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Biden plan to lower Medicare eligibility age to 60 faces hostility from hospitals
Of his many plans to expand insurance coverage, President-elect Joe Biden’s simplest strategy is lowering the eligibility age for Medicare from 65 to 60.
But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.
Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation’s hospitals, a powerful political force, are poised to derail any effort.
“Hospitals certainly are not going to be happy with it,” said Jonathan Oberlander, professor of health policy and management at the University of North Carolina at Chapel Hill.
Medicare reimbursement rates for patients admitted to hospitals average half what commercial or employer-sponsored insurance plans pay.
“It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this,” said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.
Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can’t find jobs with health benefits.
“It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs,” Biden wrote in April.
Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a KFF tracking poll from January 2019. (KHN is an editorially independent program of KFF.)
Although opposition from the hospital industry is expected to be fierce, that is not the only obstacle to Biden’s plan.
Critics, especially Republicans on Capitol Hill, will point to the nation’s $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won’t be enough money to fully pay hospitals and nursing homes for inpatient care for Medicare beneficiaries.
Moreover, it’s unclear whether expanding Medicare will fit on the Democrats’ crowded health agenda, which also includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act if the Supreme Court strikes down part or all of the law in a current case, expanding Obamacare subsidies and lowering drug costs.
Biden’s proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders’ (I-Vt.) government-run “Medicare for All” health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.
To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this “public option” initiative in 2009 during the congressional debate over the ACA.
The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.
“It is hard to find a reform idea that is more popular than opening up Medicare” to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.
The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson’s Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, though they have to wait until age 66 for full benefits.
While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they’re old enough.
Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It’s unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.
Avalere says 3.2 million people in that age group buy coverage on the individual market.
While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.
About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to also pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out-of-pocket.
Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.
Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. “Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates,” he said.
“Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole,” he said.
President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry’s prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.
Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and workplace health coverage.
Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.
Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.
“Congress is not good at parallel processing,” Hacker said, referring to handling multiple priorities at the same time. “And the window is relatively short.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Of his many plans to expand insurance coverage, President-elect Joe Biden’s simplest strategy is lowering the eligibility age for Medicare from 65 to 60.
But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.
Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation’s hospitals, a powerful political force, are poised to derail any effort.
“Hospitals certainly are not going to be happy with it,” said Jonathan Oberlander, professor of health policy and management at the University of North Carolina at Chapel Hill.
Medicare reimbursement rates for patients admitted to hospitals average half what commercial or employer-sponsored insurance plans pay.
“It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this,” said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.
Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can’t find jobs with health benefits.
“It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs,” Biden wrote in April.
Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a KFF tracking poll from January 2019. (KHN is an editorially independent program of KFF.)
Although opposition from the hospital industry is expected to be fierce, that is not the only obstacle to Biden’s plan.
Critics, especially Republicans on Capitol Hill, will point to the nation’s $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won’t be enough money to fully pay hospitals and nursing homes for inpatient care for Medicare beneficiaries.
Moreover, it’s unclear whether expanding Medicare will fit on the Democrats’ crowded health agenda, which also includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act if the Supreme Court strikes down part or all of the law in a current case, expanding Obamacare subsidies and lowering drug costs.
Biden’s proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders’ (I-Vt.) government-run “Medicare for All” health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.
To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this “public option” initiative in 2009 during the congressional debate over the ACA.
The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.
“It is hard to find a reform idea that is more popular than opening up Medicare” to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.
The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson’s Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, though they have to wait until age 66 for full benefits.
While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they’re old enough.
Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It’s unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.
Avalere says 3.2 million people in that age group buy coverage on the individual market.
While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.
About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to also pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out-of-pocket.
Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.
Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. “Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates,” he said.
“Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole,” he said.
President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry’s prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.
Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and workplace health coverage.
Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.
Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.
“Congress is not good at parallel processing,” Hacker said, referring to handling multiple priorities at the same time. “And the window is relatively short.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Of his many plans to expand insurance coverage, President-elect Joe Biden’s simplest strategy is lowering the eligibility age for Medicare from 65 to 60.
But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.
Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation’s hospitals, a powerful political force, are poised to derail any effort.
“Hospitals certainly are not going to be happy with it,” said Jonathan Oberlander, professor of health policy and management at the University of North Carolina at Chapel Hill.
Medicare reimbursement rates for patients admitted to hospitals average half what commercial or employer-sponsored insurance plans pay.
“It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this,” said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.
Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can’t find jobs with health benefits.
“It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs,” Biden wrote in April.
Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a KFF tracking poll from January 2019. (KHN is an editorially independent program of KFF.)
Although opposition from the hospital industry is expected to be fierce, that is not the only obstacle to Biden’s plan.
Critics, especially Republicans on Capitol Hill, will point to the nation’s $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won’t be enough money to fully pay hospitals and nursing homes for inpatient care for Medicare beneficiaries.
Moreover, it’s unclear whether expanding Medicare will fit on the Democrats’ crowded health agenda, which also includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act if the Supreme Court strikes down part or all of the law in a current case, expanding Obamacare subsidies and lowering drug costs.
Biden’s proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders’ (I-Vt.) government-run “Medicare for All” health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.
To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this “public option” initiative in 2009 during the congressional debate over the ACA.
The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.
“It is hard to find a reform idea that is more popular than opening up Medicare” to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.
The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson’s Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, though they have to wait until age 66 for full benefits.
While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they’re old enough.
Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It’s unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.
Avalere says 3.2 million people in that age group buy coverage on the individual market.
While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.
About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to also pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out-of-pocket.
Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.
Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. “Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates,” he said.
“Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole,” he said.
President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry’s prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.
Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and workplace health coverage.
Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.
Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.
“Congress is not good at parallel processing,” Hacker said, referring to handling multiple priorities at the same time. “And the window is relatively short.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Fenway data, the final frontier
Data, as we all know, have taken over the world. ”
Statistical objectivity is in, individuality is out. You may have taught for 30 years and gained a sense for which child has a problem that needs intervention and which one just needs patience and time to develop. You may have managed patients for decades and have a hunch about who needs immediate help and who can be watched. But “senses” and “hunches” can’t be measured and therefore do not exist, or better, don’t count. Numbers count!
Data-obsession reflects what Germans call the Zeitgeist, the spirit of the age. But the Germans will have to come up with a different word for our age, won’t they? Nobody can measure a “spirit.”
Still, you know the spirit’s there, when it knocks you over and stomps on you.
The one sphere of life that has resisted being reduced to numbers is sports. In sports, you don’t need complex analysis to know who’s No. 1 and who’s number everything else. No. 1 crosses the finish line first, wins the most games, knocks out the opponent. The one lying on the mat is No. 2.
Of course, sports always had lots of numbers. Baseball fans have always known about batting averages, runs batted in, earned run averages. But there were always those individual intangibles that goggle the eyes of small boys and keep sportswriters in business: this athlete’s “ferocious drive,” that one’s “will to win,” the way a third “always comes through in the clutch.” Pitchers who couldn’t throw fast anymore were “crafty.” Grizzled, tobacco-chewing scouts could sense which youngster “looked like a ballplayer.”
As if you didn’t already know, you can tell how old I am to talk this way. Bill James and his statistical acolytes put paid to that old kind of thinking a long time ago. Read Moneyball or see the movie. In sports too, it’s now all about the stats.
To generate flagging interest among the young for America’s now-stodgy pastime, Major League Baseball has brought out Statcast 2.0., which adds, according to a recent news story, “Doppler-based tracking of pitch velocity, exit velocity, launch angles, and spin rates, and defensive tracking of players.” Multicamera arrays produce “biomechanical imaging and skeletal models that can help pitchers with delivery issues or batters with swing path quandaries.”
And so we have lots of new data to ponder: exit velocity – how fast a hit ball leaves the bat; launch angle – what angle it leaves at; spin rate – how fast a thrown curveball spins; and defensive tracking – how many feet this shortstop can move left to snag a ground ball, or a right-fielder to catch a fly. And there are new, composite stats, like OPS (on-base plus slugging). I will not try to explain OPS, because it is a mathematical abstraction that I cannot grasp. It signifies a blend of on-base percentage and slugging percentage, which to me is like what you get when you blend a tomato with a broccoli. Or something.
And, stats aside, you do still have to win. Not long ago the Boston Red Sox had a relief pitcher whose spin rate was splendid, but he couldn’t get anybody out.
The real aim of the new broadcast innovations noted above comes at the end of the report:
In an effort to at least reach, if not grow, a younger fan base, MLB from now on will focus on video engagement, gaming, and augmented reality on Snapchat.
You got it: the goal is to reduce baseball to a video game, and its players to gaming characters, perhaps with big contracts and marketing deals. Hey, check out that dude’s OPS!
You can’t measure a Zeitgeist, but you certainly know when it’s sitting on your chest. Your respirations get depressed. Measurably.
Yeah, I sound like every cranky old man in history. But hey – I’m Emeritus! See this column’s title!
In addition, the article has one more detail:
Curiosity about whether a fly ball to deep right field at Fenway Park would be a home run at Yankee Stadium can be satisfied by overlaying the Yankee Stadium footprint on top of Fenway.
Maybe it would satisfy you, buddy, but anything that superimposes Yankee Stadium on top of Fenway Park dissatisfies me by a factor of 6.7!
Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now semiretired, after 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available online. Write to him at dermnews@mdedge.com.
Data, as we all know, have taken over the world. ”
Statistical objectivity is in, individuality is out. You may have taught for 30 years and gained a sense for which child has a problem that needs intervention and which one just needs patience and time to develop. You may have managed patients for decades and have a hunch about who needs immediate help and who can be watched. But “senses” and “hunches” can’t be measured and therefore do not exist, or better, don’t count. Numbers count!
Data-obsession reflects what Germans call the Zeitgeist, the spirit of the age. But the Germans will have to come up with a different word for our age, won’t they? Nobody can measure a “spirit.”
Still, you know the spirit’s there, when it knocks you over and stomps on you.
The one sphere of life that has resisted being reduced to numbers is sports. In sports, you don’t need complex analysis to know who’s No. 1 and who’s number everything else. No. 1 crosses the finish line first, wins the most games, knocks out the opponent. The one lying on the mat is No. 2.
Of course, sports always had lots of numbers. Baseball fans have always known about batting averages, runs batted in, earned run averages. But there were always those individual intangibles that goggle the eyes of small boys and keep sportswriters in business: this athlete’s “ferocious drive,” that one’s “will to win,” the way a third “always comes through in the clutch.” Pitchers who couldn’t throw fast anymore were “crafty.” Grizzled, tobacco-chewing scouts could sense which youngster “looked like a ballplayer.”
As if you didn’t already know, you can tell how old I am to talk this way. Bill James and his statistical acolytes put paid to that old kind of thinking a long time ago. Read Moneyball or see the movie. In sports too, it’s now all about the stats.
To generate flagging interest among the young for America’s now-stodgy pastime, Major League Baseball has brought out Statcast 2.0., which adds, according to a recent news story, “Doppler-based tracking of pitch velocity, exit velocity, launch angles, and spin rates, and defensive tracking of players.” Multicamera arrays produce “biomechanical imaging and skeletal models that can help pitchers with delivery issues or batters with swing path quandaries.”
And so we have lots of new data to ponder: exit velocity – how fast a hit ball leaves the bat; launch angle – what angle it leaves at; spin rate – how fast a thrown curveball spins; and defensive tracking – how many feet this shortstop can move left to snag a ground ball, or a right-fielder to catch a fly. And there are new, composite stats, like OPS (on-base plus slugging). I will not try to explain OPS, because it is a mathematical abstraction that I cannot grasp. It signifies a blend of on-base percentage and slugging percentage, which to me is like what you get when you blend a tomato with a broccoli. Or something.
And, stats aside, you do still have to win. Not long ago the Boston Red Sox had a relief pitcher whose spin rate was splendid, but he couldn’t get anybody out.
The real aim of the new broadcast innovations noted above comes at the end of the report:
In an effort to at least reach, if not grow, a younger fan base, MLB from now on will focus on video engagement, gaming, and augmented reality on Snapchat.
You got it: the goal is to reduce baseball to a video game, and its players to gaming characters, perhaps with big contracts and marketing deals. Hey, check out that dude’s OPS!
You can’t measure a Zeitgeist, but you certainly know when it’s sitting on your chest. Your respirations get depressed. Measurably.
Yeah, I sound like every cranky old man in history. But hey – I’m Emeritus! See this column’s title!
In addition, the article has one more detail:
Curiosity about whether a fly ball to deep right field at Fenway Park would be a home run at Yankee Stadium can be satisfied by overlaying the Yankee Stadium footprint on top of Fenway.
Maybe it would satisfy you, buddy, but anything that superimposes Yankee Stadium on top of Fenway Park dissatisfies me by a factor of 6.7!
Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now semiretired, after 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available online. Write to him at dermnews@mdedge.com.
Data, as we all know, have taken over the world. ”
Statistical objectivity is in, individuality is out. You may have taught for 30 years and gained a sense for which child has a problem that needs intervention and which one just needs patience and time to develop. You may have managed patients for decades and have a hunch about who needs immediate help and who can be watched. But “senses” and “hunches” can’t be measured and therefore do not exist, or better, don’t count. Numbers count!
Data-obsession reflects what Germans call the Zeitgeist, the spirit of the age. But the Germans will have to come up with a different word for our age, won’t they? Nobody can measure a “spirit.”
Still, you know the spirit’s there, when it knocks you over and stomps on you.
The one sphere of life that has resisted being reduced to numbers is sports. In sports, you don’t need complex analysis to know who’s No. 1 and who’s number everything else. No. 1 crosses the finish line first, wins the most games, knocks out the opponent. The one lying on the mat is No. 2.
Of course, sports always had lots of numbers. Baseball fans have always known about batting averages, runs batted in, earned run averages. But there were always those individual intangibles that goggle the eyes of small boys and keep sportswriters in business: this athlete’s “ferocious drive,” that one’s “will to win,” the way a third “always comes through in the clutch.” Pitchers who couldn’t throw fast anymore were “crafty.” Grizzled, tobacco-chewing scouts could sense which youngster “looked like a ballplayer.”
As if you didn’t already know, you can tell how old I am to talk this way. Bill James and his statistical acolytes put paid to that old kind of thinking a long time ago. Read Moneyball or see the movie. In sports too, it’s now all about the stats.
To generate flagging interest among the young for America’s now-stodgy pastime, Major League Baseball has brought out Statcast 2.0., which adds, according to a recent news story, “Doppler-based tracking of pitch velocity, exit velocity, launch angles, and spin rates, and defensive tracking of players.” Multicamera arrays produce “biomechanical imaging and skeletal models that can help pitchers with delivery issues or batters with swing path quandaries.”
And so we have lots of new data to ponder: exit velocity – how fast a hit ball leaves the bat; launch angle – what angle it leaves at; spin rate – how fast a thrown curveball spins; and defensive tracking – how many feet this shortstop can move left to snag a ground ball, or a right-fielder to catch a fly. And there are new, composite stats, like OPS (on-base plus slugging). I will not try to explain OPS, because it is a mathematical abstraction that I cannot grasp. It signifies a blend of on-base percentage and slugging percentage, which to me is like what you get when you blend a tomato with a broccoli. Or something.
And, stats aside, you do still have to win. Not long ago the Boston Red Sox had a relief pitcher whose spin rate was splendid, but he couldn’t get anybody out.
The real aim of the new broadcast innovations noted above comes at the end of the report:
In an effort to at least reach, if not grow, a younger fan base, MLB from now on will focus on video engagement, gaming, and augmented reality on Snapchat.
You got it: the goal is to reduce baseball to a video game, and its players to gaming characters, perhaps with big contracts and marketing deals. Hey, check out that dude’s OPS!
You can’t measure a Zeitgeist, but you certainly know when it’s sitting on your chest. Your respirations get depressed. Measurably.
Yeah, I sound like every cranky old man in history. But hey – I’m Emeritus! See this column’s title!
In addition, the article has one more detail:
Curiosity about whether a fly ball to deep right field at Fenway Park would be a home run at Yankee Stadium can be satisfied by overlaying the Yankee Stadium footprint on top of Fenway.
Maybe it would satisfy you, buddy, but anything that superimposes Yankee Stadium on top of Fenway Park dissatisfies me by a factor of 6.7!
Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now semiretired, after 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available online. Write to him at dermnews@mdedge.com.
Trump could clean house at health agencies
Others may soon depart voluntarily. Politico reported in late October that more than two dozen political appointees had already left the U.S. Department Health and Human Services (HHS) since the start of the COVID-19 pandemic in February and that potentially dozens of the more than 100 in the department would leave if Trump was not reelected.
Trump hasn’t conceded, he is challenging the election results, and he has already fired his Defense Secretary, Mark Esper.
Among those possibly in Trump’s sights: HHS Secretary Alex Azar, US Food and Drug Administration (FDA) Commissioner Stephen Hahn, MD, Centers for Disease Control and Prevention (CDC) Director Robert Redfield, MD, and White House Coronavirus Task Force member Anthony Fauci, MD, who is also the director of the National Institutes of Allergy and Infectious Diseases.
Seema Verma, the administrator of the Centers for Medicare & Medicaid Services (CMS), is likely safe. According to Politico, Verma is expected to leave on her own terms.
Azar has had a long run as a Trump appointee. He took office in January 2018 and has been a staunch loyalist. But he’s frequently been the butt of grousing by Trump for not doing enough to help lower drug prices and for his handling of the coronavirus pandemic. Azar was initially in charge of the Trump virus effort but was quickly replaced by Vice President Mike Pence.
It was widely reported in late April that Trump was considering firing Azar, but the president called that “fake news” in a tweet.
Azar has complained about Hahn, who was confirmed in December 2019. According to Politico, Azar was looking into how to remove Hahn as commissioner because of the FDA’s battle with the White House over standards for emergency use authorization of a coronavirus vaccine.
In addition, Trump was infuriated by the agency’s insistence that it stick to the highest bar for an emergency approval. “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd,” Trump tweeted at Hahn.
Fauci on the firing line?
Most of the president’s ire has been directed at Fauci. As far back as April, Trump retweeted a call for Fauci’s firing. Twitter removed the original tweet but kept Trump’s comments on the original tweet.
The president has frequently questioned Fauci’s advice, sidelined him from task force meetings, and infrequently met with him. Trump called Fauci a “disaster” during a call with supporters in October, and then, at a campaign rally in November, intimated that he would fire the scientist after the election, according to The Washington Post.
But such a firing cannot be easily done. Some have speculated that Trump could pressure Fauci’s boss, Francis Collins, MD, PhD — the director of the National Institutes of Health (NIH), who is a political appointee — to get rid of him. But Collins would have to come up with a reason to fire Fauci. Because he is not a political appointee, Fauci is afforded a raft of protections given to civil service employees of the federal government.
To demote or fire Fauci, Collins would have to give him 30 days’ notice unless there’s a belief that he committed a crime. Fauci would have at least a week to offer evidence and affidavits in support of his service.
He’d also be entitled to legal representation, a written decision, and the specific reasons for the action being taken quickly. He could also request a hearing, and he’d be able to appeal any action to the Merit Systems Protection Board. The process could take months, if not years.
In late October, Trump issued an executive order that would reclassify certain federal employees so that they wouldn’t have such protections. But agencies have until mid-January to come up with lists of such workers, according to Government Executive.
Collins has been with NIH since 1993, when he headed the Human Genome Project and the National Human Genome Research Institute. Politico has speculated that Collins, 70, might retire if Trump was reelected. It’s unclear what he’ll do now.
Redfield, who has taken heat for his leadership from many in public health — and was asked in October to stand up to Trump by former CDC Director William H. Foege, MD — has been openly contradicted by the president on more than one occasion, according to The New York Times.
In September, The Hill reported that Trump told reporters that he’d chastised Redfield by phone soon after Redfield had told a Senate committee that a coronavirus vaccine would not be available until mid-2021.
This article first appeared on Medscape.com.
Others may soon depart voluntarily. Politico reported in late October that more than two dozen political appointees had already left the U.S. Department Health and Human Services (HHS) since the start of the COVID-19 pandemic in February and that potentially dozens of the more than 100 in the department would leave if Trump was not reelected.
Trump hasn’t conceded, he is challenging the election results, and he has already fired his Defense Secretary, Mark Esper.
Among those possibly in Trump’s sights: HHS Secretary Alex Azar, US Food and Drug Administration (FDA) Commissioner Stephen Hahn, MD, Centers for Disease Control and Prevention (CDC) Director Robert Redfield, MD, and White House Coronavirus Task Force member Anthony Fauci, MD, who is also the director of the National Institutes of Allergy and Infectious Diseases.
Seema Verma, the administrator of the Centers for Medicare & Medicaid Services (CMS), is likely safe. According to Politico, Verma is expected to leave on her own terms.
Azar has had a long run as a Trump appointee. He took office in January 2018 and has been a staunch loyalist. But he’s frequently been the butt of grousing by Trump for not doing enough to help lower drug prices and for his handling of the coronavirus pandemic. Azar was initially in charge of the Trump virus effort but was quickly replaced by Vice President Mike Pence.
It was widely reported in late April that Trump was considering firing Azar, but the president called that “fake news” in a tweet.
Azar has complained about Hahn, who was confirmed in December 2019. According to Politico, Azar was looking into how to remove Hahn as commissioner because of the FDA’s battle with the White House over standards for emergency use authorization of a coronavirus vaccine.
In addition, Trump was infuriated by the agency’s insistence that it stick to the highest bar for an emergency approval. “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd,” Trump tweeted at Hahn.
Fauci on the firing line?
Most of the president’s ire has been directed at Fauci. As far back as April, Trump retweeted a call for Fauci’s firing. Twitter removed the original tweet but kept Trump’s comments on the original tweet.
The president has frequently questioned Fauci’s advice, sidelined him from task force meetings, and infrequently met with him. Trump called Fauci a “disaster” during a call with supporters in October, and then, at a campaign rally in November, intimated that he would fire the scientist after the election, according to The Washington Post.
But such a firing cannot be easily done. Some have speculated that Trump could pressure Fauci’s boss, Francis Collins, MD, PhD — the director of the National Institutes of Health (NIH), who is a political appointee — to get rid of him. But Collins would have to come up with a reason to fire Fauci. Because he is not a political appointee, Fauci is afforded a raft of protections given to civil service employees of the federal government.
To demote or fire Fauci, Collins would have to give him 30 days’ notice unless there’s a belief that he committed a crime. Fauci would have at least a week to offer evidence and affidavits in support of his service.
He’d also be entitled to legal representation, a written decision, and the specific reasons for the action being taken quickly. He could also request a hearing, and he’d be able to appeal any action to the Merit Systems Protection Board. The process could take months, if not years.
In late October, Trump issued an executive order that would reclassify certain federal employees so that they wouldn’t have such protections. But agencies have until mid-January to come up with lists of such workers, according to Government Executive.
Collins has been with NIH since 1993, when he headed the Human Genome Project and the National Human Genome Research Institute. Politico has speculated that Collins, 70, might retire if Trump was reelected. It’s unclear what he’ll do now.
Redfield, who has taken heat for his leadership from many in public health — and was asked in October to stand up to Trump by former CDC Director William H. Foege, MD — has been openly contradicted by the president on more than one occasion, according to The New York Times.
In September, The Hill reported that Trump told reporters that he’d chastised Redfield by phone soon after Redfield had told a Senate committee that a coronavirus vaccine would not be available until mid-2021.
This article first appeared on Medscape.com.
Others may soon depart voluntarily. Politico reported in late October that more than two dozen political appointees had already left the U.S. Department Health and Human Services (HHS) since the start of the COVID-19 pandemic in February and that potentially dozens of the more than 100 in the department would leave if Trump was not reelected.
Trump hasn’t conceded, he is challenging the election results, and he has already fired his Defense Secretary, Mark Esper.
Among those possibly in Trump’s sights: HHS Secretary Alex Azar, US Food and Drug Administration (FDA) Commissioner Stephen Hahn, MD, Centers for Disease Control and Prevention (CDC) Director Robert Redfield, MD, and White House Coronavirus Task Force member Anthony Fauci, MD, who is also the director of the National Institutes of Allergy and Infectious Diseases.
Seema Verma, the administrator of the Centers for Medicare & Medicaid Services (CMS), is likely safe. According to Politico, Verma is expected to leave on her own terms.
Azar has had a long run as a Trump appointee. He took office in January 2018 and has been a staunch loyalist. But he’s frequently been the butt of grousing by Trump for not doing enough to help lower drug prices and for his handling of the coronavirus pandemic. Azar was initially in charge of the Trump virus effort but was quickly replaced by Vice President Mike Pence.
It was widely reported in late April that Trump was considering firing Azar, but the president called that “fake news” in a tweet.
Azar has complained about Hahn, who was confirmed in December 2019. According to Politico, Azar was looking into how to remove Hahn as commissioner because of the FDA’s battle with the White House over standards for emergency use authorization of a coronavirus vaccine.
In addition, Trump was infuriated by the agency’s insistence that it stick to the highest bar for an emergency approval. “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd,” Trump tweeted at Hahn.
Fauci on the firing line?
Most of the president’s ire has been directed at Fauci. As far back as April, Trump retweeted a call for Fauci’s firing. Twitter removed the original tweet but kept Trump’s comments on the original tweet.
The president has frequently questioned Fauci’s advice, sidelined him from task force meetings, and infrequently met with him. Trump called Fauci a “disaster” during a call with supporters in October, and then, at a campaign rally in November, intimated that he would fire the scientist after the election, according to The Washington Post.
But such a firing cannot be easily done. Some have speculated that Trump could pressure Fauci’s boss, Francis Collins, MD, PhD — the director of the National Institutes of Health (NIH), who is a political appointee — to get rid of him. But Collins would have to come up with a reason to fire Fauci. Because he is not a political appointee, Fauci is afforded a raft of protections given to civil service employees of the federal government.
To demote or fire Fauci, Collins would have to give him 30 days’ notice unless there’s a belief that he committed a crime. Fauci would have at least a week to offer evidence and affidavits in support of his service.
He’d also be entitled to legal representation, a written decision, and the specific reasons for the action being taken quickly. He could also request a hearing, and he’d be able to appeal any action to the Merit Systems Protection Board. The process could take months, if not years.
In late October, Trump issued an executive order that would reclassify certain federal employees so that they wouldn’t have such protections. But agencies have until mid-January to come up with lists of such workers, according to Government Executive.
Collins has been with NIH since 1993, when he headed the Human Genome Project and the National Human Genome Research Institute. Politico has speculated that Collins, 70, might retire if Trump was reelected. It’s unclear what he’ll do now.
Redfield, who has taken heat for his leadership from many in public health — and was asked in October to stand up to Trump by former CDC Director William H. Foege, MD — has been openly contradicted by the president on more than one occasion, according to The New York Times.
In September, The Hill reported that Trump told reporters that he’d chastised Redfield by phone soon after Redfield had told a Senate committee that a coronavirus vaccine would not be available until mid-2021.
This article first appeared on Medscape.com.
Hospitalist Medicare payments are at risk for large cuts in 2021
Now is the time to act
From the beginning, SHM has consciously and consistently taken a unique approach to its advocacy efforts with the federal government. The advocacy priorities of SHM most often concern issues that we feel have an impact on our patients and the broader delivery system, as opposed to a focus on issues that have direct financial benefit to our members.
This strategy has served SHM well. It has earned respect among policymakers and we have seen significant success for a young and relatively small medical society. The issues where we spend the bulk of our time and effort include advocating for issues like alternative payment models (APMs), which reward care quality as opposed to volume, as well as issues related to data integrity that APMs require. We have advocated strongly for changes to dysfunctional observation status rules, for workforce adequacy and sustainability, and for recognition of the importance of hospital medicine’s contribution to the redesign of our nations delivery system. And SHM will continue to advocate for many other issues identified as being important to hospital medicine and our patients.
This year, for the first time in the two decades that I have served on the SHM Public Policy Committee, Medicare has proposed changes that would create unprecedented financial hardship for hospital medicine groups. Each year, as a part of its advocacy agenda, SHM reviews and comments on proposed changes to the Medicare Physician Fee Schedule (PFS). Among other things, the PFS adjusts payment rates to physicians for specific services. Changes under the PFS are required to be budget neutral. In effect, budget neutrality means that whenever certain services receive an increased payment rate, CMS is required to offset these changes by making cuts to other services. This year, in an effort to correct the long-standing underfunding of primary care services, CMS has increased payment for many Evaluation and Management (E&M) codes associated with outpatient primary care services. However, due to budget neutrality requirements, many inpatient E&M care services will be receiving significant cuts.
The goal of increasing payment rates for primary care services is laudable, as many of these cognitive services have been long underfunded. However, the proposed payment increases will only apply to outpatient E&M codes and not their corresponding inpatient codes. While our outpatient Internal Medicine and Family Practice colleagues will benefit from these changes, inpatient providers, including hospitalists, stand to lose a significant amount revenue. SHM and the hospitalists we represent estimate that the proposed budget neutrality adjustment will lead to an approximate 8 percent decrease in Medicare Fee for Services (FFS) revenue. Hospitalists are among the specialties that will be most impacted from these proposed changes. If put into effect, these proposals will leave hospital medicine behind.
These changes have been proposed at a time when hospitalists, along with their colleagues in critical care and emergency medicine, have been caring for patients on the frontlines of the COVID-19 pandemic at great risk to themselves at their families. While hospitalists are working tirelessly to provide lifesaving care to COVID-positive patients throughout the country, hospitalist groups have struggled financially as a result of the pandemic. Inpatient volumes, and therefore care reimbursement, has dropped significantly. Many hospitalists have already reported pay reductions of 20% or more. Others have seen their shifts reduced, resulting in understaffing, which may compromise the quality of care. For many groups, a Medicare reimbursement cut of this magnitude add fuel to an already strained revenue stream and will not be financially sustainable.
SHM is, of course, fighting back. We are not asking CMS to completely abandon the increases in reimbursement for primary care outpatient codes, and we support properly valuing outpatient care services. However, we are asking CMS to find a solution that does not come at the expense of hospital medicine and the other specialties that care for acutely ill hospitalized patients, including patients with COVID-19. If a better solution requires holding off on the proposal for another year, CMS should do so. Furthermore, SHM is asking Congress to abandon the statutory requirement for budget neutrality in these extraordinary times as CMS and Congress work to find towards a solution that properly values both inpatient and outpatient care services.
To send a message to your representatives urging them to stop these payment cuts, please visit SHM’s Legislative Action Center at www.votervoice.net/SHM/campaigns/77226/respond. You can read our full comments on the Medicare Physician Fee Schedule Proposed Rule at www.hospitalmedicine.org/policy--advocacy/letters/2021-physician-fee-schedule-proposed-rule/.
Now is the time to act
Now is the time to act
From the beginning, SHM has consciously and consistently taken a unique approach to its advocacy efforts with the federal government. The advocacy priorities of SHM most often concern issues that we feel have an impact on our patients and the broader delivery system, as opposed to a focus on issues that have direct financial benefit to our members.
This strategy has served SHM well. It has earned respect among policymakers and we have seen significant success for a young and relatively small medical society. The issues where we spend the bulk of our time and effort include advocating for issues like alternative payment models (APMs), which reward care quality as opposed to volume, as well as issues related to data integrity that APMs require. We have advocated strongly for changes to dysfunctional observation status rules, for workforce adequacy and sustainability, and for recognition of the importance of hospital medicine’s contribution to the redesign of our nations delivery system. And SHM will continue to advocate for many other issues identified as being important to hospital medicine and our patients.
This year, for the first time in the two decades that I have served on the SHM Public Policy Committee, Medicare has proposed changes that would create unprecedented financial hardship for hospital medicine groups. Each year, as a part of its advocacy agenda, SHM reviews and comments on proposed changes to the Medicare Physician Fee Schedule (PFS). Among other things, the PFS adjusts payment rates to physicians for specific services. Changes under the PFS are required to be budget neutral. In effect, budget neutrality means that whenever certain services receive an increased payment rate, CMS is required to offset these changes by making cuts to other services. This year, in an effort to correct the long-standing underfunding of primary care services, CMS has increased payment for many Evaluation and Management (E&M) codes associated with outpatient primary care services. However, due to budget neutrality requirements, many inpatient E&M care services will be receiving significant cuts.
The goal of increasing payment rates for primary care services is laudable, as many of these cognitive services have been long underfunded. However, the proposed payment increases will only apply to outpatient E&M codes and not their corresponding inpatient codes. While our outpatient Internal Medicine and Family Practice colleagues will benefit from these changes, inpatient providers, including hospitalists, stand to lose a significant amount revenue. SHM and the hospitalists we represent estimate that the proposed budget neutrality adjustment will lead to an approximate 8 percent decrease in Medicare Fee for Services (FFS) revenue. Hospitalists are among the specialties that will be most impacted from these proposed changes. If put into effect, these proposals will leave hospital medicine behind.
These changes have been proposed at a time when hospitalists, along with their colleagues in critical care and emergency medicine, have been caring for patients on the frontlines of the COVID-19 pandemic at great risk to themselves at their families. While hospitalists are working tirelessly to provide lifesaving care to COVID-positive patients throughout the country, hospitalist groups have struggled financially as a result of the pandemic. Inpatient volumes, and therefore care reimbursement, has dropped significantly. Many hospitalists have already reported pay reductions of 20% or more. Others have seen their shifts reduced, resulting in understaffing, which may compromise the quality of care. For many groups, a Medicare reimbursement cut of this magnitude add fuel to an already strained revenue stream and will not be financially sustainable.
SHM is, of course, fighting back. We are not asking CMS to completely abandon the increases in reimbursement for primary care outpatient codes, and we support properly valuing outpatient care services. However, we are asking CMS to find a solution that does not come at the expense of hospital medicine and the other specialties that care for acutely ill hospitalized patients, including patients with COVID-19. If a better solution requires holding off on the proposal for another year, CMS should do so. Furthermore, SHM is asking Congress to abandon the statutory requirement for budget neutrality in these extraordinary times as CMS and Congress work to find towards a solution that properly values both inpatient and outpatient care services.
To send a message to your representatives urging them to stop these payment cuts, please visit SHM’s Legislative Action Center at www.votervoice.net/SHM/campaigns/77226/respond. You can read our full comments on the Medicare Physician Fee Schedule Proposed Rule at www.hospitalmedicine.org/policy--advocacy/letters/2021-physician-fee-schedule-proposed-rule/.
From the beginning, SHM has consciously and consistently taken a unique approach to its advocacy efforts with the federal government. The advocacy priorities of SHM most often concern issues that we feel have an impact on our patients and the broader delivery system, as opposed to a focus on issues that have direct financial benefit to our members.
This strategy has served SHM well. It has earned respect among policymakers and we have seen significant success for a young and relatively small medical society. The issues where we spend the bulk of our time and effort include advocating for issues like alternative payment models (APMs), which reward care quality as opposed to volume, as well as issues related to data integrity that APMs require. We have advocated strongly for changes to dysfunctional observation status rules, for workforce adequacy and sustainability, and for recognition of the importance of hospital medicine’s contribution to the redesign of our nations delivery system. And SHM will continue to advocate for many other issues identified as being important to hospital medicine and our patients.
This year, for the first time in the two decades that I have served on the SHM Public Policy Committee, Medicare has proposed changes that would create unprecedented financial hardship for hospital medicine groups. Each year, as a part of its advocacy agenda, SHM reviews and comments on proposed changes to the Medicare Physician Fee Schedule (PFS). Among other things, the PFS adjusts payment rates to physicians for specific services. Changes under the PFS are required to be budget neutral. In effect, budget neutrality means that whenever certain services receive an increased payment rate, CMS is required to offset these changes by making cuts to other services. This year, in an effort to correct the long-standing underfunding of primary care services, CMS has increased payment for many Evaluation and Management (E&M) codes associated with outpatient primary care services. However, due to budget neutrality requirements, many inpatient E&M care services will be receiving significant cuts.
The goal of increasing payment rates for primary care services is laudable, as many of these cognitive services have been long underfunded. However, the proposed payment increases will only apply to outpatient E&M codes and not their corresponding inpatient codes. While our outpatient Internal Medicine and Family Practice colleagues will benefit from these changes, inpatient providers, including hospitalists, stand to lose a significant amount revenue. SHM and the hospitalists we represent estimate that the proposed budget neutrality adjustment will lead to an approximate 8 percent decrease in Medicare Fee for Services (FFS) revenue. Hospitalists are among the specialties that will be most impacted from these proposed changes. If put into effect, these proposals will leave hospital medicine behind.
These changes have been proposed at a time when hospitalists, along with their colleagues in critical care and emergency medicine, have been caring for patients on the frontlines of the COVID-19 pandemic at great risk to themselves at their families. While hospitalists are working tirelessly to provide lifesaving care to COVID-positive patients throughout the country, hospitalist groups have struggled financially as a result of the pandemic. Inpatient volumes, and therefore care reimbursement, has dropped significantly. Many hospitalists have already reported pay reductions of 20% or more. Others have seen their shifts reduced, resulting in understaffing, which may compromise the quality of care. For many groups, a Medicare reimbursement cut of this magnitude add fuel to an already strained revenue stream and will not be financially sustainable.
SHM is, of course, fighting back. We are not asking CMS to completely abandon the increases in reimbursement for primary care outpatient codes, and we support properly valuing outpatient care services. However, we are asking CMS to find a solution that does not come at the expense of hospital medicine and the other specialties that care for acutely ill hospitalized patients, including patients with COVID-19. If a better solution requires holding off on the proposal for another year, CMS should do so. Furthermore, SHM is asking Congress to abandon the statutory requirement for budget neutrality in these extraordinary times as CMS and Congress work to find towards a solution that properly values both inpatient and outpatient care services.
To send a message to your representatives urging them to stop these payment cuts, please visit SHM’s Legislative Action Center at www.votervoice.net/SHM/campaigns/77226/respond. You can read our full comments on the Medicare Physician Fee Schedule Proposed Rule at www.hospitalmedicine.org/policy--advocacy/letters/2021-physician-fee-schedule-proposed-rule/.
Supreme Court Justices seem skeptical of case to overturn ACA
The Justices conducted arguments by telephone in the case, California v Texas (previously California v US), which was brought by 18 Republican state officials and two individual plaintiffs. The Trump administration joined the plaintiffs in June, arguing that the entire law should be overturned. The ACA is being defended by Democratic state officials from 16 states and Washington, D.C.
The Republican plaintiffs have essentially argued that the ACA cannot stand without the individual mandate requirement – that it is not possible to “sever” it from the rest of the Act. In 2017, Congress set the tax penalty to $0 if an individual did not buy insurance. The mandate to buy insurance was left in place, but there were no longer any consequences. The plaintiffs said that congressional act was equivalent to severing the mandate.
But many Justices appeared to take a dim view of that argument.
“It’s a very straightforward case for severability under our precedents,” said Justice Brett Kavanaugh. “Meaning that we would excise the mandate and leave the rest of the Act in play. Congress knows how to write an inseverability clause and that is not the language that they chose here,” he said.
Justice Elena Kagan also questioned how it would jibe with legal precedent to allow the severing of one part of a law when there was no clear instruction from Congress on the issue. She also raised the concern that it would open the door to all sorts of challenges.
“It would seem a big deal to say that, if you can point to injury with respect to one provision and you can concoct some kind of inseverability argument, that allows you to challenge anything else in the statute,” she said.
“Isn’t that something that really cuts against all of our doctrine?” asked Kagan.
“I think it’s hard for you to argue that Congress intended the entire Act to fall if the mandate was struck down when the same Congress that lowered the penalty to zero did not even try to repeal the rest of the act,” said Chief Justice John Roberts.
“I think, frankly, that they wanted the Court to do that but that’s not our job,” he added.
Proof of harm?
To have the standing to sue, the plaintiffs have to prove they have been harmed by the ACA. Texas Solicitor General Kyle Hawkins said that individuals feel compelled to buy insurance – even without a penalty hanging over their heads.
Justice Stephen Breyer argued that many laws include what he called “precatory” language – that is, they seek to compel citizens to do something. But most don’t penalize those who fail to act – just like the ACA currently.
If, as the Texas plaintiffs argued, it’s still unconstitutional to make such a request, “I think there will be an awful lot of language in an awful lot of statutes that will suddenly be the subject of court constitutional challenge,” he said.
Hawkins disagreed. He said the ACA’s mandate “is not some suggestion, not some hortatory statement. It is the law of the United States of America today that you have to purchase health insurance and not just any health insurance, but health insurance that the federal government has decided would be best for you.”
Hawkins said that, if just one additional person signed up for Medicaid, the state of Texas and the other plaintiff states would be harmed. He said people were continuing to enroll in the program because they believed the law required them to get health insurance.
Justice Sonia Sotomayor said that defied common sense. “The problem is that your theory assumes people that people are going to pay a tax and break the law by not buying insurance, but they wouldn’t do it when the tax is zero.”
What’s at stake
It’s unlikely the justices will issue a decision immediately. They have until the end of the term in June to rule.
Katie Keith, JD, MPH, a principal at Keith Policy Solutions, LLC, outlined the potential outcomes in Health Affairs .
“The most likely scenario is that the Court maintains the status quo,” she wrote. They could get there by deciding Texas et al. did not have standing to bring the case. Or they could decide that either the mandate is constitutional or that it is unconstitutional but can be severed from the rest of the ACA.
The Court could alternatively find that some or all of the law’s insurance provisions – such as protections for people with pre-existing conditions – can’t be severed from the mandate. Or the justices could strike down all of the insurance consumer protections, the health insurance marketplaces, premium tax credits, and other provisions, which would force states to come up with the money to help people buy insurance. And states are unlikely to be able to do so, especially with the pandemic stretching their budgets.
Finally, the Court could find that the mandate can’t be separated, which would essentially overturn the law.
If that happens, some 15 million people could lose Medicaid coverage, 11 million who buy on health insurance exchanges could lose coverage, and 2.3 million young adults would no longer be able to stay on parents’ policies, according to the Kaiser Family Foundation. Kaiser also estimates that 54 million people under age 65 who have pre-existing conditions would no longer be guaranteed coverage.
The Urban Institute estimates that 21 million people could lose insurance – 15 million through Medicaid and the Children’s Health Insurance Program (CHIP) and 7.6 million through private nongroup coverage.
Medical societies weigh in
Multiple physicians’ groups, patient advocates, and hospital organizations have filed briefs with the Court in favor of keeping the law intact.
Twenty patient groups representing millions with pre-existing conditions – including the American Cancer Society, American Diabetes Association, American Heart Association, National Alliance on Mental Illness, National Organization for Rare Disorders, and the Kennedy Forum – filed a court brief in May arguing that the law has expanded access to insurance and improved patient outcomes.
“The coronavirus pandemic has only served to underscore the necessity of meaningful coverage – especially for those who are at high risk of being severely affected by the virus – including countless Americans who have pre-existing, acute or chronic conditions like heart disease, cancer, diabetes, lung diseases and multiple sclerosis,” they said in a statement.
Jacqueline W. Fincher, MD, MACP, president of the American College of Physicians, which joined a court brief in support of the law with 19 other medical organizations, said the law has worked.
“The coverage, protections and benefits provided by the ACA are critical to the well-being of millions of Americans,” she said in a statement.
“If the ACA were to be thrown out at the same time that we face the pandemic, it would cause chaos for physicians and our patients, and for the entire health care system,” said Fincher, adding that millions of Americans who have been infected could lose insurance if protections for pre-existing conditions disappeared.
“The ACA has revolutionized access to care for tens of millions of women by helping them obtain meaningful health coverage, ensuring that essential care is covered by insurers, and protecting patients from unfair insurance practices,” said Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists (ACOG), in a statement.
Overturning the ACA “would be one of the most singularly disruptive acts to be committed during this public health crisis,” she said.
American Psychiatric Association President Jeffrey Geller, MD, MPH, also warned of disruptions to care, especially for those with mental health and substance use disorders. “We urge the Supreme Court to preserve the entire Act, including the individual mandate,” he said, in a statement.
“In the midst of COVID is no time to let down the millions who we serve as our patients,” said Chip Kahn, Federation of American Health Systems president and CEO, in a statement.
“As caregivers, the goal of hospitals for our patients is to see increased access to affordable coverage for all Americans – not new obstacles,” he said, adding that the ACA “can accomplish this goal. We hope the Supreme Court will see its way clear to allow it to go forward.”
For the defense
Many legal analysts on social media who listened in to today’s hearing agreed that the tenor of the proceedings seemed to lean toward survival of the ACA.
“At this point I would say it is *extremely* likely that the ACA will be upheld, but the mandate struck down and severed out,” tweeted Raffi Melkonian, an appellate lawyer in Houston, Texas. “A decision on standing (throwing out the case entirely) is also possible. The chance that the ACA is struck down v. low.”
“Both Kavanaugh and Roberts have suggested this morning that they may view the individual mandate as severable from the rest of the law. If those two justices join the court’s three liberals in finding that the mandate is severable, that would be five votes to save the ACA,” tweeted the analysts at SCOTUS Blog.
Sean Marotta, a lawyer with Hogan Lovells’ Supreme Court group, agreed. “Oral argument is always an imperfect measure, but the Act’s defenders should feel good today,” he tweeted.
This article first appeared on Medscape.com.
The Justices conducted arguments by telephone in the case, California v Texas (previously California v US), which was brought by 18 Republican state officials and two individual plaintiffs. The Trump administration joined the plaintiffs in June, arguing that the entire law should be overturned. The ACA is being defended by Democratic state officials from 16 states and Washington, D.C.
The Republican plaintiffs have essentially argued that the ACA cannot stand without the individual mandate requirement – that it is not possible to “sever” it from the rest of the Act. In 2017, Congress set the tax penalty to $0 if an individual did not buy insurance. The mandate to buy insurance was left in place, but there were no longer any consequences. The plaintiffs said that congressional act was equivalent to severing the mandate.
But many Justices appeared to take a dim view of that argument.
“It’s a very straightforward case for severability under our precedents,” said Justice Brett Kavanaugh. “Meaning that we would excise the mandate and leave the rest of the Act in play. Congress knows how to write an inseverability clause and that is not the language that they chose here,” he said.
Justice Elena Kagan also questioned how it would jibe with legal precedent to allow the severing of one part of a law when there was no clear instruction from Congress on the issue. She also raised the concern that it would open the door to all sorts of challenges.
“It would seem a big deal to say that, if you can point to injury with respect to one provision and you can concoct some kind of inseverability argument, that allows you to challenge anything else in the statute,” she said.
“Isn’t that something that really cuts against all of our doctrine?” asked Kagan.
“I think it’s hard for you to argue that Congress intended the entire Act to fall if the mandate was struck down when the same Congress that lowered the penalty to zero did not even try to repeal the rest of the act,” said Chief Justice John Roberts.
“I think, frankly, that they wanted the Court to do that but that’s not our job,” he added.
Proof of harm?
To have the standing to sue, the plaintiffs have to prove they have been harmed by the ACA. Texas Solicitor General Kyle Hawkins said that individuals feel compelled to buy insurance – even without a penalty hanging over their heads.
Justice Stephen Breyer argued that many laws include what he called “precatory” language – that is, they seek to compel citizens to do something. But most don’t penalize those who fail to act – just like the ACA currently.
If, as the Texas plaintiffs argued, it’s still unconstitutional to make such a request, “I think there will be an awful lot of language in an awful lot of statutes that will suddenly be the subject of court constitutional challenge,” he said.
Hawkins disagreed. He said the ACA’s mandate “is not some suggestion, not some hortatory statement. It is the law of the United States of America today that you have to purchase health insurance and not just any health insurance, but health insurance that the federal government has decided would be best for you.”
Hawkins said that, if just one additional person signed up for Medicaid, the state of Texas and the other plaintiff states would be harmed. He said people were continuing to enroll in the program because they believed the law required them to get health insurance.
Justice Sonia Sotomayor said that defied common sense. “The problem is that your theory assumes people that people are going to pay a tax and break the law by not buying insurance, but they wouldn’t do it when the tax is zero.”
What’s at stake
It’s unlikely the justices will issue a decision immediately. They have until the end of the term in June to rule.
Katie Keith, JD, MPH, a principal at Keith Policy Solutions, LLC, outlined the potential outcomes in Health Affairs .
“The most likely scenario is that the Court maintains the status quo,” she wrote. They could get there by deciding Texas et al. did not have standing to bring the case. Or they could decide that either the mandate is constitutional or that it is unconstitutional but can be severed from the rest of the ACA.
The Court could alternatively find that some or all of the law’s insurance provisions – such as protections for people with pre-existing conditions – can’t be severed from the mandate. Or the justices could strike down all of the insurance consumer protections, the health insurance marketplaces, premium tax credits, and other provisions, which would force states to come up with the money to help people buy insurance. And states are unlikely to be able to do so, especially with the pandemic stretching their budgets.
Finally, the Court could find that the mandate can’t be separated, which would essentially overturn the law.
If that happens, some 15 million people could lose Medicaid coverage, 11 million who buy on health insurance exchanges could lose coverage, and 2.3 million young adults would no longer be able to stay on parents’ policies, according to the Kaiser Family Foundation. Kaiser also estimates that 54 million people under age 65 who have pre-existing conditions would no longer be guaranteed coverage.
The Urban Institute estimates that 21 million people could lose insurance – 15 million through Medicaid and the Children’s Health Insurance Program (CHIP) and 7.6 million through private nongroup coverage.
Medical societies weigh in
Multiple physicians’ groups, patient advocates, and hospital organizations have filed briefs with the Court in favor of keeping the law intact.
Twenty patient groups representing millions with pre-existing conditions – including the American Cancer Society, American Diabetes Association, American Heart Association, National Alliance on Mental Illness, National Organization for Rare Disorders, and the Kennedy Forum – filed a court brief in May arguing that the law has expanded access to insurance and improved patient outcomes.
“The coronavirus pandemic has only served to underscore the necessity of meaningful coverage – especially for those who are at high risk of being severely affected by the virus – including countless Americans who have pre-existing, acute or chronic conditions like heart disease, cancer, diabetes, lung diseases and multiple sclerosis,” they said in a statement.
Jacqueline W. Fincher, MD, MACP, president of the American College of Physicians, which joined a court brief in support of the law with 19 other medical organizations, said the law has worked.
“The coverage, protections and benefits provided by the ACA are critical to the well-being of millions of Americans,” she said in a statement.
“If the ACA were to be thrown out at the same time that we face the pandemic, it would cause chaos for physicians and our patients, and for the entire health care system,” said Fincher, adding that millions of Americans who have been infected could lose insurance if protections for pre-existing conditions disappeared.
“The ACA has revolutionized access to care for tens of millions of women by helping them obtain meaningful health coverage, ensuring that essential care is covered by insurers, and protecting patients from unfair insurance practices,” said Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists (ACOG), in a statement.
Overturning the ACA “would be one of the most singularly disruptive acts to be committed during this public health crisis,” she said.
American Psychiatric Association President Jeffrey Geller, MD, MPH, also warned of disruptions to care, especially for those with mental health and substance use disorders. “We urge the Supreme Court to preserve the entire Act, including the individual mandate,” he said, in a statement.
“In the midst of COVID is no time to let down the millions who we serve as our patients,” said Chip Kahn, Federation of American Health Systems president and CEO, in a statement.
“As caregivers, the goal of hospitals for our patients is to see increased access to affordable coverage for all Americans – not new obstacles,” he said, adding that the ACA “can accomplish this goal. We hope the Supreme Court will see its way clear to allow it to go forward.”
For the defense
Many legal analysts on social media who listened in to today’s hearing agreed that the tenor of the proceedings seemed to lean toward survival of the ACA.
“At this point I would say it is *extremely* likely that the ACA will be upheld, but the mandate struck down and severed out,” tweeted Raffi Melkonian, an appellate lawyer in Houston, Texas. “A decision on standing (throwing out the case entirely) is also possible. The chance that the ACA is struck down v. low.”
“Both Kavanaugh and Roberts have suggested this morning that they may view the individual mandate as severable from the rest of the law. If those two justices join the court’s three liberals in finding that the mandate is severable, that would be five votes to save the ACA,” tweeted the analysts at SCOTUS Blog.
Sean Marotta, a lawyer with Hogan Lovells’ Supreme Court group, agreed. “Oral argument is always an imperfect measure, but the Act’s defenders should feel good today,” he tweeted.
This article first appeared on Medscape.com.
The Justices conducted arguments by telephone in the case, California v Texas (previously California v US), which was brought by 18 Republican state officials and two individual plaintiffs. The Trump administration joined the plaintiffs in June, arguing that the entire law should be overturned. The ACA is being defended by Democratic state officials from 16 states and Washington, D.C.
The Republican plaintiffs have essentially argued that the ACA cannot stand without the individual mandate requirement – that it is not possible to “sever” it from the rest of the Act. In 2017, Congress set the tax penalty to $0 if an individual did not buy insurance. The mandate to buy insurance was left in place, but there were no longer any consequences. The plaintiffs said that congressional act was equivalent to severing the mandate.
But many Justices appeared to take a dim view of that argument.
“It’s a very straightforward case for severability under our precedents,” said Justice Brett Kavanaugh. “Meaning that we would excise the mandate and leave the rest of the Act in play. Congress knows how to write an inseverability clause and that is not the language that they chose here,” he said.
Justice Elena Kagan also questioned how it would jibe with legal precedent to allow the severing of one part of a law when there was no clear instruction from Congress on the issue. She also raised the concern that it would open the door to all sorts of challenges.
“It would seem a big deal to say that, if you can point to injury with respect to one provision and you can concoct some kind of inseverability argument, that allows you to challenge anything else in the statute,” she said.
“Isn’t that something that really cuts against all of our doctrine?” asked Kagan.
“I think it’s hard for you to argue that Congress intended the entire Act to fall if the mandate was struck down when the same Congress that lowered the penalty to zero did not even try to repeal the rest of the act,” said Chief Justice John Roberts.
“I think, frankly, that they wanted the Court to do that but that’s not our job,” he added.
Proof of harm?
To have the standing to sue, the plaintiffs have to prove they have been harmed by the ACA. Texas Solicitor General Kyle Hawkins said that individuals feel compelled to buy insurance – even without a penalty hanging over their heads.
Justice Stephen Breyer argued that many laws include what he called “precatory” language – that is, they seek to compel citizens to do something. But most don’t penalize those who fail to act – just like the ACA currently.
If, as the Texas plaintiffs argued, it’s still unconstitutional to make such a request, “I think there will be an awful lot of language in an awful lot of statutes that will suddenly be the subject of court constitutional challenge,” he said.
Hawkins disagreed. He said the ACA’s mandate “is not some suggestion, not some hortatory statement. It is the law of the United States of America today that you have to purchase health insurance and not just any health insurance, but health insurance that the federal government has decided would be best for you.”
Hawkins said that, if just one additional person signed up for Medicaid, the state of Texas and the other plaintiff states would be harmed. He said people were continuing to enroll in the program because they believed the law required them to get health insurance.
Justice Sonia Sotomayor said that defied common sense. “The problem is that your theory assumes people that people are going to pay a tax and break the law by not buying insurance, but they wouldn’t do it when the tax is zero.”
What’s at stake
It’s unlikely the justices will issue a decision immediately. They have until the end of the term in June to rule.
Katie Keith, JD, MPH, a principal at Keith Policy Solutions, LLC, outlined the potential outcomes in Health Affairs .
“The most likely scenario is that the Court maintains the status quo,” she wrote. They could get there by deciding Texas et al. did not have standing to bring the case. Or they could decide that either the mandate is constitutional or that it is unconstitutional but can be severed from the rest of the ACA.
The Court could alternatively find that some or all of the law’s insurance provisions – such as protections for people with pre-existing conditions – can’t be severed from the mandate. Or the justices could strike down all of the insurance consumer protections, the health insurance marketplaces, premium tax credits, and other provisions, which would force states to come up with the money to help people buy insurance. And states are unlikely to be able to do so, especially with the pandemic stretching their budgets.
Finally, the Court could find that the mandate can’t be separated, which would essentially overturn the law.
If that happens, some 15 million people could lose Medicaid coverage, 11 million who buy on health insurance exchanges could lose coverage, and 2.3 million young adults would no longer be able to stay on parents’ policies, according to the Kaiser Family Foundation. Kaiser also estimates that 54 million people under age 65 who have pre-existing conditions would no longer be guaranteed coverage.
The Urban Institute estimates that 21 million people could lose insurance – 15 million through Medicaid and the Children’s Health Insurance Program (CHIP) and 7.6 million through private nongroup coverage.
Medical societies weigh in
Multiple physicians’ groups, patient advocates, and hospital organizations have filed briefs with the Court in favor of keeping the law intact.
Twenty patient groups representing millions with pre-existing conditions – including the American Cancer Society, American Diabetes Association, American Heart Association, National Alliance on Mental Illness, National Organization for Rare Disorders, and the Kennedy Forum – filed a court brief in May arguing that the law has expanded access to insurance and improved patient outcomes.
“The coronavirus pandemic has only served to underscore the necessity of meaningful coverage – especially for those who are at high risk of being severely affected by the virus – including countless Americans who have pre-existing, acute or chronic conditions like heart disease, cancer, diabetes, lung diseases and multiple sclerosis,” they said in a statement.
Jacqueline W. Fincher, MD, MACP, president of the American College of Physicians, which joined a court brief in support of the law with 19 other medical organizations, said the law has worked.
“The coverage, protections and benefits provided by the ACA are critical to the well-being of millions of Americans,” she said in a statement.
“If the ACA were to be thrown out at the same time that we face the pandemic, it would cause chaos for physicians and our patients, and for the entire health care system,” said Fincher, adding that millions of Americans who have been infected could lose insurance if protections for pre-existing conditions disappeared.
“The ACA has revolutionized access to care for tens of millions of women by helping them obtain meaningful health coverage, ensuring that essential care is covered by insurers, and protecting patients from unfair insurance practices,” said Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists (ACOG), in a statement.
Overturning the ACA “would be one of the most singularly disruptive acts to be committed during this public health crisis,” she said.
American Psychiatric Association President Jeffrey Geller, MD, MPH, also warned of disruptions to care, especially for those with mental health and substance use disorders. “We urge the Supreme Court to preserve the entire Act, including the individual mandate,” he said, in a statement.
“In the midst of COVID is no time to let down the millions who we serve as our patients,” said Chip Kahn, Federation of American Health Systems president and CEO, in a statement.
“As caregivers, the goal of hospitals for our patients is to see increased access to affordable coverage for all Americans – not new obstacles,” he said, adding that the ACA “can accomplish this goal. We hope the Supreme Court will see its way clear to allow it to go forward.”
For the defense
Many legal analysts on social media who listened in to today’s hearing agreed that the tenor of the proceedings seemed to lean toward survival of the ACA.
“At this point I would say it is *extremely* likely that the ACA will be upheld, but the mandate struck down and severed out,” tweeted Raffi Melkonian, an appellate lawyer in Houston, Texas. “A decision on standing (throwing out the case entirely) is also possible. The chance that the ACA is struck down v. low.”
“Both Kavanaugh and Roberts have suggested this morning that they may view the individual mandate as severable from the rest of the law. If those two justices join the court’s three liberals in finding that the mandate is severable, that would be five votes to save the ACA,” tweeted the analysts at SCOTUS Blog.
Sean Marotta, a lawyer with Hogan Lovells’ Supreme Court group, agreed. “Oral argument is always an imperfect measure, but the Act’s defenders should feel good today,” he tweeted.
This article first appeared on Medscape.com.
New eGFR equation ‘less biased’ by age, kidney function; some disagree
The European Kidney Function Consortium (EKFC) equation surpasses existing equations by “resulting in generally lower bias across the spectrum of age and kidney function,” its developers wrote in an article published online Nov. 9 in Annals of Internal Medicine.
“The new EKFC equation may have helpful properties and perform better in estimating GFR, compared with the current KDIGO [Kidney Disease: Improving Global Outcomes]-recommended equations,” they added.
The primary KDIGO-recommended equation in its most recent guideline was the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, designed for adults, and a companion equation, the CKiD, covers children and adolescents.
“Key in our [new] equation is the adjustment for differences in serum creatinine generation between children and adults, or between men and women,” lead author Hans Pottel, PhD, KU Leuven (Belgium), said in an interview.
In an accompanying editorial, Andrew M. Levey, MD, and associates wrote: “We agree that a single eGFR equation that can be used in children and adults and performs well in the transition from adolescence to young adulthood is a worthy goal.”
“But the claim of equivalent or superior performance, compared with the CKD-EPI equation is not conclusive,” claimed Dr. Levey, who led the research team that developed the CKD-EPI equation, and coauthors.
Dr. Levey is professor of medicine at Tufts University, Boston.
What’s new is Q
Dr. Pottel and codevelopers devised what they call Q values: age- and sex-dependent median creatinine levels in normal individuals.
Q values act to “normalize or rescale creatinine before entering it into the equation, because we know that creatinine generation is different” based on factors that include age, sex, and muscle mass.
The EKFC equation extends the CKD-EPI equation and first eGFR equation by using Q values and applying across age ranges, like the full-age spectrum (FAS) equation, first reported in 2016 by a team led by Dr. Pottel.
“Although the FAS equation was designed to overcome the challenge in measuring GFR in patients transitioning from adolescence to adult nephrology care, it also underestimates GFR at low serum creatinine values and in patients with chronic kidney disease,” wrote Dr. Pottel and coauthors.
Hence, their intent to tweak the FAS equation to overcome this limitation and create the EKFC equation.
“The new equation combines the strengths of the CKD-EPI and FAS equations,” they woite.
However, “we acknowledge that lack of precision is still a major problem with all eGFR equations,” including the new EKFC, they added.
Editorialists dispute better performance of EKFC over CKD-EPI
In their editorial, Dr. Levey and coauthors noted the EKFC equations and other adapted equations in development “represent a conceptual advance over the FAS equations,” but they dispute the claims of better performance, compared with the CKD-EPI.
“We compared the performance of the EKFC and CKD-EPI equations in a different, large external validation population of Black and non-Black adults,” the external population used to validate the CKD-EPI equation, the editorialists reported.
The upshot was “our results did not confirm the author’s conclusions” about the EKFC equation.
In response, Dr. Pottel highlighted that the EKFC equation is currently not designed for use in Black patients.
“With its derivation and validation now reported in the new article, the EKFC equation is fully validated and ready for routine use in Whites,” he said. “We plan to evaluate and possibly fine tune our equation for its application in other ethnicities.”
Regarding the inferior performance, compared with the CKD-EPI equation in the non-Black population tested by the editorialists, Dr. Pottel cited “calibration issues for serum creatinine” that some experts have found in the datasets compiled by developers of the CKI-EPI equation that could limit the utility of these data.
Still room for improvement; app hopefully coming next year
Dr. Pottel and coauthors developed and validated the EKFC equation with data from 19,629 patients drawn from 13 cohorts. This included 11,251 patients from seven cohorts for development and internal validation, and 8378 from six cohorts for external validation. The EKFC effort received endorsement from the European Renal Association–European Dialysis and Transplant Association.
However, “We acknowledge that there is still room for improvement,” Dr. Pottel said.
Although the new report presents the EKFC equations (actually two slightly different equations depending on whether a patient’s serum creatinine is higher or lower than the relevant Q value), most potential users will likely find the equations easier to work with once they’re in an app form that allows someone to simply plug in age, sex, and serum creatinine level. That app currently doesn’t exist but is coming soon, promised Dr. Pottel.
“I hope to have an electronic tool by the beginning of 2021,” he said. “I have to find a programmer who can do this for me.”
The EKFC project has received no commercial funding. Dr. Pottel reported no relevant financial relationships. Dr. Levey has reported receiving research funding from AstraZeneca.
A version of this article originally appeared on Medscape.com.
The European Kidney Function Consortium (EKFC) equation surpasses existing equations by “resulting in generally lower bias across the spectrum of age and kidney function,” its developers wrote in an article published online Nov. 9 in Annals of Internal Medicine.
“The new EKFC equation may have helpful properties and perform better in estimating GFR, compared with the current KDIGO [Kidney Disease: Improving Global Outcomes]-recommended equations,” they added.
The primary KDIGO-recommended equation in its most recent guideline was the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, designed for adults, and a companion equation, the CKiD, covers children and adolescents.
“Key in our [new] equation is the adjustment for differences in serum creatinine generation between children and adults, or between men and women,” lead author Hans Pottel, PhD, KU Leuven (Belgium), said in an interview.
In an accompanying editorial, Andrew M. Levey, MD, and associates wrote: “We agree that a single eGFR equation that can be used in children and adults and performs well in the transition from adolescence to young adulthood is a worthy goal.”
“But the claim of equivalent or superior performance, compared with the CKD-EPI equation is not conclusive,” claimed Dr. Levey, who led the research team that developed the CKD-EPI equation, and coauthors.
Dr. Levey is professor of medicine at Tufts University, Boston.
What’s new is Q
Dr. Pottel and codevelopers devised what they call Q values: age- and sex-dependent median creatinine levels in normal individuals.
Q values act to “normalize or rescale creatinine before entering it into the equation, because we know that creatinine generation is different” based on factors that include age, sex, and muscle mass.
The EKFC equation extends the CKD-EPI equation and first eGFR equation by using Q values and applying across age ranges, like the full-age spectrum (FAS) equation, first reported in 2016 by a team led by Dr. Pottel.
“Although the FAS equation was designed to overcome the challenge in measuring GFR in patients transitioning from adolescence to adult nephrology care, it also underestimates GFR at low serum creatinine values and in patients with chronic kidney disease,” wrote Dr. Pottel and coauthors.
Hence, their intent to tweak the FAS equation to overcome this limitation and create the EKFC equation.
“The new equation combines the strengths of the CKD-EPI and FAS equations,” they woite.
However, “we acknowledge that lack of precision is still a major problem with all eGFR equations,” including the new EKFC, they added.
Editorialists dispute better performance of EKFC over CKD-EPI
In their editorial, Dr. Levey and coauthors noted the EKFC equations and other adapted equations in development “represent a conceptual advance over the FAS equations,” but they dispute the claims of better performance, compared with the CKD-EPI.
“We compared the performance of the EKFC and CKD-EPI equations in a different, large external validation population of Black and non-Black adults,” the external population used to validate the CKD-EPI equation, the editorialists reported.
The upshot was “our results did not confirm the author’s conclusions” about the EKFC equation.
In response, Dr. Pottel highlighted that the EKFC equation is currently not designed for use in Black patients.
“With its derivation and validation now reported in the new article, the EKFC equation is fully validated and ready for routine use in Whites,” he said. “We plan to evaluate and possibly fine tune our equation for its application in other ethnicities.”
Regarding the inferior performance, compared with the CKD-EPI equation in the non-Black population tested by the editorialists, Dr. Pottel cited “calibration issues for serum creatinine” that some experts have found in the datasets compiled by developers of the CKI-EPI equation that could limit the utility of these data.
Still room for improvement; app hopefully coming next year
Dr. Pottel and coauthors developed and validated the EKFC equation with data from 19,629 patients drawn from 13 cohorts. This included 11,251 patients from seven cohorts for development and internal validation, and 8378 from six cohorts for external validation. The EKFC effort received endorsement from the European Renal Association–European Dialysis and Transplant Association.
However, “We acknowledge that there is still room for improvement,” Dr. Pottel said.
Although the new report presents the EKFC equations (actually two slightly different equations depending on whether a patient’s serum creatinine is higher or lower than the relevant Q value), most potential users will likely find the equations easier to work with once they’re in an app form that allows someone to simply plug in age, sex, and serum creatinine level. That app currently doesn’t exist but is coming soon, promised Dr. Pottel.
“I hope to have an electronic tool by the beginning of 2021,” he said. “I have to find a programmer who can do this for me.”
The EKFC project has received no commercial funding. Dr. Pottel reported no relevant financial relationships. Dr. Levey has reported receiving research funding from AstraZeneca.
A version of this article originally appeared on Medscape.com.
The European Kidney Function Consortium (EKFC) equation surpasses existing equations by “resulting in generally lower bias across the spectrum of age and kidney function,” its developers wrote in an article published online Nov. 9 in Annals of Internal Medicine.
“The new EKFC equation may have helpful properties and perform better in estimating GFR, compared with the current KDIGO [Kidney Disease: Improving Global Outcomes]-recommended equations,” they added.
The primary KDIGO-recommended equation in its most recent guideline was the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, designed for adults, and a companion equation, the CKiD, covers children and adolescents.
“Key in our [new] equation is the adjustment for differences in serum creatinine generation between children and adults, or between men and women,” lead author Hans Pottel, PhD, KU Leuven (Belgium), said in an interview.
In an accompanying editorial, Andrew M. Levey, MD, and associates wrote: “We agree that a single eGFR equation that can be used in children and adults and performs well in the transition from adolescence to young adulthood is a worthy goal.”
“But the claim of equivalent or superior performance, compared with the CKD-EPI equation is not conclusive,” claimed Dr. Levey, who led the research team that developed the CKD-EPI equation, and coauthors.
Dr. Levey is professor of medicine at Tufts University, Boston.
What’s new is Q
Dr. Pottel and codevelopers devised what they call Q values: age- and sex-dependent median creatinine levels in normal individuals.
Q values act to “normalize or rescale creatinine before entering it into the equation, because we know that creatinine generation is different” based on factors that include age, sex, and muscle mass.
The EKFC equation extends the CKD-EPI equation and first eGFR equation by using Q values and applying across age ranges, like the full-age spectrum (FAS) equation, first reported in 2016 by a team led by Dr. Pottel.
“Although the FAS equation was designed to overcome the challenge in measuring GFR in patients transitioning from adolescence to adult nephrology care, it also underestimates GFR at low serum creatinine values and in patients with chronic kidney disease,” wrote Dr. Pottel and coauthors.
Hence, their intent to tweak the FAS equation to overcome this limitation and create the EKFC equation.
“The new equation combines the strengths of the CKD-EPI and FAS equations,” they woite.
However, “we acknowledge that lack of precision is still a major problem with all eGFR equations,” including the new EKFC, they added.
Editorialists dispute better performance of EKFC over CKD-EPI
In their editorial, Dr. Levey and coauthors noted the EKFC equations and other adapted equations in development “represent a conceptual advance over the FAS equations,” but they dispute the claims of better performance, compared with the CKD-EPI.
“We compared the performance of the EKFC and CKD-EPI equations in a different, large external validation population of Black and non-Black adults,” the external population used to validate the CKD-EPI equation, the editorialists reported.
The upshot was “our results did not confirm the author’s conclusions” about the EKFC equation.
In response, Dr. Pottel highlighted that the EKFC equation is currently not designed for use in Black patients.
“With its derivation and validation now reported in the new article, the EKFC equation is fully validated and ready for routine use in Whites,” he said. “We plan to evaluate and possibly fine tune our equation for its application in other ethnicities.”
Regarding the inferior performance, compared with the CKD-EPI equation in the non-Black population tested by the editorialists, Dr. Pottel cited “calibration issues for serum creatinine” that some experts have found in the datasets compiled by developers of the CKI-EPI equation that could limit the utility of these data.
Still room for improvement; app hopefully coming next year
Dr. Pottel and coauthors developed and validated the EKFC equation with data from 19,629 patients drawn from 13 cohorts. This included 11,251 patients from seven cohorts for development and internal validation, and 8378 from six cohorts for external validation. The EKFC effort received endorsement from the European Renal Association–European Dialysis and Transplant Association.
However, “We acknowledge that there is still room for improvement,” Dr. Pottel said.
Although the new report presents the EKFC equations (actually two slightly different equations depending on whether a patient’s serum creatinine is higher or lower than the relevant Q value), most potential users will likely find the equations easier to work with once they’re in an app form that allows someone to simply plug in age, sex, and serum creatinine level. That app currently doesn’t exist but is coming soon, promised Dr. Pottel.
“I hope to have an electronic tool by the beginning of 2021,” he said. “I have to find a programmer who can do this for me.”
The EKFC project has received no commercial funding. Dr. Pottel reported no relevant financial relationships. Dr. Levey has reported receiving research funding from AstraZeneca.
A version of this article originally appeared on Medscape.com.
Proinflammatory dietary pattern linked to higher CV risk
Dietary patterns with higher inflammatory potential were significantly associated with a higher incidence of cardiovascular disease (CVD) and stroke in a new pooled analysis of three prospective cohort studies.
The analysis included 210,145 U.S. women and men followed for up to 32 years in the Nurses’ Health Studies I and II and the Health Professionals Follow-up Study.
After adjustment for use of anti-inflammatory medications and CVD risk factors, those whose dietary pattern ranked in the highest quintile of inflammatory potential had a 38% higher risk of CVD (hazard ratio comparing highest with lowest quintiles, 1.38), a 46% higher risk of coronary heart disease (HR, 1.46), and a 28% higher risk of stroke (HR, 1.28) (all P for trend < .001).
Jun Li, MD, PhD, and colleagues at Harvard School of Public Health and Harvard Medical School, Boston, published the findings of their study in the Nov. 10 issue of the Journal of the American College of Cardiology.
The inflammatory potential of a diet was assessed using a food-based, dietary index called the “empirical dietary inflammatory pattern” or EDIP.
In an interview, Dr. Li explained that the EDIP was developed 4 years ago by many of the same authors involved with this study, including nutrition heavyweights Walter C. Willett, MD, DrPH, and Frank B. Hu, MD, PhD, both from Harvard.
“We summarized all the foods people eat into 39 defined food groups and did a reduced-rank regression analysis that looked at these 39 food groups and three inflammatory markers – interleukin-6, C-reactive protein, and tumor necrosis factor–alpha receptor 2. We found 18 food groups that are most predictive of these biomarkers, and the EDIP was calculated as the weighted sum of these 18 food groups.”
Individuals who had higher intakes of green-leafy vegetables (kale, spinach, arugula), dark-yellow vegetables (pumpkin, yellow peppers, carrots), whole grains, fruits, tea, coffee and wine had lower long-term CVD risk than those with higher intakes of red meat, processed meat, organ meat, refined carbohydrates, and sweetened beverages.
The associations were consistent across cohorts and between sexes and remained significant in multiple sensitivity analysis that adjusted for alcohol consumption, smoking pack-years, use of lipid-lowering and antihypertensive medications, sodium intake, and blood pressure.
In a secondary analysis, diets with higher inflammatory potential were also associated with significantly higher biomarker levels indicative of more systemic, vascular, and metabolic inflammation, as well as less favorable lipid profiles.
“We wanted to be able to provide guidance on dietary patterns and food combinations,” said Dr. Li. “If you tell people to eat more polyunsaturated fats instead of saturated fat or trans fat, most people don’t know what foods are higher and lower in those nutrients. Also, many foods have different nutrients – some of which are good and some of which are bad – so we wanted to help people find the foods with the higher proportion of healthy nutrients rather than point out specific nutrients to avoid.”
Researchers used prospectively gathered data from the Nurses’ Health Studies I and II starting from 1984 and from the Health Professionals Follow-up Study. After excluding participants with missing diet information or previously diagnosed heart disease, stroke or cancer, over 210,000 participants were included in the analysis. Participants completed a survey every 4 years to ascertain dietary intake.
Prevention, not treatment
In an editorial comment, Ramon Estruch, MD, PhD, from the Hospital Clinic in Barcelona, and colleagues suggested that it might be time for better dietary guidelines.
“A better knowledge of health protection provided by different foods and dietary patterns, mainly their anti-inflammatory properties, should provide the basis for designing even healthier dietary patterns to protect against heart disease,” the editorialists wrote.
They added extra-virgin olive oil, fatty fish, and tomatoes to the list of foods with “established anti-inflammatory activity.”
In a comment, Dr. Estruch said the findings of this new study are confirmatory of the PREDIMED trial, which showed a reduction in risk of major CV events in individuals at high cardiovascular risk assigned to an anti-inflammatory Mediterranean diet pattern supplemented with extra-virgin olive oil or nuts as compared with those assigned to a reduced-fat diet.
“The study of Jun Li et al. confirms that an anti-inflammatory diet is useful to prevent cardiovascular events and, more important, that healthy dietary patterns may be even healthier if subjects increase consumption of foods with the highest anti-inflammatory potential,” he said, adding that “mechanistic explanations add plausibility to the results of observational studies.”
Dr. Estruch was the principal investigator of PREDIMED. This trial was originally published in 2013 and then retracted and republished in 2018, with some required corrections, but the results had not materially changed.
Dr. Li is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and Boston Nutrition Obesity Research Center. Dr. Estruch disclosed no financial relationships relevant to the contents of this article.
A version of this article originally appeared on Medscape.com.
Dietary patterns with higher inflammatory potential were significantly associated with a higher incidence of cardiovascular disease (CVD) and stroke in a new pooled analysis of three prospective cohort studies.
The analysis included 210,145 U.S. women and men followed for up to 32 years in the Nurses’ Health Studies I and II and the Health Professionals Follow-up Study.
After adjustment for use of anti-inflammatory medications and CVD risk factors, those whose dietary pattern ranked in the highest quintile of inflammatory potential had a 38% higher risk of CVD (hazard ratio comparing highest with lowest quintiles, 1.38), a 46% higher risk of coronary heart disease (HR, 1.46), and a 28% higher risk of stroke (HR, 1.28) (all P for trend < .001).
Jun Li, MD, PhD, and colleagues at Harvard School of Public Health and Harvard Medical School, Boston, published the findings of their study in the Nov. 10 issue of the Journal of the American College of Cardiology.
The inflammatory potential of a diet was assessed using a food-based, dietary index called the “empirical dietary inflammatory pattern” or EDIP.
In an interview, Dr. Li explained that the EDIP was developed 4 years ago by many of the same authors involved with this study, including nutrition heavyweights Walter C. Willett, MD, DrPH, and Frank B. Hu, MD, PhD, both from Harvard.
“We summarized all the foods people eat into 39 defined food groups and did a reduced-rank regression analysis that looked at these 39 food groups and three inflammatory markers – interleukin-6, C-reactive protein, and tumor necrosis factor–alpha receptor 2. We found 18 food groups that are most predictive of these biomarkers, and the EDIP was calculated as the weighted sum of these 18 food groups.”
Individuals who had higher intakes of green-leafy vegetables (kale, spinach, arugula), dark-yellow vegetables (pumpkin, yellow peppers, carrots), whole grains, fruits, tea, coffee and wine had lower long-term CVD risk than those with higher intakes of red meat, processed meat, organ meat, refined carbohydrates, and sweetened beverages.
The associations were consistent across cohorts and between sexes and remained significant in multiple sensitivity analysis that adjusted for alcohol consumption, smoking pack-years, use of lipid-lowering and antihypertensive medications, sodium intake, and blood pressure.
In a secondary analysis, diets with higher inflammatory potential were also associated with significantly higher biomarker levels indicative of more systemic, vascular, and metabolic inflammation, as well as less favorable lipid profiles.
“We wanted to be able to provide guidance on dietary patterns and food combinations,” said Dr. Li. “If you tell people to eat more polyunsaturated fats instead of saturated fat or trans fat, most people don’t know what foods are higher and lower in those nutrients. Also, many foods have different nutrients – some of which are good and some of which are bad – so we wanted to help people find the foods with the higher proportion of healthy nutrients rather than point out specific nutrients to avoid.”
Researchers used prospectively gathered data from the Nurses’ Health Studies I and II starting from 1984 and from the Health Professionals Follow-up Study. After excluding participants with missing diet information or previously diagnosed heart disease, stroke or cancer, over 210,000 participants were included in the analysis. Participants completed a survey every 4 years to ascertain dietary intake.
Prevention, not treatment
In an editorial comment, Ramon Estruch, MD, PhD, from the Hospital Clinic in Barcelona, and colleagues suggested that it might be time for better dietary guidelines.
“A better knowledge of health protection provided by different foods and dietary patterns, mainly their anti-inflammatory properties, should provide the basis for designing even healthier dietary patterns to protect against heart disease,” the editorialists wrote.
They added extra-virgin olive oil, fatty fish, and tomatoes to the list of foods with “established anti-inflammatory activity.”
In a comment, Dr. Estruch said the findings of this new study are confirmatory of the PREDIMED trial, which showed a reduction in risk of major CV events in individuals at high cardiovascular risk assigned to an anti-inflammatory Mediterranean diet pattern supplemented with extra-virgin olive oil or nuts as compared with those assigned to a reduced-fat diet.
“The study of Jun Li et al. confirms that an anti-inflammatory diet is useful to prevent cardiovascular events and, more important, that healthy dietary patterns may be even healthier if subjects increase consumption of foods with the highest anti-inflammatory potential,” he said, adding that “mechanistic explanations add plausibility to the results of observational studies.”
Dr. Estruch was the principal investigator of PREDIMED. This trial was originally published in 2013 and then retracted and republished in 2018, with some required corrections, but the results had not materially changed.
Dr. Li is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and Boston Nutrition Obesity Research Center. Dr. Estruch disclosed no financial relationships relevant to the contents of this article.
A version of this article originally appeared on Medscape.com.
Dietary patterns with higher inflammatory potential were significantly associated with a higher incidence of cardiovascular disease (CVD) and stroke in a new pooled analysis of three prospective cohort studies.
The analysis included 210,145 U.S. women and men followed for up to 32 years in the Nurses’ Health Studies I and II and the Health Professionals Follow-up Study.
After adjustment for use of anti-inflammatory medications and CVD risk factors, those whose dietary pattern ranked in the highest quintile of inflammatory potential had a 38% higher risk of CVD (hazard ratio comparing highest with lowest quintiles, 1.38), a 46% higher risk of coronary heart disease (HR, 1.46), and a 28% higher risk of stroke (HR, 1.28) (all P for trend < .001).
Jun Li, MD, PhD, and colleagues at Harvard School of Public Health and Harvard Medical School, Boston, published the findings of their study in the Nov. 10 issue of the Journal of the American College of Cardiology.
The inflammatory potential of a diet was assessed using a food-based, dietary index called the “empirical dietary inflammatory pattern” or EDIP.
In an interview, Dr. Li explained that the EDIP was developed 4 years ago by many of the same authors involved with this study, including nutrition heavyweights Walter C. Willett, MD, DrPH, and Frank B. Hu, MD, PhD, both from Harvard.
“We summarized all the foods people eat into 39 defined food groups and did a reduced-rank regression analysis that looked at these 39 food groups and three inflammatory markers – interleukin-6, C-reactive protein, and tumor necrosis factor–alpha receptor 2. We found 18 food groups that are most predictive of these biomarkers, and the EDIP was calculated as the weighted sum of these 18 food groups.”
Individuals who had higher intakes of green-leafy vegetables (kale, spinach, arugula), dark-yellow vegetables (pumpkin, yellow peppers, carrots), whole grains, fruits, tea, coffee and wine had lower long-term CVD risk than those with higher intakes of red meat, processed meat, organ meat, refined carbohydrates, and sweetened beverages.
The associations were consistent across cohorts and between sexes and remained significant in multiple sensitivity analysis that adjusted for alcohol consumption, smoking pack-years, use of lipid-lowering and antihypertensive medications, sodium intake, and blood pressure.
In a secondary analysis, diets with higher inflammatory potential were also associated with significantly higher biomarker levels indicative of more systemic, vascular, and metabolic inflammation, as well as less favorable lipid profiles.
“We wanted to be able to provide guidance on dietary patterns and food combinations,” said Dr. Li. “If you tell people to eat more polyunsaturated fats instead of saturated fat or trans fat, most people don’t know what foods are higher and lower in those nutrients. Also, many foods have different nutrients – some of which are good and some of which are bad – so we wanted to help people find the foods with the higher proportion of healthy nutrients rather than point out specific nutrients to avoid.”
Researchers used prospectively gathered data from the Nurses’ Health Studies I and II starting from 1984 and from the Health Professionals Follow-up Study. After excluding participants with missing diet information or previously diagnosed heart disease, stroke or cancer, over 210,000 participants were included in the analysis. Participants completed a survey every 4 years to ascertain dietary intake.
Prevention, not treatment
In an editorial comment, Ramon Estruch, MD, PhD, from the Hospital Clinic in Barcelona, and colleagues suggested that it might be time for better dietary guidelines.
“A better knowledge of health protection provided by different foods and dietary patterns, mainly their anti-inflammatory properties, should provide the basis for designing even healthier dietary patterns to protect against heart disease,” the editorialists wrote.
They added extra-virgin olive oil, fatty fish, and tomatoes to the list of foods with “established anti-inflammatory activity.”
In a comment, Dr. Estruch said the findings of this new study are confirmatory of the PREDIMED trial, which showed a reduction in risk of major CV events in individuals at high cardiovascular risk assigned to an anti-inflammatory Mediterranean diet pattern supplemented with extra-virgin olive oil or nuts as compared with those assigned to a reduced-fat diet.
“The study of Jun Li et al. confirms that an anti-inflammatory diet is useful to prevent cardiovascular events and, more important, that healthy dietary patterns may be even healthier if subjects increase consumption of foods with the highest anti-inflammatory potential,” he said, adding that “mechanistic explanations add plausibility to the results of observational studies.”
Dr. Estruch was the principal investigator of PREDIMED. This trial was originally published in 2013 and then retracted and republished in 2018, with some required corrections, but the results had not materially changed.
Dr. Li is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and Boston Nutrition Obesity Research Center. Dr. Estruch disclosed no financial relationships relevant to the contents of this article.
A version of this article originally appeared on Medscape.com.
Comment & Controversy
OBG Manag. 2020 November; 32(11).
The Fetal Pillow: A new option for delivering the deeply impacted fetal head
Robert L. Barbieri, MD
(Editorial; July 2020)
Alternative option to the Fetal Pillow
I enjoyed Dr. Barbieri’s editorial on the Fetal Pillow. I worry, however, that applying high air pressure to the upper vagina could result in an air embolism.
I have experienced good results using a vacuum cup. Like the pillow, it distributes the force more evenly than a hand. Also, the handle makes elevation of the vertex much less awkward and allows elevation to a higher station. Whatever approach is employed, using an open internal monitor catheter allows for a gentler procedure than when brute force alone is used to “break the seal” to allow ingress of air into the uterine cavity (at just 1 atmosphere of pressure).
John H. Sand, MD
Ellensburg, Washington
Cost of device must be considered
The information on the Fetal Pillow in Dr. Barbieri’s timely editorial, while limited in scope, does make the device look like a promising option.
One of my institution’s biggest issues relates to cost. We have had some interest in incorporating the Fetal Pillow into our practice, and we have been quoted a rate of about $600.00 per device. I had our Fetal Pillow representative look into reimbursement and have been informed that, at least in our region, there has been no reimbursement for the cost.
When I look at the cost of a hospital stay for a normal spontaneous vaginal delivery (NSVD), the cost of the Fetal Pillow would actually add 15% to 20% to that stay. Now, one must consider also the cost of extension of the uterine incision versus the cost of the Fetal Pillow. When we did a superficial look at when the Fetal Pillow might be used versus how many uterine extensions we experienced, the cost of the Fetal Pillow over a year far exceeded the cost of the uterine extensions. Without reimbursement, this appeared unsustainable. It has been interesting as some sites had no awareness of cost and the fact that essentially “the system” was absorbing those costs.
This issue is worthy of thought but likely one that most obstetricians will not consider.
Casey Morris, MD
Downers Grove, Illinois
Tip for dislodging the fetal head
I read Dr. Barbieri’s editorial regarding the Fetal Pillow and would like to share my experience. Over the last 30 years, I have used a simple trick. After entering the pelvic cavity, we push on the lower uterine segment toward the fundus prior to uterine incision. This helps dislodge the fetal head. Occasionally, you can feel the “pop” when the suction is broken, which sets the head free. We then proceed with the uterine incision and delivery of the head. We have had great success over the years, and the poor nurse does not have to go under the drapes.
Walter Kobasa Jr, MD
Wilmington, Delaware
Dr. Barbieri responds
I appreciate the recommendations and insights of Drs. Sand, Morris, and Kobasa. As I mentioned in the editorial on the Fetal Pillow, there are many clinical pearls about management of a second stage, deep-transverse cephalic arrest at the time of cesarean delivery, including to extend or T the uterine incision, push with a hand from below, reverse breech extraction, use a Coyne spoon, administer nitroglycerine or terbutaline, break the vaginal suction before attempting delivery, and incise a Bandl ring. Dr. Sand adds vaginal placement of a vacuum cup to our armamentarium, and Dr. Kobasa recommends dislodging the fetal head with a push on the lower uterine segment before making the hysterotomy incision. I thank Dr. Morris for correcting my failure to report the cost of the Fetal Pillow, reporting a quoted price of $600 for each Fetal Pillow. I agree with Dr. Morris that physicians have an important responsibility to be good stewards of health care resources and weigh the benefits and costs of our decisions.
Continue to: In your practice, are you planning to have a chaperone present for all intimate examinations?
In your practice, are you planning to have a chaperone present for all intimate examinations?
Robert L. Barbieri, MD
(Editorial; June 2020)
Enough is enough
I have always thought that many doctors who write opinions and pontificate about what should be done in practice live in la-la land. This editorial, for me, confirms it.
I personally am becoming tired of all this: dividing the specialty into obstetricians and gynecologists; pelvic exams are not necessary during annual visits; HPV testing by patients at home; doing away with Pap smears; Pap smears are not necessary for patients after a certain age; scribes in your footsteps to document all findings in the EMR; heaven forbid you do not ask the patient if she has a fire extinguisher in her house or some other stupid information; interpreters for people who speak Mongolian because their partner should not be used to interpret for them; and so on.
Now you want us to have a chaperone for every pelvic exam! Not any chaperone, but a specialized one! You worry about the sanctity and privacy of the patient but now have 2 additional people in the room for the patient’s exam. First, most patients prefer to have the least number of people looking at their bodies during an exam, especially a pelvic exam. Second, where do we get the money to support all of this? Does this type of policy make any sense? Are lawyers now controlling what medical care is all about? Is that what is now considered quality medical care?
By the way, I am not a burned out physician. I use common sense and consider what is best for my patients in everything that I do. If a patient requests a chaperone, my medical assistant will come to the room and provide that service. You do not need to be specialized to provide this service! Ivory tower people have lost all common sense. You consider yourselves the authorities in whatever medical field you specialize in, but let me tell you something: You really are not.
I know I will be criticized and demonized publicly by many; however, I have the courage to say what, in my opinion, I feel is right and what is wrong. Many physicians are afraid to do so, and, like sheep, will comply with your misguided opinions. I truly do not mean any disrespect to your knowledge and good intentions. I just think that enough is enough!
Gabriel G. Hakim, MD
Waterbury, Connecticut
Dr. Barbieri responds
In response to my editorial on the American College of Obstetricians and Gynecologists (ACOG) recommendation that chaperones be present for intimate examinations (ACOG Committee Opinion No. 796), Dr. Hakim outlines many concerns with the rapidly evolving practice of medicine.1 I am confident that the ACOG Committee on Ethics wisely considered the benefits, costs, and unintended consequences of the recommendation. The United States Veterans Administration, the Royal College of Obstetricians and Gynaecologists, and the American College Health Association endorse a similar recommendation. I do not think the distinguished members of the committees who issued the recommendation “live in la-la land.”
Reference
- American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.
- American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.
OBG Manag. 2020 November; 32(11).
The Fetal Pillow: A new option for delivering the deeply impacted fetal head
Robert L. Barbieri, MD
(Editorial; July 2020)
Alternative option to the Fetal Pillow
I enjoyed Dr. Barbieri’s editorial on the Fetal Pillow. I worry, however, that applying high air pressure to the upper vagina could result in an air embolism.
I have experienced good results using a vacuum cup. Like the pillow, it distributes the force more evenly than a hand. Also, the handle makes elevation of the vertex much less awkward and allows elevation to a higher station. Whatever approach is employed, using an open internal monitor catheter allows for a gentler procedure than when brute force alone is used to “break the seal” to allow ingress of air into the uterine cavity (at just 1 atmosphere of pressure).
John H. Sand, MD
Ellensburg, Washington
Cost of device must be considered
The information on the Fetal Pillow in Dr. Barbieri’s timely editorial, while limited in scope, does make the device look like a promising option.
One of my institution’s biggest issues relates to cost. We have had some interest in incorporating the Fetal Pillow into our practice, and we have been quoted a rate of about $600.00 per device. I had our Fetal Pillow representative look into reimbursement and have been informed that, at least in our region, there has been no reimbursement for the cost.
When I look at the cost of a hospital stay for a normal spontaneous vaginal delivery (NSVD), the cost of the Fetal Pillow would actually add 15% to 20% to that stay. Now, one must consider also the cost of extension of the uterine incision versus the cost of the Fetal Pillow. When we did a superficial look at when the Fetal Pillow might be used versus how many uterine extensions we experienced, the cost of the Fetal Pillow over a year far exceeded the cost of the uterine extensions. Without reimbursement, this appeared unsustainable. It has been interesting as some sites had no awareness of cost and the fact that essentially “the system” was absorbing those costs.
This issue is worthy of thought but likely one that most obstetricians will not consider.
Casey Morris, MD
Downers Grove, Illinois
Tip for dislodging the fetal head
I read Dr. Barbieri’s editorial regarding the Fetal Pillow and would like to share my experience. Over the last 30 years, I have used a simple trick. After entering the pelvic cavity, we push on the lower uterine segment toward the fundus prior to uterine incision. This helps dislodge the fetal head. Occasionally, you can feel the “pop” when the suction is broken, which sets the head free. We then proceed with the uterine incision and delivery of the head. We have had great success over the years, and the poor nurse does not have to go under the drapes.
Walter Kobasa Jr, MD
Wilmington, Delaware
Dr. Barbieri responds
I appreciate the recommendations and insights of Drs. Sand, Morris, and Kobasa. As I mentioned in the editorial on the Fetal Pillow, there are many clinical pearls about management of a second stage, deep-transverse cephalic arrest at the time of cesarean delivery, including to extend or T the uterine incision, push with a hand from below, reverse breech extraction, use a Coyne spoon, administer nitroglycerine or terbutaline, break the vaginal suction before attempting delivery, and incise a Bandl ring. Dr. Sand adds vaginal placement of a vacuum cup to our armamentarium, and Dr. Kobasa recommends dislodging the fetal head with a push on the lower uterine segment before making the hysterotomy incision. I thank Dr. Morris for correcting my failure to report the cost of the Fetal Pillow, reporting a quoted price of $600 for each Fetal Pillow. I agree with Dr. Morris that physicians have an important responsibility to be good stewards of health care resources and weigh the benefits and costs of our decisions.
Continue to: In your practice, are you planning to have a chaperone present for all intimate examinations?
In your practice, are you planning to have a chaperone present for all intimate examinations?
Robert L. Barbieri, MD
(Editorial; June 2020)
Enough is enough
I have always thought that many doctors who write opinions and pontificate about what should be done in practice live in la-la land. This editorial, for me, confirms it.
I personally am becoming tired of all this: dividing the specialty into obstetricians and gynecologists; pelvic exams are not necessary during annual visits; HPV testing by patients at home; doing away with Pap smears; Pap smears are not necessary for patients after a certain age; scribes in your footsteps to document all findings in the EMR; heaven forbid you do not ask the patient if she has a fire extinguisher in her house or some other stupid information; interpreters for people who speak Mongolian because their partner should not be used to interpret for them; and so on.
Now you want us to have a chaperone for every pelvic exam! Not any chaperone, but a specialized one! You worry about the sanctity and privacy of the patient but now have 2 additional people in the room for the patient’s exam. First, most patients prefer to have the least number of people looking at their bodies during an exam, especially a pelvic exam. Second, where do we get the money to support all of this? Does this type of policy make any sense? Are lawyers now controlling what medical care is all about? Is that what is now considered quality medical care?
By the way, I am not a burned out physician. I use common sense and consider what is best for my patients in everything that I do. If a patient requests a chaperone, my medical assistant will come to the room and provide that service. You do not need to be specialized to provide this service! Ivory tower people have lost all common sense. You consider yourselves the authorities in whatever medical field you specialize in, but let me tell you something: You really are not.
I know I will be criticized and demonized publicly by many; however, I have the courage to say what, in my opinion, I feel is right and what is wrong. Many physicians are afraid to do so, and, like sheep, will comply with your misguided opinions. I truly do not mean any disrespect to your knowledge and good intentions. I just think that enough is enough!
Gabriel G. Hakim, MD
Waterbury, Connecticut
Dr. Barbieri responds
In response to my editorial on the American College of Obstetricians and Gynecologists (ACOG) recommendation that chaperones be present for intimate examinations (ACOG Committee Opinion No. 796), Dr. Hakim outlines many concerns with the rapidly evolving practice of medicine.1 I am confident that the ACOG Committee on Ethics wisely considered the benefits, costs, and unintended consequences of the recommendation. The United States Veterans Administration, the Royal College of Obstetricians and Gynaecologists, and the American College Health Association endorse a similar recommendation. I do not think the distinguished members of the committees who issued the recommendation “live in la-la land.”
Reference
- American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.
OBG Manag. 2020 November; 32(11).
The Fetal Pillow: A new option for delivering the deeply impacted fetal head
Robert L. Barbieri, MD
(Editorial; July 2020)
Alternative option to the Fetal Pillow
I enjoyed Dr. Barbieri’s editorial on the Fetal Pillow. I worry, however, that applying high air pressure to the upper vagina could result in an air embolism.
I have experienced good results using a vacuum cup. Like the pillow, it distributes the force more evenly than a hand. Also, the handle makes elevation of the vertex much less awkward and allows elevation to a higher station. Whatever approach is employed, using an open internal monitor catheter allows for a gentler procedure than when brute force alone is used to “break the seal” to allow ingress of air into the uterine cavity (at just 1 atmosphere of pressure).
John H. Sand, MD
Ellensburg, Washington
Cost of device must be considered
The information on the Fetal Pillow in Dr. Barbieri’s timely editorial, while limited in scope, does make the device look like a promising option.
One of my institution’s biggest issues relates to cost. We have had some interest in incorporating the Fetal Pillow into our practice, and we have been quoted a rate of about $600.00 per device. I had our Fetal Pillow representative look into reimbursement and have been informed that, at least in our region, there has been no reimbursement for the cost.
When I look at the cost of a hospital stay for a normal spontaneous vaginal delivery (NSVD), the cost of the Fetal Pillow would actually add 15% to 20% to that stay. Now, one must consider also the cost of extension of the uterine incision versus the cost of the Fetal Pillow. When we did a superficial look at when the Fetal Pillow might be used versus how many uterine extensions we experienced, the cost of the Fetal Pillow over a year far exceeded the cost of the uterine extensions. Without reimbursement, this appeared unsustainable. It has been interesting as some sites had no awareness of cost and the fact that essentially “the system” was absorbing those costs.
This issue is worthy of thought but likely one that most obstetricians will not consider.
Casey Morris, MD
Downers Grove, Illinois
Tip for dislodging the fetal head
I read Dr. Barbieri’s editorial regarding the Fetal Pillow and would like to share my experience. Over the last 30 years, I have used a simple trick. After entering the pelvic cavity, we push on the lower uterine segment toward the fundus prior to uterine incision. This helps dislodge the fetal head. Occasionally, you can feel the “pop” when the suction is broken, which sets the head free. We then proceed with the uterine incision and delivery of the head. We have had great success over the years, and the poor nurse does not have to go under the drapes.
Walter Kobasa Jr, MD
Wilmington, Delaware
Dr. Barbieri responds
I appreciate the recommendations and insights of Drs. Sand, Morris, and Kobasa. As I mentioned in the editorial on the Fetal Pillow, there are many clinical pearls about management of a second stage, deep-transverse cephalic arrest at the time of cesarean delivery, including to extend or T the uterine incision, push with a hand from below, reverse breech extraction, use a Coyne spoon, administer nitroglycerine or terbutaline, break the vaginal suction before attempting delivery, and incise a Bandl ring. Dr. Sand adds vaginal placement of a vacuum cup to our armamentarium, and Dr. Kobasa recommends dislodging the fetal head with a push on the lower uterine segment before making the hysterotomy incision. I thank Dr. Morris for correcting my failure to report the cost of the Fetal Pillow, reporting a quoted price of $600 for each Fetal Pillow. I agree with Dr. Morris that physicians have an important responsibility to be good stewards of health care resources and weigh the benefits and costs of our decisions.
Continue to: In your practice, are you planning to have a chaperone present for all intimate examinations?
In your practice, are you planning to have a chaperone present for all intimate examinations?
Robert L. Barbieri, MD
(Editorial; June 2020)
Enough is enough
I have always thought that many doctors who write opinions and pontificate about what should be done in practice live in la-la land. This editorial, for me, confirms it.
I personally am becoming tired of all this: dividing the specialty into obstetricians and gynecologists; pelvic exams are not necessary during annual visits; HPV testing by patients at home; doing away with Pap smears; Pap smears are not necessary for patients after a certain age; scribes in your footsteps to document all findings in the EMR; heaven forbid you do not ask the patient if she has a fire extinguisher in her house or some other stupid information; interpreters for people who speak Mongolian because their partner should not be used to interpret for them; and so on.
Now you want us to have a chaperone for every pelvic exam! Not any chaperone, but a specialized one! You worry about the sanctity and privacy of the patient but now have 2 additional people in the room for the patient’s exam. First, most patients prefer to have the least number of people looking at their bodies during an exam, especially a pelvic exam. Second, where do we get the money to support all of this? Does this type of policy make any sense? Are lawyers now controlling what medical care is all about? Is that what is now considered quality medical care?
By the way, I am not a burned out physician. I use common sense and consider what is best for my patients in everything that I do. If a patient requests a chaperone, my medical assistant will come to the room and provide that service. You do not need to be specialized to provide this service! Ivory tower people have lost all common sense. You consider yourselves the authorities in whatever medical field you specialize in, but let me tell you something: You really are not.
I know I will be criticized and demonized publicly by many; however, I have the courage to say what, in my opinion, I feel is right and what is wrong. Many physicians are afraid to do so, and, like sheep, will comply with your misguided opinions. I truly do not mean any disrespect to your knowledge and good intentions. I just think that enough is enough!
Gabriel G. Hakim, MD
Waterbury, Connecticut
Dr. Barbieri responds
In response to my editorial on the American College of Obstetricians and Gynecologists (ACOG) recommendation that chaperones be present for intimate examinations (ACOG Committee Opinion No. 796), Dr. Hakim outlines many concerns with the rapidly evolving practice of medicine.1 I am confident that the ACOG Committee on Ethics wisely considered the benefits, costs, and unintended consequences of the recommendation. The United States Veterans Administration, the Royal College of Obstetricians and Gynaecologists, and the American College Health Association endorse a similar recommendation. I do not think the distinguished members of the committees who issued the recommendation “live in la-la land.”
Reference
- American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.
- American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.
- American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.
Continued Dosing of Oritavancin for Complicated Gram-Positive Infections
Oritavancin is a lipoglycopeptide antibiotic. The US Food and Drug Administration (FDA) approved oritavancin in 2014 for adults with acute bacterial skin and skin structure infections (ABSSSI).1 The antibiotic is currently FDA approved for infections caused by Gram-positive organisms, including methicillin-resistant and methicillinsusceptible Staphylococcus aureus (MRSA, MSSA), a variety of Streptococcus species, and vancomycin-susceptible Enterococcus faecalis (VSE). Oritavancin demonstrates concentrationdependent bactericidal activity and has a half-life of 245 hours. This half-life allows for treatment of ABSSSI with a single 1,200 mg IV dose, which has been shown to be noninferior to vancomycin dosed twice daily for 7 to 10 days.1-3
Proposal for Expanded Uses
Although the approved indication for oritavancin is narrow, in vitro studies have shown that oritavancin also has activity against vancomycin-resistant enterococci (VRE), and rabbit studies have demonstrated its excellent bone penetration.4,5 These findings have raised the question of whether oritavancin can be safely and effectively used for infections such as endocarditis, osteomyelitis, and bacteremia, which are often caused by invasive Grampositive organisms. These types of invasive infections, particularly when MRSA is implicated, generally require IV antibiotic therapy for several weeks, often with vancomycin.6
To avoid long hospital stays solely for antibiotic administration, health care practitioners will often use outpatient parenteral antimicrobial therapy (OPAT). However, using OPAT presents many challenges due to the need for frequent dosing, the risk of peripheral or central-line infections, and therapeutic drug monitoring when using vancomycin; additionally, administration and line care oftentimes require caregiver support, which may not be present for all patients.7 Concerns also have been raised regarding the use of OPAT in patients with a history of IV drug use due to the potential increased risk of line infections or line abuse. Few studies have explored OPAT in this population, and the Infectious Diseases Society of America OPAT guidelines recommend that the decision to use OPAT should be made on a case-by-case basis.7 Thus, patients who are deemed inappropriate for OPAT oftentimes remain hospitalized or reside briefly in nursing facilities solely for antibiotic administration
Oritavancin’s long half-life and potent activity against Gram-positive organisms has led to increased interest in off-label use of infrequent dosing intervals, such as weekly, to treat complicated and invasive infections. Weekly rather than daily dosing would allow for less burdensome antibiotic administration regimens and shorter hospital stays especially for patients who are not candidates for OPAT.
Efficacy of Continued Dosing
This proposed weekly dosing pattern, referred to as continued dosing or a multiple-dose regimen, has gained traction in the literature. To date, no randomized controlled trials have been conducted to assess oritavancin’s efficacy in off-label indications or continued dosing, but several case reports and retrospective cohort analyses show promising outcomes.8-16 In an analysis of data from the Clinical and Historic Registry and Orbactiv Medical Evaluation (CHROME) patient registry, 32 patients received multiple doses of oritavancin for complicated Gram-positive infections with a 93.8% overall clinical success rate, including success rates of 90.9% (10/11) for general bone and joint infections and 87.5% (7/8) for patients diagnosed specifically with osteomyelitis.8
Patients received between 2 and 10 doses of 1,200 mg IV given every 6 to 14 days. Johnson and colleagues report using oritavancin 1,200 mg IV every other day for 3 doses followed by 1,200 mg IV once weekly for a patient with daptomycin- and vancomycin-resistant Enterococcus endocarditis, resulting in negative blood cultures while on therapy.9 However, source control via valve replacement and postoperative oritavancin 1,200 mg IV twice weekly for 10 weeks was required to fully clear the infection.
Schulz and colleagues published a retrospective cohort analysis of 17 patients who received multiple doses of oritavancin for complicated bacterial infections, including osteomyelitis, pneumonia, and bacteremia.10 They reported 100% of patients were either successfully cured or had demonstrable improvements in their infections by using a 1,200 mg IV loading dose followed by 800 mg IV if the second dose was given within 7 days or 1,200 mg IV if the second dose was given more than 10 days later. Patients received between 2 and 18 total doses, with 6 out of 17 (35%) receiving only 2 doses. One patient who received 18 doses was an outlier, as her treatment goal was palliative suppression due to an infected endovascular graft that could not be removed.
In a published case series, 1 of 10 patients receiving oritavancin for invasive Grampositive infections received multiple doses of oritavancin for an MSSA deep tissue infection.11 The 3 total doses (strength not reported) were separated by 19 days and 14 days and resulted in cure. Several case reports and a retrospective chart review study specifically show the effectiveness of oritavancin for osteomyelitis caused by MSSA, MRSA, and VRE.12-16 However, dosing strategies varied widely after the initial 1,200 mg IV loading dose.
Drug Interactions, Safety, and Tolerability
Oritavancin has minimal drug-drug interactions, the most notable being with anticoagulants. 1 Use of IV heparin within 120 hours of oritavancin administration can falsely elevate activated partial thromboplastin time (aPTT) levels; therefore, heparin should not be monitored with aPTT during this period. Oritavancin also can artificially prolong international normalized ratio (INR) values for up to 12 hours, and dose adjustments based on INRs during this window are not recommended. Of note, factor Xa laboratory monitoring is unaffected by oritavancin, as it does not depend on phospholipid reagents as do aPTT and INR measurements.
Oritavancin has been shown to be well tolerated when dosed according to both the package insert and continued dosing strategies. The most common adverse effects (AEs) (≥ 3%), occurring at similar rates to vancomycin, are nausea, vomiting, diarrhea, headache, and limb and subcutaneous abscesses.1 Infusion reactions also have been reported, although they are usually reversible on slowing or stopping the infusion. It is worth noting that the use of oritavancin for osteomyelitis is not recommended in the product labeling, as an increased rate of osteomyelitis was observed in the oritavancin vs IV vancomycin groups for the treatment of patients with acute bacterial skin and skin structure infection (SOLO) trials (0.6% in oritavancin group vs 0.1% in vancomycin group, statistical significance not reported).17 However, it was postulated that these osteomyelitis cases were likely present, yet not recognized, at baseline and were not the result of administering oritavancin. This conclusion is further corroborated by previously presented research demonstrating successful cure of osteomyelitis with continued dosing strategies.12-16
Many patients receiving multiple doses of oritavancin did not experience AEs or laboratory abnormalities.13,15 Four of 17 patients (24%) in one retrospective review experienced AEs, including infusion reactions, anemia, and leukopenia; all were reversible on discontinuation of oritavancin, and contributions of other antibiotics in some cases could not be ruled out.10 One patient experienced taste disturbance for several hours after each infusion, and a second had documented hearing loss after 3 doses of oritavancin in a 33-day period, though she had received 6 weeks of IV vancomycin prior to oritavancin.11,12 A patient treated for daptomycin- and vancomycinresistant Enterococcus faecium prosthetic valve endocarditis experienced nausea, anorexia, and minor liver function test (LFT) abnormalities after cumulative oritavancin exposure over 18 weeks.9 On discontinuation of the drug, nausea and anorexia improved, and LFTs normalized 11 months later. Overall, AEs reported with continued dosing of oritavancin have been minimal and largely reversible, mimicking the AEs in the product labeling for traditional dosing. This suggests that using a continued dosing strategy may not result in worse or more frequent AEs, though randomized controlled trials are needed to fully ascertain these preliminary findings.
Conclusions
The literature supporting the use of oritavancin beyond single-dose administration for ABSSSI is growing. Continued dosing regimens have been well tolerated and have resulted in clinical cure for many patients with barriers to first-line treatment and complicated or invasive infections. While randomized controlled trials are needed to concretely demonstrate the efficacy and safety of continued dosing of oritavancin, it may fill an important treatment niche in this era of growing antibiotic resistance and increasing complexity of patient cases.
1. Orbactiv [package insert]. Parsippany, NJ: The Medicines Company; 2019.
2. Corey GR, Kabler H, Mehra P, et al. Single-dose oritavancin in the treatment of acute bacterial skin infections. N Engl J Med. 2014;370(23):2180-2190. doi:10.1056/NEJMoa1310422
3. Corey GR, Good S, Jiang H, et al. Single-dose oritavancin versus 7-10 days of vancomycin in the treatment of gram-positive acute bacterial skin and skin structure infections: the SOLO II noninferiority study. Clin Infect Dis. 2015;60(2):254-262. doi:10.1093/cid/ciu778
4. Sweeney D, Stoneburner A, Shinabarger DL, et al. Comparative in vitro activity of oritavancin and other agents against vancomycin-susceptible and -resistant enterococci. J Antimicrob Chemother. 2017;72(2):622-624. doi.10.1093/jac/dkw451
5. Lehoux D, Ostiguy V, Vadieux C, et al. Oritavancin pharmacokinetics and bone penetration in rabbits. Antimicrob Agents Chemother. 2015;59(10):6501-6505. doi:10.1128/AAC.00981-15
6. Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011;52(3):e18-e55. doi:10.1093/cid/ciq146
7. Norris AH, Shrestha NK, Allison GM, et al. 2018 Infectious Diseases Society of America clinical practice guideline for the management of outpatient parenteral antimicrobial therapy. Clin Infect Dis. 2019;68(1):e1-e35. doi:10.1093/cid/ciy745
8. Redell M, Seirra-Hoffman M, Assi Maha, et al. The CHROME study, a real-world experience of single- and multiple-dose oritavancin for treatment of gram-positive infections. Open Forum Infect Dis. 2019;6(11):ofz479. doi:10.1093/ofid/ofz479
9. Johnson JA, Feeney ER, Kubiak DW, Corey GR. Prolonged use of oritavancin for vancomycin-resistant Enterococcus faecium prosthetic valve endocarditis. Open Forum Infect Dis. 2015;2(4):ofv156. doi:10.1093/ofid/ofv156
10. Schulz LT, Dworkin E, Dela-Pena J, Rose WE. Multipledose oritavancin evaluation in a retrospective cohort of patients with complicated infections. Pharmacotherapy. 2018;38(1):152-159. doi:10.1002/phar.2057
11. Stewart CL, Turner MS, Frens JJ, Snider CB, Smith JR. Real-world experience with oritavancin therapy in invasive gram-positive infections. Infect Dis Ther. 2017;6(2):277-289. doi:10.1007/s40121-017-0156-z
12. Delaportas DJ, Estrada SJ, Darmelio M. Successful treatment of methicillin susceptible Staphylococcus aureus osteomyelitis with oritavancin. Pharmacotherapy. 2017;37(8):e90-e92. doi:10.1002/phar.1957
13. Chastain DB, Davis A. Treatment of chronic osteomyelitis with multidose oritavancin: a case series and literature review. Int J Antimicrob Agents. 2019;53(4):429-434. doi:10.1016/j.ijantimicag.2018.11.023
14. Dahesh S, Wong B, Nizet V, Sakoulas G, Tran TT, Aitken SL. Treatment of multidrug-resistant vancomycinresistant Enterococcus faecium hardware-associated vertebral osteomyelitis with oritavancin plus ampicillin. Antimicrob Agents Chemother. 2019;63(7):e02622-18. doi:10.1128/AAC.02622-18
15. Foster RA, Philavong KP, Weissman S, Tang X, Bookstaver PB. Oritavancin for the treatment of daptomycin nonsusceptible vancomycin-resistant Enterococci osteomyelitis. Infect Dis Clin Pract. 2018;26(2):97-99. doi:10.1097/IPC.0000000000000517
16. Ruggero M, Ziegler M, Tebas P, Binkley A, Kelly B. Successful treatment of methicillin-resistant Staphylococcus aureus vertebral osteomyelitis with outpatient oritavancin therapy. Infect Dis Clin Pract. 2018;26(3):141-144. doi:10.1097/IPC.0000000000000599
17. Corey GR, Loutit J, Moeck G, et al. Single intravenous dose of oritavancin for treatment of acute skin and skin structure infections caused by gram-positive bacteria: summary of safety analysis from the phase 3 SOLO studies. Antimicrob Agents Chemother. 2018;62(4):e01919- 17. doi:10.1128/AAC.01919-17
Oritavancin is a lipoglycopeptide antibiotic. The US Food and Drug Administration (FDA) approved oritavancin in 2014 for adults with acute bacterial skin and skin structure infections (ABSSSI).1 The antibiotic is currently FDA approved for infections caused by Gram-positive organisms, including methicillin-resistant and methicillinsusceptible Staphylococcus aureus (MRSA, MSSA), a variety of Streptococcus species, and vancomycin-susceptible Enterococcus faecalis (VSE). Oritavancin demonstrates concentrationdependent bactericidal activity and has a half-life of 245 hours. This half-life allows for treatment of ABSSSI with a single 1,200 mg IV dose, which has been shown to be noninferior to vancomycin dosed twice daily for 7 to 10 days.1-3
Proposal for Expanded Uses
Although the approved indication for oritavancin is narrow, in vitro studies have shown that oritavancin also has activity against vancomycin-resistant enterococci (VRE), and rabbit studies have demonstrated its excellent bone penetration.4,5 These findings have raised the question of whether oritavancin can be safely and effectively used for infections such as endocarditis, osteomyelitis, and bacteremia, which are often caused by invasive Grampositive organisms. These types of invasive infections, particularly when MRSA is implicated, generally require IV antibiotic therapy for several weeks, often with vancomycin.6
To avoid long hospital stays solely for antibiotic administration, health care practitioners will often use outpatient parenteral antimicrobial therapy (OPAT). However, using OPAT presents many challenges due to the need for frequent dosing, the risk of peripheral or central-line infections, and therapeutic drug monitoring when using vancomycin; additionally, administration and line care oftentimes require caregiver support, which may not be present for all patients.7 Concerns also have been raised regarding the use of OPAT in patients with a history of IV drug use due to the potential increased risk of line infections or line abuse. Few studies have explored OPAT in this population, and the Infectious Diseases Society of America OPAT guidelines recommend that the decision to use OPAT should be made on a case-by-case basis.7 Thus, patients who are deemed inappropriate for OPAT oftentimes remain hospitalized or reside briefly in nursing facilities solely for antibiotic administration
Oritavancin’s long half-life and potent activity against Gram-positive organisms has led to increased interest in off-label use of infrequent dosing intervals, such as weekly, to treat complicated and invasive infections. Weekly rather than daily dosing would allow for less burdensome antibiotic administration regimens and shorter hospital stays especially for patients who are not candidates for OPAT.
Efficacy of Continued Dosing
This proposed weekly dosing pattern, referred to as continued dosing or a multiple-dose regimen, has gained traction in the literature. To date, no randomized controlled trials have been conducted to assess oritavancin’s efficacy in off-label indications or continued dosing, but several case reports and retrospective cohort analyses show promising outcomes.8-16 In an analysis of data from the Clinical and Historic Registry and Orbactiv Medical Evaluation (CHROME) patient registry, 32 patients received multiple doses of oritavancin for complicated Gram-positive infections with a 93.8% overall clinical success rate, including success rates of 90.9% (10/11) for general bone and joint infections and 87.5% (7/8) for patients diagnosed specifically with osteomyelitis.8
Patients received between 2 and 10 doses of 1,200 mg IV given every 6 to 14 days. Johnson and colleagues report using oritavancin 1,200 mg IV every other day for 3 doses followed by 1,200 mg IV once weekly for a patient with daptomycin- and vancomycin-resistant Enterococcus endocarditis, resulting in negative blood cultures while on therapy.9 However, source control via valve replacement and postoperative oritavancin 1,200 mg IV twice weekly for 10 weeks was required to fully clear the infection.
Schulz and colleagues published a retrospective cohort analysis of 17 patients who received multiple doses of oritavancin for complicated bacterial infections, including osteomyelitis, pneumonia, and bacteremia.10 They reported 100% of patients were either successfully cured or had demonstrable improvements in their infections by using a 1,200 mg IV loading dose followed by 800 mg IV if the second dose was given within 7 days or 1,200 mg IV if the second dose was given more than 10 days later. Patients received between 2 and 18 total doses, with 6 out of 17 (35%) receiving only 2 doses. One patient who received 18 doses was an outlier, as her treatment goal was palliative suppression due to an infected endovascular graft that could not be removed.
In a published case series, 1 of 10 patients receiving oritavancin for invasive Grampositive infections received multiple doses of oritavancin for an MSSA deep tissue infection.11 The 3 total doses (strength not reported) were separated by 19 days and 14 days and resulted in cure. Several case reports and a retrospective chart review study specifically show the effectiveness of oritavancin for osteomyelitis caused by MSSA, MRSA, and VRE.12-16 However, dosing strategies varied widely after the initial 1,200 mg IV loading dose.
Drug Interactions, Safety, and Tolerability
Oritavancin has minimal drug-drug interactions, the most notable being with anticoagulants. 1 Use of IV heparin within 120 hours of oritavancin administration can falsely elevate activated partial thromboplastin time (aPTT) levels; therefore, heparin should not be monitored with aPTT during this period. Oritavancin also can artificially prolong international normalized ratio (INR) values for up to 12 hours, and dose adjustments based on INRs during this window are not recommended. Of note, factor Xa laboratory monitoring is unaffected by oritavancin, as it does not depend on phospholipid reagents as do aPTT and INR measurements.
Oritavancin has been shown to be well tolerated when dosed according to both the package insert and continued dosing strategies. The most common adverse effects (AEs) (≥ 3%), occurring at similar rates to vancomycin, are nausea, vomiting, diarrhea, headache, and limb and subcutaneous abscesses.1 Infusion reactions also have been reported, although they are usually reversible on slowing or stopping the infusion. It is worth noting that the use of oritavancin for osteomyelitis is not recommended in the product labeling, as an increased rate of osteomyelitis was observed in the oritavancin vs IV vancomycin groups for the treatment of patients with acute bacterial skin and skin structure infection (SOLO) trials (0.6% in oritavancin group vs 0.1% in vancomycin group, statistical significance not reported).17 However, it was postulated that these osteomyelitis cases were likely present, yet not recognized, at baseline and were not the result of administering oritavancin. This conclusion is further corroborated by previously presented research demonstrating successful cure of osteomyelitis with continued dosing strategies.12-16
Many patients receiving multiple doses of oritavancin did not experience AEs or laboratory abnormalities.13,15 Four of 17 patients (24%) in one retrospective review experienced AEs, including infusion reactions, anemia, and leukopenia; all were reversible on discontinuation of oritavancin, and contributions of other antibiotics in some cases could not be ruled out.10 One patient experienced taste disturbance for several hours after each infusion, and a second had documented hearing loss after 3 doses of oritavancin in a 33-day period, though she had received 6 weeks of IV vancomycin prior to oritavancin.11,12 A patient treated for daptomycin- and vancomycinresistant Enterococcus faecium prosthetic valve endocarditis experienced nausea, anorexia, and minor liver function test (LFT) abnormalities after cumulative oritavancin exposure over 18 weeks.9 On discontinuation of the drug, nausea and anorexia improved, and LFTs normalized 11 months later. Overall, AEs reported with continued dosing of oritavancin have been minimal and largely reversible, mimicking the AEs in the product labeling for traditional dosing. This suggests that using a continued dosing strategy may not result in worse or more frequent AEs, though randomized controlled trials are needed to fully ascertain these preliminary findings.
Conclusions
The literature supporting the use of oritavancin beyond single-dose administration for ABSSSI is growing. Continued dosing regimens have been well tolerated and have resulted in clinical cure for many patients with barriers to first-line treatment and complicated or invasive infections. While randomized controlled trials are needed to concretely demonstrate the efficacy and safety of continued dosing of oritavancin, it may fill an important treatment niche in this era of growing antibiotic resistance and increasing complexity of patient cases.
Oritavancin is a lipoglycopeptide antibiotic. The US Food and Drug Administration (FDA) approved oritavancin in 2014 for adults with acute bacterial skin and skin structure infections (ABSSSI).1 The antibiotic is currently FDA approved for infections caused by Gram-positive organisms, including methicillin-resistant and methicillinsusceptible Staphylococcus aureus (MRSA, MSSA), a variety of Streptococcus species, and vancomycin-susceptible Enterococcus faecalis (VSE). Oritavancin demonstrates concentrationdependent bactericidal activity and has a half-life of 245 hours. This half-life allows for treatment of ABSSSI with a single 1,200 mg IV dose, which has been shown to be noninferior to vancomycin dosed twice daily for 7 to 10 days.1-3
Proposal for Expanded Uses
Although the approved indication for oritavancin is narrow, in vitro studies have shown that oritavancin also has activity against vancomycin-resistant enterococci (VRE), and rabbit studies have demonstrated its excellent bone penetration.4,5 These findings have raised the question of whether oritavancin can be safely and effectively used for infections such as endocarditis, osteomyelitis, and bacteremia, which are often caused by invasive Grampositive organisms. These types of invasive infections, particularly when MRSA is implicated, generally require IV antibiotic therapy for several weeks, often with vancomycin.6
To avoid long hospital stays solely for antibiotic administration, health care practitioners will often use outpatient parenteral antimicrobial therapy (OPAT). However, using OPAT presents many challenges due to the need for frequent dosing, the risk of peripheral or central-line infections, and therapeutic drug monitoring when using vancomycin; additionally, administration and line care oftentimes require caregiver support, which may not be present for all patients.7 Concerns also have been raised regarding the use of OPAT in patients with a history of IV drug use due to the potential increased risk of line infections or line abuse. Few studies have explored OPAT in this population, and the Infectious Diseases Society of America OPAT guidelines recommend that the decision to use OPAT should be made on a case-by-case basis.7 Thus, patients who are deemed inappropriate for OPAT oftentimes remain hospitalized or reside briefly in nursing facilities solely for antibiotic administration
Oritavancin’s long half-life and potent activity against Gram-positive organisms has led to increased interest in off-label use of infrequent dosing intervals, such as weekly, to treat complicated and invasive infections. Weekly rather than daily dosing would allow for less burdensome antibiotic administration regimens and shorter hospital stays especially for patients who are not candidates for OPAT.
Efficacy of Continued Dosing
This proposed weekly dosing pattern, referred to as continued dosing or a multiple-dose regimen, has gained traction in the literature. To date, no randomized controlled trials have been conducted to assess oritavancin’s efficacy in off-label indications or continued dosing, but several case reports and retrospective cohort analyses show promising outcomes.8-16 In an analysis of data from the Clinical and Historic Registry and Orbactiv Medical Evaluation (CHROME) patient registry, 32 patients received multiple doses of oritavancin for complicated Gram-positive infections with a 93.8% overall clinical success rate, including success rates of 90.9% (10/11) for general bone and joint infections and 87.5% (7/8) for patients diagnosed specifically with osteomyelitis.8
Patients received between 2 and 10 doses of 1,200 mg IV given every 6 to 14 days. Johnson and colleagues report using oritavancin 1,200 mg IV every other day for 3 doses followed by 1,200 mg IV once weekly for a patient with daptomycin- and vancomycin-resistant Enterococcus endocarditis, resulting in negative blood cultures while on therapy.9 However, source control via valve replacement and postoperative oritavancin 1,200 mg IV twice weekly for 10 weeks was required to fully clear the infection.
Schulz and colleagues published a retrospective cohort analysis of 17 patients who received multiple doses of oritavancin for complicated bacterial infections, including osteomyelitis, pneumonia, and bacteremia.10 They reported 100% of patients were either successfully cured or had demonstrable improvements in their infections by using a 1,200 mg IV loading dose followed by 800 mg IV if the second dose was given within 7 days or 1,200 mg IV if the second dose was given more than 10 days later. Patients received between 2 and 18 total doses, with 6 out of 17 (35%) receiving only 2 doses. One patient who received 18 doses was an outlier, as her treatment goal was palliative suppression due to an infected endovascular graft that could not be removed.
In a published case series, 1 of 10 patients receiving oritavancin for invasive Grampositive infections received multiple doses of oritavancin for an MSSA deep tissue infection.11 The 3 total doses (strength not reported) were separated by 19 days and 14 days and resulted in cure. Several case reports and a retrospective chart review study specifically show the effectiveness of oritavancin for osteomyelitis caused by MSSA, MRSA, and VRE.12-16 However, dosing strategies varied widely after the initial 1,200 mg IV loading dose.
Drug Interactions, Safety, and Tolerability
Oritavancin has minimal drug-drug interactions, the most notable being with anticoagulants. 1 Use of IV heparin within 120 hours of oritavancin administration can falsely elevate activated partial thromboplastin time (aPTT) levels; therefore, heparin should not be monitored with aPTT during this period. Oritavancin also can artificially prolong international normalized ratio (INR) values for up to 12 hours, and dose adjustments based on INRs during this window are not recommended. Of note, factor Xa laboratory monitoring is unaffected by oritavancin, as it does not depend on phospholipid reagents as do aPTT and INR measurements.
Oritavancin has been shown to be well tolerated when dosed according to both the package insert and continued dosing strategies. The most common adverse effects (AEs) (≥ 3%), occurring at similar rates to vancomycin, are nausea, vomiting, diarrhea, headache, and limb and subcutaneous abscesses.1 Infusion reactions also have been reported, although they are usually reversible on slowing or stopping the infusion. It is worth noting that the use of oritavancin for osteomyelitis is not recommended in the product labeling, as an increased rate of osteomyelitis was observed in the oritavancin vs IV vancomycin groups for the treatment of patients with acute bacterial skin and skin structure infection (SOLO) trials (0.6% in oritavancin group vs 0.1% in vancomycin group, statistical significance not reported).17 However, it was postulated that these osteomyelitis cases were likely present, yet not recognized, at baseline and were not the result of administering oritavancin. This conclusion is further corroborated by previously presented research demonstrating successful cure of osteomyelitis with continued dosing strategies.12-16
Many patients receiving multiple doses of oritavancin did not experience AEs or laboratory abnormalities.13,15 Four of 17 patients (24%) in one retrospective review experienced AEs, including infusion reactions, anemia, and leukopenia; all were reversible on discontinuation of oritavancin, and contributions of other antibiotics in some cases could not be ruled out.10 One patient experienced taste disturbance for several hours after each infusion, and a second had documented hearing loss after 3 doses of oritavancin in a 33-day period, though she had received 6 weeks of IV vancomycin prior to oritavancin.11,12 A patient treated for daptomycin- and vancomycinresistant Enterococcus faecium prosthetic valve endocarditis experienced nausea, anorexia, and minor liver function test (LFT) abnormalities after cumulative oritavancin exposure over 18 weeks.9 On discontinuation of the drug, nausea and anorexia improved, and LFTs normalized 11 months later. Overall, AEs reported with continued dosing of oritavancin have been minimal and largely reversible, mimicking the AEs in the product labeling for traditional dosing. This suggests that using a continued dosing strategy may not result in worse or more frequent AEs, though randomized controlled trials are needed to fully ascertain these preliminary findings.
Conclusions
The literature supporting the use of oritavancin beyond single-dose administration for ABSSSI is growing. Continued dosing regimens have been well tolerated and have resulted in clinical cure for many patients with barriers to first-line treatment and complicated or invasive infections. While randomized controlled trials are needed to concretely demonstrate the efficacy and safety of continued dosing of oritavancin, it may fill an important treatment niche in this era of growing antibiotic resistance and increasing complexity of patient cases.
1. Orbactiv [package insert]. Parsippany, NJ: The Medicines Company; 2019.
2. Corey GR, Kabler H, Mehra P, et al. Single-dose oritavancin in the treatment of acute bacterial skin infections. N Engl J Med. 2014;370(23):2180-2190. doi:10.1056/NEJMoa1310422
3. Corey GR, Good S, Jiang H, et al. Single-dose oritavancin versus 7-10 days of vancomycin in the treatment of gram-positive acute bacterial skin and skin structure infections: the SOLO II noninferiority study. Clin Infect Dis. 2015;60(2):254-262. doi:10.1093/cid/ciu778
4. Sweeney D, Stoneburner A, Shinabarger DL, et al. Comparative in vitro activity of oritavancin and other agents against vancomycin-susceptible and -resistant enterococci. J Antimicrob Chemother. 2017;72(2):622-624. doi.10.1093/jac/dkw451
5. Lehoux D, Ostiguy V, Vadieux C, et al. Oritavancin pharmacokinetics and bone penetration in rabbits. Antimicrob Agents Chemother. 2015;59(10):6501-6505. doi:10.1128/AAC.00981-15
6. Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011;52(3):e18-e55. doi:10.1093/cid/ciq146
7. Norris AH, Shrestha NK, Allison GM, et al. 2018 Infectious Diseases Society of America clinical practice guideline for the management of outpatient parenteral antimicrobial therapy. Clin Infect Dis. 2019;68(1):e1-e35. doi:10.1093/cid/ciy745
8. Redell M, Seirra-Hoffman M, Assi Maha, et al. The CHROME study, a real-world experience of single- and multiple-dose oritavancin for treatment of gram-positive infections. Open Forum Infect Dis. 2019;6(11):ofz479. doi:10.1093/ofid/ofz479
9. Johnson JA, Feeney ER, Kubiak DW, Corey GR. Prolonged use of oritavancin for vancomycin-resistant Enterococcus faecium prosthetic valve endocarditis. Open Forum Infect Dis. 2015;2(4):ofv156. doi:10.1093/ofid/ofv156
10. Schulz LT, Dworkin E, Dela-Pena J, Rose WE. Multipledose oritavancin evaluation in a retrospective cohort of patients with complicated infections. Pharmacotherapy. 2018;38(1):152-159. doi:10.1002/phar.2057
11. Stewart CL, Turner MS, Frens JJ, Snider CB, Smith JR. Real-world experience with oritavancin therapy in invasive gram-positive infections. Infect Dis Ther. 2017;6(2):277-289. doi:10.1007/s40121-017-0156-z
12. Delaportas DJ, Estrada SJ, Darmelio M. Successful treatment of methicillin susceptible Staphylococcus aureus osteomyelitis with oritavancin. Pharmacotherapy. 2017;37(8):e90-e92. doi:10.1002/phar.1957
13. Chastain DB, Davis A. Treatment of chronic osteomyelitis with multidose oritavancin: a case series and literature review. Int J Antimicrob Agents. 2019;53(4):429-434. doi:10.1016/j.ijantimicag.2018.11.023
14. Dahesh S, Wong B, Nizet V, Sakoulas G, Tran TT, Aitken SL. Treatment of multidrug-resistant vancomycinresistant Enterococcus faecium hardware-associated vertebral osteomyelitis with oritavancin plus ampicillin. Antimicrob Agents Chemother. 2019;63(7):e02622-18. doi:10.1128/AAC.02622-18
15. Foster RA, Philavong KP, Weissman S, Tang X, Bookstaver PB. Oritavancin for the treatment of daptomycin nonsusceptible vancomycin-resistant Enterococci osteomyelitis. Infect Dis Clin Pract. 2018;26(2):97-99. doi:10.1097/IPC.0000000000000517
16. Ruggero M, Ziegler M, Tebas P, Binkley A, Kelly B. Successful treatment of methicillin-resistant Staphylococcus aureus vertebral osteomyelitis with outpatient oritavancin therapy. Infect Dis Clin Pract. 2018;26(3):141-144. doi:10.1097/IPC.0000000000000599
17. Corey GR, Loutit J, Moeck G, et al. Single intravenous dose of oritavancin for treatment of acute skin and skin structure infections caused by gram-positive bacteria: summary of safety analysis from the phase 3 SOLO studies. Antimicrob Agents Chemother. 2018;62(4):e01919- 17. doi:10.1128/AAC.01919-17
1. Orbactiv [package insert]. Parsippany, NJ: The Medicines Company; 2019.
2. Corey GR, Kabler H, Mehra P, et al. Single-dose oritavancin in the treatment of acute bacterial skin infections. N Engl J Med. 2014;370(23):2180-2190. doi:10.1056/NEJMoa1310422
3. Corey GR, Good S, Jiang H, et al. Single-dose oritavancin versus 7-10 days of vancomycin in the treatment of gram-positive acute bacterial skin and skin structure infections: the SOLO II noninferiority study. Clin Infect Dis. 2015;60(2):254-262. doi:10.1093/cid/ciu778
4. Sweeney D, Stoneburner A, Shinabarger DL, et al. Comparative in vitro activity of oritavancin and other agents against vancomycin-susceptible and -resistant enterococci. J Antimicrob Chemother. 2017;72(2):622-624. doi.10.1093/jac/dkw451
5. Lehoux D, Ostiguy V, Vadieux C, et al. Oritavancin pharmacokinetics and bone penetration in rabbits. Antimicrob Agents Chemother. 2015;59(10):6501-6505. doi:10.1128/AAC.00981-15
6. Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011;52(3):e18-e55. doi:10.1093/cid/ciq146
7. Norris AH, Shrestha NK, Allison GM, et al. 2018 Infectious Diseases Society of America clinical practice guideline for the management of outpatient parenteral antimicrobial therapy. Clin Infect Dis. 2019;68(1):e1-e35. doi:10.1093/cid/ciy745
8. Redell M, Seirra-Hoffman M, Assi Maha, et al. The CHROME study, a real-world experience of single- and multiple-dose oritavancin for treatment of gram-positive infections. Open Forum Infect Dis. 2019;6(11):ofz479. doi:10.1093/ofid/ofz479
9. Johnson JA, Feeney ER, Kubiak DW, Corey GR. Prolonged use of oritavancin for vancomycin-resistant Enterococcus faecium prosthetic valve endocarditis. Open Forum Infect Dis. 2015;2(4):ofv156. doi:10.1093/ofid/ofv156
10. Schulz LT, Dworkin E, Dela-Pena J, Rose WE. Multipledose oritavancin evaluation in a retrospective cohort of patients with complicated infections. Pharmacotherapy. 2018;38(1):152-159. doi:10.1002/phar.2057
11. Stewart CL, Turner MS, Frens JJ, Snider CB, Smith JR. Real-world experience with oritavancin therapy in invasive gram-positive infections. Infect Dis Ther. 2017;6(2):277-289. doi:10.1007/s40121-017-0156-z
12. Delaportas DJ, Estrada SJ, Darmelio M. Successful treatment of methicillin susceptible Staphylococcus aureus osteomyelitis with oritavancin. Pharmacotherapy. 2017;37(8):e90-e92. doi:10.1002/phar.1957
13. Chastain DB, Davis A. Treatment of chronic osteomyelitis with multidose oritavancin: a case series and literature review. Int J Antimicrob Agents. 2019;53(4):429-434. doi:10.1016/j.ijantimicag.2018.11.023
14. Dahesh S, Wong B, Nizet V, Sakoulas G, Tran TT, Aitken SL. Treatment of multidrug-resistant vancomycinresistant Enterococcus faecium hardware-associated vertebral osteomyelitis with oritavancin plus ampicillin. Antimicrob Agents Chemother. 2019;63(7):e02622-18. doi:10.1128/AAC.02622-18
15. Foster RA, Philavong KP, Weissman S, Tang X, Bookstaver PB. Oritavancin for the treatment of daptomycin nonsusceptible vancomycin-resistant Enterococci osteomyelitis. Infect Dis Clin Pract. 2018;26(2):97-99. doi:10.1097/IPC.0000000000000517
16. Ruggero M, Ziegler M, Tebas P, Binkley A, Kelly B. Successful treatment of methicillin-resistant Staphylococcus aureus vertebral osteomyelitis with outpatient oritavancin therapy. Infect Dis Clin Pract. 2018;26(3):141-144. doi:10.1097/IPC.0000000000000599
17. Corey GR, Loutit J, Moeck G, et al. Single intravenous dose of oritavancin for treatment of acute skin and skin structure infections caused by gram-positive bacteria: summary of safety analysis from the phase 3 SOLO studies. Antimicrob Agents Chemother. 2018;62(4):e01919- 17. doi:10.1128/AAC.01919-17
What to know as ACA heads to Supreme Court – again
The case, California v. Texas, is the result of a change to the health law made by Congress in 2017. As part of a major tax bill, Congress reduced to zero the penalty for not having health insurance. But it was that penalty – a tax – that the high court ruled made the law constitutional in a 2012 decision, argues a group of Republican state attorneys general. Without the tax, they say in their suit, the rest of the law must fall, too.
After originally contending that the entire law should not be struck down when the suit was filed in 2018, the Trump administration changed course in 2019 and joined the GOP officials who brought the case.
Here are some key questions and answers about the case.
What are the possibilities for how the court could rule?
There is a long list of ways this could play out.
The justices could declare the entire law unconstitutional – which is what a federal district judge in Texas ruled in December 2018. But legal experts say that’s not the most likely outcome of this case.
First, the court may avoid deciding the case on its merits entirely by ruling that the plaintiffs do not have “standing” to sue. The central issue in the case is whether the requirement in the law to have insurance – which remains even though Congress eliminated the penalty or tax – is constitutional. But states are not subject to the so-called individual mandate, so some analysts suggest the Republican officials have no standing. In addition, questions have been raised about the individual plaintiffs in the case, two consultants from Texas who argue that they felt compelled to buy insurance even without a possible penalty.
The court could also rule that, by eliminating the penalty but not the rest of the mandate (which Congress could not do in that 2017 tax bill for procedural reasons), lawmakers “didn’t mean to coerce anyone to do anything, and so there’s no constitutional problem,” University of Michigan law professor Nicholas Bagley said in a recent webinar for the NIHCM Foundation, the Commonwealth Fund, and the University of Southern California’s Center for Health Journalism.
Or, said Bagley, the court could rule that, without the tax, the requirement to have health insurance is unconstitutional, but the rest of the law is not. In that case, the justices might strike the mandate only, which would have basically no impact.
It gets more complicated if the court decides that, as the plaintiffs argue, the individual mandate language without the penalty is unconstitutional and so closely tied to other parts of the law that some of them must fall as well.
Even there the court has choices. One option would be, as the Trump administration originally argued, to strike down the mandate and just the pieces of the law most closely related to it – which happen to include the insurance protections for people with preexisting conditions, an extremely popular provision of the law. The two parts are connected because the original purpose of the mandate was to make sure enough healthy people sign up for insurance to offset the added costs to insurers of sicker people.
Another option, of course, would be for the court to follow the lead of the Texas judge and strike down the entire law.
While that’s not the most likely outcome, said Bagley, if it happens it could be “a hot mess” for the nation’s entire health care system. As just one example, he said, “every hospital is getting paid pursuant to changes made by the ACA. How do you even go about making payments if the thing that you are looking to guide what those payments ought to be is itself invalid?”
What impact will new Justice Amy Coney Barrett have?
Perhaps a lot. Before the death of Justice Ruth Bader Ginsburg, most court observers thought the case was highly unlikely to result in the entire law being struck down. That’s because Chief Justice John Roberts voted to uphold the law in 2012, and again when it was challenged in a less sweeping way in 2015.
But with Barrett replacing Ginsburg, even if Roberts joined the court’s remaining three liberals they could still be outvoted by the other five conservatives. Barrett was coy about her views on the Affordable Care Act during her confirmation hearings in October, but she has written that she thinks Roberts was wrong to uphold the law in 2012.
Could a new president and Congress make the case go away?
Many have suggested that, if Joe Biden assumes the presidency, his Justice Department could simply drop the case. But the administration did not bring the case; the GOP state officials did. And while normally the Justice Department’s job is to defend existing laws in court, in this case the ACA is being defended by a group of Democratic state attorneys general. A new administration could change that position, but that’s not the same as dropping the case.
Congress, on the other hand, could easily make the case moot. It could add back even a nominal financial penalty for not having insurance. It could eliminate the mandate altogether, although that would require 60 votes in the Senate under current rules. Congress could also pass a “severability” provision saying that, if any portion of the law is struck down, the rest should remain.
“The problem is not technical,” said Bagley. “It’s political.”
What is the timeline for a decision? Could the court delay implementation of its ruling?
The court usually hears oral arguments in a case months before it issues a decision. Unless the decision is unanimous or turns out to be very simple, Bagley said, he would expect to see an opinion “sometime in the spring.”
As to whether the court could find some or all of the law unconstitutional but delay when its decision takes effect, Bagley said that happened from time to time as recently as the 1970s. “That practice has been more or less abandoned,” he said, but in the case of a law so large, “you could imagine the Supreme Court using its discretion to say the decision wouldn’t take effect immediately.”
If the court does invalidate the entire ACA, Congress could act to fix things, but it’s unclear if it will be able to, especially if Republicans still control the Senate. If the justices strike the law, Bagley said, “I honestly think the likeliest outcome is that Congress runs around like a chicken with its head cut off, doesn’t come to a deal, and we’re back to where we were before 2010” when the ACA passed.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
The case, California v. Texas, is the result of a change to the health law made by Congress in 2017. As part of a major tax bill, Congress reduced to zero the penalty for not having health insurance. But it was that penalty – a tax – that the high court ruled made the law constitutional in a 2012 decision, argues a group of Republican state attorneys general. Without the tax, they say in their suit, the rest of the law must fall, too.
After originally contending that the entire law should not be struck down when the suit was filed in 2018, the Trump administration changed course in 2019 and joined the GOP officials who brought the case.
Here are some key questions and answers about the case.
What are the possibilities for how the court could rule?
There is a long list of ways this could play out.
The justices could declare the entire law unconstitutional – which is what a federal district judge in Texas ruled in December 2018. But legal experts say that’s not the most likely outcome of this case.
First, the court may avoid deciding the case on its merits entirely by ruling that the plaintiffs do not have “standing” to sue. The central issue in the case is whether the requirement in the law to have insurance – which remains even though Congress eliminated the penalty or tax – is constitutional. But states are not subject to the so-called individual mandate, so some analysts suggest the Republican officials have no standing. In addition, questions have been raised about the individual plaintiffs in the case, two consultants from Texas who argue that they felt compelled to buy insurance even without a possible penalty.
The court could also rule that, by eliminating the penalty but not the rest of the mandate (which Congress could not do in that 2017 tax bill for procedural reasons), lawmakers “didn’t mean to coerce anyone to do anything, and so there’s no constitutional problem,” University of Michigan law professor Nicholas Bagley said in a recent webinar for the NIHCM Foundation, the Commonwealth Fund, and the University of Southern California’s Center for Health Journalism.
Or, said Bagley, the court could rule that, without the tax, the requirement to have health insurance is unconstitutional, but the rest of the law is not. In that case, the justices might strike the mandate only, which would have basically no impact.
It gets more complicated if the court decides that, as the plaintiffs argue, the individual mandate language without the penalty is unconstitutional and so closely tied to other parts of the law that some of them must fall as well.
Even there the court has choices. One option would be, as the Trump administration originally argued, to strike down the mandate and just the pieces of the law most closely related to it – which happen to include the insurance protections for people with preexisting conditions, an extremely popular provision of the law. The two parts are connected because the original purpose of the mandate was to make sure enough healthy people sign up for insurance to offset the added costs to insurers of sicker people.
Another option, of course, would be for the court to follow the lead of the Texas judge and strike down the entire law.
While that’s not the most likely outcome, said Bagley, if it happens it could be “a hot mess” for the nation’s entire health care system. As just one example, he said, “every hospital is getting paid pursuant to changes made by the ACA. How do you even go about making payments if the thing that you are looking to guide what those payments ought to be is itself invalid?”
What impact will new Justice Amy Coney Barrett have?
Perhaps a lot. Before the death of Justice Ruth Bader Ginsburg, most court observers thought the case was highly unlikely to result in the entire law being struck down. That’s because Chief Justice John Roberts voted to uphold the law in 2012, and again when it was challenged in a less sweeping way in 2015.
But with Barrett replacing Ginsburg, even if Roberts joined the court’s remaining three liberals they could still be outvoted by the other five conservatives. Barrett was coy about her views on the Affordable Care Act during her confirmation hearings in October, but she has written that she thinks Roberts was wrong to uphold the law in 2012.
Could a new president and Congress make the case go away?
Many have suggested that, if Joe Biden assumes the presidency, his Justice Department could simply drop the case. But the administration did not bring the case; the GOP state officials did. And while normally the Justice Department’s job is to defend existing laws in court, in this case the ACA is being defended by a group of Democratic state attorneys general. A new administration could change that position, but that’s not the same as dropping the case.
Congress, on the other hand, could easily make the case moot. It could add back even a nominal financial penalty for not having insurance. It could eliminate the mandate altogether, although that would require 60 votes in the Senate under current rules. Congress could also pass a “severability” provision saying that, if any portion of the law is struck down, the rest should remain.
“The problem is not technical,” said Bagley. “It’s political.”
What is the timeline for a decision? Could the court delay implementation of its ruling?
The court usually hears oral arguments in a case months before it issues a decision. Unless the decision is unanimous or turns out to be very simple, Bagley said, he would expect to see an opinion “sometime in the spring.”
As to whether the court could find some or all of the law unconstitutional but delay when its decision takes effect, Bagley said that happened from time to time as recently as the 1970s. “That practice has been more or less abandoned,” he said, but in the case of a law so large, “you could imagine the Supreme Court using its discretion to say the decision wouldn’t take effect immediately.”
If the court does invalidate the entire ACA, Congress could act to fix things, but it’s unclear if it will be able to, especially if Republicans still control the Senate. If the justices strike the law, Bagley said, “I honestly think the likeliest outcome is that Congress runs around like a chicken with its head cut off, doesn’t come to a deal, and we’re back to where we were before 2010” when the ACA passed.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
The case, California v. Texas, is the result of a change to the health law made by Congress in 2017. As part of a major tax bill, Congress reduced to zero the penalty for not having health insurance. But it was that penalty – a tax – that the high court ruled made the law constitutional in a 2012 decision, argues a group of Republican state attorneys general. Without the tax, they say in their suit, the rest of the law must fall, too.
After originally contending that the entire law should not be struck down when the suit was filed in 2018, the Trump administration changed course in 2019 and joined the GOP officials who brought the case.
Here are some key questions and answers about the case.
What are the possibilities for how the court could rule?
There is a long list of ways this could play out.
The justices could declare the entire law unconstitutional – which is what a federal district judge in Texas ruled in December 2018. But legal experts say that’s not the most likely outcome of this case.
First, the court may avoid deciding the case on its merits entirely by ruling that the plaintiffs do not have “standing” to sue. The central issue in the case is whether the requirement in the law to have insurance – which remains even though Congress eliminated the penalty or tax – is constitutional. But states are not subject to the so-called individual mandate, so some analysts suggest the Republican officials have no standing. In addition, questions have been raised about the individual plaintiffs in the case, two consultants from Texas who argue that they felt compelled to buy insurance even without a possible penalty.
The court could also rule that, by eliminating the penalty but not the rest of the mandate (which Congress could not do in that 2017 tax bill for procedural reasons), lawmakers “didn’t mean to coerce anyone to do anything, and so there’s no constitutional problem,” University of Michigan law professor Nicholas Bagley said in a recent webinar for the NIHCM Foundation, the Commonwealth Fund, and the University of Southern California’s Center for Health Journalism.
Or, said Bagley, the court could rule that, without the tax, the requirement to have health insurance is unconstitutional, but the rest of the law is not. In that case, the justices might strike the mandate only, which would have basically no impact.
It gets more complicated if the court decides that, as the plaintiffs argue, the individual mandate language without the penalty is unconstitutional and so closely tied to other parts of the law that some of them must fall as well.
Even there the court has choices. One option would be, as the Trump administration originally argued, to strike down the mandate and just the pieces of the law most closely related to it – which happen to include the insurance protections for people with preexisting conditions, an extremely popular provision of the law. The two parts are connected because the original purpose of the mandate was to make sure enough healthy people sign up for insurance to offset the added costs to insurers of sicker people.
Another option, of course, would be for the court to follow the lead of the Texas judge and strike down the entire law.
While that’s not the most likely outcome, said Bagley, if it happens it could be “a hot mess” for the nation’s entire health care system. As just one example, he said, “every hospital is getting paid pursuant to changes made by the ACA. How do you even go about making payments if the thing that you are looking to guide what those payments ought to be is itself invalid?”
What impact will new Justice Amy Coney Barrett have?
Perhaps a lot. Before the death of Justice Ruth Bader Ginsburg, most court observers thought the case was highly unlikely to result in the entire law being struck down. That’s because Chief Justice John Roberts voted to uphold the law in 2012, and again when it was challenged in a less sweeping way in 2015.
But with Barrett replacing Ginsburg, even if Roberts joined the court’s remaining three liberals they could still be outvoted by the other five conservatives. Barrett was coy about her views on the Affordable Care Act during her confirmation hearings in October, but she has written that she thinks Roberts was wrong to uphold the law in 2012.
Could a new president and Congress make the case go away?
Many have suggested that, if Joe Biden assumes the presidency, his Justice Department could simply drop the case. But the administration did not bring the case; the GOP state officials did. And while normally the Justice Department’s job is to defend existing laws in court, in this case the ACA is being defended by a group of Democratic state attorneys general. A new administration could change that position, but that’s not the same as dropping the case.
Congress, on the other hand, could easily make the case moot. It could add back even a nominal financial penalty for not having insurance. It could eliminate the mandate altogether, although that would require 60 votes in the Senate under current rules. Congress could also pass a “severability” provision saying that, if any portion of the law is struck down, the rest should remain.
“The problem is not technical,” said Bagley. “It’s political.”
What is the timeline for a decision? Could the court delay implementation of its ruling?
The court usually hears oral arguments in a case months before it issues a decision. Unless the decision is unanimous or turns out to be very simple, Bagley said, he would expect to see an opinion “sometime in the spring.”
As to whether the court could find some or all of the law unconstitutional but delay when its decision takes effect, Bagley said that happened from time to time as recently as the 1970s. “That practice has been more or less abandoned,” he said, but in the case of a law so large, “you could imagine the Supreme Court using its discretion to say the decision wouldn’t take effect immediately.”
If the court does invalidate the entire ACA, Congress could act to fix things, but it’s unclear if it will be able to, especially if Republicans still control the Senate. If the justices strike the law, Bagley said, “I honestly think the likeliest outcome is that Congress runs around like a chicken with its head cut off, doesn’t come to a deal, and we’re back to where we were before 2010” when the ACA passed.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.