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House Republicans start work on ACA repeal/replace
House Republicans have formally begun their efforts to repeal and replace the Affordable Care Act, but a group of four GOP senators could present a significant hurdle to getting the budget reconciliation package to the president’s desk.
The budget reconciliation language – introduced March 6 – represents the first of three phases in their planned effort to quash the ACA.
“Second are all the regulatory modifications and changes that can be put into place,” Dr. Price said, noting that the Obama administration made 192 specific rules related to the ACA and published more than 5,000 letters of guidance. “We are going to go through every single one of those and ... if they help patients, we need to continue them. If they harm patients or increase costs, they need to be addressed.”
He added that additional legislation could be needed to address changes that cannot be made through the reconciliation process, such as addressing prescription drug costs and allowing health insurance to be sold across state lines.
Sections of the reconciliation package were introduced in the House Energy and Commerce and House Ways and Means Committees, covering areas relative to each committee’s jurisdiction. Taken together, they put forth the plan to repeal and replace certain revenue aspects of the ACA.
Provisions to repeal Medicaid expansion likely will prove the most problematic. The Energy and Commerce language calls for the repeal of Medicaid expansion provisions by 2020. It also repeals a requirement that state Medicaid plans offer the same minimum essential health benefits that are required by plans on the exchanges.
Starting in fiscal 2020, states would begin to receive a per capita allotment to fund their Medicaid programs, a fixed amount per Medicaid enrollee that will adjust over time for inflation using the consumer price index. States spending more than their annual allotment per beneficiary would be penalized with reduced funding in the following year.
That provision has run afoul of certain Republican senators whose votes are needed to gain a simple majority and pass the budget reconciliation package. Because of the slim nature of the Republican majority, any defection from the party line could endanger passage.
“We are concerned that any poorly implemented or poorly timed change in the current funding structure in Medicaid could result in a reduction in access to life-saving health care services,” Sen. Rob Portman (R-Ohio), Sen. Shelley Moore Capito (R-W.Va.), Sen. Cory Gardner (R-Colo.), and Sen. Lisa Murkowski (R-Alaska) said in a letter to Senate Majority Leader Mitch McConnell (R-Ky.). The letter was based on an earlier draft of the legislative language but remains valid as little substantive change has occurred in the formal, introduced language.
“We believe Medicaid needs to be reformed, but reform should not come at the cost of disruption in access to health care for our country’s most vulnerable and sickest individuals,” the senators continued. “Any changes made to how Medicaid is financed through the state and federal governments should be coupled with significant new flexibility so they can efficiently and effectively manage their Medicaid programs to best meet their own needs. ... [The House proposal] does not meet the test of stability for individuals currently enrolled in the program, and we will not support a plan that does not include stability for Medicaid expansion populations or flexibility for states.”
The Energy and Commerce language also includes provisions for block grants to states that would allow them to be used in a manner they see fit within a defined list, including providing financial assistance to high-risk individuals; arrangements that help stabilize premiums in the individual market; reduce the cost of providing insurance in the small group and individual markets; promoting participation in the small group and individual markets; and promoting access to preventive, dental, and vision services as well as treatment for mental and substance abuse disorders. Funds could also be used to provide payments for care or assistance to reduce out-of-pocket costs.
The House proposal also would repeal the premium cost sharing subsidies in the ACA, which would be replaced with refundable tax credits, according to the language released by the Ways and Means Committee.
The credit can be used to purchase a state-approved, major health insurance or unsubsidized COBRA (the Consolidated Omnibus Budget Reconciliation Act) coverage and increases based on age. Individuals younger than age 30 years would get $2,000, and the credit increases in $500 increments per 10-year age block, plateauing at $4,000 for those aged 60 years and older. The caps will adjust over time, based on inflation, and are available to those making up to $75,000 ($150,000 for joint filers); the credit phases out by $100 for every $1,000 over those thresholds.
The Ways and Means language also repeals a number of revenue provisions, including the individual mandate and associated penalties; the employer mandate and associated penalties; taxes on high-cost health plans (Cadillac tax); over-the-counter and prescription medications; health savings accounts; tanning; investment; and on health insurers.
In place of the individual mandate, the language will allow insurers to raise premiums by up to 30%.
The bill does not repeal the provisions regarding young adults being able to stay on their parents’ policies to the age of 26 years, nor does it allow insurers to deny coverage for preexisting conditions.
The House committees will begin consideration of their respective languages on March 8.
House Republicans have formally begun their efforts to repeal and replace the Affordable Care Act, but a group of four GOP senators could present a significant hurdle to getting the budget reconciliation package to the president’s desk.
The budget reconciliation language – introduced March 6 – represents the first of three phases in their planned effort to quash the ACA.
“Second are all the regulatory modifications and changes that can be put into place,” Dr. Price said, noting that the Obama administration made 192 specific rules related to the ACA and published more than 5,000 letters of guidance. “We are going to go through every single one of those and ... if they help patients, we need to continue them. If they harm patients or increase costs, they need to be addressed.”
He added that additional legislation could be needed to address changes that cannot be made through the reconciliation process, such as addressing prescription drug costs and allowing health insurance to be sold across state lines.
Sections of the reconciliation package were introduced in the House Energy and Commerce and House Ways and Means Committees, covering areas relative to each committee’s jurisdiction. Taken together, they put forth the plan to repeal and replace certain revenue aspects of the ACA.
Provisions to repeal Medicaid expansion likely will prove the most problematic. The Energy and Commerce language calls for the repeal of Medicaid expansion provisions by 2020. It also repeals a requirement that state Medicaid plans offer the same minimum essential health benefits that are required by plans on the exchanges.
Starting in fiscal 2020, states would begin to receive a per capita allotment to fund their Medicaid programs, a fixed amount per Medicaid enrollee that will adjust over time for inflation using the consumer price index. States spending more than their annual allotment per beneficiary would be penalized with reduced funding in the following year.
That provision has run afoul of certain Republican senators whose votes are needed to gain a simple majority and pass the budget reconciliation package. Because of the slim nature of the Republican majority, any defection from the party line could endanger passage.
“We are concerned that any poorly implemented or poorly timed change in the current funding structure in Medicaid could result in a reduction in access to life-saving health care services,” Sen. Rob Portman (R-Ohio), Sen. Shelley Moore Capito (R-W.Va.), Sen. Cory Gardner (R-Colo.), and Sen. Lisa Murkowski (R-Alaska) said in a letter to Senate Majority Leader Mitch McConnell (R-Ky.). The letter was based on an earlier draft of the legislative language but remains valid as little substantive change has occurred in the formal, introduced language.
“We believe Medicaid needs to be reformed, but reform should not come at the cost of disruption in access to health care for our country’s most vulnerable and sickest individuals,” the senators continued. “Any changes made to how Medicaid is financed through the state and federal governments should be coupled with significant new flexibility so they can efficiently and effectively manage their Medicaid programs to best meet their own needs. ... [The House proposal] does not meet the test of stability for individuals currently enrolled in the program, and we will not support a plan that does not include stability for Medicaid expansion populations or flexibility for states.”
The Energy and Commerce language also includes provisions for block grants to states that would allow them to be used in a manner they see fit within a defined list, including providing financial assistance to high-risk individuals; arrangements that help stabilize premiums in the individual market; reduce the cost of providing insurance in the small group and individual markets; promoting participation in the small group and individual markets; and promoting access to preventive, dental, and vision services as well as treatment for mental and substance abuse disorders. Funds could also be used to provide payments for care or assistance to reduce out-of-pocket costs.
The House proposal also would repeal the premium cost sharing subsidies in the ACA, which would be replaced with refundable tax credits, according to the language released by the Ways and Means Committee.
The credit can be used to purchase a state-approved, major health insurance or unsubsidized COBRA (the Consolidated Omnibus Budget Reconciliation Act) coverage and increases based on age. Individuals younger than age 30 years would get $2,000, and the credit increases in $500 increments per 10-year age block, plateauing at $4,000 for those aged 60 years and older. The caps will adjust over time, based on inflation, and are available to those making up to $75,000 ($150,000 for joint filers); the credit phases out by $100 for every $1,000 over those thresholds.
The Ways and Means language also repeals a number of revenue provisions, including the individual mandate and associated penalties; the employer mandate and associated penalties; taxes on high-cost health plans (Cadillac tax); over-the-counter and prescription medications; health savings accounts; tanning; investment; and on health insurers.
In place of the individual mandate, the language will allow insurers to raise premiums by up to 30%.
The bill does not repeal the provisions regarding young adults being able to stay on their parents’ policies to the age of 26 years, nor does it allow insurers to deny coverage for preexisting conditions.
The House committees will begin consideration of their respective languages on March 8.
House Republicans have formally begun their efforts to repeal and replace the Affordable Care Act, but a group of four GOP senators could present a significant hurdle to getting the budget reconciliation package to the president’s desk.
The budget reconciliation language – introduced March 6 – represents the first of three phases in their planned effort to quash the ACA.
“Second are all the regulatory modifications and changes that can be put into place,” Dr. Price said, noting that the Obama administration made 192 specific rules related to the ACA and published more than 5,000 letters of guidance. “We are going to go through every single one of those and ... if they help patients, we need to continue them. If they harm patients or increase costs, they need to be addressed.”
He added that additional legislation could be needed to address changes that cannot be made through the reconciliation process, such as addressing prescription drug costs and allowing health insurance to be sold across state lines.
Sections of the reconciliation package were introduced in the House Energy and Commerce and House Ways and Means Committees, covering areas relative to each committee’s jurisdiction. Taken together, they put forth the plan to repeal and replace certain revenue aspects of the ACA.
Provisions to repeal Medicaid expansion likely will prove the most problematic. The Energy and Commerce language calls for the repeal of Medicaid expansion provisions by 2020. It also repeals a requirement that state Medicaid plans offer the same minimum essential health benefits that are required by plans on the exchanges.
Starting in fiscal 2020, states would begin to receive a per capita allotment to fund their Medicaid programs, a fixed amount per Medicaid enrollee that will adjust over time for inflation using the consumer price index. States spending more than their annual allotment per beneficiary would be penalized with reduced funding in the following year.
That provision has run afoul of certain Republican senators whose votes are needed to gain a simple majority and pass the budget reconciliation package. Because of the slim nature of the Republican majority, any defection from the party line could endanger passage.
“We are concerned that any poorly implemented or poorly timed change in the current funding structure in Medicaid could result in a reduction in access to life-saving health care services,” Sen. Rob Portman (R-Ohio), Sen. Shelley Moore Capito (R-W.Va.), Sen. Cory Gardner (R-Colo.), and Sen. Lisa Murkowski (R-Alaska) said in a letter to Senate Majority Leader Mitch McConnell (R-Ky.). The letter was based on an earlier draft of the legislative language but remains valid as little substantive change has occurred in the formal, introduced language.
“We believe Medicaid needs to be reformed, but reform should not come at the cost of disruption in access to health care for our country’s most vulnerable and sickest individuals,” the senators continued. “Any changes made to how Medicaid is financed through the state and federal governments should be coupled with significant new flexibility so they can efficiently and effectively manage their Medicaid programs to best meet their own needs. ... [The House proposal] does not meet the test of stability for individuals currently enrolled in the program, and we will not support a plan that does not include stability for Medicaid expansion populations or flexibility for states.”
The Energy and Commerce language also includes provisions for block grants to states that would allow them to be used in a manner they see fit within a defined list, including providing financial assistance to high-risk individuals; arrangements that help stabilize premiums in the individual market; reduce the cost of providing insurance in the small group and individual markets; promoting participation in the small group and individual markets; and promoting access to preventive, dental, and vision services as well as treatment for mental and substance abuse disorders. Funds could also be used to provide payments for care or assistance to reduce out-of-pocket costs.
The House proposal also would repeal the premium cost sharing subsidies in the ACA, which would be replaced with refundable tax credits, according to the language released by the Ways and Means Committee.
The credit can be used to purchase a state-approved, major health insurance or unsubsidized COBRA (the Consolidated Omnibus Budget Reconciliation Act) coverage and increases based on age. Individuals younger than age 30 years would get $2,000, and the credit increases in $500 increments per 10-year age block, plateauing at $4,000 for those aged 60 years and older. The caps will adjust over time, based on inflation, and are available to those making up to $75,000 ($150,000 for joint filers); the credit phases out by $100 for every $1,000 over those thresholds.
The Ways and Means language also repeals a number of revenue provisions, including the individual mandate and associated penalties; the employer mandate and associated penalties; taxes on high-cost health plans (Cadillac tax); over-the-counter and prescription medications; health savings accounts; tanning; investment; and on health insurers.
In place of the individual mandate, the language will allow insurers to raise premiums by up to 30%.
The bill does not repeal the provisions regarding young adults being able to stay on their parents’ policies to the age of 26 years, nor does it allow insurers to deny coverage for preexisting conditions.
The House committees will begin consideration of their respective languages on March 8.
Cancers in patients deemed lowest risk under Lung-RADS
A reporting system for lung cancer screening with low-dose computed tomography may underemphasize important abnormal findings other than nodules, researchers say, potentially leading to missed malignancies.
The American College of Radiology Lung Imaging Reporting and Data System, or Lung-RADS, was introduced in 2014 to standardize reporting for low-dose CT findings and also to reduce false-positive rates, by applying tighter criteria that was used in the National Lung Screening Trial.
Lung-RADS does not have specific reporting categories for patients with isolated hilar and mediastinal adenopathy or pleural effusion in the absence of lung nodules, even though these can indicate malignancy. It does allow for the inclusion of what is called an “S” code to indicate clinically significant findings other than nodules.
In the March 2017 issue of CHEST, Hiren Mehta, MD, and his colleagues at the University of Florida in Gainesville, report on four cases from their center in which patients with these pathologies had their scans read as Lung-RADS category 1, indicating a less than 1% likelihood of malignancy. No S codes were added to their reports. Subsequent testing in these patients revealed cancers (CHEST. 2017 March;151[3]:525-26).
The four cases were:
- A 56-year-old male with hilar and mediastinal adenopathy who was recommended for repeat screening at 12 months. The patient presented 6 months later with pneumonia; biopsy revealed large cell lung cancer.
- A 76-year-old male with paratracheal lymph nodes and a solitary subcarinal lymph node. A subsequent biopsy revealed adenocarcinoma.
- A 67-year-old male whose scan showed bulky hilar and mediastinal adenopathy. Subsequent testing revealed Hodgkin’s lymphoma.
- A 75-year-old female whose scan showed a small pleural effusion and no nodules. Repeat scanning at 1 year showed enlargement of the effusion and lung adenocarcinoma.
Dr. Mehta and colleagues noted in their analysis that Lung-RADS has not been studied prospectively in real practice settings and that the four cases – two of which involved delayed diagnosis – reveal “a significant limitation” of Lung-RADS.
“Based on our experience, we believe that particular caution should be exercised in reporting Lung-RADS 1 category for patients with adenopathy/pleural effusion with no lung nodules, as a majority of the lung cancer screening scans will be ordered by [primary care providers] ... [As] with any new system, an ongoing evaluation of the performance of Lung-RADS should be conducted so that the sensitivity and mortality benefit seen in the [National Lung Screening Trial] is not compromised.”
We strongly believe, based on our experience with these 4 cases that the new version of Lung-RADS 2.0 should [account for shortcomings of the current Lung-RADS] and have a separate category for findings that are highly suspicious for malignancy but do not have an accompanying lung nodule,” they wrote.
The investigators did not disclose outside funding or conflicts of interest related to their findings.
*This story was updated March 16, 2017, with the correct journal source.
The performance of lung cancer screening does not absolve the interpreter from pointing out clinically important findings whether or not they are related to lung cancer. Review of the entire examination for other potentially significant findings should be performed and reported in accordance with applicable standards, says The Joint American College of Radiology and Society of Thoracic Radiology practice parameter for the performance and reporting of lung cancer screening thoracic CT. In addition to adenopathy and pleural effusion, detection of abnormalities such as severe coronary artery calcifications, aortic aneurysms, severe emphysema and suspicious masses in the upper abdomen should be called out not just in the body of the report, but also in the final impression so that it is easily available to the reader of the report.
Lung-RADS recognizes the importance of incidental findings with an additional coding letter, the “S” code. The letter “S” should be attached any time there is an abnormality considered clinically important that is not a pulmonary nodule. For the cases presented in this study, the appropriate code for the subjects should have been Lung-RADS 1S with a specific recommendation for the management of the “S” findings. It is incumbent on individuals interpreting these examinations to appropriately account for and report all significant findings, not simply lung nodules, and to be familiar with and understand Lung-RADS. Judicious use of the Lung-RADS “S” code along with specific discussion of the report’s final impression is recommended as a means of improving communication.
James Ravenel, MD; Nichole Tanner, MD, MSCR, FCCP; and Gerard Silvestri, MD, MS, FCCP, are with the Medical University of South Carolina, Charleston. Dr. Tanner also is with the Ralph H. Johnson Veterans Affairs Hospital, Charleston.
These comments have been modified from an editorial accompanying Dr. Mehta and his colleagues’ study in CHEST (Chest. 2017 March;151[3]:539-43). The authors disclosed no conflicts of interest related to their editorial.
The performance of lung cancer screening does not absolve the interpreter from pointing out clinically important findings whether or not they are related to lung cancer. Review of the entire examination for other potentially significant findings should be performed and reported in accordance with applicable standards, says The Joint American College of Radiology and Society of Thoracic Radiology practice parameter for the performance and reporting of lung cancer screening thoracic CT. In addition to adenopathy and pleural effusion, detection of abnormalities such as severe coronary artery calcifications, aortic aneurysms, severe emphysema and suspicious masses in the upper abdomen should be called out not just in the body of the report, but also in the final impression so that it is easily available to the reader of the report.
Lung-RADS recognizes the importance of incidental findings with an additional coding letter, the “S” code. The letter “S” should be attached any time there is an abnormality considered clinically important that is not a pulmonary nodule. For the cases presented in this study, the appropriate code for the subjects should have been Lung-RADS 1S with a specific recommendation for the management of the “S” findings. It is incumbent on individuals interpreting these examinations to appropriately account for and report all significant findings, not simply lung nodules, and to be familiar with and understand Lung-RADS. Judicious use of the Lung-RADS “S” code along with specific discussion of the report’s final impression is recommended as a means of improving communication.
James Ravenel, MD; Nichole Tanner, MD, MSCR, FCCP; and Gerard Silvestri, MD, MS, FCCP, are with the Medical University of South Carolina, Charleston. Dr. Tanner also is with the Ralph H. Johnson Veterans Affairs Hospital, Charleston.
These comments have been modified from an editorial accompanying Dr. Mehta and his colleagues’ study in CHEST (Chest. 2017 March;151[3]:539-43). The authors disclosed no conflicts of interest related to their editorial.
The performance of lung cancer screening does not absolve the interpreter from pointing out clinically important findings whether or not they are related to lung cancer. Review of the entire examination for other potentially significant findings should be performed and reported in accordance with applicable standards, says The Joint American College of Radiology and Society of Thoracic Radiology practice parameter for the performance and reporting of lung cancer screening thoracic CT. In addition to adenopathy and pleural effusion, detection of abnormalities such as severe coronary artery calcifications, aortic aneurysms, severe emphysema and suspicious masses in the upper abdomen should be called out not just in the body of the report, but also in the final impression so that it is easily available to the reader of the report.
Lung-RADS recognizes the importance of incidental findings with an additional coding letter, the “S” code. The letter “S” should be attached any time there is an abnormality considered clinically important that is not a pulmonary nodule. For the cases presented in this study, the appropriate code for the subjects should have been Lung-RADS 1S with a specific recommendation for the management of the “S” findings. It is incumbent on individuals interpreting these examinations to appropriately account for and report all significant findings, not simply lung nodules, and to be familiar with and understand Lung-RADS. Judicious use of the Lung-RADS “S” code along with specific discussion of the report’s final impression is recommended as a means of improving communication.
James Ravenel, MD; Nichole Tanner, MD, MSCR, FCCP; and Gerard Silvestri, MD, MS, FCCP, are with the Medical University of South Carolina, Charleston. Dr. Tanner also is with the Ralph H. Johnson Veterans Affairs Hospital, Charleston.
These comments have been modified from an editorial accompanying Dr. Mehta and his colleagues’ study in CHEST (Chest. 2017 March;151[3]:539-43). The authors disclosed no conflicts of interest related to their editorial.
A reporting system for lung cancer screening with low-dose computed tomography may underemphasize important abnormal findings other than nodules, researchers say, potentially leading to missed malignancies.
The American College of Radiology Lung Imaging Reporting and Data System, or Lung-RADS, was introduced in 2014 to standardize reporting for low-dose CT findings and also to reduce false-positive rates, by applying tighter criteria that was used in the National Lung Screening Trial.
Lung-RADS does not have specific reporting categories for patients with isolated hilar and mediastinal adenopathy or pleural effusion in the absence of lung nodules, even though these can indicate malignancy. It does allow for the inclusion of what is called an “S” code to indicate clinically significant findings other than nodules.
In the March 2017 issue of CHEST, Hiren Mehta, MD, and his colleagues at the University of Florida in Gainesville, report on four cases from their center in which patients with these pathologies had their scans read as Lung-RADS category 1, indicating a less than 1% likelihood of malignancy. No S codes were added to their reports. Subsequent testing in these patients revealed cancers (CHEST. 2017 March;151[3]:525-26).
The four cases were:
- A 56-year-old male with hilar and mediastinal adenopathy who was recommended for repeat screening at 12 months. The patient presented 6 months later with pneumonia; biopsy revealed large cell lung cancer.
- A 76-year-old male with paratracheal lymph nodes and a solitary subcarinal lymph node. A subsequent biopsy revealed adenocarcinoma.
- A 67-year-old male whose scan showed bulky hilar and mediastinal adenopathy. Subsequent testing revealed Hodgkin’s lymphoma.
- A 75-year-old female whose scan showed a small pleural effusion and no nodules. Repeat scanning at 1 year showed enlargement of the effusion and lung adenocarcinoma.
Dr. Mehta and colleagues noted in their analysis that Lung-RADS has not been studied prospectively in real practice settings and that the four cases – two of which involved delayed diagnosis – reveal “a significant limitation” of Lung-RADS.
“Based on our experience, we believe that particular caution should be exercised in reporting Lung-RADS 1 category for patients with adenopathy/pleural effusion with no lung nodules, as a majority of the lung cancer screening scans will be ordered by [primary care providers] ... [As] with any new system, an ongoing evaluation of the performance of Lung-RADS should be conducted so that the sensitivity and mortality benefit seen in the [National Lung Screening Trial] is not compromised.”
We strongly believe, based on our experience with these 4 cases that the new version of Lung-RADS 2.0 should [account for shortcomings of the current Lung-RADS] and have a separate category for findings that are highly suspicious for malignancy but do not have an accompanying lung nodule,” they wrote.
The investigators did not disclose outside funding or conflicts of interest related to their findings.
*This story was updated March 16, 2017, with the correct journal source.
A reporting system for lung cancer screening with low-dose computed tomography may underemphasize important abnormal findings other than nodules, researchers say, potentially leading to missed malignancies.
The American College of Radiology Lung Imaging Reporting and Data System, or Lung-RADS, was introduced in 2014 to standardize reporting for low-dose CT findings and also to reduce false-positive rates, by applying tighter criteria that was used in the National Lung Screening Trial.
Lung-RADS does not have specific reporting categories for patients with isolated hilar and mediastinal adenopathy or pleural effusion in the absence of lung nodules, even though these can indicate malignancy. It does allow for the inclusion of what is called an “S” code to indicate clinically significant findings other than nodules.
In the March 2017 issue of CHEST, Hiren Mehta, MD, and his colleagues at the University of Florida in Gainesville, report on four cases from their center in which patients with these pathologies had their scans read as Lung-RADS category 1, indicating a less than 1% likelihood of malignancy. No S codes were added to their reports. Subsequent testing in these patients revealed cancers (CHEST. 2017 March;151[3]:525-26).
The four cases were:
- A 56-year-old male with hilar and mediastinal adenopathy who was recommended for repeat screening at 12 months. The patient presented 6 months later with pneumonia; biopsy revealed large cell lung cancer.
- A 76-year-old male with paratracheal lymph nodes and a solitary subcarinal lymph node. A subsequent biopsy revealed adenocarcinoma.
- A 67-year-old male whose scan showed bulky hilar and mediastinal adenopathy. Subsequent testing revealed Hodgkin’s lymphoma.
- A 75-year-old female whose scan showed a small pleural effusion and no nodules. Repeat scanning at 1 year showed enlargement of the effusion and lung adenocarcinoma.
Dr. Mehta and colleagues noted in their analysis that Lung-RADS has not been studied prospectively in real practice settings and that the four cases – two of which involved delayed diagnosis – reveal “a significant limitation” of Lung-RADS.
“Based on our experience, we believe that particular caution should be exercised in reporting Lung-RADS 1 category for patients with adenopathy/pleural effusion with no lung nodules, as a majority of the lung cancer screening scans will be ordered by [primary care providers] ... [As] with any new system, an ongoing evaluation of the performance of Lung-RADS should be conducted so that the sensitivity and mortality benefit seen in the [National Lung Screening Trial] is not compromised.”
We strongly believe, based on our experience with these 4 cases that the new version of Lung-RADS 2.0 should [account for shortcomings of the current Lung-RADS] and have a separate category for findings that are highly suspicious for malignancy but do not have an accompanying lung nodule,” they wrote.
The investigators did not disclose outside funding or conflicts of interest related to their findings.
*This story was updated March 16, 2017, with the correct journal source.
FROM CHEST*
Key clinical point: The current Lung-RADS system for classing low-dose CT results may not adequately capture cancer risk in patients with adenopathy or pleural effusion
Major finding: Four patients with adenopathy or pleural effusion in the absence of nodules were found to have lung cancer despite first scans classed as negative
Data source: Case reports from a university based center using Lung-RADS 1.0 in its lung cancer screening program.
Disclosures: The investigators did not disclose outside funding or conflicts of interest related to their findings.
Apply for a 2017 Award Program
The AATS Graham Foundation is proud to announce that the following 2017 award programs are accepting applications:
Denton A. Cooley Fellowship
Provides North American thoracic surgeons who are in their final year of their residencies or have recently completed their residencies within the past two years with the opportunity to spend four weeks studying at the Texas Heart Institute and Baylor St. Luke’s Medical Center.
Application Deadline: March 31, 2017
Every Heartbeat Matters Valve Fellowship – Sponsored by Edwards LifeSciences Foundation
Aims to enhance the heart valve disease knowledge and skill training for surgeons around the world who treat individuals with limited access to healthcare. Surgeons may apply for up to three months of study visiting a host institution for advanced VHD training and education to acquire skills that can be clinically implemented in their daily practice.
Application Deadline: March 31, 2017
Graham Surgical Investigator Program
Grants up to $50,000 annually to support innovative clinical or translational research by young CT surgeons for up to two years. A limited number of research proposals will be awarded in 2017, including a named award, the Texas Medical Center Surgical Investigator.
Application Deadline: April 1, 2017
James L. Cox Fellowship in Atrial Fibrillation Surgery – Sponsored by AtriCure Inc.
Gives newly graduated CT surgeons from around the world an immersive two-to-four-week, hands-on educational opportunity to enhance their clinical understanding and surgical proficiency in treating patients with atrial fibrillation under the guidance of leading surgeon-educators in this field.
Application Deadline: March 31, 2017
Japanese Association for Thoracic Surgery/AATS Graham Foundation Fellowship – Sponsored by Medtronic
Offers an interactive educational experience for young Japanese cardiothoracic surgeons to spend two to three months at host institutions in North America. Fellows will observe and have discussions with specialists in the treatment of heart valve disease, while concurrently obtaining technical skills and cardiothoracic patient management.
Application Deadline: March 31, 2017
Lawrence H. Cohn Clinical Scholar Program – Sponsored by Edwards LifeSciences Foundation
Designed for young cardiac surgeons who are in the final year of their residencies or have recently completed their residencies and are interested in obtaining an advanced experience with valvular surgery or care.
Application Deadline: March 31, 2017
Learn from the Masters: A Clinical Program
For cardiac surgeons from around the world who have recently completed their residencies or fellowship. The award will support the applicant to spend three or six months at the mentor’s institution either in North America or abroad.
Application Deadline: March 31, 2017
Surgical Robotics Fellowship – Sponsored by Intuitive Surgical
Familiarizes North American general thoracic fellows and their attending surgeons with the Da Vinci robotics system during two days of onsite, advanced training. Awardees who complete the fellowship will be eligible to participate in the Advanced Lobectomy Course.
Application Deadline: April 1, 2017.
Apply online at AATSGrahamFoundation.org.
The AATS Graham Foundation is proud to announce that the following 2017 award programs are accepting applications:
Denton A. Cooley Fellowship
Provides North American thoracic surgeons who are in their final year of their residencies or have recently completed their residencies within the past two years with the opportunity to spend four weeks studying at the Texas Heart Institute and Baylor St. Luke’s Medical Center.
Application Deadline: March 31, 2017
Every Heartbeat Matters Valve Fellowship – Sponsored by Edwards LifeSciences Foundation
Aims to enhance the heart valve disease knowledge and skill training for surgeons around the world who treat individuals with limited access to healthcare. Surgeons may apply for up to three months of study visiting a host institution for advanced VHD training and education to acquire skills that can be clinically implemented in their daily practice.
Application Deadline: March 31, 2017
Graham Surgical Investigator Program
Grants up to $50,000 annually to support innovative clinical or translational research by young CT surgeons for up to two years. A limited number of research proposals will be awarded in 2017, including a named award, the Texas Medical Center Surgical Investigator.
Application Deadline: April 1, 2017
James L. Cox Fellowship in Atrial Fibrillation Surgery – Sponsored by AtriCure Inc.
Gives newly graduated CT surgeons from around the world an immersive two-to-four-week, hands-on educational opportunity to enhance their clinical understanding and surgical proficiency in treating patients with atrial fibrillation under the guidance of leading surgeon-educators in this field.
Application Deadline: March 31, 2017
Japanese Association for Thoracic Surgery/AATS Graham Foundation Fellowship – Sponsored by Medtronic
Offers an interactive educational experience for young Japanese cardiothoracic surgeons to spend two to three months at host institutions in North America. Fellows will observe and have discussions with specialists in the treatment of heart valve disease, while concurrently obtaining technical skills and cardiothoracic patient management.
Application Deadline: March 31, 2017
Lawrence H. Cohn Clinical Scholar Program – Sponsored by Edwards LifeSciences Foundation
Designed for young cardiac surgeons who are in the final year of their residencies or have recently completed their residencies and are interested in obtaining an advanced experience with valvular surgery or care.
Application Deadline: March 31, 2017
Learn from the Masters: A Clinical Program
For cardiac surgeons from around the world who have recently completed their residencies or fellowship. The award will support the applicant to spend three or six months at the mentor’s institution either in North America or abroad.
Application Deadline: March 31, 2017
Surgical Robotics Fellowship – Sponsored by Intuitive Surgical
Familiarizes North American general thoracic fellows and their attending surgeons with the Da Vinci robotics system during two days of onsite, advanced training. Awardees who complete the fellowship will be eligible to participate in the Advanced Lobectomy Course.
Application Deadline: April 1, 2017.
Apply online at AATSGrahamFoundation.org.
The AATS Graham Foundation is proud to announce that the following 2017 award programs are accepting applications:
Denton A. Cooley Fellowship
Provides North American thoracic surgeons who are in their final year of their residencies or have recently completed their residencies within the past two years with the opportunity to spend four weeks studying at the Texas Heart Institute and Baylor St. Luke’s Medical Center.
Application Deadline: March 31, 2017
Every Heartbeat Matters Valve Fellowship – Sponsored by Edwards LifeSciences Foundation
Aims to enhance the heart valve disease knowledge and skill training for surgeons around the world who treat individuals with limited access to healthcare. Surgeons may apply for up to three months of study visiting a host institution for advanced VHD training and education to acquire skills that can be clinically implemented in their daily practice.
Application Deadline: March 31, 2017
Graham Surgical Investigator Program
Grants up to $50,000 annually to support innovative clinical or translational research by young CT surgeons for up to two years. A limited number of research proposals will be awarded in 2017, including a named award, the Texas Medical Center Surgical Investigator.
Application Deadline: April 1, 2017
James L. Cox Fellowship in Atrial Fibrillation Surgery – Sponsored by AtriCure Inc.
Gives newly graduated CT surgeons from around the world an immersive two-to-four-week, hands-on educational opportunity to enhance their clinical understanding and surgical proficiency in treating patients with atrial fibrillation under the guidance of leading surgeon-educators in this field.
Application Deadline: March 31, 2017
Japanese Association for Thoracic Surgery/AATS Graham Foundation Fellowship – Sponsored by Medtronic
Offers an interactive educational experience for young Japanese cardiothoracic surgeons to spend two to three months at host institutions in North America. Fellows will observe and have discussions with specialists in the treatment of heart valve disease, while concurrently obtaining technical skills and cardiothoracic patient management.
Application Deadline: March 31, 2017
Lawrence H. Cohn Clinical Scholar Program – Sponsored by Edwards LifeSciences Foundation
Designed for young cardiac surgeons who are in the final year of their residencies or have recently completed their residencies and are interested in obtaining an advanced experience with valvular surgery or care.
Application Deadline: March 31, 2017
Learn from the Masters: A Clinical Program
For cardiac surgeons from around the world who have recently completed their residencies or fellowship. The award will support the applicant to spend three or six months at the mentor’s institution either in North America or abroad.
Application Deadline: March 31, 2017
Surgical Robotics Fellowship – Sponsored by Intuitive Surgical
Familiarizes North American general thoracic fellows and their attending surgeons with the Da Vinci robotics system during two days of onsite, advanced training. Awardees who complete the fellowship will be eligible to participate in the Advanced Lobectomy Course.
Application Deadline: April 1, 2017.
Apply online at AATSGrahamFoundation.org.
Learn How to Write a Successful Grant Submission
Mark your calendar for the 2017 AATS Grant Writing Workshop.
Friday, March 10, 2017
Doubletree Hotel Bethesda
Bethesda, MD
Program Directors
David R. Jones
Y. Joseph Woo
Target Audience
Designed for all levels of academic cardiothoracic surgeons interested in applying for grants.
Overview
The workshop offers a unique opportunity to learn from and interact with faculty members who have successfully secured grants, as well as representatives from the NIH. It will provide attendees with a better understanding of the complex nature of preparing and submitting grant proposals along with the techniques required to ensure submissions are of the highest quality.
Mark your calendar for the 2017 AATS Grant Writing Workshop.
Friday, March 10, 2017
Doubletree Hotel Bethesda
Bethesda, MD
Program Directors
David R. Jones
Y. Joseph Woo
Target Audience
Designed for all levels of academic cardiothoracic surgeons interested in applying for grants.
Overview
The workshop offers a unique opportunity to learn from and interact with faculty members who have successfully secured grants, as well as representatives from the NIH. It will provide attendees with a better understanding of the complex nature of preparing and submitting grant proposals along with the techniques required to ensure submissions are of the highest quality.
Mark your calendar for the 2017 AATS Grant Writing Workshop.
Friday, March 10, 2017
Doubletree Hotel Bethesda
Bethesda, MD
Program Directors
David R. Jones
Y. Joseph Woo
Target Audience
Designed for all levels of academic cardiothoracic surgeons interested in applying for grants.
Overview
The workshop offers a unique opportunity to learn from and interact with faculty members who have successfully secured grants, as well as representatives from the NIH. It will provide attendees with a better understanding of the complex nature of preparing and submitting grant proposals along with the techniques required to ensure submissions are of the highest quality.
Join Us at the AATS Innovation Summit
Ignite your spirit for innovation at the 2017 AATS Innovation Summit.
Friday, April 29, 2017
Boston Marriott Copley Place Hotel
Boston, MA
Course Director
W. Randolph Chitwood, Jr.
Program Committee
Yolonda L. Colson
David R. Jones
Mark D. Rodefeld,
Todd K. Rosengart
Target Audience
The summit is aimed at cardiothoracic surgeons who are interested in gaining the knowledge and tools to develop new clinically applicable technology.
Program Overview
This one-day program will help CT surgeons develop new clinically applicable technology by providing them with the cross-specialty knowledge needed to be successful in novel idea generation, intellectual property protection, prototyping, developmental funding, clinical trials, regulatory pathways, and industry relations.
Ignite your spirit for innovation at the 2017 AATS Innovation Summit.
Friday, April 29, 2017
Boston Marriott Copley Place Hotel
Boston, MA
Course Director
W. Randolph Chitwood, Jr.
Program Committee
Yolonda L. Colson
David R. Jones
Mark D. Rodefeld,
Todd K. Rosengart
Target Audience
The summit is aimed at cardiothoracic surgeons who are interested in gaining the knowledge and tools to develop new clinically applicable technology.
Program Overview
This one-day program will help CT surgeons develop new clinically applicable technology by providing them with the cross-specialty knowledge needed to be successful in novel idea generation, intellectual property protection, prototyping, developmental funding, clinical trials, regulatory pathways, and industry relations.
Ignite your spirit for innovation at the 2017 AATS Innovation Summit.
Friday, April 29, 2017
Boston Marriott Copley Place Hotel
Boston, MA
Course Director
W. Randolph Chitwood, Jr.
Program Committee
Yolonda L. Colson
David R. Jones
Mark D. Rodefeld,
Todd K. Rosengart
Target Audience
The summit is aimed at cardiothoracic surgeons who are interested in gaining the knowledge and tools to develop new clinically applicable technology.
Program Overview
This one-day program will help CT surgeons develop new clinically applicable technology by providing them with the cross-specialty knowledge needed to be successful in novel idea generation, intellectual property protection, prototyping, developmental funding, clinical trials, regulatory pathways, and industry relations.
Arteriovenous coupler for structural hypertension poised for sham-controlled study
WASHINGTON – A new device may be the best opportunity yet to achieve sustained blood pressure control in individuals aged 60 years and older, according to Paul Sobotka, MD, Chief Scientific Officer at ROX Medical, the maker of the device.
The experimental device is an arteriovenous coupler that provides an anastomosis between artery and vein to lower arterial volume and reduce blood pressure due to a structural cause. The device has already performed well in initial clinical studies, including a controlled, open-label trial, he reported at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
While neurohormonally driven elevations drive increases in diastolic and systolic blood pressures in younger patients, aortic stiffness and loss of vascular elasticity characterize the structurally driven hypertension of older patients, he said. While diuretics can lower arterial volume to achieve reductions in structurally related systolic hypertension, large doses are typically required to have meaningful results and are likely to be accompanied by unacceptable side effects in a large proportion of patients, he said.
“Somewhere between the age of 50 and 60 years, the majority of hypertensive patients will no longer be principally responsive to drugs acting on neurohormonal pathways or to renal denervation strategies.” In the elderly, cardiovascular risk is largely driven by hypertension principally related to the loss of aortic elasticity, which does not respond to most antihypertensive drugs.
The investigational arteriovenous coupler being developed by ROX Medical is intended to lower systolic blood pressure by reducing vascular resistance and therefore arterial volume. The coupler can be placed during cardiac catheterization, does not require sedation, takes about 1 hour to insert, and can be removed if necessary.
In a randomized, open-label study (Lancet. 2015 Apr;385:1634-41), mean systolic blood pressure was reduced by 26.9 mmHg on average in the 44 patients who received the arteriovenous coupler (P less than .001 vs. baseline) and by 3.7 mmHg (P = .31 vs. baseline) in the 39 patients who were maintained on antihypertensive medication, said Dr. Sobotka, who was a coauthor on this and several other clinical studies testing the efficacy and safety of the coupler. Systolic blood pressure falls almost immediately after the device is positioned, and blood pressure control has been sustained for up to 2 years of follow-up so far.
The procedure has been effective in patients resistant to antihypertensive medications and in those who have failed renal denervation, he said.
“The most significant adverse event observed has been venous stenosis related to turbulence, which occurs within in the first 12 months” after device placement, Dr. Sobotka reported. He said that venous stenting has resolved the problem in all affected patients. “Adverse events beyond that have been trivial.”
WASHINGTON – A new device may be the best opportunity yet to achieve sustained blood pressure control in individuals aged 60 years and older, according to Paul Sobotka, MD, Chief Scientific Officer at ROX Medical, the maker of the device.
The experimental device is an arteriovenous coupler that provides an anastomosis between artery and vein to lower arterial volume and reduce blood pressure due to a structural cause. The device has already performed well in initial clinical studies, including a controlled, open-label trial, he reported at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
While neurohormonally driven elevations drive increases in diastolic and systolic blood pressures in younger patients, aortic stiffness and loss of vascular elasticity characterize the structurally driven hypertension of older patients, he said. While diuretics can lower arterial volume to achieve reductions in structurally related systolic hypertension, large doses are typically required to have meaningful results and are likely to be accompanied by unacceptable side effects in a large proportion of patients, he said.
“Somewhere between the age of 50 and 60 years, the majority of hypertensive patients will no longer be principally responsive to drugs acting on neurohormonal pathways or to renal denervation strategies.” In the elderly, cardiovascular risk is largely driven by hypertension principally related to the loss of aortic elasticity, which does not respond to most antihypertensive drugs.
The investigational arteriovenous coupler being developed by ROX Medical is intended to lower systolic blood pressure by reducing vascular resistance and therefore arterial volume. The coupler can be placed during cardiac catheterization, does not require sedation, takes about 1 hour to insert, and can be removed if necessary.
In a randomized, open-label study (Lancet. 2015 Apr;385:1634-41), mean systolic blood pressure was reduced by 26.9 mmHg on average in the 44 patients who received the arteriovenous coupler (P less than .001 vs. baseline) and by 3.7 mmHg (P = .31 vs. baseline) in the 39 patients who were maintained on antihypertensive medication, said Dr. Sobotka, who was a coauthor on this and several other clinical studies testing the efficacy and safety of the coupler. Systolic blood pressure falls almost immediately after the device is positioned, and blood pressure control has been sustained for up to 2 years of follow-up so far.
The procedure has been effective in patients resistant to antihypertensive medications and in those who have failed renal denervation, he said.
“The most significant adverse event observed has been venous stenosis related to turbulence, which occurs within in the first 12 months” after device placement, Dr. Sobotka reported. He said that venous stenting has resolved the problem in all affected patients. “Adverse events beyond that have been trivial.”
WASHINGTON – A new device may be the best opportunity yet to achieve sustained blood pressure control in individuals aged 60 years and older, according to Paul Sobotka, MD, Chief Scientific Officer at ROX Medical, the maker of the device.
The experimental device is an arteriovenous coupler that provides an anastomosis between artery and vein to lower arterial volume and reduce blood pressure due to a structural cause. The device has already performed well in initial clinical studies, including a controlled, open-label trial, he reported at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
While neurohormonally driven elevations drive increases in diastolic and systolic blood pressures in younger patients, aortic stiffness and loss of vascular elasticity characterize the structurally driven hypertension of older patients, he said. While diuretics can lower arterial volume to achieve reductions in structurally related systolic hypertension, large doses are typically required to have meaningful results and are likely to be accompanied by unacceptable side effects in a large proportion of patients, he said.
“Somewhere between the age of 50 and 60 years, the majority of hypertensive patients will no longer be principally responsive to drugs acting on neurohormonal pathways or to renal denervation strategies.” In the elderly, cardiovascular risk is largely driven by hypertension principally related to the loss of aortic elasticity, which does not respond to most antihypertensive drugs.
The investigational arteriovenous coupler being developed by ROX Medical is intended to lower systolic blood pressure by reducing vascular resistance and therefore arterial volume. The coupler can be placed during cardiac catheterization, does not require sedation, takes about 1 hour to insert, and can be removed if necessary.
In a randomized, open-label study (Lancet. 2015 Apr;385:1634-41), mean systolic blood pressure was reduced by 26.9 mmHg on average in the 44 patients who received the arteriovenous coupler (P less than .001 vs. baseline) and by 3.7 mmHg (P = .31 vs. baseline) in the 39 patients who were maintained on antihypertensive medication, said Dr. Sobotka, who was a coauthor on this and several other clinical studies testing the efficacy and safety of the coupler. Systolic blood pressure falls almost immediately after the device is positioned, and blood pressure control has been sustained for up to 2 years of follow-up so far.
The procedure has been effective in patients resistant to antihypertensive medications and in those who have failed renal denervation, he said.
“The most significant adverse event observed has been venous stenosis related to turbulence, which occurs within in the first 12 months” after device placement, Dr. Sobotka reported. He said that venous stenting has resolved the problem in all affected patients. “Adverse events beyond that have been trivial.”
EXPERT ANALYSIS AT CRT 2017
When STEMI door-to-balloon times deteriorate
WASHINGTON – The interventional cardiology team at Geisinger Medical Center, Danville, Pa., reorganized their care for ST segment elevation MI (STEMI) in 2004 to improve their door-to-balloon angioplasty times. Their highly successful efforts soon streamlined the process, placing Geisinger in the top 10% nationally for low average door-to-balloon (DTB) times.
Then, Geisinger began to see their DTB times creep up.
After witnessing a 5- to 10-minute increase in DTB times for STEMI patients – whether picked up by ambulance, appearing in the emergency department (ED), or referred from neighboring hospitals – James Blankenship, MD, director of the division of cardiology, and fellow Geisinger researchers took on an institutional analysis, which was presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Their analysis failed to identify a single explanation, but it did reinforce the importance of constantly reinvigorating processes, Dr. Blankenship said. And their analysis indicated that delays don’t necessarily translate into poorer outcomes.
One proposed explanation was that delays had been caused by an increased reliance on radial rather than femoral catheter access. Dr. Blankenship cited studies suggesting that radial access increases DTB times by 1 to 12 minutes. The proportion of percutaneous coronary interventions performed radially at Geisinger had risen from 2% to 85% over the time period that DTB times had risen.
“There is evidence of benefit from radial access, so even if it slows you down a few minutes, it may be worth doing,” Dr. Blankenship noted. However, when this variable was evaluated, the DTB times were, if anything, slightly faster with radial relative to femoral access.
Another theory was that the decision to provide fellows with a greater role in STEMI management had produced treatment delays. In the cath lab at Geisinger, the increased fellow participation “correlated perfectly” with the decline in DTB times, according to Dr. Blankenship. However, a close look at this variable failed to show any meaningful impact on DTB times.
Changes in process were also examined. For one example, a form must now be completed documenting airway assessment. However, Dr. Blankenship found that filling out this form only takes about a minute and could account for only a small part of the observed loss.
The most significant cause for the increased DTB times among STEMI patients presenting in the ED may well have been a 2012 change in the configuration of the hospital. Prior to 2012, the distance from the ED to the cath lab was less than 100 yards and a 1-minute walk. After the change in the configuration, the cath lab was approximately 7 minutes away, a change that “correlated somewhat” to a prolongation in DTB times.
Similarly, regional hospital STEMI referral patterns changed when a hospital in relatively close proximity opened a cath lab. Up until that time, most referrals had been a 5-minute helicopter transfer, according to Dr. Blankenship. Afterwards, some helicopter transfer times rose to 25 minutes.
Yet, no explanation seemed to be more important than simply ensuring that new staff understand and adhere to the processes. Recounting his experience with a “secret shopper” approach in which he called Geisinger posing as a referring physician to report a potential STEMI, he was disappointed to reach a staff member uncertain of the meaning of the term STEMI.
“STEMI systems need a lot of maintenance,” Dr. Blankenship said. He cautioned that staff changes are common and frequent, making it important to continually assess whether all the participants in delivering STEMI care understand their role.
Some published studies challenge the importance of small changes in DTB times as a predictor of STEMI survival, according to Dr. Blankenship, citing one national survey unable to link a reduction in DTB times with a change in in-hospital mortality (N Engl J Med. 2013;369:901-09). However, he has been more convinced by those studies that do show a relationship. He cited one large study that found an 8% loss in the mortality benefit for each 10-minute delay in DTB (Lancet. 2015;385:1114-22).
Rapid DTB times cannot be divorced from quality of care, Dr. Blankenship said. He cited an experience at one center in which an aggressive program for reducing DTB times led to an increase in mortality among false-positive patients. “It is okay to sacrifice time for quality.”
It was at the 2016 CRT meeting that Dr. Blankenship first provided data showing the decline in DTB times at his institution. At that time and prior to the more comprehensive evaluation of the reasons for the delay presented at this year’s meeting, he speculated that it may be just a question of fatigue from sustaining a rapid response posture over several years.
“My original observation, that after a while you just get tired, is probably still true,” he said.
WASHINGTON – The interventional cardiology team at Geisinger Medical Center, Danville, Pa., reorganized their care for ST segment elevation MI (STEMI) in 2004 to improve their door-to-balloon angioplasty times. Their highly successful efforts soon streamlined the process, placing Geisinger in the top 10% nationally for low average door-to-balloon (DTB) times.
Then, Geisinger began to see their DTB times creep up.
After witnessing a 5- to 10-minute increase in DTB times for STEMI patients – whether picked up by ambulance, appearing in the emergency department (ED), or referred from neighboring hospitals – James Blankenship, MD, director of the division of cardiology, and fellow Geisinger researchers took on an institutional analysis, which was presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Their analysis failed to identify a single explanation, but it did reinforce the importance of constantly reinvigorating processes, Dr. Blankenship said. And their analysis indicated that delays don’t necessarily translate into poorer outcomes.
One proposed explanation was that delays had been caused by an increased reliance on radial rather than femoral catheter access. Dr. Blankenship cited studies suggesting that radial access increases DTB times by 1 to 12 minutes. The proportion of percutaneous coronary interventions performed radially at Geisinger had risen from 2% to 85% over the time period that DTB times had risen.
“There is evidence of benefit from radial access, so even if it slows you down a few minutes, it may be worth doing,” Dr. Blankenship noted. However, when this variable was evaluated, the DTB times were, if anything, slightly faster with radial relative to femoral access.
Another theory was that the decision to provide fellows with a greater role in STEMI management had produced treatment delays. In the cath lab at Geisinger, the increased fellow participation “correlated perfectly” with the decline in DTB times, according to Dr. Blankenship. However, a close look at this variable failed to show any meaningful impact on DTB times.
Changes in process were also examined. For one example, a form must now be completed documenting airway assessment. However, Dr. Blankenship found that filling out this form only takes about a minute and could account for only a small part of the observed loss.
The most significant cause for the increased DTB times among STEMI patients presenting in the ED may well have been a 2012 change in the configuration of the hospital. Prior to 2012, the distance from the ED to the cath lab was less than 100 yards and a 1-minute walk. After the change in the configuration, the cath lab was approximately 7 minutes away, a change that “correlated somewhat” to a prolongation in DTB times.
Similarly, regional hospital STEMI referral patterns changed when a hospital in relatively close proximity opened a cath lab. Up until that time, most referrals had been a 5-minute helicopter transfer, according to Dr. Blankenship. Afterwards, some helicopter transfer times rose to 25 minutes.
Yet, no explanation seemed to be more important than simply ensuring that new staff understand and adhere to the processes. Recounting his experience with a “secret shopper” approach in which he called Geisinger posing as a referring physician to report a potential STEMI, he was disappointed to reach a staff member uncertain of the meaning of the term STEMI.
“STEMI systems need a lot of maintenance,” Dr. Blankenship said. He cautioned that staff changes are common and frequent, making it important to continually assess whether all the participants in delivering STEMI care understand their role.
Some published studies challenge the importance of small changes in DTB times as a predictor of STEMI survival, according to Dr. Blankenship, citing one national survey unable to link a reduction in DTB times with a change in in-hospital mortality (N Engl J Med. 2013;369:901-09). However, he has been more convinced by those studies that do show a relationship. He cited one large study that found an 8% loss in the mortality benefit for each 10-minute delay in DTB (Lancet. 2015;385:1114-22).
Rapid DTB times cannot be divorced from quality of care, Dr. Blankenship said. He cited an experience at one center in which an aggressive program for reducing DTB times led to an increase in mortality among false-positive patients. “It is okay to sacrifice time for quality.”
It was at the 2016 CRT meeting that Dr. Blankenship first provided data showing the decline in DTB times at his institution. At that time and prior to the more comprehensive evaluation of the reasons for the delay presented at this year’s meeting, he speculated that it may be just a question of fatigue from sustaining a rapid response posture over several years.
“My original observation, that after a while you just get tired, is probably still true,” he said.
WASHINGTON – The interventional cardiology team at Geisinger Medical Center, Danville, Pa., reorganized their care for ST segment elevation MI (STEMI) in 2004 to improve their door-to-balloon angioplasty times. Their highly successful efforts soon streamlined the process, placing Geisinger in the top 10% nationally for low average door-to-balloon (DTB) times.
Then, Geisinger began to see their DTB times creep up.
After witnessing a 5- to 10-minute increase in DTB times for STEMI patients – whether picked up by ambulance, appearing in the emergency department (ED), or referred from neighboring hospitals – James Blankenship, MD, director of the division of cardiology, and fellow Geisinger researchers took on an institutional analysis, which was presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Their analysis failed to identify a single explanation, but it did reinforce the importance of constantly reinvigorating processes, Dr. Blankenship said. And their analysis indicated that delays don’t necessarily translate into poorer outcomes.
One proposed explanation was that delays had been caused by an increased reliance on radial rather than femoral catheter access. Dr. Blankenship cited studies suggesting that radial access increases DTB times by 1 to 12 minutes. The proportion of percutaneous coronary interventions performed radially at Geisinger had risen from 2% to 85% over the time period that DTB times had risen.
“There is evidence of benefit from radial access, so even if it slows you down a few minutes, it may be worth doing,” Dr. Blankenship noted. However, when this variable was evaluated, the DTB times were, if anything, slightly faster with radial relative to femoral access.
Another theory was that the decision to provide fellows with a greater role in STEMI management had produced treatment delays. In the cath lab at Geisinger, the increased fellow participation “correlated perfectly” with the decline in DTB times, according to Dr. Blankenship. However, a close look at this variable failed to show any meaningful impact on DTB times.
Changes in process were also examined. For one example, a form must now be completed documenting airway assessment. However, Dr. Blankenship found that filling out this form only takes about a minute and could account for only a small part of the observed loss.
The most significant cause for the increased DTB times among STEMI patients presenting in the ED may well have been a 2012 change in the configuration of the hospital. Prior to 2012, the distance from the ED to the cath lab was less than 100 yards and a 1-minute walk. After the change in the configuration, the cath lab was approximately 7 minutes away, a change that “correlated somewhat” to a prolongation in DTB times.
Similarly, regional hospital STEMI referral patterns changed when a hospital in relatively close proximity opened a cath lab. Up until that time, most referrals had been a 5-minute helicopter transfer, according to Dr. Blankenship. Afterwards, some helicopter transfer times rose to 25 minutes.
Yet, no explanation seemed to be more important than simply ensuring that new staff understand and adhere to the processes. Recounting his experience with a “secret shopper” approach in which he called Geisinger posing as a referring physician to report a potential STEMI, he was disappointed to reach a staff member uncertain of the meaning of the term STEMI.
“STEMI systems need a lot of maintenance,” Dr. Blankenship said. He cautioned that staff changes are common and frequent, making it important to continually assess whether all the participants in delivering STEMI care understand their role.
Some published studies challenge the importance of small changes in DTB times as a predictor of STEMI survival, according to Dr. Blankenship, citing one national survey unable to link a reduction in DTB times with a change in in-hospital mortality (N Engl J Med. 2013;369:901-09). However, he has been more convinced by those studies that do show a relationship. He cited one large study that found an 8% loss in the mortality benefit for each 10-minute delay in DTB (Lancet. 2015;385:1114-22).
Rapid DTB times cannot be divorced from quality of care, Dr. Blankenship said. He cited an experience at one center in which an aggressive program for reducing DTB times led to an increase in mortality among false-positive patients. “It is okay to sacrifice time for quality.”
It was at the 2016 CRT meeting that Dr. Blankenship first provided data showing the decline in DTB times at his institution. At that time and prior to the more comprehensive evaluation of the reasons for the delay presented at this year’s meeting, he speculated that it may be just a question of fatigue from sustaining a rapid response posture over several years.
“My original observation, that after a while you just get tired, is probably still true,” he said.
AT CRT 2017
Key clinical point: With small deviations in process over time, delays build in the emergency treatment of ST segment elevation MI (STEMI).
Major finding: Processes must be regularly reinvigorated, a systematic evaluation of deteriorating door-to-balloon times for STEMI care suggests.
Data source: Nonrandomized retrospective analysis.
Disclosures: Dr. Blankenship reported no financial relationships to disclose.
The percutaneous mitral valve replacement pipe dream
SNOWMASS, COLO. – Percutaneous mitral valve replacement is unlikely to ever catch on in any way remotely approaching that of transcatheter aortic valve replacement for the treatment of aortic stenosis, Blase A. Carabello, MD, predicted at the Annual Cardiovascular Conference at Snowmass.
“We’ve spent $2 billion looking for methods of percutaneous mitral valve replacement, and yet, I have to wonder if that makes any sense,” said Dr. Carabello, professor of medicine and chief of cardiology at East Carolina University in Greenville, N.C.
“If repair is superior to replacement in primary MR [mitral regurgitation], which I think we all agree is true, and you don’t need to get rid of every last molecule of blood going backward across the mitral valve when you’ve got a good left ventricle, then a percutaneous replacement in primary MR would have only the niche of patients who are inoperable and whose leaflets can’t be grabbed by the MitraClip or some new percutaneous device down the road. And, in secondary MR, it doesn’t seem to matter whether you replace or repair the valve, so why not just repair it with a clip?” he argued.
Numerous nonrandomized studies have invariably demonstrated superior survival for surgical repair versus replacement in patients with primary MR.
“There’s never going to be a randomized controlled trial of repair versus replacement; there’s no equipoise there. We all believe that, in primary MR, repair is superior to replacement. There are no data anywhere to suggest the opposite. It’s essentially sacrosanct,” according to the cardiologist.
In contrast, a major randomized trial of surgical repair versus replacement has been conducted in patients with severe secondary MR. This NIH-funded study conducted by the Cardiothoracic Surgical Trials Network found no difference in survival between the two groups (N Engl J Med. 2016 Jan 28; 374[4]:344-53). That’s not a surprising result, Dr. Carabello said, since the underlying cause of this type of valve disease is a sick left ventricle. But, since surgical repair entails less morbidity than replacement – and a percutaneous repair with a leaflet-grasping device such as the MitraClip is simpler and safer than a surgical repair – it seems likely that the future treatment for secondary MR will be a percutaneous device, he said.
That future could depend upon the results of the ongoing COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy), in which the MitraClip is being studied as an alternative to surgical repair for significant secondary MR. The MitraClip, which doesn’t entail a concomitant annuloplasty, is currently approved by the Food and Drug Administration only for patients with primary, degenerative mitral regurgitation not amenable to surgical repair. But, if COAPT yields positive results, the role of the MitraClip will greatly expand.
An intriguing and poorly understood difference exists in the significance of residual mitral regurgitation following surgical repair as opposed to percutaneous MitraClip repair, Dr. Carabello observed.
“I go to the OR a lot, and I know of no surgeon [who] will leave 2+ MR behind. Most surgeons won’t leave 1+ MR behind. They’ll put the patient back on the pump to repair even mild residual MR, accepting only trace MR or zero before they leave the OR because they know that the best predictor of a failed mitral repair is the presence of residual MR in the OR,” he said.
In contrast, following successful deployment of the MitraClip most patients are left with 1-2+ MR. Yet, as was demonstrated in the 5-year results of the randomized EVEREST II trial (Endovascular Valve Edge-to-Edge Repair Study), this residual MR wasn’t a harbinger of poor outcomes long-term (J Am Coll Cardiol. 2015 Dec 29;66[25]:2844-54).
“You would have expected, with that much residual MR, there would be a perpetually increasing failure rate over time, but that didn’t happen. In Everest II, there was an early failure rate for percutaneous repair, where the MitraClip didn’t work and those patients required surgical mitral valve repair. But, after the first 6 months, the failure rate for the clip was exactly the same as the surgical failure rate, even though, with the clip, you start with more MR to begin with,” the cardiologist noted.
The MitraClip procedure is modeled after the surgical Alfieri double-orifice end-to-end stitch technique, which has been shown to have durable results when performed in conjunction with an annuloplasty ring for primary MR.
“The MitraClip essentially joins the valve in the middle the way the Alfieri stitch does, but it doesn’t appear to behave the same way. Why is that? Maybe the clip does something different than the Alfieri stitch on which it was modeled. Maybe that bar in the middle of the mitral valve does something in terms of scarring or stabilization that we don’t know about yet,” he speculated.
As for the prospects for percutaneous mitral valve replacement, Dr. Carabello said that this type of procedure “is a very difficult thing to do, and so far, has been met with a fair amount of failure. It’ll be very interesting to see what percentage of market share it gets 10 years down the road. My prediction is that, for mitral regurgitation, repair is always going to be it.”
Dr. Carabello reported serving on a data safety monitoring board for Edwards Lifesciences.
The author provides valuable insight into how the definition of “success” of a procedure can change depending on the approach to the problem. While the gold standard of open mitral valve repair is 1+ regurgitation or less, those promoting percutaneous valve replacement are willing to accept long term 1+ to 2+ regurgitation. New technology and innovation is critical in medicine, provided the results are at least equivalent or superior to the standard techniques.
The author provides valuable insight into how the definition of “success” of a procedure can change depending on the approach to the problem. While the gold standard of open mitral valve repair is 1+ regurgitation or less, those promoting percutaneous valve replacement are willing to accept long term 1+ to 2+ regurgitation. New technology and innovation is critical in medicine, provided the results are at least equivalent or superior to the standard techniques.
The author provides valuable insight into how the definition of “success” of a procedure can change depending on the approach to the problem. While the gold standard of open mitral valve repair is 1+ regurgitation or less, those promoting percutaneous valve replacement are willing to accept long term 1+ to 2+ regurgitation. New technology and innovation is critical in medicine, provided the results are at least equivalent or superior to the standard techniques.
SNOWMASS, COLO. – Percutaneous mitral valve replacement is unlikely to ever catch on in any way remotely approaching that of transcatheter aortic valve replacement for the treatment of aortic stenosis, Blase A. Carabello, MD, predicted at the Annual Cardiovascular Conference at Snowmass.
“We’ve spent $2 billion looking for methods of percutaneous mitral valve replacement, and yet, I have to wonder if that makes any sense,” said Dr. Carabello, professor of medicine and chief of cardiology at East Carolina University in Greenville, N.C.
“If repair is superior to replacement in primary MR [mitral regurgitation], which I think we all agree is true, and you don’t need to get rid of every last molecule of blood going backward across the mitral valve when you’ve got a good left ventricle, then a percutaneous replacement in primary MR would have only the niche of patients who are inoperable and whose leaflets can’t be grabbed by the MitraClip or some new percutaneous device down the road. And, in secondary MR, it doesn’t seem to matter whether you replace or repair the valve, so why not just repair it with a clip?” he argued.
Numerous nonrandomized studies have invariably demonstrated superior survival for surgical repair versus replacement in patients with primary MR.
“There’s never going to be a randomized controlled trial of repair versus replacement; there’s no equipoise there. We all believe that, in primary MR, repair is superior to replacement. There are no data anywhere to suggest the opposite. It’s essentially sacrosanct,” according to the cardiologist.
In contrast, a major randomized trial of surgical repair versus replacement has been conducted in patients with severe secondary MR. This NIH-funded study conducted by the Cardiothoracic Surgical Trials Network found no difference in survival between the two groups (N Engl J Med. 2016 Jan 28; 374[4]:344-53). That’s not a surprising result, Dr. Carabello said, since the underlying cause of this type of valve disease is a sick left ventricle. But, since surgical repair entails less morbidity than replacement – and a percutaneous repair with a leaflet-grasping device such as the MitraClip is simpler and safer than a surgical repair – it seems likely that the future treatment for secondary MR will be a percutaneous device, he said.
That future could depend upon the results of the ongoing COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy), in which the MitraClip is being studied as an alternative to surgical repair for significant secondary MR. The MitraClip, which doesn’t entail a concomitant annuloplasty, is currently approved by the Food and Drug Administration only for patients with primary, degenerative mitral regurgitation not amenable to surgical repair. But, if COAPT yields positive results, the role of the MitraClip will greatly expand.
An intriguing and poorly understood difference exists in the significance of residual mitral regurgitation following surgical repair as opposed to percutaneous MitraClip repair, Dr. Carabello observed.
“I go to the OR a lot, and I know of no surgeon [who] will leave 2+ MR behind. Most surgeons won’t leave 1+ MR behind. They’ll put the patient back on the pump to repair even mild residual MR, accepting only trace MR or zero before they leave the OR because they know that the best predictor of a failed mitral repair is the presence of residual MR in the OR,” he said.
In contrast, following successful deployment of the MitraClip most patients are left with 1-2+ MR. Yet, as was demonstrated in the 5-year results of the randomized EVEREST II trial (Endovascular Valve Edge-to-Edge Repair Study), this residual MR wasn’t a harbinger of poor outcomes long-term (J Am Coll Cardiol. 2015 Dec 29;66[25]:2844-54).
“You would have expected, with that much residual MR, there would be a perpetually increasing failure rate over time, but that didn’t happen. In Everest II, there was an early failure rate for percutaneous repair, where the MitraClip didn’t work and those patients required surgical mitral valve repair. But, after the first 6 months, the failure rate for the clip was exactly the same as the surgical failure rate, even though, with the clip, you start with more MR to begin with,” the cardiologist noted.
The MitraClip procedure is modeled after the surgical Alfieri double-orifice end-to-end stitch technique, which has been shown to have durable results when performed in conjunction with an annuloplasty ring for primary MR.
“The MitraClip essentially joins the valve in the middle the way the Alfieri stitch does, but it doesn’t appear to behave the same way. Why is that? Maybe the clip does something different than the Alfieri stitch on which it was modeled. Maybe that bar in the middle of the mitral valve does something in terms of scarring or stabilization that we don’t know about yet,” he speculated.
As for the prospects for percutaneous mitral valve replacement, Dr. Carabello said that this type of procedure “is a very difficult thing to do, and so far, has been met with a fair amount of failure. It’ll be very interesting to see what percentage of market share it gets 10 years down the road. My prediction is that, for mitral regurgitation, repair is always going to be it.”
Dr. Carabello reported serving on a data safety monitoring board for Edwards Lifesciences.
SNOWMASS, COLO. – Percutaneous mitral valve replacement is unlikely to ever catch on in any way remotely approaching that of transcatheter aortic valve replacement for the treatment of aortic stenosis, Blase A. Carabello, MD, predicted at the Annual Cardiovascular Conference at Snowmass.
“We’ve spent $2 billion looking for methods of percutaneous mitral valve replacement, and yet, I have to wonder if that makes any sense,” said Dr. Carabello, professor of medicine and chief of cardiology at East Carolina University in Greenville, N.C.
“If repair is superior to replacement in primary MR [mitral regurgitation], which I think we all agree is true, and you don’t need to get rid of every last molecule of blood going backward across the mitral valve when you’ve got a good left ventricle, then a percutaneous replacement in primary MR would have only the niche of patients who are inoperable and whose leaflets can’t be grabbed by the MitraClip or some new percutaneous device down the road. And, in secondary MR, it doesn’t seem to matter whether you replace or repair the valve, so why not just repair it with a clip?” he argued.
Numerous nonrandomized studies have invariably demonstrated superior survival for surgical repair versus replacement in patients with primary MR.
“There’s never going to be a randomized controlled trial of repair versus replacement; there’s no equipoise there. We all believe that, in primary MR, repair is superior to replacement. There are no data anywhere to suggest the opposite. It’s essentially sacrosanct,” according to the cardiologist.
In contrast, a major randomized trial of surgical repair versus replacement has been conducted in patients with severe secondary MR. This NIH-funded study conducted by the Cardiothoracic Surgical Trials Network found no difference in survival between the two groups (N Engl J Med. 2016 Jan 28; 374[4]:344-53). That’s not a surprising result, Dr. Carabello said, since the underlying cause of this type of valve disease is a sick left ventricle. But, since surgical repair entails less morbidity than replacement – and a percutaneous repair with a leaflet-grasping device such as the MitraClip is simpler and safer than a surgical repair – it seems likely that the future treatment for secondary MR will be a percutaneous device, he said.
That future could depend upon the results of the ongoing COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy), in which the MitraClip is being studied as an alternative to surgical repair for significant secondary MR. The MitraClip, which doesn’t entail a concomitant annuloplasty, is currently approved by the Food and Drug Administration only for patients with primary, degenerative mitral regurgitation not amenable to surgical repair. But, if COAPT yields positive results, the role of the MitraClip will greatly expand.
An intriguing and poorly understood difference exists in the significance of residual mitral regurgitation following surgical repair as opposed to percutaneous MitraClip repair, Dr. Carabello observed.
“I go to the OR a lot, and I know of no surgeon [who] will leave 2+ MR behind. Most surgeons won’t leave 1+ MR behind. They’ll put the patient back on the pump to repair even mild residual MR, accepting only trace MR or zero before they leave the OR because they know that the best predictor of a failed mitral repair is the presence of residual MR in the OR,” he said.
In contrast, following successful deployment of the MitraClip most patients are left with 1-2+ MR. Yet, as was demonstrated in the 5-year results of the randomized EVEREST II trial (Endovascular Valve Edge-to-Edge Repair Study), this residual MR wasn’t a harbinger of poor outcomes long-term (J Am Coll Cardiol. 2015 Dec 29;66[25]:2844-54).
“You would have expected, with that much residual MR, there would be a perpetually increasing failure rate over time, but that didn’t happen. In Everest II, there was an early failure rate for percutaneous repair, where the MitraClip didn’t work and those patients required surgical mitral valve repair. But, after the first 6 months, the failure rate for the clip was exactly the same as the surgical failure rate, even though, with the clip, you start with more MR to begin with,” the cardiologist noted.
The MitraClip procedure is modeled after the surgical Alfieri double-orifice end-to-end stitch technique, which has been shown to have durable results when performed in conjunction with an annuloplasty ring for primary MR.
“The MitraClip essentially joins the valve in the middle the way the Alfieri stitch does, but it doesn’t appear to behave the same way. Why is that? Maybe the clip does something different than the Alfieri stitch on which it was modeled. Maybe that bar in the middle of the mitral valve does something in terms of scarring or stabilization that we don’t know about yet,” he speculated.
As for the prospects for percutaneous mitral valve replacement, Dr. Carabello said that this type of procedure “is a very difficult thing to do, and so far, has been met with a fair amount of failure. It’ll be very interesting to see what percentage of market share it gets 10 years down the road. My prediction is that, for mitral regurgitation, repair is always going to be it.”
Dr. Carabello reported serving on a data safety monitoring board for Edwards Lifesciences.
CMS nominee Verma clears Senate Finance hurdle
Seema Verma has moved one step closer to becoming the administrator of the Centers for Medicare & Medicaid Services.
The Senate Finance Committee voted 13-12 on March 2 to approve Ms. Verma’s nomination after a delayed vote the day before. The vote, conducted during a meeting off the floor, was a straight party-line vote, with 13 Republicans voting for Ms. Verma and 12 Democrats voting against. One proxy vote was not counted into the final tally per Senate rules.
Her nomination will now be considered by the full Senate.
Senate Finance Committee Chairman Orrin Hatch (R-Utah) praised Ms. Verma as a qualified leader who will help improve CMS.
Senate Finance Committee Ranking Member Ron Wyden, (D-Ore.) denounced Ms. Verma, stressing that she failed to adequately answer questions during her nomination hearing and has presented no clear vision of her plans as the next CMS administrator.
During her nomination hearing on Feb. 16, Ms. Verma came under fire for past consulting agreements with states while working for Hewlett Packard, a company that had financial interests in the health programs she designed. The issue was raised again during a preliminary vote by the Finance Committee on March 1.
“Ms. Verma was on both sides of the deal, helping manage the state’s health programs while being paid by vendors to those same programs,” Sen. Wyden said during the hearing. “I am concerned that if Ms. Verma is confirmed to lead CMS, where many of the companies she worked for are major vendors, there will not be adequate scrutiny of her past relationships with them, just as there wasn’t in Indiana.”
Ms. Verma previously said she never negotiated on behalf of Hewlett Packard and that the work she conducted for the states did not overlap with work she completed for HP.
“I hold honesty and integrity and adherence to a high ethical standard as part of my personal philosophy. That’s for me, I demand that from my employees, and I set that example for my own children,” she said during the Feb. 16 hearing. “We were never in a position where we were negotiating on behalf of HP or any other contractor with the state that we had a relationship with. If there was the potential [for a conflict], we would recuse ourselves.”
Ms. Verma’s nomination will now move to the full Senate. No date has yet been set for the vote.
[email protected]
On Twitter @legal_med
Seema Verma has moved one step closer to becoming the administrator of the Centers for Medicare & Medicaid Services.
The Senate Finance Committee voted 13-12 on March 2 to approve Ms. Verma’s nomination after a delayed vote the day before. The vote, conducted during a meeting off the floor, was a straight party-line vote, with 13 Republicans voting for Ms. Verma and 12 Democrats voting against. One proxy vote was not counted into the final tally per Senate rules.
Her nomination will now be considered by the full Senate.
Senate Finance Committee Chairman Orrin Hatch (R-Utah) praised Ms. Verma as a qualified leader who will help improve CMS.
Senate Finance Committee Ranking Member Ron Wyden, (D-Ore.) denounced Ms. Verma, stressing that she failed to adequately answer questions during her nomination hearing and has presented no clear vision of her plans as the next CMS administrator.
During her nomination hearing on Feb. 16, Ms. Verma came under fire for past consulting agreements with states while working for Hewlett Packard, a company that had financial interests in the health programs she designed. The issue was raised again during a preliminary vote by the Finance Committee on March 1.
“Ms. Verma was on both sides of the deal, helping manage the state’s health programs while being paid by vendors to those same programs,” Sen. Wyden said during the hearing. “I am concerned that if Ms. Verma is confirmed to lead CMS, where many of the companies she worked for are major vendors, there will not be adequate scrutiny of her past relationships with them, just as there wasn’t in Indiana.”
Ms. Verma previously said she never negotiated on behalf of Hewlett Packard and that the work she conducted for the states did not overlap with work she completed for HP.
“I hold honesty and integrity and adherence to a high ethical standard as part of my personal philosophy. That’s for me, I demand that from my employees, and I set that example for my own children,” she said during the Feb. 16 hearing. “We were never in a position where we were negotiating on behalf of HP or any other contractor with the state that we had a relationship with. If there was the potential [for a conflict], we would recuse ourselves.”
Ms. Verma’s nomination will now move to the full Senate. No date has yet been set for the vote.
[email protected]
On Twitter @legal_med
Seema Verma has moved one step closer to becoming the administrator of the Centers for Medicare & Medicaid Services.
The Senate Finance Committee voted 13-12 on March 2 to approve Ms. Verma’s nomination after a delayed vote the day before. The vote, conducted during a meeting off the floor, was a straight party-line vote, with 13 Republicans voting for Ms. Verma and 12 Democrats voting against. One proxy vote was not counted into the final tally per Senate rules.
Her nomination will now be considered by the full Senate.
Senate Finance Committee Chairman Orrin Hatch (R-Utah) praised Ms. Verma as a qualified leader who will help improve CMS.
Senate Finance Committee Ranking Member Ron Wyden, (D-Ore.) denounced Ms. Verma, stressing that she failed to adequately answer questions during her nomination hearing and has presented no clear vision of her plans as the next CMS administrator.
During her nomination hearing on Feb. 16, Ms. Verma came under fire for past consulting agreements with states while working for Hewlett Packard, a company that had financial interests in the health programs she designed. The issue was raised again during a preliminary vote by the Finance Committee on March 1.
“Ms. Verma was on both sides of the deal, helping manage the state’s health programs while being paid by vendors to those same programs,” Sen. Wyden said during the hearing. “I am concerned that if Ms. Verma is confirmed to lead CMS, where many of the companies she worked for are major vendors, there will not be adequate scrutiny of her past relationships with them, just as there wasn’t in Indiana.”
Ms. Verma previously said she never negotiated on behalf of Hewlett Packard and that the work she conducted for the states did not overlap with work she completed for HP.
“I hold honesty and integrity and adherence to a high ethical standard as part of my personal philosophy. That’s for me, I demand that from my employees, and I set that example for my own children,” she said during the Feb. 16 hearing. “We were never in a position where we were negotiating on behalf of HP or any other contractor with the state that we had a relationship with. If there was the potential [for a conflict], we would recuse ourselves.”
Ms. Verma’s nomination will now move to the full Senate. No date has yet been set for the vote.
[email protected]
On Twitter @legal_med
Trump lays out principles for ACA replacement
Flexibility and choice were key themes in the health care reform vision President Trump outlined in his first speech to a joint session of Congress on Feb. 28.
Specifically, Americans should be able to “purchase their own coverage through the use of tax credits and expanded health savings accounts, but it must be the plan they want, not the plan forced on them by our government,” Mr. Trump said. They also should be able to purchase insurance across state lines, which “will create a truly competitive national marketplace that will bring costs way down and provide far better care.”
He also advocated providing more flexibility to states to improve Medicaid but did not provide any specifics on how that would be accomplished.
Finally, Mr. Trump called for “legal reforms that protect patients and doctors from unnecessary costs that drive up the price of insurance and work to bring down the artificially high price of drugs and bring them down immediately,” he said, adding that the Food and Drug Administration needs to slash the time to approval for drugs and other medical treatments.
Some of these concepts were mirrored in a talking-points memo from the House Republican leadership earlier in February.
According to the memo, Republican efforts to repeal and replace the ACA will focus on the following areas:
• Repealing the ACA’s Medicaid expansion and allowing states to choose between block grands or per capita grants for Medicaid funding. States could choose to use those grants and per capita grants to keep expansion.
• Rebranding high-risk pools as “state innovation grants” to provide states with flexibility to design coverage that meets the needs of their populations. States could use the innovation grants to reduce patient out-of-pocket costs, lower the cost of providing care, stabilize the individual and small-group markets, provide access to preventive care, and promote participation in private health care plans.
• Promoting health savings accounts tied to high-deductible plans through increasing maximum contribution limits and other administrative fixes to allow for greater flexibility in their use.
• Replacing ACA premium subsides with refundable flat tax credits. Credit would be age-based, with younger recipients receiving smaller credits and older taxpayers being eligible for more. Tax credits would be available to those who are not eligible to receive coverage through other sources, such as an employer or government program.
Many of these provisions were included in a health reform plan known as A Better Way, which was announced in June 2016 by House Speaker Paul Ryan (R-Wis.).
Like Mr. Trump’s outline to Congress, the GOP talking-points memo was light on specifics, including how the bill will be paid for, how much money will be distributed to states for Medicaid, and how these provisions would alter current insurance coverage rates, which government actuaries project would reach 91.5% by 2025 under current law.
The GOP talking-points memo followed a Feb. 10 discussion draft that included the legislative language required to implement these concepts and allowed insurers to charge higher premiums to people with coverage lapses; repealed a number of taxes imposed on insurers, pharmaceutical companies, and device manufacturers; eliminated many of the ACA’s essential benefits; and ended tax penalties on companies that do not provide coverage to their employees.
This proposal, however, is already running into opposition from House Republicans, with reports stating that blocks of Republicans would not approve of the provisions.
It also could run aground in the Senate, where Sen. Lamar Alexander (R-Tenn.), chairman of the Committee on Health, Education, Labor, and Pensions, has expressed his intent to tackle heath care reform in pieces (public programs, the individual market, and employer market) to avoid getting bogged down in one overarching piece of legislation.
Getting Republicans on the same page is going to be a huge hurdle to get any legislation passed long before it comes down to trying to secure any Democratic votes to help pass any replacement legislation.
As former House Speaker John Boehner told physicians and health care IT leaders at the HIMSS annual conference on Feb. 23, “In the 25 years that I served in the Unites States Congress, Republicans never ever one time agreed on what a health care proposal should look like. Not once. … If you repeal without replace, anything that happens is your fault. You broke it. … If you pass repeal without replace, you’ll never pass replace because they will never ever agree on what the [replacement] bill should be.”
Flexibility and choice were key themes in the health care reform vision President Trump outlined in his first speech to a joint session of Congress on Feb. 28.
Specifically, Americans should be able to “purchase their own coverage through the use of tax credits and expanded health savings accounts, but it must be the plan they want, not the plan forced on them by our government,” Mr. Trump said. They also should be able to purchase insurance across state lines, which “will create a truly competitive national marketplace that will bring costs way down and provide far better care.”
He also advocated providing more flexibility to states to improve Medicaid but did not provide any specifics on how that would be accomplished.
Finally, Mr. Trump called for “legal reforms that protect patients and doctors from unnecessary costs that drive up the price of insurance and work to bring down the artificially high price of drugs and bring them down immediately,” he said, adding that the Food and Drug Administration needs to slash the time to approval for drugs and other medical treatments.
Some of these concepts were mirrored in a talking-points memo from the House Republican leadership earlier in February.
According to the memo, Republican efforts to repeal and replace the ACA will focus on the following areas:
• Repealing the ACA’s Medicaid expansion and allowing states to choose between block grands or per capita grants for Medicaid funding. States could choose to use those grants and per capita grants to keep expansion.
• Rebranding high-risk pools as “state innovation grants” to provide states with flexibility to design coverage that meets the needs of their populations. States could use the innovation grants to reduce patient out-of-pocket costs, lower the cost of providing care, stabilize the individual and small-group markets, provide access to preventive care, and promote participation in private health care plans.
• Promoting health savings accounts tied to high-deductible plans through increasing maximum contribution limits and other administrative fixes to allow for greater flexibility in their use.
• Replacing ACA premium subsides with refundable flat tax credits. Credit would be age-based, with younger recipients receiving smaller credits and older taxpayers being eligible for more. Tax credits would be available to those who are not eligible to receive coverage through other sources, such as an employer or government program.
Many of these provisions were included in a health reform plan known as A Better Way, which was announced in June 2016 by House Speaker Paul Ryan (R-Wis.).
Like Mr. Trump’s outline to Congress, the GOP talking-points memo was light on specifics, including how the bill will be paid for, how much money will be distributed to states for Medicaid, and how these provisions would alter current insurance coverage rates, which government actuaries project would reach 91.5% by 2025 under current law.
The GOP talking-points memo followed a Feb. 10 discussion draft that included the legislative language required to implement these concepts and allowed insurers to charge higher premiums to people with coverage lapses; repealed a number of taxes imposed on insurers, pharmaceutical companies, and device manufacturers; eliminated many of the ACA’s essential benefits; and ended tax penalties on companies that do not provide coverage to their employees.
This proposal, however, is already running into opposition from House Republicans, with reports stating that blocks of Republicans would not approve of the provisions.
It also could run aground in the Senate, where Sen. Lamar Alexander (R-Tenn.), chairman of the Committee on Health, Education, Labor, and Pensions, has expressed his intent to tackle heath care reform in pieces (public programs, the individual market, and employer market) to avoid getting bogged down in one overarching piece of legislation.
Getting Republicans on the same page is going to be a huge hurdle to get any legislation passed long before it comes down to trying to secure any Democratic votes to help pass any replacement legislation.
As former House Speaker John Boehner told physicians and health care IT leaders at the HIMSS annual conference on Feb. 23, “In the 25 years that I served in the Unites States Congress, Republicans never ever one time agreed on what a health care proposal should look like. Not once. … If you repeal without replace, anything that happens is your fault. You broke it. … If you pass repeal without replace, you’ll never pass replace because they will never ever agree on what the [replacement] bill should be.”
Flexibility and choice were key themes in the health care reform vision President Trump outlined in his first speech to a joint session of Congress on Feb. 28.
Specifically, Americans should be able to “purchase their own coverage through the use of tax credits and expanded health savings accounts, but it must be the plan they want, not the plan forced on them by our government,” Mr. Trump said. They also should be able to purchase insurance across state lines, which “will create a truly competitive national marketplace that will bring costs way down and provide far better care.”
He also advocated providing more flexibility to states to improve Medicaid but did not provide any specifics on how that would be accomplished.
Finally, Mr. Trump called for “legal reforms that protect patients and doctors from unnecessary costs that drive up the price of insurance and work to bring down the artificially high price of drugs and bring them down immediately,” he said, adding that the Food and Drug Administration needs to slash the time to approval for drugs and other medical treatments.
Some of these concepts were mirrored in a talking-points memo from the House Republican leadership earlier in February.
According to the memo, Republican efforts to repeal and replace the ACA will focus on the following areas:
• Repealing the ACA’s Medicaid expansion and allowing states to choose between block grands or per capita grants for Medicaid funding. States could choose to use those grants and per capita grants to keep expansion.
• Rebranding high-risk pools as “state innovation grants” to provide states with flexibility to design coverage that meets the needs of their populations. States could use the innovation grants to reduce patient out-of-pocket costs, lower the cost of providing care, stabilize the individual and small-group markets, provide access to preventive care, and promote participation in private health care plans.
• Promoting health savings accounts tied to high-deductible plans through increasing maximum contribution limits and other administrative fixes to allow for greater flexibility in their use.
• Replacing ACA premium subsides with refundable flat tax credits. Credit would be age-based, with younger recipients receiving smaller credits and older taxpayers being eligible for more. Tax credits would be available to those who are not eligible to receive coverage through other sources, such as an employer or government program.
Many of these provisions were included in a health reform plan known as A Better Way, which was announced in June 2016 by House Speaker Paul Ryan (R-Wis.).
Like Mr. Trump’s outline to Congress, the GOP talking-points memo was light on specifics, including how the bill will be paid for, how much money will be distributed to states for Medicaid, and how these provisions would alter current insurance coverage rates, which government actuaries project would reach 91.5% by 2025 under current law.
The GOP talking-points memo followed a Feb. 10 discussion draft that included the legislative language required to implement these concepts and allowed insurers to charge higher premiums to people with coverage lapses; repealed a number of taxes imposed on insurers, pharmaceutical companies, and device manufacturers; eliminated many of the ACA’s essential benefits; and ended tax penalties on companies that do not provide coverage to their employees.
This proposal, however, is already running into opposition from House Republicans, with reports stating that blocks of Republicans would not approve of the provisions.
It also could run aground in the Senate, where Sen. Lamar Alexander (R-Tenn.), chairman of the Committee on Health, Education, Labor, and Pensions, has expressed his intent to tackle heath care reform in pieces (public programs, the individual market, and employer market) to avoid getting bogged down in one overarching piece of legislation.
Getting Republicans on the same page is going to be a huge hurdle to get any legislation passed long before it comes down to trying to secure any Democratic votes to help pass any replacement legislation.
As former House Speaker John Boehner told physicians and health care IT leaders at the HIMSS annual conference on Feb. 23, “In the 25 years that I served in the Unites States Congress, Republicans never ever one time agreed on what a health care proposal should look like. Not once. … If you repeal without replace, anything that happens is your fault. You broke it. … If you pass repeal without replace, you’ll never pass replace because they will never ever agree on what the [replacement] bill should be.”