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Cognitive screening of older physicians: What’s fair?
Cognitive screening of 141 clinicians 70 years or older at Yale New Haven (Conn.) Hospital identified 18 with cognitive deficits likely to impair their ability to practice medicine. Six retired and 12 agreed to limit their practice to closely proctored environments, according to a report in JAMA.
It was part of a program to screen all practitioners 70 years or older who apply for reappointment to the medical staff, and every 2 years thereafter, due to “concerns about the potentially compromised ability of older clinicians,” said the authors, Yale rheumatologist and geriatrician Leo M. Cooney Jr., MD, and Thomas Balcezak, MD, Yale New Haven’s chief medical officer.
Yale is not alone. Intermountain Healthcare, Stanford Hospitals and Clinics, Scripps Health Care, Penn Medicine, and the University of California, San Diego, are among the institutions with similar programs.
The move is being driven by the aging of the medical community. About 15% of U.S. physicians are over 65 years old, a tripling from 23,000 in 1980 to 73,000 in 2012-2016, and the number is growing, according to an editorial by Jeffrey L. Saver, MD, professor of neurology and senior associate vice president of neurology at the University of California, Los Angeles.
Given the trend, “it is not surprising that the issue of screening aging physicians for cognitive deficits has gained attention over the last decade,” Katrina Armstrong, MD, chair of the department of medicine at Massachusetts General Hospital, Boston, and Eileen E. Reynolds, MD, associate professor of medicine at Beth Israel Deaconess Medical Center, Boston, noted in a second editorial.
“Cognitive decline often accompanies aging, and the prevalence of dementia increases rapidly after age 70 years,” they said.
The data on whether older clinicians pose a risk to patients is limited and somewhat mixed. An analysis of 736,537 Medicare hospitalizations found no association between physician age and 30-day patient mortality among physicians 60 years or older with more than 201 admissions per year, but higher mortality among older physicians with lower volumes.
A meta-analysis of 62 studies showed that “older physicians have less factual knowledge, are less likely to adhere to appropriate standards of care, and may also have poorer patient outcomes.”
The new Yale data, meanwhile, suggests that “approximately 13% [18 of 141] of physicians and other clinicians older than 70 years should not be practicing independently,” Dr. Armstrong and Dr. Reynolds said in their editorial.
There is support for screening efforts. “As a profession that deals with human life, medical practitioners must obviously have the cognitive capacity to safely practice medicine. I applaud the approach taken by Yale New Haven Hospital in that cognitive abilities themselves, and not simply funds of knowledge, are assessed,” said Richard J. Caselli, MD, professor of neurology at the Mayo Clinic Arizona, Scottsdale, and a leader of the Alzheimer’s disease program there.
However, it’s not hard to imagine highly competent but older physicians taking umbrage at cognitive screening, and there’s been pushback. Stanford was considering a Yale-like approach but opted instead for peer review after opposition. Objections from the Utah Medical Association led Utah to enact a law banning age-based physician screening. In 2015, the American Medical Association issued a report calling for the development of guidelines and standards for assessing competency in aging physicians, but the AMA House of Delegates shelved it pending further study.
There are concerns about age discrimination, discounting the accumulated wisdom of long-practicing physicians, and misclassifying competent physicians, particularly those who provide quality care in rural and other underserved areas. Indeed, 8 of 14 clinicians who screened positive at Yale and underwent more extensive testing were allowed to recredential, “suggesting that the false-positive screening rate could be as high as 57%,” Dr. Armstrong and Dr. Reynolds noted.
The consensus seems to be that there probably is a need for some sort of screening, but it must be both sound and fair. Rather than a piecemeal institutional approach, perhaps there is “an important opportunity for other groups, including specialty boards and state licensing boards” to standardize the process, they said.
Among other things, assessments could focus less on test scores and more on the practice of medicine. For instance, fine motor skill/motor planning assessments for surgeons, and intermediate results could trigger a more extensive assessment of actual clinical performance, perhaps even direct observation, Dr. Saver said in his editorial.
As far as clinical performance goes, none of the 18 clinicians at Yale had previous performance problems. “Was this a failure of the system to report impaired physicians or were these physicians compensating sufficiently to avoid detection?” In either case, “cognitive testing should be a red flag that triggers other clinical assessments,” said Carl I. Cohen, MD, professor and director of the division of geriatric psychiatry at the State University of New York, Brooklyn.
The original plan at Yale was for neurologic and ophthalmologic examinations beginning at age 70, but ultimately it was decided to go with a battery of 16 tests to assess visual scanning and psychomotor efficiency, processing speed under pressure, concentration, and working memory, among other things. Testing takes about 50-90 minutes, and is graded by single neuropsychologist to ensure consistency. Results were compared with normative scores from both older and younger clinicians.
To prevent clinicians from preparing for it, Yale isn’t releasing its test battery.
Suboptimal performance triggered additional evaluations, including in-depth assessment of intellectual, memory, and executive function. Final reviews and recommendations were made by a committee that included a geriatrician, the clinician’s section or department chair, and current and past chief medical officers.
Among the 18 providers who demonstrated deficits impairing their ability to practice medicine, 5 were 70-74 years old; 4 were 75-79; and 9 were 80 years or older. Minor abnormalities were found in 34 other candidates (24.1%); they were allowed to recredential but were scheduled for rescreening at 1-year intervals, instead of every 2 years.
The mean age among the 141 screened clinicians was 74.3 years and ranged from 69 to 92 years; 86% were men. Applicants included 125 physicians (88.7%) as well as 5 advanced practice registered nurses; 4 dentists; 3 psychologists; 2 podiatrists; 1 physician associate; and 1 midwife.
The authors had no relevant disclosures.
SOURCE: Cooney L et al. JAMA. 2020 Jan 14;323(2):179-80.
Cognitive screening of 141 clinicians 70 years or older at Yale New Haven (Conn.) Hospital identified 18 with cognitive deficits likely to impair their ability to practice medicine. Six retired and 12 agreed to limit their practice to closely proctored environments, according to a report in JAMA.
It was part of a program to screen all practitioners 70 years or older who apply for reappointment to the medical staff, and every 2 years thereafter, due to “concerns about the potentially compromised ability of older clinicians,” said the authors, Yale rheumatologist and geriatrician Leo M. Cooney Jr., MD, and Thomas Balcezak, MD, Yale New Haven’s chief medical officer.
Yale is not alone. Intermountain Healthcare, Stanford Hospitals and Clinics, Scripps Health Care, Penn Medicine, and the University of California, San Diego, are among the institutions with similar programs.
The move is being driven by the aging of the medical community. About 15% of U.S. physicians are over 65 years old, a tripling from 23,000 in 1980 to 73,000 in 2012-2016, and the number is growing, according to an editorial by Jeffrey L. Saver, MD, professor of neurology and senior associate vice president of neurology at the University of California, Los Angeles.
Given the trend, “it is not surprising that the issue of screening aging physicians for cognitive deficits has gained attention over the last decade,” Katrina Armstrong, MD, chair of the department of medicine at Massachusetts General Hospital, Boston, and Eileen E. Reynolds, MD, associate professor of medicine at Beth Israel Deaconess Medical Center, Boston, noted in a second editorial.
“Cognitive decline often accompanies aging, and the prevalence of dementia increases rapidly after age 70 years,” they said.
The data on whether older clinicians pose a risk to patients is limited and somewhat mixed. An analysis of 736,537 Medicare hospitalizations found no association between physician age and 30-day patient mortality among physicians 60 years or older with more than 201 admissions per year, but higher mortality among older physicians with lower volumes.
A meta-analysis of 62 studies showed that “older physicians have less factual knowledge, are less likely to adhere to appropriate standards of care, and may also have poorer patient outcomes.”
The new Yale data, meanwhile, suggests that “approximately 13% [18 of 141] of physicians and other clinicians older than 70 years should not be practicing independently,” Dr. Armstrong and Dr. Reynolds said in their editorial.
There is support for screening efforts. “As a profession that deals with human life, medical practitioners must obviously have the cognitive capacity to safely practice medicine. I applaud the approach taken by Yale New Haven Hospital in that cognitive abilities themselves, and not simply funds of knowledge, are assessed,” said Richard J. Caselli, MD, professor of neurology at the Mayo Clinic Arizona, Scottsdale, and a leader of the Alzheimer’s disease program there.
However, it’s not hard to imagine highly competent but older physicians taking umbrage at cognitive screening, and there’s been pushback. Stanford was considering a Yale-like approach but opted instead for peer review after opposition. Objections from the Utah Medical Association led Utah to enact a law banning age-based physician screening. In 2015, the American Medical Association issued a report calling for the development of guidelines and standards for assessing competency in aging physicians, but the AMA House of Delegates shelved it pending further study.
There are concerns about age discrimination, discounting the accumulated wisdom of long-practicing physicians, and misclassifying competent physicians, particularly those who provide quality care in rural and other underserved areas. Indeed, 8 of 14 clinicians who screened positive at Yale and underwent more extensive testing were allowed to recredential, “suggesting that the false-positive screening rate could be as high as 57%,” Dr. Armstrong and Dr. Reynolds noted.
The consensus seems to be that there probably is a need for some sort of screening, but it must be both sound and fair. Rather than a piecemeal institutional approach, perhaps there is “an important opportunity for other groups, including specialty boards and state licensing boards” to standardize the process, they said.
Among other things, assessments could focus less on test scores and more on the practice of medicine. For instance, fine motor skill/motor planning assessments for surgeons, and intermediate results could trigger a more extensive assessment of actual clinical performance, perhaps even direct observation, Dr. Saver said in his editorial.
As far as clinical performance goes, none of the 18 clinicians at Yale had previous performance problems. “Was this a failure of the system to report impaired physicians or were these physicians compensating sufficiently to avoid detection?” In either case, “cognitive testing should be a red flag that triggers other clinical assessments,” said Carl I. Cohen, MD, professor and director of the division of geriatric psychiatry at the State University of New York, Brooklyn.
The original plan at Yale was for neurologic and ophthalmologic examinations beginning at age 70, but ultimately it was decided to go with a battery of 16 tests to assess visual scanning and psychomotor efficiency, processing speed under pressure, concentration, and working memory, among other things. Testing takes about 50-90 minutes, and is graded by single neuropsychologist to ensure consistency. Results were compared with normative scores from both older and younger clinicians.
To prevent clinicians from preparing for it, Yale isn’t releasing its test battery.
Suboptimal performance triggered additional evaluations, including in-depth assessment of intellectual, memory, and executive function. Final reviews and recommendations were made by a committee that included a geriatrician, the clinician’s section or department chair, and current and past chief medical officers.
Among the 18 providers who demonstrated deficits impairing their ability to practice medicine, 5 were 70-74 years old; 4 were 75-79; and 9 were 80 years or older. Minor abnormalities were found in 34 other candidates (24.1%); they were allowed to recredential but were scheduled for rescreening at 1-year intervals, instead of every 2 years.
The mean age among the 141 screened clinicians was 74.3 years and ranged from 69 to 92 years; 86% were men. Applicants included 125 physicians (88.7%) as well as 5 advanced practice registered nurses; 4 dentists; 3 psychologists; 2 podiatrists; 1 physician associate; and 1 midwife.
The authors had no relevant disclosures.
SOURCE: Cooney L et al. JAMA. 2020 Jan 14;323(2):179-80.
Cognitive screening of 141 clinicians 70 years or older at Yale New Haven (Conn.) Hospital identified 18 with cognitive deficits likely to impair their ability to practice medicine. Six retired and 12 agreed to limit their practice to closely proctored environments, according to a report in JAMA.
It was part of a program to screen all practitioners 70 years or older who apply for reappointment to the medical staff, and every 2 years thereafter, due to “concerns about the potentially compromised ability of older clinicians,” said the authors, Yale rheumatologist and geriatrician Leo M. Cooney Jr., MD, and Thomas Balcezak, MD, Yale New Haven’s chief medical officer.
Yale is not alone. Intermountain Healthcare, Stanford Hospitals and Clinics, Scripps Health Care, Penn Medicine, and the University of California, San Diego, are among the institutions with similar programs.
The move is being driven by the aging of the medical community. About 15% of U.S. physicians are over 65 years old, a tripling from 23,000 in 1980 to 73,000 in 2012-2016, and the number is growing, according to an editorial by Jeffrey L. Saver, MD, professor of neurology and senior associate vice president of neurology at the University of California, Los Angeles.
Given the trend, “it is not surprising that the issue of screening aging physicians for cognitive deficits has gained attention over the last decade,” Katrina Armstrong, MD, chair of the department of medicine at Massachusetts General Hospital, Boston, and Eileen E. Reynolds, MD, associate professor of medicine at Beth Israel Deaconess Medical Center, Boston, noted in a second editorial.
“Cognitive decline often accompanies aging, and the prevalence of dementia increases rapidly after age 70 years,” they said.
The data on whether older clinicians pose a risk to patients is limited and somewhat mixed. An analysis of 736,537 Medicare hospitalizations found no association between physician age and 30-day patient mortality among physicians 60 years or older with more than 201 admissions per year, but higher mortality among older physicians with lower volumes.
A meta-analysis of 62 studies showed that “older physicians have less factual knowledge, are less likely to adhere to appropriate standards of care, and may also have poorer patient outcomes.”
The new Yale data, meanwhile, suggests that “approximately 13% [18 of 141] of physicians and other clinicians older than 70 years should not be practicing independently,” Dr. Armstrong and Dr. Reynolds said in their editorial.
There is support for screening efforts. “As a profession that deals with human life, medical practitioners must obviously have the cognitive capacity to safely practice medicine. I applaud the approach taken by Yale New Haven Hospital in that cognitive abilities themselves, and not simply funds of knowledge, are assessed,” said Richard J. Caselli, MD, professor of neurology at the Mayo Clinic Arizona, Scottsdale, and a leader of the Alzheimer’s disease program there.
However, it’s not hard to imagine highly competent but older physicians taking umbrage at cognitive screening, and there’s been pushback. Stanford was considering a Yale-like approach but opted instead for peer review after opposition. Objections from the Utah Medical Association led Utah to enact a law banning age-based physician screening. In 2015, the American Medical Association issued a report calling for the development of guidelines and standards for assessing competency in aging physicians, but the AMA House of Delegates shelved it pending further study.
There are concerns about age discrimination, discounting the accumulated wisdom of long-practicing physicians, and misclassifying competent physicians, particularly those who provide quality care in rural and other underserved areas. Indeed, 8 of 14 clinicians who screened positive at Yale and underwent more extensive testing were allowed to recredential, “suggesting that the false-positive screening rate could be as high as 57%,” Dr. Armstrong and Dr. Reynolds noted.
The consensus seems to be that there probably is a need for some sort of screening, but it must be both sound and fair. Rather than a piecemeal institutional approach, perhaps there is “an important opportunity for other groups, including specialty boards and state licensing boards” to standardize the process, they said.
Among other things, assessments could focus less on test scores and more on the practice of medicine. For instance, fine motor skill/motor planning assessments for surgeons, and intermediate results could trigger a more extensive assessment of actual clinical performance, perhaps even direct observation, Dr. Saver said in his editorial.
As far as clinical performance goes, none of the 18 clinicians at Yale had previous performance problems. “Was this a failure of the system to report impaired physicians or were these physicians compensating sufficiently to avoid detection?” In either case, “cognitive testing should be a red flag that triggers other clinical assessments,” said Carl I. Cohen, MD, professor and director of the division of geriatric psychiatry at the State University of New York, Brooklyn.
The original plan at Yale was for neurologic and ophthalmologic examinations beginning at age 70, but ultimately it was decided to go with a battery of 16 tests to assess visual scanning and psychomotor efficiency, processing speed under pressure, concentration, and working memory, among other things. Testing takes about 50-90 minutes, and is graded by single neuropsychologist to ensure consistency. Results were compared with normative scores from both older and younger clinicians.
To prevent clinicians from preparing for it, Yale isn’t releasing its test battery.
Suboptimal performance triggered additional evaluations, including in-depth assessment of intellectual, memory, and executive function. Final reviews and recommendations were made by a committee that included a geriatrician, the clinician’s section or department chair, and current and past chief medical officers.
Among the 18 providers who demonstrated deficits impairing their ability to practice medicine, 5 were 70-74 years old; 4 were 75-79; and 9 were 80 years or older. Minor abnormalities were found in 34 other candidates (24.1%); they were allowed to recredential but were scheduled for rescreening at 1-year intervals, instead of every 2 years.
The mean age among the 141 screened clinicians was 74.3 years and ranged from 69 to 92 years; 86% were men. Applicants included 125 physicians (88.7%) as well as 5 advanced practice registered nurses; 4 dentists; 3 psychologists; 2 podiatrists; 1 physician associate; and 1 midwife.
The authors had no relevant disclosures.
SOURCE: Cooney L et al. JAMA. 2020 Jan 14;323(2):179-80.
FROM JAMA
Appropriations bill, now law, eliminates ACA taxes, raises tobacco age
Congress took steps to permanently eliminate three taxes from within the Affordable Care Act that were enacted to help offset the law’s cost, but have been sporadically implemented.
The appropriations bill, H.R. 1865, signed into law Dec. 20 by President Trump, includes a number of other health-related provisions, including increasing the minimum age for purchasing tobacco to 21.
The repealed ACA-related taxes include the medical device tax (which previously had been delayed twice); the health insurance tax (which taxed insurers that offered fully insured health coverage in the individual market and has been under sporadic moratorium); and the so-called Cadillac tax on high-cost health plans, which is currently under suspension until the end of 2022.
The appropriations bill offers no offset for the lost revenue.
The tax repeals come on the heels of the U.S. Fifth Circuit Court of Appeals’ ruling that the ACA’s individual mandate is unconstitutional, which is putting the ACA in its entirety in jeopardy should the district court rule that the individual mandate is not severable from the rest of the law, which would invalidate the ACA.
Other key provisions in H.R. 1865 include the short-term extension of a number of federal programs, including a delay in Medicaid disproportionate share hospital payment reductions, payments to community health centers, funding for teaching health centers, and the special diabetes program. Funding for these extenders will go through May 22, 2020.
H.R. 1865 is also notable for what is missing, including any broad provisions that address the price of prescription drugs and surprise billing.
The House of Representatives earlier this month passed a bill, H.R. 3, aimed at lowering the cost of prescription drugs, but that bill was essentially dead on arrival in the Senate, with Speaker Mitch McConnell (R-Ky.) saying he would not bring it to the floor for consideration. There was also a veto threat from the White House hanging over it on the off chance it got past the upper chamber.
There was some optimism that surprise billing would be addressed in the appropriations bill after a bipartisan agreement was reached with the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee, but that stalled after a different bipartisan agreement forged in the House Ways and Means Committee was introduced. More work is expected on surprise billing in the coming year.
One portion of H.R. 1865 that does address the cost of drugs is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which is designed to allow generic manufacturers easier access to brand-name samples to help bring more generic drugs to market.
Another provision that gained applause from the American College of Physicians is the funding for research into gun violence.
“We are particularly encouraged that the legislation authorizes funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence and safety for the first time in decades,” ACP President Robert McLean, MD, said in a statement. “The key to solving any public health crisis is knowledge, and our efforts to prevent firearms-related injuries and deaths have been hampered by inadequate research. This funding is a promising first step.
However, ACP called for more action in this area.
“Congress should do more to reduce injuries and deaths from firearms,” Dr. McLean said. “The Senate should pass the Bipartisan Background Check Act and reauthorize the Violence Against Women Act, which would close the ‘domestic violence’ loophole in the background check system, as passed by the House of Representatives.”
H.R. 1865 also reauthorizes the Patient-Centered Outcomes Research Institute for 10 additional years.
Congress took steps to permanently eliminate three taxes from within the Affordable Care Act that were enacted to help offset the law’s cost, but have been sporadically implemented.
The appropriations bill, H.R. 1865, signed into law Dec. 20 by President Trump, includes a number of other health-related provisions, including increasing the minimum age for purchasing tobacco to 21.
The repealed ACA-related taxes include the medical device tax (which previously had been delayed twice); the health insurance tax (which taxed insurers that offered fully insured health coverage in the individual market and has been under sporadic moratorium); and the so-called Cadillac tax on high-cost health plans, which is currently under suspension until the end of 2022.
The appropriations bill offers no offset for the lost revenue.
The tax repeals come on the heels of the U.S. Fifth Circuit Court of Appeals’ ruling that the ACA’s individual mandate is unconstitutional, which is putting the ACA in its entirety in jeopardy should the district court rule that the individual mandate is not severable from the rest of the law, which would invalidate the ACA.
Other key provisions in H.R. 1865 include the short-term extension of a number of federal programs, including a delay in Medicaid disproportionate share hospital payment reductions, payments to community health centers, funding for teaching health centers, and the special diabetes program. Funding for these extenders will go through May 22, 2020.
H.R. 1865 is also notable for what is missing, including any broad provisions that address the price of prescription drugs and surprise billing.
The House of Representatives earlier this month passed a bill, H.R. 3, aimed at lowering the cost of prescription drugs, but that bill was essentially dead on arrival in the Senate, with Speaker Mitch McConnell (R-Ky.) saying he would not bring it to the floor for consideration. There was also a veto threat from the White House hanging over it on the off chance it got past the upper chamber.
There was some optimism that surprise billing would be addressed in the appropriations bill after a bipartisan agreement was reached with the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee, but that stalled after a different bipartisan agreement forged in the House Ways and Means Committee was introduced. More work is expected on surprise billing in the coming year.
One portion of H.R. 1865 that does address the cost of drugs is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which is designed to allow generic manufacturers easier access to brand-name samples to help bring more generic drugs to market.
Another provision that gained applause from the American College of Physicians is the funding for research into gun violence.
“We are particularly encouraged that the legislation authorizes funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence and safety for the first time in decades,” ACP President Robert McLean, MD, said in a statement. “The key to solving any public health crisis is knowledge, and our efforts to prevent firearms-related injuries and deaths have been hampered by inadequate research. This funding is a promising first step.
However, ACP called for more action in this area.
“Congress should do more to reduce injuries and deaths from firearms,” Dr. McLean said. “The Senate should pass the Bipartisan Background Check Act and reauthorize the Violence Against Women Act, which would close the ‘domestic violence’ loophole in the background check system, as passed by the House of Representatives.”
H.R. 1865 also reauthorizes the Patient-Centered Outcomes Research Institute for 10 additional years.
Congress took steps to permanently eliminate three taxes from within the Affordable Care Act that were enacted to help offset the law’s cost, but have been sporadically implemented.
The appropriations bill, H.R. 1865, signed into law Dec. 20 by President Trump, includes a number of other health-related provisions, including increasing the minimum age for purchasing tobacco to 21.
The repealed ACA-related taxes include the medical device tax (which previously had been delayed twice); the health insurance tax (which taxed insurers that offered fully insured health coverage in the individual market and has been under sporadic moratorium); and the so-called Cadillac tax on high-cost health plans, which is currently under suspension until the end of 2022.
The appropriations bill offers no offset for the lost revenue.
The tax repeals come on the heels of the U.S. Fifth Circuit Court of Appeals’ ruling that the ACA’s individual mandate is unconstitutional, which is putting the ACA in its entirety in jeopardy should the district court rule that the individual mandate is not severable from the rest of the law, which would invalidate the ACA.
Other key provisions in H.R. 1865 include the short-term extension of a number of federal programs, including a delay in Medicaid disproportionate share hospital payment reductions, payments to community health centers, funding for teaching health centers, and the special diabetes program. Funding for these extenders will go through May 22, 2020.
H.R. 1865 is also notable for what is missing, including any broad provisions that address the price of prescription drugs and surprise billing.
The House of Representatives earlier this month passed a bill, H.R. 3, aimed at lowering the cost of prescription drugs, but that bill was essentially dead on arrival in the Senate, with Speaker Mitch McConnell (R-Ky.) saying he would not bring it to the floor for consideration. There was also a veto threat from the White House hanging over it on the off chance it got past the upper chamber.
There was some optimism that surprise billing would be addressed in the appropriations bill after a bipartisan agreement was reached with the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee, but that stalled after a different bipartisan agreement forged in the House Ways and Means Committee was introduced. More work is expected on surprise billing in the coming year.
One portion of H.R. 1865 that does address the cost of drugs is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which is designed to allow generic manufacturers easier access to brand-name samples to help bring more generic drugs to market.
Another provision that gained applause from the American College of Physicians is the funding for research into gun violence.
“We are particularly encouraged that the legislation authorizes funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence and safety for the first time in decades,” ACP President Robert McLean, MD, said in a statement. “The key to solving any public health crisis is knowledge, and our efforts to prevent firearms-related injuries and deaths have been hampered by inadequate research. This funding is a promising first step.
However, ACP called for more action in this area.
“Congress should do more to reduce injuries and deaths from firearms,” Dr. McLean said. “The Senate should pass the Bipartisan Background Check Act and reauthorize the Violence Against Women Act, which would close the ‘domestic violence’ loophole in the background check system, as passed by the House of Representatives.”
H.R. 1865 also reauthorizes the Patient-Centered Outcomes Research Institute for 10 additional years.
Appeals court rules ACA’s individual mandate is unconstitutional
A federal appeals court ruled Dec. 18 that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, but the panel sent the case back to a lower court to decide how much of the remainder of the law could topple along with it.
The three-judge panel of the New Orleans-based U.S. Fifth Circuit Court of Appeals said, “The individual mandate is unconstitutional because, under [a previous ruling, National Federation of Independent Business v Sebelius], it finds no constitutional footing in either the Interstate Commerce Clause or the Necessary and Proper Clause.”
The ruling upholds a December 2018 US District Court decision in which Judge Reed O’Connor found that the individual mandate that most Americans must have health insurance or pay a fine was unconstitutional and that without it the ACA itself was invalid.
In sending the case back to a Texas district court, however, the federal panel is asking for a central question to be resolved: Whether the individual mandate is “severable” from the rest of the law, while the rest of the law can be left intact.
If the district court eventually decides that the individual mandate cannot be severed from the rest of the ACA, the entire law will likely be ruled invalid, and some 24 million Americans could lose health coverage.
“Today’s ruling is the result of the Trump administration and congressional Republicans attempting to make dangerous health policy using the courts since they failed to succeed in Congress,” House Ways and Means Committee Chairman Richard E. Neal (D-Mass.) said in a statement. “This is a blow to our nation’s health care system and the millions of Americans who have gained coverage and protections under the Affordable Care Act. Democrats will continue to fight to protect Americans’ access to quality, affordable care.”
Some groups are applauding the decision, though. The Citizens’ Council for Health Freedom (CCHF), which filed an amicus brief with the Fifth Circuit arguing against the ACA, said it wants more.
“We are pleased with the Fifth Circuit Court of Appeals ruling, but it didn’t go far enough,” said Twila Brase, president and cofounder of CCHF, in a statement. “The individual mandate cannot be severed from the rest of the 2,700-page Affordable Care Act, thus the court should have ruled that the entire law is invalid, as the lower district court found.
“As the Court notes in the first paragraph of the ruling, we argued in our Amicus Brief, filed jointly with the Association of American Physicians and Surgeons, that the Act ‘has deprived patients nationwide of a competitive market for affordable high-deductible health insurance,’ leaving ‘patients with no alternative to ... skyrocketing premiums,’ “ Ms. Brase added. “Sending it back to the lower court, which already ruled the right way, continues to deprive citizens and patients of the affordable coverage that freedom from Obamacare would bring.”
Future uncertain
The ruling in Texas v Azar is not a surprise because, during oral arguments in July, as reported by Medscape Medical News, at least two of the three judges – Jennifer Walker Elrod, appointed by President George W. Bush in 2007, and Kurt Engelhardt, appointed by President Donald J. Trump in 2018 – appeared to be more receptive to the arguments of a group of 18 Republican states and two individuals seeking to invalidate the ACA.
Judge Carolyn Dineen King, appointed by President Jimmy Carter in 1979, did not comment during the hearing.
The Trump administration chose not to defend the ACA, but it does not seem entirely prepared for what might happen if the law is overturned. In a briefing before the Fifth Circuit hearing, the administration argued that, if ultimately the law is ruled unconstitutional, it should be struck down only in the states seeking to overturn the law.
“A lot of this has to get sorted out – it’s complicated,” said August E. Flentje, a U.S. Department of Justice lawyer, at the oral arguments in July.
For now, though, the ACA remains.
“In 2012, the Supreme Court upheld Obamacare, despite serious constitutional issues with the federal government forcing Americans to purchase a product from a private company. Until an ultimate decision is made by the Supreme Court or Congress decides otherwise, the Affordable Care Act will remain the law of the land,” Senate Finance Committee Chairman Chuck Grassley (R-Iowa), said in a statement.
And those who have led the court battle to keep the ACA intact plan to keep fighting. “For now, the President got the gift he wanted – uncertainty in the health care system and a pathway to repeal – so that the health care that seniors, workers, and families secured under the Affordable Care Act can be yanked from under them. This decision could take us to a dangerous and irresponsible place, not just for the 133 million Americans with pre-existing conditions, but for our seniors who use Medicare, our children under the age of 26, and the 20 million additional Americans covered directly through the ACA marketplace. California will move swiftly to challenge this decision because this could mean the difference between life and death for so many Americans and their families,” California Attorney General Xavier Becerra said in a statement.
A version of this story first appeared on Medscape.com.
A federal appeals court ruled Dec. 18 that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, but the panel sent the case back to a lower court to decide how much of the remainder of the law could topple along with it.
The three-judge panel of the New Orleans-based U.S. Fifth Circuit Court of Appeals said, “The individual mandate is unconstitutional because, under [a previous ruling, National Federation of Independent Business v Sebelius], it finds no constitutional footing in either the Interstate Commerce Clause or the Necessary and Proper Clause.”
The ruling upholds a December 2018 US District Court decision in which Judge Reed O’Connor found that the individual mandate that most Americans must have health insurance or pay a fine was unconstitutional and that without it the ACA itself was invalid.
In sending the case back to a Texas district court, however, the federal panel is asking for a central question to be resolved: Whether the individual mandate is “severable” from the rest of the law, while the rest of the law can be left intact.
If the district court eventually decides that the individual mandate cannot be severed from the rest of the ACA, the entire law will likely be ruled invalid, and some 24 million Americans could lose health coverage.
“Today’s ruling is the result of the Trump administration and congressional Republicans attempting to make dangerous health policy using the courts since they failed to succeed in Congress,” House Ways and Means Committee Chairman Richard E. Neal (D-Mass.) said in a statement. “This is a blow to our nation’s health care system and the millions of Americans who have gained coverage and protections under the Affordable Care Act. Democrats will continue to fight to protect Americans’ access to quality, affordable care.”
Some groups are applauding the decision, though. The Citizens’ Council for Health Freedom (CCHF), which filed an amicus brief with the Fifth Circuit arguing against the ACA, said it wants more.
“We are pleased with the Fifth Circuit Court of Appeals ruling, but it didn’t go far enough,” said Twila Brase, president and cofounder of CCHF, in a statement. “The individual mandate cannot be severed from the rest of the 2,700-page Affordable Care Act, thus the court should have ruled that the entire law is invalid, as the lower district court found.
“As the Court notes in the first paragraph of the ruling, we argued in our Amicus Brief, filed jointly with the Association of American Physicians and Surgeons, that the Act ‘has deprived patients nationwide of a competitive market for affordable high-deductible health insurance,’ leaving ‘patients with no alternative to ... skyrocketing premiums,’ “ Ms. Brase added. “Sending it back to the lower court, which already ruled the right way, continues to deprive citizens and patients of the affordable coverage that freedom from Obamacare would bring.”
Future uncertain
The ruling in Texas v Azar is not a surprise because, during oral arguments in July, as reported by Medscape Medical News, at least two of the three judges – Jennifer Walker Elrod, appointed by President George W. Bush in 2007, and Kurt Engelhardt, appointed by President Donald J. Trump in 2018 – appeared to be more receptive to the arguments of a group of 18 Republican states and two individuals seeking to invalidate the ACA.
Judge Carolyn Dineen King, appointed by President Jimmy Carter in 1979, did not comment during the hearing.
The Trump administration chose not to defend the ACA, but it does not seem entirely prepared for what might happen if the law is overturned. In a briefing before the Fifth Circuit hearing, the administration argued that, if ultimately the law is ruled unconstitutional, it should be struck down only in the states seeking to overturn the law.
“A lot of this has to get sorted out – it’s complicated,” said August E. Flentje, a U.S. Department of Justice lawyer, at the oral arguments in July.
For now, though, the ACA remains.
“In 2012, the Supreme Court upheld Obamacare, despite serious constitutional issues with the federal government forcing Americans to purchase a product from a private company. Until an ultimate decision is made by the Supreme Court or Congress decides otherwise, the Affordable Care Act will remain the law of the land,” Senate Finance Committee Chairman Chuck Grassley (R-Iowa), said in a statement.
And those who have led the court battle to keep the ACA intact plan to keep fighting. “For now, the President got the gift he wanted – uncertainty in the health care system and a pathway to repeal – so that the health care that seniors, workers, and families secured under the Affordable Care Act can be yanked from under them. This decision could take us to a dangerous and irresponsible place, not just for the 133 million Americans with pre-existing conditions, but for our seniors who use Medicare, our children under the age of 26, and the 20 million additional Americans covered directly through the ACA marketplace. California will move swiftly to challenge this decision because this could mean the difference between life and death for so many Americans and their families,” California Attorney General Xavier Becerra said in a statement.
A version of this story first appeared on Medscape.com.
A federal appeals court ruled Dec. 18 that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, but the panel sent the case back to a lower court to decide how much of the remainder of the law could topple along with it.
The three-judge panel of the New Orleans-based U.S. Fifth Circuit Court of Appeals said, “The individual mandate is unconstitutional because, under [a previous ruling, National Federation of Independent Business v Sebelius], it finds no constitutional footing in either the Interstate Commerce Clause or the Necessary and Proper Clause.”
The ruling upholds a December 2018 US District Court decision in which Judge Reed O’Connor found that the individual mandate that most Americans must have health insurance or pay a fine was unconstitutional and that without it the ACA itself was invalid.
In sending the case back to a Texas district court, however, the federal panel is asking for a central question to be resolved: Whether the individual mandate is “severable” from the rest of the law, while the rest of the law can be left intact.
If the district court eventually decides that the individual mandate cannot be severed from the rest of the ACA, the entire law will likely be ruled invalid, and some 24 million Americans could lose health coverage.
“Today’s ruling is the result of the Trump administration and congressional Republicans attempting to make dangerous health policy using the courts since they failed to succeed in Congress,” House Ways and Means Committee Chairman Richard E. Neal (D-Mass.) said in a statement. “This is a blow to our nation’s health care system and the millions of Americans who have gained coverage and protections under the Affordable Care Act. Democrats will continue to fight to protect Americans’ access to quality, affordable care.”
Some groups are applauding the decision, though. The Citizens’ Council for Health Freedom (CCHF), which filed an amicus brief with the Fifth Circuit arguing against the ACA, said it wants more.
“We are pleased with the Fifth Circuit Court of Appeals ruling, but it didn’t go far enough,” said Twila Brase, president and cofounder of CCHF, in a statement. “The individual mandate cannot be severed from the rest of the 2,700-page Affordable Care Act, thus the court should have ruled that the entire law is invalid, as the lower district court found.
“As the Court notes in the first paragraph of the ruling, we argued in our Amicus Brief, filed jointly with the Association of American Physicians and Surgeons, that the Act ‘has deprived patients nationwide of a competitive market for affordable high-deductible health insurance,’ leaving ‘patients with no alternative to ... skyrocketing premiums,’ “ Ms. Brase added. “Sending it back to the lower court, which already ruled the right way, continues to deprive citizens and patients of the affordable coverage that freedom from Obamacare would bring.”
Future uncertain
The ruling in Texas v Azar is not a surprise because, during oral arguments in July, as reported by Medscape Medical News, at least two of the three judges – Jennifer Walker Elrod, appointed by President George W. Bush in 2007, and Kurt Engelhardt, appointed by President Donald J. Trump in 2018 – appeared to be more receptive to the arguments of a group of 18 Republican states and two individuals seeking to invalidate the ACA.
Judge Carolyn Dineen King, appointed by President Jimmy Carter in 1979, did not comment during the hearing.
The Trump administration chose not to defend the ACA, but it does not seem entirely prepared for what might happen if the law is overturned. In a briefing before the Fifth Circuit hearing, the administration argued that, if ultimately the law is ruled unconstitutional, it should be struck down only in the states seeking to overturn the law.
“A lot of this has to get sorted out – it’s complicated,” said August E. Flentje, a U.S. Department of Justice lawyer, at the oral arguments in July.
For now, though, the ACA remains.
“In 2012, the Supreme Court upheld Obamacare, despite serious constitutional issues with the federal government forcing Americans to purchase a product from a private company. Until an ultimate decision is made by the Supreme Court or Congress decides otherwise, the Affordable Care Act will remain the law of the land,” Senate Finance Committee Chairman Chuck Grassley (R-Iowa), said in a statement.
And those who have led the court battle to keep the ACA intact plan to keep fighting. “For now, the President got the gift he wanted – uncertainty in the health care system and a pathway to repeal – so that the health care that seniors, workers, and families secured under the Affordable Care Act can be yanked from under them. This decision could take us to a dangerous and irresponsible place, not just for the 133 million Americans with pre-existing conditions, but for our seniors who use Medicare, our children under the age of 26, and the 20 million additional Americans covered directly through the ACA marketplace. California will move swiftly to challenge this decision because this could mean the difference between life and death for so many Americans and their families,” California Attorney General Xavier Becerra said in a statement.
A version of this story first appeared on Medscape.com.
HHS drug importation proposals aim to address high costs
The Department of Health & Human Services is taking the first steps in allowing drugs to be imported into the United States.
HHS proposes to offer two different pathways for importation: One allowing states to design programs to import certain drugs directly from Canada and another allowing manufacturers to obtain a new National Drug Code (NDC) number to import their own Food and Drug Administration–approved products manufactured outside of the United States.
“The importation proposals we are rolling out ... are a historic step forward in efforts to bring down drug prices and out-of-pocket costs,” HHS Secretary Alex Azar said during a Dec. 17, 2019, press conference. “New pathways for importation can move us toward a more open and competitive marketplace that supplies American patients with safe, effective, affordable prescription drugs.”
The proposals were made public on Dec. 18, the day the House Rules committee was scheduled to vote on impeaching President Trump.
He emphasized that these proposals “are both important steps in advancing the FDA’s safe-importation action plan, [which] aims to insure that importation is done in a way that prioritizes safety and includes elements to help insure importation does not put patients or the U.S. drug supply chain at risk.”
The pathway for states to import drugs from Canada will be proposed through the federal regulatory process. The notice of proposed rulemaking, which implements authority for FDA regulation of importation granted in the Medicare Modernization Act of 2003, will outline a process by which states, potentially working with wholesalers and/or pharmacies, will submit proposals for FDA review and approval on how they would implement an importation program.
Only certain drugs would be eligible for importation from Canada under this proposal. The drugs would need to be approved in Canada and, except for Canadian labeling, need to meet the conditions of an FDA-approved new drug application or abbreviated new drug application.
Controlled substances, biologics, intravenously injected drugs, drugs with a risk evaluation and management strategy, and drugs injected into the spinal column or eye would be excluded from importation.
Drugs coming in from Canada would be relabeled with U.S.-approved labels and would be subject to testing to ensure they are authentic, not degraded, and compliant with U.S. standards.
States would be required to show that importing drugs poses no additional risk in public health and safety and it would result in the reduction of costs, according to information provided by HHS.
Many of the most expensive drugs, as well as insulins, would not be eligible for importation under this pathway, Mr. Azar acknowledged, adding that “I would envision that as we demonstrate the safety as well as the cost savings from this pathway, [this could serve as] a pilot and a proof of concept that Congress could then look to and potentially take up for more complex molecules that involve cold-chain storage and more complex distribution channels.”
The proposed regulations do not offer any estimates on how much savings could be achieved. He said that there is no way to estimate which states might develop importation plans and how those plans might work.
The second proposed pathway would involve FDA guidance to manufacturers allowing them to import their own FDA-approved products manufactured abroad. Under this proposal, there would be no restriction on which type or kind of FDA-approved product to be imported.
“The FDA has become aware that manufacturers of some brand-name drugs want to offer their drugs at lower costs in the U.S. market but, due to certain challenges in the private market, are not readily [able] to do so without obtaining a different national drug code for their drugs,” Adm. Brett Giroir, MD, HHS assistant secretary for health, said during the press conference.
Obtaining a separate NDC for imported drugs could address the challenges, particularly those posed by the incentives to raise list prices and offer higher rebates to pharmacy benefit managers, Mr. Azar said.
The draft guidance outlines procedures manufacturers could follow to get that NDC for those products and how manufacturers can demonstrate that these products meet U.S. regulatory standards. Products imported in this pathway could be made available to patients in hospitals, physician offices, and pharmacies. Generic drugs are not part of this guidance, but the proposed guidance asked for feedback on whether a similar approach is needed for generic products.
“This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drugmakers new flexibility to reduce list prices,” Mr. Azar said.
The proposed regulation on state-level importation will have a 75-day comment period from the day it is published in the Federal Register, and Mr. Azar said that the FDA is committing resources to getting the comments analyzed and reflected in the final rule.
“We will be moving as quickly as we possibly can,” Mr. Azar said, adding that the FDA guidance to manufacturers may move more quickly through its approval process because it is not a formal rule.
The Department of Health & Human Services is taking the first steps in allowing drugs to be imported into the United States.
HHS proposes to offer two different pathways for importation: One allowing states to design programs to import certain drugs directly from Canada and another allowing manufacturers to obtain a new National Drug Code (NDC) number to import their own Food and Drug Administration–approved products manufactured outside of the United States.
“The importation proposals we are rolling out ... are a historic step forward in efforts to bring down drug prices and out-of-pocket costs,” HHS Secretary Alex Azar said during a Dec. 17, 2019, press conference. “New pathways for importation can move us toward a more open and competitive marketplace that supplies American patients with safe, effective, affordable prescription drugs.”
The proposals were made public on Dec. 18, the day the House Rules committee was scheduled to vote on impeaching President Trump.
He emphasized that these proposals “are both important steps in advancing the FDA’s safe-importation action plan, [which] aims to insure that importation is done in a way that prioritizes safety and includes elements to help insure importation does not put patients or the U.S. drug supply chain at risk.”
The pathway for states to import drugs from Canada will be proposed through the federal regulatory process. The notice of proposed rulemaking, which implements authority for FDA regulation of importation granted in the Medicare Modernization Act of 2003, will outline a process by which states, potentially working with wholesalers and/or pharmacies, will submit proposals for FDA review and approval on how they would implement an importation program.
Only certain drugs would be eligible for importation from Canada under this proposal. The drugs would need to be approved in Canada and, except for Canadian labeling, need to meet the conditions of an FDA-approved new drug application or abbreviated new drug application.
Controlled substances, biologics, intravenously injected drugs, drugs with a risk evaluation and management strategy, and drugs injected into the spinal column or eye would be excluded from importation.
Drugs coming in from Canada would be relabeled with U.S.-approved labels and would be subject to testing to ensure they are authentic, not degraded, and compliant with U.S. standards.
States would be required to show that importing drugs poses no additional risk in public health and safety and it would result in the reduction of costs, according to information provided by HHS.
Many of the most expensive drugs, as well as insulins, would not be eligible for importation under this pathway, Mr. Azar acknowledged, adding that “I would envision that as we demonstrate the safety as well as the cost savings from this pathway, [this could serve as] a pilot and a proof of concept that Congress could then look to and potentially take up for more complex molecules that involve cold-chain storage and more complex distribution channels.”
The proposed regulations do not offer any estimates on how much savings could be achieved. He said that there is no way to estimate which states might develop importation plans and how those plans might work.
The second proposed pathway would involve FDA guidance to manufacturers allowing them to import their own FDA-approved products manufactured abroad. Under this proposal, there would be no restriction on which type or kind of FDA-approved product to be imported.
“The FDA has become aware that manufacturers of some brand-name drugs want to offer their drugs at lower costs in the U.S. market but, due to certain challenges in the private market, are not readily [able] to do so without obtaining a different national drug code for their drugs,” Adm. Brett Giroir, MD, HHS assistant secretary for health, said during the press conference.
Obtaining a separate NDC for imported drugs could address the challenges, particularly those posed by the incentives to raise list prices and offer higher rebates to pharmacy benefit managers, Mr. Azar said.
The draft guidance outlines procedures manufacturers could follow to get that NDC for those products and how manufacturers can demonstrate that these products meet U.S. regulatory standards. Products imported in this pathway could be made available to patients in hospitals, physician offices, and pharmacies. Generic drugs are not part of this guidance, but the proposed guidance asked for feedback on whether a similar approach is needed for generic products.
“This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drugmakers new flexibility to reduce list prices,” Mr. Azar said.
The proposed regulation on state-level importation will have a 75-day comment period from the day it is published in the Federal Register, and Mr. Azar said that the FDA is committing resources to getting the comments analyzed and reflected in the final rule.
“We will be moving as quickly as we possibly can,” Mr. Azar said, adding that the FDA guidance to manufacturers may move more quickly through its approval process because it is not a formal rule.
The Department of Health & Human Services is taking the first steps in allowing drugs to be imported into the United States.
HHS proposes to offer two different pathways for importation: One allowing states to design programs to import certain drugs directly from Canada and another allowing manufacturers to obtain a new National Drug Code (NDC) number to import their own Food and Drug Administration–approved products manufactured outside of the United States.
“The importation proposals we are rolling out ... are a historic step forward in efforts to bring down drug prices and out-of-pocket costs,” HHS Secretary Alex Azar said during a Dec. 17, 2019, press conference. “New pathways for importation can move us toward a more open and competitive marketplace that supplies American patients with safe, effective, affordable prescription drugs.”
The proposals were made public on Dec. 18, the day the House Rules committee was scheduled to vote on impeaching President Trump.
He emphasized that these proposals “are both important steps in advancing the FDA’s safe-importation action plan, [which] aims to insure that importation is done in a way that prioritizes safety and includes elements to help insure importation does not put patients or the U.S. drug supply chain at risk.”
The pathway for states to import drugs from Canada will be proposed through the federal regulatory process. The notice of proposed rulemaking, which implements authority for FDA regulation of importation granted in the Medicare Modernization Act of 2003, will outline a process by which states, potentially working with wholesalers and/or pharmacies, will submit proposals for FDA review and approval on how they would implement an importation program.
Only certain drugs would be eligible for importation from Canada under this proposal. The drugs would need to be approved in Canada and, except for Canadian labeling, need to meet the conditions of an FDA-approved new drug application or abbreviated new drug application.
Controlled substances, biologics, intravenously injected drugs, drugs with a risk evaluation and management strategy, and drugs injected into the spinal column or eye would be excluded from importation.
Drugs coming in from Canada would be relabeled with U.S.-approved labels and would be subject to testing to ensure they are authentic, not degraded, and compliant with U.S. standards.
States would be required to show that importing drugs poses no additional risk in public health and safety and it would result in the reduction of costs, according to information provided by HHS.
Many of the most expensive drugs, as well as insulins, would not be eligible for importation under this pathway, Mr. Azar acknowledged, adding that “I would envision that as we demonstrate the safety as well as the cost savings from this pathway, [this could serve as] a pilot and a proof of concept that Congress could then look to and potentially take up for more complex molecules that involve cold-chain storage and more complex distribution channels.”
The proposed regulations do not offer any estimates on how much savings could be achieved. He said that there is no way to estimate which states might develop importation plans and how those plans might work.
The second proposed pathway would involve FDA guidance to manufacturers allowing them to import their own FDA-approved products manufactured abroad. Under this proposal, there would be no restriction on which type or kind of FDA-approved product to be imported.
“The FDA has become aware that manufacturers of some brand-name drugs want to offer their drugs at lower costs in the U.S. market but, due to certain challenges in the private market, are not readily [able] to do so without obtaining a different national drug code for their drugs,” Adm. Brett Giroir, MD, HHS assistant secretary for health, said during the press conference.
Obtaining a separate NDC for imported drugs could address the challenges, particularly those posed by the incentives to raise list prices and offer higher rebates to pharmacy benefit managers, Mr. Azar said.
The draft guidance outlines procedures manufacturers could follow to get that NDC for those products and how manufacturers can demonstrate that these products meet U.S. regulatory standards. Products imported in this pathway could be made available to patients in hospitals, physician offices, and pharmacies. Generic drugs are not part of this guidance, but the proposed guidance asked for feedback on whether a similar approach is needed for generic products.
“This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drugmakers new flexibility to reduce list prices,” Mr. Azar said.
The proposed regulation on state-level importation will have a 75-day comment period from the day it is published in the Federal Register, and Mr. Azar said that the FDA is committing resources to getting the comments analyzed and reflected in the final rule.
“We will be moving as quickly as we possibly can,” Mr. Azar said, adding that the FDA guidance to manufacturers may move more quickly through its approval process because it is not a formal rule.
Consider a Donation to the SVS Foundation
The SVS Foundation is a fundamental part of the Society for Vascular Surgery, entrusted with supporting programs that advance our knowledge of vascular disease and improve the care we provide our patients and communities. A little while back the SVS Foundation published its 2019 Annual Report. This year, the report focuses on how past award recipients have used their grants to impact and improve patient care. More than $13 million in grants over the past three decades have given recipients the support they need to impact the lives of patients and those who provide care. Consider a donation today.
The SVS Foundation is a fundamental part of the Society for Vascular Surgery, entrusted with supporting programs that advance our knowledge of vascular disease and improve the care we provide our patients and communities. A little while back the SVS Foundation published its 2019 Annual Report. This year, the report focuses on how past award recipients have used their grants to impact and improve patient care. More than $13 million in grants over the past three decades have given recipients the support they need to impact the lives of patients and those who provide care. Consider a donation today.
The SVS Foundation is a fundamental part of the Society for Vascular Surgery, entrusted with supporting programs that advance our knowledge of vascular disease and improve the care we provide our patients and communities. A little while back the SVS Foundation published its 2019 Annual Report. This year, the report focuses on how past award recipients have used their grants to impact and improve patient care. More than $13 million in grants over the past three decades have given recipients the support they need to impact the lives of patients and those who provide care. Consider a donation today.
Supreme Court weighs ACA back pay case
U.S. Supreme Court Justices heard oral arguments Dec. 10 in a case that centers on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law.
Maine Community Health Options v. United States, which consolidates several lawsuits against the government, involves the ACA’s risk corridor program, which required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses.
Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them $12 billion.
The U.S. Department of Justice counters that the government is not required to pay the plans because of appropriations measures passed by Congress in 2014 and later years that limited the funding available to compensate insurers for their losses. The federal government is not obligated to pay the insurers back for the losses and the suits should be dismissed, the DOJ attorneys argue.
The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.
Insurers, economists, and state government led by both parties have weighed in on the case via court briefs.
The case could have important ramifications that have an impact on more than just insurers, said Timothy Jost, a health law expert and retired professor from Washington and Lee University in Lexington, Va.
“The insurers are left holding the bag, but a number of insurers went insolvent [due to the losses], so in those cases, the states are left holding the bag,” Mr. Jost said in an interview.
The outcome could influence future partnerships between the federal government and private entities, according to Katie Keith, an attorney and health law analyst who writes for the Health Affairs Blog. She noted that the U.S. Chamber of Commerce, which historically has not supported the ACA, sided with insurers in the case. In a court brief, attorneys for the chamber wrote that businesses make substantial financial investments to participate in federal programs, and their willingness to do so is based on having assurance that the government will honor its statutory commitments. If left uncorrected, the circuit’s decision “will have far-reaching consequences for myriad areas in which U.S. businesses partner with the federal government to provide vital goods and services,” chamber attorneys wrote.
“This is about more than the ACA. It’s about the fundamentals of public/private partnerships,” Ms. Keith said in an interview. “If you’re contracting with the government, can the government just break those promises or break those obligations after the fact? Folks at the chamber are making it about bigger, broader issues about what it means when the government partners with private organizations.”
Mr. Jost said it’s hard to say which way the Supreme Court will rule, but the fact that the court is reviewing the case speaks volumes.
“Its kind of hard to believe they’re going to order the federal government to pay $12 billion,” he said. “On the other hand, they didn’t have to take the case.”
A Supreme Court decision is expected in early 2020.
U.S. Supreme Court Justices heard oral arguments Dec. 10 in a case that centers on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law.
Maine Community Health Options v. United States, which consolidates several lawsuits against the government, involves the ACA’s risk corridor program, which required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses.
Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them $12 billion.
The U.S. Department of Justice counters that the government is not required to pay the plans because of appropriations measures passed by Congress in 2014 and later years that limited the funding available to compensate insurers for their losses. The federal government is not obligated to pay the insurers back for the losses and the suits should be dismissed, the DOJ attorneys argue.
The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.
Insurers, economists, and state government led by both parties have weighed in on the case via court briefs.
The case could have important ramifications that have an impact on more than just insurers, said Timothy Jost, a health law expert and retired professor from Washington and Lee University in Lexington, Va.
“The insurers are left holding the bag, but a number of insurers went insolvent [due to the losses], so in those cases, the states are left holding the bag,” Mr. Jost said in an interview.
The outcome could influence future partnerships between the federal government and private entities, according to Katie Keith, an attorney and health law analyst who writes for the Health Affairs Blog. She noted that the U.S. Chamber of Commerce, which historically has not supported the ACA, sided with insurers in the case. In a court brief, attorneys for the chamber wrote that businesses make substantial financial investments to participate in federal programs, and their willingness to do so is based on having assurance that the government will honor its statutory commitments. If left uncorrected, the circuit’s decision “will have far-reaching consequences for myriad areas in which U.S. businesses partner with the federal government to provide vital goods and services,” chamber attorneys wrote.
“This is about more than the ACA. It’s about the fundamentals of public/private partnerships,” Ms. Keith said in an interview. “If you’re contracting with the government, can the government just break those promises or break those obligations after the fact? Folks at the chamber are making it about bigger, broader issues about what it means when the government partners with private organizations.”
Mr. Jost said it’s hard to say which way the Supreme Court will rule, but the fact that the court is reviewing the case speaks volumes.
“Its kind of hard to believe they’re going to order the federal government to pay $12 billion,” he said. “On the other hand, they didn’t have to take the case.”
A Supreme Court decision is expected in early 2020.
U.S. Supreme Court Justices heard oral arguments Dec. 10 in a case that centers on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law.
Maine Community Health Options v. United States, which consolidates several lawsuits against the government, involves the ACA’s risk corridor program, which required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses.
Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them $12 billion.
The U.S. Department of Justice counters that the government is not required to pay the plans because of appropriations measures passed by Congress in 2014 and later years that limited the funding available to compensate insurers for their losses. The federal government is not obligated to pay the insurers back for the losses and the suits should be dismissed, the DOJ attorneys argue.
The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.
Insurers, economists, and state government led by both parties have weighed in on the case via court briefs.
The case could have important ramifications that have an impact on more than just insurers, said Timothy Jost, a health law expert and retired professor from Washington and Lee University in Lexington, Va.
“The insurers are left holding the bag, but a number of insurers went insolvent [due to the losses], so in those cases, the states are left holding the bag,” Mr. Jost said in an interview.
The outcome could influence future partnerships between the federal government and private entities, according to Katie Keith, an attorney and health law analyst who writes for the Health Affairs Blog. She noted that the U.S. Chamber of Commerce, which historically has not supported the ACA, sided with insurers in the case. In a court brief, attorneys for the chamber wrote that businesses make substantial financial investments to participate in federal programs, and their willingness to do so is based on having assurance that the government will honor its statutory commitments. If left uncorrected, the circuit’s decision “will have far-reaching consequences for myriad areas in which U.S. businesses partner with the federal government to provide vital goods and services,” chamber attorneys wrote.
“This is about more than the ACA. It’s about the fundamentals of public/private partnerships,” Ms. Keith said in an interview. “If you’re contracting with the government, can the government just break those promises or break those obligations after the fact? Folks at the chamber are making it about bigger, broader issues about what it means when the government partners with private organizations.”
Mr. Jost said it’s hard to say which way the Supreme Court will rule, but the fact that the court is reviewing the case speaks volumes.
“Its kind of hard to believe they’re going to order the federal government to pay $12 billion,” he said. “On the other hand, they didn’t have to take the case.”
A Supreme Court decision is expected in early 2020.
House passes drug pricing bill, likely ending its journey
The House of Representatives passed a partisan drug pricing bill, a move that likely ends its legislative journey as Senate Majority Leader Mitch McConnell (R-Ky.) has already signaled he will not bring it to the Senate floor.
The Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3) passed Dec. 12 on a near party-line vote of 230-192, with two Republicans crossing the aisle to join the Democrats in support of the bill, and no Democrats voting against it. Four members from each party did not record votes.
“The American people are fed up with paying 3, 4, or 10 times more than people in other countries for the exact same drug,” House Energy and Commerce Committee Chairman Frank Pallone (D-N.J) said in a statement following the passage. “I’m proud that the House took decisive action today to finally level the playing field and provide real relief to the American people.”
H.R. 3 would give the secretary of Health and Human Services the ability to negotiate with drug manufacturers on the price of pharmaceuticals in Medicare Part D (and available in the commercial markets) using an international pricing benchmark and would penalize manufacturers who do not negotiate or fail to lower prices to be more in line with generally lower costs internationally.
Drug prices would need to be within 120% of the average price in a reference group of six nations: Australia, Canada, France, Germany, Japan, and the United Kingdom.
Savings from the lower costs that result from negotiations would be reinvested into medical research.
Passage of H.R. 3 would “lower ... medication by 65%” per year for women with breast cancer, Rep. Haley Stevens (D-Mich.) said during the floor debate.
The Congressional Budget Office estimated that the drug price negotiation provision would lower spending on pharmaceuticals by $465 billion over the next 10 years, offset partially by an increase in spending by $358 billion associated with provisions to provide dental, vision, and hearing coverage.
The bill also includes mandatory rebates to the federal government when a drug’s price rises faster than the rate of inflation. It includes an annual cap on out-of-pocket spending on pharmaceuticals of $2,000 for Medicare Part D participants.
The bill was contentious from its introduction, which erased bipartisan work across the committees of jurisdiction, including a number of individual bills that passed at the committee level with bipartisan support.
The price negotiation scheme, using the international benchmark, was a key point of objection, which some argued was more akin to price-setting.
“Government price setting will kill innovation in clinical areas where it is most needed,” Rep. George Holding (R-N.C.) said during the floor debate. “The pricing scheme outlined in H.R. 3 would disincentivize research and development for drugs that are first in their class, such as the future cure for Alzheimer’s.”
The CBO estimates that if the bill were enacted, “8 fewer drugs would be introduced to the U.S. market over the 2020-2029 period, and about 30 fewer drugs over the subsequent decade.”
An amendment offered by House Energy and Commerce Committee Ranking Member Greg Walden (R-Ore.) attempted to replace the language of H.R. 3 with substitute language that collected all the individual drug pricing–related bills that had previously passed with bipartisan support at the committee level, but that was voted down by 223-201 vote with 12 members not voting.
Rep. Walden noted that policies within his substitute “unanimously passed the Energy and Commerce Committee earlier this year. They would have unanimously passed on this House floor had a poison pill not been put in up in the Rules Committee.”
Rep. Katie Porter (D-Calif.) countered that Rep. Walden’s amendment “doesn’t tackle the fundamental problem, which is reducing drug prices. This amendment fails to solve the main problem of actually lowering drug prices.”
The House of Representatives passed a partisan drug pricing bill, a move that likely ends its legislative journey as Senate Majority Leader Mitch McConnell (R-Ky.) has already signaled he will not bring it to the Senate floor.
The Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3) passed Dec. 12 on a near party-line vote of 230-192, with two Republicans crossing the aisle to join the Democrats in support of the bill, and no Democrats voting against it. Four members from each party did not record votes.
“The American people are fed up with paying 3, 4, or 10 times more than people in other countries for the exact same drug,” House Energy and Commerce Committee Chairman Frank Pallone (D-N.J) said in a statement following the passage. “I’m proud that the House took decisive action today to finally level the playing field and provide real relief to the American people.”
H.R. 3 would give the secretary of Health and Human Services the ability to negotiate with drug manufacturers on the price of pharmaceuticals in Medicare Part D (and available in the commercial markets) using an international pricing benchmark and would penalize manufacturers who do not negotiate or fail to lower prices to be more in line with generally lower costs internationally.
Drug prices would need to be within 120% of the average price in a reference group of six nations: Australia, Canada, France, Germany, Japan, and the United Kingdom.
Savings from the lower costs that result from negotiations would be reinvested into medical research.
Passage of H.R. 3 would “lower ... medication by 65%” per year for women with breast cancer, Rep. Haley Stevens (D-Mich.) said during the floor debate.
The Congressional Budget Office estimated that the drug price negotiation provision would lower spending on pharmaceuticals by $465 billion over the next 10 years, offset partially by an increase in spending by $358 billion associated with provisions to provide dental, vision, and hearing coverage.
The bill also includes mandatory rebates to the federal government when a drug’s price rises faster than the rate of inflation. It includes an annual cap on out-of-pocket spending on pharmaceuticals of $2,000 for Medicare Part D participants.
The bill was contentious from its introduction, which erased bipartisan work across the committees of jurisdiction, including a number of individual bills that passed at the committee level with bipartisan support.
The price negotiation scheme, using the international benchmark, was a key point of objection, which some argued was more akin to price-setting.
“Government price setting will kill innovation in clinical areas where it is most needed,” Rep. George Holding (R-N.C.) said during the floor debate. “The pricing scheme outlined in H.R. 3 would disincentivize research and development for drugs that are first in their class, such as the future cure for Alzheimer’s.”
The CBO estimates that if the bill were enacted, “8 fewer drugs would be introduced to the U.S. market over the 2020-2029 period, and about 30 fewer drugs over the subsequent decade.”
An amendment offered by House Energy and Commerce Committee Ranking Member Greg Walden (R-Ore.) attempted to replace the language of H.R. 3 with substitute language that collected all the individual drug pricing–related bills that had previously passed with bipartisan support at the committee level, but that was voted down by 223-201 vote with 12 members not voting.
Rep. Walden noted that policies within his substitute “unanimously passed the Energy and Commerce Committee earlier this year. They would have unanimously passed on this House floor had a poison pill not been put in up in the Rules Committee.”
Rep. Katie Porter (D-Calif.) countered that Rep. Walden’s amendment “doesn’t tackle the fundamental problem, which is reducing drug prices. This amendment fails to solve the main problem of actually lowering drug prices.”
The House of Representatives passed a partisan drug pricing bill, a move that likely ends its legislative journey as Senate Majority Leader Mitch McConnell (R-Ky.) has already signaled he will not bring it to the Senate floor.
The Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3) passed Dec. 12 on a near party-line vote of 230-192, with two Republicans crossing the aisle to join the Democrats in support of the bill, and no Democrats voting against it. Four members from each party did not record votes.
“The American people are fed up with paying 3, 4, or 10 times more than people in other countries for the exact same drug,” House Energy and Commerce Committee Chairman Frank Pallone (D-N.J) said in a statement following the passage. “I’m proud that the House took decisive action today to finally level the playing field and provide real relief to the American people.”
H.R. 3 would give the secretary of Health and Human Services the ability to negotiate with drug manufacturers on the price of pharmaceuticals in Medicare Part D (and available in the commercial markets) using an international pricing benchmark and would penalize manufacturers who do not negotiate or fail to lower prices to be more in line with generally lower costs internationally.
Drug prices would need to be within 120% of the average price in a reference group of six nations: Australia, Canada, France, Germany, Japan, and the United Kingdom.
Savings from the lower costs that result from negotiations would be reinvested into medical research.
Passage of H.R. 3 would “lower ... medication by 65%” per year for women with breast cancer, Rep. Haley Stevens (D-Mich.) said during the floor debate.
The Congressional Budget Office estimated that the drug price negotiation provision would lower spending on pharmaceuticals by $465 billion over the next 10 years, offset partially by an increase in spending by $358 billion associated with provisions to provide dental, vision, and hearing coverage.
The bill also includes mandatory rebates to the federal government when a drug’s price rises faster than the rate of inflation. It includes an annual cap on out-of-pocket spending on pharmaceuticals of $2,000 for Medicare Part D participants.
The bill was contentious from its introduction, which erased bipartisan work across the committees of jurisdiction, including a number of individual bills that passed at the committee level with bipartisan support.
The price negotiation scheme, using the international benchmark, was a key point of objection, which some argued was more akin to price-setting.
“Government price setting will kill innovation in clinical areas where it is most needed,” Rep. George Holding (R-N.C.) said during the floor debate. “The pricing scheme outlined in H.R. 3 would disincentivize research and development for drugs that are first in their class, such as the future cure for Alzheimer’s.”
The CBO estimates that if the bill were enacted, “8 fewer drugs would be introduced to the U.S. market over the 2020-2029 period, and about 30 fewer drugs over the subsequent decade.”
An amendment offered by House Energy and Commerce Committee Ranking Member Greg Walden (R-Ore.) attempted to replace the language of H.R. 3 with substitute language that collected all the individual drug pricing–related bills that had previously passed with bipartisan support at the committee level, but that was voted down by 223-201 vote with 12 members not voting.
Rep. Walden noted that policies within his substitute “unanimously passed the Energy and Commerce Committee earlier this year. They would have unanimously passed on this House floor had a poison pill not been put in up in the Rules Committee.”
Rep. Katie Porter (D-Calif.) countered that Rep. Walden’s amendment “doesn’t tackle the fundamental problem, which is reducing drug prices. This amendment fails to solve the main problem of actually lowering drug prices.”
New ASH guideline: VTE prophylaxis after major surgery
ORLANDO – The latest American Society of Hematology guideline on venous thromboembolism (VTE) tackles 30 key questions regarding prophylaxis in hospitalized patients undergoing surgery, according to the chair of the guideline panel, who highlighted 9 of those questions during a special session at the society’s annual meeting.
The clinical practice guideline, published just about a week before the annual meeting of the American Society of Hematology, focuses mainly on pharmacologic prophylaxis in specific surgical settings, said David R. Anderson, MD, dean of the faculty of medicine of Dalhousie University, Halifax, N.S.
“Our guidelines focused upon clinically important symptomatic outcomes, with less emphasis being placed on asymptomatic deep vein thrombosis detected by screening tests,” Dr. Anderson said.
At the special education session, Dr. Anderson highlighted several specific recommendations on prophylaxis in surgical patients.
Pharmacologic prophylaxis is not recommended for patients experiencing major trauma deemed to be at high risk of bleeding. Its use does reduce risk of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) by about 10 events per 1,000 patients treated; however, Dr. Anderson said, the panel’s opinion was that this benefit was outweighed by increased risk of major bleeding, at 24 events per 1,000 patients treated.
“We do recommend, however that this risk of bleeding must be reevaluated over the course of recovery of patients, and this may change the decision around this intervention over time,” Dr. Anderson told attendees at the special session.
That’s because pharmacologic prophylaxis is recommended in surgical patients at low to moderate risk of bleeding. In this scenario, the incremental risk of major bleeding (14 events per 1,000 patients treated) is outweighed by the benefit of the reduction of symptomatic VTE events, according to Dr. Anderson.
When pharmacologic prophylaxis is used, the panel recommends combined prophylaxis – mechanical prophylaxis in addition to pharmacologic prophylaxis – especially in those patients at high or very high risk of VTE. Evidence shows that the combination approach significantly reduces risk of PE, and strongly suggests it may also reduce risk of symptomatic proximal DVT, Dr. Anderson said.
In surgical patients not receiving pharmacologic prophylaxis, mechanical prophylaxis is recommended over no mechanical prophylaxis, he added. Moreover, in those patients receiving mechanical prophylaxis, the ASH panel recommends use of intermittent compression devices over graduated compression stockings.
The panel comes out against prophylactic inferior vena cava (IVC) filter insertion in the guidelines. Dr. Anderson said that the “small reduction” in PE risk seen in observational studies is outweighed by increased risk of DVT, and a resulting trend for increased mortality, associated with insertion of the devices.
“We did not consider other risks of IVC filters such as filter embolization or perforation, which again would be complications that would support our recommendation against routine use of these devices in patients undergoing major surgery,” he said.
In terms of the type of pharmacologic prophylaxis to use, the panel said low-molecular-weight heparin or unfractionated heparin would be reasonable choices in this setting. Available data do not demonstrate any significant differences between these choices for major clinical outcomes, Dr. Anderson added.
The guideline also addresses duration of pharmacologic prophylaxis, stating that extended prophylaxis – of at least 3 weeks – is favored over short-term prophylaxis, or up to 2 weeks of treatment. The extended approach significantly reduces risk of symptomatic PE and proximal DVT, though most of the supporting data come from studies of major joint arthroplasty and major general surgical procedures for patients with cancer. “We need more studies in other clinical areas to examine this particular question,” Dr. Anderson said.
The guideline on prophylaxis in surgical patients was published in Blood Advances (2019 Dec 3;3[23]:3898-944). Six other ASH VTE guidelines, all published in 2018, covered prophylaxis in medical patients, diagnosis, VTE in pregnancy, optimal anticoagulation, heparin-induced thrombocytopenia, and pediatric considerations. The guidelines are available on the ASH website.
Dr. Anderson reported having no relevant conflicts of interest.
ORLANDO – The latest American Society of Hematology guideline on venous thromboembolism (VTE) tackles 30 key questions regarding prophylaxis in hospitalized patients undergoing surgery, according to the chair of the guideline panel, who highlighted 9 of those questions during a special session at the society’s annual meeting.
The clinical practice guideline, published just about a week before the annual meeting of the American Society of Hematology, focuses mainly on pharmacologic prophylaxis in specific surgical settings, said David R. Anderson, MD, dean of the faculty of medicine of Dalhousie University, Halifax, N.S.
“Our guidelines focused upon clinically important symptomatic outcomes, with less emphasis being placed on asymptomatic deep vein thrombosis detected by screening tests,” Dr. Anderson said.
At the special education session, Dr. Anderson highlighted several specific recommendations on prophylaxis in surgical patients.
Pharmacologic prophylaxis is not recommended for patients experiencing major trauma deemed to be at high risk of bleeding. Its use does reduce risk of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) by about 10 events per 1,000 patients treated; however, Dr. Anderson said, the panel’s opinion was that this benefit was outweighed by increased risk of major bleeding, at 24 events per 1,000 patients treated.
“We do recommend, however that this risk of bleeding must be reevaluated over the course of recovery of patients, and this may change the decision around this intervention over time,” Dr. Anderson told attendees at the special session.
That’s because pharmacologic prophylaxis is recommended in surgical patients at low to moderate risk of bleeding. In this scenario, the incremental risk of major bleeding (14 events per 1,000 patients treated) is outweighed by the benefit of the reduction of symptomatic VTE events, according to Dr. Anderson.
When pharmacologic prophylaxis is used, the panel recommends combined prophylaxis – mechanical prophylaxis in addition to pharmacologic prophylaxis – especially in those patients at high or very high risk of VTE. Evidence shows that the combination approach significantly reduces risk of PE, and strongly suggests it may also reduce risk of symptomatic proximal DVT, Dr. Anderson said.
In surgical patients not receiving pharmacologic prophylaxis, mechanical prophylaxis is recommended over no mechanical prophylaxis, he added. Moreover, in those patients receiving mechanical prophylaxis, the ASH panel recommends use of intermittent compression devices over graduated compression stockings.
The panel comes out against prophylactic inferior vena cava (IVC) filter insertion in the guidelines. Dr. Anderson said that the “small reduction” in PE risk seen in observational studies is outweighed by increased risk of DVT, and a resulting trend for increased mortality, associated with insertion of the devices.
“We did not consider other risks of IVC filters such as filter embolization or perforation, which again would be complications that would support our recommendation against routine use of these devices in patients undergoing major surgery,” he said.
In terms of the type of pharmacologic prophylaxis to use, the panel said low-molecular-weight heparin or unfractionated heparin would be reasonable choices in this setting. Available data do not demonstrate any significant differences between these choices for major clinical outcomes, Dr. Anderson added.
The guideline also addresses duration of pharmacologic prophylaxis, stating that extended prophylaxis – of at least 3 weeks – is favored over short-term prophylaxis, or up to 2 weeks of treatment. The extended approach significantly reduces risk of symptomatic PE and proximal DVT, though most of the supporting data come from studies of major joint arthroplasty and major general surgical procedures for patients with cancer. “We need more studies in other clinical areas to examine this particular question,” Dr. Anderson said.
The guideline on prophylaxis in surgical patients was published in Blood Advances (2019 Dec 3;3[23]:3898-944). Six other ASH VTE guidelines, all published in 2018, covered prophylaxis in medical patients, diagnosis, VTE in pregnancy, optimal anticoagulation, heparin-induced thrombocytopenia, and pediatric considerations. The guidelines are available on the ASH website.
Dr. Anderson reported having no relevant conflicts of interest.
ORLANDO – The latest American Society of Hematology guideline on venous thromboembolism (VTE) tackles 30 key questions regarding prophylaxis in hospitalized patients undergoing surgery, according to the chair of the guideline panel, who highlighted 9 of those questions during a special session at the society’s annual meeting.
The clinical practice guideline, published just about a week before the annual meeting of the American Society of Hematology, focuses mainly on pharmacologic prophylaxis in specific surgical settings, said David R. Anderson, MD, dean of the faculty of medicine of Dalhousie University, Halifax, N.S.
“Our guidelines focused upon clinically important symptomatic outcomes, with less emphasis being placed on asymptomatic deep vein thrombosis detected by screening tests,” Dr. Anderson said.
At the special education session, Dr. Anderson highlighted several specific recommendations on prophylaxis in surgical patients.
Pharmacologic prophylaxis is not recommended for patients experiencing major trauma deemed to be at high risk of bleeding. Its use does reduce risk of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) by about 10 events per 1,000 patients treated; however, Dr. Anderson said, the panel’s opinion was that this benefit was outweighed by increased risk of major bleeding, at 24 events per 1,000 patients treated.
“We do recommend, however that this risk of bleeding must be reevaluated over the course of recovery of patients, and this may change the decision around this intervention over time,” Dr. Anderson told attendees at the special session.
That’s because pharmacologic prophylaxis is recommended in surgical patients at low to moderate risk of bleeding. In this scenario, the incremental risk of major bleeding (14 events per 1,000 patients treated) is outweighed by the benefit of the reduction of symptomatic VTE events, according to Dr. Anderson.
When pharmacologic prophylaxis is used, the panel recommends combined prophylaxis – mechanical prophylaxis in addition to pharmacologic prophylaxis – especially in those patients at high or very high risk of VTE. Evidence shows that the combination approach significantly reduces risk of PE, and strongly suggests it may also reduce risk of symptomatic proximal DVT, Dr. Anderson said.
In surgical patients not receiving pharmacologic prophylaxis, mechanical prophylaxis is recommended over no mechanical prophylaxis, he added. Moreover, in those patients receiving mechanical prophylaxis, the ASH panel recommends use of intermittent compression devices over graduated compression stockings.
The panel comes out against prophylactic inferior vena cava (IVC) filter insertion in the guidelines. Dr. Anderson said that the “small reduction” in PE risk seen in observational studies is outweighed by increased risk of DVT, and a resulting trend for increased mortality, associated with insertion of the devices.
“We did not consider other risks of IVC filters such as filter embolization or perforation, which again would be complications that would support our recommendation against routine use of these devices in patients undergoing major surgery,” he said.
In terms of the type of pharmacologic prophylaxis to use, the panel said low-molecular-weight heparin or unfractionated heparin would be reasonable choices in this setting. Available data do not demonstrate any significant differences between these choices for major clinical outcomes, Dr. Anderson added.
The guideline also addresses duration of pharmacologic prophylaxis, stating that extended prophylaxis – of at least 3 weeks – is favored over short-term prophylaxis, or up to 2 weeks of treatment. The extended approach significantly reduces risk of symptomatic PE and proximal DVT, though most of the supporting data come from studies of major joint arthroplasty and major general surgical procedures for patients with cancer. “We need more studies in other clinical areas to examine this particular question,” Dr. Anderson said.
The guideline on prophylaxis in surgical patients was published in Blood Advances (2019 Dec 3;3[23]:3898-944). Six other ASH VTE guidelines, all published in 2018, covered prophylaxis in medical patients, diagnosis, VTE in pregnancy, optimal anticoagulation, heparin-induced thrombocytopenia, and pediatric considerations. The guidelines are available on the ASH website.
Dr. Anderson reported having no relevant conflicts of interest.
EXPERT ANALYSIS FROM ASH 2019
Docs push back on surprise billing compromise
Compromise bipartisan legislation to address surprise medical bills is getting push back from physician groups.
Leadership from the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee on Dec. 9 unveiled a compromise bill that includes rate-setting for small surprise billing and arbitration for larger ones at a lower threshold than what was originally proposed.
The new bill, part of a broader Lower Health Care Costs Act, would protect patients from surprise medical bills related to emergency care, holding them responsible for in-network cost-sharing rates for out-of-network care provided at an in-network facility without their informed consent. Out-of-network surprise bills would be applied to the patient’s in-network deductible.
Under the legislation, providers would be paid at minimum the local, market-based median in-network negotiated rate for services, with a median rate under a $750 threshold. When the median exceeds $750, the provider or insurer would be allowed to choose arbitration process to resolve payment disputes.
The bill also protects patients by banning out-of-network facilities and providers from sending balance bills for more than in-network cost-sharing amounts.
Physician groups, however, see the legislation as a giveback to insurers that puts health care professionals at a disadvantage when negotiating to be included in insurer networks.
At issue is the $750 threshold for optional arbitration.
“If you set the arbitration system in such a way that limits the ability of a physician to go to arbitration to settle a dispute between a health plan and the doctor, and if you say that can only be done when there [are] bills that are greater than $750 for a particular service, then the vast majority of services provided by doctors will not be able to go to arbitration,” Christian Shalgian, director of advocacy and health policy at the American College of Surgeons, said in an interview.
Cynthia Moran, executive vice president of government relations and health policy at the American College of Radiology, agreed.
“This particular product is going in a direction that we’re not comfortable with so we can’t support it on the basis of the benchmarks and the independent dispute resolution (IDR) process with the $750 threshold,” she said in an interview. The services radiologists provide tend to be in the $100-200 range, she said, so that would automatically exclude them from accessing arbitration. She also said that it is her understanding that many physician services will fall under that $750 threshold.
“That $750 is really going to mean that the vast majority of this policy is a benchmark-driven policy,” she said. “It is not going to be an IDR-driven policy and that is the crux of our objection to it.”
And by taking arbitration off the table, insurers have no incentive to negotiate in good faith with doctors to ensure that doctors are getting paid for the services they perform.
“For those situations where there is an out-of-network physician at an in-network facility, we believe that the patient should not have to pay any more for those emergency situations where they patient doesn’t get to choose their doctor,” Mr. Shalgian said. “The dispute really comes down to how much does the health plan have to pay the doctor.”
He noted that the legislation ties the rate to median in-network rates “and that’s a problem for us as well because of the fact that [this is] going to allow the health plans to set median in-network rates as the rate that they can pay the doctors.”
If the bill becomes law, “when you have a situation where you have an in-network physician trying to negotiate with a health plan to stay in network, that health plan now has more power in that negotiation because if [the physician] is making more than median in-network rates, then the health plan can say, ‘go out of network because we will just pay you median in-network’ at that point. That is a significant concern to us as well.”
Mr. Shalgian said that the ideal solution would be to eliminate the threshold entirely and just send disputes to arbitration. Recognizing that it might not be practical, the $750 threshold should be lowered.
ACS supported a $300 threshold, he added.
The bill is expected to be tacked on to one of the mandatory spending bills that Congress needs to pass by the end of the year.
The $750 threshold would be a savings generator for the government and an important bill such as this should be passed on its own merits, Mr. Shalgian said.
Ms. Moran called for Congress to take its time with the legislation.
“We do think that this whole issue needs more time for everyone to understand what the impact is on this first run of the solution and we think it should be slowed down a bit,” she said. “It should not go to the floor until you hear more from the providers [after] the providers figure out what the impact will be.”
The American Medical Association also called for Congress to slow down.
“The current proposal relies on benchmark rate setting that would serve only to benefit the bottom line of insurance companies at the expense of patients seeking a robust network of physicians for their care,” AMA President Patrice Harris, MD, said in a statement. “Rather than rushing to meet arbitrary deadlines, it is important to get this legislation right.”
Compromise bipartisan legislation to address surprise medical bills is getting push back from physician groups.
Leadership from the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee on Dec. 9 unveiled a compromise bill that includes rate-setting for small surprise billing and arbitration for larger ones at a lower threshold than what was originally proposed.
The new bill, part of a broader Lower Health Care Costs Act, would protect patients from surprise medical bills related to emergency care, holding them responsible for in-network cost-sharing rates for out-of-network care provided at an in-network facility without their informed consent. Out-of-network surprise bills would be applied to the patient’s in-network deductible.
Under the legislation, providers would be paid at minimum the local, market-based median in-network negotiated rate for services, with a median rate under a $750 threshold. When the median exceeds $750, the provider or insurer would be allowed to choose arbitration process to resolve payment disputes.
The bill also protects patients by banning out-of-network facilities and providers from sending balance bills for more than in-network cost-sharing amounts.
Physician groups, however, see the legislation as a giveback to insurers that puts health care professionals at a disadvantage when negotiating to be included in insurer networks.
At issue is the $750 threshold for optional arbitration.
“If you set the arbitration system in such a way that limits the ability of a physician to go to arbitration to settle a dispute between a health plan and the doctor, and if you say that can only be done when there [are] bills that are greater than $750 for a particular service, then the vast majority of services provided by doctors will not be able to go to arbitration,” Christian Shalgian, director of advocacy and health policy at the American College of Surgeons, said in an interview.
Cynthia Moran, executive vice president of government relations and health policy at the American College of Radiology, agreed.
“This particular product is going in a direction that we’re not comfortable with so we can’t support it on the basis of the benchmarks and the independent dispute resolution (IDR) process with the $750 threshold,” she said in an interview. The services radiologists provide tend to be in the $100-200 range, she said, so that would automatically exclude them from accessing arbitration. She also said that it is her understanding that many physician services will fall under that $750 threshold.
“That $750 is really going to mean that the vast majority of this policy is a benchmark-driven policy,” she said. “It is not going to be an IDR-driven policy and that is the crux of our objection to it.”
And by taking arbitration off the table, insurers have no incentive to negotiate in good faith with doctors to ensure that doctors are getting paid for the services they perform.
“For those situations where there is an out-of-network physician at an in-network facility, we believe that the patient should not have to pay any more for those emergency situations where they patient doesn’t get to choose their doctor,” Mr. Shalgian said. “The dispute really comes down to how much does the health plan have to pay the doctor.”
He noted that the legislation ties the rate to median in-network rates “and that’s a problem for us as well because of the fact that [this is] going to allow the health plans to set median in-network rates as the rate that they can pay the doctors.”
If the bill becomes law, “when you have a situation where you have an in-network physician trying to negotiate with a health plan to stay in network, that health plan now has more power in that negotiation because if [the physician] is making more than median in-network rates, then the health plan can say, ‘go out of network because we will just pay you median in-network’ at that point. That is a significant concern to us as well.”
Mr. Shalgian said that the ideal solution would be to eliminate the threshold entirely and just send disputes to arbitration. Recognizing that it might not be practical, the $750 threshold should be lowered.
ACS supported a $300 threshold, he added.
The bill is expected to be tacked on to one of the mandatory spending bills that Congress needs to pass by the end of the year.
The $750 threshold would be a savings generator for the government and an important bill such as this should be passed on its own merits, Mr. Shalgian said.
Ms. Moran called for Congress to take its time with the legislation.
“We do think that this whole issue needs more time for everyone to understand what the impact is on this first run of the solution and we think it should be slowed down a bit,” she said. “It should not go to the floor until you hear more from the providers [after] the providers figure out what the impact will be.”
The American Medical Association also called for Congress to slow down.
“The current proposal relies on benchmark rate setting that would serve only to benefit the bottom line of insurance companies at the expense of patients seeking a robust network of physicians for their care,” AMA President Patrice Harris, MD, said in a statement. “Rather than rushing to meet arbitrary deadlines, it is important to get this legislation right.”
Compromise bipartisan legislation to address surprise medical bills is getting push back from physician groups.
Leadership from the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee on Dec. 9 unveiled a compromise bill that includes rate-setting for small surprise billing and arbitration for larger ones at a lower threshold than what was originally proposed.
The new bill, part of a broader Lower Health Care Costs Act, would protect patients from surprise medical bills related to emergency care, holding them responsible for in-network cost-sharing rates for out-of-network care provided at an in-network facility without their informed consent. Out-of-network surprise bills would be applied to the patient’s in-network deductible.
Under the legislation, providers would be paid at minimum the local, market-based median in-network negotiated rate for services, with a median rate under a $750 threshold. When the median exceeds $750, the provider or insurer would be allowed to choose arbitration process to resolve payment disputes.
The bill also protects patients by banning out-of-network facilities and providers from sending balance bills for more than in-network cost-sharing amounts.
Physician groups, however, see the legislation as a giveback to insurers that puts health care professionals at a disadvantage when negotiating to be included in insurer networks.
At issue is the $750 threshold for optional arbitration.
“If you set the arbitration system in such a way that limits the ability of a physician to go to arbitration to settle a dispute between a health plan and the doctor, and if you say that can only be done when there [are] bills that are greater than $750 for a particular service, then the vast majority of services provided by doctors will not be able to go to arbitration,” Christian Shalgian, director of advocacy and health policy at the American College of Surgeons, said in an interview.
Cynthia Moran, executive vice president of government relations and health policy at the American College of Radiology, agreed.
“This particular product is going in a direction that we’re not comfortable with so we can’t support it on the basis of the benchmarks and the independent dispute resolution (IDR) process with the $750 threshold,” she said in an interview. The services radiologists provide tend to be in the $100-200 range, she said, so that would automatically exclude them from accessing arbitration. She also said that it is her understanding that many physician services will fall under that $750 threshold.
“That $750 is really going to mean that the vast majority of this policy is a benchmark-driven policy,” she said. “It is not going to be an IDR-driven policy and that is the crux of our objection to it.”
And by taking arbitration off the table, insurers have no incentive to negotiate in good faith with doctors to ensure that doctors are getting paid for the services they perform.
“For those situations where there is an out-of-network physician at an in-network facility, we believe that the patient should not have to pay any more for those emergency situations where they patient doesn’t get to choose their doctor,” Mr. Shalgian said. “The dispute really comes down to how much does the health plan have to pay the doctor.”
He noted that the legislation ties the rate to median in-network rates “and that’s a problem for us as well because of the fact that [this is] going to allow the health plans to set median in-network rates as the rate that they can pay the doctors.”
If the bill becomes law, “when you have a situation where you have an in-network physician trying to negotiate with a health plan to stay in network, that health plan now has more power in that negotiation because if [the physician] is making more than median in-network rates, then the health plan can say, ‘go out of network because we will just pay you median in-network’ at that point. That is a significant concern to us as well.”
Mr. Shalgian said that the ideal solution would be to eliminate the threshold entirely and just send disputes to arbitration. Recognizing that it might not be practical, the $750 threshold should be lowered.
ACS supported a $300 threshold, he added.
The bill is expected to be tacked on to one of the mandatory spending bills that Congress needs to pass by the end of the year.
The $750 threshold would be a savings generator for the government and an important bill such as this should be passed on its own merits, Mr. Shalgian said.
Ms. Moran called for Congress to take its time with the legislation.
“We do think that this whole issue needs more time for everyone to understand what the impact is on this first run of the solution and we think it should be slowed down a bit,” she said. “It should not go to the floor until you hear more from the providers [after] the providers figure out what the impact will be.”
The American Medical Association also called for Congress to slow down.
“The current proposal relies on benchmark rate setting that would serve only to benefit the bottom line of insurance companies at the expense of patients seeking a robust network of physicians for their care,” AMA President Patrice Harris, MD, said in a statement. “Rather than rushing to meet arbitrary deadlines, it is important to get this legislation right.”
Task force advocates selective screening for abdominal aortic aneurysms
Men aged 65-75 years with a history of smoking should undergo one-time screening for abdominal aortic aneurysms (AAA), but clinicians can selectively screen men in this age group who don’t smoke, according to updated recommendations from the U.S. Preventive Services Task Force published in JAMA.
The task force issued a B recommendation for screening men aged 65-75 years with a smoking history and a C recommendation for selectively screening male never smokers in this age group in an update to the previous recommendations issued in 2014.
The task force also recommended against screening for AAA in women with no history of smoking (D recommendation) and cited insufficient evidence to make recommendations about AAA screening for women with a history of smoking or a family history of AAA (I statement).
The current prevalence of AAA in the United States is unclear because of the low rate of screening, but data from countries including the United Kingdom, Sweden, Denmark, and New Zealand have shown a decline in AAA among screened men aged 65 years and older, according to the USPSTF report.
Risk factors for AAA include smoking, male gender, older age, and having a first-degree relative with AAA, the task force noted.
In an evidence review accompanying the recommendations, Janelle M. Guirguis-Blake, MD, of the University of Washington, Tacoma, and colleagues analyzed data from 33 studies. They found a significant reduction in AAA-related mortality over 12-15 years’ follow-up among men aged 65 years and older who underwent AAA screening, compared with unscreened controls (odds ratio, 0.65). In addition, the risk of ruptures related to AAA was significantly lower over 12-15 years among men who underwent screening, compared with unscreened controls (OR, 0.62). However, no significant difference was noted in all-cause mortality over 12-15 years between screened and unscreened groups (relative risk, 0.99; 95% confidence interval, 0.98-1.00).
Data from four studies of early surgery to treat small aneurysms showed no significant difference in AAA-related mortality or all-cause mortality.
“Screening for AAA entails a simple, noninvasive, and focused ultrasonography examination that costs roughly $50. The only potential harms are the psychologic burden of knowing of the presence of an aneurysm and the risk of elective surgery,” wrote Marc Schermerhorn, MD, of Beth Israel Deaconess Medical Center, Boston, in an accompanying editorial published in JAMA Surgery (doi: 10.1001/jamasurg.2019.5234).
“The latter can be calculated for each patient, weighed against the risk of rupture, and together with the estimated life expectancy, should be factored into the decision to screen and the decision to operate. We as a country can do better to detect and treat this disease cost effectively for all appropriate patients including women and elderly individuals,” he said.
Dr. Schermerhorn noted that overall the recommendations are reasonable, but he expressed concern for three populations excluded from the guidelines that warrant additional consideration: nonsmokers with equivalent risk factors, patients older than 75 years, and women. “In the meantime, we should work to ensure that patients determined appropriate by the USPSTF are actually screened,” he said.
The USPSTF is supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Schermerhorn disclosed relationships with Abbott, Cook Medical, Endologix, Medtronic, and Philips.
SOURCE: Guirguis-Blake JM et al. JAMA. 2019. doi: 10.1001/jama.2019.17021.
Men aged 65-75 years with a history of smoking should undergo one-time screening for abdominal aortic aneurysms (AAA), but clinicians can selectively screen men in this age group who don’t smoke, according to updated recommendations from the U.S. Preventive Services Task Force published in JAMA.
The task force issued a B recommendation for screening men aged 65-75 years with a smoking history and a C recommendation for selectively screening male never smokers in this age group in an update to the previous recommendations issued in 2014.
The task force also recommended against screening for AAA in women with no history of smoking (D recommendation) and cited insufficient evidence to make recommendations about AAA screening for women with a history of smoking or a family history of AAA (I statement).
The current prevalence of AAA in the United States is unclear because of the low rate of screening, but data from countries including the United Kingdom, Sweden, Denmark, and New Zealand have shown a decline in AAA among screened men aged 65 years and older, according to the USPSTF report.
Risk factors for AAA include smoking, male gender, older age, and having a first-degree relative with AAA, the task force noted.
In an evidence review accompanying the recommendations, Janelle M. Guirguis-Blake, MD, of the University of Washington, Tacoma, and colleagues analyzed data from 33 studies. They found a significant reduction in AAA-related mortality over 12-15 years’ follow-up among men aged 65 years and older who underwent AAA screening, compared with unscreened controls (odds ratio, 0.65). In addition, the risk of ruptures related to AAA was significantly lower over 12-15 years among men who underwent screening, compared with unscreened controls (OR, 0.62). However, no significant difference was noted in all-cause mortality over 12-15 years between screened and unscreened groups (relative risk, 0.99; 95% confidence interval, 0.98-1.00).
Data from four studies of early surgery to treat small aneurysms showed no significant difference in AAA-related mortality or all-cause mortality.
“Screening for AAA entails a simple, noninvasive, and focused ultrasonography examination that costs roughly $50. The only potential harms are the psychologic burden of knowing of the presence of an aneurysm and the risk of elective surgery,” wrote Marc Schermerhorn, MD, of Beth Israel Deaconess Medical Center, Boston, in an accompanying editorial published in JAMA Surgery (doi: 10.1001/jamasurg.2019.5234).
“The latter can be calculated for each patient, weighed against the risk of rupture, and together with the estimated life expectancy, should be factored into the decision to screen and the decision to operate. We as a country can do better to detect and treat this disease cost effectively for all appropriate patients including women and elderly individuals,” he said.
Dr. Schermerhorn noted that overall the recommendations are reasonable, but he expressed concern for three populations excluded from the guidelines that warrant additional consideration: nonsmokers with equivalent risk factors, patients older than 75 years, and women. “In the meantime, we should work to ensure that patients determined appropriate by the USPSTF are actually screened,” he said.
The USPSTF is supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Schermerhorn disclosed relationships with Abbott, Cook Medical, Endologix, Medtronic, and Philips.
SOURCE: Guirguis-Blake JM et al. JAMA. 2019. doi: 10.1001/jama.2019.17021.
Men aged 65-75 years with a history of smoking should undergo one-time screening for abdominal aortic aneurysms (AAA), but clinicians can selectively screen men in this age group who don’t smoke, according to updated recommendations from the U.S. Preventive Services Task Force published in JAMA.
The task force issued a B recommendation for screening men aged 65-75 years with a smoking history and a C recommendation for selectively screening male never smokers in this age group in an update to the previous recommendations issued in 2014.
The task force also recommended against screening for AAA in women with no history of smoking (D recommendation) and cited insufficient evidence to make recommendations about AAA screening for women with a history of smoking or a family history of AAA (I statement).
The current prevalence of AAA in the United States is unclear because of the low rate of screening, but data from countries including the United Kingdom, Sweden, Denmark, and New Zealand have shown a decline in AAA among screened men aged 65 years and older, according to the USPSTF report.
Risk factors for AAA include smoking, male gender, older age, and having a first-degree relative with AAA, the task force noted.
In an evidence review accompanying the recommendations, Janelle M. Guirguis-Blake, MD, of the University of Washington, Tacoma, and colleagues analyzed data from 33 studies. They found a significant reduction in AAA-related mortality over 12-15 years’ follow-up among men aged 65 years and older who underwent AAA screening, compared with unscreened controls (odds ratio, 0.65). In addition, the risk of ruptures related to AAA was significantly lower over 12-15 years among men who underwent screening, compared with unscreened controls (OR, 0.62). However, no significant difference was noted in all-cause mortality over 12-15 years between screened and unscreened groups (relative risk, 0.99; 95% confidence interval, 0.98-1.00).
Data from four studies of early surgery to treat small aneurysms showed no significant difference in AAA-related mortality or all-cause mortality.
“Screening for AAA entails a simple, noninvasive, and focused ultrasonography examination that costs roughly $50. The only potential harms are the psychologic burden of knowing of the presence of an aneurysm and the risk of elective surgery,” wrote Marc Schermerhorn, MD, of Beth Israel Deaconess Medical Center, Boston, in an accompanying editorial published in JAMA Surgery (doi: 10.1001/jamasurg.2019.5234).
“The latter can be calculated for each patient, weighed against the risk of rupture, and together with the estimated life expectancy, should be factored into the decision to screen and the decision to operate. We as a country can do better to detect and treat this disease cost effectively for all appropriate patients including women and elderly individuals,” he said.
Dr. Schermerhorn noted that overall the recommendations are reasonable, but he expressed concern for three populations excluded from the guidelines that warrant additional consideration: nonsmokers with equivalent risk factors, patients older than 75 years, and women. “In the meantime, we should work to ensure that patients determined appropriate by the USPSTF are actually screened,” he said.
The USPSTF is supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Schermerhorn disclosed relationships with Abbott, Cook Medical, Endologix, Medtronic, and Philips.
SOURCE: Guirguis-Blake JM et al. JAMA. 2019. doi: 10.1001/jama.2019.17021.
FROM JAMA