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HHS proposes to streamline Medicare appeals process
The Department of Health and Human Services on June 28 proposed key changes in the Medicare appeals process to help reduce the backlog of more than 700,000 cases.
The measures “will help us get a leg up on this problem,” said Nancy Griswold, chief law judge of the Office of Medicare Hearings and Appeals.
If there was not a single additional appeal filed and no changes in the system, it would take 11 years to eliminate the backlog, Ms. Griswold said in an interview.
Her office has faced increased criticism from health care providers and beneficiary advocates for its inability to speed up appeals and reduce the backlog. The latest critique came earlier this month in an investigation from the Government Accountability Office.
This latest effort still falls short of what is needed, said Tom Nickels, executive vice president at the American Hospital Association. “We are deeply disappointed that HHS has not made more progress in addressing the delays despite the more than 2 years since the delays began,” he said.
The new proposals, as well as increased funding requests, are expected to eliminate the backlog by 2021 by streamlining the decision-making process and reducing the number of cases that go to the third level of appeals, where many cases linger waiting for a hearing and then a decision from an administrative law judge. From the day of the hearing, it currently takes an average of slightly more than 2 years for a decision in appeals from hospitals, nursing homes, medical device suppliers and other health care providers.
Among the proposed changes:
• Designate some decisions from the Medicare Appeals Council, the last of four stages of appeals, as precedents that decision-makers at lower levels would have to follow. That could eliminate redundant appeals and resolve inconsistencies in interpretation of Medicare policies.
• Allow senior attorneys to handle some of the procedural matters that come before the administrative law judges, such as dismissing a request for a hearing after the appellant has withdrawn the request, Ms. Griswold said.
• Revise how the minimum amount necessary to lodge an appeal is determined. Under current rules, an appeal must involve payment of at least $150, based on the amount the provider charged. HHS is proposing to use Medicare’s allowed amount instead, which tends to be lower, and that could reduce the number of claims that could be appealed.
• Eliminate some steps in the appeals process to simplify the system.
Although advocates have sought changes to speed up the appeal process, Alice Bers, an attorney at the Center for Medicare Advocacy, said she was skeptical about some of the proposals. The effort to set up a system of precedents “could restrict coverage for needed items and benefits for seniors that they are entitled to by law.”
And the change in calculating the minimal amounts “could make it harder for beneficiaries to reach that threshold,” said Ms. Bers. It might not sound like a lot of money, Ms. Bers said, “but for an elderly woman living on Social Security that’s several meals or copays for medicine.”
The proposals do not address what hospital representatives say is a key cause of increasing appeals, independent audit contractors who can reject payments to hospitals. The American Hospital Association contends that those contractors unnecessarily cut off many payments and that hospitals frequently win the appeals.
According to the GAO study, audit-related appeals decided at the administrative law judge stage – the third level of appeals – increased 37-fold from 2010 through 2014, compared to only 1.5 times for appeals of other kinds of claims.
But Ms. Griswold said that currently only about a third of the pending cases at this stage involved recovery audit contractors, after settlements were reached with appellants who agreed to accept partial payment. As a result of these agreements, 4,245 cases from just 16 appellants were withdrawn from the system as of May 12, according to government statistics.
Ms. Griswold also said Medicare will continue to process beneficiary appeals before those from hospitals, doctors, and other health care providers. The practice began in 2014.
The proposed changes will be posted on the Federal Register website and open to comments through Aug. 29.
This story appears courtesy of Kaiser Health News (KHN). KHN’s coverage of aging and long-term care issues is supported in part by a grant from The SCAN Foundation.
The Department of Health and Human Services on June 28 proposed key changes in the Medicare appeals process to help reduce the backlog of more than 700,000 cases.
The measures “will help us get a leg up on this problem,” said Nancy Griswold, chief law judge of the Office of Medicare Hearings and Appeals.
If there was not a single additional appeal filed and no changes in the system, it would take 11 years to eliminate the backlog, Ms. Griswold said in an interview.
Her office has faced increased criticism from health care providers and beneficiary advocates for its inability to speed up appeals and reduce the backlog. The latest critique came earlier this month in an investigation from the Government Accountability Office.
This latest effort still falls short of what is needed, said Tom Nickels, executive vice president at the American Hospital Association. “We are deeply disappointed that HHS has not made more progress in addressing the delays despite the more than 2 years since the delays began,” he said.
The new proposals, as well as increased funding requests, are expected to eliminate the backlog by 2021 by streamlining the decision-making process and reducing the number of cases that go to the third level of appeals, where many cases linger waiting for a hearing and then a decision from an administrative law judge. From the day of the hearing, it currently takes an average of slightly more than 2 years for a decision in appeals from hospitals, nursing homes, medical device suppliers and other health care providers.
Among the proposed changes:
• Designate some decisions from the Medicare Appeals Council, the last of four stages of appeals, as precedents that decision-makers at lower levels would have to follow. That could eliminate redundant appeals and resolve inconsistencies in interpretation of Medicare policies.
• Allow senior attorneys to handle some of the procedural matters that come before the administrative law judges, such as dismissing a request for a hearing after the appellant has withdrawn the request, Ms. Griswold said.
• Revise how the minimum amount necessary to lodge an appeal is determined. Under current rules, an appeal must involve payment of at least $150, based on the amount the provider charged. HHS is proposing to use Medicare’s allowed amount instead, which tends to be lower, and that could reduce the number of claims that could be appealed.
• Eliminate some steps in the appeals process to simplify the system.
Although advocates have sought changes to speed up the appeal process, Alice Bers, an attorney at the Center for Medicare Advocacy, said she was skeptical about some of the proposals. The effort to set up a system of precedents “could restrict coverage for needed items and benefits for seniors that they are entitled to by law.”
And the change in calculating the minimal amounts “could make it harder for beneficiaries to reach that threshold,” said Ms. Bers. It might not sound like a lot of money, Ms. Bers said, “but for an elderly woman living on Social Security that’s several meals or copays for medicine.”
The proposals do not address what hospital representatives say is a key cause of increasing appeals, independent audit contractors who can reject payments to hospitals. The American Hospital Association contends that those contractors unnecessarily cut off many payments and that hospitals frequently win the appeals.
According to the GAO study, audit-related appeals decided at the administrative law judge stage – the third level of appeals – increased 37-fold from 2010 through 2014, compared to only 1.5 times for appeals of other kinds of claims.
But Ms. Griswold said that currently only about a third of the pending cases at this stage involved recovery audit contractors, after settlements were reached with appellants who agreed to accept partial payment. As a result of these agreements, 4,245 cases from just 16 appellants were withdrawn from the system as of May 12, according to government statistics.
Ms. Griswold also said Medicare will continue to process beneficiary appeals before those from hospitals, doctors, and other health care providers. The practice began in 2014.
The proposed changes will be posted on the Federal Register website and open to comments through Aug. 29.
This story appears courtesy of Kaiser Health News (KHN). KHN’s coverage of aging and long-term care issues is supported in part by a grant from The SCAN Foundation.
The Department of Health and Human Services on June 28 proposed key changes in the Medicare appeals process to help reduce the backlog of more than 700,000 cases.
The measures “will help us get a leg up on this problem,” said Nancy Griswold, chief law judge of the Office of Medicare Hearings and Appeals.
If there was not a single additional appeal filed and no changes in the system, it would take 11 years to eliminate the backlog, Ms. Griswold said in an interview.
Her office has faced increased criticism from health care providers and beneficiary advocates for its inability to speed up appeals and reduce the backlog. The latest critique came earlier this month in an investigation from the Government Accountability Office.
This latest effort still falls short of what is needed, said Tom Nickels, executive vice president at the American Hospital Association. “We are deeply disappointed that HHS has not made more progress in addressing the delays despite the more than 2 years since the delays began,” he said.
The new proposals, as well as increased funding requests, are expected to eliminate the backlog by 2021 by streamlining the decision-making process and reducing the number of cases that go to the third level of appeals, where many cases linger waiting for a hearing and then a decision from an administrative law judge. From the day of the hearing, it currently takes an average of slightly more than 2 years for a decision in appeals from hospitals, nursing homes, medical device suppliers and other health care providers.
Among the proposed changes:
• Designate some decisions from the Medicare Appeals Council, the last of four stages of appeals, as precedents that decision-makers at lower levels would have to follow. That could eliminate redundant appeals and resolve inconsistencies in interpretation of Medicare policies.
• Allow senior attorneys to handle some of the procedural matters that come before the administrative law judges, such as dismissing a request for a hearing after the appellant has withdrawn the request, Ms. Griswold said.
• Revise how the minimum amount necessary to lodge an appeal is determined. Under current rules, an appeal must involve payment of at least $150, based on the amount the provider charged. HHS is proposing to use Medicare’s allowed amount instead, which tends to be lower, and that could reduce the number of claims that could be appealed.
• Eliminate some steps in the appeals process to simplify the system.
Although advocates have sought changes to speed up the appeal process, Alice Bers, an attorney at the Center for Medicare Advocacy, said she was skeptical about some of the proposals. The effort to set up a system of precedents “could restrict coverage for needed items and benefits for seniors that they are entitled to by law.”
And the change in calculating the minimal amounts “could make it harder for beneficiaries to reach that threshold,” said Ms. Bers. It might not sound like a lot of money, Ms. Bers said, “but for an elderly woman living on Social Security that’s several meals or copays for medicine.”
The proposals do not address what hospital representatives say is a key cause of increasing appeals, independent audit contractors who can reject payments to hospitals. The American Hospital Association contends that those contractors unnecessarily cut off many payments and that hospitals frequently win the appeals.
According to the GAO study, audit-related appeals decided at the administrative law judge stage – the third level of appeals – increased 37-fold from 2010 through 2014, compared to only 1.5 times for appeals of other kinds of claims.
But Ms. Griswold said that currently only about a third of the pending cases at this stage involved recovery audit contractors, after settlements were reached with appellants who agreed to accept partial payment. As a result of these agreements, 4,245 cases from just 16 appellants were withdrawn from the system as of May 12, according to government statistics.
Ms. Griswold also said Medicare will continue to process beneficiary appeals before those from hospitals, doctors, and other health care providers. The practice began in 2014.
The proposed changes will be posted on the Federal Register website and open to comments through Aug. 29.
This story appears courtesy of Kaiser Health News (KHN). KHN’s coverage of aging and long-term care issues is supported in part by a grant from The SCAN Foundation.
The hospitalist perspective on opioid prescribing
In the United States, we are currently experiencing an opioid epidemic. The rate of opioid-related overdose deaths has reached an all-time high. Hospitalists manage a large number of patients admitted to hospitals in the U.S., and pain is a frequent symptom among these patients.
My colleagues and I wanted to explore hospitalists’ attitudes, beliefs, and practices associated with opioid prescribing during hospitalization and at discharge. In this way, we can begin a conversation about how opioids have impacted the physician’s day to day clinical practice.
For our study, published in the Journal of Hospital Medicine (doi: 10.1002/jhm.2602), we recruited and interviewed 25 hospitalists working in a variety of hospital settings, including two university hospitals, a safety-net hospital, a Veterans Affairs hospital, and a private hospital, located in Colorado and South Carolina. All 25 hospitalists were trained in internal medicine and the majority of them had completed residency within the past 5 to 10 years (48%).
Hospitalists perceived limited success in managing acute exacerbations of chronic pain with opioids, but felt confident in their ability to control acute pain with opioids. They recounted negative sentinel events with their patients that impacted their opioid prescribing practices. Hospitalists described prescribing opioids as a pragmatic tool to facilitate hospital discharges or prevent readmissions, which left them feeling conflicted about how this practice could impact their patients over the long term.
Hospitalists also described feeling uncomfortable treating hospitalized patients with acute exacerbations of a chronic pain condition. One physician said of his experience, “You never get an adequate level of pain control and you keep adding the doses up, and they get habituated.” Another physician described his challenge with controlling chronic pain in hospitalized patients. He said, “Of course their pain is not controlled, because their pain is never going to be less than 5 out of 10. And no opioid is going to get them there, unless they are unconscious.”
Negative sentinel events influenced how hospitalists prescribed opioids in their clinical practice. One physician reflected on an avoidable in-hospital overdose death, which left her more guarded when prescribing opioids. “I’ve had an experience where my patient overdosed,” she said. “She crushed up the oxycodone we were giving her in the hospital, shot it up in her central line, and died.”
Hospitalists described past experiences with patients who altered opioid prescriptions for personal gain. One hospitalist recounted such an experience, saying the patient had “forged my script and changed it from 18 pills to 180 pills.” The physician added, “I got a call from the DEA... I think she [the patient] is in prison now.”
These experiences inspired hospitalists to adopt strategies around opioid prescribing that would make it hard for a patient to jeopardize their DEA license. One physician said, “When I write the prescription, I put the name of the patient on the paper prescription with the patient’s sticker on top. I don’t want the patients to pull it off and sell the prescriptions. Especially when it is my license.”
Hospitalists felt institutional pressure to reduce hospital readmissions and to facilitate discharges. Uncontrolled pain often prolongs a hospital admission. Physicians viewed opioid prescriptions as a pragmatic tool to buffer against readmission or long hospital stays, in order to save health care dollars. On physician described his thoughts on opioid prescribing and efficiency: “If the patient comes back [to the hospital] and gets readmitted when they don’t have pain medicine, it’s a $3,000, 2-day stay in the hospital. When they have pain medicine, they stay out of the hospital. That is utterly pragmatic.”
While opioid prescribing at discharge may improve efficiency and reduce health care costs, one hospitalist also described his discomfort with the practice: “At times, especially when a patient lacks a diagnosis which is known to cause pain [opioid prescribing to prevent readmissions], it can feel cheap and dirty.”
Our study concluded that strategies to provide adequate pain relief to hospitalized patients, which allowed hospitalists to safely and optimally prescribe opioids while maintaining current standards of efficiency, are urgently needed.
Currently, our group is developing predictive tools to be embedded within the electronic medical record to inform physicians about their patient’s future risk for chronic opioid use or opioid use disorders. The goal is to inform physicians, to assist them in making safe, patient-centered, and informed opioid prescribing decisions.
Dr. Calcaterra practices in the Department of Hospital Medicine, Denver Health Medical Center, and is Assistant Professor of Medicine at the University of Colorado School of Medicine, Aurora. She reported having no financial disclosures.
In the United States, we are currently experiencing an opioid epidemic. The rate of opioid-related overdose deaths has reached an all-time high. Hospitalists manage a large number of patients admitted to hospitals in the U.S., and pain is a frequent symptom among these patients.
My colleagues and I wanted to explore hospitalists’ attitudes, beliefs, and practices associated with opioid prescribing during hospitalization and at discharge. In this way, we can begin a conversation about how opioids have impacted the physician’s day to day clinical practice.
For our study, published in the Journal of Hospital Medicine (doi: 10.1002/jhm.2602), we recruited and interviewed 25 hospitalists working in a variety of hospital settings, including two university hospitals, a safety-net hospital, a Veterans Affairs hospital, and a private hospital, located in Colorado and South Carolina. All 25 hospitalists were trained in internal medicine and the majority of them had completed residency within the past 5 to 10 years (48%).
Hospitalists perceived limited success in managing acute exacerbations of chronic pain with opioids, but felt confident in their ability to control acute pain with opioids. They recounted negative sentinel events with their patients that impacted their opioid prescribing practices. Hospitalists described prescribing opioids as a pragmatic tool to facilitate hospital discharges or prevent readmissions, which left them feeling conflicted about how this practice could impact their patients over the long term.
Hospitalists also described feeling uncomfortable treating hospitalized patients with acute exacerbations of a chronic pain condition. One physician said of his experience, “You never get an adequate level of pain control and you keep adding the doses up, and they get habituated.” Another physician described his challenge with controlling chronic pain in hospitalized patients. He said, “Of course their pain is not controlled, because their pain is never going to be less than 5 out of 10. And no opioid is going to get them there, unless they are unconscious.”
Negative sentinel events influenced how hospitalists prescribed opioids in their clinical practice. One physician reflected on an avoidable in-hospital overdose death, which left her more guarded when prescribing opioids. “I’ve had an experience where my patient overdosed,” she said. “She crushed up the oxycodone we were giving her in the hospital, shot it up in her central line, and died.”
Hospitalists described past experiences with patients who altered opioid prescriptions for personal gain. One hospitalist recounted such an experience, saying the patient had “forged my script and changed it from 18 pills to 180 pills.” The physician added, “I got a call from the DEA... I think she [the patient] is in prison now.”
These experiences inspired hospitalists to adopt strategies around opioid prescribing that would make it hard for a patient to jeopardize their DEA license. One physician said, “When I write the prescription, I put the name of the patient on the paper prescription with the patient’s sticker on top. I don’t want the patients to pull it off and sell the prescriptions. Especially when it is my license.”
Hospitalists felt institutional pressure to reduce hospital readmissions and to facilitate discharges. Uncontrolled pain often prolongs a hospital admission. Physicians viewed opioid prescriptions as a pragmatic tool to buffer against readmission or long hospital stays, in order to save health care dollars. On physician described his thoughts on opioid prescribing and efficiency: “If the patient comes back [to the hospital] and gets readmitted when they don’t have pain medicine, it’s a $3,000, 2-day stay in the hospital. When they have pain medicine, they stay out of the hospital. That is utterly pragmatic.”
While opioid prescribing at discharge may improve efficiency and reduce health care costs, one hospitalist also described his discomfort with the practice: “At times, especially when a patient lacks a diagnosis which is known to cause pain [opioid prescribing to prevent readmissions], it can feel cheap and dirty.”
Our study concluded that strategies to provide adequate pain relief to hospitalized patients, which allowed hospitalists to safely and optimally prescribe opioids while maintaining current standards of efficiency, are urgently needed.
Currently, our group is developing predictive tools to be embedded within the electronic medical record to inform physicians about their patient’s future risk for chronic opioid use or opioid use disorders. The goal is to inform physicians, to assist them in making safe, patient-centered, and informed opioid prescribing decisions.
Dr. Calcaterra practices in the Department of Hospital Medicine, Denver Health Medical Center, and is Assistant Professor of Medicine at the University of Colorado School of Medicine, Aurora. She reported having no financial disclosures.
In the United States, we are currently experiencing an opioid epidemic. The rate of opioid-related overdose deaths has reached an all-time high. Hospitalists manage a large number of patients admitted to hospitals in the U.S., and pain is a frequent symptom among these patients.
My colleagues and I wanted to explore hospitalists’ attitudes, beliefs, and practices associated with opioid prescribing during hospitalization and at discharge. In this way, we can begin a conversation about how opioids have impacted the physician’s day to day clinical practice.
For our study, published in the Journal of Hospital Medicine (doi: 10.1002/jhm.2602), we recruited and interviewed 25 hospitalists working in a variety of hospital settings, including two university hospitals, a safety-net hospital, a Veterans Affairs hospital, and a private hospital, located in Colorado and South Carolina. All 25 hospitalists were trained in internal medicine and the majority of them had completed residency within the past 5 to 10 years (48%).
Hospitalists perceived limited success in managing acute exacerbations of chronic pain with opioids, but felt confident in their ability to control acute pain with opioids. They recounted negative sentinel events with their patients that impacted their opioid prescribing practices. Hospitalists described prescribing opioids as a pragmatic tool to facilitate hospital discharges or prevent readmissions, which left them feeling conflicted about how this practice could impact their patients over the long term.
Hospitalists also described feeling uncomfortable treating hospitalized patients with acute exacerbations of a chronic pain condition. One physician said of his experience, “You never get an adequate level of pain control and you keep adding the doses up, and they get habituated.” Another physician described his challenge with controlling chronic pain in hospitalized patients. He said, “Of course their pain is not controlled, because their pain is never going to be less than 5 out of 10. And no opioid is going to get them there, unless they are unconscious.”
Negative sentinel events influenced how hospitalists prescribed opioids in their clinical practice. One physician reflected on an avoidable in-hospital overdose death, which left her more guarded when prescribing opioids. “I’ve had an experience where my patient overdosed,” she said. “She crushed up the oxycodone we were giving her in the hospital, shot it up in her central line, and died.”
Hospitalists described past experiences with patients who altered opioid prescriptions for personal gain. One hospitalist recounted such an experience, saying the patient had “forged my script and changed it from 18 pills to 180 pills.” The physician added, “I got a call from the DEA... I think she [the patient] is in prison now.”
These experiences inspired hospitalists to adopt strategies around opioid prescribing that would make it hard for a patient to jeopardize their DEA license. One physician said, “When I write the prescription, I put the name of the patient on the paper prescription with the patient’s sticker on top. I don’t want the patients to pull it off and sell the prescriptions. Especially when it is my license.”
Hospitalists felt institutional pressure to reduce hospital readmissions and to facilitate discharges. Uncontrolled pain often prolongs a hospital admission. Physicians viewed opioid prescriptions as a pragmatic tool to buffer against readmission or long hospital stays, in order to save health care dollars. On physician described his thoughts on opioid prescribing and efficiency: “If the patient comes back [to the hospital] and gets readmitted when they don’t have pain medicine, it’s a $3,000, 2-day stay in the hospital. When they have pain medicine, they stay out of the hospital. That is utterly pragmatic.”
While opioid prescribing at discharge may improve efficiency and reduce health care costs, one hospitalist also described his discomfort with the practice: “At times, especially when a patient lacks a diagnosis which is known to cause pain [opioid prescribing to prevent readmissions], it can feel cheap and dirty.”
Our study concluded that strategies to provide adequate pain relief to hospitalized patients, which allowed hospitalists to safely and optimally prescribe opioids while maintaining current standards of efficiency, are urgently needed.
Currently, our group is developing predictive tools to be embedded within the electronic medical record to inform physicians about their patient’s future risk for chronic opioid use or opioid use disorders. The goal is to inform physicians, to assist them in making safe, patient-centered, and informed opioid prescribing decisions.
Dr. Calcaterra practices in the Department of Hospital Medicine, Denver Health Medical Center, and is Assistant Professor of Medicine at the University of Colorado School of Medicine, Aurora. She reported having no financial disclosures.
Primary care management of sepsis survivors does not improve mental health quality of life
Patients who have survived sepsis or septic shock do not receive any significant benefit in the quality of their mental health by receiving primary care management intervention, according to a new study published by JAMA.
“Many survivors of sepsis have multiple medical comorbidities that are typically managed in primary care [but] interventions for managing sepsis sequelae in primary care have not been developed,” states the study, which was led by Jochen Gensichen, MD, of the Institute of General Practice & Family Medicine at Jena (Germany) University Hospital.
“To our knowledge, this is the first large-scale, randomized controlled clinical trial of an intervention to improve outcomes in survivors of sepsis in primary care,” Dr. Gensichen and his coinvestigators added.
The study recruited sepsis and septic shock survivors from nine ICUs across Germany between February 2011 and December 2014, excluding any patients with cognitive impairment, defined as a Telephone Interview of Cognitive Status score no greater than 27. Ultimately, 291 patients aged 18 years or older (mean age of 61.6 years) were selected for inclusion and randomized into cohorts receiving either primary care–based intervention (n = 148) or usual care (n = 143) (JAMA. 2016;315:2703-11. doi: 10.1001/jama.2016.7207).
Those assigned to the usual care cohort received the standard care that their primary care providers would normally carry out, which included “periodic contacts, referrals to specialists, and prescription of medication and therapeutic aids at quantities comparable with those for other populations with multiple chronic conditions.” Those in the other cohort were given active monitoring of symptoms from providers who had been given evidence-based care training and clinical decision support from nurses who underwent training to become case managers. Case managers would take patients through an hour-long face-to-face training on sepsis sequelae within 2-20 days of ICU discharge, along with subsequent follow-up conversations over the phone.
“Case managers monitored patients’ symptoms using validated screening tools to assess critical illness polyneuropathy/myopathy, wasting, neurocognitive deficits, [posttraumatic stress disorder], depressive and pain symptoms, as well as patient self-management behaviors focusing on physical activity and individual self-management goals,” the authors said, noting that case managers would report their results to a consulting physician who “supervised the case managers and provided clinical decision support to the [primary care physicians].”
Baseline Mental Component Summary (MCS) scores were taken for subjects in both cohorts to determine mental health-based quality of life, which averaged 49.1 for the intervention cohort and 49.3 for the control. MCS scores at 6 months’ follow-up were 52.9 for the intervention group (95% confidence interval, 1.05-6.54) and 51.0 for the control group (95% CI, –1.22-4.51), for a mean change of 3.8 in the intervention cohort and 1.6 for the control group. The mean treatment effect was 2.15 (95% CI, –1.79-6.09; P = .28), indicating no significant difference between the two.
“There was no evidence for a differential treatment effect on the study’s primary outcome, postsepsis MCS scores,” the authors concluded. “This finding is similar to those from previous trials of care management interventions following critical illness.”
The authors added that “further research is needed to determine if modified approaches to primary care management may be more effective.”
The study was funded by the Center for Sepsis Control and Care, the German Federal Ministry of Education and Research, and the German Sepsis Society. Dr. Gensichen reported receiving personal fees from the Primary Health Care Foundation and receiving a grant from the German Federal Ministry of Education and Research.
Patients who have survived sepsis or septic shock do not receive any significant benefit in the quality of their mental health by receiving primary care management intervention, according to a new study published by JAMA.
“Many survivors of sepsis have multiple medical comorbidities that are typically managed in primary care [but] interventions for managing sepsis sequelae in primary care have not been developed,” states the study, which was led by Jochen Gensichen, MD, of the Institute of General Practice & Family Medicine at Jena (Germany) University Hospital.
“To our knowledge, this is the first large-scale, randomized controlled clinical trial of an intervention to improve outcomes in survivors of sepsis in primary care,” Dr. Gensichen and his coinvestigators added.
The study recruited sepsis and septic shock survivors from nine ICUs across Germany between February 2011 and December 2014, excluding any patients with cognitive impairment, defined as a Telephone Interview of Cognitive Status score no greater than 27. Ultimately, 291 patients aged 18 years or older (mean age of 61.6 years) were selected for inclusion and randomized into cohorts receiving either primary care–based intervention (n = 148) or usual care (n = 143) (JAMA. 2016;315:2703-11. doi: 10.1001/jama.2016.7207).
Those assigned to the usual care cohort received the standard care that their primary care providers would normally carry out, which included “periodic contacts, referrals to specialists, and prescription of medication and therapeutic aids at quantities comparable with those for other populations with multiple chronic conditions.” Those in the other cohort were given active monitoring of symptoms from providers who had been given evidence-based care training and clinical decision support from nurses who underwent training to become case managers. Case managers would take patients through an hour-long face-to-face training on sepsis sequelae within 2-20 days of ICU discharge, along with subsequent follow-up conversations over the phone.
“Case managers monitored patients’ symptoms using validated screening tools to assess critical illness polyneuropathy/myopathy, wasting, neurocognitive deficits, [posttraumatic stress disorder], depressive and pain symptoms, as well as patient self-management behaviors focusing on physical activity and individual self-management goals,” the authors said, noting that case managers would report their results to a consulting physician who “supervised the case managers and provided clinical decision support to the [primary care physicians].”
Baseline Mental Component Summary (MCS) scores were taken for subjects in both cohorts to determine mental health-based quality of life, which averaged 49.1 for the intervention cohort and 49.3 for the control. MCS scores at 6 months’ follow-up were 52.9 for the intervention group (95% confidence interval, 1.05-6.54) and 51.0 for the control group (95% CI, –1.22-4.51), for a mean change of 3.8 in the intervention cohort and 1.6 for the control group. The mean treatment effect was 2.15 (95% CI, –1.79-6.09; P = .28), indicating no significant difference between the two.
“There was no evidence for a differential treatment effect on the study’s primary outcome, postsepsis MCS scores,” the authors concluded. “This finding is similar to those from previous trials of care management interventions following critical illness.”
The authors added that “further research is needed to determine if modified approaches to primary care management may be more effective.”
The study was funded by the Center for Sepsis Control and Care, the German Federal Ministry of Education and Research, and the German Sepsis Society. Dr. Gensichen reported receiving personal fees from the Primary Health Care Foundation and receiving a grant from the German Federal Ministry of Education and Research.
Patients who have survived sepsis or septic shock do not receive any significant benefit in the quality of their mental health by receiving primary care management intervention, according to a new study published by JAMA.
“Many survivors of sepsis have multiple medical comorbidities that are typically managed in primary care [but] interventions for managing sepsis sequelae in primary care have not been developed,” states the study, which was led by Jochen Gensichen, MD, of the Institute of General Practice & Family Medicine at Jena (Germany) University Hospital.
“To our knowledge, this is the first large-scale, randomized controlled clinical trial of an intervention to improve outcomes in survivors of sepsis in primary care,” Dr. Gensichen and his coinvestigators added.
The study recruited sepsis and septic shock survivors from nine ICUs across Germany between February 2011 and December 2014, excluding any patients with cognitive impairment, defined as a Telephone Interview of Cognitive Status score no greater than 27. Ultimately, 291 patients aged 18 years or older (mean age of 61.6 years) were selected for inclusion and randomized into cohorts receiving either primary care–based intervention (n = 148) or usual care (n = 143) (JAMA. 2016;315:2703-11. doi: 10.1001/jama.2016.7207).
Those assigned to the usual care cohort received the standard care that their primary care providers would normally carry out, which included “periodic contacts, referrals to specialists, and prescription of medication and therapeutic aids at quantities comparable with those for other populations with multiple chronic conditions.” Those in the other cohort were given active monitoring of symptoms from providers who had been given evidence-based care training and clinical decision support from nurses who underwent training to become case managers. Case managers would take patients through an hour-long face-to-face training on sepsis sequelae within 2-20 days of ICU discharge, along with subsequent follow-up conversations over the phone.
“Case managers monitored patients’ symptoms using validated screening tools to assess critical illness polyneuropathy/myopathy, wasting, neurocognitive deficits, [posttraumatic stress disorder], depressive and pain symptoms, as well as patient self-management behaviors focusing on physical activity and individual self-management goals,” the authors said, noting that case managers would report their results to a consulting physician who “supervised the case managers and provided clinical decision support to the [primary care physicians].”
Baseline Mental Component Summary (MCS) scores were taken for subjects in both cohorts to determine mental health-based quality of life, which averaged 49.1 for the intervention cohort and 49.3 for the control. MCS scores at 6 months’ follow-up were 52.9 for the intervention group (95% confidence interval, 1.05-6.54) and 51.0 for the control group (95% CI, –1.22-4.51), for a mean change of 3.8 in the intervention cohort and 1.6 for the control group. The mean treatment effect was 2.15 (95% CI, –1.79-6.09; P = .28), indicating no significant difference between the two.
“There was no evidence for a differential treatment effect on the study’s primary outcome, postsepsis MCS scores,” the authors concluded. “This finding is similar to those from previous trials of care management interventions following critical illness.”
The authors added that “further research is needed to determine if modified approaches to primary care management may be more effective.”
The study was funded by the Center for Sepsis Control and Care, the German Federal Ministry of Education and Research, and the German Sepsis Society. Dr. Gensichen reported receiving personal fees from the Primary Health Care Foundation and receiving a grant from the German Federal Ministry of Education and Research.
FROM JAMA
Key clinical point: Primary care intervention does not improve mental health–related quality of life in survivors of sepsis or septic shock.
Major finding: Mean Mental Component Summary (MCS) scores showed no significant change between the time of ICU discharge (49.1) versus at 6 months postdischarge (52.9) (95% CI, 1.05-6.54), compared with the control group: 49.3 at baseline vs. 51.0 at 6 months follow-up (95% CI, –1.22-4.51).
Data source: A multicenter, unblinded, two-group randomized clinical trial of 291 adult sepsis or septic shock survivors recruited from nine German ICUs from February 2011 through December 2014.
Disclosures: Study funded by the Center for Sepsis Control and Care, the German Federal Ministry of Education and Research, and the German Sepsis Society. Dr. Gensichen reported receiving personal fees from The Primary Health Care Foundation and receiving a grant from the German Federal Ministry of Education and Research.
ICU-based therapy fails to shorten hospital stay
Standardized rehabilitation therapy did not reduce hospital length of stay in patients with acute respiratory failure, based on data from a randomized trial of 300 adults published online in JAMA.
Hospital length of stay averaged 10 days for patients in the standardized rehabilitation therapy group (SRT) and 10 days in the control group that received usual ICU care, wrote Dr. Peter E. Morris of the division of pulmonary, critical care and sleep medicine at the University of Kentucky, Lexington, and his colleagues (JAMA. 2016 Jun;315:2694-702. doi: 10.1001/jama.2016.7201).
The patients were followed for 6 months; 84 patients in the SRT group and 81 in the usual group completed the study.
Patients in the SRT group received daily therapy including passive range of motion, physical therapy, and progressive-resistance exercises. The usual care group received weekday physical therapy as determined by the clinical team.
The researchers also assessed secondary outcomes related to physical function and quality of life, including ventilator days, Short Physical Performance Battery (SPPB) score, handgrip, Mini-Mental State Examination, and Functional Performance Inventory (FPI).
Overall, there was no difference in duration of ventilation or ICU care between the two groups, and score of handgrip strength and mental health also were similar at 6 months’ follow up. However, the SF-36 physical function scores were significantly higher in the SRT group (difference, 12.2; 95% confidence interval, 3.8-20.7; P = .001), and the FPI scores and SPPB scores were higher, compared with the usual care group at 6 months.
“These findings from the exploratory analysis may highlight the emerging role of placing long-term outcomes within critical care clinical trial design not only as a secondary outcome, but possibly as the primary outcome,” the researchers noted. “In view of the SPPB, SF-36 PFS, and FPI data at 6 months, the SRT group demonstrated a potential signal of improvement compared with the usual care group that was not evident at hospital discharge,” they wrote.
The study was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Lead author, Dr. Morris, had no financial conflicts to disclose.
Standardized rehabilitation therapy did not reduce hospital length of stay in patients with acute respiratory failure, based on data from a randomized trial of 300 adults published online in JAMA.
Hospital length of stay averaged 10 days for patients in the standardized rehabilitation therapy group (SRT) and 10 days in the control group that received usual ICU care, wrote Dr. Peter E. Morris of the division of pulmonary, critical care and sleep medicine at the University of Kentucky, Lexington, and his colleagues (JAMA. 2016 Jun;315:2694-702. doi: 10.1001/jama.2016.7201).
The patients were followed for 6 months; 84 patients in the SRT group and 81 in the usual group completed the study.
Patients in the SRT group received daily therapy including passive range of motion, physical therapy, and progressive-resistance exercises. The usual care group received weekday physical therapy as determined by the clinical team.
The researchers also assessed secondary outcomes related to physical function and quality of life, including ventilator days, Short Physical Performance Battery (SPPB) score, handgrip, Mini-Mental State Examination, and Functional Performance Inventory (FPI).
Overall, there was no difference in duration of ventilation or ICU care between the two groups, and score of handgrip strength and mental health also were similar at 6 months’ follow up. However, the SF-36 physical function scores were significantly higher in the SRT group (difference, 12.2; 95% confidence interval, 3.8-20.7; P = .001), and the FPI scores and SPPB scores were higher, compared with the usual care group at 6 months.
“These findings from the exploratory analysis may highlight the emerging role of placing long-term outcomes within critical care clinical trial design not only as a secondary outcome, but possibly as the primary outcome,” the researchers noted. “In view of the SPPB, SF-36 PFS, and FPI data at 6 months, the SRT group demonstrated a potential signal of improvement compared with the usual care group that was not evident at hospital discharge,” they wrote.
The study was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Lead author, Dr. Morris, had no financial conflicts to disclose.
Standardized rehabilitation therapy did not reduce hospital length of stay in patients with acute respiratory failure, based on data from a randomized trial of 300 adults published online in JAMA.
Hospital length of stay averaged 10 days for patients in the standardized rehabilitation therapy group (SRT) and 10 days in the control group that received usual ICU care, wrote Dr. Peter E. Morris of the division of pulmonary, critical care and sleep medicine at the University of Kentucky, Lexington, and his colleagues (JAMA. 2016 Jun;315:2694-702. doi: 10.1001/jama.2016.7201).
The patients were followed for 6 months; 84 patients in the SRT group and 81 in the usual group completed the study.
Patients in the SRT group received daily therapy including passive range of motion, physical therapy, and progressive-resistance exercises. The usual care group received weekday physical therapy as determined by the clinical team.
The researchers also assessed secondary outcomes related to physical function and quality of life, including ventilator days, Short Physical Performance Battery (SPPB) score, handgrip, Mini-Mental State Examination, and Functional Performance Inventory (FPI).
Overall, there was no difference in duration of ventilation or ICU care between the two groups, and score of handgrip strength and mental health also were similar at 6 months’ follow up. However, the SF-36 physical function scores were significantly higher in the SRT group (difference, 12.2; 95% confidence interval, 3.8-20.7; P = .001), and the FPI scores and SPPB scores were higher, compared with the usual care group at 6 months.
“These findings from the exploratory analysis may highlight the emerging role of placing long-term outcomes within critical care clinical trial design not only as a secondary outcome, but possibly as the primary outcome,” the researchers noted. “In view of the SPPB, SF-36 PFS, and FPI data at 6 months, the SRT group demonstrated a potential signal of improvement compared with the usual care group that was not evident at hospital discharge,” they wrote.
The study was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Lead author, Dr. Morris, had no financial conflicts to disclose.
FROM JAMA
Key clinical point: Rehabilitation therapy in the ICU did not reduce hospital stay in patients with acute respiratory failure.
Major finding: The average length of stay was 10 days in both the therapy and control groups.
Data source: A randomized, single-center study including 300 adults with acute respiratory failure.
Disclosures: The study was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Lead author Dr. Morris had no financial conflicts to disclose.
As preventive, H2RA poses risks for patients on clopidogrel after bleeding ulcer
SAN DIEGO – New research suggests histamine-2 receptor antagonists aren’t a viable alternative to proton pump inhibitors to prevent recurrence of bleeding peptic ulcers in clopidogrel users.
U.S. and European agencies have warned of interactions between proton pump inhibitors (PPIs) and clopidogrel. But a study presented at the annual Digestive Disease Week finds significant upper GI events were much more common in patients who took famotidine (Protonix), a histamine-2 receptor antagonist (H2RA), compared with those who took pantoprazole (Pepcid), a PPI, as a preventive treatment.
“The findings will change the practice of some physicians who prescribe H2RA to prevent UGI [upper GI] events in clopidogrel users,” said study lead author Dr. Ping-I Hsu, chief of gastroenterology at Kaohsiung Veterans General Hospital and professor of medicine at National Yang-Ming University, both in Taiwan.
Currently, Dr. Hsu said, “physicians often use PPIs to prevent ulcer complications in clopidogrel users because it is the only drug proven useful in the prevention of peptic ulcers and ulcer complications in clopidogrel users.”
But “both the U.S. Food & Drug Administration and the European Medicines Agency have posted safety warnings and discourage the use of PPIs with clopidogrel unless absolutely necessary,” he said.
Enter the prospect of H2RA medications as an alternative. The new study, Dr. Hsu said, is the first to explore the GI protection effect and safety of H2RAs in patients on clopidogrel monotherapy.
The randomized prospective study followed 120 patients with a history of peptic ulcer bleeding (but not at initial endoscopy) and atherosclerosis. All long-term users of ADP receptor antagonists, they were assigned to pantoprazole (40 mg daily) or famotidine (40 mg daily) for 48 weeks.
Patients were examined via endoscopy when they experienced events like severe epigastric discomfort.
The famotidine group had more significant upper GI events (13.3%) than the pantoprazole group (1.7%). Diarrhea was equal in both groups (1.7%). Pneumonia was comparable (0% and 1.7% for pantoprazole and famotidine, respectively), as was fracture (1.7% and 0%).
Wider differences were found in acute myocardial infarction (1.5% and 4.5%), and cerebral vascular accident (0% and 3.4%) for pantoprazole and famotidine, respectively.
According to Dr. Hsu, three earlier studies linked concurrent use of PPIs and clopidogrel to significant increases in cardiovascular events. But this study linked a higher cardiac risk to the H2RA medication.
The researchers found no differences between the drugs in sequential changes of serum magnesium levels and bone mineral densities.
Dr. Hsu made this recommendation to physicians: “Please don’t use H2RAs to prevent peptic ulcer or ulcer complications in clopidogrel users. It is ineffective to prevent UGI [upper GI] events in clopidogrel users who have a history of ulcer bleeding. PPIs can effectively prevent UGI events in clopidogrel users with a history of ulcer bleeding.”
In addition, he said, the risk of thrombotic events is lower on a PPI.
SAN DIEGO – New research suggests histamine-2 receptor antagonists aren’t a viable alternative to proton pump inhibitors to prevent recurrence of bleeding peptic ulcers in clopidogrel users.
U.S. and European agencies have warned of interactions between proton pump inhibitors (PPIs) and clopidogrel. But a study presented at the annual Digestive Disease Week finds significant upper GI events were much more common in patients who took famotidine (Protonix), a histamine-2 receptor antagonist (H2RA), compared with those who took pantoprazole (Pepcid), a PPI, as a preventive treatment.
“The findings will change the practice of some physicians who prescribe H2RA to prevent UGI [upper GI] events in clopidogrel users,” said study lead author Dr. Ping-I Hsu, chief of gastroenterology at Kaohsiung Veterans General Hospital and professor of medicine at National Yang-Ming University, both in Taiwan.
Currently, Dr. Hsu said, “physicians often use PPIs to prevent ulcer complications in clopidogrel users because it is the only drug proven useful in the prevention of peptic ulcers and ulcer complications in clopidogrel users.”
But “both the U.S. Food & Drug Administration and the European Medicines Agency have posted safety warnings and discourage the use of PPIs with clopidogrel unless absolutely necessary,” he said.
Enter the prospect of H2RA medications as an alternative. The new study, Dr. Hsu said, is the first to explore the GI protection effect and safety of H2RAs in patients on clopidogrel monotherapy.
The randomized prospective study followed 120 patients with a history of peptic ulcer bleeding (but not at initial endoscopy) and atherosclerosis. All long-term users of ADP receptor antagonists, they were assigned to pantoprazole (40 mg daily) or famotidine (40 mg daily) for 48 weeks.
Patients were examined via endoscopy when they experienced events like severe epigastric discomfort.
The famotidine group had more significant upper GI events (13.3%) than the pantoprazole group (1.7%). Diarrhea was equal in both groups (1.7%). Pneumonia was comparable (0% and 1.7% for pantoprazole and famotidine, respectively), as was fracture (1.7% and 0%).
Wider differences were found in acute myocardial infarction (1.5% and 4.5%), and cerebral vascular accident (0% and 3.4%) for pantoprazole and famotidine, respectively.
According to Dr. Hsu, three earlier studies linked concurrent use of PPIs and clopidogrel to significant increases in cardiovascular events. But this study linked a higher cardiac risk to the H2RA medication.
The researchers found no differences between the drugs in sequential changes of serum magnesium levels and bone mineral densities.
Dr. Hsu made this recommendation to physicians: “Please don’t use H2RAs to prevent peptic ulcer or ulcer complications in clopidogrel users. It is ineffective to prevent UGI [upper GI] events in clopidogrel users who have a history of ulcer bleeding. PPIs can effectively prevent UGI events in clopidogrel users with a history of ulcer bleeding.”
In addition, he said, the risk of thrombotic events is lower on a PPI.
SAN DIEGO – New research suggests histamine-2 receptor antagonists aren’t a viable alternative to proton pump inhibitors to prevent recurrence of bleeding peptic ulcers in clopidogrel users.
U.S. and European agencies have warned of interactions between proton pump inhibitors (PPIs) and clopidogrel. But a study presented at the annual Digestive Disease Week finds significant upper GI events were much more common in patients who took famotidine (Protonix), a histamine-2 receptor antagonist (H2RA), compared with those who took pantoprazole (Pepcid), a PPI, as a preventive treatment.
“The findings will change the practice of some physicians who prescribe H2RA to prevent UGI [upper GI] events in clopidogrel users,” said study lead author Dr. Ping-I Hsu, chief of gastroenterology at Kaohsiung Veterans General Hospital and professor of medicine at National Yang-Ming University, both in Taiwan.
Currently, Dr. Hsu said, “physicians often use PPIs to prevent ulcer complications in clopidogrel users because it is the only drug proven useful in the prevention of peptic ulcers and ulcer complications in clopidogrel users.”
But “both the U.S. Food & Drug Administration and the European Medicines Agency have posted safety warnings and discourage the use of PPIs with clopidogrel unless absolutely necessary,” he said.
Enter the prospect of H2RA medications as an alternative. The new study, Dr. Hsu said, is the first to explore the GI protection effect and safety of H2RAs in patients on clopidogrel monotherapy.
The randomized prospective study followed 120 patients with a history of peptic ulcer bleeding (but not at initial endoscopy) and atherosclerosis. All long-term users of ADP receptor antagonists, they were assigned to pantoprazole (40 mg daily) or famotidine (40 mg daily) for 48 weeks.
Patients were examined via endoscopy when they experienced events like severe epigastric discomfort.
The famotidine group had more significant upper GI events (13.3%) than the pantoprazole group (1.7%). Diarrhea was equal in both groups (1.7%). Pneumonia was comparable (0% and 1.7% for pantoprazole and famotidine, respectively), as was fracture (1.7% and 0%).
Wider differences were found in acute myocardial infarction (1.5% and 4.5%), and cerebral vascular accident (0% and 3.4%) for pantoprazole and famotidine, respectively.
According to Dr. Hsu, three earlier studies linked concurrent use of PPIs and clopidogrel to significant increases in cardiovascular events. But this study linked a higher cardiac risk to the H2RA medication.
The researchers found no differences between the drugs in sequential changes of serum magnesium levels and bone mineral densities.
Dr. Hsu made this recommendation to physicians: “Please don’t use H2RAs to prevent peptic ulcer or ulcer complications in clopidogrel users. It is ineffective to prevent UGI [upper GI] events in clopidogrel users who have a history of ulcer bleeding. PPIs can effectively prevent UGI events in clopidogrel users with a history of ulcer bleeding.”
In addition, he said, the risk of thrombotic events is lower on a PPI.
AT DDW® 2016
Key clinical point: Compared with PPIs, H2RAs pose more risks – on both GI and cardiovascular fronts – as a preventive in patients with atherosclerosis and a history of peptic ulcer bleeding.
Major finding: After 48 weeks, 1.7% of patients in the pantoprazole (PPI) group (n = 60) suffered significant upper GI events; 13.3% of patients in the famotidine (H2RA) group (n = 60) did (P = 0.017). Cardiovascular events were also more common in the H2RA group.
Data source: Randomized prospective study of 120 patients with history of peptic ulcer bleeding (but not at initial endoscopy) assigned to pantoprazole (40 mg daily) or famotidine (40 mg daily) for 48 weeks.
Disclosures: The study is hospital funded. The authors report no disclosures.
Resident transitions increase inpatients’ risk of death
SAN FRANCISCO – Hospitalized patients who have a change in the medical residents responsible for their care are more likely to die, finds a retrospective cohort study of roughly a quarter million discharges from Veterans Affairs medical centers.
A monthly change in resident care was associated with 9%-20% higher adjusted odds of death during the hospital stay and after discharge, investigators reported in a poster discussion session and press briefing at an international conference of the American Thoracic Society. Analyses suggested that such transitions accounted for 718 additional deaths in the hospital alone during the 6-year study period.
“These are very strong findings,” said Dr. Joshua L. Denson, a fellow in the divisions of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.
The study results represent an important initial step in bringing the problem to light, he said. “Handoffs shift to shift have been looked at, but not this end-of-month, more permanent switching, which I think is a much more substantial transition in care.”
The factors driving the increased mortality are unclear, according to Dr. Denson; however, “when you go on to a new service [as a resident] ... you are now responsible for 20 new people all of a sudden that night.” Therefore, these transitions can be a hectic time characterized by reduced communication and inefficient discharges. In addition, the incoming residents lack familiarity with their new patients’ particulars.
“The handoffs are definitely not preventable, so this is something that has to be dealt with,” he maintained. The study’s findings hint at several possible areas for improvement.
None of the 10 residency programs surveyed provided formal education for monthly resident handoffs, focusing instead on handoffs at shift changes, and most programs lacked a standard procedure, with just one requiring that the handoff be done in person. The programs also varied greatly in their staggering of handoffs – separating transitions of interns (first-year residents) and higher-level residents by at least a few days – to minimize impact.
Despite the absence of outcomes data in this area, some hospitals are forging ahead with their own interventions intended to smooth care transitions, Dr. Denson reported. “In at least two hospitals that I’ve worked in, they are implementing what is called a warm handoff,” he explained. “Basically, a resident from the prior rotation comes the next day and rounds with the new team so he can tell them, ‘Oh, this guy looks a little worse today, you may want to watch him,’ or ‘He looks a little better.’ ”
In the study, conducted while Dr. Denson was chief resident at the NYU School of Medicine, he and his colleagues analyzed data from 10 university-affiliated Veterans Affairs hospitals and internal medicine residency programs that provided their residents’ schedules. Analyses were based on a total of 230,701 discharges of adult medical patients between July 2008 and June 2014.
Hospitalized patients were categorized as having a transition in resident care if they were admitted before the date of an end-of-month house staff transition in care and were discharged in the week after it.
In unadjusted analyses, patients who had a transition of care – whether of intern only, resident only, or both – had significantly higher odds of inpatient mortality and of 30-day mortality and 90-day postdischarge mortality, compared with counterparts who did not have the corresponding transition of care.
In adjusted analyses, patients who had an intern transition still had higher odds of in-hospital mortality (odds ratio, 1.14). In addition, patients had persistently elevated odds of 30-day mortality and 90-day postdischarge mortality if they had an intern transition (odds ratios, 1.20 and 1.17, respectively), a resident transition (1.15 and 1.14), or both (1.10 and 1.09).
The findings “suggest possibly a level-of-training effect to these transitions, as it’s the most inexperienced people that have the higher rate of mortality,” noted Dr. Denson, who disclosed that he had no relevant conflicts of interest. “Interns, being the first-years, tend to carry the bulk of the work in most hospitals, which is an interesting paradigm in our organization. And that may be a good explanation for why we are seeing this.”
SAN FRANCISCO – Hospitalized patients who have a change in the medical residents responsible for their care are more likely to die, finds a retrospective cohort study of roughly a quarter million discharges from Veterans Affairs medical centers.
A monthly change in resident care was associated with 9%-20% higher adjusted odds of death during the hospital stay and after discharge, investigators reported in a poster discussion session and press briefing at an international conference of the American Thoracic Society. Analyses suggested that such transitions accounted for 718 additional deaths in the hospital alone during the 6-year study period.
“These are very strong findings,” said Dr. Joshua L. Denson, a fellow in the divisions of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.
The study results represent an important initial step in bringing the problem to light, he said. “Handoffs shift to shift have been looked at, but not this end-of-month, more permanent switching, which I think is a much more substantial transition in care.”
The factors driving the increased mortality are unclear, according to Dr. Denson; however, “when you go on to a new service [as a resident] ... you are now responsible for 20 new people all of a sudden that night.” Therefore, these transitions can be a hectic time characterized by reduced communication and inefficient discharges. In addition, the incoming residents lack familiarity with their new patients’ particulars.
“The handoffs are definitely not preventable, so this is something that has to be dealt with,” he maintained. The study’s findings hint at several possible areas for improvement.
None of the 10 residency programs surveyed provided formal education for monthly resident handoffs, focusing instead on handoffs at shift changes, and most programs lacked a standard procedure, with just one requiring that the handoff be done in person. The programs also varied greatly in their staggering of handoffs – separating transitions of interns (first-year residents) and higher-level residents by at least a few days – to minimize impact.
Despite the absence of outcomes data in this area, some hospitals are forging ahead with their own interventions intended to smooth care transitions, Dr. Denson reported. “In at least two hospitals that I’ve worked in, they are implementing what is called a warm handoff,” he explained. “Basically, a resident from the prior rotation comes the next day and rounds with the new team so he can tell them, ‘Oh, this guy looks a little worse today, you may want to watch him,’ or ‘He looks a little better.’ ”
In the study, conducted while Dr. Denson was chief resident at the NYU School of Medicine, he and his colleagues analyzed data from 10 university-affiliated Veterans Affairs hospitals and internal medicine residency programs that provided their residents’ schedules. Analyses were based on a total of 230,701 discharges of adult medical patients between July 2008 and June 2014.
Hospitalized patients were categorized as having a transition in resident care if they were admitted before the date of an end-of-month house staff transition in care and were discharged in the week after it.
In unadjusted analyses, patients who had a transition of care – whether of intern only, resident only, or both – had significantly higher odds of inpatient mortality and of 30-day mortality and 90-day postdischarge mortality, compared with counterparts who did not have the corresponding transition of care.
In adjusted analyses, patients who had an intern transition still had higher odds of in-hospital mortality (odds ratio, 1.14). In addition, patients had persistently elevated odds of 30-day mortality and 90-day postdischarge mortality if they had an intern transition (odds ratios, 1.20 and 1.17, respectively), a resident transition (1.15 and 1.14), or both (1.10 and 1.09).
The findings “suggest possibly a level-of-training effect to these transitions, as it’s the most inexperienced people that have the higher rate of mortality,” noted Dr. Denson, who disclosed that he had no relevant conflicts of interest. “Interns, being the first-years, tend to carry the bulk of the work in most hospitals, which is an interesting paradigm in our organization. And that may be a good explanation for why we are seeing this.”
SAN FRANCISCO – Hospitalized patients who have a change in the medical residents responsible for their care are more likely to die, finds a retrospective cohort study of roughly a quarter million discharges from Veterans Affairs medical centers.
A monthly change in resident care was associated with 9%-20% higher adjusted odds of death during the hospital stay and after discharge, investigators reported in a poster discussion session and press briefing at an international conference of the American Thoracic Society. Analyses suggested that such transitions accounted for 718 additional deaths in the hospital alone during the 6-year study period.
“These are very strong findings,” said Dr. Joshua L. Denson, a fellow in the divisions of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.
The study results represent an important initial step in bringing the problem to light, he said. “Handoffs shift to shift have been looked at, but not this end-of-month, more permanent switching, which I think is a much more substantial transition in care.”
The factors driving the increased mortality are unclear, according to Dr. Denson; however, “when you go on to a new service [as a resident] ... you are now responsible for 20 new people all of a sudden that night.” Therefore, these transitions can be a hectic time characterized by reduced communication and inefficient discharges. In addition, the incoming residents lack familiarity with their new patients’ particulars.
“The handoffs are definitely not preventable, so this is something that has to be dealt with,” he maintained. The study’s findings hint at several possible areas for improvement.
None of the 10 residency programs surveyed provided formal education for monthly resident handoffs, focusing instead on handoffs at shift changes, and most programs lacked a standard procedure, with just one requiring that the handoff be done in person. The programs also varied greatly in their staggering of handoffs – separating transitions of interns (first-year residents) and higher-level residents by at least a few days – to minimize impact.
Despite the absence of outcomes data in this area, some hospitals are forging ahead with their own interventions intended to smooth care transitions, Dr. Denson reported. “In at least two hospitals that I’ve worked in, they are implementing what is called a warm handoff,” he explained. “Basically, a resident from the prior rotation comes the next day and rounds with the new team so he can tell them, ‘Oh, this guy looks a little worse today, you may want to watch him,’ or ‘He looks a little better.’ ”
In the study, conducted while Dr. Denson was chief resident at the NYU School of Medicine, he and his colleagues analyzed data from 10 university-affiliated Veterans Affairs hospitals and internal medicine residency programs that provided their residents’ schedules. Analyses were based on a total of 230,701 discharges of adult medical patients between July 2008 and June 2014.
Hospitalized patients were categorized as having a transition in resident care if they were admitted before the date of an end-of-month house staff transition in care and were discharged in the week after it.
In unadjusted analyses, patients who had a transition of care – whether of intern only, resident only, or both – had significantly higher odds of inpatient mortality and of 30-day mortality and 90-day postdischarge mortality, compared with counterparts who did not have the corresponding transition of care.
In adjusted analyses, patients who had an intern transition still had higher odds of in-hospital mortality (odds ratio, 1.14). In addition, patients had persistently elevated odds of 30-day mortality and 90-day postdischarge mortality if they had an intern transition (odds ratios, 1.20 and 1.17, respectively), a resident transition (1.15 and 1.14), or both (1.10 and 1.09).
The findings “suggest possibly a level-of-training effect to these transitions, as it’s the most inexperienced people that have the higher rate of mortality,” noted Dr. Denson, who disclosed that he had no relevant conflicts of interest. “Interns, being the first-years, tend to carry the bulk of the work in most hospitals, which is an interesting paradigm in our organization. And that may be a good explanation for why we are seeing this.”
AT ATS 2016
Key clinical point: The risk of death for hospitalized patients rises when their care is handed off from one resident to another.
Major finding: Patients who had a resident transition in care during their stay had 9%-20% higher adjusted odds of death.
Data source: A multicenter retrospective cohort study of 230,701 discharges of adult medical patients from Veterans Affairs medical centers.
Disclosures: Dr. Denson disclosed that he had no relevant conflicts of interest.
Rising expenses for hospital stays pressure patients
Total patient out-of-pocket cost sharing – per inpatient hospitalization – is on the rise, driven by a number of insurance benefit design changes in recent years, according to a new study.
Researchers at the University of Michigan, Ann Arbor, performed a retrospective analysis of medical claims for 7.3 million hospitalizations using data from Aetna, UnitedHealthcare and Humana, and found that between 2009 and 2013, total cost sharing per inpatient hospitalization for patients aged 18-64 years increased by 37% – to $1,013 in 2013 from $738 in 2009 – after adjusting for inflation and case-mix differences.
“We found that the growth in cost sharing was driven primarily by increases in the amount applied to patients’ deductibles, which rose by 86%, and by increases in coinsurance, which grew by 33% during the study period, rather than by copayments,” wrote Emily Adrion, Ph.D., of the University of Michigan, Ann Arbor, and colleagues in a study published online in JAMA Internal Medicine (JAMA Intern Med. 2016 Jun 27. doi:10.1001/jamainternmed.2016.3663).
“Our findings indicate a trend toward fewer plans requiring copayments at the point of service and more plans requiring higher coinsurance and deductibles after care is delivered,” the authors said.
The investigators called these trends “notable,” as research cited in the article suggests “that most Americans lack a basic understanding of the different forms of cost sharing associated with medical care.”
Dr. Adrion and colleagues also point out a large part of the variation in cost sharing for inpatient hospitalizations is driven by the type of insurance product. Those enrolled in individual market and consumer-directed health plans were associated with significantly higher cost sharing for inpatient hospitalizations during the study period.
“Increasing cost sharing may also reflect a recent elevation in insurer and provider consolidation, which may limit competition and increase costs for beneficiaries,” the authors noted, adding that future research should “assess the market dynamics” underlying patient cost sharing.
“With an estimated 85% of all commercial health insurance benefit packages requiring coinsurance for inpatient hospitalizations in addition to meeting an annual deductible, cost sharing for inpatient hospitalization remains an important, if often overlooked, area for policy reform,” Dr. Adrion and colleagues concluded.
The report’s authors claimed no financial conflicts of interest.
As plans begin requiring more and more cost sharing, the role of insurance moves further away from what it is designed to do.
“Even our language suggests that we have forgotten that the core purpose of health insurance is to protect people when an unexpected problem develops,” Dr. Mitchell Katz said in an editor’s note published June 27 online in JAMA Internal Medicine. “When we speak of coinsurance, we mean the portion of the bill that the person has to pay: there is no ‘coinsurer.’ ”
Dr. Katz is advocating for no out-of-pocket expenses for unavoidable emergency hospitalizations.
“To require consumers to pay large amounts of out-of-pocket expenses for health care may lead to delay or foregoing of needed care or to financial ruin, the latter of which insurance is supposed to protect you against,” Dr. Katz wrote. “There are no easy answers for how to deal with the rising cost of medical care, but increasing out-of-pocket spending for unavoidable, necessary care is counter to the goals of a health insurance system.”
Dr. Mitchell Katz of Los Angeles is deputy editor of JAMA Internal Medicine. The comments above were adapted from his Editor’s Note accompanying the study. He reported no conflicts of interest.
As plans begin requiring more and more cost sharing, the role of insurance moves further away from what it is designed to do.
“Even our language suggests that we have forgotten that the core purpose of health insurance is to protect people when an unexpected problem develops,” Dr. Mitchell Katz said in an editor’s note published June 27 online in JAMA Internal Medicine. “When we speak of coinsurance, we mean the portion of the bill that the person has to pay: there is no ‘coinsurer.’ ”
Dr. Katz is advocating for no out-of-pocket expenses for unavoidable emergency hospitalizations.
“To require consumers to pay large amounts of out-of-pocket expenses for health care may lead to delay or foregoing of needed care or to financial ruin, the latter of which insurance is supposed to protect you against,” Dr. Katz wrote. “There are no easy answers for how to deal with the rising cost of medical care, but increasing out-of-pocket spending for unavoidable, necessary care is counter to the goals of a health insurance system.”
Dr. Mitchell Katz of Los Angeles is deputy editor of JAMA Internal Medicine. The comments above were adapted from his Editor’s Note accompanying the study. He reported no conflicts of interest.
As plans begin requiring more and more cost sharing, the role of insurance moves further away from what it is designed to do.
“Even our language suggests that we have forgotten that the core purpose of health insurance is to protect people when an unexpected problem develops,” Dr. Mitchell Katz said in an editor’s note published June 27 online in JAMA Internal Medicine. “When we speak of coinsurance, we mean the portion of the bill that the person has to pay: there is no ‘coinsurer.’ ”
Dr. Katz is advocating for no out-of-pocket expenses for unavoidable emergency hospitalizations.
“To require consumers to pay large amounts of out-of-pocket expenses for health care may lead to delay or foregoing of needed care or to financial ruin, the latter of which insurance is supposed to protect you against,” Dr. Katz wrote. “There are no easy answers for how to deal with the rising cost of medical care, but increasing out-of-pocket spending for unavoidable, necessary care is counter to the goals of a health insurance system.”
Dr. Mitchell Katz of Los Angeles is deputy editor of JAMA Internal Medicine. The comments above were adapted from his Editor’s Note accompanying the study. He reported no conflicts of interest.
Total patient out-of-pocket cost sharing – per inpatient hospitalization – is on the rise, driven by a number of insurance benefit design changes in recent years, according to a new study.
Researchers at the University of Michigan, Ann Arbor, performed a retrospective analysis of medical claims for 7.3 million hospitalizations using data from Aetna, UnitedHealthcare and Humana, and found that between 2009 and 2013, total cost sharing per inpatient hospitalization for patients aged 18-64 years increased by 37% – to $1,013 in 2013 from $738 in 2009 – after adjusting for inflation and case-mix differences.
“We found that the growth in cost sharing was driven primarily by increases in the amount applied to patients’ deductibles, which rose by 86%, and by increases in coinsurance, which grew by 33% during the study period, rather than by copayments,” wrote Emily Adrion, Ph.D., of the University of Michigan, Ann Arbor, and colleagues in a study published online in JAMA Internal Medicine (JAMA Intern Med. 2016 Jun 27. doi:10.1001/jamainternmed.2016.3663).
“Our findings indicate a trend toward fewer plans requiring copayments at the point of service and more plans requiring higher coinsurance and deductibles after care is delivered,” the authors said.
The investigators called these trends “notable,” as research cited in the article suggests “that most Americans lack a basic understanding of the different forms of cost sharing associated with medical care.”
Dr. Adrion and colleagues also point out a large part of the variation in cost sharing for inpatient hospitalizations is driven by the type of insurance product. Those enrolled in individual market and consumer-directed health plans were associated with significantly higher cost sharing for inpatient hospitalizations during the study period.
“Increasing cost sharing may also reflect a recent elevation in insurer and provider consolidation, which may limit competition and increase costs for beneficiaries,” the authors noted, adding that future research should “assess the market dynamics” underlying patient cost sharing.
“With an estimated 85% of all commercial health insurance benefit packages requiring coinsurance for inpatient hospitalizations in addition to meeting an annual deductible, cost sharing for inpatient hospitalization remains an important, if often overlooked, area for policy reform,” Dr. Adrion and colleagues concluded.
The report’s authors claimed no financial conflicts of interest.
Total patient out-of-pocket cost sharing – per inpatient hospitalization – is on the rise, driven by a number of insurance benefit design changes in recent years, according to a new study.
Researchers at the University of Michigan, Ann Arbor, performed a retrospective analysis of medical claims for 7.3 million hospitalizations using data from Aetna, UnitedHealthcare and Humana, and found that between 2009 and 2013, total cost sharing per inpatient hospitalization for patients aged 18-64 years increased by 37% – to $1,013 in 2013 from $738 in 2009 – after adjusting for inflation and case-mix differences.
“We found that the growth in cost sharing was driven primarily by increases in the amount applied to patients’ deductibles, which rose by 86%, and by increases in coinsurance, which grew by 33% during the study period, rather than by copayments,” wrote Emily Adrion, Ph.D., of the University of Michigan, Ann Arbor, and colleagues in a study published online in JAMA Internal Medicine (JAMA Intern Med. 2016 Jun 27. doi:10.1001/jamainternmed.2016.3663).
“Our findings indicate a trend toward fewer plans requiring copayments at the point of service and more plans requiring higher coinsurance and deductibles after care is delivered,” the authors said.
The investigators called these trends “notable,” as research cited in the article suggests “that most Americans lack a basic understanding of the different forms of cost sharing associated with medical care.”
Dr. Adrion and colleagues also point out a large part of the variation in cost sharing for inpatient hospitalizations is driven by the type of insurance product. Those enrolled in individual market and consumer-directed health plans were associated with significantly higher cost sharing for inpatient hospitalizations during the study period.
“Increasing cost sharing may also reflect a recent elevation in insurer and provider consolidation, which may limit competition and increase costs for beneficiaries,” the authors noted, adding that future research should “assess the market dynamics” underlying patient cost sharing.
“With an estimated 85% of all commercial health insurance benefit packages requiring coinsurance for inpatient hospitalizations in addition to meeting an annual deductible, cost sharing for inpatient hospitalization remains an important, if often overlooked, area for policy reform,” Dr. Adrion and colleagues concluded.
The report’s authors claimed no financial conflicts of interest.
FROM JAMA INTERNAL MEDICINE
Supreme Court deadlocks on immigration policy case
Supreme Court justices have deadlocked on whether protections for undocumented immigrants can be expanded under an executive order by the President.
In a June 23 decision, justices were equally divided on the constitutionality of two of President Obama’s immigration policies: the Deferred Action for Parents of Americans and Lawful Permanent Residents (DAPA) and an expanded version of the Deferred Action for Childhood Arrivals (DACA). The former protects undocumented immigrants who are parents of U.S. citizens from deportation, if they meet certain criteria. The second extends work authorization under the original DACA program from 2 years to 3 years and broadens age requirements.
The 4-to-4 split decision in Texas v. United States mean the policies remain blocked by the lower court, and the expanded programs will not go forward anytime soon. The decision does not affect original DACA, which protects from deportation undocumented immigrants brought to the United States as children and offers access to work authorization.
President Obama expressed disappointment at the lack of agreement, saying the tie vote underscores the need for nine justices on the court.
“As disappointing as it was to be challenged for taking the kind of action that other administrations have taken, the country was looking to the Supreme Court to resolve the important legal questions raised in this case,” President Obama said during a June 23 press conference. “Today, the Supreme Court was unable to reach a decision ... it means the expanded set of common sense deferred action policies that I announced 2 years ago cannot go forward at this stage until there is a ninth justice on the court to break the tie.”
Texas Attorney General Ken Paxton was satisfied with the decision, calling it a victory for the state plaintiffs.
“Today’s decision keeps in place what we have maintained from the very start: one person, even a president, cannot unilaterally change the law,” Mr. Paxton said in a statement. “This is a major setback to President Obama’s attempts to expand executive power, and a victory for those who believe in the separation of powers and the rule of law.”
Texas was 1 of 26 states that sued over DAPA and expanded DACA. The states argued the president does not have the authority to issue the new immigration policies, and that the programs violate the Constitution as well as the Administrative Procedure Act for notice-and-comment rule making. Justices heard oral arguments April 18.
Immigration advocates were worried that if expanded DACA were struck down, a similar fate would follow for the original DACA policy. As it stands, undocumented immigrants who benefit from deportation protection and work authorization under original DACA, including undocumented medical students, will not be affected by the Supreme Court decision.
Marielena Hincapié, executive director for the National Immigration Law Center, vowed to continue fighting for the policies to take effect.
“Immigrants and allies fought for and won these significant policy victories, which would have brought much-needed emotional and economic stability to millions of our community members, and we will not sit back,” she said in a statement. “We urge the Department of Justice to seek a rehearing for when a ninth justice is confirmed for the Supreme Court.”
Federation for American Immigration Reform President Dan Stein said the split decision upholds the rule of law and helps preserve the balance of power in the United States.
“By ruling in favor of the federal court’s injunction, half of the nation’s Supreme Court Justices have shown that they have deep concerns about this president’s attempt at a power grab by his efforts to amend federal laws from the Oval Office,” Mr. Stein said in a statement.
Texas v. United States will be sent back to U.S. District Court Judge Andrew Hanen in Texas who will hear the case on its merits. The case could wind its way back to the U.S. Supreme Court for a rehearing after a ninth justice is confirmed.
On Twitter @legal_med
Supreme Court justices have deadlocked on whether protections for undocumented immigrants can be expanded under an executive order by the President.
In a June 23 decision, justices were equally divided on the constitutionality of two of President Obama’s immigration policies: the Deferred Action for Parents of Americans and Lawful Permanent Residents (DAPA) and an expanded version of the Deferred Action for Childhood Arrivals (DACA). The former protects undocumented immigrants who are parents of U.S. citizens from deportation, if they meet certain criteria. The second extends work authorization under the original DACA program from 2 years to 3 years and broadens age requirements.
The 4-to-4 split decision in Texas v. United States mean the policies remain blocked by the lower court, and the expanded programs will not go forward anytime soon. The decision does not affect original DACA, which protects from deportation undocumented immigrants brought to the United States as children and offers access to work authorization.
President Obama expressed disappointment at the lack of agreement, saying the tie vote underscores the need for nine justices on the court.
“As disappointing as it was to be challenged for taking the kind of action that other administrations have taken, the country was looking to the Supreme Court to resolve the important legal questions raised in this case,” President Obama said during a June 23 press conference. “Today, the Supreme Court was unable to reach a decision ... it means the expanded set of common sense deferred action policies that I announced 2 years ago cannot go forward at this stage until there is a ninth justice on the court to break the tie.”
Texas Attorney General Ken Paxton was satisfied with the decision, calling it a victory for the state plaintiffs.
“Today’s decision keeps in place what we have maintained from the very start: one person, even a president, cannot unilaterally change the law,” Mr. Paxton said in a statement. “This is a major setback to President Obama’s attempts to expand executive power, and a victory for those who believe in the separation of powers and the rule of law.”
Texas was 1 of 26 states that sued over DAPA and expanded DACA. The states argued the president does not have the authority to issue the new immigration policies, and that the programs violate the Constitution as well as the Administrative Procedure Act for notice-and-comment rule making. Justices heard oral arguments April 18.
Immigration advocates were worried that if expanded DACA were struck down, a similar fate would follow for the original DACA policy. As it stands, undocumented immigrants who benefit from deportation protection and work authorization under original DACA, including undocumented medical students, will not be affected by the Supreme Court decision.
Marielena Hincapié, executive director for the National Immigration Law Center, vowed to continue fighting for the policies to take effect.
“Immigrants and allies fought for and won these significant policy victories, which would have brought much-needed emotional and economic stability to millions of our community members, and we will not sit back,” she said in a statement. “We urge the Department of Justice to seek a rehearing for when a ninth justice is confirmed for the Supreme Court.”
Federation for American Immigration Reform President Dan Stein said the split decision upholds the rule of law and helps preserve the balance of power in the United States.
“By ruling in favor of the federal court’s injunction, half of the nation’s Supreme Court Justices have shown that they have deep concerns about this president’s attempt at a power grab by his efforts to amend federal laws from the Oval Office,” Mr. Stein said in a statement.
Texas v. United States will be sent back to U.S. District Court Judge Andrew Hanen in Texas who will hear the case on its merits. The case could wind its way back to the U.S. Supreme Court for a rehearing after a ninth justice is confirmed.
On Twitter @legal_med
Supreme Court justices have deadlocked on whether protections for undocumented immigrants can be expanded under an executive order by the President.
In a June 23 decision, justices were equally divided on the constitutionality of two of President Obama’s immigration policies: the Deferred Action for Parents of Americans and Lawful Permanent Residents (DAPA) and an expanded version of the Deferred Action for Childhood Arrivals (DACA). The former protects undocumented immigrants who are parents of U.S. citizens from deportation, if they meet certain criteria. The second extends work authorization under the original DACA program from 2 years to 3 years and broadens age requirements.
The 4-to-4 split decision in Texas v. United States mean the policies remain blocked by the lower court, and the expanded programs will not go forward anytime soon. The decision does not affect original DACA, which protects from deportation undocumented immigrants brought to the United States as children and offers access to work authorization.
President Obama expressed disappointment at the lack of agreement, saying the tie vote underscores the need for nine justices on the court.
“As disappointing as it was to be challenged for taking the kind of action that other administrations have taken, the country was looking to the Supreme Court to resolve the important legal questions raised in this case,” President Obama said during a June 23 press conference. “Today, the Supreme Court was unable to reach a decision ... it means the expanded set of common sense deferred action policies that I announced 2 years ago cannot go forward at this stage until there is a ninth justice on the court to break the tie.”
Texas Attorney General Ken Paxton was satisfied with the decision, calling it a victory for the state plaintiffs.
“Today’s decision keeps in place what we have maintained from the very start: one person, even a president, cannot unilaterally change the law,” Mr. Paxton said in a statement. “This is a major setback to President Obama’s attempts to expand executive power, and a victory for those who believe in the separation of powers and the rule of law.”
Texas was 1 of 26 states that sued over DAPA and expanded DACA. The states argued the president does not have the authority to issue the new immigration policies, and that the programs violate the Constitution as well as the Administrative Procedure Act for notice-and-comment rule making. Justices heard oral arguments April 18.
Immigration advocates were worried that if expanded DACA were struck down, a similar fate would follow for the original DACA policy. As it stands, undocumented immigrants who benefit from deportation protection and work authorization under original DACA, including undocumented medical students, will not be affected by the Supreme Court decision.
Marielena Hincapié, executive director for the National Immigration Law Center, vowed to continue fighting for the policies to take effect.
“Immigrants and allies fought for and won these significant policy victories, which would have brought much-needed emotional and economic stability to millions of our community members, and we will not sit back,” she said in a statement. “We urge the Department of Justice to seek a rehearing for when a ninth justice is confirmed for the Supreme Court.”
Federation for American Immigration Reform President Dan Stein said the split decision upholds the rule of law and helps preserve the balance of power in the United States.
“By ruling in favor of the federal court’s injunction, half of the nation’s Supreme Court Justices have shown that they have deep concerns about this president’s attempt at a power grab by his efforts to amend federal laws from the Oval Office,” Mr. Stein said in a statement.
Texas v. United States will be sent back to U.S. District Court Judge Andrew Hanen in Texas who will hear the case on its merits. The case could wind its way back to the U.S. Supreme Court for a rehearing after a ninth justice is confirmed.
On Twitter @legal_med
Elusive evidence pervades ESC’s 2016 heart failure guidelines
FLORENCE, ITALY – The 2016 revision of the European Society of Cardiology’s guidelines for diagnosing and treating acute and chronic heart failure highlights the extent to which thinking in the field has changed during the past 4 years, since the prior edition in 2012.
The new European guidelines, unveiled by the ESC’s Heart Failure Association during the group’s annual meeting, also underscore the great dependence that many new approaches have on expert opinion rather than what’s become the keystone of guidelines writing, evidence-based medicine. Frequent reliance on consensus decisions rather than indisputable proof from controlled trials defines what some U.S. specialists see as a divide as wide as the Atlantic between the European and U.S. approaches to guideline writing.
“The guidelines from the ESC are articulated very well; they made their recommendations very clear. But a lot is consensus driven, without new data,” said Dr. Mariell L. Jessup, who serves as both vice chair of the panel currently revising the U.S. heart failure guidelines – expected out later in 2016 – and was also the sole American representative on the panel that produced the ESC guidelines. “The ESC guidelines make clear all the things that need to happen to patients. I hope it will result in better patient care. We are clearly not doing a good job in heart failure. We not only don’t have evidence-based treatments, but people often don’t do a good job [caring for heart failure patients] and they die in the hospital all the time.”
Dr. Javed Butler, another member of the U.S. guidelines panel and professor and chief of cardiology at Stony Brook (N.Y.) University, called the U.S. and European divide a “philosophical perspective of evidence-based medicine.
“U.S. physicians should read the ESC guidelines and make up their own minds. The ESC guidelines are excellent and give you perspective. But U.S. regulatory and payment issues will be driven by U.S. guidelines,” Dr. Butler said in an interview.
But despite their limitations and the limited weight that the ESC guidelines carry for U.S. practice, they have many redeeming features, noted Dr. Mandeep R. Mehra, medical director of the Heart and Vascular Center at Brigham and Women’s Hospital in Boston. The 2016 ESC guidelines “are extraordinarily clear, very practical, and very concise. They are very usable, and provide a fantastic algorithm for managing patients with heart failure with reduced ejection fraction [HFrEF],” he said while discussing the guidelines during the meeting.
U.S. and Europe largely agree on sacubitril/valsartan and ivabradine
Clearly the greatest area of U.S. and European agreement was in the adoption by both guidelines groups of sacubitril/valsartan (Entresto) and ivabradine (Corlanor) as important new components of the basic drug formula for treating patients with HFrEF. In fact, the U.S. guideline writers saw these two additions as so important and timely that they issued a “focused update” in May to the existing, 2013 U.S. heart failure guidelines, and timed release of this update to occur on May 20, 2016, a day before release of the ESC guidelines. But as Dr. Butler noted, this was more of a temporal harmonization than a substantive one, because even here, in a very evidence-based change, the U.S. guidelines for using sacubitril/valsartan differed subtly but importantly from the ESC version.
The U.S. focused update says that treatment of patients with stage C (symptomatic heart failure with structural heart disease) HFrEF should receive treatment with sacubitril/valsartan (also know as an angiotensin receptor neprilysin inhibitor, or ARNI), an ACE inhibitor, or an angiotensin receptor blocker (ARB), as well as evidence-based treatment with a beta-blocker and with a mineralocorticoid receptor antagonist (MRA). A subsequent recommendation in the U.S. focused update said that HFrEF patients with chronic symptoms and New York Heart Association class II or III disease should switch from a stable, tolerated regimen with either an ACE inhibitor or ARB to treatment with sacubitril/valsartan.
In contrast, the new European guideline for sacubitril/valsartan recommends starting patients on this combination formulation only after first demonstrating that patients tolerated treatment with an ACE inhibitor or ARB for at least 30 days and determining that patients remained symptomatic while on one of these treatments. In short, the U.S. guideline gives a green light to starting patients with newly diagnosed, symptomatic HFrEF on sacubitril/valsartan immediately, while the European guideline only sanctions sacubitril/valsartan to start after a patient has spent at least 30 days settling into a multidrug regimen featuring an ACE inhibitor or an ARB when an ACE inhibitor isn’t well tolerated.
“The European guidelines are closely related to the study population enrolled in the PARADIGM-HF trial,” the pivotal trial that showed superiority of sacubitril/valsartan to an ACE inhibitor (N Engl J Med. 2014;371:993-1004), noted Dr. Butler in an interview. “The U.S. guidelines interpreted [the PARADIGM-HF] results in the best interests of a larger patient population. The European guidelines are far more proscriptive in replicating the clinical criteria of the trial. In some patients the sequence of starting a MRA and sacubitril/valsartan matters, but in other patients it is less important.”
Dr. Frank Ruschitzka, a coauthor of the ESC guidelines, said that the reason for the more cautious ESC approach was lack of widespread familiarity with sacubitril/valsartan treatment among cardiologists.
The ESC guidelines on using sacubitril/valsartan “replicated the PARADIGM-HF trial. We have no data right now that it is justifiable to put a [treatment-naive] patient on sacubitril/valsartan to begin with. Another difference between the U.S. and ESC guidelines is when to start a MRA,” said Dr. Ruschitzka, professor and head of cardiology at the Heart Center of the University Hospital in Zurich. “It makes a lot of sense to me to start sacubitril/valsartan early. The PARADIGM trial was positive, but no one has a feel for how to use sacubitril/valsartan. Should we give it to everyone? We said replicate the trial, and gain experience using the drug. We want to bring a life-saving drug to patients, but this is the approach we took. We need more data.”
Dr. Jessup noted that a lot of uncertainty also exists among U.S. clinicians about when to start sacubitril/valsartan. “It’s not been clear which patients to put on sacubitril/valsartan. No guidelines had been out on using it” until mid-May, and “the cost of sacubitril/valsartan is daunting. I have received calls from many people who ask whom am I supposed to use sacubitril/valsartan on? It took years and years to get people to [routinely] start patients on an ACE inhibitor and a beta-blocker, and now we’re telling them to do something else. In my practice it’s a 30-minute conversation with each patient that you need to first stop your ACE inhibitor, and then they often get denied coverage by their insurer,” said Dr. Jessup, professor of medicine at the University of Pennsylvania in Philadelphia. She expressed hope that coverage issues will diminish now that clear guidelines are out endorsing a key role for sacubitril/valsartan.
“We now all have started sacubitril/valsartan on patients” without first starting them on an ACE inhibitor, “but we all need to get a sense of what we can get away with” when using this drug, noted Dr. JoAnn Lindenfeld, professor and director of heart failure and transplant at Vanderbilt University in Nashville.
At least one European cardiologist was skeptical of just how proscriptive the ESC guideline for sacubitril/valsartan will be in actual practice.
“The best treatment [for symptomatic HFrEF] is sacubitril/valsartan, a beta-blocker, and a MRA,” said Dr. John J.V. McMurray, professor of cardiology at Glasgow University and lead investigator for the PARADIGM-HF pivotal trial for sacubitril/valsartan. “The treatment sequence advocated in the guidelines – treat with an ACE inhibitor first and if patients remain symptomatic change to sacubitril/valsartan – is evidence-based medicine. As a guidelines writer and as a promoter of evidence-based medicine, this is absolutely the correct approach. But as a practicing physician I’d go straight for sacubitril/valsartan. Otherwise you’re wasting everybody’s time starting with an ACE inhibitor and then waiting a month to switch,” Dr. McMurray said in an interview.
“It’s pointless to wait. We saw results within 30 days of starting sacubitril/valsartan, so it’s a theoretical risk to wait. Very few patients will become completely asymptomatic on an ACE inhibitor. Everyone who entered PARADIGM-HF was at New York Heart Association class II or higher, and at the time of randomization only a handful of patients were in New York Heart Association class I. Very few patients get to class I. That tells you it’s pretty uncommon for a heart failure patient to become truly asymptomatic with ACE inhibitor treatment. The main problem is that you are inconveniencing everybody with more blood tests and more clinic visits by waiting to start sacubitril/valsartan, said Dr. McMurray, who was not a member of the panel that wrote the new ESC guidelines.
Even less separates the new U.S. focused update and the ESC guidelines for using ivabradine. Both agree on starting the drug on HFrEF patients who remain symptomatic and with a left ventricular ejection fraction of 35% or less despite being on guideline-directed therapy including titration to a maximum beta-blocker dosage and with a persistent heart rate of at least 70 beats/min. The goal of ivabradine treatment is to further reduce heart rate beyond what’s achieved by a maximal beta-blocker dosage.
Perhaps the biggest questions about ivabradine have been why it took so long to enter the U.S. guidelines, and why it is listed in both the U.S. and ESC guidelines as a level II recommendation. Results from the pivotal trial that supported ivabradine’s use in HFrEF patients, SHIFT, first appeared in 2010 (Lancet. 2010 Sep 11;376[9744]:875-95).
Dr. Butler chalked up the drug’s slow entry into U.S. guidelines as the result of a lack of initiative by ivabradine’s initial developer, Servier. “SHIFT did not have any U.S. sites, and Servier never sought Food and Drug Administration approval,” he noted. “Amgen acquired the U.S. rights to ivabradine in 2013,” and the drug received FDA approval in April 2015, Dr. Butler noted, in explaining the drug’s U.S. timeline. As to why its use is a level II recommendation, he noted that the evidence for efficacy came only from the SHIFT trial, questions exist whether the beta-blocker dosages were fully optimized in all patients in this trial, and the benefit was limited to a reduction in heart failure hospitalizations but not in mortality. “I think that patients with persistent heart failure symptoms [and a persistently elevated heart rate] should get ivabradine,” but these caveats limit it to a class II level recommendation, Dr. Butler said.
“There were questions about ivabradine’s benefit in reducing heart failure hospitalization but not mortality, and questions about whether it would benefit patients if their beta-blocker dosage was adequately up titrated. There were also questions about which heart failure patients to use it on,” noted Dr. Lindenfeld, a member of the panel that wrote the U.S. focused update. These concerns in part help explain the delay to integrating ivabradine into U.S. practice guidelines, she said in an interview, but added that additional data and analysis published during the past 3 or so years have clarified ivabradine’s potentially useful role in treating selected HFrEF patients.
New ESC guidelines based on expert opinion
The sections on sacubitril/valsartan and ivabradine occupy a mere 2 pages among more than 55 pages of text and charts that spell out the ESC’s current vision of how physicians should diagnose and manage heart failure patients. While much of what carried over from prior editions of the guidelines is rooted in evidence, many of the new approaches advocated rely on expert opinion or new interpretations of existing data. Here are some of the notable changes and highlights of the 2016 ESC recommendations:
• Heart failure diagnosis. The new ESC guidelines streamline the diagnostic process, which now focuses on five key elements: The patient’s history, physical examination, ECG, serum level of either brain natriuretic peptide (BNP) or N-terminal(NT)-proBNP, and echocardiography. The guidelines specify threshold levels of BNP and NT-proBNP that can effectively rule out heart failure, a BNP level of at least 35 pg/mL or a NT-proBNP level of at least 125 pg/mL.
“The diagnostic minimum levels of BNP and NT-proBNP were designed to rule out heart failure. They both have a high negative predictive value, but at these levels their positive predictive value is low,” explained Dr. Adriaan A. Voors, cochair of the ESC’s guideline-writing panel and professor of cardiology at the University of Groningen, the Netherlands.
But while these levels might be effective for reliable rule out of heart failure, they could mean a large number of patients would qualify for an echocardiographic assessment.
“If we used the ESC’s natriuretic peptide cutoffs, there would be a clear concern about overuse of echo. It’s a cost-effectiveness issue. You wind up doing a lot of echos that will be normal. Echocardiography is very safe, but each echo costs about $400-$500,” commented Dr. Butler.
“The results from the STOP-HF and PONTIAC studies showed that BNP levels can identify people at increased risk for developing heart failure who need more intensive assessment and could also potentially benefit from more attention to heart failure prevention. I suspect the full U.S. guideline update will address this issue, but we have not yet finalized our decisions,” he added.
• Heart failure classification. The new ESC guidelines created a new heart failure category, midrange ejection fraction, that the writing panel positioned squarely between the two more classic heart failure subgroups, HFrEF and heart failure with preserved ejection fraction (HFpEF). The definition of each of the three subgroups depends on left ventricular ejection fraction as determined by echocardiography: A LVEF of less than 40% defined HFrEF, a LVEF of 40%-49% defined heart failure with midrange ejection fraction (HFmrEF), and a LVEF of 50% or higher defined HFpEF. Diagnostic confirmation of both HFmrEF and HFpEF also requires that patients fulfill certain criteria of structural or functional heart abnormalities.
The category of HFmrEF was created “to stimulate research into how to best manage these patients,” explained Dr. Piotr Ponikowski, chair of the ESC guidelines writing panel. For the time being, it remains a category with only theoretical importance as nothing is known to suggest that management of patients with HFmrEF should in any way differ from patients with HFpEF.
• Acute heart failure. Perhaps the most revolutionary element of the new guidelines is the detailed map they provide to managing patients who present with acute decompensated heart failure and the underlying principles cited to justify this radically different approach.
“The acute heart failure section was completely rewritten,” noted Dr. Ponikowski, professor of heart diseases at the Medical University in Wroclaw, Poland. “We don’t yet have evidence-based treatments” to apply to acute heart failure patients, he admitted, “however we strongly recommend the concept that the shorter the better. Shorten the time of diagnosis and for therapeutic decisions. We have borrowed from acute coronary syndrome. Don’t keep patients in the emergency department for another couple of hours just to see if they will respond. We must be aware that we need to do our best to shorten diagnosis and treatment decisions. Time is an issue. Manage a patient’s congestion and impaired peripheral perfusion within a time frame of 1-2 hours.”
The concept that acute heart failure must be quickly managed as an emergency condition similar to acute coronary syndrome first appeared as a European practice recommendation in 2015, a consensus statement from the European Heart Failure Association and two other collaborating organizations (Eur Heart J. 2015 Aug 7;36[30]:1958-66).
“In 2015, the consensus paper talked about how to handle acute heart failure patients in the emergency department. Now, we have focused on defining the patients’ phenotype and how to categorize their treatment options. We built on the 2015 statement, but the algorithms we now have are original to 2016; they were not in the 2015 paper,” said Dr. Veli-Pekka Harjola, a member of the 2015 consensus group and 2016 guidelines panel who spearheaded writing the acute heart failure section of the new ESC guidelines.
An additional new and notable feature of this section in the 2016 guidelines is its creation of an acronym, CHAMP, designed to guide the management of patients with acute heart failure. CHAMP stands for acute Coronary syndrome, Hypertension emergency, Arrhythmia, acute Mechanical cause, and Pulmonary embolism. The CHAMP acronym’s purpose is to “focus attention on these five specific, potential causes of acute heart failure, life-threatening conditions that need immediate treatment,” explained Dr. Ponikowski.
“CHAMP emphasizes the most critical causes of acute heart failure,” added Dr. Harjola, a cardiologist at Helsinki University Central Hospital. “We created this new acronym” to help clinicians keep in mind what to look for in a patient presenting with acute heart failure.
U.S. cardiologists find things to like in what the Europeans say about managing acute heart failure, as well as aspects to question.
“It makes no sense not to aggressively treat a patient who arrives at an emergency department with acute heart failure. But there is a difference between acute MI or stroke and acute heart failure,” said Dr. Butler. “In acute MI there is the ruptured plaque and thrombus that blocks a coronary artery. In stroke there is a thrombus. These are diseases with a specific onset and treatment target. But with acute heart failure we don’t have a thrombus to treat; we don’t have a specific target. What we’ve learned from studying implanted devices [such as CardioMems] is that the congestion that causes acute heart failure can start 2-3 weeks before a patient develops acute decompensated heart failure and goes to the hospital. We have not found a specific pathophysiologic abnormality in the patient with acute heart failure that is any different from chronic heart failure. This begs the question: If a patient who presents with acute heart failure has a congestion process that’s been going on for 2 or 3 weeks what difference will another 3 hours make? Do we need to replicate the concept of an acute stroke team or acute MI response for acute heart failure?”
Dr. Butler stressed that additional data are expected soon that may help clarify this issue.
“Some large outcome trials in patients with acute heart failure are now underway, one testing serelaxin treatment, another testing ularitide treatment, that are also testing the hypothesis that rapid treatment with these drugs can produce more end-organ protection, stop damage to the heart, kidney and liver, and lead to better long-term outcomes. Until we have those data, the jury is still out” on the benefit patients gain from rapid treatment of acute heart failure. “Until then, it’s not that the data say don’t treat acute heart failure patients aggressively. But we have not yet proven it is similar to treating an acute MI or stroke,” said Dr. Butler.
“U.S. guidelines have tended to stay away from areas where there are no evidence-based data. To their credit, the Europeans will take on something like acute heart failure where we don’t have an adequate evidence base. Despite that, they provide guidelines, which is important because clinicians need guidance even when the evidence is not very good, when the guideline is based mostly on experience and expert consensus.” commented Dr. William T. Abraham, professor and director of cardiovascular medicine at the Ohio State University Wexner Medical Center in Columbus.
“It’s absolutely appropriate to think of acute heart failure as an emergency situation. We know from high-sensitivity troponin assays that troponin levels are increased in 90% of patients who present with acute decompensated heart failure. So most acute heart failure patients are losing heart muscle cells and we should treat them like we treat acute coronary syndrome. Time matters in acute heart failure; time is heart muscle. Treatment needs to break the hemodynamic and neurohormonal storm of acute decompensated heart failure; get the patient stabilized; improve vital organ perfusion, including within the heart; and shift the myocardial oxygen supply and demand equation so myocardial necrosis stops. All of this is important, and study results suggest it’s the correct approach. I’m not sure study results prove it, but studies that have looked at the time course of treatment for acute heart failure showed that early initiation of treatment – within the first 6 hours of onset – compared with 12-24 hours of onset makes a difference in outcomes,” Dr. Abraham said in an interview.
But a major limitation to the potential efficacy of a rapidly initiated management strategy is that few interventions currently exist with proven benefits for acute heart failure patients.
For the time being, rapid intervention means using diuretics relatively quickly and, if there is an indication for treating with a vasoactive medication, using that quickly too. “The rapid approach is really more relevant to the future; it’s relevant to the design of future acute heart failure treatment trials. That is where this early treatment paradigm is important,” as it could potentially apply to new, more effective treatments of the future rather than to the marginally effective treatments now available, Dr. Abraham said.
“For a long we time haven’t pushed how quickly we should act when implementing guideline-directed treatment” for patients with acute heart failure, noted Dr. Mehra. “The CHAMP approach is interesting, and the ESC guidelines are a very interesting move in the direction” of faster action. “They speak to the period of time during which one should act. Hopefully this will help the science of acute decompensated heart failure move forward.”
But for other U.S. experts the issue again pivots on the lack of evidence.
“There is nothing new” about managing acute heart failure, said Dr. Jessup. “The ESC guideline was articulated very well; they made their recommendations very clear. But a lot is consensus driven. There are no new data. The problem with acute heart failure is that the recommendations are what we think clinicians should do. CHAMP is a nice acronym; it’s packaged better, but there are not any new data.”
Comorbidities
A dramatic contrast distinguishes the extent to which the ESC guidelines highlight comorbidities, compared with prevailing U.S. guidelines. The new ESC guidelines highlight and discuss with some detail 16 distinct comorbidities for clinicians to keep in mind when managing heart failure patients, compared with three comorbidities (atrial fibrillation, anemia, and depression) discussed with similar detail in the 2013 U.S. guidelines.
“We are targeting comorbidities to personalize medicine, by subgrouping [heart failure] patients into groups that need to receive special attention,” explained Dr. Stefan D. Anker, a coauthor on the ESC guidelines. “We care about comorbidities because they make the diagnosis of heart failure difficult. They aggravate symptoms and contribute to additional hospitalizations. They interfere with [heart failure] treatment, and because comorbidities have led to exclusions of heart failure patients from trials, we lack evidence of treatment efficacy in patients with certain comorbidities,” said Dr. Anker, a professor of innovative clinical trials at the Medical University in Göttingen, Germany.
“The comorbidity discussion in the ESC guidelines is extremely important,” commented Dr. Abraham. “It supports the need for a multidimensional approach to heart failure patients. A cardiologist may not have all the resources to manage all the comorbidities [a heart failure patient might have]. This is why having a sleep medicine specialist, a diabetes specialist, a nephrologist, etc., involved as part of a heart failure management team can be very valuable. We need to involve subspecialists in managing the comorbidities of heart failure because they clearly have an impact on patient outcome.”
But Dr. Butler had a somewhat different take on how comorbidity management fits into the broader picture of heart failure management.
“There is no doubt that heart failure worsens other comorbidities and other comorbidities worsen heart failure. The relationship is bidirectional between heart failure and chronic obstructive pulmonary disease, liver disease, depression, sleep apnea, renal disease, lung disease, diabetes, etc. The problem is that treating a comorbidity does not necessarily translate into improved heart failure outcomes. Comorbidities are important for heart failure patients and worsen their heart failure outcomes. However, management of a comorbidity should be done primarily for the sake of improving the comorbidity. If you treat depression, for example, and it does not improve a patient’s heart failure, that doesn’t mean you shouldn’t have treated the depression. It just means that we don’t have good data that it will improve heart failure.”
Another limitation from a U.S. perspective is what role treatment of various comorbidities can play in benefiting heart failure patients and how compelling the evidence is for this. Dr. Butler gave as an example the problem with treating iron deficiency in heart failure patients who do not have anemia, a strategy endorsed in the ESC guidelines as a level IIa recommendation.
“The data regarding improved exercise capacity from treatment with intravenous ferric carboxymaltose is pretty convincing,” he said. But patients have benefited from this treatment only with improved function and quality of life, and not with improved survival or fewer hospitalizations.
“Is treating patients to improve their function and help them feel better enough?” Dr. Butler asked. “In other diseases it is. In gastrointestinal disease, if a drug helps patients feel better you approve the drug. We value improved functional capacity for patients with pulmonary hypertension, angina, and peripheral vascular disease. All these indications have drugs approved for improving functional capacity and quality of life. But for heart failure the bar has been set higher. There is a lot of interest in changing this” for heart failure.
“There is interest in running a study of ferric carboxymaltose for heart failure with a mortality endpoint. In the meantime, the impact on improving functional capacity is compelling, and it will be interesting to see what happens in the U.S. guidelines. Currently, in U.S. practice if a heart failure patient has iron-deficiency anemia you treat with intravenous iron replacement and the treatment gets reimbursed without a problem. But if the heart failure patient has iron deficiency without anemia then reimbursement for the cost of iron supplementation can be a problem,” Dr. Butler noted. This may change only if the experts who write the next U.S. heart failure guidelines decide to change the rules of what constitutes a useful heart failure treatment, he said.
Dr. Butler has been a consultant to Novartis and Amgen and several other companies. Dr. Jessup had no disclosures. Dr. Mehra has been a consultant to Teva, Johnson & Johnson, Boston Scientific, and St. Jude. Dr. Ruschitzka has been a consultant to Novartis, Servier, Sanofi, Cardiorentis, Heartware, and St. Jude. Dr. McMurray has received research support from Novartis and Amgen. Dr. Lindenfeld has been a consultant to Novartis, Abbott, Janssen, Relypsa, and Resmed. Dr. Voors has been a consultant to Novartis, Amgen, Servier, and several other drug companies. Dr. Ponikowski has been a consultant to Amgen, Novartis, Servier, and several other drug companies. Dr. Harjola has been a consultant to Novartis, Servier, Bayer, Boehringer Ingelheim, Pfizer, and Resmed. Dr. Abraham has been a consultant to Amgen, Novartis, and several device companies. Dr. Anker has been a consultant to Novartis, Servier, and several other companies.
On Twitter @mitchelzoler
FLORENCE, ITALY – The 2016 revision of the European Society of Cardiology’s guidelines for diagnosing and treating acute and chronic heart failure highlights the extent to which thinking in the field has changed during the past 4 years, since the prior edition in 2012.
The new European guidelines, unveiled by the ESC’s Heart Failure Association during the group’s annual meeting, also underscore the great dependence that many new approaches have on expert opinion rather than what’s become the keystone of guidelines writing, evidence-based medicine. Frequent reliance on consensus decisions rather than indisputable proof from controlled trials defines what some U.S. specialists see as a divide as wide as the Atlantic between the European and U.S. approaches to guideline writing.
“The guidelines from the ESC are articulated very well; they made their recommendations very clear. But a lot is consensus driven, without new data,” said Dr. Mariell L. Jessup, who serves as both vice chair of the panel currently revising the U.S. heart failure guidelines – expected out later in 2016 – and was also the sole American representative on the panel that produced the ESC guidelines. “The ESC guidelines make clear all the things that need to happen to patients. I hope it will result in better patient care. We are clearly not doing a good job in heart failure. We not only don’t have evidence-based treatments, but people often don’t do a good job [caring for heart failure patients] and they die in the hospital all the time.”
Dr. Javed Butler, another member of the U.S. guidelines panel and professor and chief of cardiology at Stony Brook (N.Y.) University, called the U.S. and European divide a “philosophical perspective of evidence-based medicine.
“U.S. physicians should read the ESC guidelines and make up their own minds. The ESC guidelines are excellent and give you perspective. But U.S. regulatory and payment issues will be driven by U.S. guidelines,” Dr. Butler said in an interview.
But despite their limitations and the limited weight that the ESC guidelines carry for U.S. practice, they have many redeeming features, noted Dr. Mandeep R. Mehra, medical director of the Heart and Vascular Center at Brigham and Women’s Hospital in Boston. The 2016 ESC guidelines “are extraordinarily clear, very practical, and very concise. They are very usable, and provide a fantastic algorithm for managing patients with heart failure with reduced ejection fraction [HFrEF],” he said while discussing the guidelines during the meeting.
U.S. and Europe largely agree on sacubitril/valsartan and ivabradine
Clearly the greatest area of U.S. and European agreement was in the adoption by both guidelines groups of sacubitril/valsartan (Entresto) and ivabradine (Corlanor) as important new components of the basic drug formula for treating patients with HFrEF. In fact, the U.S. guideline writers saw these two additions as so important and timely that they issued a “focused update” in May to the existing, 2013 U.S. heart failure guidelines, and timed release of this update to occur on May 20, 2016, a day before release of the ESC guidelines. But as Dr. Butler noted, this was more of a temporal harmonization than a substantive one, because even here, in a very evidence-based change, the U.S. guidelines for using sacubitril/valsartan differed subtly but importantly from the ESC version.
The U.S. focused update says that treatment of patients with stage C (symptomatic heart failure with structural heart disease) HFrEF should receive treatment with sacubitril/valsartan (also know as an angiotensin receptor neprilysin inhibitor, or ARNI), an ACE inhibitor, or an angiotensin receptor blocker (ARB), as well as evidence-based treatment with a beta-blocker and with a mineralocorticoid receptor antagonist (MRA). A subsequent recommendation in the U.S. focused update said that HFrEF patients with chronic symptoms and New York Heart Association class II or III disease should switch from a stable, tolerated regimen with either an ACE inhibitor or ARB to treatment with sacubitril/valsartan.
In contrast, the new European guideline for sacubitril/valsartan recommends starting patients on this combination formulation only after first demonstrating that patients tolerated treatment with an ACE inhibitor or ARB for at least 30 days and determining that patients remained symptomatic while on one of these treatments. In short, the U.S. guideline gives a green light to starting patients with newly diagnosed, symptomatic HFrEF on sacubitril/valsartan immediately, while the European guideline only sanctions sacubitril/valsartan to start after a patient has spent at least 30 days settling into a multidrug regimen featuring an ACE inhibitor or an ARB when an ACE inhibitor isn’t well tolerated.
“The European guidelines are closely related to the study population enrolled in the PARADIGM-HF trial,” the pivotal trial that showed superiority of sacubitril/valsartan to an ACE inhibitor (N Engl J Med. 2014;371:993-1004), noted Dr. Butler in an interview. “The U.S. guidelines interpreted [the PARADIGM-HF] results in the best interests of a larger patient population. The European guidelines are far more proscriptive in replicating the clinical criteria of the trial. In some patients the sequence of starting a MRA and sacubitril/valsartan matters, but in other patients it is less important.”
Dr. Frank Ruschitzka, a coauthor of the ESC guidelines, said that the reason for the more cautious ESC approach was lack of widespread familiarity with sacubitril/valsartan treatment among cardiologists.
The ESC guidelines on using sacubitril/valsartan “replicated the PARADIGM-HF trial. We have no data right now that it is justifiable to put a [treatment-naive] patient on sacubitril/valsartan to begin with. Another difference between the U.S. and ESC guidelines is when to start a MRA,” said Dr. Ruschitzka, professor and head of cardiology at the Heart Center of the University Hospital in Zurich. “It makes a lot of sense to me to start sacubitril/valsartan early. The PARADIGM trial was positive, but no one has a feel for how to use sacubitril/valsartan. Should we give it to everyone? We said replicate the trial, and gain experience using the drug. We want to bring a life-saving drug to patients, but this is the approach we took. We need more data.”
Dr. Jessup noted that a lot of uncertainty also exists among U.S. clinicians about when to start sacubitril/valsartan. “It’s not been clear which patients to put on sacubitril/valsartan. No guidelines had been out on using it” until mid-May, and “the cost of sacubitril/valsartan is daunting. I have received calls from many people who ask whom am I supposed to use sacubitril/valsartan on? It took years and years to get people to [routinely] start patients on an ACE inhibitor and a beta-blocker, and now we’re telling them to do something else. In my practice it’s a 30-minute conversation with each patient that you need to first stop your ACE inhibitor, and then they often get denied coverage by their insurer,” said Dr. Jessup, professor of medicine at the University of Pennsylvania in Philadelphia. She expressed hope that coverage issues will diminish now that clear guidelines are out endorsing a key role for sacubitril/valsartan.
“We now all have started sacubitril/valsartan on patients” without first starting them on an ACE inhibitor, “but we all need to get a sense of what we can get away with” when using this drug, noted Dr. JoAnn Lindenfeld, professor and director of heart failure and transplant at Vanderbilt University in Nashville.
At least one European cardiologist was skeptical of just how proscriptive the ESC guideline for sacubitril/valsartan will be in actual practice.
“The best treatment [for symptomatic HFrEF] is sacubitril/valsartan, a beta-blocker, and a MRA,” said Dr. John J.V. McMurray, professor of cardiology at Glasgow University and lead investigator for the PARADIGM-HF pivotal trial for sacubitril/valsartan. “The treatment sequence advocated in the guidelines – treat with an ACE inhibitor first and if patients remain symptomatic change to sacubitril/valsartan – is evidence-based medicine. As a guidelines writer and as a promoter of evidence-based medicine, this is absolutely the correct approach. But as a practicing physician I’d go straight for sacubitril/valsartan. Otherwise you’re wasting everybody’s time starting with an ACE inhibitor and then waiting a month to switch,” Dr. McMurray said in an interview.
“It’s pointless to wait. We saw results within 30 days of starting sacubitril/valsartan, so it’s a theoretical risk to wait. Very few patients will become completely asymptomatic on an ACE inhibitor. Everyone who entered PARADIGM-HF was at New York Heart Association class II or higher, and at the time of randomization only a handful of patients were in New York Heart Association class I. Very few patients get to class I. That tells you it’s pretty uncommon for a heart failure patient to become truly asymptomatic with ACE inhibitor treatment. The main problem is that you are inconveniencing everybody with more blood tests and more clinic visits by waiting to start sacubitril/valsartan, said Dr. McMurray, who was not a member of the panel that wrote the new ESC guidelines.
Even less separates the new U.S. focused update and the ESC guidelines for using ivabradine. Both agree on starting the drug on HFrEF patients who remain symptomatic and with a left ventricular ejection fraction of 35% or less despite being on guideline-directed therapy including titration to a maximum beta-blocker dosage and with a persistent heart rate of at least 70 beats/min. The goal of ivabradine treatment is to further reduce heart rate beyond what’s achieved by a maximal beta-blocker dosage.
Perhaps the biggest questions about ivabradine have been why it took so long to enter the U.S. guidelines, and why it is listed in both the U.S. and ESC guidelines as a level II recommendation. Results from the pivotal trial that supported ivabradine’s use in HFrEF patients, SHIFT, first appeared in 2010 (Lancet. 2010 Sep 11;376[9744]:875-95).
Dr. Butler chalked up the drug’s slow entry into U.S. guidelines as the result of a lack of initiative by ivabradine’s initial developer, Servier. “SHIFT did not have any U.S. sites, and Servier never sought Food and Drug Administration approval,” he noted. “Amgen acquired the U.S. rights to ivabradine in 2013,” and the drug received FDA approval in April 2015, Dr. Butler noted, in explaining the drug’s U.S. timeline. As to why its use is a level II recommendation, he noted that the evidence for efficacy came only from the SHIFT trial, questions exist whether the beta-blocker dosages were fully optimized in all patients in this trial, and the benefit was limited to a reduction in heart failure hospitalizations but not in mortality. “I think that patients with persistent heart failure symptoms [and a persistently elevated heart rate] should get ivabradine,” but these caveats limit it to a class II level recommendation, Dr. Butler said.
“There were questions about ivabradine’s benefit in reducing heart failure hospitalization but not mortality, and questions about whether it would benefit patients if their beta-blocker dosage was adequately up titrated. There were also questions about which heart failure patients to use it on,” noted Dr. Lindenfeld, a member of the panel that wrote the U.S. focused update. These concerns in part help explain the delay to integrating ivabradine into U.S. practice guidelines, she said in an interview, but added that additional data and analysis published during the past 3 or so years have clarified ivabradine’s potentially useful role in treating selected HFrEF patients.
New ESC guidelines based on expert opinion
The sections on sacubitril/valsartan and ivabradine occupy a mere 2 pages among more than 55 pages of text and charts that spell out the ESC’s current vision of how physicians should diagnose and manage heart failure patients. While much of what carried over from prior editions of the guidelines is rooted in evidence, many of the new approaches advocated rely on expert opinion or new interpretations of existing data. Here are some of the notable changes and highlights of the 2016 ESC recommendations:
• Heart failure diagnosis. The new ESC guidelines streamline the diagnostic process, which now focuses on five key elements: The patient’s history, physical examination, ECG, serum level of either brain natriuretic peptide (BNP) or N-terminal(NT)-proBNP, and echocardiography. The guidelines specify threshold levels of BNP and NT-proBNP that can effectively rule out heart failure, a BNP level of at least 35 pg/mL or a NT-proBNP level of at least 125 pg/mL.
“The diagnostic minimum levels of BNP and NT-proBNP were designed to rule out heart failure. They both have a high negative predictive value, but at these levels their positive predictive value is low,” explained Dr. Adriaan A. Voors, cochair of the ESC’s guideline-writing panel and professor of cardiology at the University of Groningen, the Netherlands.
But while these levels might be effective for reliable rule out of heart failure, they could mean a large number of patients would qualify for an echocardiographic assessment.
“If we used the ESC’s natriuretic peptide cutoffs, there would be a clear concern about overuse of echo. It’s a cost-effectiveness issue. You wind up doing a lot of echos that will be normal. Echocardiography is very safe, but each echo costs about $400-$500,” commented Dr. Butler.
“The results from the STOP-HF and PONTIAC studies showed that BNP levels can identify people at increased risk for developing heart failure who need more intensive assessment and could also potentially benefit from more attention to heart failure prevention. I suspect the full U.S. guideline update will address this issue, but we have not yet finalized our decisions,” he added.
• Heart failure classification. The new ESC guidelines created a new heart failure category, midrange ejection fraction, that the writing panel positioned squarely between the two more classic heart failure subgroups, HFrEF and heart failure with preserved ejection fraction (HFpEF). The definition of each of the three subgroups depends on left ventricular ejection fraction as determined by echocardiography: A LVEF of less than 40% defined HFrEF, a LVEF of 40%-49% defined heart failure with midrange ejection fraction (HFmrEF), and a LVEF of 50% or higher defined HFpEF. Diagnostic confirmation of both HFmrEF and HFpEF also requires that patients fulfill certain criteria of structural or functional heart abnormalities.
The category of HFmrEF was created “to stimulate research into how to best manage these patients,” explained Dr. Piotr Ponikowski, chair of the ESC guidelines writing panel. For the time being, it remains a category with only theoretical importance as nothing is known to suggest that management of patients with HFmrEF should in any way differ from patients with HFpEF.
• Acute heart failure. Perhaps the most revolutionary element of the new guidelines is the detailed map they provide to managing patients who present with acute decompensated heart failure and the underlying principles cited to justify this radically different approach.
“The acute heart failure section was completely rewritten,” noted Dr. Ponikowski, professor of heart diseases at the Medical University in Wroclaw, Poland. “We don’t yet have evidence-based treatments” to apply to acute heart failure patients, he admitted, “however we strongly recommend the concept that the shorter the better. Shorten the time of diagnosis and for therapeutic decisions. We have borrowed from acute coronary syndrome. Don’t keep patients in the emergency department for another couple of hours just to see if they will respond. We must be aware that we need to do our best to shorten diagnosis and treatment decisions. Time is an issue. Manage a patient’s congestion and impaired peripheral perfusion within a time frame of 1-2 hours.”
The concept that acute heart failure must be quickly managed as an emergency condition similar to acute coronary syndrome first appeared as a European practice recommendation in 2015, a consensus statement from the European Heart Failure Association and two other collaborating organizations (Eur Heart J. 2015 Aug 7;36[30]:1958-66).
“In 2015, the consensus paper talked about how to handle acute heart failure patients in the emergency department. Now, we have focused on defining the patients’ phenotype and how to categorize their treatment options. We built on the 2015 statement, but the algorithms we now have are original to 2016; they were not in the 2015 paper,” said Dr. Veli-Pekka Harjola, a member of the 2015 consensus group and 2016 guidelines panel who spearheaded writing the acute heart failure section of the new ESC guidelines.
An additional new and notable feature of this section in the 2016 guidelines is its creation of an acronym, CHAMP, designed to guide the management of patients with acute heart failure. CHAMP stands for acute Coronary syndrome, Hypertension emergency, Arrhythmia, acute Mechanical cause, and Pulmonary embolism. The CHAMP acronym’s purpose is to “focus attention on these five specific, potential causes of acute heart failure, life-threatening conditions that need immediate treatment,” explained Dr. Ponikowski.
“CHAMP emphasizes the most critical causes of acute heart failure,” added Dr. Harjola, a cardiologist at Helsinki University Central Hospital. “We created this new acronym” to help clinicians keep in mind what to look for in a patient presenting with acute heart failure.
U.S. cardiologists find things to like in what the Europeans say about managing acute heart failure, as well as aspects to question.
“It makes no sense not to aggressively treat a patient who arrives at an emergency department with acute heart failure. But there is a difference between acute MI or stroke and acute heart failure,” said Dr. Butler. “In acute MI there is the ruptured plaque and thrombus that blocks a coronary artery. In stroke there is a thrombus. These are diseases with a specific onset and treatment target. But with acute heart failure we don’t have a thrombus to treat; we don’t have a specific target. What we’ve learned from studying implanted devices [such as CardioMems] is that the congestion that causes acute heart failure can start 2-3 weeks before a patient develops acute decompensated heart failure and goes to the hospital. We have not found a specific pathophysiologic abnormality in the patient with acute heart failure that is any different from chronic heart failure. This begs the question: If a patient who presents with acute heart failure has a congestion process that’s been going on for 2 or 3 weeks what difference will another 3 hours make? Do we need to replicate the concept of an acute stroke team or acute MI response for acute heart failure?”
Dr. Butler stressed that additional data are expected soon that may help clarify this issue.
“Some large outcome trials in patients with acute heart failure are now underway, one testing serelaxin treatment, another testing ularitide treatment, that are also testing the hypothesis that rapid treatment with these drugs can produce more end-organ protection, stop damage to the heart, kidney and liver, and lead to better long-term outcomes. Until we have those data, the jury is still out” on the benefit patients gain from rapid treatment of acute heart failure. “Until then, it’s not that the data say don’t treat acute heart failure patients aggressively. But we have not yet proven it is similar to treating an acute MI or stroke,” said Dr. Butler.
“U.S. guidelines have tended to stay away from areas where there are no evidence-based data. To their credit, the Europeans will take on something like acute heart failure where we don’t have an adequate evidence base. Despite that, they provide guidelines, which is important because clinicians need guidance even when the evidence is not very good, when the guideline is based mostly on experience and expert consensus.” commented Dr. William T. Abraham, professor and director of cardiovascular medicine at the Ohio State University Wexner Medical Center in Columbus.
“It’s absolutely appropriate to think of acute heart failure as an emergency situation. We know from high-sensitivity troponin assays that troponin levels are increased in 90% of patients who present with acute decompensated heart failure. So most acute heart failure patients are losing heart muscle cells and we should treat them like we treat acute coronary syndrome. Time matters in acute heart failure; time is heart muscle. Treatment needs to break the hemodynamic and neurohormonal storm of acute decompensated heart failure; get the patient stabilized; improve vital organ perfusion, including within the heart; and shift the myocardial oxygen supply and demand equation so myocardial necrosis stops. All of this is important, and study results suggest it’s the correct approach. I’m not sure study results prove it, but studies that have looked at the time course of treatment for acute heart failure showed that early initiation of treatment – within the first 6 hours of onset – compared with 12-24 hours of onset makes a difference in outcomes,” Dr. Abraham said in an interview.
But a major limitation to the potential efficacy of a rapidly initiated management strategy is that few interventions currently exist with proven benefits for acute heart failure patients.
For the time being, rapid intervention means using diuretics relatively quickly and, if there is an indication for treating with a vasoactive medication, using that quickly too. “The rapid approach is really more relevant to the future; it’s relevant to the design of future acute heart failure treatment trials. That is where this early treatment paradigm is important,” as it could potentially apply to new, more effective treatments of the future rather than to the marginally effective treatments now available, Dr. Abraham said.
“For a long we time haven’t pushed how quickly we should act when implementing guideline-directed treatment” for patients with acute heart failure, noted Dr. Mehra. “The CHAMP approach is interesting, and the ESC guidelines are a very interesting move in the direction” of faster action. “They speak to the period of time during which one should act. Hopefully this will help the science of acute decompensated heart failure move forward.”
But for other U.S. experts the issue again pivots on the lack of evidence.
“There is nothing new” about managing acute heart failure, said Dr. Jessup. “The ESC guideline was articulated very well; they made their recommendations very clear. But a lot is consensus driven. There are no new data. The problem with acute heart failure is that the recommendations are what we think clinicians should do. CHAMP is a nice acronym; it’s packaged better, but there are not any new data.”
Comorbidities
A dramatic contrast distinguishes the extent to which the ESC guidelines highlight comorbidities, compared with prevailing U.S. guidelines. The new ESC guidelines highlight and discuss with some detail 16 distinct comorbidities for clinicians to keep in mind when managing heart failure patients, compared with three comorbidities (atrial fibrillation, anemia, and depression) discussed with similar detail in the 2013 U.S. guidelines.
“We are targeting comorbidities to personalize medicine, by subgrouping [heart failure] patients into groups that need to receive special attention,” explained Dr. Stefan D. Anker, a coauthor on the ESC guidelines. “We care about comorbidities because they make the diagnosis of heart failure difficult. They aggravate symptoms and contribute to additional hospitalizations. They interfere with [heart failure] treatment, and because comorbidities have led to exclusions of heart failure patients from trials, we lack evidence of treatment efficacy in patients with certain comorbidities,” said Dr. Anker, a professor of innovative clinical trials at the Medical University in Göttingen, Germany.
“The comorbidity discussion in the ESC guidelines is extremely important,” commented Dr. Abraham. “It supports the need for a multidimensional approach to heart failure patients. A cardiologist may not have all the resources to manage all the comorbidities [a heart failure patient might have]. This is why having a sleep medicine specialist, a diabetes specialist, a nephrologist, etc., involved as part of a heart failure management team can be very valuable. We need to involve subspecialists in managing the comorbidities of heart failure because they clearly have an impact on patient outcome.”
But Dr. Butler had a somewhat different take on how comorbidity management fits into the broader picture of heart failure management.
“There is no doubt that heart failure worsens other comorbidities and other comorbidities worsen heart failure. The relationship is bidirectional between heart failure and chronic obstructive pulmonary disease, liver disease, depression, sleep apnea, renal disease, lung disease, diabetes, etc. The problem is that treating a comorbidity does not necessarily translate into improved heart failure outcomes. Comorbidities are important for heart failure patients and worsen their heart failure outcomes. However, management of a comorbidity should be done primarily for the sake of improving the comorbidity. If you treat depression, for example, and it does not improve a patient’s heart failure, that doesn’t mean you shouldn’t have treated the depression. It just means that we don’t have good data that it will improve heart failure.”
Another limitation from a U.S. perspective is what role treatment of various comorbidities can play in benefiting heart failure patients and how compelling the evidence is for this. Dr. Butler gave as an example the problem with treating iron deficiency in heart failure patients who do not have anemia, a strategy endorsed in the ESC guidelines as a level IIa recommendation.
“The data regarding improved exercise capacity from treatment with intravenous ferric carboxymaltose is pretty convincing,” he said. But patients have benefited from this treatment only with improved function and quality of life, and not with improved survival or fewer hospitalizations.
“Is treating patients to improve their function and help them feel better enough?” Dr. Butler asked. “In other diseases it is. In gastrointestinal disease, if a drug helps patients feel better you approve the drug. We value improved functional capacity for patients with pulmonary hypertension, angina, and peripheral vascular disease. All these indications have drugs approved for improving functional capacity and quality of life. But for heart failure the bar has been set higher. There is a lot of interest in changing this” for heart failure.
“There is interest in running a study of ferric carboxymaltose for heart failure with a mortality endpoint. In the meantime, the impact on improving functional capacity is compelling, and it will be interesting to see what happens in the U.S. guidelines. Currently, in U.S. practice if a heart failure patient has iron-deficiency anemia you treat with intravenous iron replacement and the treatment gets reimbursed without a problem. But if the heart failure patient has iron deficiency without anemia then reimbursement for the cost of iron supplementation can be a problem,” Dr. Butler noted. This may change only if the experts who write the next U.S. heart failure guidelines decide to change the rules of what constitutes a useful heart failure treatment, he said.
Dr. Butler has been a consultant to Novartis and Amgen and several other companies. Dr. Jessup had no disclosures. Dr. Mehra has been a consultant to Teva, Johnson & Johnson, Boston Scientific, and St. Jude. Dr. Ruschitzka has been a consultant to Novartis, Servier, Sanofi, Cardiorentis, Heartware, and St. Jude. Dr. McMurray has received research support from Novartis and Amgen. Dr. Lindenfeld has been a consultant to Novartis, Abbott, Janssen, Relypsa, and Resmed. Dr. Voors has been a consultant to Novartis, Amgen, Servier, and several other drug companies. Dr. Ponikowski has been a consultant to Amgen, Novartis, Servier, and several other drug companies. Dr. Harjola has been a consultant to Novartis, Servier, Bayer, Boehringer Ingelheim, Pfizer, and Resmed. Dr. Abraham has been a consultant to Amgen, Novartis, and several device companies. Dr. Anker has been a consultant to Novartis, Servier, and several other companies.
On Twitter @mitchelzoler
FLORENCE, ITALY – The 2016 revision of the European Society of Cardiology’s guidelines for diagnosing and treating acute and chronic heart failure highlights the extent to which thinking in the field has changed during the past 4 years, since the prior edition in 2012.
The new European guidelines, unveiled by the ESC’s Heart Failure Association during the group’s annual meeting, also underscore the great dependence that many new approaches have on expert opinion rather than what’s become the keystone of guidelines writing, evidence-based medicine. Frequent reliance on consensus decisions rather than indisputable proof from controlled trials defines what some U.S. specialists see as a divide as wide as the Atlantic between the European and U.S. approaches to guideline writing.
“The guidelines from the ESC are articulated very well; they made their recommendations very clear. But a lot is consensus driven, without new data,” said Dr. Mariell L. Jessup, who serves as both vice chair of the panel currently revising the U.S. heart failure guidelines – expected out later in 2016 – and was also the sole American representative on the panel that produced the ESC guidelines. “The ESC guidelines make clear all the things that need to happen to patients. I hope it will result in better patient care. We are clearly not doing a good job in heart failure. We not only don’t have evidence-based treatments, but people often don’t do a good job [caring for heart failure patients] and they die in the hospital all the time.”
Dr. Javed Butler, another member of the U.S. guidelines panel and professor and chief of cardiology at Stony Brook (N.Y.) University, called the U.S. and European divide a “philosophical perspective of evidence-based medicine.
“U.S. physicians should read the ESC guidelines and make up their own minds. The ESC guidelines are excellent and give you perspective. But U.S. regulatory and payment issues will be driven by U.S. guidelines,” Dr. Butler said in an interview.
But despite their limitations and the limited weight that the ESC guidelines carry for U.S. practice, they have many redeeming features, noted Dr. Mandeep R. Mehra, medical director of the Heart and Vascular Center at Brigham and Women’s Hospital in Boston. The 2016 ESC guidelines “are extraordinarily clear, very practical, and very concise. They are very usable, and provide a fantastic algorithm for managing patients with heart failure with reduced ejection fraction [HFrEF],” he said while discussing the guidelines during the meeting.
U.S. and Europe largely agree on sacubitril/valsartan and ivabradine
Clearly the greatest area of U.S. and European agreement was in the adoption by both guidelines groups of sacubitril/valsartan (Entresto) and ivabradine (Corlanor) as important new components of the basic drug formula for treating patients with HFrEF. In fact, the U.S. guideline writers saw these two additions as so important and timely that they issued a “focused update” in May to the existing, 2013 U.S. heart failure guidelines, and timed release of this update to occur on May 20, 2016, a day before release of the ESC guidelines. But as Dr. Butler noted, this was more of a temporal harmonization than a substantive one, because even here, in a very evidence-based change, the U.S. guidelines for using sacubitril/valsartan differed subtly but importantly from the ESC version.
The U.S. focused update says that treatment of patients with stage C (symptomatic heart failure with structural heart disease) HFrEF should receive treatment with sacubitril/valsartan (also know as an angiotensin receptor neprilysin inhibitor, or ARNI), an ACE inhibitor, or an angiotensin receptor blocker (ARB), as well as evidence-based treatment with a beta-blocker and with a mineralocorticoid receptor antagonist (MRA). A subsequent recommendation in the U.S. focused update said that HFrEF patients with chronic symptoms and New York Heart Association class II or III disease should switch from a stable, tolerated regimen with either an ACE inhibitor or ARB to treatment with sacubitril/valsartan.
In contrast, the new European guideline for sacubitril/valsartan recommends starting patients on this combination formulation only after first demonstrating that patients tolerated treatment with an ACE inhibitor or ARB for at least 30 days and determining that patients remained symptomatic while on one of these treatments. In short, the U.S. guideline gives a green light to starting patients with newly diagnosed, symptomatic HFrEF on sacubitril/valsartan immediately, while the European guideline only sanctions sacubitril/valsartan to start after a patient has spent at least 30 days settling into a multidrug regimen featuring an ACE inhibitor or an ARB when an ACE inhibitor isn’t well tolerated.
“The European guidelines are closely related to the study population enrolled in the PARADIGM-HF trial,” the pivotal trial that showed superiority of sacubitril/valsartan to an ACE inhibitor (N Engl J Med. 2014;371:993-1004), noted Dr. Butler in an interview. “The U.S. guidelines interpreted [the PARADIGM-HF] results in the best interests of a larger patient population. The European guidelines are far more proscriptive in replicating the clinical criteria of the trial. In some patients the sequence of starting a MRA and sacubitril/valsartan matters, but in other patients it is less important.”
Dr. Frank Ruschitzka, a coauthor of the ESC guidelines, said that the reason for the more cautious ESC approach was lack of widespread familiarity with sacubitril/valsartan treatment among cardiologists.
The ESC guidelines on using sacubitril/valsartan “replicated the PARADIGM-HF trial. We have no data right now that it is justifiable to put a [treatment-naive] patient on sacubitril/valsartan to begin with. Another difference between the U.S. and ESC guidelines is when to start a MRA,” said Dr. Ruschitzka, professor and head of cardiology at the Heart Center of the University Hospital in Zurich. “It makes a lot of sense to me to start sacubitril/valsartan early. The PARADIGM trial was positive, but no one has a feel for how to use sacubitril/valsartan. Should we give it to everyone? We said replicate the trial, and gain experience using the drug. We want to bring a life-saving drug to patients, but this is the approach we took. We need more data.”
Dr. Jessup noted that a lot of uncertainty also exists among U.S. clinicians about when to start sacubitril/valsartan. “It’s not been clear which patients to put on sacubitril/valsartan. No guidelines had been out on using it” until mid-May, and “the cost of sacubitril/valsartan is daunting. I have received calls from many people who ask whom am I supposed to use sacubitril/valsartan on? It took years and years to get people to [routinely] start patients on an ACE inhibitor and a beta-blocker, and now we’re telling them to do something else. In my practice it’s a 30-minute conversation with each patient that you need to first stop your ACE inhibitor, and then they often get denied coverage by their insurer,” said Dr. Jessup, professor of medicine at the University of Pennsylvania in Philadelphia. She expressed hope that coverage issues will diminish now that clear guidelines are out endorsing a key role for sacubitril/valsartan.
“We now all have started sacubitril/valsartan on patients” without first starting them on an ACE inhibitor, “but we all need to get a sense of what we can get away with” when using this drug, noted Dr. JoAnn Lindenfeld, professor and director of heart failure and transplant at Vanderbilt University in Nashville.
At least one European cardiologist was skeptical of just how proscriptive the ESC guideline for sacubitril/valsartan will be in actual practice.
“The best treatment [for symptomatic HFrEF] is sacubitril/valsartan, a beta-blocker, and a MRA,” said Dr. John J.V. McMurray, professor of cardiology at Glasgow University and lead investigator for the PARADIGM-HF pivotal trial for sacubitril/valsartan. “The treatment sequence advocated in the guidelines – treat with an ACE inhibitor first and if patients remain symptomatic change to sacubitril/valsartan – is evidence-based medicine. As a guidelines writer and as a promoter of evidence-based medicine, this is absolutely the correct approach. But as a practicing physician I’d go straight for sacubitril/valsartan. Otherwise you’re wasting everybody’s time starting with an ACE inhibitor and then waiting a month to switch,” Dr. McMurray said in an interview.
“It’s pointless to wait. We saw results within 30 days of starting sacubitril/valsartan, so it’s a theoretical risk to wait. Very few patients will become completely asymptomatic on an ACE inhibitor. Everyone who entered PARADIGM-HF was at New York Heart Association class II or higher, and at the time of randomization only a handful of patients were in New York Heart Association class I. Very few patients get to class I. That tells you it’s pretty uncommon for a heart failure patient to become truly asymptomatic with ACE inhibitor treatment. The main problem is that you are inconveniencing everybody with more blood tests and more clinic visits by waiting to start sacubitril/valsartan, said Dr. McMurray, who was not a member of the panel that wrote the new ESC guidelines.
Even less separates the new U.S. focused update and the ESC guidelines for using ivabradine. Both agree on starting the drug on HFrEF patients who remain symptomatic and with a left ventricular ejection fraction of 35% or less despite being on guideline-directed therapy including titration to a maximum beta-blocker dosage and with a persistent heart rate of at least 70 beats/min. The goal of ivabradine treatment is to further reduce heart rate beyond what’s achieved by a maximal beta-blocker dosage.
Perhaps the biggest questions about ivabradine have been why it took so long to enter the U.S. guidelines, and why it is listed in both the U.S. and ESC guidelines as a level II recommendation. Results from the pivotal trial that supported ivabradine’s use in HFrEF patients, SHIFT, first appeared in 2010 (Lancet. 2010 Sep 11;376[9744]:875-95).
Dr. Butler chalked up the drug’s slow entry into U.S. guidelines as the result of a lack of initiative by ivabradine’s initial developer, Servier. “SHIFT did not have any U.S. sites, and Servier never sought Food and Drug Administration approval,” he noted. “Amgen acquired the U.S. rights to ivabradine in 2013,” and the drug received FDA approval in April 2015, Dr. Butler noted, in explaining the drug’s U.S. timeline. As to why its use is a level II recommendation, he noted that the evidence for efficacy came only from the SHIFT trial, questions exist whether the beta-blocker dosages were fully optimized in all patients in this trial, and the benefit was limited to a reduction in heart failure hospitalizations but not in mortality. “I think that patients with persistent heart failure symptoms [and a persistently elevated heart rate] should get ivabradine,” but these caveats limit it to a class II level recommendation, Dr. Butler said.
“There were questions about ivabradine’s benefit in reducing heart failure hospitalization but not mortality, and questions about whether it would benefit patients if their beta-blocker dosage was adequately up titrated. There were also questions about which heart failure patients to use it on,” noted Dr. Lindenfeld, a member of the panel that wrote the U.S. focused update. These concerns in part help explain the delay to integrating ivabradine into U.S. practice guidelines, she said in an interview, but added that additional data and analysis published during the past 3 or so years have clarified ivabradine’s potentially useful role in treating selected HFrEF patients.
New ESC guidelines based on expert opinion
The sections on sacubitril/valsartan and ivabradine occupy a mere 2 pages among more than 55 pages of text and charts that spell out the ESC’s current vision of how physicians should diagnose and manage heart failure patients. While much of what carried over from prior editions of the guidelines is rooted in evidence, many of the new approaches advocated rely on expert opinion or new interpretations of existing data. Here are some of the notable changes and highlights of the 2016 ESC recommendations:
• Heart failure diagnosis. The new ESC guidelines streamline the diagnostic process, which now focuses on five key elements: The patient’s history, physical examination, ECG, serum level of either brain natriuretic peptide (BNP) or N-terminal(NT)-proBNP, and echocardiography. The guidelines specify threshold levels of BNP and NT-proBNP that can effectively rule out heart failure, a BNP level of at least 35 pg/mL or a NT-proBNP level of at least 125 pg/mL.
“The diagnostic minimum levels of BNP and NT-proBNP were designed to rule out heart failure. They both have a high negative predictive value, but at these levels their positive predictive value is low,” explained Dr. Adriaan A. Voors, cochair of the ESC’s guideline-writing panel and professor of cardiology at the University of Groningen, the Netherlands.
But while these levels might be effective for reliable rule out of heart failure, they could mean a large number of patients would qualify for an echocardiographic assessment.
“If we used the ESC’s natriuretic peptide cutoffs, there would be a clear concern about overuse of echo. It’s a cost-effectiveness issue. You wind up doing a lot of echos that will be normal. Echocardiography is very safe, but each echo costs about $400-$500,” commented Dr. Butler.
“The results from the STOP-HF and PONTIAC studies showed that BNP levels can identify people at increased risk for developing heart failure who need more intensive assessment and could also potentially benefit from more attention to heart failure prevention. I suspect the full U.S. guideline update will address this issue, but we have not yet finalized our decisions,” he added.
• Heart failure classification. The new ESC guidelines created a new heart failure category, midrange ejection fraction, that the writing panel positioned squarely between the two more classic heart failure subgroups, HFrEF and heart failure with preserved ejection fraction (HFpEF). The definition of each of the three subgroups depends on left ventricular ejection fraction as determined by echocardiography: A LVEF of less than 40% defined HFrEF, a LVEF of 40%-49% defined heart failure with midrange ejection fraction (HFmrEF), and a LVEF of 50% or higher defined HFpEF. Diagnostic confirmation of both HFmrEF and HFpEF also requires that patients fulfill certain criteria of structural or functional heart abnormalities.
The category of HFmrEF was created “to stimulate research into how to best manage these patients,” explained Dr. Piotr Ponikowski, chair of the ESC guidelines writing panel. For the time being, it remains a category with only theoretical importance as nothing is known to suggest that management of patients with HFmrEF should in any way differ from patients with HFpEF.
• Acute heart failure. Perhaps the most revolutionary element of the new guidelines is the detailed map they provide to managing patients who present with acute decompensated heart failure and the underlying principles cited to justify this radically different approach.
“The acute heart failure section was completely rewritten,” noted Dr. Ponikowski, professor of heart diseases at the Medical University in Wroclaw, Poland. “We don’t yet have evidence-based treatments” to apply to acute heart failure patients, he admitted, “however we strongly recommend the concept that the shorter the better. Shorten the time of diagnosis and for therapeutic decisions. We have borrowed from acute coronary syndrome. Don’t keep patients in the emergency department for another couple of hours just to see if they will respond. We must be aware that we need to do our best to shorten diagnosis and treatment decisions. Time is an issue. Manage a patient’s congestion and impaired peripheral perfusion within a time frame of 1-2 hours.”
The concept that acute heart failure must be quickly managed as an emergency condition similar to acute coronary syndrome first appeared as a European practice recommendation in 2015, a consensus statement from the European Heart Failure Association and two other collaborating organizations (Eur Heart J. 2015 Aug 7;36[30]:1958-66).
“In 2015, the consensus paper talked about how to handle acute heart failure patients in the emergency department. Now, we have focused on defining the patients’ phenotype and how to categorize their treatment options. We built on the 2015 statement, but the algorithms we now have are original to 2016; they were not in the 2015 paper,” said Dr. Veli-Pekka Harjola, a member of the 2015 consensus group and 2016 guidelines panel who spearheaded writing the acute heart failure section of the new ESC guidelines.
An additional new and notable feature of this section in the 2016 guidelines is its creation of an acronym, CHAMP, designed to guide the management of patients with acute heart failure. CHAMP stands for acute Coronary syndrome, Hypertension emergency, Arrhythmia, acute Mechanical cause, and Pulmonary embolism. The CHAMP acronym’s purpose is to “focus attention on these five specific, potential causes of acute heart failure, life-threatening conditions that need immediate treatment,” explained Dr. Ponikowski.
“CHAMP emphasizes the most critical causes of acute heart failure,” added Dr. Harjola, a cardiologist at Helsinki University Central Hospital. “We created this new acronym” to help clinicians keep in mind what to look for in a patient presenting with acute heart failure.
U.S. cardiologists find things to like in what the Europeans say about managing acute heart failure, as well as aspects to question.
“It makes no sense not to aggressively treat a patient who arrives at an emergency department with acute heart failure. But there is a difference between acute MI or stroke and acute heart failure,” said Dr. Butler. “In acute MI there is the ruptured plaque and thrombus that blocks a coronary artery. In stroke there is a thrombus. These are diseases with a specific onset and treatment target. But with acute heart failure we don’t have a thrombus to treat; we don’t have a specific target. What we’ve learned from studying implanted devices [such as CardioMems] is that the congestion that causes acute heart failure can start 2-3 weeks before a patient develops acute decompensated heart failure and goes to the hospital. We have not found a specific pathophysiologic abnormality in the patient with acute heart failure that is any different from chronic heart failure. This begs the question: If a patient who presents with acute heart failure has a congestion process that’s been going on for 2 or 3 weeks what difference will another 3 hours make? Do we need to replicate the concept of an acute stroke team or acute MI response for acute heart failure?”
Dr. Butler stressed that additional data are expected soon that may help clarify this issue.
“Some large outcome trials in patients with acute heart failure are now underway, one testing serelaxin treatment, another testing ularitide treatment, that are also testing the hypothesis that rapid treatment with these drugs can produce more end-organ protection, stop damage to the heart, kidney and liver, and lead to better long-term outcomes. Until we have those data, the jury is still out” on the benefit patients gain from rapid treatment of acute heart failure. “Until then, it’s not that the data say don’t treat acute heart failure patients aggressively. But we have not yet proven it is similar to treating an acute MI or stroke,” said Dr. Butler.
“U.S. guidelines have tended to stay away from areas where there are no evidence-based data. To their credit, the Europeans will take on something like acute heart failure where we don’t have an adequate evidence base. Despite that, they provide guidelines, which is important because clinicians need guidance even when the evidence is not very good, when the guideline is based mostly on experience and expert consensus.” commented Dr. William T. Abraham, professor and director of cardiovascular medicine at the Ohio State University Wexner Medical Center in Columbus.
“It’s absolutely appropriate to think of acute heart failure as an emergency situation. We know from high-sensitivity troponin assays that troponin levels are increased in 90% of patients who present with acute decompensated heart failure. So most acute heart failure patients are losing heart muscle cells and we should treat them like we treat acute coronary syndrome. Time matters in acute heart failure; time is heart muscle. Treatment needs to break the hemodynamic and neurohormonal storm of acute decompensated heart failure; get the patient stabilized; improve vital organ perfusion, including within the heart; and shift the myocardial oxygen supply and demand equation so myocardial necrosis stops. All of this is important, and study results suggest it’s the correct approach. I’m not sure study results prove it, but studies that have looked at the time course of treatment for acute heart failure showed that early initiation of treatment – within the first 6 hours of onset – compared with 12-24 hours of onset makes a difference in outcomes,” Dr. Abraham said in an interview.
But a major limitation to the potential efficacy of a rapidly initiated management strategy is that few interventions currently exist with proven benefits for acute heart failure patients.
For the time being, rapid intervention means using diuretics relatively quickly and, if there is an indication for treating with a vasoactive medication, using that quickly too. “The rapid approach is really more relevant to the future; it’s relevant to the design of future acute heart failure treatment trials. That is where this early treatment paradigm is important,” as it could potentially apply to new, more effective treatments of the future rather than to the marginally effective treatments now available, Dr. Abraham said.
“For a long we time haven’t pushed how quickly we should act when implementing guideline-directed treatment” for patients with acute heart failure, noted Dr. Mehra. “The CHAMP approach is interesting, and the ESC guidelines are a very interesting move in the direction” of faster action. “They speak to the period of time during which one should act. Hopefully this will help the science of acute decompensated heart failure move forward.”
But for other U.S. experts the issue again pivots on the lack of evidence.
“There is nothing new” about managing acute heart failure, said Dr. Jessup. “The ESC guideline was articulated very well; they made their recommendations very clear. But a lot is consensus driven. There are no new data. The problem with acute heart failure is that the recommendations are what we think clinicians should do. CHAMP is a nice acronym; it’s packaged better, but there are not any new data.”
Comorbidities
A dramatic contrast distinguishes the extent to which the ESC guidelines highlight comorbidities, compared with prevailing U.S. guidelines. The new ESC guidelines highlight and discuss with some detail 16 distinct comorbidities for clinicians to keep in mind when managing heart failure patients, compared with three comorbidities (atrial fibrillation, anemia, and depression) discussed with similar detail in the 2013 U.S. guidelines.
“We are targeting comorbidities to personalize medicine, by subgrouping [heart failure] patients into groups that need to receive special attention,” explained Dr. Stefan D. Anker, a coauthor on the ESC guidelines. “We care about comorbidities because they make the diagnosis of heart failure difficult. They aggravate symptoms and contribute to additional hospitalizations. They interfere with [heart failure] treatment, and because comorbidities have led to exclusions of heart failure patients from trials, we lack evidence of treatment efficacy in patients with certain comorbidities,” said Dr. Anker, a professor of innovative clinical trials at the Medical University in Göttingen, Germany.
“The comorbidity discussion in the ESC guidelines is extremely important,” commented Dr. Abraham. “It supports the need for a multidimensional approach to heart failure patients. A cardiologist may not have all the resources to manage all the comorbidities [a heart failure patient might have]. This is why having a sleep medicine specialist, a diabetes specialist, a nephrologist, etc., involved as part of a heart failure management team can be very valuable. We need to involve subspecialists in managing the comorbidities of heart failure because they clearly have an impact on patient outcome.”
But Dr. Butler had a somewhat different take on how comorbidity management fits into the broader picture of heart failure management.
“There is no doubt that heart failure worsens other comorbidities and other comorbidities worsen heart failure. The relationship is bidirectional between heart failure and chronic obstructive pulmonary disease, liver disease, depression, sleep apnea, renal disease, lung disease, diabetes, etc. The problem is that treating a comorbidity does not necessarily translate into improved heart failure outcomes. Comorbidities are important for heart failure patients and worsen their heart failure outcomes. However, management of a comorbidity should be done primarily for the sake of improving the comorbidity. If you treat depression, for example, and it does not improve a patient’s heart failure, that doesn’t mean you shouldn’t have treated the depression. It just means that we don’t have good data that it will improve heart failure.”
Another limitation from a U.S. perspective is what role treatment of various comorbidities can play in benefiting heart failure patients and how compelling the evidence is for this. Dr. Butler gave as an example the problem with treating iron deficiency in heart failure patients who do not have anemia, a strategy endorsed in the ESC guidelines as a level IIa recommendation.
“The data regarding improved exercise capacity from treatment with intravenous ferric carboxymaltose is pretty convincing,” he said. But patients have benefited from this treatment only with improved function and quality of life, and not with improved survival or fewer hospitalizations.
“Is treating patients to improve their function and help them feel better enough?” Dr. Butler asked. “In other diseases it is. In gastrointestinal disease, if a drug helps patients feel better you approve the drug. We value improved functional capacity for patients with pulmonary hypertension, angina, and peripheral vascular disease. All these indications have drugs approved for improving functional capacity and quality of life. But for heart failure the bar has been set higher. There is a lot of interest in changing this” for heart failure.
“There is interest in running a study of ferric carboxymaltose for heart failure with a mortality endpoint. In the meantime, the impact on improving functional capacity is compelling, and it will be interesting to see what happens in the U.S. guidelines. Currently, in U.S. practice if a heart failure patient has iron-deficiency anemia you treat with intravenous iron replacement and the treatment gets reimbursed without a problem. But if the heart failure patient has iron deficiency without anemia then reimbursement for the cost of iron supplementation can be a problem,” Dr. Butler noted. This may change only if the experts who write the next U.S. heart failure guidelines decide to change the rules of what constitutes a useful heart failure treatment, he said.
Dr. Butler has been a consultant to Novartis and Amgen and several other companies. Dr. Jessup had no disclosures. Dr. Mehra has been a consultant to Teva, Johnson & Johnson, Boston Scientific, and St. Jude. Dr. Ruschitzka has been a consultant to Novartis, Servier, Sanofi, Cardiorentis, Heartware, and St. Jude. Dr. McMurray has received research support from Novartis and Amgen. Dr. Lindenfeld has been a consultant to Novartis, Abbott, Janssen, Relypsa, and Resmed. Dr. Voors has been a consultant to Novartis, Amgen, Servier, and several other drug companies. Dr. Ponikowski has been a consultant to Amgen, Novartis, Servier, and several other drug companies. Dr. Harjola has been a consultant to Novartis, Servier, Bayer, Boehringer Ingelheim, Pfizer, and Resmed. Dr. Abraham has been a consultant to Amgen, Novartis, and several device companies. Dr. Anker has been a consultant to Novartis, Servier, and several other companies.
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM HEART FAILURE 2016
House Republicans unveil long-awaited plan to replace health law
Six years after promising a plan to “repeal and replace” the federal health law, House Republicans are finally ready to deliver.
The 37-page white paper, called “A Better Way,” includes virtually every idea on health care proposed by Republicans going back at least 2 decades. It would bring back “high-risk pools” for people with very high medical expenses, end open-ended funding for the Medicaid program, and encourage small businesses to band together to get better bargaining power in “Association Health Plans.”
What the plan does not include, however, is any idea of how much it would cost, or how it would be financed. Also unclear is how many of the 20 million Americans who have gained coverage since the law took effect would be able to remain insured.
“It’s a framework,” a senior House Republican leadership aide said on a conference call with reporters Tuesday, with the specifics to be determined next year by congressional committees, assuming the GOP maintains its majority. He likened the document to the white paper issued just after President Barack Obama’s election by then–Senate Finance Committee Chairman Max Baucus (D-Mont.). That document foreshadowed many of the key elements of the Affordable Care Act.
The plan starts with repeal of the health law and its requirements and taxes, but it would then put back many of its most popular elements: Allowing young adults to stay on their parents’ health plan to age 26; banning insurers from charging people with preexisting health problems higher premiums; and forbidding insurers from dropping coverage if a policyholder gets sick.
It would repeal the current scheme of exchanges where consumers buy insurance and government tax credits to help moderate-income Americans pay their premiums if they don’t have an employer to help. Instead, everyone buying policies in the individual market would receive tax credits. Older people charged more by insurers would receive larger credits, though the House Republicans don’t specify how much.
But the GOP plan also would likely make insurance more expensive for older people by proposing a broader range for premiums based on age. Current premiums can vary only threefold based on age, which is “driving out younger and healthier patients” who can’t afford them, the GOP aide said.
Under the plan, insurance companies could not charge higher rates to people with preexisting conditions so long as they maintain continuous coverage, whether from an employer or in a policy they purchase themselves. The new high-risk pools would be available for those who have a break in coverage, or who fail to purchase during a one-time open enrollment under the plan.
The plan would get rid of most of the coverage requirements under the Medicaid program for the poor, so states could make them more or less generous than they are currently. It would also limit funding. States could opt for either a per-person cap or a block grant to spend much as they wish.
On Medicare, the proposal would encourage the existing movement of patients from the program’s traditional fee-for-service program to managed care plans, and would transition from the existing financing structure based on benefits to a controversial structure called “premium support” that puts cost-controlling responsibilities more on private insurance companies. That change has been pushed by House Speaker Paul Ryan (R-Wisc.) for nearly a decade.
Backers of the existing health law were quick to criticize the GOP outline.
“The proposal introduced by Speaker Ryan is nothing more than vague and recycled ideas to take health insurance away from millions and increase costs for seniors and hardworking families,” said White House Assistant Press Secretary Katie Hill.
Families USA Executive Director Ron Pollack, who pushed hard for passage of the Affordable Care Act, said: “Make no mistake, Ryan’s approach is not a better way forward, but a bitter path backward that returns us to the bad old days when vast swaths of Americans were left to the tender mercies of the insurance industry and could not afford needed care.”
This story appears courtesy of Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Six years after promising a plan to “repeal and replace” the federal health law, House Republicans are finally ready to deliver.
The 37-page white paper, called “A Better Way,” includes virtually every idea on health care proposed by Republicans going back at least 2 decades. It would bring back “high-risk pools” for people with very high medical expenses, end open-ended funding for the Medicaid program, and encourage small businesses to band together to get better bargaining power in “Association Health Plans.”
What the plan does not include, however, is any idea of how much it would cost, or how it would be financed. Also unclear is how many of the 20 million Americans who have gained coverage since the law took effect would be able to remain insured.
“It’s a framework,” a senior House Republican leadership aide said on a conference call with reporters Tuesday, with the specifics to be determined next year by congressional committees, assuming the GOP maintains its majority. He likened the document to the white paper issued just after President Barack Obama’s election by then–Senate Finance Committee Chairman Max Baucus (D-Mont.). That document foreshadowed many of the key elements of the Affordable Care Act.
The plan starts with repeal of the health law and its requirements and taxes, but it would then put back many of its most popular elements: Allowing young adults to stay on their parents’ health plan to age 26; banning insurers from charging people with preexisting health problems higher premiums; and forbidding insurers from dropping coverage if a policyholder gets sick.
It would repeal the current scheme of exchanges where consumers buy insurance and government tax credits to help moderate-income Americans pay their premiums if they don’t have an employer to help. Instead, everyone buying policies in the individual market would receive tax credits. Older people charged more by insurers would receive larger credits, though the House Republicans don’t specify how much.
But the GOP plan also would likely make insurance more expensive for older people by proposing a broader range for premiums based on age. Current premiums can vary only threefold based on age, which is “driving out younger and healthier patients” who can’t afford them, the GOP aide said.
Under the plan, insurance companies could not charge higher rates to people with preexisting conditions so long as they maintain continuous coverage, whether from an employer or in a policy they purchase themselves. The new high-risk pools would be available for those who have a break in coverage, or who fail to purchase during a one-time open enrollment under the plan.
The plan would get rid of most of the coverage requirements under the Medicaid program for the poor, so states could make them more or less generous than they are currently. It would also limit funding. States could opt for either a per-person cap or a block grant to spend much as they wish.
On Medicare, the proposal would encourage the existing movement of patients from the program’s traditional fee-for-service program to managed care plans, and would transition from the existing financing structure based on benefits to a controversial structure called “premium support” that puts cost-controlling responsibilities more on private insurance companies. That change has been pushed by House Speaker Paul Ryan (R-Wisc.) for nearly a decade.
Backers of the existing health law were quick to criticize the GOP outline.
“The proposal introduced by Speaker Ryan is nothing more than vague and recycled ideas to take health insurance away from millions and increase costs for seniors and hardworking families,” said White House Assistant Press Secretary Katie Hill.
Families USA Executive Director Ron Pollack, who pushed hard for passage of the Affordable Care Act, said: “Make no mistake, Ryan’s approach is not a better way forward, but a bitter path backward that returns us to the bad old days when vast swaths of Americans were left to the tender mercies of the insurance industry and could not afford needed care.”
This story appears courtesy of Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Six years after promising a plan to “repeal and replace” the federal health law, House Republicans are finally ready to deliver.
The 37-page white paper, called “A Better Way,” includes virtually every idea on health care proposed by Republicans going back at least 2 decades. It would bring back “high-risk pools” for people with very high medical expenses, end open-ended funding for the Medicaid program, and encourage small businesses to band together to get better bargaining power in “Association Health Plans.”
What the plan does not include, however, is any idea of how much it would cost, or how it would be financed. Also unclear is how many of the 20 million Americans who have gained coverage since the law took effect would be able to remain insured.
“It’s a framework,” a senior House Republican leadership aide said on a conference call with reporters Tuesday, with the specifics to be determined next year by congressional committees, assuming the GOP maintains its majority. He likened the document to the white paper issued just after President Barack Obama’s election by then–Senate Finance Committee Chairman Max Baucus (D-Mont.). That document foreshadowed many of the key elements of the Affordable Care Act.
The plan starts with repeal of the health law and its requirements and taxes, but it would then put back many of its most popular elements: Allowing young adults to stay on their parents’ health plan to age 26; banning insurers from charging people with preexisting health problems higher premiums; and forbidding insurers from dropping coverage if a policyholder gets sick.
It would repeal the current scheme of exchanges where consumers buy insurance and government tax credits to help moderate-income Americans pay their premiums if they don’t have an employer to help. Instead, everyone buying policies in the individual market would receive tax credits. Older people charged more by insurers would receive larger credits, though the House Republicans don’t specify how much.
But the GOP plan also would likely make insurance more expensive for older people by proposing a broader range for premiums based on age. Current premiums can vary only threefold based on age, which is “driving out younger and healthier patients” who can’t afford them, the GOP aide said.
Under the plan, insurance companies could not charge higher rates to people with preexisting conditions so long as they maintain continuous coverage, whether from an employer or in a policy they purchase themselves. The new high-risk pools would be available for those who have a break in coverage, or who fail to purchase during a one-time open enrollment under the plan.
The plan would get rid of most of the coverage requirements under the Medicaid program for the poor, so states could make them more or less generous than they are currently. It would also limit funding. States could opt for either a per-person cap or a block grant to spend much as they wish.
On Medicare, the proposal would encourage the existing movement of patients from the program’s traditional fee-for-service program to managed care plans, and would transition from the existing financing structure based on benefits to a controversial structure called “premium support” that puts cost-controlling responsibilities more on private insurance companies. That change has been pushed by House Speaker Paul Ryan (R-Wisc.) for nearly a decade.
Backers of the existing health law were quick to criticize the GOP outline.
“The proposal introduced by Speaker Ryan is nothing more than vague and recycled ideas to take health insurance away from millions and increase costs for seniors and hardworking families,” said White House Assistant Press Secretary Katie Hill.
Families USA Executive Director Ron Pollack, who pushed hard for passage of the Affordable Care Act, said: “Make no mistake, Ryan’s approach is not a better way forward, but a bitter path backward that returns us to the bad old days when vast swaths of Americans were left to the tender mercies of the insurance industry and could not afford needed care.”
This story appears courtesy of Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
