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Doing Everything

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Doing Everything

We were called to the emergency department to see a young woman, DR, with metastatic endometrial cancer. She had presented with abdominal pain and was found to have evidence of perforation on CT imaging. The CT also demonstrated the unresectable uterus and multiple peritoneal implants. The tumor had not been responsive to the last bout of chemotherapy. DR had been less active, and had lost significant weight over the last several months. A former real estate agent, she hadn’t worked since her diagnosis. She lived with a friend and had a daughter who was very worried about her condition.

I was also worried. After looking at the CT I had told the resident over the phone that operation might not be a great choice. Yes but the family "wants everything done," she replied... CRINGE. "I’ll be over," I said.

Dr. Michael S. Weinstein

Why do we cringe at this statement? Perhaps we feel trapped by a family (or a medical team) who suggests we do everything. There is no out. The die has been cast. This is certainly the case when a non-surgical team has suggested to a family the option of a last-ditch operative intervention. What scares us about the family who wants "everything done"? Often, we don’t think we should be intervening with a surgical operation when the outcome appears dismal. We are concerned with litigation if we don’t try "everything." We fear the communication challenge of speaking with a family with "unrealistic expectations."

But if we take a step back, we might gain some appreciation for the family perspective. Who wouldn’t want everything done to save a loved one, or to prolong our time with a loved one? Who wouldn’t want everything done that might maximize the opportunity for recovery? And who would ever want to do nothing for a loved one in a medical crisis?

I have witnessed (and participated in) two responses to these challenging moments. The first is to acquiesce and perform an operation as a "last-ditch effort." The second is to simply refuse to intervene or even refuse the consult. Neither of these approaches is serves the patient, his or her family, or the health care team (including ourselves). To simply acquiesce puts the patient at increased risk of suffering, gives the family a false notion of hope, and creates moral distress in our team. To simply refuse and walk away leads to patient and family abandonment (with a lack of understanding why operative intervention is not indicated) and leads to conflict within our health care team.

I suggest we enter these situations with the premise that we always do everything and we never do nothing. We do our best to provide treatments to meet the goals and needs of our patients and their loved ones. At times, this may mean a surgical intervention to restore a patient to full premorbid health. At others, this may mean an operation to alleviate suffering, for example, from a malignant bowel obstruction. And sometimes this means not operating as it will only increase or prolong suffering. Yet in the latter situation, there are plenty of appropriate interventions: relieving pain or dyspnea, providing spiritual support, promoting bereavement, and assisting all participants in avoiding complicated grief. These therapies can and should be provided with the same aggressive approach with which we provide operative therapy.

With this approach we are able to reassure our patients and their loved ones that our interests lie in providing the best possible treatments in meeting their goals and needs. And that no matter what, we will find a means to help in some way.

As we sat in the emergency department, we reassured DR that we were there to help and find the best course of action. We admitted our uncertainty with the immediate prognosis with or without operative intervention, but that ultimately she was dying from the cancer. She expressed that she was not ready to die. "I hope we can avoid death as long as possible," I said. "While I am unsure which course of action will prolong your life the most, I am concerned that with operation your death has a higher likelihood of occurring in the midst of a prolonged ICU stay. If we try antibiotic therapy and pain control you might have more of an opportunity to spend time with your daughter and friends." We recommended avoiding operation, focusing on symptom management, and maximizing time with her loved ones.

DR wanted time. She was admitted for antibiotic therapy and aggressive symptom control with a consult to palliative medicine. She stabilized and was able to be transitioned to home hospice with her daughter and friend as caretakers.

 

 

This approach is effectively one of risk and benefit, recognition of uncertainty, and adherence to patient values. We recognize the inevitability of death from the beginning of a serious illness and openly discuss with our patients their fears and goals. We join with them in the uncertain future and the hard decisions to come. We work with patients to embrace life-enhancing therapies and to forgo death-avoiding therapies in order to maximize those that work toward patient-centered outcomes. This is a world in which we aggressively do everything to promote health, broadly defined, and ameliorate suffering. We always do everything.

Dr. Weinstein is an ACS Fellow and associate professor of surgery at Thomas Jefferson University in Philadelphia. He is director of the surgical intensive care unit and Executive Medical Co-Director of the Thomas Jefferson University Hospital Center for Critical Care. He is a member of the Palliative Care Task Force of the American College of Surgeons.

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We were called to the emergency department to see a young woman, DR, with metastatic endometrial cancer. She had presented with abdominal pain and was found to have evidence of perforation on CT imaging. The CT also demonstrated the unresectable uterus and multiple peritoneal implants. The tumor had not been responsive to the last bout of chemotherapy. DR had been less active, and had lost significant weight over the last several months. A former real estate agent, she hadn’t worked since her diagnosis. She lived with a friend and had a daughter who was very worried about her condition.

I was also worried. After looking at the CT I had told the resident over the phone that operation might not be a great choice. Yes but the family "wants everything done," she replied... CRINGE. "I’ll be over," I said.

Dr. Michael S. Weinstein

Why do we cringe at this statement? Perhaps we feel trapped by a family (or a medical team) who suggests we do everything. There is no out. The die has been cast. This is certainly the case when a non-surgical team has suggested to a family the option of a last-ditch operative intervention. What scares us about the family who wants "everything done"? Often, we don’t think we should be intervening with a surgical operation when the outcome appears dismal. We are concerned with litigation if we don’t try "everything." We fear the communication challenge of speaking with a family with "unrealistic expectations."

But if we take a step back, we might gain some appreciation for the family perspective. Who wouldn’t want everything done to save a loved one, or to prolong our time with a loved one? Who wouldn’t want everything done that might maximize the opportunity for recovery? And who would ever want to do nothing for a loved one in a medical crisis?

I have witnessed (and participated in) two responses to these challenging moments. The first is to acquiesce and perform an operation as a "last-ditch effort." The second is to simply refuse to intervene or even refuse the consult. Neither of these approaches is serves the patient, his or her family, or the health care team (including ourselves). To simply acquiesce puts the patient at increased risk of suffering, gives the family a false notion of hope, and creates moral distress in our team. To simply refuse and walk away leads to patient and family abandonment (with a lack of understanding why operative intervention is not indicated) and leads to conflict within our health care team.

I suggest we enter these situations with the premise that we always do everything and we never do nothing. We do our best to provide treatments to meet the goals and needs of our patients and their loved ones. At times, this may mean a surgical intervention to restore a patient to full premorbid health. At others, this may mean an operation to alleviate suffering, for example, from a malignant bowel obstruction. And sometimes this means not operating as it will only increase or prolong suffering. Yet in the latter situation, there are plenty of appropriate interventions: relieving pain or dyspnea, providing spiritual support, promoting bereavement, and assisting all participants in avoiding complicated grief. These therapies can and should be provided with the same aggressive approach with which we provide operative therapy.

With this approach we are able to reassure our patients and their loved ones that our interests lie in providing the best possible treatments in meeting their goals and needs. And that no matter what, we will find a means to help in some way.

As we sat in the emergency department, we reassured DR that we were there to help and find the best course of action. We admitted our uncertainty with the immediate prognosis with or without operative intervention, but that ultimately she was dying from the cancer. She expressed that she was not ready to die. "I hope we can avoid death as long as possible," I said. "While I am unsure which course of action will prolong your life the most, I am concerned that with operation your death has a higher likelihood of occurring in the midst of a prolonged ICU stay. If we try antibiotic therapy and pain control you might have more of an opportunity to spend time with your daughter and friends." We recommended avoiding operation, focusing on symptom management, and maximizing time with her loved ones.

DR wanted time. She was admitted for antibiotic therapy and aggressive symptom control with a consult to palliative medicine. She stabilized and was able to be transitioned to home hospice with her daughter and friend as caretakers.

 

 

This approach is effectively one of risk and benefit, recognition of uncertainty, and adherence to patient values. We recognize the inevitability of death from the beginning of a serious illness and openly discuss with our patients their fears and goals. We join with them in the uncertain future and the hard decisions to come. We work with patients to embrace life-enhancing therapies and to forgo death-avoiding therapies in order to maximize those that work toward patient-centered outcomes. This is a world in which we aggressively do everything to promote health, broadly defined, and ameliorate suffering. We always do everything.

Dr. Weinstein is an ACS Fellow and associate professor of surgery at Thomas Jefferson University in Philadelphia. He is director of the surgical intensive care unit and Executive Medical Co-Director of the Thomas Jefferson University Hospital Center for Critical Care. He is a member of the Palliative Care Task Force of the American College of Surgeons.

We were called to the emergency department to see a young woman, DR, with metastatic endometrial cancer. She had presented with abdominal pain and was found to have evidence of perforation on CT imaging. The CT also demonstrated the unresectable uterus and multiple peritoneal implants. The tumor had not been responsive to the last bout of chemotherapy. DR had been less active, and had lost significant weight over the last several months. A former real estate agent, she hadn’t worked since her diagnosis. She lived with a friend and had a daughter who was very worried about her condition.

I was also worried. After looking at the CT I had told the resident over the phone that operation might not be a great choice. Yes but the family "wants everything done," she replied... CRINGE. "I’ll be over," I said.

Dr. Michael S. Weinstein

Why do we cringe at this statement? Perhaps we feel trapped by a family (or a medical team) who suggests we do everything. There is no out. The die has been cast. This is certainly the case when a non-surgical team has suggested to a family the option of a last-ditch operative intervention. What scares us about the family who wants "everything done"? Often, we don’t think we should be intervening with a surgical operation when the outcome appears dismal. We are concerned with litigation if we don’t try "everything." We fear the communication challenge of speaking with a family with "unrealistic expectations."

But if we take a step back, we might gain some appreciation for the family perspective. Who wouldn’t want everything done to save a loved one, or to prolong our time with a loved one? Who wouldn’t want everything done that might maximize the opportunity for recovery? And who would ever want to do nothing for a loved one in a medical crisis?

I have witnessed (and participated in) two responses to these challenging moments. The first is to acquiesce and perform an operation as a "last-ditch effort." The second is to simply refuse to intervene or even refuse the consult. Neither of these approaches is serves the patient, his or her family, or the health care team (including ourselves). To simply acquiesce puts the patient at increased risk of suffering, gives the family a false notion of hope, and creates moral distress in our team. To simply refuse and walk away leads to patient and family abandonment (with a lack of understanding why operative intervention is not indicated) and leads to conflict within our health care team.

I suggest we enter these situations with the premise that we always do everything and we never do nothing. We do our best to provide treatments to meet the goals and needs of our patients and their loved ones. At times, this may mean a surgical intervention to restore a patient to full premorbid health. At others, this may mean an operation to alleviate suffering, for example, from a malignant bowel obstruction. And sometimes this means not operating as it will only increase or prolong suffering. Yet in the latter situation, there are plenty of appropriate interventions: relieving pain or dyspnea, providing spiritual support, promoting bereavement, and assisting all participants in avoiding complicated grief. These therapies can and should be provided with the same aggressive approach with which we provide operative therapy.

With this approach we are able to reassure our patients and their loved ones that our interests lie in providing the best possible treatments in meeting their goals and needs. And that no matter what, we will find a means to help in some way.

As we sat in the emergency department, we reassured DR that we were there to help and find the best course of action. We admitted our uncertainty with the immediate prognosis with or without operative intervention, but that ultimately she was dying from the cancer. She expressed that she was not ready to die. "I hope we can avoid death as long as possible," I said. "While I am unsure which course of action will prolong your life the most, I am concerned that with operation your death has a higher likelihood of occurring in the midst of a prolonged ICU stay. If we try antibiotic therapy and pain control you might have more of an opportunity to spend time with your daughter and friends." We recommended avoiding operation, focusing on symptom management, and maximizing time with her loved ones.

DR wanted time. She was admitted for antibiotic therapy and aggressive symptom control with a consult to palliative medicine. She stabilized and was able to be transitioned to home hospice with her daughter and friend as caretakers.

 

 

This approach is effectively one of risk and benefit, recognition of uncertainty, and adherence to patient values. We recognize the inevitability of death from the beginning of a serious illness and openly discuss with our patients their fears and goals. We join with them in the uncertain future and the hard decisions to come. We work with patients to embrace life-enhancing therapies and to forgo death-avoiding therapies in order to maximize those that work toward patient-centered outcomes. This is a world in which we aggressively do everything to promote health, broadly defined, and ameliorate suffering. We always do everything.

Dr. Weinstein is an ACS Fellow and associate professor of surgery at Thomas Jefferson University in Philadelphia. He is director of the surgical intensive care unit and Executive Medical Co-Director of the Thomas Jefferson University Hospital Center for Critical Care. He is a member of the Palliative Care Task Force of the American College of Surgeons.

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Lynn Erdman, RN, MN, OCNS, FAAN, hired as Administrative Director, ACS Cancer Programs

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The new Administrative Director of Cancer Programs, Lynn Erdman, RN, MN, OCNS, FAAN, joined the American College of Surgeons (ACS) on September 23. The Administrative Director oversees the activities of the Commission on Cancer (CoC), National Cancer Data Base, National Accreditation Program for Breast Centers (NAPBC), American Joint Committee on Cancer, and the ACS Clinical Research Program. Ms. Erdman replaced Connie Bura, who is now Associate Director of the College’s Division of Member Services.

A Fellow of the American Academy of Nursing, Ms. Erdman has more than 30 years of clinical and administrative experience in the health care and not-for-profit sectors and brings a rich oncology clinical nurse specialist background to the ACS. Most recently, she served as national vice-president of community health for the Susan G. Komen Global Headquarters based in Dallas, TX. For nine months earlier this year, she also served as a member of the six-person, interim leadership team at Susan G. Komen, overseeing all operations and fiscal responsibilities during the search for a new president for the organization.

Ms. Lynn Erdman

Ms. Erdman’s responsibilities at Komen included overseeing 2,000 community grants awarded across the nation totaling over $100 million. She worked with all Komen affiliates (more than 120 nationwide) and managed all national and some international corporate grants awarded to the organization. Ms. Erdman also was responsible for Komen’s educational materials and a helpline for patients and families.

Previously, she worked for more than 25 years in hospitals and health care systems in various roles. Ms. Erdman served as divisional vice-president of medical affairs for the American Cancer Society, Chicago, IL, developing effective partnerships with health care providers, researchers, other not-for-profit organizations, community health leaders, and volunteers and advocating for access to care. In addition, she was the founding director of the Presbyterian Cancer Center in Charlotte, NC, and was responsible for creating all programs from medical and surgical oncology to research, transplant services, and palliative care.

Ms. Erdman holds a bachelor of science degree in nursing from the University of North Carolina, Greensboro, where she was recently named to the board of visitors, and a master’s degree in nursing from the University of South Carolina, Columbia. She currently serves as consulting faculty for Duke University’s Graduate School of Nursing in Durham, NC.

She has written numerous articles and book chapters on topics related to oncology, state cancer plans, and customer service. She is a nationally recognized speaker, having presented more than 800 lectures in the U.S. and abroad on a range of issues, including cancer center and breast center development, state cancer plan implementation, advocacy, grant making, clinical trials expansion, supportive care options, ethics in cancer care, and patient education.

Ms. Erdman has served on the national boards and task forces of many cancer organizations, such as the Comprehensive Cancer Control National Partnerships, the CoC Steering Committee and NAPBC, the Oncology Nursing Society, The Cancer and Leukemia Group B, the American Cancer Society, Oncology Supply, the Association of Community Cancer Centers, and Purdue Pharma to name a few. She also was the first woman and first nurse to chair the breast and cervical cancer committee for the American Cancer Society and recently completed a government-appointed four-year term as chair of the North Carolina Advisory Committee on Cancer Coordination and Control.

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The new Administrative Director of Cancer Programs, Lynn Erdman, RN, MN, OCNS, FAAN, joined the American College of Surgeons (ACS) on September 23. The Administrative Director oversees the activities of the Commission on Cancer (CoC), National Cancer Data Base, National Accreditation Program for Breast Centers (NAPBC), American Joint Committee on Cancer, and the ACS Clinical Research Program. Ms. Erdman replaced Connie Bura, who is now Associate Director of the College’s Division of Member Services.

A Fellow of the American Academy of Nursing, Ms. Erdman has more than 30 years of clinical and administrative experience in the health care and not-for-profit sectors and brings a rich oncology clinical nurse specialist background to the ACS. Most recently, she served as national vice-president of community health for the Susan G. Komen Global Headquarters based in Dallas, TX. For nine months earlier this year, she also served as a member of the six-person, interim leadership team at Susan G. Komen, overseeing all operations and fiscal responsibilities during the search for a new president for the organization.

Ms. Lynn Erdman

Ms. Erdman’s responsibilities at Komen included overseeing 2,000 community grants awarded across the nation totaling over $100 million. She worked with all Komen affiliates (more than 120 nationwide) and managed all national and some international corporate grants awarded to the organization. Ms. Erdman also was responsible for Komen’s educational materials and a helpline for patients and families.

Previously, she worked for more than 25 years in hospitals and health care systems in various roles. Ms. Erdman served as divisional vice-president of medical affairs for the American Cancer Society, Chicago, IL, developing effective partnerships with health care providers, researchers, other not-for-profit organizations, community health leaders, and volunteers and advocating for access to care. In addition, she was the founding director of the Presbyterian Cancer Center in Charlotte, NC, and was responsible for creating all programs from medical and surgical oncology to research, transplant services, and palliative care.

Ms. Erdman holds a bachelor of science degree in nursing from the University of North Carolina, Greensboro, where she was recently named to the board of visitors, and a master’s degree in nursing from the University of South Carolina, Columbia. She currently serves as consulting faculty for Duke University’s Graduate School of Nursing in Durham, NC.

She has written numerous articles and book chapters on topics related to oncology, state cancer plans, and customer service. She is a nationally recognized speaker, having presented more than 800 lectures in the U.S. and abroad on a range of issues, including cancer center and breast center development, state cancer plan implementation, advocacy, grant making, clinical trials expansion, supportive care options, ethics in cancer care, and patient education.

Ms. Erdman has served on the national boards and task forces of many cancer organizations, such as the Comprehensive Cancer Control National Partnerships, the CoC Steering Committee and NAPBC, the Oncology Nursing Society, The Cancer and Leukemia Group B, the American Cancer Society, Oncology Supply, the Association of Community Cancer Centers, and Purdue Pharma to name a few. She also was the first woman and first nurse to chair the breast and cervical cancer committee for the American Cancer Society and recently completed a government-appointed four-year term as chair of the North Carolina Advisory Committee on Cancer Coordination and Control.

The new Administrative Director of Cancer Programs, Lynn Erdman, RN, MN, OCNS, FAAN, joined the American College of Surgeons (ACS) on September 23. The Administrative Director oversees the activities of the Commission on Cancer (CoC), National Cancer Data Base, National Accreditation Program for Breast Centers (NAPBC), American Joint Committee on Cancer, and the ACS Clinical Research Program. Ms. Erdman replaced Connie Bura, who is now Associate Director of the College’s Division of Member Services.

A Fellow of the American Academy of Nursing, Ms. Erdman has more than 30 years of clinical and administrative experience in the health care and not-for-profit sectors and brings a rich oncology clinical nurse specialist background to the ACS. Most recently, she served as national vice-president of community health for the Susan G. Komen Global Headquarters based in Dallas, TX. For nine months earlier this year, she also served as a member of the six-person, interim leadership team at Susan G. Komen, overseeing all operations and fiscal responsibilities during the search for a new president for the organization.

Ms. Lynn Erdman

Ms. Erdman’s responsibilities at Komen included overseeing 2,000 community grants awarded across the nation totaling over $100 million. She worked with all Komen affiliates (more than 120 nationwide) and managed all national and some international corporate grants awarded to the organization. Ms. Erdman also was responsible for Komen’s educational materials and a helpline for patients and families.

Previously, she worked for more than 25 years in hospitals and health care systems in various roles. Ms. Erdman served as divisional vice-president of medical affairs for the American Cancer Society, Chicago, IL, developing effective partnerships with health care providers, researchers, other not-for-profit organizations, community health leaders, and volunteers and advocating for access to care. In addition, she was the founding director of the Presbyterian Cancer Center in Charlotte, NC, and was responsible for creating all programs from medical and surgical oncology to research, transplant services, and palliative care.

Ms. Erdman holds a bachelor of science degree in nursing from the University of North Carolina, Greensboro, where she was recently named to the board of visitors, and a master’s degree in nursing from the University of South Carolina, Columbia. She currently serves as consulting faculty for Duke University’s Graduate School of Nursing in Durham, NC.

She has written numerous articles and book chapters on topics related to oncology, state cancer plans, and customer service. She is a nationally recognized speaker, having presented more than 800 lectures in the U.S. and abroad on a range of issues, including cancer center and breast center development, state cancer plan implementation, advocacy, grant making, clinical trials expansion, supportive care options, ethics in cancer care, and patient education.

Ms. Erdman has served on the national boards and task forces of many cancer organizations, such as the Comprehensive Cancer Control National Partnerships, the CoC Steering Committee and NAPBC, the Oncology Nursing Society, The Cancer and Leukemia Group B, the American Cancer Society, Oncology Supply, the Association of Community Cancer Centers, and Purdue Pharma to name a few. She also was the first woman and first nurse to chair the breast and cervical cancer committee for the American Cancer Society and recently completed a government-appointed four-year term as chair of the North Carolina Advisory Committee on Cancer Coordination and Control.

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New officers installed, leaders elected at Clinical Congress

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Carlos A. Pellegrini, MD, FACS, FRCSI (Hon), The Henry N. Hawkins Professor and Chair, department of surgery, University of Washington, Seattle, was installed as the 94th President of the American College of Surgeons (ACS) during Convocation ceremonies on October 6 at the 2013 Clinical Congress in Washington, DC.

Dr. Carlos A. Pellegrini    

Dr. Pellegrini is a leader in minimally invasive gastrointestinal surgery and a pioneer in the development of video endoscopy for the surgical treatment of gastro-esophageal reflux diseases and esophageal motility disorders.

Also installed during the Convocation was Layton "Bing" Rikkers, MD, FACS, as First Vice-President. Dr. Rikkers is professor emeritus at the University of Wisconsin-Madison and Editor-in-Chief of Surgery News.

John T. Preskitt, MD, FACS, was installed as Second Vice-President. Dr. Preskitt is clinical professor of surgery, Texas A&M Health Science Center, Baylor campus, and director of surgical oncology at the Baylor Sammons Cancer Center in Dallas. Dr. Preskitt chaired the Board of Governors' Committee on Chapter Relations (1997-2000), the Committee on Ethics (2006-2009), and the General Surgery Coding and Reimbursement Committee (2006-2011). He is a Past-President of the North Texas Chapter of the College (1997-1998).

Dr. John T. Preskitt    

During the Annual Business Meeting, Andrew L. Warshaw, MD, FACS, surgeon-in-chief emeritus, Massachusetts General Hospital (MGH) and the W. Gerald Austen Professor of Surgery at Harvard Medical School, Boston, MA, was elected President-Elect. Dr. Warshaw, who also is senior consultant for international and regional clinical relations at MGH and Partners Healthcare, became an ACS Fellow in 1974. Since then, he has served the College in various leadership capacities, including his current role as Chair of Health Policy and Advocacy. An eminent surgical researcher, educator, and clinician, Dr. Warshaw has contributed significantly to the diagnosis, treatment, and understanding of the pathogenesis of inflammatory and malignant lesions of the pancreas. He is the director of the Andrew L. Warshaw Institute for Pancreatic Cancer Research at MGH.

    Dr. Layton Rikkers

The Vice-Presidents-Elect also were elected during the Annual Business Meeting. The First Vice-President-Elect is Jay L. Grosfeld, MD, FACS, Lafayette F. Page Professor Emeritus of Pediatric Surgery, Indiana University School of Medicine, Indianapolis. The Second Vice-President-Elect is Kenneth L. Mattox, MD, FACS, Distinguished Service Professor, Michael E. DeBakey Department of Surgery, Baylor College of Medicine; and chief of staff and chief of surgery, Ben Taub General Hospital, Houston, TX.

Reelected to additional three-year terms on the Board of Regents were: Margaret M. Dunn, MD, FACS, a general surgeon, Dayton, OH; Howard M. Snyder III, MD, FACS, a urological surgeon, Philadelphia, PA, and Michael J. Zinner, MD, FACS, a general surgeon, Boston, MA.

    Dr. James Gigantelli

The ACS Board of Governors elected James Gigantelli, MD, FACS, professor of ophthalmology and assistant dean of government relations at the University of Nebraska Medical Center, Omaha, to the Board of Regents. The Board of Governors elected Gary L. Timmerman, MD, FACS, a general surgeon, Sioux Falls, SD, to serve as Chair of its Executive Committee; Fabrizio Michelassi, MD, FACS, a general surgeon, New York, NY, as Vice-Chair; and Lorrie Langdale, MD, FACS, a general surgeon, Seattle, WA, as Secretary. Newly elected to serve on the Board of Governors' Executive Committee are Karen Brasel, MD, FACS, a general surgeon, Milwaukee, WI, and Joseph H. Tepas III, MD, FACS, a pediatric surgeon, Jacksonville, FL. In addition, Sherry M. Wren, MD, FACS, a general surgeon, Palo Alto, CA, has been reappointed to the Executive Committee.

    Dr. Edward E. Cornwell III

Edward E. Cornwell III, MD, FACS, FCCM, LaSalle D. Leffall, Jr., MD, Professor and Chairman of Surgery, Howard University College of Medicine, and surgeon-in-chief, Howard University Hospital, Washington, DC, replaces Courtney M. Townsend, Jr., MD, FACS, as ACS Secretary. An ACS Fellow since 1992, Dr. Cornwell serves on the ACS Legislative Committee and is Past-Chair and member of the Nominating Committee of the Fellows (2003-2004 and 2001-2003, respectively). Dr. Cornwell has served on several other ACS committees, including the COT (2004-2010 as a member and 2010-2012 as a special member), the COT's Committee on Trauma Systems (2004-2010), the Pre-and Postoperative Care Committee (2000-2002), and the Committee on Diversity Issues (2002-2005).

    Dr. William G. Cioffi, Jr.

Replacing Dr. Warshaw as ACS Treasurer is William G. Cioffi, Jr., MD, FACS, J. Murray Beardsley Professor and Chairman, department of surgery, Alpert Medical School of Brown University, and surgeon-in-chief, Rhode Island Hospital and The Miriam Hospital, Providence. A Fellow of the College since 1990, Dr. Cioffi completed his service as Secretary of the Board of Governors at this year's Clinical Congress. He began serving on the Board of Governors in 1999. After serving as member of the Governors Committee to Study the Fiscal Affairs of the College (2001-2002, 2004-2005), he was elected Vice-Chair and Chair of that committee (2002-2004 and 2011-2013, respectively). Dr. Cioffi also served as Vice-Chair of the Governors Committee on Chapter Relations (2009-2011) and the Ad Hoc Committee to Restructure the Board of Governors Committees. He has been an active member of the Pre-Operative and Postoperative Care Committee (1995-2002), the COT (2004-2010), and the Program Committee (2007-2010). Additionally, he has served on the Regents' Finance Committee (2011-2013) and the Executive Compensation Committee (2011-2013).

 

 

A complete and updated listing of the College's 2013-2014 Officers and Board of Regents appears in the November 2013 Bulletin of the American College of Surgeons and on the ACS website at http://www. facs.org.

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Carlos A. Pellegrini, MD, FACS, FRCSI (Hon), The Henry N. Hawkins Professor and Chair, department of surgery, University of Washington, Seattle, was installed as the 94th President of the American College of Surgeons (ACS) during Convocation ceremonies on October 6 at the 2013 Clinical Congress in Washington, DC.

Dr. Carlos A. Pellegrini    

Dr. Pellegrini is a leader in minimally invasive gastrointestinal surgery and a pioneer in the development of video endoscopy for the surgical treatment of gastro-esophageal reflux diseases and esophageal motility disorders.

Also installed during the Convocation was Layton "Bing" Rikkers, MD, FACS, as First Vice-President. Dr. Rikkers is professor emeritus at the University of Wisconsin-Madison and Editor-in-Chief of Surgery News.

John T. Preskitt, MD, FACS, was installed as Second Vice-President. Dr. Preskitt is clinical professor of surgery, Texas A&M Health Science Center, Baylor campus, and director of surgical oncology at the Baylor Sammons Cancer Center in Dallas. Dr. Preskitt chaired the Board of Governors' Committee on Chapter Relations (1997-2000), the Committee on Ethics (2006-2009), and the General Surgery Coding and Reimbursement Committee (2006-2011). He is a Past-President of the North Texas Chapter of the College (1997-1998).

Dr. John T. Preskitt    

During the Annual Business Meeting, Andrew L. Warshaw, MD, FACS, surgeon-in-chief emeritus, Massachusetts General Hospital (MGH) and the W. Gerald Austen Professor of Surgery at Harvard Medical School, Boston, MA, was elected President-Elect. Dr. Warshaw, who also is senior consultant for international and regional clinical relations at MGH and Partners Healthcare, became an ACS Fellow in 1974. Since then, he has served the College in various leadership capacities, including his current role as Chair of Health Policy and Advocacy. An eminent surgical researcher, educator, and clinician, Dr. Warshaw has contributed significantly to the diagnosis, treatment, and understanding of the pathogenesis of inflammatory and malignant lesions of the pancreas. He is the director of the Andrew L. Warshaw Institute for Pancreatic Cancer Research at MGH.

    Dr. Layton Rikkers

The Vice-Presidents-Elect also were elected during the Annual Business Meeting. The First Vice-President-Elect is Jay L. Grosfeld, MD, FACS, Lafayette F. Page Professor Emeritus of Pediatric Surgery, Indiana University School of Medicine, Indianapolis. The Second Vice-President-Elect is Kenneth L. Mattox, MD, FACS, Distinguished Service Professor, Michael E. DeBakey Department of Surgery, Baylor College of Medicine; and chief of staff and chief of surgery, Ben Taub General Hospital, Houston, TX.

Reelected to additional three-year terms on the Board of Regents were: Margaret M. Dunn, MD, FACS, a general surgeon, Dayton, OH; Howard M. Snyder III, MD, FACS, a urological surgeon, Philadelphia, PA, and Michael J. Zinner, MD, FACS, a general surgeon, Boston, MA.

    Dr. James Gigantelli

The ACS Board of Governors elected James Gigantelli, MD, FACS, professor of ophthalmology and assistant dean of government relations at the University of Nebraska Medical Center, Omaha, to the Board of Regents. The Board of Governors elected Gary L. Timmerman, MD, FACS, a general surgeon, Sioux Falls, SD, to serve as Chair of its Executive Committee; Fabrizio Michelassi, MD, FACS, a general surgeon, New York, NY, as Vice-Chair; and Lorrie Langdale, MD, FACS, a general surgeon, Seattle, WA, as Secretary. Newly elected to serve on the Board of Governors' Executive Committee are Karen Brasel, MD, FACS, a general surgeon, Milwaukee, WI, and Joseph H. Tepas III, MD, FACS, a pediatric surgeon, Jacksonville, FL. In addition, Sherry M. Wren, MD, FACS, a general surgeon, Palo Alto, CA, has been reappointed to the Executive Committee.

    Dr. Edward E. Cornwell III

Edward E. Cornwell III, MD, FACS, FCCM, LaSalle D. Leffall, Jr., MD, Professor and Chairman of Surgery, Howard University College of Medicine, and surgeon-in-chief, Howard University Hospital, Washington, DC, replaces Courtney M. Townsend, Jr., MD, FACS, as ACS Secretary. An ACS Fellow since 1992, Dr. Cornwell serves on the ACS Legislative Committee and is Past-Chair and member of the Nominating Committee of the Fellows (2003-2004 and 2001-2003, respectively). Dr. Cornwell has served on several other ACS committees, including the COT (2004-2010 as a member and 2010-2012 as a special member), the COT's Committee on Trauma Systems (2004-2010), the Pre-and Postoperative Care Committee (2000-2002), and the Committee on Diversity Issues (2002-2005).

    Dr. William G. Cioffi, Jr.

Replacing Dr. Warshaw as ACS Treasurer is William G. Cioffi, Jr., MD, FACS, J. Murray Beardsley Professor and Chairman, department of surgery, Alpert Medical School of Brown University, and surgeon-in-chief, Rhode Island Hospital and The Miriam Hospital, Providence. A Fellow of the College since 1990, Dr. Cioffi completed his service as Secretary of the Board of Governors at this year's Clinical Congress. He began serving on the Board of Governors in 1999. After serving as member of the Governors Committee to Study the Fiscal Affairs of the College (2001-2002, 2004-2005), he was elected Vice-Chair and Chair of that committee (2002-2004 and 2011-2013, respectively). Dr. Cioffi also served as Vice-Chair of the Governors Committee on Chapter Relations (2009-2011) and the Ad Hoc Committee to Restructure the Board of Governors Committees. He has been an active member of the Pre-Operative and Postoperative Care Committee (1995-2002), the COT (2004-2010), and the Program Committee (2007-2010). Additionally, he has served on the Regents' Finance Committee (2011-2013) and the Executive Compensation Committee (2011-2013).

 

 

A complete and updated listing of the College's 2013-2014 Officers and Board of Regents appears in the November 2013 Bulletin of the American College of Surgeons and on the ACS website at http://www. facs.org.

Carlos A. Pellegrini, MD, FACS, FRCSI (Hon), The Henry N. Hawkins Professor and Chair, department of surgery, University of Washington, Seattle, was installed as the 94th President of the American College of Surgeons (ACS) during Convocation ceremonies on October 6 at the 2013 Clinical Congress in Washington, DC.

Dr. Carlos A. Pellegrini    

Dr. Pellegrini is a leader in minimally invasive gastrointestinal surgery and a pioneer in the development of video endoscopy for the surgical treatment of gastro-esophageal reflux diseases and esophageal motility disorders.

Also installed during the Convocation was Layton "Bing" Rikkers, MD, FACS, as First Vice-President. Dr. Rikkers is professor emeritus at the University of Wisconsin-Madison and Editor-in-Chief of Surgery News.

John T. Preskitt, MD, FACS, was installed as Second Vice-President. Dr. Preskitt is clinical professor of surgery, Texas A&M Health Science Center, Baylor campus, and director of surgical oncology at the Baylor Sammons Cancer Center in Dallas. Dr. Preskitt chaired the Board of Governors' Committee on Chapter Relations (1997-2000), the Committee on Ethics (2006-2009), and the General Surgery Coding and Reimbursement Committee (2006-2011). He is a Past-President of the North Texas Chapter of the College (1997-1998).

Dr. John T. Preskitt    

During the Annual Business Meeting, Andrew L. Warshaw, MD, FACS, surgeon-in-chief emeritus, Massachusetts General Hospital (MGH) and the W. Gerald Austen Professor of Surgery at Harvard Medical School, Boston, MA, was elected President-Elect. Dr. Warshaw, who also is senior consultant for international and regional clinical relations at MGH and Partners Healthcare, became an ACS Fellow in 1974. Since then, he has served the College in various leadership capacities, including his current role as Chair of Health Policy and Advocacy. An eminent surgical researcher, educator, and clinician, Dr. Warshaw has contributed significantly to the diagnosis, treatment, and understanding of the pathogenesis of inflammatory and malignant lesions of the pancreas. He is the director of the Andrew L. Warshaw Institute for Pancreatic Cancer Research at MGH.

    Dr. Layton Rikkers

The Vice-Presidents-Elect also were elected during the Annual Business Meeting. The First Vice-President-Elect is Jay L. Grosfeld, MD, FACS, Lafayette F. Page Professor Emeritus of Pediatric Surgery, Indiana University School of Medicine, Indianapolis. The Second Vice-President-Elect is Kenneth L. Mattox, MD, FACS, Distinguished Service Professor, Michael E. DeBakey Department of Surgery, Baylor College of Medicine; and chief of staff and chief of surgery, Ben Taub General Hospital, Houston, TX.

Reelected to additional three-year terms on the Board of Regents were: Margaret M. Dunn, MD, FACS, a general surgeon, Dayton, OH; Howard M. Snyder III, MD, FACS, a urological surgeon, Philadelphia, PA, and Michael J. Zinner, MD, FACS, a general surgeon, Boston, MA.

    Dr. James Gigantelli

The ACS Board of Governors elected James Gigantelli, MD, FACS, professor of ophthalmology and assistant dean of government relations at the University of Nebraska Medical Center, Omaha, to the Board of Regents. The Board of Governors elected Gary L. Timmerman, MD, FACS, a general surgeon, Sioux Falls, SD, to serve as Chair of its Executive Committee; Fabrizio Michelassi, MD, FACS, a general surgeon, New York, NY, as Vice-Chair; and Lorrie Langdale, MD, FACS, a general surgeon, Seattle, WA, as Secretary. Newly elected to serve on the Board of Governors' Executive Committee are Karen Brasel, MD, FACS, a general surgeon, Milwaukee, WI, and Joseph H. Tepas III, MD, FACS, a pediatric surgeon, Jacksonville, FL. In addition, Sherry M. Wren, MD, FACS, a general surgeon, Palo Alto, CA, has been reappointed to the Executive Committee.

    Dr. Edward E. Cornwell III

Edward E. Cornwell III, MD, FACS, FCCM, LaSalle D. Leffall, Jr., MD, Professor and Chairman of Surgery, Howard University College of Medicine, and surgeon-in-chief, Howard University Hospital, Washington, DC, replaces Courtney M. Townsend, Jr., MD, FACS, as ACS Secretary. An ACS Fellow since 1992, Dr. Cornwell serves on the ACS Legislative Committee and is Past-Chair and member of the Nominating Committee of the Fellows (2003-2004 and 2001-2003, respectively). Dr. Cornwell has served on several other ACS committees, including the COT (2004-2010 as a member and 2010-2012 as a special member), the COT's Committee on Trauma Systems (2004-2010), the Pre-and Postoperative Care Committee (2000-2002), and the Committee on Diversity Issues (2002-2005).

    Dr. William G. Cioffi, Jr.

Replacing Dr. Warshaw as ACS Treasurer is William G. Cioffi, Jr., MD, FACS, J. Murray Beardsley Professor and Chairman, department of surgery, Alpert Medical School of Brown University, and surgeon-in-chief, Rhode Island Hospital and The Miriam Hospital, Providence. A Fellow of the College since 1990, Dr. Cioffi completed his service as Secretary of the Board of Governors at this year's Clinical Congress. He began serving on the Board of Governors in 1999. After serving as member of the Governors Committee to Study the Fiscal Affairs of the College (2001-2002, 2004-2005), he was elected Vice-Chair and Chair of that committee (2002-2004 and 2011-2013, respectively). Dr. Cioffi also served as Vice-Chair of the Governors Committee on Chapter Relations (2009-2011) and the Ad Hoc Committee to Restructure the Board of Governors Committees. He has been an active member of the Pre-Operative and Postoperative Care Committee (1995-2002), the COT (2004-2010), and the Program Committee (2007-2010). Additionally, he has served on the Regents' Finance Committee (2011-2013) and the Executive Compensation Committee (2011-2013).

 

 

A complete and updated listing of the College's 2013-2014 Officers and Board of Regents appears in the November 2013 Bulletin of the American College of Surgeons and on the ACS website at http://www. facs.org.

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Bariatric surgery: Asking the right questions

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The article by Weiner et al recently published in JAMA focuses on data derived from seven Blue Cross Insurance plans on patients who underwent bariatric surgery versus case-matched individuals in that plan who did not ("Studies question bariatric surgery health cost savings, October 2013, p. 1). The study found that although the patients who underwent surgery had lower non-hospital costs for the 6-year follow-up period overall, these costs did not overcome the initial expenditure for the operation and postoperative care or for other postoperative costs after surgery.

My initial reaction was: Why would we expect bariatric surgery to save money, or why must it? Name me three operations that are expected to save health care costs. Here are some procedures to consider:

Dr. Bruce Schirmer

• Joint replacements? Well, they certainly get people back on their feet but do we expect them to cut medical costs? No

• Hernia repairs? These operations may allow people to work more effectively, but actually cut health care costs?? I’ve never seen that study.

• Cataract surgery? These operations may or may not end up reducing health costs but they are not evaluated on cost savings

• Lung resections for cancer? Well, no but after all we are dealing with cancer. It’s not like obesity can kill you, right?

So why do we expect bariatric surgery to be cost effective? Who set that standard? Is it because of the innate societal bias against obesity as being a byproduct of character flaws and not a disease? Yet even though the American Medical Association and CMS have declared that obesity is a disease, treatment is under special scrutiny for cost savings. Even if bariatric surgery does not achieve cost effectiveness, I agree with the final conclusion of this paper that "studies should focus on the improved health and well-being of persons undergoing the procedure."

Bariatric surgery certainly does promote health and well-being in patients. It improves survival, decreases the incidence of cancer, puts most cases of type 2 diabetes into remission, decreases the need for multiple medications for hypertension, hypercholesterolemia, degenerative joint disease, and dramatically improves the overall quality of life for severely obese patients. Its benefits are well documented and undisputable.

And what about obesity? Dieting hasn’t been very effective against a disease that is rated the number two health threat in the U.S. today after cardiovascular disease. Recent news reports in fact said obesity may be the leading childhood risk factor for future cardiovascular disease. It certainly has increased the incidence of diabetes, renal failure, colon, breast, and prostate cancer as well as others. Today’s youth may live shorter lives than their parents due solely to this disease.

Since the data from this study were first collected, the incidence of postoperative death after bariatric surgery has dropped to one-fourth its level a decade ago. Large databases now demonstrate the fact that outcomes for bariatric surgery are much improved in the last decade. A significant percentage of the operations in this study were done using an open surgical approach, whereas today almost all metabolic and bariatric surgery is done with a laparoscopic approach. Laparoscopy is associated with lower morbidity, mortality, faster recovery, and shorter hospitalization. It is surprising that the transition to laparoscopic surgery did not show an improvement in costs when analyzed as an individual procedure compared to open surgery. Perhaps the double digit inflation of hospital costs over the years of the study may be a factor.

One also might contemplate the fact that an American can fly to some European and Asian countries, have a laparoscopic gastric bypass, stay for 2 weeks of convalescence afterward, and fly home all for less cost than for the hospital bill alone generated by most U.S. hospitals. Why is that? It would appear that even as our bariatric outcomes improve, our way of paying for health care in the United States system does not.

Many insurance companies do not cover bariatric surgery. As the Affordable Care Act is getting underway, it is not clear that even a majority of the states will have metabolic and bariatric surgery as a guaranteed part of the health insurance coverage. Yet scientific evidence shows that bariatric and metabolic surgery improve life expectancy and quality, and improve or put into remission many of the co-morbid medical problems associated with obesity. It does work for to the benefit of individuals.

We need to be asking the correct question about bariatric surgery. This operation may not save money, but it does save lives. So the question asked should not be whether it saves money but why it isn’t routinely covered by insurance plans?

 

 

Dr. Schirmer is an ACS Fellow and the Stephen H. Watts Professor of Surgery, University of Virginia Health Sciences Center, Charlottesville.
 

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The article by Weiner et al recently published in JAMA focuses on data derived from seven Blue Cross Insurance plans on patients who underwent bariatric surgery versus case-matched individuals in that plan who did not ("Studies question bariatric surgery health cost savings, October 2013, p. 1). The study found that although the patients who underwent surgery had lower non-hospital costs for the 6-year follow-up period overall, these costs did not overcome the initial expenditure for the operation and postoperative care or for other postoperative costs after surgery.

My initial reaction was: Why would we expect bariatric surgery to save money, or why must it? Name me three operations that are expected to save health care costs. Here are some procedures to consider:

Dr. Bruce Schirmer

• Joint replacements? Well, they certainly get people back on their feet but do we expect them to cut medical costs? No

• Hernia repairs? These operations may allow people to work more effectively, but actually cut health care costs?? I’ve never seen that study.

• Cataract surgery? These operations may or may not end up reducing health costs but they are not evaluated on cost savings

• Lung resections for cancer? Well, no but after all we are dealing with cancer. It’s not like obesity can kill you, right?

So why do we expect bariatric surgery to be cost effective? Who set that standard? Is it because of the innate societal bias against obesity as being a byproduct of character flaws and not a disease? Yet even though the American Medical Association and CMS have declared that obesity is a disease, treatment is under special scrutiny for cost savings. Even if bariatric surgery does not achieve cost effectiveness, I agree with the final conclusion of this paper that "studies should focus on the improved health and well-being of persons undergoing the procedure."

Bariatric surgery certainly does promote health and well-being in patients. It improves survival, decreases the incidence of cancer, puts most cases of type 2 diabetes into remission, decreases the need for multiple medications for hypertension, hypercholesterolemia, degenerative joint disease, and dramatically improves the overall quality of life for severely obese patients. Its benefits are well documented and undisputable.

And what about obesity? Dieting hasn’t been very effective against a disease that is rated the number two health threat in the U.S. today after cardiovascular disease. Recent news reports in fact said obesity may be the leading childhood risk factor for future cardiovascular disease. It certainly has increased the incidence of diabetes, renal failure, colon, breast, and prostate cancer as well as others. Today’s youth may live shorter lives than their parents due solely to this disease.

Since the data from this study were first collected, the incidence of postoperative death after bariatric surgery has dropped to one-fourth its level a decade ago. Large databases now demonstrate the fact that outcomes for bariatric surgery are much improved in the last decade. A significant percentage of the operations in this study were done using an open surgical approach, whereas today almost all metabolic and bariatric surgery is done with a laparoscopic approach. Laparoscopy is associated with lower morbidity, mortality, faster recovery, and shorter hospitalization. It is surprising that the transition to laparoscopic surgery did not show an improvement in costs when analyzed as an individual procedure compared to open surgery. Perhaps the double digit inflation of hospital costs over the years of the study may be a factor.

One also might contemplate the fact that an American can fly to some European and Asian countries, have a laparoscopic gastric bypass, stay for 2 weeks of convalescence afterward, and fly home all for less cost than for the hospital bill alone generated by most U.S. hospitals. Why is that? It would appear that even as our bariatric outcomes improve, our way of paying for health care in the United States system does not.

Many insurance companies do not cover bariatric surgery. As the Affordable Care Act is getting underway, it is not clear that even a majority of the states will have metabolic and bariatric surgery as a guaranteed part of the health insurance coverage. Yet scientific evidence shows that bariatric and metabolic surgery improve life expectancy and quality, and improve or put into remission many of the co-morbid medical problems associated with obesity. It does work for to the benefit of individuals.

We need to be asking the correct question about bariatric surgery. This operation may not save money, but it does save lives. So the question asked should not be whether it saves money but why it isn’t routinely covered by insurance plans?

 

 

Dr. Schirmer is an ACS Fellow and the Stephen H. Watts Professor of Surgery, University of Virginia Health Sciences Center, Charlottesville.
 

The article by Weiner et al recently published in JAMA focuses on data derived from seven Blue Cross Insurance plans on patients who underwent bariatric surgery versus case-matched individuals in that plan who did not ("Studies question bariatric surgery health cost savings, October 2013, p. 1). The study found that although the patients who underwent surgery had lower non-hospital costs for the 6-year follow-up period overall, these costs did not overcome the initial expenditure for the operation and postoperative care or for other postoperative costs after surgery.

My initial reaction was: Why would we expect bariatric surgery to save money, or why must it? Name me three operations that are expected to save health care costs. Here are some procedures to consider:

Dr. Bruce Schirmer

• Joint replacements? Well, they certainly get people back on their feet but do we expect them to cut medical costs? No

• Hernia repairs? These operations may allow people to work more effectively, but actually cut health care costs?? I’ve never seen that study.

• Cataract surgery? These operations may or may not end up reducing health costs but they are not evaluated on cost savings

• Lung resections for cancer? Well, no but after all we are dealing with cancer. It’s not like obesity can kill you, right?

So why do we expect bariatric surgery to be cost effective? Who set that standard? Is it because of the innate societal bias against obesity as being a byproduct of character flaws and not a disease? Yet even though the American Medical Association and CMS have declared that obesity is a disease, treatment is under special scrutiny for cost savings. Even if bariatric surgery does not achieve cost effectiveness, I agree with the final conclusion of this paper that "studies should focus on the improved health and well-being of persons undergoing the procedure."

Bariatric surgery certainly does promote health and well-being in patients. It improves survival, decreases the incidence of cancer, puts most cases of type 2 diabetes into remission, decreases the need for multiple medications for hypertension, hypercholesterolemia, degenerative joint disease, and dramatically improves the overall quality of life for severely obese patients. Its benefits are well documented and undisputable.

And what about obesity? Dieting hasn’t been very effective against a disease that is rated the number two health threat in the U.S. today after cardiovascular disease. Recent news reports in fact said obesity may be the leading childhood risk factor for future cardiovascular disease. It certainly has increased the incidence of diabetes, renal failure, colon, breast, and prostate cancer as well as others. Today’s youth may live shorter lives than their parents due solely to this disease.

Since the data from this study were first collected, the incidence of postoperative death after bariatric surgery has dropped to one-fourth its level a decade ago. Large databases now demonstrate the fact that outcomes for bariatric surgery are much improved in the last decade. A significant percentage of the operations in this study were done using an open surgical approach, whereas today almost all metabolic and bariatric surgery is done with a laparoscopic approach. Laparoscopy is associated with lower morbidity, mortality, faster recovery, and shorter hospitalization. It is surprising that the transition to laparoscopic surgery did not show an improvement in costs when analyzed as an individual procedure compared to open surgery. Perhaps the double digit inflation of hospital costs over the years of the study may be a factor.

One also might contemplate the fact that an American can fly to some European and Asian countries, have a laparoscopic gastric bypass, stay for 2 weeks of convalescence afterward, and fly home all for less cost than for the hospital bill alone generated by most U.S. hospitals. Why is that? It would appear that even as our bariatric outcomes improve, our way of paying for health care in the United States system does not.

Many insurance companies do not cover bariatric surgery. As the Affordable Care Act is getting underway, it is not clear that even a majority of the states will have metabolic and bariatric surgery as a guaranteed part of the health insurance coverage. Yet scientific evidence shows that bariatric and metabolic surgery improve life expectancy and quality, and improve or put into remission many of the co-morbid medical problems associated with obesity. It does work for to the benefit of individuals.

We need to be asking the correct question about bariatric surgery. This operation may not save money, but it does save lives. So the question asked should not be whether it saves money but why it isn’t routinely covered by insurance plans?

 

 

Dr. Schirmer is an ACS Fellow and the Stephen H. Watts Professor of Surgery, University of Virginia Health Sciences Center, Charlottesville.
 

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RUC panel aims for transparency

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The RUC, seen by many as vaguely mysterious – but very influential – advisors to Medicare on the value of physician services, is trying to be more open about its process.

Formally known as the Relative Value Scale Update Committee, the RUC will begin posting votes totals for each CPT code it considers and publishing its meeting minutes, starting in November. It also plans to publicize its meeting more widely.

According to the American Medical Association, which operates the committee jointly with the medical specialty societies, the RUC is already transparent in its operations with more than 300 individuals attending each of its meetings. That said, the panel often has been criticized as being secretive.

Dr. Barbara Levy, the RUC chairwoman, said that, over her entire time on the panel, she has never denied a request for an individual to attend a meeting. However, she added, those wishing to attend a RUC meeting must register. The group does not employ a completely open meeting process, as a way to protect its expert members from lobbying by groups or companies with a stake in how the codes are valued.

The RUC also has a confidentiality policy that bars its members and meeting attendees from publicizing the specifics of the panel’s discussions. This policy is to protect the "deliberative process," Dr. Levy said.

Dr. Yul D. Ejnes, an internist who serves as an alternate for the RUC primary care rotating seat, said that the panel has to strike a tough balance.

"The challenge for the RUC is to try to respond to all the concerns regarding transparency and accountability, while at the same time allowing the RUC to remain an effective body," he said.

As a new member to the RUC, Dr. Ejnes said he was struck by the fact that, before he got to know the individuals on the panel, he couldn’t tell which specialty they represented based on their comments.

RUC members are not there to "protect their own" specialty, Dr. Ejnes said.

Not everyone, though, is impressed by the panel’s efforts. Dr. Paul M. Fischer, a family physician in Augusta, Ga., who is part of an effort to replace the RUC, said the changes are simply "window dressing" that will not do anything to change the fundamental structure of the panel or its bias toward procedural specialties. Dr. Fischer previously filed an unsuccessful lawsuit against the RUC, claiming that it violates the Federal Advisory Committee Act.

The RUC also voted to make other changes, including updating its methodology on physician surveys.

The panel is increasing the minimum number of respondents required for each survey of commonly performed CPT codes. For instance, for physician services that are performed more than 1 million times each year among Medicare patients, at least 75 physicians must complete the survey. At least 50 physicians must be surveyed if the services are performed more than 100,000 times each year.

The panel also will begin using a centralized online survey process operated by the AMA, rather than relying on individual medical specialty societies to collect and report on survey results.

Part of the reason for the change is to make the survey process uniform across specialties, but it’s also an attempt to address the appearance of the "fox guarding the hen house" that comes from having specialty societies control the collection of data so important to determining how their members get paid, Dr. Levy said.

Although they haven’t had any problems with the old procedure, they wanted to avoid any appearance of conflict, she said.

"We’re consistently looking at our own processes and trying to improve them," Dr. Levy said.

What’s the RUC?

The Relative Value Scale Update Committee, better known as the RUC, is one of the most powerful panels in medicine that many physicians know nothing about.

The expert panel is run by the American Medical Association in conjunction with medical specialty societies and offers advice to the Centers for Medicare and Medicaid Services (CMS) on how to set the relative values for services performed by physicians, based on CPT code.

As a result, decisions made by the RUC have a major impact on how much physicians get paid both by Medicare and by private insurers, which often follow Medicare’s lead.

The CMS doesn’t accept all of the annual RUC recommendations, but the panel’s success rate is very high. The agency has adopted 95% of the RUC’s work relative value recommendations, according to the AMA.

The RUC is comprised of 31 members, 28 of whom vote. The bulk of the seats (25) are appointed by major national medical specialty societies.

 

 

Four of those 25 seats rotate every 2 years. This year, the rotating seats are filled by representatives from infectious disease, oncology/hematology, pediatric surgery, and primary care.

The remaining six seats are reserved for the RUC chair, a representative of the Health Care Professionals Advisory Committee Review Board, a representative from the Practice Expense Review Committee, a representative from the CPT Editorial Panel, an AMA representative, and a representative of the American Osteopathic Association.

The AMA Board of Trustees selects the RUC chair; RUC members are nominated by their specialty societies and approved by the AMA.

The RUC has been criticized as lacking adequate representation from primary care. The AMA tried to address some of that criticism in 2012 by adding a permanent seat for geriatrics and a rotating seat for a primary care representative.

Members of the RUC are appointed as technical experts, not as representatives of an individual medical society. Recommendations must be approved by two-thirds of the RUC to be sent on to CMS.

[email protected]

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The RUC, seen by many as vaguely mysterious – but very influential – advisors to Medicare on the value of physician services, is trying to be more open about its process.

Formally known as the Relative Value Scale Update Committee, the RUC will begin posting votes totals for each CPT code it considers and publishing its meeting minutes, starting in November. It also plans to publicize its meeting more widely.

According to the American Medical Association, which operates the committee jointly with the medical specialty societies, the RUC is already transparent in its operations with more than 300 individuals attending each of its meetings. That said, the panel often has been criticized as being secretive.

Dr. Barbara Levy, the RUC chairwoman, said that, over her entire time on the panel, she has never denied a request for an individual to attend a meeting. However, she added, those wishing to attend a RUC meeting must register. The group does not employ a completely open meeting process, as a way to protect its expert members from lobbying by groups or companies with a stake in how the codes are valued.

The RUC also has a confidentiality policy that bars its members and meeting attendees from publicizing the specifics of the panel’s discussions. This policy is to protect the "deliberative process," Dr. Levy said.

Dr. Yul D. Ejnes, an internist who serves as an alternate for the RUC primary care rotating seat, said that the panel has to strike a tough balance.

"The challenge for the RUC is to try to respond to all the concerns regarding transparency and accountability, while at the same time allowing the RUC to remain an effective body," he said.

As a new member to the RUC, Dr. Ejnes said he was struck by the fact that, before he got to know the individuals on the panel, he couldn’t tell which specialty they represented based on their comments.

RUC members are not there to "protect their own" specialty, Dr. Ejnes said.

Not everyone, though, is impressed by the panel’s efforts. Dr. Paul M. Fischer, a family physician in Augusta, Ga., who is part of an effort to replace the RUC, said the changes are simply "window dressing" that will not do anything to change the fundamental structure of the panel or its bias toward procedural specialties. Dr. Fischer previously filed an unsuccessful lawsuit against the RUC, claiming that it violates the Federal Advisory Committee Act.

The RUC also voted to make other changes, including updating its methodology on physician surveys.

The panel is increasing the minimum number of respondents required for each survey of commonly performed CPT codes. For instance, for physician services that are performed more than 1 million times each year among Medicare patients, at least 75 physicians must complete the survey. At least 50 physicians must be surveyed if the services are performed more than 100,000 times each year.

The panel also will begin using a centralized online survey process operated by the AMA, rather than relying on individual medical specialty societies to collect and report on survey results.

Part of the reason for the change is to make the survey process uniform across specialties, but it’s also an attempt to address the appearance of the "fox guarding the hen house" that comes from having specialty societies control the collection of data so important to determining how their members get paid, Dr. Levy said.

Although they haven’t had any problems with the old procedure, they wanted to avoid any appearance of conflict, she said.

"We’re consistently looking at our own processes and trying to improve them," Dr. Levy said.

What’s the RUC?

The Relative Value Scale Update Committee, better known as the RUC, is one of the most powerful panels in medicine that many physicians know nothing about.

The expert panel is run by the American Medical Association in conjunction with medical specialty societies and offers advice to the Centers for Medicare and Medicaid Services (CMS) on how to set the relative values for services performed by physicians, based on CPT code.

As a result, decisions made by the RUC have a major impact on how much physicians get paid both by Medicare and by private insurers, which often follow Medicare’s lead.

The CMS doesn’t accept all of the annual RUC recommendations, but the panel’s success rate is very high. The agency has adopted 95% of the RUC’s work relative value recommendations, according to the AMA.

The RUC is comprised of 31 members, 28 of whom vote. The bulk of the seats (25) are appointed by major national medical specialty societies.

 

 

Four of those 25 seats rotate every 2 years. This year, the rotating seats are filled by representatives from infectious disease, oncology/hematology, pediatric surgery, and primary care.

The remaining six seats are reserved for the RUC chair, a representative of the Health Care Professionals Advisory Committee Review Board, a representative from the Practice Expense Review Committee, a representative from the CPT Editorial Panel, an AMA representative, and a representative of the American Osteopathic Association.

The AMA Board of Trustees selects the RUC chair; RUC members are nominated by their specialty societies and approved by the AMA.

The RUC has been criticized as lacking adequate representation from primary care. The AMA tried to address some of that criticism in 2012 by adding a permanent seat for geriatrics and a rotating seat for a primary care representative.

Members of the RUC are appointed as technical experts, not as representatives of an individual medical society. Recommendations must be approved by two-thirds of the RUC to be sent on to CMS.

[email protected]

On Twitter @MaryEllenNY

The RUC, seen by many as vaguely mysterious – but very influential – advisors to Medicare on the value of physician services, is trying to be more open about its process.

Formally known as the Relative Value Scale Update Committee, the RUC will begin posting votes totals for each CPT code it considers and publishing its meeting minutes, starting in November. It also plans to publicize its meeting more widely.

According to the American Medical Association, which operates the committee jointly with the medical specialty societies, the RUC is already transparent in its operations with more than 300 individuals attending each of its meetings. That said, the panel often has been criticized as being secretive.

Dr. Barbara Levy, the RUC chairwoman, said that, over her entire time on the panel, she has never denied a request for an individual to attend a meeting. However, she added, those wishing to attend a RUC meeting must register. The group does not employ a completely open meeting process, as a way to protect its expert members from lobbying by groups or companies with a stake in how the codes are valued.

The RUC also has a confidentiality policy that bars its members and meeting attendees from publicizing the specifics of the panel’s discussions. This policy is to protect the "deliberative process," Dr. Levy said.

Dr. Yul D. Ejnes, an internist who serves as an alternate for the RUC primary care rotating seat, said that the panel has to strike a tough balance.

"The challenge for the RUC is to try to respond to all the concerns regarding transparency and accountability, while at the same time allowing the RUC to remain an effective body," he said.

As a new member to the RUC, Dr. Ejnes said he was struck by the fact that, before he got to know the individuals on the panel, he couldn’t tell which specialty they represented based on their comments.

RUC members are not there to "protect their own" specialty, Dr. Ejnes said.

Not everyone, though, is impressed by the panel’s efforts. Dr. Paul M. Fischer, a family physician in Augusta, Ga., who is part of an effort to replace the RUC, said the changes are simply "window dressing" that will not do anything to change the fundamental structure of the panel or its bias toward procedural specialties. Dr. Fischer previously filed an unsuccessful lawsuit against the RUC, claiming that it violates the Federal Advisory Committee Act.

The RUC also voted to make other changes, including updating its methodology on physician surveys.

The panel is increasing the minimum number of respondents required for each survey of commonly performed CPT codes. For instance, for physician services that are performed more than 1 million times each year among Medicare patients, at least 75 physicians must complete the survey. At least 50 physicians must be surveyed if the services are performed more than 100,000 times each year.

The panel also will begin using a centralized online survey process operated by the AMA, rather than relying on individual medical specialty societies to collect and report on survey results.

Part of the reason for the change is to make the survey process uniform across specialties, but it’s also an attempt to address the appearance of the "fox guarding the hen house" that comes from having specialty societies control the collection of data so important to determining how their members get paid, Dr. Levy said.

Although they haven’t had any problems with the old procedure, they wanted to avoid any appearance of conflict, she said.

"We’re consistently looking at our own processes and trying to improve them," Dr. Levy said.

What’s the RUC?

The Relative Value Scale Update Committee, better known as the RUC, is one of the most powerful panels in medicine that many physicians know nothing about.

The expert panel is run by the American Medical Association in conjunction with medical specialty societies and offers advice to the Centers for Medicare and Medicaid Services (CMS) on how to set the relative values for services performed by physicians, based on CPT code.

As a result, decisions made by the RUC have a major impact on how much physicians get paid both by Medicare and by private insurers, which often follow Medicare’s lead.

The CMS doesn’t accept all of the annual RUC recommendations, but the panel’s success rate is very high. The agency has adopted 95% of the RUC’s work relative value recommendations, according to the AMA.

The RUC is comprised of 31 members, 28 of whom vote. The bulk of the seats (25) are appointed by major national medical specialty societies.

 

 

Four of those 25 seats rotate every 2 years. This year, the rotating seats are filled by representatives from infectious disease, oncology/hematology, pediatric surgery, and primary care.

The remaining six seats are reserved for the RUC chair, a representative of the Health Care Professionals Advisory Committee Review Board, a representative from the Practice Expense Review Committee, a representative from the CPT Editorial Panel, an AMA representative, and a representative of the American Osteopathic Association.

The AMA Board of Trustees selects the RUC chair; RUC members are nominated by their specialty societies and approved by the AMA.

The RUC has been criticized as lacking adequate representation from primary care. The AMA tried to address some of that criticism in 2012 by adding a permanent seat for geriatrics and a rotating seat for a primary care representative.

Members of the RUC are appointed as technical experts, not as representatives of an individual medical society. Recommendations must be approved by two-thirds of the RUC to be sent on to CMS.

[email protected]

On Twitter @MaryEllenNY

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‘Substantial’ weight loss seen 3 years after bariatric surgery

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‘Substantial’ weight loss seen 3 years after bariatric surgery

Clinicians can expect "substantial" weight loss in severely obese patients 3 years after they undergo Roux-en-Y gastric bypass but less impressive weight loss 3 years after laparoscopic adjustable gastric banding, according to a report published online Nov. 4 in JAMA.

In a multicenter follow-up study of 2,348 such patients, those who underwent Roux-en-Y gastric bypass (RYGB) lost a median of 31.5% of their baseline weight and those who underwent laparoscopic adjustable gastric banding (LAGB) lost a median of 15.9% of their baseline weight at 3 years, said Dr. Anita P. Courcoulas of the department of surgery, University of Pittsburgh Medical Center, and her associates.

"Because our patient population was diverse and our results were from a large number of surgeons and surgical centers, long-term sustained weight loss can be expected from RYGB, and the results are likely generalizable. [However,] weight loss associated with the LAGB procedure was less than anticipated ... and less than what would be expected based on published series," the investigators noted.

Dr. Courcoulas and her colleagues in the Longitudinal Assessment of Bariatric Surgery consortium performed this observational cohort study at 10 hospitals across the United States. A total of 1,738 adults underwent RYGB, and 610 underwent LAGB. The median age was 46 years (range, 18-78 years). Most of the study subjects were women (79%), and 14% were nonwhite.

After 3 years, patients in the RYGB group lost a median of 41 kg (range, 110-kg loss to a 1-kg gain). Most of that loss occurred during the first postsurgical year, and typically there was "mild" weight regain between years 2 and 3.

Patients in the LAGB group lost a median of 20 kg (range, 75-kg loss to a 20-kg gain). Most of that loss also occurred during the first postsurgical year, with less than 20% of patients losing much weight after that. Typically, that weight loss was maintained between years 2 and 3, the investigators said (JAMA 2013 Nov. 4 [doi:10.1001/jama.2013.280928]).

Approximately 67% of patients in the RYGB group had at least partial remission of diabetes at year 3, a percentage similar to that reported in the literature. In contrast, only 27% of those in the LAGB group had at least partial remission of diabetes at year 3, which is a substantially lower rate than the 73% reported in the literature.

At the same time, 0.9% of patients in the RYGB group and 3.2% of those in the LAGB group developed new-onset diabetes during follow-up.

Approximately 62% of the RYGB group had remission of dyslipidemia, while 3.2% developed new-onset dyslipidemia. In contrast, only 27% of the LAGB group had remission of dyslipidemia, while 16% developed new-onset dyslipidemia. The pattern was similar for hyperlipidemia.

Approximately 38% of the RYGB group had remission of hypertension, while 13% developed new-onset hypertension during follow-up. For the LAGB group, the proportion of new-onset cases of hypertension (18.1%) actually exceeded the proportion of remissions (17.4%).

Concerning adverse events, three deaths occurred within 30 days of an RYGB procedure, and two revision procedures and two reversal procedures were required during 3-year follow-up. The corresponding figures for LAGB were zero postsurgical deaths and 77 surgeries to remove the band or revise the surgery during follow-up.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Courcoulas reported ties to Allergan, Covidien, EndoGastric Solutions, Ethicon J & J Healthcare System, Nutrisystem, and Pfizer, and her associates reported ties to several industry sources.

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Clinicians can expect "substantial" weight loss in severely obese patients 3 years after they undergo Roux-en-Y gastric bypass but less impressive weight loss 3 years after laparoscopic adjustable gastric banding, according to a report published online Nov. 4 in JAMA.

In a multicenter follow-up study of 2,348 such patients, those who underwent Roux-en-Y gastric bypass (RYGB) lost a median of 31.5% of their baseline weight and those who underwent laparoscopic adjustable gastric banding (LAGB) lost a median of 15.9% of their baseline weight at 3 years, said Dr. Anita P. Courcoulas of the department of surgery, University of Pittsburgh Medical Center, and her associates.

"Because our patient population was diverse and our results were from a large number of surgeons and surgical centers, long-term sustained weight loss can be expected from RYGB, and the results are likely generalizable. [However,] weight loss associated with the LAGB procedure was less than anticipated ... and less than what would be expected based on published series," the investigators noted.

Dr. Courcoulas and her colleagues in the Longitudinal Assessment of Bariatric Surgery consortium performed this observational cohort study at 10 hospitals across the United States. A total of 1,738 adults underwent RYGB, and 610 underwent LAGB. The median age was 46 years (range, 18-78 years). Most of the study subjects were women (79%), and 14% were nonwhite.

After 3 years, patients in the RYGB group lost a median of 41 kg (range, 110-kg loss to a 1-kg gain). Most of that loss occurred during the first postsurgical year, and typically there was "mild" weight regain between years 2 and 3.

Patients in the LAGB group lost a median of 20 kg (range, 75-kg loss to a 20-kg gain). Most of that loss also occurred during the first postsurgical year, with less than 20% of patients losing much weight after that. Typically, that weight loss was maintained between years 2 and 3, the investigators said (JAMA 2013 Nov. 4 [doi:10.1001/jama.2013.280928]).

Approximately 67% of patients in the RYGB group had at least partial remission of diabetes at year 3, a percentage similar to that reported in the literature. In contrast, only 27% of those in the LAGB group had at least partial remission of diabetes at year 3, which is a substantially lower rate than the 73% reported in the literature.

At the same time, 0.9% of patients in the RYGB group and 3.2% of those in the LAGB group developed new-onset diabetes during follow-up.

Approximately 62% of the RYGB group had remission of dyslipidemia, while 3.2% developed new-onset dyslipidemia. In contrast, only 27% of the LAGB group had remission of dyslipidemia, while 16% developed new-onset dyslipidemia. The pattern was similar for hyperlipidemia.

Approximately 38% of the RYGB group had remission of hypertension, while 13% developed new-onset hypertension during follow-up. For the LAGB group, the proportion of new-onset cases of hypertension (18.1%) actually exceeded the proportion of remissions (17.4%).

Concerning adverse events, three deaths occurred within 30 days of an RYGB procedure, and two revision procedures and two reversal procedures were required during 3-year follow-up. The corresponding figures for LAGB were zero postsurgical deaths and 77 surgeries to remove the band or revise the surgery during follow-up.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Courcoulas reported ties to Allergan, Covidien, EndoGastric Solutions, Ethicon J & J Healthcare System, Nutrisystem, and Pfizer, and her associates reported ties to several industry sources.

Clinicians can expect "substantial" weight loss in severely obese patients 3 years after they undergo Roux-en-Y gastric bypass but less impressive weight loss 3 years after laparoscopic adjustable gastric banding, according to a report published online Nov. 4 in JAMA.

In a multicenter follow-up study of 2,348 such patients, those who underwent Roux-en-Y gastric bypass (RYGB) lost a median of 31.5% of their baseline weight and those who underwent laparoscopic adjustable gastric banding (LAGB) lost a median of 15.9% of their baseline weight at 3 years, said Dr. Anita P. Courcoulas of the department of surgery, University of Pittsburgh Medical Center, and her associates.

"Because our patient population was diverse and our results were from a large number of surgeons and surgical centers, long-term sustained weight loss can be expected from RYGB, and the results are likely generalizable. [However,] weight loss associated with the LAGB procedure was less than anticipated ... and less than what would be expected based on published series," the investigators noted.

Dr. Courcoulas and her colleagues in the Longitudinal Assessment of Bariatric Surgery consortium performed this observational cohort study at 10 hospitals across the United States. A total of 1,738 adults underwent RYGB, and 610 underwent LAGB. The median age was 46 years (range, 18-78 years). Most of the study subjects were women (79%), and 14% were nonwhite.

After 3 years, patients in the RYGB group lost a median of 41 kg (range, 110-kg loss to a 1-kg gain). Most of that loss occurred during the first postsurgical year, and typically there was "mild" weight regain between years 2 and 3.

Patients in the LAGB group lost a median of 20 kg (range, 75-kg loss to a 20-kg gain). Most of that loss also occurred during the first postsurgical year, with less than 20% of patients losing much weight after that. Typically, that weight loss was maintained between years 2 and 3, the investigators said (JAMA 2013 Nov. 4 [doi:10.1001/jama.2013.280928]).

Approximately 67% of patients in the RYGB group had at least partial remission of diabetes at year 3, a percentage similar to that reported in the literature. In contrast, only 27% of those in the LAGB group had at least partial remission of diabetes at year 3, which is a substantially lower rate than the 73% reported in the literature.

At the same time, 0.9% of patients in the RYGB group and 3.2% of those in the LAGB group developed new-onset diabetes during follow-up.

Approximately 62% of the RYGB group had remission of dyslipidemia, while 3.2% developed new-onset dyslipidemia. In contrast, only 27% of the LAGB group had remission of dyslipidemia, while 16% developed new-onset dyslipidemia. The pattern was similar for hyperlipidemia.

Approximately 38% of the RYGB group had remission of hypertension, while 13% developed new-onset hypertension during follow-up. For the LAGB group, the proportion of new-onset cases of hypertension (18.1%) actually exceeded the proportion of remissions (17.4%).

Concerning adverse events, three deaths occurred within 30 days of an RYGB procedure, and two revision procedures and two reversal procedures were required during 3-year follow-up. The corresponding figures for LAGB were zero postsurgical deaths and 77 surgeries to remove the band or revise the surgery during follow-up.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Courcoulas reported ties to Allergan, Covidien, EndoGastric Solutions, Ethicon J & J Healthcare System, Nutrisystem, and Pfizer, and her associates reported ties to several industry sources.

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Major finding: Patients who underwent Roux-en-Y gastric bypass lost a median of 31.5% of their baseline weight, or 41 kg, while those who underwent laparoscopic adjustable gastric banding lost a median of 15.9% of their baseline weight, or 20 kg.

Data source: A multicenter observational cohort study involving 1,738 adults who underwent RYGB and 610 who underwent LAGB, who were followed for 3 years.

Disclosures: This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Courcoulas reported ties to Allergan, Covidien, EndoGastric Solutions, Ethicon J & J Healthcare System, Nutrisystem, and Pfizer, and her associates reported ties to several industry sources.

Adding melatonin to alprazolam boosts preoperative anxiolysis

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SAN FRANCISCO – Adding melatonin to alprazolam significantly decreased preoperative anxiety, compared with either medication alone or with placebo, in a randomized, double-blind trial of 80 patients.

Adult patients undergoing laparoscopic cholecystectomy who reported a preoperative anxiety level of at least 3 cm on a 10-cm Visual Analog Scale (VAS) had average anxiety scores of 5 cm before being randomized to preoperative medication with alprazolam 0.5 mg, melatonin 3 mg, both drugs, or placebo (with 20 patients in each group).

Dr. Krishna Pokharel

After 1 hour spent in a quiet room following the premedication, VAS scores had fallen by an average of 3 cm in the two-drug group, significantly more than average 2-cm reductions with either drug alone, or a 1-cm decline on placebo, Dr. Krishna Pokharel and her associates reported.

Adding melatonin did not seem to worsen the sedative or amnesiac effects of alprazolam, she reported in a poster presentation at the annual meeting of the American Society of Anesthesiologists.

In the past, some of her patients who had been premedicated with a benzodiazepine before general anesthesia and surgery sometimes became aroused during the procedure, perhaps because benzodiazepines suppress endogenous melatonin levels, Dr. Pokharel said. She hypothesized that adding melatonin might help, and the study results have convinced her institution to routinely add melatonin to alprazolam for surgical premedication in anxious patients, said Dr. Pokharel of B.P. Koirala Institute of Health Sciences, Dharan, Nepal.

Patients were shown different pictures during assessments of anxiety and sedation at various time points before surgery. At 24 hours after surgery, 10 patients on alprazolam plus melatonin could recall the picture they saw 1 hour after taking the presurgical medication, compared with 9 patients on alprazolam alone, 18 patients on melatonin alone, and 16 patients on placebo, the poster reported.

In other results, average scores on a 5-point scale for sedation at 1 hour were 0.5 with melatonin, 1 for each group using alprazolam, and 0 with placebo, among other secondary outcomes. At 24 hours after surgery, five patients in the two-drug group could not remember being transferred to the OR, compared with four patients on alprazolam, one patient on melatonin, and none of the patients on placebo.

All groups scored 2 on a 3-point scale for orientation 1 hour after taking the premedication. The amount of propofol needed to achieve a loss of response to verbal commands at the time of general anesthesia induction averaged 66 mg in the alprazolam plus melatonin group, 59 mg after alprazolam alone, 79 mg after melatonin alone, and 76 mg on placebo.

No patients developed serious adverse events.

Dr. Pokharel reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

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SAN FRANCISCO – Adding melatonin to alprazolam significantly decreased preoperative anxiety, compared with either medication alone or with placebo, in a randomized, double-blind trial of 80 patients.

Adult patients undergoing laparoscopic cholecystectomy who reported a preoperative anxiety level of at least 3 cm on a 10-cm Visual Analog Scale (VAS) had average anxiety scores of 5 cm before being randomized to preoperative medication with alprazolam 0.5 mg, melatonin 3 mg, both drugs, or placebo (with 20 patients in each group).

Dr. Krishna Pokharel

After 1 hour spent in a quiet room following the premedication, VAS scores had fallen by an average of 3 cm in the two-drug group, significantly more than average 2-cm reductions with either drug alone, or a 1-cm decline on placebo, Dr. Krishna Pokharel and her associates reported.

Adding melatonin did not seem to worsen the sedative or amnesiac effects of alprazolam, she reported in a poster presentation at the annual meeting of the American Society of Anesthesiologists.

In the past, some of her patients who had been premedicated with a benzodiazepine before general anesthesia and surgery sometimes became aroused during the procedure, perhaps because benzodiazepines suppress endogenous melatonin levels, Dr. Pokharel said. She hypothesized that adding melatonin might help, and the study results have convinced her institution to routinely add melatonin to alprazolam for surgical premedication in anxious patients, said Dr. Pokharel of B.P. Koirala Institute of Health Sciences, Dharan, Nepal.

Patients were shown different pictures during assessments of anxiety and sedation at various time points before surgery. At 24 hours after surgery, 10 patients on alprazolam plus melatonin could recall the picture they saw 1 hour after taking the presurgical medication, compared with 9 patients on alprazolam alone, 18 patients on melatonin alone, and 16 patients on placebo, the poster reported.

In other results, average scores on a 5-point scale for sedation at 1 hour were 0.5 with melatonin, 1 for each group using alprazolam, and 0 with placebo, among other secondary outcomes. At 24 hours after surgery, five patients in the two-drug group could not remember being transferred to the OR, compared with four patients on alprazolam, one patient on melatonin, and none of the patients on placebo.

All groups scored 2 on a 3-point scale for orientation 1 hour after taking the premedication. The amount of propofol needed to achieve a loss of response to verbal commands at the time of general anesthesia induction averaged 66 mg in the alprazolam plus melatonin group, 59 mg after alprazolam alone, 79 mg after melatonin alone, and 76 mg on placebo.

No patients developed serious adverse events.

Dr. Pokharel reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Adding melatonin to alprazolam significantly decreased preoperative anxiety, compared with either medication alone or with placebo, in a randomized, double-blind trial of 80 patients.

Adult patients undergoing laparoscopic cholecystectomy who reported a preoperative anxiety level of at least 3 cm on a 10-cm Visual Analog Scale (VAS) had average anxiety scores of 5 cm before being randomized to preoperative medication with alprazolam 0.5 mg, melatonin 3 mg, both drugs, or placebo (with 20 patients in each group).

Dr. Krishna Pokharel

After 1 hour spent in a quiet room following the premedication, VAS scores had fallen by an average of 3 cm in the two-drug group, significantly more than average 2-cm reductions with either drug alone, or a 1-cm decline on placebo, Dr. Krishna Pokharel and her associates reported.

Adding melatonin did not seem to worsen the sedative or amnesiac effects of alprazolam, she reported in a poster presentation at the annual meeting of the American Society of Anesthesiologists.

In the past, some of her patients who had been premedicated with a benzodiazepine before general anesthesia and surgery sometimes became aroused during the procedure, perhaps because benzodiazepines suppress endogenous melatonin levels, Dr. Pokharel said. She hypothesized that adding melatonin might help, and the study results have convinced her institution to routinely add melatonin to alprazolam for surgical premedication in anxious patients, said Dr. Pokharel of B.P. Koirala Institute of Health Sciences, Dharan, Nepal.

Patients were shown different pictures during assessments of anxiety and sedation at various time points before surgery. At 24 hours after surgery, 10 patients on alprazolam plus melatonin could recall the picture they saw 1 hour after taking the presurgical medication, compared with 9 patients on alprazolam alone, 18 patients on melatonin alone, and 16 patients on placebo, the poster reported.

In other results, average scores on a 5-point scale for sedation at 1 hour were 0.5 with melatonin, 1 for each group using alprazolam, and 0 with placebo, among other secondary outcomes. At 24 hours after surgery, five patients in the two-drug group could not remember being transferred to the OR, compared with four patients on alprazolam, one patient on melatonin, and none of the patients on placebo.

All groups scored 2 on a 3-point scale for orientation 1 hour after taking the premedication. The amount of propofol needed to achieve a loss of response to verbal commands at the time of general anesthesia induction averaged 66 mg in the alprazolam plus melatonin group, 59 mg after alprazolam alone, 79 mg after melatonin alone, and 76 mg on placebo.

No patients developed serious adverse events.

Dr. Pokharel reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

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Major finding: Anxiety VAS scores at 60 minutes, compared with baseline, fell by 3 cm with melatonin plus alprazolam, 2 cm with either drug alone, or 1 cm with placebo.

Data source: A prospective, randomized, controlled trial of 80 adults undergoing laparoscopic cholecystectomy at one hospital.

Disclosures: Dr. Pokharel reported having no financial disclosures.

Stereotactic lung radiotherapy of central lung tumors can achieve good overall survival with limited toxicity

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SYDNEY – Stereotactic lung radiotherapy for centrally located non–small cell lung carcinomas can result in overall survival outcomes that are similar to those for peripheral tumors, but with an increased risk of local failure and pneumonitis, based on the results of an analysis of a large international data set.

Overall survival at 3 years was similar for 100 centrally located non–small cell lung cancers – defined as being located within 2 cm of the proximal bronchial tree – and for 869 peripheral tumors treated with stereotactic body radiotherapy (50% vs. 51%; P = .70), based on data presented by Dr. Maria Werner-Wasik at a world conference on lung cancer, sponsored by the International Association for the Study of Lung Cancer.

Dr. Maria Werner-Wasik

Also, the two groups did not significantly differ in the incidence of chest wall pain and myositis, rib fracture, and dermatitis. Patients with central tumors had a significantly higher incidence of grade 2 or above pneumonitis (8% vs. 1% in those with peripheral tumors; P less than .001). The incidence of grade 3 pneumonitis was similar between the two groups.

Central tumors were associated with a lower rate of cause-specific survival than were peripheral tumors (75% vs. 88%; P less than .001) and higher local failure rates at 3 years (16.2% vs. 5.9%; P less than .001) and 5 years (20.4% vs. 8.3%; P less than .001).

Dr. Werner-Wasik said central tumors had fallen into a "no-fly zone" for stereotactic body radiotherapy since an earlier trial showed unacceptable levels of toxicities from treating centrally located lung tumors. Thereafter, prospective trials examined only peripheral tumors.

"If you have a central tumor you have to do something. You can always treat with standard fractionation, but that’s not the idea. We want to give those patients (with centrally located tumors) the benefit of a short, effective regimen," said Dr. Werner-Wasik, professor and director of clinical research at the department of radiation oncology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia.

The data from the Elekta Lung Research Groupshowed a higher rate of local failure. Dr. Werner-Wasik said this was still "respectable," especially as the centrally located tumors did receive slightly less radiation than the peripheral tumors did and were significantly larger at baseline (3.1 vs. 2.4 cm; P less than .001).

"The local control was worse for central tumors versus peripheral tumors, presumably because we treated them with lower biologically effective doses," said Dr. Werner-Wasik in an interview. "But also, these tumors were slightly different ... as illustrated by higher values on PET scans."

Results from the upcoming RTOG 0813 study may shed more light on the question of how to deliver stereotactic body radiotherapy to centrally located tumors, she said. "We have to find an effective central dose radiation fractionation and total dose so these patients do not suffer complications and yet are assured local control."

The research was partly supported by a grant from Elekta, makers of stereotactic body radiation technology products. Dr. Werner-Wasik said she had no relevant financial disclosures. The Elekta Lung Research Group includes participants from William Beaumont Hospital in Royal Oak, Mich.; Princess Margaret Cancer Centre, Toronto; Thomas Jefferson University, Philadelphia; Julius Maximilian University of Würzburg (Germany); and the Netherlands Cancer Institute–Antoni van Leeuwenhoek Hospital in Amsterdam.

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SYDNEY – Stereotactic lung radiotherapy for centrally located non–small cell lung carcinomas can result in overall survival outcomes that are similar to those for peripheral tumors, but with an increased risk of local failure and pneumonitis, based on the results of an analysis of a large international data set.

Overall survival at 3 years was similar for 100 centrally located non–small cell lung cancers – defined as being located within 2 cm of the proximal bronchial tree – and for 869 peripheral tumors treated with stereotactic body radiotherapy (50% vs. 51%; P = .70), based on data presented by Dr. Maria Werner-Wasik at a world conference on lung cancer, sponsored by the International Association for the Study of Lung Cancer.

Dr. Maria Werner-Wasik

Also, the two groups did not significantly differ in the incidence of chest wall pain and myositis, rib fracture, and dermatitis. Patients with central tumors had a significantly higher incidence of grade 2 or above pneumonitis (8% vs. 1% in those with peripheral tumors; P less than .001). The incidence of grade 3 pneumonitis was similar between the two groups.

Central tumors were associated with a lower rate of cause-specific survival than were peripheral tumors (75% vs. 88%; P less than .001) and higher local failure rates at 3 years (16.2% vs. 5.9%; P less than .001) and 5 years (20.4% vs. 8.3%; P less than .001).

Dr. Werner-Wasik said central tumors had fallen into a "no-fly zone" for stereotactic body radiotherapy since an earlier trial showed unacceptable levels of toxicities from treating centrally located lung tumors. Thereafter, prospective trials examined only peripheral tumors.

"If you have a central tumor you have to do something. You can always treat with standard fractionation, but that’s not the idea. We want to give those patients (with centrally located tumors) the benefit of a short, effective regimen," said Dr. Werner-Wasik, professor and director of clinical research at the department of radiation oncology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia.

The data from the Elekta Lung Research Groupshowed a higher rate of local failure. Dr. Werner-Wasik said this was still "respectable," especially as the centrally located tumors did receive slightly less radiation than the peripheral tumors did and were significantly larger at baseline (3.1 vs. 2.4 cm; P less than .001).

"The local control was worse for central tumors versus peripheral tumors, presumably because we treated them with lower biologically effective doses," said Dr. Werner-Wasik in an interview. "But also, these tumors were slightly different ... as illustrated by higher values on PET scans."

Results from the upcoming RTOG 0813 study may shed more light on the question of how to deliver stereotactic body radiotherapy to centrally located tumors, she said. "We have to find an effective central dose radiation fractionation and total dose so these patients do not suffer complications and yet are assured local control."

The research was partly supported by a grant from Elekta, makers of stereotactic body radiation technology products. Dr. Werner-Wasik said she had no relevant financial disclosures. The Elekta Lung Research Group includes participants from William Beaumont Hospital in Royal Oak, Mich.; Princess Margaret Cancer Centre, Toronto; Thomas Jefferson University, Philadelphia; Julius Maximilian University of Würzburg (Germany); and the Netherlands Cancer Institute–Antoni van Leeuwenhoek Hospital in Amsterdam.

SYDNEY – Stereotactic lung radiotherapy for centrally located non–small cell lung carcinomas can result in overall survival outcomes that are similar to those for peripheral tumors, but with an increased risk of local failure and pneumonitis, based on the results of an analysis of a large international data set.

Overall survival at 3 years was similar for 100 centrally located non–small cell lung cancers – defined as being located within 2 cm of the proximal bronchial tree – and for 869 peripheral tumors treated with stereotactic body radiotherapy (50% vs. 51%; P = .70), based on data presented by Dr. Maria Werner-Wasik at a world conference on lung cancer, sponsored by the International Association for the Study of Lung Cancer.

Dr. Maria Werner-Wasik

Also, the two groups did not significantly differ in the incidence of chest wall pain and myositis, rib fracture, and dermatitis. Patients with central tumors had a significantly higher incidence of grade 2 or above pneumonitis (8% vs. 1% in those with peripheral tumors; P less than .001). The incidence of grade 3 pneumonitis was similar between the two groups.

Central tumors were associated with a lower rate of cause-specific survival than were peripheral tumors (75% vs. 88%; P less than .001) and higher local failure rates at 3 years (16.2% vs. 5.9%; P less than .001) and 5 years (20.4% vs. 8.3%; P less than .001).

Dr. Werner-Wasik said central tumors had fallen into a "no-fly zone" for stereotactic body radiotherapy since an earlier trial showed unacceptable levels of toxicities from treating centrally located lung tumors. Thereafter, prospective trials examined only peripheral tumors.

"If you have a central tumor you have to do something. You can always treat with standard fractionation, but that’s not the idea. We want to give those patients (with centrally located tumors) the benefit of a short, effective regimen," said Dr. Werner-Wasik, professor and director of clinical research at the department of radiation oncology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia.

The data from the Elekta Lung Research Groupshowed a higher rate of local failure. Dr. Werner-Wasik said this was still "respectable," especially as the centrally located tumors did receive slightly less radiation than the peripheral tumors did and were significantly larger at baseline (3.1 vs. 2.4 cm; P less than .001).

"The local control was worse for central tumors versus peripheral tumors, presumably because we treated them with lower biologically effective doses," said Dr. Werner-Wasik in an interview. "But also, these tumors were slightly different ... as illustrated by higher values on PET scans."

Results from the upcoming RTOG 0813 study may shed more light on the question of how to deliver stereotactic body radiotherapy to centrally located tumors, she said. "We have to find an effective central dose radiation fractionation and total dose so these patients do not suffer complications and yet are assured local control."

The research was partly supported by a grant from Elekta, makers of stereotactic body radiation technology products. Dr. Werner-Wasik said she had no relevant financial disclosures. The Elekta Lung Research Group includes participants from William Beaumont Hospital in Royal Oak, Mich.; Princess Margaret Cancer Centre, Toronto; Thomas Jefferson University, Philadelphia; Julius Maximilian University of Würzburg (Germany); and the Netherlands Cancer Institute–Antoni van Leeuwenhoek Hospital in Amsterdam.

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Major finding: Overall survival at 3 years was similar for 100 centrally located non–small cell lung cancers – defined as being located within 2 cm of the proximal bronchial tree – and for 869 peripheral tumors treated with stereotactic body radiotherapy (50% vs. 51%; P = .70).

Data source: A retrospective analysis of data from the Elekta Lung Research Group.

Disclosures: The research is partly funded by a grant from Elekta, makers of stereotactic body radiation technology products. Dr. Werner-Wasik said she had no relevant financial disclosures.

Lawmakers unveil bipartisan SGR repeal plan

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A new bipartisan, bicameral plan to repeal the Medicare Sustainable Growth Rate formula has surfaced on Capitol Hill.

On Oct. 30, the Senate Finance Committee and the House Ways and Means Committee jointly released a legislative framework that would scrap Medicare’s Sustainable Growth Rate (SGR) formula and freeze physician payments for the next decade.

Rep. Dave Camp     

Starting in 2017, physicians would see their payments tied to cost and quality of care using a single quality incentive program. Under the proposal, Medicare would create the Value-Based Performance Payment Program to adjust physician payments based on quality, resource use, clinical practice improvement activities, and the use of electronic health records.

Since the program is budget neutral, some physicians would see increases while others would see cuts.

At the end of 2016, Medicare would end a group of existing incentive programs including the Physician Quality Reporting System; the Value-Based Modifier Program; and the Electronic Health Record (EHR) Incentive Program, which requires the meaningful use of certified EHR technology.

Physicians who treat few Medicare patients or who receive a significant portion of their payments from advanced alternative payment models, such as accountable care organizations, would be excluded from the new Value-Based Performance Payment Program. Physicians in ACOs and other models that involved taking on financial risk and reporting on quality measures would instead be eligible for bonus payments under the proposal.

After 2023, physicians who participate in these advanced alternative payment models would see an annual 2% payment increase, and other physicians would earn updates of 1% each year, according to the proposal circulated by the two committees.

"This discussion draft is an important step in a long-term solution to this failed policy," Rep. Dave Camp, chairman of the House Ways and Means Committee, said in a statement. "Creating a policy that rewards providers for delivering high-quality, efficient health care is the ultimate goal, and this draft brings us one step closer to that reality."

    Dr. Ardis Hoven

The release of the proposal follows a summer of feverish activity in the House on the issue of the SGR. After months of hearings, the Energy and Commerce Committee unanimously approved a bill on July 31 (H.R. 2810) that would repeal the SGR and provide 0.5% payment increases for physicians through 2018.

Momentum slowed after Labor Day with the continuing debate over the Affordable Care Act and the federal government shutdown that began on Oct. 1. This latest plan incorporates ideas from both the Democratic-led Senate and the GOP-controlled House.

While physician groups were still reviewing the proposal at press time, they hailed the renewed focus on the SGR as a move in the right direction.

"Congress is demonstrating that they understand that ending the failed SGR this year is fiscally responsible, and that the current Medicare payment system is a barrier to adoption of health care delivery and payment reforms that will improve health care for America’s seniors and rein in overall costs," Dr. Ardis Dee Hoven, president of the American Medical Association, said in a statement.

Physicians can comment on the proposal until Nov. 12. Send comments to the Senate Finance Committee at [email protected] and to the House Ways and Means Committee at [email protected].

[email protected]

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A new bipartisan, bicameral plan to repeal the Medicare Sustainable Growth Rate formula has surfaced on Capitol Hill.

On Oct. 30, the Senate Finance Committee and the House Ways and Means Committee jointly released a legislative framework that would scrap Medicare’s Sustainable Growth Rate (SGR) formula and freeze physician payments for the next decade.

Rep. Dave Camp     

Starting in 2017, physicians would see their payments tied to cost and quality of care using a single quality incentive program. Under the proposal, Medicare would create the Value-Based Performance Payment Program to adjust physician payments based on quality, resource use, clinical practice improvement activities, and the use of electronic health records.

Since the program is budget neutral, some physicians would see increases while others would see cuts.

At the end of 2016, Medicare would end a group of existing incentive programs including the Physician Quality Reporting System; the Value-Based Modifier Program; and the Electronic Health Record (EHR) Incentive Program, which requires the meaningful use of certified EHR technology.

Physicians who treat few Medicare patients or who receive a significant portion of their payments from advanced alternative payment models, such as accountable care organizations, would be excluded from the new Value-Based Performance Payment Program. Physicians in ACOs and other models that involved taking on financial risk and reporting on quality measures would instead be eligible for bonus payments under the proposal.

After 2023, physicians who participate in these advanced alternative payment models would see an annual 2% payment increase, and other physicians would earn updates of 1% each year, according to the proposal circulated by the two committees.

"This discussion draft is an important step in a long-term solution to this failed policy," Rep. Dave Camp, chairman of the House Ways and Means Committee, said in a statement. "Creating a policy that rewards providers for delivering high-quality, efficient health care is the ultimate goal, and this draft brings us one step closer to that reality."

    Dr. Ardis Hoven

The release of the proposal follows a summer of feverish activity in the House on the issue of the SGR. After months of hearings, the Energy and Commerce Committee unanimously approved a bill on July 31 (H.R. 2810) that would repeal the SGR and provide 0.5% payment increases for physicians through 2018.

Momentum slowed after Labor Day with the continuing debate over the Affordable Care Act and the federal government shutdown that began on Oct. 1. This latest plan incorporates ideas from both the Democratic-led Senate and the GOP-controlled House.

While physician groups were still reviewing the proposal at press time, they hailed the renewed focus on the SGR as a move in the right direction.

"Congress is demonstrating that they understand that ending the failed SGR this year is fiscally responsible, and that the current Medicare payment system is a barrier to adoption of health care delivery and payment reforms that will improve health care for America’s seniors and rein in overall costs," Dr. Ardis Dee Hoven, president of the American Medical Association, said in a statement.

Physicians can comment on the proposal until Nov. 12. Send comments to the Senate Finance Committee at [email protected] and to the House Ways and Means Committee at [email protected].

[email protected]

A new bipartisan, bicameral plan to repeal the Medicare Sustainable Growth Rate formula has surfaced on Capitol Hill.

On Oct. 30, the Senate Finance Committee and the House Ways and Means Committee jointly released a legislative framework that would scrap Medicare’s Sustainable Growth Rate (SGR) formula and freeze physician payments for the next decade.

Rep. Dave Camp     

Starting in 2017, physicians would see their payments tied to cost and quality of care using a single quality incentive program. Under the proposal, Medicare would create the Value-Based Performance Payment Program to adjust physician payments based on quality, resource use, clinical practice improvement activities, and the use of electronic health records.

Since the program is budget neutral, some physicians would see increases while others would see cuts.

At the end of 2016, Medicare would end a group of existing incentive programs including the Physician Quality Reporting System; the Value-Based Modifier Program; and the Electronic Health Record (EHR) Incentive Program, which requires the meaningful use of certified EHR technology.

Physicians who treat few Medicare patients or who receive a significant portion of their payments from advanced alternative payment models, such as accountable care organizations, would be excluded from the new Value-Based Performance Payment Program. Physicians in ACOs and other models that involved taking on financial risk and reporting on quality measures would instead be eligible for bonus payments under the proposal.

After 2023, physicians who participate in these advanced alternative payment models would see an annual 2% payment increase, and other physicians would earn updates of 1% each year, according to the proposal circulated by the two committees.

"This discussion draft is an important step in a long-term solution to this failed policy," Rep. Dave Camp, chairman of the House Ways and Means Committee, said in a statement. "Creating a policy that rewards providers for delivering high-quality, efficient health care is the ultimate goal, and this draft brings us one step closer to that reality."

    Dr. Ardis Hoven

The release of the proposal follows a summer of feverish activity in the House on the issue of the SGR. After months of hearings, the Energy and Commerce Committee unanimously approved a bill on July 31 (H.R. 2810) that would repeal the SGR and provide 0.5% payment increases for physicians through 2018.

Momentum slowed after Labor Day with the continuing debate over the Affordable Care Act and the federal government shutdown that began on Oct. 1. This latest plan incorporates ideas from both the Democratic-led Senate and the GOP-controlled House.

While physician groups were still reviewing the proposal at press time, they hailed the renewed focus on the SGR as a move in the right direction.

"Congress is demonstrating that they understand that ending the failed SGR this year is fiscally responsible, and that the current Medicare payment system is a barrier to adoption of health care delivery and payment reforms that will improve health care for America’s seniors and rein in overall costs," Dr. Ardis Dee Hoven, president of the American Medical Association, said in a statement.

Physicians can comment on the proposal until Nov. 12. Send comments to the Senate Finance Committee at [email protected] and to the House Ways and Means Committee at [email protected].

[email protected]

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Proposed FDA measures aim to reduce drug shortages

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The Food and Drug Administration announced on Oct. 31 two initiatives aimed at cutting down on drug shortages and improving communications with drug companies.

The first is a proposed rule to require drug manufacturers to alert the FDA if certain "medically important drug products" are running low, Dr. Margaret Hamburg, commissioner of the agency, said during a teleconference announcing the initiatives. This proposal expands on early notification requirements included in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which created a task force designated to deal with drug shortages. The proposal also would extend those requirements to biologically manufactured drugs.

Dr. Margaret Hamburg

The second initiative is a strategic plan to improve communications between the FDA and drug manufacturers, develop short- and long-term contingency plans for drug shortages, and revamp communications processes within the agency to improve response times to potential shortages.

The strategy was developed with both internal and external input and analysis from work groups, drug manufacturers, and health care organizations. For the plan to work "this has to be a group effort," Dr. Hamburg said.

Drug shortages have declined significantly since 2012, with 117 drug shortages in 2012, down from 212 in 2011. But early notification from manufacturers about possible shortages can help drive those numbers down even further, said FDA representatives.

The strategic plan, which was required by FDASIA and is being sent to Congress Oct. 31, also includes new ideas such as the development of a smartphone app for real-time drug shortage news, a proposal for rewarding drug manufacturers based on cooperation with the FDA, and a new office within the Center for Drug Evaluation and Research focused exclusively on pharmaceutical quality.

Members of the public may comment on the proposed rule, which is scheduled to be published in the Federal Register on Nov. 4.

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The Food and Drug Administration announced on Oct. 31 two initiatives aimed at cutting down on drug shortages and improving communications with drug companies.

The first is a proposed rule to require drug manufacturers to alert the FDA if certain "medically important drug products" are running low, Dr. Margaret Hamburg, commissioner of the agency, said during a teleconference announcing the initiatives. This proposal expands on early notification requirements included in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which created a task force designated to deal with drug shortages. The proposal also would extend those requirements to biologically manufactured drugs.

Dr. Margaret Hamburg

The second initiative is a strategic plan to improve communications between the FDA and drug manufacturers, develop short- and long-term contingency plans for drug shortages, and revamp communications processes within the agency to improve response times to potential shortages.

The strategy was developed with both internal and external input and analysis from work groups, drug manufacturers, and health care organizations. For the plan to work "this has to be a group effort," Dr. Hamburg said.

Drug shortages have declined significantly since 2012, with 117 drug shortages in 2012, down from 212 in 2011. But early notification from manufacturers about possible shortages can help drive those numbers down even further, said FDA representatives.

The strategic plan, which was required by FDASIA and is being sent to Congress Oct. 31, also includes new ideas such as the development of a smartphone app for real-time drug shortage news, a proposal for rewarding drug manufacturers based on cooperation with the FDA, and a new office within the Center for Drug Evaluation and Research focused exclusively on pharmaceutical quality.

Members of the public may comment on the proposed rule, which is scheduled to be published in the Federal Register on Nov. 4.

[email protected]

The Food and Drug Administration announced on Oct. 31 two initiatives aimed at cutting down on drug shortages and improving communications with drug companies.

The first is a proposed rule to require drug manufacturers to alert the FDA if certain "medically important drug products" are running low, Dr. Margaret Hamburg, commissioner of the agency, said during a teleconference announcing the initiatives. This proposal expands on early notification requirements included in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which created a task force designated to deal with drug shortages. The proposal also would extend those requirements to biologically manufactured drugs.

Dr. Margaret Hamburg

The second initiative is a strategic plan to improve communications between the FDA and drug manufacturers, develop short- and long-term contingency plans for drug shortages, and revamp communications processes within the agency to improve response times to potential shortages.

The strategy was developed with both internal and external input and analysis from work groups, drug manufacturers, and health care organizations. For the plan to work "this has to be a group effort," Dr. Hamburg said.

Drug shortages have declined significantly since 2012, with 117 drug shortages in 2012, down from 212 in 2011. But early notification from manufacturers about possible shortages can help drive those numbers down even further, said FDA representatives.

The strategic plan, which was required by FDASIA and is being sent to Congress Oct. 31, also includes new ideas such as the development of a smartphone app for real-time drug shortage news, a proposal for rewarding drug manufacturers based on cooperation with the FDA, and a new office within the Center for Drug Evaluation and Research focused exclusively on pharmaceutical quality.

Members of the public may comment on the proposed rule, which is scheduled to be published in the Federal Register on Nov. 4.

[email protected]

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