protected]