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Supreme Court to decide whether doctors can sue over low Medicaid payments
Physicians are closely watching a U.S. Supreme Court case that could affect their ability to fight low Medicaid payments.
On Jan. 20, the justices will hear arguments in Armstrong v. Exceptional Child Center Inc., a legal dispute that centers on whether physicians and other health care providers have the right to sue states to compel them to raise Medicaid payment rates.
Allowing providers to seek legal action over low Medicaid payments helps to ensure that payment is adequate and that states are held accountable, according to Dr. Reid B. Blackwelder, board chair of the American Academy of Family Physicians. Under the equal access provision of the Medicaid Act, states that accept federal Medicaid funding are required to set reimbursement rates at levels sufficient to retain enough providers and make sure patients have proper access to care.
“States really have the freedom and the will to make [payment] decisions based on their budgets,” Dr. Blackwelder said in an interview. “We feel the only way to create a remedy to the state’s noncompliance [to the equal access provision] is the individual’s right to sue.”
The case stems from a 2009 lawsuit by Exceptional Child Center Inc. of Twin Falls, Idaho, and four other residential habilitation centers against Richard Armstrong, director for the Idaho Department of Health and Welfare. The centers claimed the state should have raised its Medicaid payment rates after studies determined rate increases were necessary. The Idaho Department of Health and Welfare and its Medicaid division had conducted yearly cost studies between 2006 and 2009, developed a new rate-setting methodology, and recommended substantial increases in reimbursement rates for supported living services, according to court documents. However, the new methodology and rate increases were not enacted for budgetary reasons.
A district court ruled in favor of the centers, and the 9th U.S. Circuit Court of Appeals affirmed the ruling. The state petitioned the Supreme Court to resolve the issue. Idaho noted a split among the lower courts as to whether the Constitution’s Supremacy Clause – which establishes the Constitution and federal law as the law of the land – supplies a private right of action to enforce Medicaid funding conditions against states. In a court brief, Idaho Attorney General Lawrence G. Wasden said the Supremacy Clause does not do so and that only Congress has the authority to enforce federal statutes.
Mr. Wasden added that the Centers for Medicare & Medicaid Services had not found issue with Idaho’s payment rates nor had initiated any disciplinary actions against the state.
“If CMS believes a state has failed to correct a deficiency, CMS may initiate a process to withhold federal funds, either entirely or limited to the fund associated with the noncompliant service,” Mr. Wasden said in court documents. “At no time relevant to this case has CMS ever initiated any compliance action or otherwise complained about the state’s rates.”
Twenty-seven states reached out to the high court in support of Idaho. The states said they have been subject to numerous, unwarranted lawsuits because of misguided interpretations of the Supremacy Clause.
A number of physician and patient advocacy associations joined a friend-of-the-court brief in support of the centers, including the AAFP and the American Medical Association. The physicians’ court brief noted that 32 states reduced and/or froze Medicaid rates in 2012, and 23 did the same in 2013. As a result, Medicaid payment rates have often fallen below the average cost to deliver care and make it untenable for physicians to take on Medicaid patients.
“Noncompliance with Medicaid’s equal-access mandate will continue unless private enforcement is allowed to challenge states that adopt Medicaid payment rates based on arbitrary or politically expedient budgetary decisions,” AMA President Dr. Robert M. Wah said in a statement.
The Supreme Court’s decision will have a significant impact on whether physicians and other providers continue to participate in Medicaid and whether patients can find necessary care, added Jane Perkins, legal director of the National Health Law Program, a nonprofit that advocates the rights of low-income patients. The National Health Law Program issued its own friend-of-the-court brief in support of the centers.
“There are a tremendous number of potential ‘bigger picture’ impacts” to the court’s decision, Ms. Perkins said in an interview. “Researchers have found time and again that while many things go into a provider’s decision whether or not to participate in Medicaid, one of the main things is the payment rate. If [Idaho wins], I really fear the already problematic state of provider participation in many places is only going to get worse."
OnTwitter @legal_med
Physicians are closely watching a U.S. Supreme Court case that could affect their ability to fight low Medicaid payments.
On Jan. 20, the justices will hear arguments in Armstrong v. Exceptional Child Center Inc., a legal dispute that centers on whether physicians and other health care providers have the right to sue states to compel them to raise Medicaid payment rates.
Allowing providers to seek legal action over low Medicaid payments helps to ensure that payment is adequate and that states are held accountable, according to Dr. Reid B. Blackwelder, board chair of the American Academy of Family Physicians. Under the equal access provision of the Medicaid Act, states that accept federal Medicaid funding are required to set reimbursement rates at levels sufficient to retain enough providers and make sure patients have proper access to care.
“States really have the freedom and the will to make [payment] decisions based on their budgets,” Dr. Blackwelder said in an interview. “We feel the only way to create a remedy to the state’s noncompliance [to the equal access provision] is the individual’s right to sue.”
The case stems from a 2009 lawsuit by Exceptional Child Center Inc. of Twin Falls, Idaho, and four other residential habilitation centers against Richard Armstrong, director for the Idaho Department of Health and Welfare. The centers claimed the state should have raised its Medicaid payment rates after studies determined rate increases were necessary. The Idaho Department of Health and Welfare and its Medicaid division had conducted yearly cost studies between 2006 and 2009, developed a new rate-setting methodology, and recommended substantial increases in reimbursement rates for supported living services, according to court documents. However, the new methodology and rate increases were not enacted for budgetary reasons.
A district court ruled in favor of the centers, and the 9th U.S. Circuit Court of Appeals affirmed the ruling. The state petitioned the Supreme Court to resolve the issue. Idaho noted a split among the lower courts as to whether the Constitution’s Supremacy Clause – which establishes the Constitution and federal law as the law of the land – supplies a private right of action to enforce Medicaid funding conditions against states. In a court brief, Idaho Attorney General Lawrence G. Wasden said the Supremacy Clause does not do so and that only Congress has the authority to enforce federal statutes.
Mr. Wasden added that the Centers for Medicare & Medicaid Services had not found issue with Idaho’s payment rates nor had initiated any disciplinary actions against the state.
“If CMS believes a state has failed to correct a deficiency, CMS may initiate a process to withhold federal funds, either entirely or limited to the fund associated with the noncompliant service,” Mr. Wasden said in court documents. “At no time relevant to this case has CMS ever initiated any compliance action or otherwise complained about the state’s rates.”
Twenty-seven states reached out to the high court in support of Idaho. The states said they have been subject to numerous, unwarranted lawsuits because of misguided interpretations of the Supremacy Clause.
A number of physician and patient advocacy associations joined a friend-of-the-court brief in support of the centers, including the AAFP and the American Medical Association. The physicians’ court brief noted that 32 states reduced and/or froze Medicaid rates in 2012, and 23 did the same in 2013. As a result, Medicaid payment rates have often fallen below the average cost to deliver care and make it untenable for physicians to take on Medicaid patients.
“Noncompliance with Medicaid’s equal-access mandate will continue unless private enforcement is allowed to challenge states that adopt Medicaid payment rates based on arbitrary or politically expedient budgetary decisions,” AMA President Dr. Robert M. Wah said in a statement.
The Supreme Court’s decision will have a significant impact on whether physicians and other providers continue to participate in Medicaid and whether patients can find necessary care, added Jane Perkins, legal director of the National Health Law Program, a nonprofit that advocates the rights of low-income patients. The National Health Law Program issued its own friend-of-the-court brief in support of the centers.
“There are a tremendous number of potential ‘bigger picture’ impacts” to the court’s decision, Ms. Perkins said in an interview. “Researchers have found time and again that while many things go into a provider’s decision whether or not to participate in Medicaid, one of the main things is the payment rate. If [Idaho wins], I really fear the already problematic state of provider participation in many places is only going to get worse."
OnTwitter @legal_med
Physicians are closely watching a U.S. Supreme Court case that could affect their ability to fight low Medicaid payments.
On Jan. 20, the justices will hear arguments in Armstrong v. Exceptional Child Center Inc., a legal dispute that centers on whether physicians and other health care providers have the right to sue states to compel them to raise Medicaid payment rates.
Allowing providers to seek legal action over low Medicaid payments helps to ensure that payment is adequate and that states are held accountable, according to Dr. Reid B. Blackwelder, board chair of the American Academy of Family Physicians. Under the equal access provision of the Medicaid Act, states that accept federal Medicaid funding are required to set reimbursement rates at levels sufficient to retain enough providers and make sure patients have proper access to care.
“States really have the freedom and the will to make [payment] decisions based on their budgets,” Dr. Blackwelder said in an interview. “We feel the only way to create a remedy to the state’s noncompliance [to the equal access provision] is the individual’s right to sue.”
The case stems from a 2009 lawsuit by Exceptional Child Center Inc. of Twin Falls, Idaho, and four other residential habilitation centers against Richard Armstrong, director for the Idaho Department of Health and Welfare. The centers claimed the state should have raised its Medicaid payment rates after studies determined rate increases were necessary. The Idaho Department of Health and Welfare and its Medicaid division had conducted yearly cost studies between 2006 and 2009, developed a new rate-setting methodology, and recommended substantial increases in reimbursement rates for supported living services, according to court documents. However, the new methodology and rate increases were not enacted for budgetary reasons.
A district court ruled in favor of the centers, and the 9th U.S. Circuit Court of Appeals affirmed the ruling. The state petitioned the Supreme Court to resolve the issue. Idaho noted a split among the lower courts as to whether the Constitution’s Supremacy Clause – which establishes the Constitution and federal law as the law of the land – supplies a private right of action to enforce Medicaid funding conditions against states. In a court brief, Idaho Attorney General Lawrence G. Wasden said the Supremacy Clause does not do so and that only Congress has the authority to enforce federal statutes.
Mr. Wasden added that the Centers for Medicare & Medicaid Services had not found issue with Idaho’s payment rates nor had initiated any disciplinary actions against the state.
“If CMS believes a state has failed to correct a deficiency, CMS may initiate a process to withhold federal funds, either entirely or limited to the fund associated with the noncompliant service,” Mr. Wasden said in court documents. “At no time relevant to this case has CMS ever initiated any compliance action or otherwise complained about the state’s rates.”
Twenty-seven states reached out to the high court in support of Idaho. The states said they have been subject to numerous, unwarranted lawsuits because of misguided interpretations of the Supremacy Clause.
A number of physician and patient advocacy associations joined a friend-of-the-court brief in support of the centers, including the AAFP and the American Medical Association. The physicians’ court brief noted that 32 states reduced and/or froze Medicaid rates in 2012, and 23 did the same in 2013. As a result, Medicaid payment rates have often fallen below the average cost to deliver care and make it untenable for physicians to take on Medicaid patients.
“Noncompliance with Medicaid’s equal-access mandate will continue unless private enforcement is allowed to challenge states that adopt Medicaid payment rates based on arbitrary or politically expedient budgetary decisions,” AMA President Dr. Robert M. Wah said in a statement.
The Supreme Court’s decision will have a significant impact on whether physicians and other providers continue to participate in Medicaid and whether patients can find necessary care, added Jane Perkins, legal director of the National Health Law Program, a nonprofit that advocates the rights of low-income patients. The National Health Law Program issued its own friend-of-the-court brief in support of the centers.
“There are a tremendous number of potential ‘bigger picture’ impacts” to the court’s decision, Ms. Perkins said in an interview. “Researchers have found time and again that while many things go into a provider’s decision whether or not to participate in Medicaid, one of the main things is the payment rate. If [Idaho wins], I really fear the already problematic state of provider participation in many places is only going to get worse."
OnTwitter @legal_med
NIH report on long-term opioid treatment cites lack of data, research needs
The striking lack of data on the effectiveness and risks of long-term opioid treatment for the increasing number of people in the United States with chronic pain is reflected in the recommendations made by an expert panel convened by the National Institutes of Health.
To address the role of opioids in the treatment of chronic pain, the panelists met during an NIH Pathways to Prevention workshop in late September where more than 20 invited experts spoke on the topic. The panel produced a draft report shortly after the meeting concluded and received public comments, and the final report has been published on the NIH website. An abridged version of the panel’s final report, which highlights key issues surrounding the use of opioids and chronic pain treatment and provides recommendations on the types of research needed in this area, was published online Jan. 13 in the Annals of Internal Medicine (doi:10.7326/M14-2775).
“The overriding question posed to the panel is whether we as a nation are currently approaching chronic pain in the best possible manner that maximizes effectiveness and minimizes harm. The panel determined that the answer was an unequivocal no,” Dr. David Reuben, the panel chair and lead author of the report, said during a Jan. 16 telebriefing that was held to review the panel’s findings and recommendations. “We hope that the information presented in the panel report will shed light on the issues that need further attention and help facilitate research and better practice to improve outcomes for patients,” added Dr. Reuben, who is chief of geriatric medicine and professor of medicine at the University of California, Los Angeles.
The first recommendation in the panel’s position paper is that federal and non-federal agencies should fund research to identify what types of pain, diseases, and patients “are most likely to benefit and incur harm” from opioids. Agencies should also fund the development and evaluation of multi-disciplinary pain interventions, including cost-benefit analyses, and fund research to “develop and validate research measurement tools” that identify patient risk and outcomes, “related to long-term opioid use that can be adapted for clinical settings,” the panel recommended.
The one recommendation that directly pertains to current clinical practice states that “in the absence of definitive evidence, clinicians and health care systems should follow current guidelines by professional societies about which patients and which types of pain should be treated with opioids and about how best to monitor patients and mitigate risk for harm.” In addition, the report “identifies several key evidence gaps and research priorities that must be addressed so that physicians can recognize patients for whom opioids are most appropriate and use optimal regimens for these patients.”
Considering professional society guidelines is one of the main take home-messages of the report for clinicians, Dr. David Steffens, another panelist and author of the paper, said during the telebriefing. Dr. Steffens, professor and chair of the department of psychiatry, University of Connecticut, Farmington, observed that during the workshop, “the core part of what we heard was an astounding lack of data on efficacy of these drugs,” and noted that the majority of recommendations are “forward-looking in terms of a need to get more data.”
Among the main conclusions of the position paper is that while opioids are “clearly the best treatment for some patients with chronic pain ... there are probably more effective approaches” for many other patients. “The challenge is to identify the conditions in patients for which opioid use is most appropriate, the optimal regimens, the alternatives for those who are unlikely to benefit from opioids, and the best approach to ensuring that every patient’s needs are met by a patient-centered health care system,” the report concludes.
A systematic review of the effectiveness and risks of long-term opioids for chronic pain, prepared specifically for the workshop by the Pacific Northwest Evidence-based Practice Center (EPC) at Oregon Health & Science University, Portland, with funding by the Agency for Healthcare Research and Quality, was also published in the same issue of Annals of Internal Medicine (doi:10.7326/M14-2559).
The review, which evaluated evidence in the medical literature about the effectiveness and risks of long-term opioid therapy (more than 3 months) to treat chronic pain in adults, concluded that “reliable conclusions about the effectiveness of long-term opioid therapy for chronic pain are not possible due to the paucity of research to date.” Moreover, evidence indicating that long-term opioid therapy is associated with significant risks for overdoses, abuse, and other sequelae is increasing, according to the review, which defines chronic pain as pain “lasting longer than 3 months or past the normal time for tissue healing.” Dr. Roger Chou, director of the Pacific Northwest EPC and a physician in the OHSU internal medicine clinic, was the lead author of the review.
An estimated 100 million Americans have chronic pain, of whom about 25 million have moderate-to-severe pain that limits activities and adversely affects their quality of life, according to the position paper. Despite other available treatments, opioids are used for long-term management of chronic pain in an estimated 5-8 million Americans and prescriptions for opioids to treat pain increased from 76 million in 1991 to 219 million in 2011. This increase has been accompanied by a rise in opioid overdoses and treatment for addictions to prescription pain medications. The paper cites Centers for Disease Control and Prevention figures estimating that in 2011, there were more than 17,000 opioid-related overdose deaths.
The NIH Pathways to Prevention Workshop was sponsored by the NIH Office of Disease Prevention, the NIH Pain Consortium, the National Institute on Drug Abuse, and the National Institute of Neurological Disorders and Stroke.
None of the authors of the report had disclosures relevant to the topic. Dr. Chou’s disclosures included having received grants from the AHRQ during the study. He has also been a consultant for the U.S. Department of Health and Human Services and the Providers’ Clinical Support System for Opioid Therapies, which is funded by the Substance Abuse and Mental Health Services Administration.
The striking lack of data on the effectiveness and risks of long-term opioid treatment for the increasing number of people in the United States with chronic pain is reflected in the recommendations made by an expert panel convened by the National Institutes of Health.
To address the role of opioids in the treatment of chronic pain, the panelists met during an NIH Pathways to Prevention workshop in late September where more than 20 invited experts spoke on the topic. The panel produced a draft report shortly after the meeting concluded and received public comments, and the final report has been published on the NIH website. An abridged version of the panel’s final report, which highlights key issues surrounding the use of opioids and chronic pain treatment and provides recommendations on the types of research needed in this area, was published online Jan. 13 in the Annals of Internal Medicine (doi:10.7326/M14-2775).
“The overriding question posed to the panel is whether we as a nation are currently approaching chronic pain in the best possible manner that maximizes effectiveness and minimizes harm. The panel determined that the answer was an unequivocal no,” Dr. David Reuben, the panel chair and lead author of the report, said during a Jan. 16 telebriefing that was held to review the panel’s findings and recommendations. “We hope that the information presented in the panel report will shed light on the issues that need further attention and help facilitate research and better practice to improve outcomes for patients,” added Dr. Reuben, who is chief of geriatric medicine and professor of medicine at the University of California, Los Angeles.
The first recommendation in the panel’s position paper is that federal and non-federal agencies should fund research to identify what types of pain, diseases, and patients “are most likely to benefit and incur harm” from opioids. Agencies should also fund the development and evaluation of multi-disciplinary pain interventions, including cost-benefit analyses, and fund research to “develop and validate research measurement tools” that identify patient risk and outcomes, “related to long-term opioid use that can be adapted for clinical settings,” the panel recommended.
The one recommendation that directly pertains to current clinical practice states that “in the absence of definitive evidence, clinicians and health care systems should follow current guidelines by professional societies about which patients and which types of pain should be treated with opioids and about how best to monitor patients and mitigate risk for harm.” In addition, the report “identifies several key evidence gaps and research priorities that must be addressed so that physicians can recognize patients for whom opioids are most appropriate and use optimal regimens for these patients.”
Considering professional society guidelines is one of the main take home-messages of the report for clinicians, Dr. David Steffens, another panelist and author of the paper, said during the telebriefing. Dr. Steffens, professor and chair of the department of psychiatry, University of Connecticut, Farmington, observed that during the workshop, “the core part of what we heard was an astounding lack of data on efficacy of these drugs,” and noted that the majority of recommendations are “forward-looking in terms of a need to get more data.”
Among the main conclusions of the position paper is that while opioids are “clearly the best treatment for some patients with chronic pain ... there are probably more effective approaches” for many other patients. “The challenge is to identify the conditions in patients for which opioid use is most appropriate, the optimal regimens, the alternatives for those who are unlikely to benefit from opioids, and the best approach to ensuring that every patient’s needs are met by a patient-centered health care system,” the report concludes.
A systematic review of the effectiveness and risks of long-term opioids for chronic pain, prepared specifically for the workshop by the Pacific Northwest Evidence-based Practice Center (EPC) at Oregon Health & Science University, Portland, with funding by the Agency for Healthcare Research and Quality, was also published in the same issue of Annals of Internal Medicine (doi:10.7326/M14-2559).
The review, which evaluated evidence in the medical literature about the effectiveness and risks of long-term opioid therapy (more than 3 months) to treat chronic pain in adults, concluded that “reliable conclusions about the effectiveness of long-term opioid therapy for chronic pain are not possible due to the paucity of research to date.” Moreover, evidence indicating that long-term opioid therapy is associated with significant risks for overdoses, abuse, and other sequelae is increasing, according to the review, which defines chronic pain as pain “lasting longer than 3 months or past the normal time for tissue healing.” Dr. Roger Chou, director of the Pacific Northwest EPC and a physician in the OHSU internal medicine clinic, was the lead author of the review.
An estimated 100 million Americans have chronic pain, of whom about 25 million have moderate-to-severe pain that limits activities and adversely affects their quality of life, according to the position paper. Despite other available treatments, opioids are used for long-term management of chronic pain in an estimated 5-8 million Americans and prescriptions for opioids to treat pain increased from 76 million in 1991 to 219 million in 2011. This increase has been accompanied by a rise in opioid overdoses and treatment for addictions to prescription pain medications. The paper cites Centers for Disease Control and Prevention figures estimating that in 2011, there were more than 17,000 opioid-related overdose deaths.
The NIH Pathways to Prevention Workshop was sponsored by the NIH Office of Disease Prevention, the NIH Pain Consortium, the National Institute on Drug Abuse, and the National Institute of Neurological Disorders and Stroke.
None of the authors of the report had disclosures relevant to the topic. Dr. Chou’s disclosures included having received grants from the AHRQ during the study. He has also been a consultant for the U.S. Department of Health and Human Services and the Providers’ Clinical Support System for Opioid Therapies, which is funded by the Substance Abuse and Mental Health Services Administration.
The striking lack of data on the effectiveness and risks of long-term opioid treatment for the increasing number of people in the United States with chronic pain is reflected in the recommendations made by an expert panel convened by the National Institutes of Health.
To address the role of opioids in the treatment of chronic pain, the panelists met during an NIH Pathways to Prevention workshop in late September where more than 20 invited experts spoke on the topic. The panel produced a draft report shortly after the meeting concluded and received public comments, and the final report has been published on the NIH website. An abridged version of the panel’s final report, which highlights key issues surrounding the use of opioids and chronic pain treatment and provides recommendations on the types of research needed in this area, was published online Jan. 13 in the Annals of Internal Medicine (doi:10.7326/M14-2775).
“The overriding question posed to the panel is whether we as a nation are currently approaching chronic pain in the best possible manner that maximizes effectiveness and minimizes harm. The panel determined that the answer was an unequivocal no,” Dr. David Reuben, the panel chair and lead author of the report, said during a Jan. 16 telebriefing that was held to review the panel’s findings and recommendations. “We hope that the information presented in the panel report will shed light on the issues that need further attention and help facilitate research and better practice to improve outcomes for patients,” added Dr. Reuben, who is chief of geriatric medicine and professor of medicine at the University of California, Los Angeles.
The first recommendation in the panel’s position paper is that federal and non-federal agencies should fund research to identify what types of pain, diseases, and patients “are most likely to benefit and incur harm” from opioids. Agencies should also fund the development and evaluation of multi-disciplinary pain interventions, including cost-benefit analyses, and fund research to “develop and validate research measurement tools” that identify patient risk and outcomes, “related to long-term opioid use that can be adapted for clinical settings,” the panel recommended.
The one recommendation that directly pertains to current clinical practice states that “in the absence of definitive evidence, clinicians and health care systems should follow current guidelines by professional societies about which patients and which types of pain should be treated with opioids and about how best to monitor patients and mitigate risk for harm.” In addition, the report “identifies several key evidence gaps and research priorities that must be addressed so that physicians can recognize patients for whom opioids are most appropriate and use optimal regimens for these patients.”
Considering professional society guidelines is one of the main take home-messages of the report for clinicians, Dr. David Steffens, another panelist and author of the paper, said during the telebriefing. Dr. Steffens, professor and chair of the department of psychiatry, University of Connecticut, Farmington, observed that during the workshop, “the core part of what we heard was an astounding lack of data on efficacy of these drugs,” and noted that the majority of recommendations are “forward-looking in terms of a need to get more data.”
Among the main conclusions of the position paper is that while opioids are “clearly the best treatment for some patients with chronic pain ... there are probably more effective approaches” for many other patients. “The challenge is to identify the conditions in patients for which opioid use is most appropriate, the optimal regimens, the alternatives for those who are unlikely to benefit from opioids, and the best approach to ensuring that every patient’s needs are met by a patient-centered health care system,” the report concludes.
A systematic review of the effectiveness and risks of long-term opioids for chronic pain, prepared specifically for the workshop by the Pacific Northwest Evidence-based Practice Center (EPC) at Oregon Health & Science University, Portland, with funding by the Agency for Healthcare Research and Quality, was also published in the same issue of Annals of Internal Medicine (doi:10.7326/M14-2559).
The review, which evaluated evidence in the medical literature about the effectiveness and risks of long-term opioid therapy (more than 3 months) to treat chronic pain in adults, concluded that “reliable conclusions about the effectiveness of long-term opioid therapy for chronic pain are not possible due to the paucity of research to date.” Moreover, evidence indicating that long-term opioid therapy is associated with significant risks for overdoses, abuse, and other sequelae is increasing, according to the review, which defines chronic pain as pain “lasting longer than 3 months or past the normal time for tissue healing.” Dr. Roger Chou, director of the Pacific Northwest EPC and a physician in the OHSU internal medicine clinic, was the lead author of the review.
An estimated 100 million Americans have chronic pain, of whom about 25 million have moderate-to-severe pain that limits activities and adversely affects their quality of life, according to the position paper. Despite other available treatments, opioids are used for long-term management of chronic pain in an estimated 5-8 million Americans and prescriptions for opioids to treat pain increased from 76 million in 1991 to 219 million in 2011. This increase has been accompanied by a rise in opioid overdoses and treatment for addictions to prescription pain medications. The paper cites Centers for Disease Control and Prevention figures estimating that in 2011, there were more than 17,000 opioid-related overdose deaths.
The NIH Pathways to Prevention Workshop was sponsored by the NIH Office of Disease Prevention, the NIH Pain Consortium, the National Institute on Drug Abuse, and the National Institute of Neurological Disorders and Stroke.
None of the authors of the report had disclosures relevant to the topic. Dr. Chou’s disclosures included having received grants from the AHRQ during the study. He has also been a consultant for the U.S. Department of Health and Human Services and the Providers’ Clinical Support System for Opioid Therapies, which is funded by the Substance Abuse and Mental Health Services Administration.
CMS Administrator Tavenner to step down in February
Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner announced Jan. 16 that she will resign her post at the end of February.
Ms. Tavenner joined CMS in February 2010 and oversaw the implementation of the Affordable Care Act, passed a month into her leadership tenure. She was the first administrator to be confirmed by the U.S. Senate in more than 6 years.
In a Jan. 16 e-mail to CMS staff, Ms. Tavenner highlighted a number of agency achievements during her time as administrator, commending staff’s “hard work, dedication, commitment, and resolve” that are “truly transforming health care in this country.”
Among the achievements she highlighted were improvements in quality of health care delivered, historically overall low growth in health care spending, increased fraud detection, greater transparency, publication of health care data and indicators, and improved access to health care.
“Marilyn led the effort to accelerate the development and expansion of innovative new health care payment and delivery models,” HHS Secretary Sylvia Burwell said Jan. 16 in an e-mail to all CMS staff.
A low point of Tavenner’s tenure was the troubled launch of HealthCare.gov; however, Ms. Burwell commended her for her work to “help right the ship, bringing aboard a systems integrator and overseeing an overhaul of the website.”
Principal Deputy Administrator Andy Slavitt will take over as acting administrator in March, Ms. Burwell said.
Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner announced Jan. 16 that she will resign her post at the end of February.
Ms. Tavenner joined CMS in February 2010 and oversaw the implementation of the Affordable Care Act, passed a month into her leadership tenure. She was the first administrator to be confirmed by the U.S. Senate in more than 6 years.
In a Jan. 16 e-mail to CMS staff, Ms. Tavenner highlighted a number of agency achievements during her time as administrator, commending staff’s “hard work, dedication, commitment, and resolve” that are “truly transforming health care in this country.”
Among the achievements she highlighted were improvements in quality of health care delivered, historically overall low growth in health care spending, increased fraud detection, greater transparency, publication of health care data and indicators, and improved access to health care.
“Marilyn led the effort to accelerate the development and expansion of innovative new health care payment and delivery models,” HHS Secretary Sylvia Burwell said Jan. 16 in an e-mail to all CMS staff.
A low point of Tavenner’s tenure was the troubled launch of HealthCare.gov; however, Ms. Burwell commended her for her work to “help right the ship, bringing aboard a systems integrator and overseeing an overhaul of the website.”
Principal Deputy Administrator Andy Slavitt will take over as acting administrator in March, Ms. Burwell said.
Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner announced Jan. 16 that she will resign her post at the end of February.
Ms. Tavenner joined CMS in February 2010 and oversaw the implementation of the Affordable Care Act, passed a month into her leadership tenure. She was the first administrator to be confirmed by the U.S. Senate in more than 6 years.
In a Jan. 16 e-mail to CMS staff, Ms. Tavenner highlighted a number of agency achievements during her time as administrator, commending staff’s “hard work, dedication, commitment, and resolve” that are “truly transforming health care in this country.”
Among the achievements she highlighted were improvements in quality of health care delivered, historically overall low growth in health care spending, increased fraud detection, greater transparency, publication of health care data and indicators, and improved access to health care.
“Marilyn led the effort to accelerate the development and expansion of innovative new health care payment and delivery models,” HHS Secretary Sylvia Burwell said Jan. 16 in an e-mail to all CMS staff.
A low point of Tavenner’s tenure was the troubled launch of HealthCare.gov; however, Ms. Burwell commended her for her work to “help right the ship, bringing aboard a systems integrator and overseeing an overhaul of the website.”
Principal Deputy Administrator Andy Slavitt will take over as acting administrator in March, Ms. Burwell said.
Stage IV CRC survival rates up, resection rates down
Although significantly fewer patients with stage IV colorectal cancer have undergone primary tumor resection (PTR) since 1988, overall rates of patient survival have improved over that period, according to the results of a study published in JAMA.
“The role of PTR for asymptomatic patients remains controversial. Some physicians advocate PTR to prevent the development of symptoms associated with an intact primary tumor,” wrote lead author Chung-Yuan Hu, Ph.D., of the University of Texas M.D. Anderson Cancer Center in Houston, and his associates. “Approximately 10%-25% of patients with intact primary tumors will develop symptoms, but there is considerable morbidity (4%-30%) and mortality (2%-10%) associated with noncurative PTR” (JAMA Surg. [doi:10.1001/jamasurg.2014.2253]).
In a retrospective cohort study, Dr. Hu and his colleagues used data on 64,157 patients diagnosed with stage IV colon or rectal cancer between Jan. 1, 1988, and Dec. 31, 2010, from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) CRC registry. The primary outcome measured was difference in PTR rates over the study period. Included subjects had either undergone PTR or not, and investigators calculated rates of PTR and median relative survival for each year. Joinpoint regression analyses were used to determine when a “significant change” in PTR rate had occurred, while logistic regression analyses were used to assess factors associated with PTR.
Findings indicated that 43,273 (67.4%) of the patients analyzed for the study had undergone PTR; overall, between 1988 and 2010, annual PTR rates declined from 74.5% to 57.4%, respectively (P < .001). “Significant change” was noted between 1998 and 2001 and from 2001 to 2010: –0.41% and –2.39%, respectively (P < .001 in both cases). However, median annual survival rates improved substantially from 1988 to 2009, changing from 8.6% to 17.8%, respectively (P < .001).
“Despite the availability of more effective chemotherapeutic options, a considerable number of patients with stage IV CRC continue to undergo PTR,” wrote the authors. “Our findings indicate potential overuse of PTR among these patients and highlight a need to better understand the clinical decisions and outcomes associated with that treatment.”
This study was supported in part by grants from the National Institute of Health’s National Cancer Institute, and the American Society of Clinical Oncology Foundation Career Development Award. Authors reported no financial conflicts of interest.
Although significantly fewer patients with stage IV colorectal cancer have undergone primary tumor resection (PTR) since 1988, overall rates of patient survival have improved over that period, according to the results of a study published in JAMA.
“The role of PTR for asymptomatic patients remains controversial. Some physicians advocate PTR to prevent the development of symptoms associated with an intact primary tumor,” wrote lead author Chung-Yuan Hu, Ph.D., of the University of Texas M.D. Anderson Cancer Center in Houston, and his associates. “Approximately 10%-25% of patients with intact primary tumors will develop symptoms, but there is considerable morbidity (4%-30%) and mortality (2%-10%) associated with noncurative PTR” (JAMA Surg. [doi:10.1001/jamasurg.2014.2253]).
In a retrospective cohort study, Dr. Hu and his colleagues used data on 64,157 patients diagnosed with stage IV colon or rectal cancer between Jan. 1, 1988, and Dec. 31, 2010, from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) CRC registry. The primary outcome measured was difference in PTR rates over the study period. Included subjects had either undergone PTR or not, and investigators calculated rates of PTR and median relative survival for each year. Joinpoint regression analyses were used to determine when a “significant change” in PTR rate had occurred, while logistic regression analyses were used to assess factors associated with PTR.
Findings indicated that 43,273 (67.4%) of the patients analyzed for the study had undergone PTR; overall, between 1988 and 2010, annual PTR rates declined from 74.5% to 57.4%, respectively (P < .001). “Significant change” was noted between 1998 and 2001 and from 2001 to 2010: –0.41% and –2.39%, respectively (P < .001 in both cases). However, median annual survival rates improved substantially from 1988 to 2009, changing from 8.6% to 17.8%, respectively (P < .001).
“Despite the availability of more effective chemotherapeutic options, a considerable number of patients with stage IV CRC continue to undergo PTR,” wrote the authors. “Our findings indicate potential overuse of PTR among these patients and highlight a need to better understand the clinical decisions and outcomes associated with that treatment.”
This study was supported in part by grants from the National Institute of Health’s National Cancer Institute, and the American Society of Clinical Oncology Foundation Career Development Award. Authors reported no financial conflicts of interest.
Although significantly fewer patients with stage IV colorectal cancer have undergone primary tumor resection (PTR) since 1988, overall rates of patient survival have improved over that period, according to the results of a study published in JAMA.
“The role of PTR for asymptomatic patients remains controversial. Some physicians advocate PTR to prevent the development of symptoms associated with an intact primary tumor,” wrote lead author Chung-Yuan Hu, Ph.D., of the University of Texas M.D. Anderson Cancer Center in Houston, and his associates. “Approximately 10%-25% of patients with intact primary tumors will develop symptoms, but there is considerable morbidity (4%-30%) and mortality (2%-10%) associated with noncurative PTR” (JAMA Surg. [doi:10.1001/jamasurg.2014.2253]).
In a retrospective cohort study, Dr. Hu and his colleagues used data on 64,157 patients diagnosed with stage IV colon or rectal cancer between Jan. 1, 1988, and Dec. 31, 2010, from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) CRC registry. The primary outcome measured was difference in PTR rates over the study period. Included subjects had either undergone PTR or not, and investigators calculated rates of PTR and median relative survival for each year. Joinpoint regression analyses were used to determine when a “significant change” in PTR rate had occurred, while logistic regression analyses were used to assess factors associated with PTR.
Findings indicated that 43,273 (67.4%) of the patients analyzed for the study had undergone PTR; overall, between 1988 and 2010, annual PTR rates declined from 74.5% to 57.4%, respectively (P < .001). “Significant change” was noted between 1998 and 2001 and from 2001 to 2010: –0.41% and –2.39%, respectively (P < .001 in both cases). However, median annual survival rates improved substantially from 1988 to 2009, changing from 8.6% to 17.8%, respectively (P < .001).
“Despite the availability of more effective chemotherapeutic options, a considerable number of patients with stage IV CRC continue to undergo PTR,” wrote the authors. “Our findings indicate potential overuse of PTR among these patients and highlight a need to better understand the clinical decisions and outcomes associated with that treatment.”
This study was supported in part by grants from the National Institute of Health’s National Cancer Institute, and the American Society of Clinical Oncology Foundation Career Development Award. Authors reported no financial conflicts of interest.
FROM JAMA SURGERY
Key clinical point: Although rates of primary tumor resection in patients with stage IV colorectal cancer have decreased in recent years, patient survival rates have improved.
Major finding: The annual rate of primary tumor resection decreased from 74.5% in 1988 to 57.4% in 2010, while median relative survival rate improved from 8.6% in 1988 to 17.8% in 2009.
Data source: Retrospective cohort study examining data on 64,157 subjects in the National Cancer Institute’s SEER CRC registry.
Disclosures: Study was supported in part by grants from the National Institute of Health’s National Cancer Institute, and the American Society of Clinical Oncology Foundation Career Development Award. Authors reported no financial conflicts of interest.
CDC: Hospital-acquired infections decreasing
Hospitals reduced significantly the number of surgical site and central-line associated bloodstream infections in 2013, according to a national analysis by the Centers for Disease Control and Prevention.
A review of data submitted by 14,500 health facilities found that central line–associated bloodstream infections (CLABSIs) fell by 46% between 2008 and 2013, and surgical site infections (SSIs) dropped by 19% over the same period. SSI data were derived from 10 select procedures, including hip arthroplasty, knee arthroplasty, colon surgery, rectal surgery, abdominal hysterectomy, vaginal hysterectomy, coronary artery bypass graft, other cardiac surgery, peripheral vascular bypass surgery, and abdominal aortic aneurysm repair.
Increased reporting by health care providers and quality measures imposed by the Centers for Medicare and Medicaid Services are likely contributors to the report’s findings, said Dr. Henry Pitt, chief quality officer for Temple University Health System, Philadelphia.
“Because of all the reporting that is being done, and the potential financial burdens that exist through CMS’s value-based purchasing program, and the work people are doing to improve these things, it’s not surprising that the data are looking better,” Dr. Pitt said in an interview.
The CDC’s annual National and State Healthcare-associated Infection Progress report summarizes data submitted to the CDC’s National Healthcare Safety Network (NHSN), a nationwide infection tracking system used by all 50 states, Washington, and Puerto Rico. In addition to SSIs and CLABSIs, findings of the report show also that methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections decreased by 8% from 2011 to 2013 and that Clostridium difficile infections dropped by 10% between 2011 and 2013. However, catheter-associated urinary tract infections have risen by 6% since 2009.
In a state-by-state comparison, 26 states performed better than the nation on at least two of the six infection types tracked by state. Sixteen states performed better than the nation on three or more infections and 19 states performed worse than the nation on two infections. Not all states reported or had enough data to calculate valid infection information on every infection in the report. Among the 2,543 U.S. hospitals with enough data to calculate a standardized infection ratio (SIR), 9% had an SIR significantly worse than the national SIR of 0.81.
Despite the progress, the report calls for more action to eliminate hospital infections and recommends its report be used by health departments, hospital associations, professional societies, health care systems and facilities, and quality improvement groups to identify infections that need additional prevention efforts.
Dr. Pitt added that CMS programs that use infection control and reduction as quality metrics will no doubt continue to impact infection reporting and outcomes. The three CMS programs associated with infection control and hospital payments include its hospital value-based purchasing, hospital readmissions reduction, and hospital-acquired condition reduction programs.
“Again, people are paying more attention, in addition to it’s the right thing to do, because more money is at risk,” Dr. Pitt said.
Data in the CDC report are from acute hospitals only.
On Twitter @legal_med
Hospitals reduced significantly the number of surgical site and central-line associated bloodstream infections in 2013, according to a national analysis by the Centers for Disease Control and Prevention.
A review of data submitted by 14,500 health facilities found that central line–associated bloodstream infections (CLABSIs) fell by 46% between 2008 and 2013, and surgical site infections (SSIs) dropped by 19% over the same period. SSI data were derived from 10 select procedures, including hip arthroplasty, knee arthroplasty, colon surgery, rectal surgery, abdominal hysterectomy, vaginal hysterectomy, coronary artery bypass graft, other cardiac surgery, peripheral vascular bypass surgery, and abdominal aortic aneurysm repair.
Increased reporting by health care providers and quality measures imposed by the Centers for Medicare and Medicaid Services are likely contributors to the report’s findings, said Dr. Henry Pitt, chief quality officer for Temple University Health System, Philadelphia.
“Because of all the reporting that is being done, and the potential financial burdens that exist through CMS’s value-based purchasing program, and the work people are doing to improve these things, it’s not surprising that the data are looking better,” Dr. Pitt said in an interview.
The CDC’s annual National and State Healthcare-associated Infection Progress report summarizes data submitted to the CDC’s National Healthcare Safety Network (NHSN), a nationwide infection tracking system used by all 50 states, Washington, and Puerto Rico. In addition to SSIs and CLABSIs, findings of the report show also that methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections decreased by 8% from 2011 to 2013 and that Clostridium difficile infections dropped by 10% between 2011 and 2013. However, catheter-associated urinary tract infections have risen by 6% since 2009.
In a state-by-state comparison, 26 states performed better than the nation on at least two of the six infection types tracked by state. Sixteen states performed better than the nation on three or more infections and 19 states performed worse than the nation on two infections. Not all states reported or had enough data to calculate valid infection information on every infection in the report. Among the 2,543 U.S. hospitals with enough data to calculate a standardized infection ratio (SIR), 9% had an SIR significantly worse than the national SIR of 0.81.
Despite the progress, the report calls for more action to eliminate hospital infections and recommends its report be used by health departments, hospital associations, professional societies, health care systems and facilities, and quality improvement groups to identify infections that need additional prevention efforts.
Dr. Pitt added that CMS programs that use infection control and reduction as quality metrics will no doubt continue to impact infection reporting and outcomes. The three CMS programs associated with infection control and hospital payments include its hospital value-based purchasing, hospital readmissions reduction, and hospital-acquired condition reduction programs.
“Again, people are paying more attention, in addition to it’s the right thing to do, because more money is at risk,” Dr. Pitt said.
Data in the CDC report are from acute hospitals only.
On Twitter @legal_med
Hospitals reduced significantly the number of surgical site and central-line associated bloodstream infections in 2013, according to a national analysis by the Centers for Disease Control and Prevention.
A review of data submitted by 14,500 health facilities found that central line–associated bloodstream infections (CLABSIs) fell by 46% between 2008 and 2013, and surgical site infections (SSIs) dropped by 19% over the same period. SSI data were derived from 10 select procedures, including hip arthroplasty, knee arthroplasty, colon surgery, rectal surgery, abdominal hysterectomy, vaginal hysterectomy, coronary artery bypass graft, other cardiac surgery, peripheral vascular bypass surgery, and abdominal aortic aneurysm repair.
Increased reporting by health care providers and quality measures imposed by the Centers for Medicare and Medicaid Services are likely contributors to the report’s findings, said Dr. Henry Pitt, chief quality officer for Temple University Health System, Philadelphia.
“Because of all the reporting that is being done, and the potential financial burdens that exist through CMS’s value-based purchasing program, and the work people are doing to improve these things, it’s not surprising that the data are looking better,” Dr. Pitt said in an interview.
The CDC’s annual National and State Healthcare-associated Infection Progress report summarizes data submitted to the CDC’s National Healthcare Safety Network (NHSN), a nationwide infection tracking system used by all 50 states, Washington, and Puerto Rico. In addition to SSIs and CLABSIs, findings of the report show also that methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections decreased by 8% from 2011 to 2013 and that Clostridium difficile infections dropped by 10% between 2011 and 2013. However, catheter-associated urinary tract infections have risen by 6% since 2009.
In a state-by-state comparison, 26 states performed better than the nation on at least two of the six infection types tracked by state. Sixteen states performed better than the nation on three or more infections and 19 states performed worse than the nation on two infections. Not all states reported or had enough data to calculate valid infection information on every infection in the report. Among the 2,543 U.S. hospitals with enough data to calculate a standardized infection ratio (SIR), 9% had an SIR significantly worse than the national SIR of 0.81.
Despite the progress, the report calls for more action to eliminate hospital infections and recommends its report be used by health departments, hospital associations, professional societies, health care systems and facilities, and quality improvement groups to identify infections that need additional prevention efforts.
Dr. Pitt added that CMS programs that use infection control and reduction as quality metrics will no doubt continue to impact infection reporting and outcomes. The three CMS programs associated with infection control and hospital payments include its hospital value-based purchasing, hospital readmissions reduction, and hospital-acquired condition reduction programs.
“Again, people are paying more attention, in addition to it’s the right thing to do, because more money is at risk,” Dr. Pitt said.
Data in the CDC report are from acute hospitals only.
On Twitter @legal_med
Legislation would ease burden of Stage 2 meaningful use
Legislation to ease the attestation burden physicians must meet under Stage 2 of meaningful use has been reintroduced in Congress.
The Flexibility in Health IT Reporting (H.R. 270), introduced by Rep. Renee Ellmers (R-N.C.) and Rep. Ron Kind (D-Wis.), would allow physicians to choose any 3-month quarter as their attestation period to qualify for incentive payments under Stage 2. Current law requires they report for a full year. In previous years and under Stage 1, the attestation period was 90 days. This year also marks the first year physicians and hospitals will be subject to a 1% reduction in Medicare payments for not meeting meaningful use requirements.
The legislation was introduced as the Centers for Medicare & Medicaid Services reported low participation in Stage 2. At a Jan. 13 meeting of the Health IT Policy Committee, an advisory committee to the Office of the National Coordinator for Health Information Technology, CMS officials reported that 16,455 eligible health care professionals had successfully attested to Stage 2 of meaningful use, while a total of 337,861 had registered for the Medicare meaningful use incentive program.
“The time constraints imposed on doctors and hospitals are inflexible and simply unmanageable – and this is evident by the dreadful Stage 2 meaningful use attestation numbers released by CMS,” Rep. Ellmers said in a statement.
The legislation is supported by several physician and health care organizations including the American Academy of Family Physicians, American Hospital Association, American Medical Association, Medical Group Management Association, College of Healthcare Information Management Executives, and Healthcare Information and Management Systems Society.
“Stage 2 of meaningful use has proven extremely challenging and, absent this reporting flexibility, a significant number of physicians will be unable to participate in the program and unfairly penalized,” Anders Gillberg, senior vice president of government affairs for the Medical Group Management Association, said in a statement.
The bill has been referred to both the Ways and Means and Energy and Commerce Committees.
Legislation to ease the attestation burden physicians must meet under Stage 2 of meaningful use has been reintroduced in Congress.
The Flexibility in Health IT Reporting (H.R. 270), introduced by Rep. Renee Ellmers (R-N.C.) and Rep. Ron Kind (D-Wis.), would allow physicians to choose any 3-month quarter as their attestation period to qualify for incentive payments under Stage 2. Current law requires they report for a full year. In previous years and under Stage 1, the attestation period was 90 days. This year also marks the first year physicians and hospitals will be subject to a 1% reduction in Medicare payments for not meeting meaningful use requirements.
The legislation was introduced as the Centers for Medicare & Medicaid Services reported low participation in Stage 2. At a Jan. 13 meeting of the Health IT Policy Committee, an advisory committee to the Office of the National Coordinator for Health Information Technology, CMS officials reported that 16,455 eligible health care professionals had successfully attested to Stage 2 of meaningful use, while a total of 337,861 had registered for the Medicare meaningful use incentive program.
“The time constraints imposed on doctors and hospitals are inflexible and simply unmanageable – and this is evident by the dreadful Stage 2 meaningful use attestation numbers released by CMS,” Rep. Ellmers said in a statement.
The legislation is supported by several physician and health care organizations including the American Academy of Family Physicians, American Hospital Association, American Medical Association, Medical Group Management Association, College of Healthcare Information Management Executives, and Healthcare Information and Management Systems Society.
“Stage 2 of meaningful use has proven extremely challenging and, absent this reporting flexibility, a significant number of physicians will be unable to participate in the program and unfairly penalized,” Anders Gillberg, senior vice president of government affairs for the Medical Group Management Association, said in a statement.
The bill has been referred to both the Ways and Means and Energy and Commerce Committees.
Legislation to ease the attestation burden physicians must meet under Stage 2 of meaningful use has been reintroduced in Congress.
The Flexibility in Health IT Reporting (H.R. 270), introduced by Rep. Renee Ellmers (R-N.C.) and Rep. Ron Kind (D-Wis.), would allow physicians to choose any 3-month quarter as their attestation period to qualify for incentive payments under Stage 2. Current law requires they report for a full year. In previous years and under Stage 1, the attestation period was 90 days. This year also marks the first year physicians and hospitals will be subject to a 1% reduction in Medicare payments for not meeting meaningful use requirements.
The legislation was introduced as the Centers for Medicare & Medicaid Services reported low participation in Stage 2. At a Jan. 13 meeting of the Health IT Policy Committee, an advisory committee to the Office of the National Coordinator for Health Information Technology, CMS officials reported that 16,455 eligible health care professionals had successfully attested to Stage 2 of meaningful use, while a total of 337,861 had registered for the Medicare meaningful use incentive program.
“The time constraints imposed on doctors and hospitals are inflexible and simply unmanageable – and this is evident by the dreadful Stage 2 meaningful use attestation numbers released by CMS,” Rep. Ellmers said in a statement.
The legislation is supported by several physician and health care organizations including the American Academy of Family Physicians, American Hospital Association, American Medical Association, Medical Group Management Association, College of Healthcare Information Management Executives, and Healthcare Information and Management Systems Society.
“Stage 2 of meaningful use has proven extremely challenging and, absent this reporting flexibility, a significant number of physicians will be unable to participate in the program and unfairly penalized,” Anders Gillberg, senior vice president of government affairs for the Medical Group Management Association, said in a statement.
The bill has been referred to both the Ways and Means and Energy and Commerce Committees.
Transsplenic TIPS procedure catching on for portal vein thrombosis
CHICAGO – Portal vein recanalization using a transsplenic approach can be utilized to improve transplant candidacy in patients with cirrhosis and chronic portal vein thrombosis, according to Dr. Bartley Thornburg.
“It’s a safe and effective procedure that allows for end-to-end anastomoses at transplant in patients who otherwise would not be able to have them or would require thrombectomy without transplant, and we know that end-to-end anastomoses are associated with decreased morbidity and mortality,” said Dr. Thornburg of Northwestern University Medical Center in Chicago.
Historically, and at his institution, portal vein thrombosis (PVT) is a relative contraindication to liver transplant. The American Association for the Study of Liver Diseases also recommends that transjugular intrahepatic portosystemic shunt (TIPS) placement be avoided in patients with a Model for End-State Liver Disease (MELD) score >18.
In 2013, colleague Dr. Riad Salem demonstrated the efficacy of portal vein recanalization during TIPS using a transhepatic approach in 44 patients, with only one technical failure and three cases of rethrombosis. Among six patients with a baseline MELD score >18, four went on to successful liver transplant, one is awaiting transplant, and one died as a result of bleeding 45 days post procedure despite an improvement in MELD score.
The last three patients in the series underwent TIPS with a transsplenic approach, and not only were the results equally good, but the approach was technically easier, Dr. Thornburg said at a symposium on vascular surgery sponsored by Northwestern University.
Since then, this increasingly common alternative approach has been assessed in another 11 consecutive patients with cirrhosis, portal hypertension, and chronic PVT. All patients had been denied listing for transplant because of their PVT, and four had a baseline MELD score >18.
At the end of the procedure, thrombus persisted in 45% (5 of 11 patients). On a 1-month follow-up venogram, however, three of the five patients had complete resolution of the thrombus without any added anticoagulation, one had persistent partial thrombus that was smaller than at stent placement, and one went on to transplant, Dr. Thornburg said.
All six of the patients with portal vein (PV) patency post procedure have retained patency after a median follow-up of 6.4 months.
“What we’ve learned from doing these cases is that complete elimination of the portal vein thrombus at the time of TIPS placement isn’t necessary,” he said. “It would be easy to get carried away and do suction or AngioJet [mechanical thrombectomy], but what we’ve found is that because of how much flow there is in the portal vein once it’s recanalized and the TIPS is in place, basically establishing a flow allowed for clot clearance by 1 month in all patients, except one.”
The procedure starts like a typical TIPS, with access achieved by advancing a 21-guage needle into the peripheral splenic vein or hilum under ultrasound guidance. A 5-French sheath is then placed through the parenchyma to the origin of splenic vein or the clot and an intrahepatic venogram performed to confirm occlusion, Dr. Thornburg said.
A 5-French Kumpe catheter and glide wire are used to recanalize the thrombosed portal vein, with a 10-mm gooseneck snare placed through the Kumpe in the peripheral portal vein as a target for the TIPS needle.
“Then, we basically get through-and-through access from the IJ [internal jugular] through this splenic access, and that gives us the workability to get our sheath across the portal vein and place our TIPS,” he said.
The remainder of the procedure is similar to that of the transhepatic approach. Angioplasty of the thrombosed PV is performed with an 8-by-40-mm balloon, followed by deployment of a Viatorr stent graft. The stent and PV are dilated with a 10-by-40-mm balloon and the splenic tract embolized with a couple of 4-by-14-cm Nester coils.
Based on their experience, short TIPS are always placed to maximize the amount of portal vein that is available at transplant for the end-to-end anastomoses, Dr. Thornburg said.
All patients who went on to transplant have received end-to-end anastomoses on what transplant surgeons have described as “totally normal” walled portal veins, including one patient who underwent transplant just 1 week post TIPS, he added.
There have been no major bleeding events with the transsplenic approach and only two adverse events: one case of transient encephalopathy and one low-grade fever.
Dr. Thornburg and Dr. Salem reported having no relevant financial disclosures.
CHICAGO – Portal vein recanalization using a transsplenic approach can be utilized to improve transplant candidacy in patients with cirrhosis and chronic portal vein thrombosis, according to Dr. Bartley Thornburg.
“It’s a safe and effective procedure that allows for end-to-end anastomoses at transplant in patients who otherwise would not be able to have them or would require thrombectomy without transplant, and we know that end-to-end anastomoses are associated with decreased morbidity and mortality,” said Dr. Thornburg of Northwestern University Medical Center in Chicago.
Historically, and at his institution, portal vein thrombosis (PVT) is a relative contraindication to liver transplant. The American Association for the Study of Liver Diseases also recommends that transjugular intrahepatic portosystemic shunt (TIPS) placement be avoided in patients with a Model for End-State Liver Disease (MELD) score >18.
In 2013, colleague Dr. Riad Salem demonstrated the efficacy of portal vein recanalization during TIPS using a transhepatic approach in 44 patients, with only one technical failure and three cases of rethrombosis. Among six patients with a baseline MELD score >18, four went on to successful liver transplant, one is awaiting transplant, and one died as a result of bleeding 45 days post procedure despite an improvement in MELD score.
The last three patients in the series underwent TIPS with a transsplenic approach, and not only were the results equally good, but the approach was technically easier, Dr. Thornburg said at a symposium on vascular surgery sponsored by Northwestern University.
Since then, this increasingly common alternative approach has been assessed in another 11 consecutive patients with cirrhosis, portal hypertension, and chronic PVT. All patients had been denied listing for transplant because of their PVT, and four had a baseline MELD score >18.
At the end of the procedure, thrombus persisted in 45% (5 of 11 patients). On a 1-month follow-up venogram, however, three of the five patients had complete resolution of the thrombus without any added anticoagulation, one had persistent partial thrombus that was smaller than at stent placement, and one went on to transplant, Dr. Thornburg said.
All six of the patients with portal vein (PV) patency post procedure have retained patency after a median follow-up of 6.4 months.
“What we’ve learned from doing these cases is that complete elimination of the portal vein thrombus at the time of TIPS placement isn’t necessary,” he said. “It would be easy to get carried away and do suction or AngioJet [mechanical thrombectomy], but what we’ve found is that because of how much flow there is in the portal vein once it’s recanalized and the TIPS is in place, basically establishing a flow allowed for clot clearance by 1 month in all patients, except one.”
The procedure starts like a typical TIPS, with access achieved by advancing a 21-guage needle into the peripheral splenic vein or hilum under ultrasound guidance. A 5-French sheath is then placed through the parenchyma to the origin of splenic vein or the clot and an intrahepatic venogram performed to confirm occlusion, Dr. Thornburg said.
A 5-French Kumpe catheter and glide wire are used to recanalize the thrombosed portal vein, with a 10-mm gooseneck snare placed through the Kumpe in the peripheral portal vein as a target for the TIPS needle.
“Then, we basically get through-and-through access from the IJ [internal jugular] through this splenic access, and that gives us the workability to get our sheath across the portal vein and place our TIPS,” he said.
The remainder of the procedure is similar to that of the transhepatic approach. Angioplasty of the thrombosed PV is performed with an 8-by-40-mm balloon, followed by deployment of a Viatorr stent graft. The stent and PV are dilated with a 10-by-40-mm balloon and the splenic tract embolized with a couple of 4-by-14-cm Nester coils.
Based on their experience, short TIPS are always placed to maximize the amount of portal vein that is available at transplant for the end-to-end anastomoses, Dr. Thornburg said.
All patients who went on to transplant have received end-to-end anastomoses on what transplant surgeons have described as “totally normal” walled portal veins, including one patient who underwent transplant just 1 week post TIPS, he added.
There have been no major bleeding events with the transsplenic approach and only two adverse events: one case of transient encephalopathy and one low-grade fever.
Dr. Thornburg and Dr. Salem reported having no relevant financial disclosures.
CHICAGO – Portal vein recanalization using a transsplenic approach can be utilized to improve transplant candidacy in patients with cirrhosis and chronic portal vein thrombosis, according to Dr. Bartley Thornburg.
“It’s a safe and effective procedure that allows for end-to-end anastomoses at transplant in patients who otherwise would not be able to have them or would require thrombectomy without transplant, and we know that end-to-end anastomoses are associated with decreased morbidity and mortality,” said Dr. Thornburg of Northwestern University Medical Center in Chicago.
Historically, and at his institution, portal vein thrombosis (PVT) is a relative contraindication to liver transplant. The American Association for the Study of Liver Diseases also recommends that transjugular intrahepatic portosystemic shunt (TIPS) placement be avoided in patients with a Model for End-State Liver Disease (MELD) score >18.
In 2013, colleague Dr. Riad Salem demonstrated the efficacy of portal vein recanalization during TIPS using a transhepatic approach in 44 patients, with only one technical failure and three cases of rethrombosis. Among six patients with a baseline MELD score >18, four went on to successful liver transplant, one is awaiting transplant, and one died as a result of bleeding 45 days post procedure despite an improvement in MELD score.
The last three patients in the series underwent TIPS with a transsplenic approach, and not only were the results equally good, but the approach was technically easier, Dr. Thornburg said at a symposium on vascular surgery sponsored by Northwestern University.
Since then, this increasingly common alternative approach has been assessed in another 11 consecutive patients with cirrhosis, portal hypertension, and chronic PVT. All patients had been denied listing for transplant because of their PVT, and four had a baseline MELD score >18.
At the end of the procedure, thrombus persisted in 45% (5 of 11 patients). On a 1-month follow-up venogram, however, three of the five patients had complete resolution of the thrombus without any added anticoagulation, one had persistent partial thrombus that was smaller than at stent placement, and one went on to transplant, Dr. Thornburg said.
All six of the patients with portal vein (PV) patency post procedure have retained patency after a median follow-up of 6.4 months.
“What we’ve learned from doing these cases is that complete elimination of the portal vein thrombus at the time of TIPS placement isn’t necessary,” he said. “It would be easy to get carried away and do suction or AngioJet [mechanical thrombectomy], but what we’ve found is that because of how much flow there is in the portal vein once it’s recanalized and the TIPS is in place, basically establishing a flow allowed for clot clearance by 1 month in all patients, except one.”
The procedure starts like a typical TIPS, with access achieved by advancing a 21-guage needle into the peripheral splenic vein or hilum under ultrasound guidance. A 5-French sheath is then placed through the parenchyma to the origin of splenic vein or the clot and an intrahepatic venogram performed to confirm occlusion, Dr. Thornburg said.
A 5-French Kumpe catheter and glide wire are used to recanalize the thrombosed portal vein, with a 10-mm gooseneck snare placed through the Kumpe in the peripheral portal vein as a target for the TIPS needle.
“Then, we basically get through-and-through access from the IJ [internal jugular] through this splenic access, and that gives us the workability to get our sheath across the portal vein and place our TIPS,” he said.
The remainder of the procedure is similar to that of the transhepatic approach. Angioplasty of the thrombosed PV is performed with an 8-by-40-mm balloon, followed by deployment of a Viatorr stent graft. The stent and PV are dilated with a 10-by-40-mm balloon and the splenic tract embolized with a couple of 4-by-14-cm Nester coils.
Based on their experience, short TIPS are always placed to maximize the amount of portal vein that is available at transplant for the end-to-end anastomoses, Dr. Thornburg said.
All patients who went on to transplant have received end-to-end anastomoses on what transplant surgeons have described as “totally normal” walled portal veins, including one patient who underwent transplant just 1 week post TIPS, he added.
There have been no major bleeding events with the transsplenic approach and only two adverse events: one case of transient encephalopathy and one low-grade fever.
Dr. Thornburg and Dr. Salem reported having no relevant financial disclosures.
AT THE NORTHWESTERN VASCULAR SYMPOSIUM
Skipping surgery is an option for some patients with rectal cancer
Patients with locally advanced rectal cancer who have a complete response to neoadjuvant therapy can skip surgery with little compromise in outcomes, according to a retrospective review that will be reported this week at the annual Gastrointestinal Cancers Symposium.
Investigators at the Memorial Sloan-Kettering Cancer Center in New York studied 145 patients with stage I to III rectal cancer who received neoadjuvant therapy there between 2006 and 2013. The meeting was cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology
After a median follow-up of 3.5 years, there were no significant differences in disease-specific or overall survival between patients who had a clinical complete response to neoadjuvant therapy of radiation and chemotherapy and skipped surgery, and patients who underwent rectal resection (the current standard strategy in the United States) with a pathologic complete response. Additionally, more than three-fourths of the group skipping surgery had preservation of rectal function.
“Nonoperative management appears to be a safe and effective treatment strategy and achieves a high rate of rectal preservation,” senior investigator Dr. Philip B. Paty, a surgical oncologist at Memorial Sloan-Kettering Cancer Center, New York, commented in a press briefing held before the symposium.
Ideally, the findings would be tested in a randomized trial, he said; however, “there’s too many factors and too much patient autonomy involved here, so that no one really believes asking people to sign up for a randomized trial where rectal resection is decided by a flip of the coin would ever accrue patients.” Short of that, rigorous prospective studies, such as a phase II trial now open at the center, will provide critical information.
Press briefing moderator Dr. Smitha S. Krishnamurthi of Case Western Reserve University, Cleveland, commented, “These are important findings for patients with rectal cancer because removal of the rectum can result in altered bowel habits or the need for permanent colostomy. This study set the bar very high, comparing the results of nonoperative management to the results seen in patients who had no cancer left under the microscope at the time of surgery, and in this study, the nonoperative management appears to compare favorably.”
“We do need longer follow-up though, to be sure that these patients will have disease-specific survival that equals what is achieved with surgery in the long term,” she cautioned, such as the conventional 5 years of observation patients typically receive. “And then of course a prospective study also would be helpful to see the effects of this approach.”
In the study, Dr. Paty and colleagues identified 73 patients who had a clinical complete response (no cancer detected on physical exam, endoscopy, or imaging) to neoadjuvant therapy of radiation and chemotherapy and—by mutual agreement of physician and patient—had nonoperative management (watchful waiting), consisting initially of follow-up at 3- to 4-month intervals by digital rectal and endoscopic exams and at 6-month intervals by imaging. They used as a comparison group 72 patients who underwent standard total mesorectal excision and had a pathologic complete response (no viable cancer cells found microscopically in the resected tissue).
Results showed that 74% of the patients who did not have surgery had a sustained clinical complete response, with no regrowth of tumor during follow-up, reported Dr. Paty. Among the other 26% whose tumors regrew, most of the recurrences were clinically detectable and all patients had successful resections with clean margins. Overall, 77% of the nonsurgical patients had rectal preservation and 98% had local control.
The nonsurgical group did not differ significantly from the surgical group with respect to 4-year rates of disease-specific survival (91% vs. 96%) and overall survival (91% vs. 95%).
The investigators plan to report quality of life data in the future, Dr. Paty said. “But I think it’s pretty obvious to everyone who’s managed these patients that if you can avoid rectal surgery, the quality of life and particularly bowel function is far superior to those who have had rectal resection.”
Successful nonoperative management hinges critically on careful patient selection, close follow-up, and use of salvage surgery, he stressed. Additionally, “the informed consent process in nonoperative management is extremely important, and I always tell patients that they are taking a slight risk. It’s hard to imagine that not operating is going to have 100% equivalent cancer outcomes as operating. That is hard to believe. So we never sell it as being absolutely as good, but …with good follow-up, the results seem to be very close if not equivalent.”
In his experience, most patients are willing to accept this option. “In fact, I have only had two patients [out of more than 100] decline nonoperative management when I thought they were candidates—both young, both with young children, both not wanting to take even the slightest risk of leaving cancer in the rectal wall or their body,” he commented.
Adoption of nonoperative management has been slow in the United States for a variety of reasons, according to Dr. Paty. “I think the bottom line is that practicing watch and wait, nonoperative management is more difficult for the surgeon. It requires first the judgment that the cancer’s gone. You have to follow the patient longer after radiation; sometimes the complete response will take up to 3 months. And there is also the medical-legal issue of deviating from the standard of care. … So I think it was operationally a difficult thing to do, it didn’t fit with the existing paradigm very well.”
But that is changing as more data roll in. “What’s happened in the last I will say 2-3 years is that there are centers publishing their experience, ours being the largest outside Brazil and the first in North America. Another group in the Netherlands has published a group of about 25 patients,” he explained. “Talking with people at meetings around the world, centers are adopting it, and I think that many leaders in clinical trials in rectal cancer recognize that this option is not only reasonable, but perhaps it’s necessary to inform patients that it is an option.”
Patients with locally advanced rectal cancer who have a complete response to neoadjuvant therapy can skip surgery with little compromise in outcomes, according to a retrospective review that will be reported this week at the annual Gastrointestinal Cancers Symposium.
Investigators at the Memorial Sloan-Kettering Cancer Center in New York studied 145 patients with stage I to III rectal cancer who received neoadjuvant therapy there between 2006 and 2013. The meeting was cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology
After a median follow-up of 3.5 years, there were no significant differences in disease-specific or overall survival between patients who had a clinical complete response to neoadjuvant therapy of radiation and chemotherapy and skipped surgery, and patients who underwent rectal resection (the current standard strategy in the United States) with a pathologic complete response. Additionally, more than three-fourths of the group skipping surgery had preservation of rectal function.
“Nonoperative management appears to be a safe and effective treatment strategy and achieves a high rate of rectal preservation,” senior investigator Dr. Philip B. Paty, a surgical oncologist at Memorial Sloan-Kettering Cancer Center, New York, commented in a press briefing held before the symposium.
Ideally, the findings would be tested in a randomized trial, he said; however, “there’s too many factors and too much patient autonomy involved here, so that no one really believes asking people to sign up for a randomized trial where rectal resection is decided by a flip of the coin would ever accrue patients.” Short of that, rigorous prospective studies, such as a phase II trial now open at the center, will provide critical information.
Press briefing moderator Dr. Smitha S. Krishnamurthi of Case Western Reserve University, Cleveland, commented, “These are important findings for patients with rectal cancer because removal of the rectum can result in altered bowel habits or the need for permanent colostomy. This study set the bar very high, comparing the results of nonoperative management to the results seen in patients who had no cancer left under the microscope at the time of surgery, and in this study, the nonoperative management appears to compare favorably.”
“We do need longer follow-up though, to be sure that these patients will have disease-specific survival that equals what is achieved with surgery in the long term,” she cautioned, such as the conventional 5 years of observation patients typically receive. “And then of course a prospective study also would be helpful to see the effects of this approach.”
In the study, Dr. Paty and colleagues identified 73 patients who had a clinical complete response (no cancer detected on physical exam, endoscopy, or imaging) to neoadjuvant therapy of radiation and chemotherapy and—by mutual agreement of physician and patient—had nonoperative management (watchful waiting), consisting initially of follow-up at 3- to 4-month intervals by digital rectal and endoscopic exams and at 6-month intervals by imaging. They used as a comparison group 72 patients who underwent standard total mesorectal excision and had a pathologic complete response (no viable cancer cells found microscopically in the resected tissue).
Results showed that 74% of the patients who did not have surgery had a sustained clinical complete response, with no regrowth of tumor during follow-up, reported Dr. Paty. Among the other 26% whose tumors regrew, most of the recurrences were clinically detectable and all patients had successful resections with clean margins. Overall, 77% of the nonsurgical patients had rectal preservation and 98% had local control.
The nonsurgical group did not differ significantly from the surgical group with respect to 4-year rates of disease-specific survival (91% vs. 96%) and overall survival (91% vs. 95%).
The investigators plan to report quality of life data in the future, Dr. Paty said. “But I think it’s pretty obvious to everyone who’s managed these patients that if you can avoid rectal surgery, the quality of life and particularly bowel function is far superior to those who have had rectal resection.”
Successful nonoperative management hinges critically on careful patient selection, close follow-up, and use of salvage surgery, he stressed. Additionally, “the informed consent process in nonoperative management is extremely important, and I always tell patients that they are taking a slight risk. It’s hard to imagine that not operating is going to have 100% equivalent cancer outcomes as operating. That is hard to believe. So we never sell it as being absolutely as good, but …with good follow-up, the results seem to be very close if not equivalent.”
In his experience, most patients are willing to accept this option. “In fact, I have only had two patients [out of more than 100] decline nonoperative management when I thought they were candidates—both young, both with young children, both not wanting to take even the slightest risk of leaving cancer in the rectal wall or their body,” he commented.
Adoption of nonoperative management has been slow in the United States for a variety of reasons, according to Dr. Paty. “I think the bottom line is that practicing watch and wait, nonoperative management is more difficult for the surgeon. It requires first the judgment that the cancer’s gone. You have to follow the patient longer after radiation; sometimes the complete response will take up to 3 months. And there is also the medical-legal issue of deviating from the standard of care. … So I think it was operationally a difficult thing to do, it didn’t fit with the existing paradigm very well.”
But that is changing as more data roll in. “What’s happened in the last I will say 2-3 years is that there are centers publishing their experience, ours being the largest outside Brazil and the first in North America. Another group in the Netherlands has published a group of about 25 patients,” he explained. “Talking with people at meetings around the world, centers are adopting it, and I think that many leaders in clinical trials in rectal cancer recognize that this option is not only reasonable, but perhaps it’s necessary to inform patients that it is an option.”
Patients with locally advanced rectal cancer who have a complete response to neoadjuvant therapy can skip surgery with little compromise in outcomes, according to a retrospective review that will be reported this week at the annual Gastrointestinal Cancers Symposium.
Investigators at the Memorial Sloan-Kettering Cancer Center in New York studied 145 patients with stage I to III rectal cancer who received neoadjuvant therapy there between 2006 and 2013. The meeting was cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology
After a median follow-up of 3.5 years, there were no significant differences in disease-specific or overall survival between patients who had a clinical complete response to neoadjuvant therapy of radiation and chemotherapy and skipped surgery, and patients who underwent rectal resection (the current standard strategy in the United States) with a pathologic complete response. Additionally, more than three-fourths of the group skipping surgery had preservation of rectal function.
“Nonoperative management appears to be a safe and effective treatment strategy and achieves a high rate of rectal preservation,” senior investigator Dr. Philip B. Paty, a surgical oncologist at Memorial Sloan-Kettering Cancer Center, New York, commented in a press briefing held before the symposium.
Ideally, the findings would be tested in a randomized trial, he said; however, “there’s too many factors and too much patient autonomy involved here, so that no one really believes asking people to sign up for a randomized trial where rectal resection is decided by a flip of the coin would ever accrue patients.” Short of that, rigorous prospective studies, such as a phase II trial now open at the center, will provide critical information.
Press briefing moderator Dr. Smitha S. Krishnamurthi of Case Western Reserve University, Cleveland, commented, “These are important findings for patients with rectal cancer because removal of the rectum can result in altered bowel habits or the need for permanent colostomy. This study set the bar very high, comparing the results of nonoperative management to the results seen in patients who had no cancer left under the microscope at the time of surgery, and in this study, the nonoperative management appears to compare favorably.”
“We do need longer follow-up though, to be sure that these patients will have disease-specific survival that equals what is achieved with surgery in the long term,” she cautioned, such as the conventional 5 years of observation patients typically receive. “And then of course a prospective study also would be helpful to see the effects of this approach.”
In the study, Dr. Paty and colleagues identified 73 patients who had a clinical complete response (no cancer detected on physical exam, endoscopy, or imaging) to neoadjuvant therapy of radiation and chemotherapy and—by mutual agreement of physician and patient—had nonoperative management (watchful waiting), consisting initially of follow-up at 3- to 4-month intervals by digital rectal and endoscopic exams and at 6-month intervals by imaging. They used as a comparison group 72 patients who underwent standard total mesorectal excision and had a pathologic complete response (no viable cancer cells found microscopically in the resected tissue).
Results showed that 74% of the patients who did not have surgery had a sustained clinical complete response, with no regrowth of tumor during follow-up, reported Dr. Paty. Among the other 26% whose tumors regrew, most of the recurrences were clinically detectable and all patients had successful resections with clean margins. Overall, 77% of the nonsurgical patients had rectal preservation and 98% had local control.
The nonsurgical group did not differ significantly from the surgical group with respect to 4-year rates of disease-specific survival (91% vs. 96%) and overall survival (91% vs. 95%).
The investigators plan to report quality of life data in the future, Dr. Paty said. “But I think it’s pretty obvious to everyone who’s managed these patients that if you can avoid rectal surgery, the quality of life and particularly bowel function is far superior to those who have had rectal resection.”
Successful nonoperative management hinges critically on careful patient selection, close follow-up, and use of salvage surgery, he stressed. Additionally, “the informed consent process in nonoperative management is extremely important, and I always tell patients that they are taking a slight risk. It’s hard to imagine that not operating is going to have 100% equivalent cancer outcomes as operating. That is hard to believe. So we never sell it as being absolutely as good, but …with good follow-up, the results seem to be very close if not equivalent.”
In his experience, most patients are willing to accept this option. “In fact, I have only had two patients [out of more than 100] decline nonoperative management when I thought they were candidates—both young, both with young children, both not wanting to take even the slightest risk of leaving cancer in the rectal wall or their body,” he commented.
Adoption of nonoperative management has been slow in the United States for a variety of reasons, according to Dr. Paty. “I think the bottom line is that practicing watch and wait, nonoperative management is more difficult for the surgeon. It requires first the judgment that the cancer’s gone. You have to follow the patient longer after radiation; sometimes the complete response will take up to 3 months. And there is also the medical-legal issue of deviating from the standard of care. … So I think it was operationally a difficult thing to do, it didn’t fit with the existing paradigm very well.”
But that is changing as more data roll in. “What’s happened in the last I will say 2-3 years is that there are centers publishing their experience, ours being the largest outside Brazil and the first in North America. Another group in the Netherlands has published a group of about 25 patients,” he explained. “Talking with people at meetings around the world, centers are adopting it, and I think that many leaders in clinical trials in rectal cancer recognize that this option is not only reasonable, but perhaps it’s necessary to inform patients that it is an option.”
AT THE GASTROINTESTINAL CANCERS SYMPOSIUM
Key clinical point: Patients with rectal cancer who have a clinical complete response to neoadjuvant therapy can safely skip surgery.
Major finding: Nonsurgical patients with clinical complete response did not differ significantly from surgical patients with pathologic complete response in terms of 4-year overall survival (91% vs. 95%) and disease-specific survival (91% vs. 96%).
Data source: A retrospective review of 145 patients given neoadjuvant therapy for stage I to III rectal cancer.
Disclosures: Dr. Paty disclosed that he had no relevant conflicts of interest.
RNA sequencing characterized high-risk squamous cell carcinomas
SAN DIEGO – Cutaneous squamous cell carcinomas from organ transplant recipients had a more aggressive molecular profile than did tumor samples from immunocompetent patients, according to an RNA sequencing study presented at the annual meeting of the American Society for Dermatologic Surgery.
Specimens from organ transplant recipients showed greater induction of biologic pathways related to cancer signaling, fibrosis, and extracellular matrix remodeling, said Dr. Cameron Chesnut, a dermatologist in private practice in Spokane, Wash., who carried out the research while he was a dermatologic surgery resident at the University of California, Los Angeles.
Furthermore, the TP53 tumor suppressor gene was inhibited at least five times more in samples from organ transplant recipients, compared with those from immunocompetent patients, Dr. Chesnut said in an interview.
Squamous cell carcinoma (SCC) is the most common cancer to occur after organ transplantation, Dr. Chesnut and his associates noted. The malignancy is 65-250 times more common, is more than 4 times more likely to metastasize, and has a mortality rate of 5% compared with a rate of less than 1% in immunocompetent patients, based on data published online in the journal F1000 Prime Reports, they said.
To characterize these high-risk SCCs and compare them with lower-risk SCCs, the researchers performed RNA sequencing of three normal skin samples and SCC specimens from 15 patients – 7 organ transplant recipients and 8 otherwise healthy individuals. The researchers used an Illumina GAIIx RNA Seq instrument to generate RNA sequencing libraries of the specimens. They also used the web-based Ingenuity Pathway Analysis technique to identify the major biological pathways regulated within the tumors.
In all, 690 highly expressed genes were induced at least fivefold in SCCs from organ transplant recipients compared with those from otherwise healthy patients. These genes encoded pathways related to fibrosis, extracellular remodeling, the cell cycle, and tumor signaling, the investigators said. The COX-2 pathway for prostaglandin synthesis also was induced fivefold or more in the high-risk SCCs compared with those from immunocompetent patients, Dr. Chesnut added.
The researchers also identified 1,290 highly expressed genes that were inhibited at least fivefold in SCCs from organ transplant recipients compared with specimens from immunocompetent patients. The most strongly inhibited pathways were related to sterol biosynthesis and epithelial differentiation, followed by nucleotide excision repair, interleukin-6 and IL-17, and apoptosis, they said.
Based on these findings, novel therapeutics might someday be able to target specific biologic pathways that are highly induced in SCCs from organ transplant recipients, Dr. Chesnut said. “It’s hard to say what the most likely candidates are,” but based on the study findings, “regulating inflammation may be a target,” he added. Dr. Chesnut and his associates reported no external funding sources or conflicts of interest.
SAN DIEGO – Cutaneous squamous cell carcinomas from organ transplant recipients had a more aggressive molecular profile than did tumor samples from immunocompetent patients, according to an RNA sequencing study presented at the annual meeting of the American Society for Dermatologic Surgery.
Specimens from organ transplant recipients showed greater induction of biologic pathways related to cancer signaling, fibrosis, and extracellular matrix remodeling, said Dr. Cameron Chesnut, a dermatologist in private practice in Spokane, Wash., who carried out the research while he was a dermatologic surgery resident at the University of California, Los Angeles.
Furthermore, the TP53 tumor suppressor gene was inhibited at least five times more in samples from organ transplant recipients, compared with those from immunocompetent patients, Dr. Chesnut said in an interview.
Squamous cell carcinoma (SCC) is the most common cancer to occur after organ transplantation, Dr. Chesnut and his associates noted. The malignancy is 65-250 times more common, is more than 4 times more likely to metastasize, and has a mortality rate of 5% compared with a rate of less than 1% in immunocompetent patients, based on data published online in the journal F1000 Prime Reports, they said.
To characterize these high-risk SCCs and compare them with lower-risk SCCs, the researchers performed RNA sequencing of three normal skin samples and SCC specimens from 15 patients – 7 organ transplant recipients and 8 otherwise healthy individuals. The researchers used an Illumina GAIIx RNA Seq instrument to generate RNA sequencing libraries of the specimens. They also used the web-based Ingenuity Pathway Analysis technique to identify the major biological pathways regulated within the tumors.
In all, 690 highly expressed genes were induced at least fivefold in SCCs from organ transplant recipients compared with those from otherwise healthy patients. These genes encoded pathways related to fibrosis, extracellular remodeling, the cell cycle, and tumor signaling, the investigators said. The COX-2 pathway for prostaglandin synthesis also was induced fivefold or more in the high-risk SCCs compared with those from immunocompetent patients, Dr. Chesnut added.
The researchers also identified 1,290 highly expressed genes that were inhibited at least fivefold in SCCs from organ transplant recipients compared with specimens from immunocompetent patients. The most strongly inhibited pathways were related to sterol biosynthesis and epithelial differentiation, followed by nucleotide excision repair, interleukin-6 and IL-17, and apoptosis, they said.
Based on these findings, novel therapeutics might someday be able to target specific biologic pathways that are highly induced in SCCs from organ transplant recipients, Dr. Chesnut said. “It’s hard to say what the most likely candidates are,” but based on the study findings, “regulating inflammation may be a target,” he added. Dr. Chesnut and his associates reported no external funding sources or conflicts of interest.
SAN DIEGO – Cutaneous squamous cell carcinomas from organ transplant recipients had a more aggressive molecular profile than did tumor samples from immunocompetent patients, according to an RNA sequencing study presented at the annual meeting of the American Society for Dermatologic Surgery.
Specimens from organ transplant recipients showed greater induction of biologic pathways related to cancer signaling, fibrosis, and extracellular matrix remodeling, said Dr. Cameron Chesnut, a dermatologist in private practice in Spokane, Wash., who carried out the research while he was a dermatologic surgery resident at the University of California, Los Angeles.
Furthermore, the TP53 tumor suppressor gene was inhibited at least five times more in samples from organ transplant recipients, compared with those from immunocompetent patients, Dr. Chesnut said in an interview.
Squamous cell carcinoma (SCC) is the most common cancer to occur after organ transplantation, Dr. Chesnut and his associates noted. The malignancy is 65-250 times more common, is more than 4 times more likely to metastasize, and has a mortality rate of 5% compared with a rate of less than 1% in immunocompetent patients, based on data published online in the journal F1000 Prime Reports, they said.
To characterize these high-risk SCCs and compare them with lower-risk SCCs, the researchers performed RNA sequencing of three normal skin samples and SCC specimens from 15 patients – 7 organ transplant recipients and 8 otherwise healthy individuals. The researchers used an Illumina GAIIx RNA Seq instrument to generate RNA sequencing libraries of the specimens. They also used the web-based Ingenuity Pathway Analysis technique to identify the major biological pathways regulated within the tumors.
In all, 690 highly expressed genes were induced at least fivefold in SCCs from organ transplant recipients compared with those from otherwise healthy patients. These genes encoded pathways related to fibrosis, extracellular remodeling, the cell cycle, and tumor signaling, the investigators said. The COX-2 pathway for prostaglandin synthesis also was induced fivefold or more in the high-risk SCCs compared with those from immunocompetent patients, Dr. Chesnut added.
The researchers also identified 1,290 highly expressed genes that were inhibited at least fivefold in SCCs from organ transplant recipients compared with specimens from immunocompetent patients. The most strongly inhibited pathways were related to sterol biosynthesis and epithelial differentiation, followed by nucleotide excision repair, interleukin-6 and IL-17, and apoptosis, they said.
Based on these findings, novel therapeutics might someday be able to target specific biologic pathways that are highly induced in SCCs from organ transplant recipients, Dr. Chesnut said. “It’s hard to say what the most likely candidates are,” but based on the study findings, “regulating inflammation may be a target,” he added. Dr. Chesnut and his associates reported no external funding sources or conflicts of interest.
Key clinical point: Squamous cell carcinomas from organ transplant recipients showed a more aggressive molecular profile than did those from immunocompetent individuals.
Major finding: The high-risk tumors showed greater induction of biologic pathways related to cancer signaling, fibrosis, and extracellular matrix remodeling, and inhibition of the tp53 tumor suppressor gene.
Data source: RNA sequencing of 15 squamous cell carcinomas, including seven from organ transplant recipients.
Disclosures: The investigators reported no external funding sources or conflicts of interest.
Study aims to determine prognostic factors for subset of thyroid cancer patients
CORONADO, CALIF. – In patients with radioactive iodine–refractory differentiated thyroid cancer, those with target lesions less than 1.5 cm in size appeared to derive less benefit from sorafenib in terms of progression-free survival, results from an international study showed.
In addition, papillary histology was a positive predictive factor and a predictive factor for benefit from sorafenib.
“Patients with radioactive iodine–refractory differentiated thyroid cancer have a poor prognosis, and there is a lack of effective treatments,” Dr. Martin Schlumberger said at the annual meeting of the American Thyroid Association. “The median survival for this subset is estimated to be 2.5-5 years.”
Sorafenib was approved by the Food and Drug Administration in November 2013 for the treatment of radioactive iodine–refractory differentiated thyroid cancer based on results from the randomized, controlled, double-blind phase III DECISION trial (Lancet 2014;384:319-28). Investigators found that the use of sorafenib extended median progression-free survival by 5 months, compared with placebo (10.8 vs 5.8 months; P < .0001). The purpose of the current analysis was to determine which demographic baseline or disease-related characteristics are prognostic for better outcomes in this patient population. To do so, Dr. Schlumberger of the department of nuclear medicine and endocrine oncology at Gustave Roussy, Villejuif, France, and his associates performed multivariate Cox proportional hazards models adjusted for treatment effect.
He reported findings from 417 patients. Of these, 210 were randomized to receive placebo and 207 were randomized to receive sorafenib. Variables found to be prognostic factors for progression-free survival in placebo patients, and in all patients when adjusted for sorafenib treatment, included papillary histology, lower targeted tumor size, baseline thyroglobulin less than 486 ng/mL, lower number of lesions, and residing in Asia vs. Europe and North America. Subgroup analyses of patients in the sorafenib arm revealed that the following baseline or disease-related variables were predictive of progression-free survival: papillary histology, tumor size of at least 1.5 cm, and having only lung metastases.
In a post-hoc exploratory analysis of progression-free survival by thyroid cancer symptoms among all 417 patients at study entry, the researchers found that both symptomatic and asymptomatic patients had improved progression-free survival following treatment with sorafenib.
On the basis of these findings, radioactive iodine–refractory differentiated thyroid cancer patients with no progressive disease and a tumor size of less than 1.5 cm “appear to have a good prognosis and may be candidates for a ‘watch and wait’ approach before initiating treatment with sorafenib,” Dr. Schlumberger concluded.
Dr. Schlumberger is an adviser to AstraZeneca, Bayer, Eisai, Exelixis, and Genzyme. He has also received research support from Genzyme and Bayer.
On Twitter @dougbrunk
CORONADO, CALIF. – In patients with radioactive iodine–refractory differentiated thyroid cancer, those with target lesions less than 1.5 cm in size appeared to derive less benefit from sorafenib in terms of progression-free survival, results from an international study showed.
In addition, papillary histology was a positive predictive factor and a predictive factor for benefit from sorafenib.
“Patients with radioactive iodine–refractory differentiated thyroid cancer have a poor prognosis, and there is a lack of effective treatments,” Dr. Martin Schlumberger said at the annual meeting of the American Thyroid Association. “The median survival for this subset is estimated to be 2.5-5 years.”
Sorafenib was approved by the Food and Drug Administration in November 2013 for the treatment of radioactive iodine–refractory differentiated thyroid cancer based on results from the randomized, controlled, double-blind phase III DECISION trial (Lancet 2014;384:319-28). Investigators found that the use of sorafenib extended median progression-free survival by 5 months, compared with placebo (10.8 vs 5.8 months; P < .0001). The purpose of the current analysis was to determine which demographic baseline or disease-related characteristics are prognostic for better outcomes in this patient population. To do so, Dr. Schlumberger of the department of nuclear medicine and endocrine oncology at Gustave Roussy, Villejuif, France, and his associates performed multivariate Cox proportional hazards models adjusted for treatment effect.
He reported findings from 417 patients. Of these, 210 were randomized to receive placebo and 207 were randomized to receive sorafenib. Variables found to be prognostic factors for progression-free survival in placebo patients, and in all patients when adjusted for sorafenib treatment, included papillary histology, lower targeted tumor size, baseline thyroglobulin less than 486 ng/mL, lower number of lesions, and residing in Asia vs. Europe and North America. Subgroup analyses of patients in the sorafenib arm revealed that the following baseline or disease-related variables were predictive of progression-free survival: papillary histology, tumor size of at least 1.5 cm, and having only lung metastases.
In a post-hoc exploratory analysis of progression-free survival by thyroid cancer symptoms among all 417 patients at study entry, the researchers found that both symptomatic and asymptomatic patients had improved progression-free survival following treatment with sorafenib.
On the basis of these findings, radioactive iodine–refractory differentiated thyroid cancer patients with no progressive disease and a tumor size of less than 1.5 cm “appear to have a good prognosis and may be candidates for a ‘watch and wait’ approach before initiating treatment with sorafenib,” Dr. Schlumberger concluded.
Dr. Schlumberger is an adviser to AstraZeneca, Bayer, Eisai, Exelixis, and Genzyme. He has also received research support from Genzyme and Bayer.
On Twitter @dougbrunk
CORONADO, CALIF. – In patients with radioactive iodine–refractory differentiated thyroid cancer, those with target lesions less than 1.5 cm in size appeared to derive less benefit from sorafenib in terms of progression-free survival, results from an international study showed.
In addition, papillary histology was a positive predictive factor and a predictive factor for benefit from sorafenib.
“Patients with radioactive iodine–refractory differentiated thyroid cancer have a poor prognosis, and there is a lack of effective treatments,” Dr. Martin Schlumberger said at the annual meeting of the American Thyroid Association. “The median survival for this subset is estimated to be 2.5-5 years.”
Sorafenib was approved by the Food and Drug Administration in November 2013 for the treatment of radioactive iodine–refractory differentiated thyroid cancer based on results from the randomized, controlled, double-blind phase III DECISION trial (Lancet 2014;384:319-28). Investigators found that the use of sorafenib extended median progression-free survival by 5 months, compared with placebo (10.8 vs 5.8 months; P < .0001). The purpose of the current analysis was to determine which demographic baseline or disease-related characteristics are prognostic for better outcomes in this patient population. To do so, Dr. Schlumberger of the department of nuclear medicine and endocrine oncology at Gustave Roussy, Villejuif, France, and his associates performed multivariate Cox proportional hazards models adjusted for treatment effect.
He reported findings from 417 patients. Of these, 210 were randomized to receive placebo and 207 were randomized to receive sorafenib. Variables found to be prognostic factors for progression-free survival in placebo patients, and in all patients when adjusted for sorafenib treatment, included papillary histology, lower targeted tumor size, baseline thyroglobulin less than 486 ng/mL, lower number of lesions, and residing in Asia vs. Europe and North America. Subgroup analyses of patients in the sorafenib arm revealed that the following baseline or disease-related variables were predictive of progression-free survival: papillary histology, tumor size of at least 1.5 cm, and having only lung metastases.
In a post-hoc exploratory analysis of progression-free survival by thyroid cancer symptoms among all 417 patients at study entry, the researchers found that both symptomatic and asymptomatic patients had improved progression-free survival following treatment with sorafenib.
On the basis of these findings, radioactive iodine–refractory differentiated thyroid cancer patients with no progressive disease and a tumor size of less than 1.5 cm “appear to have a good prognosis and may be candidates for a ‘watch and wait’ approach before initiating treatment with sorafenib,” Dr. Schlumberger concluded.
Dr. Schlumberger is an adviser to AstraZeneca, Bayer, Eisai, Exelixis, and Genzyme. He has also received research support from Genzyme and Bayer.
On Twitter @dougbrunk
AT THE ATA ANNUAL MEETING
Key clinical point: Radioactive iodine–refractory differentiated thyroid cancer patients with no progressive disease and a tumor size of less than 1.5 cm may be candidates for a “watch and wait” approach before initiating treatment with sorafenib.
Major finding: Baseline or disease-related variables found to be prognostic factors for progression-free survival in placebo patients and in all patients when adjusted for sorafenib treatment included papillary histology, lower targeted tumor size, baseline thyroglobulin less than 486 ng/mL, lower number of lesions, and residing in Asia versus Europe and North America.
Data source: An analysis of 417 patients from the randomized, controlled, double-blind, phase III DECISION trial.
Disclosures: Dr. Schlumberger is an adviser to AstraZeneca, Bayer, Eisai, Exelixis, and Genzyme. He has also received research support from Genzyme and Bayer.
