Alicia Gallegos

A third of medical malpractice cases associated with patient death or permanent disability result from diagnostic errors by health providers, an analysis finds.

Lead investigator David E. Newman-Toker, MD, PhD, of Johns Hopkins University, Baltimore, and colleagues reviewed malpractice claims during 2006-2015 from medical liability insurer CRICO’s Comparative Benchmarking System database, which represents 30% of all malpractice claims in the United States.

Investigators sought to identify diseases accounting for the majority of serious diagnosis-related harms associated with the claims. Of 55,377 closed claims, researchers identified 11,592 diagnostic error cases, of which 7,379 resulted in high-severity harm.

Of the high-severity claims, 34% stemmed from inaccurate or delayed diagnosis (Diagnosis 2019 Jul 11. doi. org/10.1515/dx-2019-0019).

The majority of diagnostic mistakes (74%) causing the most severe harm were attributable to cancer (38%), vascular events (23%), and infection (14%). These cases resulted in nearly $2 billion in malpractice payouts over a 10-year period, investigators found.

Clinical judgment factors were the primary reason behind the alleged errors, specifically: failure or delay in ordering a diagnostic test, narrow diagnostic focus with failure to establish a differential diagnosis, failure to appreciate and reconcile relevant symptoms or test results, and failure or delay in obtaining consultation or referral and misinterpretation of diagnostic studies.

“Diagnostic errors are the most common, the most catastrophic, and the most costly of medical errors,” Dr. Newman-Toker said at a press conference July 11. “We know that this is a major problem, at an individual, personal level, but also at a societal level and something we really have to take action toward fixing.”

This study breaks new ground by drilling into the major diseases most commonly associated with diagnostic errors, Dr. Newman-Toker said. In the cancer category, the most common cancers linked to severe harm were lung, breast, colorectal, prostate, and melanoma. In the vascular category, the most common conditions were stroke; myocardial infarction; venous thromboembolism; aortic aneurysm and dissection; and arterial thromboembolism. In the area of infection, sepsis; meningitis and encephalitis; spinal abscess; pneumonia; and endocarditis were the most common infections identified.

The findings provide a starting point to make improvements in the area of medical errors, said Dr. Newman-Toker, president of the Society to Improve Diagnosis in Medicine, an organization that aims to improve diagnosis and eliminate harm from diagnostic error.

“Although diagnostic errors happen everywhere, across all of medicine in every discipline with every disease, we might be able to take a big chunk out of this problem if we save a lot of lives and prevent a lot disability and if we focus some energy on tackling these problems,” he said. “It at least gives us a starting place and a roadmap for how to move the ball forward in this regard.”

The Society to Improve Diagnosis in Medicine has called on Congress to invest more funding into research to address diagnostic errors. Society CEO and cofounder Paul L. Epner noted that the 2019 House appropriations bill proposes not less than $4 million for diagnostic safety and quality research, which is up from $2 million last year.

“It’s a small step, but in the right direction,” Mr. Epner said. “[However,] the federal investment in research remains trivially small in relation to the public burden. That’s why we urge Congress to commit to research funding levels proportionate to the societal cost, in both human lives and in dollars.”

agallegos@mdedge.com
 

A third of medical malpractice cases associated with patient death or permanent disability result from diagnostic errors by health providers, an analysis finds.

Lead investigator David E. Newman-Toker, MD, PhD, of Johns Hopkins University, Baltimore, and colleagues reviewed malpractice claims during 2006-2015 from medical liability insurer CRICO’s Comparative Benchmarking System database, which represents 30% of all malpractice claims in the United States.

Investigators sought to identify diseases accounting for the majority of serious diagnosis-related harms associated with the claims. Of 55,377 closed claims, researchers identified 11,592 diagnostic error cases, of which 7,379 resulted in high-severity harm.

Of the high-severity claims, 34% stemmed from inaccurate or delayed diagnosis (Diagnosis 2019 Jul 11. doi. org/10.1515/dx-2019-0019).

The majority of diagnostic mistakes (74%) causing the most severe harm were attributable to cancer (38%), vascular events (23%), and infection (14%). These cases resulted in nearly $2 billion in malpractice payouts over a 10-year period, investigators found.

Clinical judgment factors were the primary reason behind the alleged errors, specifically: failure or delay in ordering a diagnostic test, narrow diagnostic focus with failure to establish a differential diagnosis, failure to appreciate and reconcile relevant symptoms or test results, and failure or delay in obtaining consultation or referral and misinterpretation of diagnostic studies.

“Diagnostic errors are the most common, the most catastrophic, and the most costly of medical errors,” Dr. Newman-Toker said at a press conference July 11. “We know that this is a major problem, at an individual, personal level, but also at a societal level and something we really have to take action toward fixing.”

This study breaks new ground by drilling into the major diseases most commonly associated with diagnostic errors, Dr. Newman-Toker said. In the cancer category, the most common cancers linked to severe harm were lung, breast, colorectal, prostate, and melanoma. In the vascular category, the most common conditions were stroke; myocardial infarction; venous thromboembolism; aortic aneurysm and dissection; and arterial thromboembolism. In the area of infection, sepsis; meningitis and encephalitis; spinal abscess; pneumonia; and endocarditis were the most common infections identified.

The findings provide a starting point to make improvements in the area of medical errors, said Dr. Newman-Toker, president of the Society to Improve Diagnosis in Medicine, an organization that aims to improve diagnosis and eliminate harm from diagnostic error.

“Although diagnostic errors happen everywhere, across all of medicine in every discipline with every disease, we might be able to take a big chunk out of this problem if we save a lot of lives and prevent a lot disability and if we focus some energy on tackling these problems,” he said. “It at least gives us a starting place and a roadmap for how to move the ball forward in this regard.”

The Society to Improve Diagnosis in Medicine has called on Congress to invest more funding into research to address diagnostic errors. Society CEO and cofounder Paul L. Epner noted that the 2019 House appropriations bill proposes not less than $4 million for diagnostic safety and quality research, which is up from $2 million last year.

“It’s a small step, but in the right direction,” Mr. Epner said. “[However,] the federal investment in research remains trivially small in relation to the public burden. That’s why we urge Congress to commit to research funding levels proportionate to the societal cost, in both human lives and in dollars.”

agallegos@mdedge.com
 

A third of medical malpractice cases associated with patient death or permanent disability result from diagnostic errors by health providers, an analysis finds.

Lead investigator David E. Newman-Toker, MD, PhD, of Johns Hopkins University, Baltimore, and colleagues reviewed malpractice claims during 2006-2015 from medical liability insurer CRICO’s Comparative Benchmarking System database, which represents 30% of all malpractice claims in the United States.

Investigators sought to identify diseases accounting for the majority of serious diagnosis-related harms associated with the claims. Of 55,377 closed claims, researchers identified 11,592 diagnostic error cases, of which 7,379 resulted in high-severity harm.

Of the high-severity claims, 34% stemmed from inaccurate or delayed diagnosis (Diagnosis 2019 Jul 11. doi. org/10.1515/dx-2019-0019).

The majority of diagnostic mistakes (74%) causing the most severe harm were attributable to cancer (38%), vascular events (23%), and infection (14%). These cases resulted in nearly $2 billion in malpractice payouts over a 10-year period, investigators found.

Clinical judgment factors were the primary reason behind the alleged errors, specifically: failure or delay in ordering a diagnostic test, narrow diagnostic focus with failure to establish a differential diagnosis, failure to appreciate and reconcile relevant symptoms or test results, and failure or delay in obtaining consultation or referral and misinterpretation of diagnostic studies.

“Diagnostic errors are the most common, the most catastrophic, and the most costly of medical errors,” Dr. Newman-Toker said at a press conference July 11. “We know that this is a major problem, at an individual, personal level, but also at a societal level and something we really have to take action toward fixing.”

This study breaks new ground by drilling into the major diseases most commonly associated with diagnostic errors, Dr. Newman-Toker said. In the cancer category, the most common cancers linked to severe harm were lung, breast, colorectal, prostate, and melanoma. In the vascular category, the most common conditions were stroke; myocardial infarction; venous thromboembolism; aortic aneurysm and dissection; and arterial thromboembolism. In the area of infection, sepsis; meningitis and encephalitis; spinal abscess; pneumonia; and endocarditis were the most common infections identified.

The findings provide a starting point to make improvements in the area of medical errors, said Dr. Newman-Toker, president of the Society to Improve Diagnosis in Medicine, an organization that aims to improve diagnosis and eliminate harm from diagnostic error.

“Although diagnostic errors happen everywhere, across all of medicine in every discipline with every disease, we might be able to take a big chunk out of this problem if we save a lot of lives and prevent a lot disability and if we focus some energy on tackling these problems,” he said. “It at least gives us a starting place and a roadmap for how to move the ball forward in this regard.”

The Society to Improve Diagnosis in Medicine has called on Congress to invest more funding into research to address diagnostic errors. Society CEO and cofounder Paul L. Epner noted that the 2019 House appropriations bill proposes not less than $4 million for diagnostic safety and quality research, which is up from $2 million last year.

“It’s a small step, but in the right direction,” Mr. Epner said. “[However,] the federal investment in research remains trivially small in relation to the public burden. That’s why we urge Congress to commit to research funding levels proportionate to the societal cost, in both human lives and in dollars.”

agallegos@mdedge.com
 

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.

Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.

“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”

By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.

“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

agallegos@mdedge.com

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.

Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.

“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”

By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.

“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

agallegos@mdedge.com

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.

Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.

“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”

By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.

“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

agallegos@mdedge.com

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

AGA calls on Congress to enact legislation that contains essential patient protections and other improvements to ensure affordability, accessibility, and quality health care for all Americans. Learn more at https://www.gastro.org/advocacy-and-policy/issues-and-news/top-issues/patient-protections-and-access-to-care.

agallegos@mdedge.com



 

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

AGA calls on Congress to enact legislation that contains essential patient protections and other improvements to ensure affordability, accessibility, and quality health care for all Americans. Learn more at https://www.gastro.org/advocacy-and-policy/issues-and-news/top-issues/patient-protections-and-access-to-care.

agallegos@mdedge.com



 

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

AGA calls on Congress to enact legislation that contains essential patient protections and other improvements to ensure affordability, accessibility, and quality health care for all Americans. Learn more at https://www.gastro.org/advocacy-and-policy/issues-and-news/top-issues/patient-protections-and-access-to-care.

agallegos@mdedge.com



 

Two studies show a link between industry payments by drug manufacturers to physicians and doctors’ prescribing patterns for certain medications.

Artfoliophoto/Thinkstock

In the first study, lead author Taeho Greg Rhee, PhD, of the University of Connecticut, Farmington, and colleagues analyzed Centers for Medicare & Medicaid Services Part D data and Open Payments data for general payments from industry to physicians associated with gabapentinoids.

Specifically, investigators examined data for three brand name products: Gralise (Assertio) and Horizant (Arbor), both of which are extended release formulas approved for the treatment of seizure disorders and postherpetic neuralgia, and Lyrica (Pfizer), which is approved for treatment of seizure disorders, postherpetic neuralgia, neuropathic pain, and fibromyalgia. To evaluate prescribing patterns, researchers estimated physician prescribing as the physician’s proportion of prescription days filled for the three brand-name gabapentinoids in aggregate of all gabapentinoid prescription days filled.

Between 2014 and 2016, manufacturers of the three brand-name gabapentinoids made approximately 510,000 general payments ($11.5 million) to 51,005 physicians, according to Dr. Rhee and colleagues. The doctors represented 14% of physicians who prescribed any gabapentinoid product under Part D during the same time period.

Among physicians who prescribed any gabapentinoid, generic forms of Gralise (gabapentin; 87%) and Lyrica (pregabalin; 12%) were most frequently prescribed. However, physicians receiving payments from industry were more likely to prescribe the three brand-name gabapentinoids than they were gabapentin (JAMA Intern Med. 2019 July 8. doi: 10.1001/jamainternmed.2019.1082).

Generalist physicians received the majority of payments (62%) payments totaling about $4 million, followed by about $7 million for pain medication specialists and $1 million for other physicians.

The majority of payments were for food and beverages, gifts, or educational materials. In addition, industry payments were most commonly paid to physicians in the southern and eastern regions of the United States.

Among physicians who prescribed gabapentinoids, industry payment was associated with a higher likelihood of prescribing brand-name products than generic gabapentin and that such prescribing patterns increase Medicare spending. Data show that brand name gabapentinoids typically cost account for nearly $2,500 in mean Medicare spending per beneficiary in 2016, compared with less than $20 for a 1-month supply of gabapentin, authors noted.

In the second study, Rishad Khan, MD, of the University of Toronto and colleagues examined the association between industry payments to physicians and Medicare spending on adalimumab (Humira; AbbVie) and certolizumab (Cimzia; Union Chimique Belge), both of which are approved for Crohn’s disease and numerous other indications. Investigators analyzed CMS Part D data and Open Payments data linked to the prescribing of adalimumab and certolizumab. Payments were considered relevant if a gastroenterologist received them from a drug manufacturer the year that the medication was prescribed.

From 2014 to 2016, drug makers made more than $10 million in payments to gastroenterologists prescribing adalimumab or certolizumab, the study found. Investigators found that for every $1 in physician payments, there was a $3.16 increase in spending for adalimumab and a $4.72 increase for certolizumab (JAMA Intern Med. 2019 July 8. doi: 10.1001/jamainternmed.2019.0999).

For adalimumab, payments totaled $5.5 million for speaking and consulting, $4.9 million for food, travel,and lodging expenses, and $13,000 for education. For certolizumab, payments totaled $180,000 for speaking and consulting, $117,000 for food, travel,and lodging expenses, and $60,000 for education.

Dr. Khan and associates concluded that the findings suggest a significant association between industry payments by drug manufacturers to physicians and Medicare spending.

agallegos@mdedge.com

Two studies show a link between industry payments by drug manufacturers to physicians and doctors’ prescribing patterns for certain medications.

Artfoliophoto/Thinkstock

In the first study, lead author Taeho Greg Rhee, PhD, of the University of Connecticut, Farmington, and colleagues analyzed Centers for Medicare & Medicaid Services Part D data and Open Payments data for general payments from industry to physicians associated with gabapentinoids.

Specifically, investigators examined data for three brand name products: Gralise (Assertio) and Horizant (Arbor), both of which are extended release formulas approved for the treatment of seizure disorders and postherpetic neuralgia, and Lyrica (Pfizer), which is approved for treatment of seizure disorders, postherpetic neuralgia, neuropathic pain, and fibromyalgia. To evaluate prescribing patterns, researchers estimated physician prescribing as the physician’s proportion of prescription days filled for the three brand-name gabapentinoids in aggregate of all gabapentinoid prescription days filled.

Between 2014 and 2016, manufacturers of the three brand-name gabapentinoids made approximately 510,000 general payments ($11.5 million) to 51,005 physicians, according to Dr. Rhee and colleagues. The doctors represented 14% of physicians who prescribed any gabapentinoid product under Part D during the same time period.

Among physicians who prescribed any gabapentinoid, generic forms of Gralise (gabapentin; 87%) and Lyrica (pregabalin; 12%) were most frequently prescribed. However, physicians receiving payments from industry were more likely to prescribe the three brand-name gabapentinoids than they were gabapentin (JAMA Intern Med. 2019 July 8. doi: 10.1001/jamainternmed.2019.1082).

Generalist physicians received the majority of payments (62%) payments totaling about $4 million, followed by about $7 million for pain medication specialists and $1 million for other physicians.

The majority of payments were for food and beverages, gifts, or educational materials. In addition, industry payments were most commonly paid to physicians in the southern and eastern regions of the United States.

Among physicians who prescribed gabapentinoids, industry payment was associated with a higher likelihood of prescribing brand-name products than generic gabapentin and that such prescribing patterns increase Medicare spending. Data show that brand name gabapentinoids typically cost account for nearly $2,500 in mean Medicare spending per beneficiary in 2016, compared with less than $20 for a 1-month supply of gabapentin, authors noted.

In the second study, Rishad Khan, MD, of the University of Toronto and colleagues examined the association between industry payments to physicians and Medicare spending on adalimumab (Humira; AbbVie) and certolizumab (Cimzia; Union Chimique Belge), both of which are approved for Crohn’s disease and numerous other indications. Investigators analyzed CMS Part D data and Open Payments data linked to the prescribing of adalimumab and certolizumab. Payments were considered relevant if a gastroenterologist received them from a drug manufacturer the year that the medication was prescribed.

From 2014 to 2016, drug makers made more than $10 million in payments to gastroenterologists prescribing adalimumab or certolizumab, the study found. Investigators found that for every $1 in physician payments, there was a $3.16 increase in spending for adalimumab and a $4.72 increase for certolizumab (JAMA Intern Med. 2019 July 8. doi: 10.1001/jamainternmed.2019.0999).

For adalimumab, payments totaled $5.5 million for speaking and consulting, $4.9 million for food, travel,and lodging expenses, and $13,000 for education. For certolizumab, payments totaled $180,000 for speaking and consulting, $117,000 for food, travel,and lodging expenses, and $60,000 for education.

Dr. Khan and associates concluded that the findings suggest a significant association between industry payments by drug manufacturers to physicians and Medicare spending.

agallegos@mdedge.com

Two studies show a link between industry payments by drug manufacturers to physicians and doctors’ prescribing patterns for certain medications.

Artfoliophoto/Thinkstock

In the first study, lead author Taeho Greg Rhee, PhD, of the University of Connecticut, Farmington, and colleagues analyzed Centers for Medicare & Medicaid Services Part D data and Open Payments data for general payments from industry to physicians associated with gabapentinoids.

Specifically, investigators examined data for three brand name products: Gralise (Assertio) and Horizant (Arbor), both of which are extended release formulas approved for the treatment of seizure disorders and postherpetic neuralgia, and Lyrica (Pfizer), which is approved for treatment of seizure disorders, postherpetic neuralgia, neuropathic pain, and fibromyalgia. To evaluate prescribing patterns, researchers estimated physician prescribing as the physician’s proportion of prescription days filled for the three brand-name gabapentinoids in aggregate of all gabapentinoid prescription days filled.

Between 2014 and 2016, manufacturers of the three brand-name gabapentinoids made approximately 510,000 general payments ($11.5 million) to 51,005 physicians, according to Dr. Rhee and colleagues. The doctors represented 14% of physicians who prescribed any gabapentinoid product under Part D during the same time period.

Among physicians who prescribed any gabapentinoid, generic forms of Gralise (gabapentin; 87%) and Lyrica (pregabalin; 12%) were most frequently prescribed. However, physicians receiving payments from industry were more likely to prescribe the three brand-name gabapentinoids than they were gabapentin (JAMA Intern Med. 2019 July 8. doi: 10.1001/jamainternmed.2019.1082).

Generalist physicians received the majority of payments (62%) payments totaling about $4 million, followed by about $7 million for pain medication specialists and $1 million for other physicians.

The majority of payments were for food and beverages, gifts, or educational materials. In addition, industry payments were most commonly paid to physicians in the southern and eastern regions of the United States.

Among physicians who prescribed gabapentinoids, industry payment was associated with a higher likelihood of prescribing brand-name products than generic gabapentin and that such prescribing patterns increase Medicare spending. Data show that brand name gabapentinoids typically cost account for nearly $2,500 in mean Medicare spending per beneficiary in 2016, compared with less than $20 for a 1-month supply of gabapentin, authors noted.

In the second study, Rishad Khan, MD, of the University of Toronto and colleagues examined the association between industry payments to physicians and Medicare spending on adalimumab (Humira; AbbVie) and certolizumab (Cimzia; Union Chimique Belge), both of which are approved for Crohn’s disease and numerous other indications. Investigators analyzed CMS Part D data and Open Payments data linked to the prescribing of adalimumab and certolizumab. Payments were considered relevant if a gastroenterologist received them from a drug manufacturer the year that the medication was prescribed.

From 2014 to 2016, drug makers made more than $10 million in payments to gastroenterologists prescribing adalimumab or certolizumab, the study found. Investigators found that for every $1 in physician payments, there was a $3.16 increase in spending for adalimumab and a $4.72 increase for certolizumab (JAMA Intern Med. 2019 July 8. doi: 10.1001/jamainternmed.2019.0999).

For adalimumab, payments totaled $5.5 million for speaking and consulting, $4.9 million for food, travel,and lodging expenses, and $13,000 for education. For certolizumab, payments totaled $180,000 for speaking and consulting, $117,000 for food, travel,and lodging expenses, and $60,000 for education.

Dr. Khan and associates concluded that the findings suggest a significant association between industry payments by drug manufacturers to physicians and Medicare spending.

agallegos@mdedge.com

Daniel Boffa, MD, was never able to shake the unfortunate incident from his mind. An acquaintance receiving cancer care at an affiliate center of a top-ranked cancer hospital had experienced a poor, and possibly preventable, outcome.

“As I learned more about the outcome, it became clear to me that the affiliate wasn’t prepared to handle a complication that was not unexpected,” said Dr. Boffa, a thoracic surgeon at Yale Cancer Center in New Haven, Conn. “When I talked to this individual and the people who helped make the decision for where care was going to be given, they kept saying over and over, ‘It says the name of a top-ranked hospital on the sign [of the affiliate], therefore it’s the same.’ ”

The incident compelled Dr. Boffa and colleagues to learn more about the safety at affiliate cancer centers. The result is an analysis that found that patients who underwent complex cancer surgery at affiliate hospitals were significantly more likely to die within 90 days, compared with patients receiving the same surgery at the flagship hospital. When the relative safety of each top-ranked cancer hospital was compared with its collective affiliates, the top-ranked hospital was safer than affiliates in 41 of 49 networks studied (JAMA Netw Open. 2019 Apr 12. doi: 10.1001/jamanetworkopen.2019.1912).

The analysis illustrates that a patient’s chances of surviving a complex cancer surgery are markedly lower at affiliates, compared with the hospital whose brand it shares, Dr. Boffa explained.

“Every patient and everybody that is supporting a patient in making these [care] decisions can’t assume the care is the same,” he said. “This is not to say that the affiliates are unsafe, they are just less safe than the top-ranked hospitals.”

The findings come as more top-ranked cancer hospital align with affiliate cancer centers and grow partnerships with smaller, community hospitals.

Leaders at these institutions say the partnerships expand access to care and enable regional centers to draw from the expertise at specialized cancer hospitals. However, in addition to safety concerns, the recent data pose questions about whether marketing by some institutions is creating inaccurate perceptions about the relationship between top hospitals and their affiliates. At the same time, it’s uncertain whether network affiliations really improve cost or quality, said Lesly Dossett, MD, an oncologist and researcher at the University of Michigan, Ann Arbor.

“Affiliation has the theoretical advantage of improving efficiency and quality across hospitals and facilitating regionalization of the most complex patients,” said Dr. Dossett, who wrote a commentary for JAMA on the subject. “An ideal network would provide the patient the most convenient access to the right specialist and service at the right time. Disadvantages are that patients and families can attribute quality and safety outcomes achieved at the flagship hospital to the smaller branded affiliate and decline to travel to the flagship, even though some services, like complex surgery, may be best delivered at the flagship.”

What’s an affiliate?

Part of the problem is the ambiguity surrounding the many different relationships among top-ranked cancer hospitals and associated institutions, said J. Leonard Lichtenfeld, MD, interim chief medical officer for the American Cancer Society. In some cases, the primary institution is closely aligned with an affiliate, sharing staff and collaborating on patient cases. In other instances, a reputable hospital offers its brand to a hospital in a distant location, and the relationship is more marketing and information-sharing based.

“Just because a name shows up on a building, doesn’t necessarily mean the same level of care is being provided at an affiliated institution,” Dr. Lichtenfeld said. “There are factors that neither you nor me can look into to determine how close the affiliation is. Sometimes, it can be a very tight relationship. Sometimes it can be a loose relationship, and it’s very hard to figure that out.”

In a survey of 1,010 patients, 94% of respondents felt that cancer care at a smaller hospital would improve after affiliating with a larger hospital specializing in cancer, and most patients expected physicians at the larger hospital to be involved considerably in the care of patients at the smaller hospital after affiliation (JAMA Oncol. 2018;4[7]:1008-9).

In another survey, 85% of patients said they would rather travel an hour for complex surgery at a larger hospital specializing in cancer, rather than a smaller local hospital. However, if the smaller hospital was affiliated with a top-ranked cancer hospital, 31% of respondents changed their preference to the smaller hospital, according to the analysis (Ann Surg Oncol. 2019 Mar;26[3]:732-8).

When asked to compare leading cancer hospitals and their smaller affiliates, 47% of respondents said they felt that surgical safety would be the same at both hospitals, 66% said that guideline compliance would be the same, and 53% of patients said they believed that cure rates would be the same at both institutions.

“A majority of the public feels when the brand is shared between a top-ranked hospital and a hospital in the community, the quality and safety is the same,” said Dr. Boffa, a coauthor of both survey studies. “The advertising differs for each affiliate, but there are certainly instances where the messaging can be misinterpreted. There are instances where there are billboards and advertisements where the implication is the community hospital to some degree has care that is similar to the main hospital.”

Hospitals: Collaborations beneficial

For the University of Wisconsin–Madison (UW) Carbone Cancer Center, its relationships with several community institutions have enhanced consistency among physician teams and provided new care opportunities for patients, said Dan Mulkerin, MD, regional director of UW’s regional cancer center network. Carbone includes 12 locales of service and four affiliates in various stages of maturity.

In some cases, UW physicians travel to the affiliate to help care for patients but refer surgeries back to the main institution. In other cases, UW surgical specialists operate jointly with local surgeons at the community hospital, according to Dr. Mulkerin.

The surgical safety of affiliates is an issue that UW started to address about 5 years ago, he said.

“We recognized that this was a potential area of concern for our cancer programs and we started incorporating surgical oncology into our affiliate structure,” Dr. Mulkerin said. “We look at the quality outcomes of our partners on a quarterly basis. That drives our approach about which types of surgery gets triaged to come to the main institution and which types of surgeries can appropriately be done in community settings under our brand, and under our guidance.”

Kevin Kirby

At H. Lee Moffitt Cancer Center & Research Institute, physicians travel from the headquarters to its partner hospitals to deliver care and work with doctors at each site. For example, Moffitt leaders are overseeing a program with Memorial Healthcare System in South Florida that focuses on malignant hematology and blood and marrow transplantation, said Louis Harrison, MD, chair for Moffitt’s radiation oncology department and vice president, chief partnership officer.

“These are real partnerships where we put our faculty and our know-how on the ground at these sites,” he said in an interview. “We feel like the only way to deliver care that is representative to Moffitt is to have Moffitt doctors deliver the care.”

The University of Texas MD Anderson Cancer Center, Houston, meanwhile, boasts a robust network of partner members, certified member hospitals, associate members, and affiliates. Partner members are U.S.-based relationships where member health systems integrate their clinical cancer care operations with MD Anderson, said Michael Kupferman, MD, senior vice president of clinical and academic network development at MD Anderson. Certified members receive assessments by MD Anderson and tailored recommendations for clinical quality improvements, while associate members stem from international clinical relationships with MD Anderson. Affiliates have a relationship with MD Anderson in one specialty- or modality-focused area, such as radiation oncology.

“All MD Anderson Cancer Network members operate independently from MD Anderson Cancer Center,” Dr. Kupferman said in an interview. “All cancer network members have access to our expertise and clinical knowledge to improve the level of cancer care in their communities.”

In terms of marketing the different types of network members, Dr. Kupferman said that MD Anderson collaborates with members on internal and external marketing and communications strategies to offer “best practices and guidance on how to best educate the alignment and benefits of the relationship to internal staff and local communities.”

Dr. Kupferman declined to directly comment on how surgical safety at MD Anderson’s member institutions is addressed or respond to the JAMA study findings. “We believe that our cancer network members strive to practice at a level higher than the national safety average, as evidenced by the consistent quality reviews we conduct with our members.”

An opportunity to improve

A key advantage to affiliate cancer centers is the expanded care access they can provide to patients, said Dr. Lichtenfeld. While some patients can bypass their community hospital and travel to a top-ranked cancer hospital for treatment, others do not have that capability.

“Some people will not leave their communities,” he said. “It would be wrong to take this research and point at bad doctors for not sending their patient [to a more specialized hospital]. Sometimes, its patients themselves, by choice or necessity, who can’t go somewhere else.”

Dr. Boffa emphasized that the recent research on safety presents an exciting opportunity for flagship institutions and their affiliates to analyze their structure and make improvements where necessary.

“The fact that [the hospitals] are already connected in some way is a huge advance; that’s half the battle,” Dr. Boffa said. “The next step is how do we distill what elements of care are transferable. How do we leverage this connection to share what makes the safer hospitals safer?”

agallegos@mdedge.com

Daniel Boffa, MD, was never able to shake the unfortunate incident from his mind. An acquaintance receiving cancer care at an affiliate center of a top-ranked cancer hospital had experienced a poor, and possibly preventable, outcome.

“As I learned more about the outcome, it became clear to me that the affiliate wasn’t prepared to handle a complication that was not unexpected,” said Dr. Boffa, a thoracic surgeon at Yale Cancer Center in New Haven, Conn. “When I talked to this individual and the people who helped make the decision for where care was going to be given, they kept saying over and over, ‘It says the name of a top-ranked hospital on the sign [of the affiliate], therefore it’s the same.’ ”

The incident compelled Dr. Boffa and colleagues to learn more about the safety at affiliate cancer centers. The result is an analysis that found that patients who underwent complex cancer surgery at affiliate hospitals were significantly more likely to die within 90 days, compared with patients receiving the same surgery at the flagship hospital. When the relative safety of each top-ranked cancer hospital was compared with its collective affiliates, the top-ranked hospital was safer than affiliates in 41 of 49 networks studied (JAMA Netw Open. 2019 Apr 12. doi: 10.1001/jamanetworkopen.2019.1912).

The analysis illustrates that a patient’s chances of surviving a complex cancer surgery are markedly lower at affiliates, compared with the hospital whose brand it shares, Dr. Boffa explained.

“Every patient and everybody that is supporting a patient in making these [care] decisions can’t assume the care is the same,” he said. “This is not to say that the affiliates are unsafe, they are just less safe than the top-ranked hospitals.”

The findings come as more top-ranked cancer hospital align with affiliate cancer centers and grow partnerships with smaller, community hospitals.

Leaders at these institutions say the partnerships expand access to care and enable regional centers to draw from the expertise at specialized cancer hospitals. However, in addition to safety concerns, the recent data pose questions about whether marketing by some institutions is creating inaccurate perceptions about the relationship between top hospitals and their affiliates. At the same time, it’s uncertain whether network affiliations really improve cost or quality, said Lesly Dossett, MD, an oncologist and researcher at the University of Michigan, Ann Arbor.

“Affiliation has the theoretical advantage of improving efficiency and quality across hospitals and facilitating regionalization of the most complex patients,” said Dr. Dossett, who wrote a commentary for JAMA on the subject. “An ideal network would provide the patient the most convenient access to the right specialist and service at the right time. Disadvantages are that patients and families can attribute quality and safety outcomes achieved at the flagship hospital to the smaller branded affiliate and decline to travel to the flagship, even though some services, like complex surgery, may be best delivered at the flagship.”

What’s an affiliate?

Part of the problem is the ambiguity surrounding the many different relationships among top-ranked cancer hospitals and associated institutions, said J. Leonard Lichtenfeld, MD, interim chief medical officer for the American Cancer Society. In some cases, the primary institution is closely aligned with an affiliate, sharing staff and collaborating on patient cases. In other instances, a reputable hospital offers its brand to a hospital in a distant location, and the relationship is more marketing and information-sharing based.

“Just because a name shows up on a building, doesn’t necessarily mean the same level of care is being provided at an affiliated institution,” Dr. Lichtenfeld said. “There are factors that neither you nor me can look into to determine how close the affiliation is. Sometimes, it can be a very tight relationship. Sometimes it can be a loose relationship, and it’s very hard to figure that out.”

In a survey of 1,010 patients, 94% of respondents felt that cancer care at a smaller hospital would improve after affiliating with a larger hospital specializing in cancer, and most patients expected physicians at the larger hospital to be involved considerably in the care of patients at the smaller hospital after affiliation (JAMA Oncol. 2018;4[7]:1008-9).

In another survey, 85% of patients said they would rather travel an hour for complex surgery at a larger hospital specializing in cancer, rather than a smaller local hospital. However, if the smaller hospital was affiliated with a top-ranked cancer hospital, 31% of respondents changed their preference to the smaller hospital, according to the analysis (Ann Surg Oncol. 2019 Mar;26[3]:732-8).

When asked to compare leading cancer hospitals and their smaller affiliates, 47% of respondents said they felt that surgical safety would be the same at both hospitals, 66% said that guideline compliance would be the same, and 53% of patients said they believed that cure rates would be the same at both institutions.

“A majority of the public feels when the brand is shared between a top-ranked hospital and a hospital in the community, the quality and safety is the same,” said Dr. Boffa, a coauthor of both survey studies. “The advertising differs for each affiliate, but there are certainly instances where the messaging can be misinterpreted. There are instances where there are billboards and advertisements where the implication is the community hospital to some degree has care that is similar to the main hospital.”

Hospitals: Collaborations beneficial

For the University of Wisconsin–Madison (UW) Carbone Cancer Center, its relationships with several community institutions have enhanced consistency among physician teams and provided new care opportunities for patients, said Dan Mulkerin, MD, regional director of UW’s regional cancer center network. Carbone includes 12 locales of service and four affiliates in various stages of maturity.

In some cases, UW physicians travel to the affiliate to help care for patients but refer surgeries back to the main institution. In other cases, UW surgical specialists operate jointly with local surgeons at the community hospital, according to Dr. Mulkerin.

The surgical safety of affiliates is an issue that UW started to address about 5 years ago, he said.

“We recognized that this was a potential area of concern for our cancer programs and we started incorporating surgical oncology into our affiliate structure,” Dr. Mulkerin said. “We look at the quality outcomes of our partners on a quarterly basis. That drives our approach about which types of surgery gets triaged to come to the main institution and which types of surgeries can appropriately be done in community settings under our brand, and under our guidance.”

Kevin Kirby

At H. Lee Moffitt Cancer Center & Research Institute, physicians travel from the headquarters to its partner hospitals to deliver care and work with doctors at each site. For example, Moffitt leaders are overseeing a program with Memorial Healthcare System in South Florida that focuses on malignant hematology and blood and marrow transplantation, said Louis Harrison, MD, chair for Moffitt’s radiation oncology department and vice president, chief partnership officer.

“These are real partnerships where we put our faculty and our know-how on the ground at these sites,” he said in an interview. “We feel like the only way to deliver care that is representative to Moffitt is to have Moffitt doctors deliver the care.”

The University of Texas MD Anderson Cancer Center, Houston, meanwhile, boasts a robust network of partner members, certified member hospitals, associate members, and affiliates. Partner members are U.S.-based relationships where member health systems integrate their clinical cancer care operations with MD Anderson, said Michael Kupferman, MD, senior vice president of clinical and academic network development at MD Anderson. Certified members receive assessments by MD Anderson and tailored recommendations for clinical quality improvements, while associate members stem from international clinical relationships with MD Anderson. Affiliates have a relationship with MD Anderson in one specialty- or modality-focused area, such as radiation oncology.

“All MD Anderson Cancer Network members operate independently from MD Anderson Cancer Center,” Dr. Kupferman said in an interview. “All cancer network members have access to our expertise and clinical knowledge to improve the level of cancer care in their communities.”

In terms of marketing the different types of network members, Dr. Kupferman said that MD Anderson collaborates with members on internal and external marketing and communications strategies to offer “best practices and guidance on how to best educate the alignment and benefits of the relationship to internal staff and local communities.”

Dr. Kupferman declined to directly comment on how surgical safety at MD Anderson’s member institutions is addressed or respond to the JAMA study findings. “We believe that our cancer network members strive to practice at a level higher than the national safety average, as evidenced by the consistent quality reviews we conduct with our members.”

An opportunity to improve

A key advantage to affiliate cancer centers is the expanded care access they can provide to patients, said Dr. Lichtenfeld. While some patients can bypass their community hospital and travel to a top-ranked cancer hospital for treatment, others do not have that capability.

“Some people will not leave their communities,” he said. “It would be wrong to take this research and point at bad doctors for not sending their patient [to a more specialized hospital]. Sometimes, its patients themselves, by choice or necessity, who can’t go somewhere else.”

Dr. Boffa emphasized that the recent research on safety presents an exciting opportunity for flagship institutions and their affiliates to analyze their structure and make improvements where necessary.

“The fact that [the hospitals] are already connected in some way is a huge advance; that’s half the battle,” Dr. Boffa said. “The next step is how do we distill what elements of care are transferable. How do we leverage this connection to share what makes the safer hospitals safer?”

agallegos@mdedge.com

Daniel Boffa, MD, was never able to shake the unfortunate incident from his mind. An acquaintance receiving cancer care at an affiliate center of a top-ranked cancer hospital had experienced a poor, and possibly preventable, outcome.

“As I learned more about the outcome, it became clear to me that the affiliate wasn’t prepared to handle a complication that was not unexpected,” said Dr. Boffa, a thoracic surgeon at Yale Cancer Center in New Haven, Conn. “When I talked to this individual and the people who helped make the decision for where care was going to be given, they kept saying over and over, ‘It says the name of a top-ranked hospital on the sign [of the affiliate], therefore it’s the same.’ ”

The incident compelled Dr. Boffa and colleagues to learn more about the safety at affiliate cancer centers. The result is an analysis that found that patients who underwent complex cancer surgery at affiliate hospitals were significantly more likely to die within 90 days, compared with patients receiving the same surgery at the flagship hospital. When the relative safety of each top-ranked cancer hospital was compared with its collective affiliates, the top-ranked hospital was safer than affiliates in 41 of 49 networks studied (JAMA Netw Open. 2019 Apr 12. doi: 10.1001/jamanetworkopen.2019.1912).

The analysis illustrates that a patient’s chances of surviving a complex cancer surgery are markedly lower at affiliates, compared with the hospital whose brand it shares, Dr. Boffa explained.

“Every patient and everybody that is supporting a patient in making these [care] decisions can’t assume the care is the same,” he said. “This is not to say that the affiliates are unsafe, they are just less safe than the top-ranked hospitals.”

The findings come as more top-ranked cancer hospital align with affiliate cancer centers and grow partnerships with smaller, community hospitals.

Leaders at these institutions say the partnerships expand access to care and enable regional centers to draw from the expertise at specialized cancer hospitals. However, in addition to safety concerns, the recent data pose questions about whether marketing by some institutions is creating inaccurate perceptions about the relationship between top hospitals and their affiliates. At the same time, it’s uncertain whether network affiliations really improve cost or quality, said Lesly Dossett, MD, an oncologist and researcher at the University of Michigan, Ann Arbor.

“Affiliation has the theoretical advantage of improving efficiency and quality across hospitals and facilitating regionalization of the most complex patients,” said Dr. Dossett, who wrote a commentary for JAMA on the subject. “An ideal network would provide the patient the most convenient access to the right specialist and service at the right time. Disadvantages are that patients and families can attribute quality and safety outcomes achieved at the flagship hospital to the smaller branded affiliate and decline to travel to the flagship, even though some services, like complex surgery, may be best delivered at the flagship.”

What’s an affiliate?

Part of the problem is the ambiguity surrounding the many different relationships among top-ranked cancer hospitals and associated institutions, said J. Leonard Lichtenfeld, MD, interim chief medical officer for the American Cancer Society. In some cases, the primary institution is closely aligned with an affiliate, sharing staff and collaborating on patient cases. In other instances, a reputable hospital offers its brand to a hospital in a distant location, and the relationship is more marketing and information-sharing based.

“Just because a name shows up on a building, doesn’t necessarily mean the same level of care is being provided at an affiliated institution,” Dr. Lichtenfeld said. “There are factors that neither you nor me can look into to determine how close the affiliation is. Sometimes, it can be a very tight relationship. Sometimes it can be a loose relationship, and it’s very hard to figure that out.”

In a survey of 1,010 patients, 94% of respondents felt that cancer care at a smaller hospital would improve after affiliating with a larger hospital specializing in cancer, and most patients expected physicians at the larger hospital to be involved considerably in the care of patients at the smaller hospital after affiliation (JAMA Oncol. 2018;4[7]:1008-9).

In another survey, 85% of patients said they would rather travel an hour for complex surgery at a larger hospital specializing in cancer, rather than a smaller local hospital. However, if the smaller hospital was affiliated with a top-ranked cancer hospital, 31% of respondents changed their preference to the smaller hospital, according to the analysis (Ann Surg Oncol. 2019 Mar;26[3]:732-8).

When asked to compare leading cancer hospitals and their smaller affiliates, 47% of respondents said they felt that surgical safety would be the same at both hospitals, 66% said that guideline compliance would be the same, and 53% of patients said they believed that cure rates would be the same at both institutions.

“A majority of the public feels when the brand is shared between a top-ranked hospital and a hospital in the community, the quality and safety is the same,” said Dr. Boffa, a coauthor of both survey studies. “The advertising differs for each affiliate, but there are certainly instances where the messaging can be misinterpreted. There are instances where there are billboards and advertisements where the implication is the community hospital to some degree has care that is similar to the main hospital.”

Hospitals: Collaborations beneficial

For the University of Wisconsin–Madison (UW) Carbone Cancer Center, its relationships with several community institutions have enhanced consistency among physician teams and provided new care opportunities for patients, said Dan Mulkerin, MD, regional director of UW’s regional cancer center network. Carbone includes 12 locales of service and four affiliates in various stages of maturity.

In some cases, UW physicians travel to the affiliate to help care for patients but refer surgeries back to the main institution. In other cases, UW surgical specialists operate jointly with local surgeons at the community hospital, according to Dr. Mulkerin.

The surgical safety of affiliates is an issue that UW started to address about 5 years ago, he said.

“We recognized that this was a potential area of concern for our cancer programs and we started incorporating surgical oncology into our affiliate structure,” Dr. Mulkerin said. “We look at the quality outcomes of our partners on a quarterly basis. That drives our approach about which types of surgery gets triaged to come to the main institution and which types of surgeries can appropriately be done in community settings under our brand, and under our guidance.”

Kevin Kirby

At H. Lee Moffitt Cancer Center & Research Institute, physicians travel from the headquarters to its partner hospitals to deliver care and work with doctors at each site. For example, Moffitt leaders are overseeing a program with Memorial Healthcare System in South Florida that focuses on malignant hematology and blood and marrow transplantation, said Louis Harrison, MD, chair for Moffitt’s radiation oncology department and vice president, chief partnership officer.

“These are real partnerships where we put our faculty and our know-how on the ground at these sites,” he said in an interview. “We feel like the only way to deliver care that is representative to Moffitt is to have Moffitt doctors deliver the care.”

The University of Texas MD Anderson Cancer Center, Houston, meanwhile, boasts a robust network of partner members, certified member hospitals, associate members, and affiliates. Partner members are U.S.-based relationships where member health systems integrate their clinical cancer care operations with MD Anderson, said Michael Kupferman, MD, senior vice president of clinical and academic network development at MD Anderson. Certified members receive assessments by MD Anderson and tailored recommendations for clinical quality improvements, while associate members stem from international clinical relationships with MD Anderson. Affiliates have a relationship with MD Anderson in one specialty- or modality-focused area, such as radiation oncology.

“All MD Anderson Cancer Network members operate independently from MD Anderson Cancer Center,” Dr. Kupferman said in an interview. “All cancer network members have access to our expertise and clinical knowledge to improve the level of cancer care in their communities.”

In terms of marketing the different types of network members, Dr. Kupferman said that MD Anderson collaborates with members on internal and external marketing and communications strategies to offer “best practices and guidance on how to best educate the alignment and benefits of the relationship to internal staff and local communities.”

Dr. Kupferman declined to directly comment on how surgical safety at MD Anderson’s member institutions is addressed or respond to the JAMA study findings. “We believe that our cancer network members strive to practice at a level higher than the national safety average, as evidenced by the consistent quality reviews we conduct with our members.”

An opportunity to improve

A key advantage to affiliate cancer centers is the expanded care access they can provide to patients, said Dr. Lichtenfeld. While some patients can bypass their community hospital and travel to a top-ranked cancer hospital for treatment, others do not have that capability.

“Some people will not leave their communities,” he said. “It would be wrong to take this research and point at bad doctors for not sending their patient [to a more specialized hospital]. Sometimes, its patients themselves, by choice or necessity, who can’t go somewhere else.”

Dr. Boffa emphasized that the recent research on safety presents an exciting opportunity for flagship institutions and their affiliates to analyze their structure and make improvements where necessary.

“The fact that [the hospitals] are already connected in some way is a huge advance; that’s half the battle,” Dr. Boffa said. “The next step is how do we distill what elements of care are transferable. How do we leverage this connection to share what makes the safer hospitals safer?”

agallegos@mdedge.com

The federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or that refer patients for abortion services under a June 20 decision by the 9th U.S. Circuit Court of Appeals.

The panel ruled that the Trump administration’s funding restrictions were a reasonable interpretation of the federal Title X statute and that the administration is likely to prevail in its argument that lower courts erroneously halted the rules from taking effect. The ruling means the restrictions can take effect in every state except for Maryland, which passed a 2019 measure approving the use of state funds to replace federal Title X money if the new rule is enacted.

Alex Azar, secretary of the Department of Health & Human Services, said agency officials were pleased the 9th Circuit recognized there was no need to hold up the new family planning rules that simply enforce laws already on the books.

“We are also pleased that the [9th] Circuit agreed that the three preliminary injunctions against the new rules, including two nationwide injunctions, were inappropriate,” Mr. Azar said in the statement. “This decision is a major step toward the Trump administration being able to ensure that all Title X projects comply with the Title X statute and do not support abortion as a method of family planning.”

Leana Wen, MD, president for the Planned Parenthood Federation of America called the court ruling “devastating” for the millions of patients who rely on Title X health centers for cancer screenings, HIV tests, affordable birth control, and other critical primary and preventive care.

“We will be immediately seeking emergency relief from the [U.S.] Court of Appeals,” Dr. Wen said in a statement. “Planned Parenthood will not let the government censor our doctors and nurses from informing patients where and how they can access health care. We will continue to fight the Trump administration in the courts and alongside champions in Congress to protect everyone’s fundamental right to health care.”

The changes to the Title X program – originally scheduled to take effect May 3 – make health clinics ineligible for Title X funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD testing, cancer screenings, and contraception – to low-income families. Under the rule, the government would withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services.

More than 20 states and several abortion rights organizations sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. The 9th Circuit ruling overturns these injunctions.

The American College of Physicians, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and other groups have voiced their opposition to the Title X restrictions.

In a joint court brief, the medical societies wrote that the Trump administration’s limitations to the Title X program will create cultural, geographic, and financial barriers to care; erode the physician-patient relationship; and cause extreme, immediate, and irreparable harm to millions of patients.

agallegos@mdedge.com

The federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or that refer patients for abortion services under a June 20 decision by the 9th U.S. Circuit Court of Appeals.

The panel ruled that the Trump administration’s funding restrictions were a reasonable interpretation of the federal Title X statute and that the administration is likely to prevail in its argument that lower courts erroneously halted the rules from taking effect. The ruling means the restrictions can take effect in every state except for Maryland, which passed a 2019 measure approving the use of state funds to replace federal Title X money if the new rule is enacted.

Alex Azar, secretary of the Department of Health & Human Services, said agency officials were pleased the 9th Circuit recognized there was no need to hold up the new family planning rules that simply enforce laws already on the books.

“We are also pleased that the [9th] Circuit agreed that the three preliminary injunctions against the new rules, including two nationwide injunctions, were inappropriate,” Mr. Azar said in the statement. “This decision is a major step toward the Trump administration being able to ensure that all Title X projects comply with the Title X statute and do not support abortion as a method of family planning.”

Leana Wen, MD, president for the Planned Parenthood Federation of America called the court ruling “devastating” for the millions of patients who rely on Title X health centers for cancer screenings, HIV tests, affordable birth control, and other critical primary and preventive care.

“We will be immediately seeking emergency relief from the [U.S.] Court of Appeals,” Dr. Wen said in a statement. “Planned Parenthood will not let the government censor our doctors and nurses from informing patients where and how they can access health care. We will continue to fight the Trump administration in the courts and alongside champions in Congress to protect everyone’s fundamental right to health care.”

The changes to the Title X program – originally scheduled to take effect May 3 – make health clinics ineligible for Title X funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD testing, cancer screenings, and contraception – to low-income families. Under the rule, the government would withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services.

More than 20 states and several abortion rights organizations sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. The 9th Circuit ruling overturns these injunctions.

The American College of Physicians, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and other groups have voiced their opposition to the Title X restrictions.

In a joint court brief, the medical societies wrote that the Trump administration’s limitations to the Title X program will create cultural, geographic, and financial barriers to care; erode the physician-patient relationship; and cause extreme, immediate, and irreparable harm to millions of patients.

agallegos@mdedge.com

The federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or that refer patients for abortion services under a June 20 decision by the 9th U.S. Circuit Court of Appeals.

The panel ruled that the Trump administration’s funding restrictions were a reasonable interpretation of the federal Title X statute and that the administration is likely to prevail in its argument that lower courts erroneously halted the rules from taking effect. The ruling means the restrictions can take effect in every state except for Maryland, which passed a 2019 measure approving the use of state funds to replace federal Title X money if the new rule is enacted.

Alex Azar, secretary of the Department of Health & Human Services, said agency officials were pleased the 9th Circuit recognized there was no need to hold up the new family planning rules that simply enforce laws already on the books.

“We are also pleased that the [9th] Circuit agreed that the three preliminary injunctions against the new rules, including two nationwide injunctions, were inappropriate,” Mr. Azar said in the statement. “This decision is a major step toward the Trump administration being able to ensure that all Title X projects comply with the Title X statute and do not support abortion as a method of family planning.”

Leana Wen, MD, president for the Planned Parenthood Federation of America called the court ruling “devastating” for the millions of patients who rely on Title X health centers for cancer screenings, HIV tests, affordable birth control, and other critical primary and preventive care.

“We will be immediately seeking emergency relief from the [U.S.] Court of Appeals,” Dr. Wen said in a statement. “Planned Parenthood will not let the government censor our doctors and nurses from informing patients where and how they can access health care. We will continue to fight the Trump administration in the courts and alongside champions in Congress to protect everyone’s fundamental right to health care.”

The changes to the Title X program – originally scheduled to take effect May 3 – make health clinics ineligible for Title X funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD testing, cancer screenings, and contraception – to low-income families. Under the rule, the government would withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services.

More than 20 states and several abortion rights organizations sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. The 9th Circuit ruling overturns these injunctions.

The American College of Physicians, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and other groups have voiced their opposition to the Title X restrictions.

In a joint court brief, the medical societies wrote that the Trump administration’s limitations to the Title X program will create cultural, geographic, and financial barriers to care; erode the physician-patient relationship; and cause extreme, immediate, and irreparable harm to millions of patients.

agallegos@mdedge.com

After 30 years in a traditional family medicine practice, Jesse Hsieh, MD, was ready for a change.

Alicia Gallegos/MDedge News

Data entry and insurance paperwork had drastically reduced his time with patients, and practicing medicine was no longer enjoyable or meaningful, said Dr. Hsieh of Granger, Ind.

“I felt very strongly that we were not delivering the kind of care that could be the best for the patient,” he said. “I explored other ways I could continue to practice the way I wanted; spend time with patients, teach them about things, and not spend so much time with regulatory paperwork and insurance.”

The answer for Dr. Hsieh was direct primary care (DPC), a model that cuts out insurance and centers on unlimited physician access for a flat, membership fee. For $2,500 a year, Dr. Hsieh’s patients can schedule visits as often as they like and communicate with him as the need arises by phone, text, or email.

For Dr. Hsieh, the model allows for a more manageable panel size, ample time to spend with patients, and the ability to make a greater impact on their health.

“I’m practicing the way I did 30 years ago,” Dr. Hsieh said. “I’m spending more time with people, I can call the patient myself about their labs and results and take their questions. I spend a lot more time educating the patient.”

Dr. Hsieh is one of a growing number of physicians moving to direct primary care. In 2009, about 100 practices were providing direct primary care, according to Jay Keese, executive director for the Direct Primary Care Coalition. Today, about 1,000 practices in 48 states provide direct primary care to more than 300,000 patients.

A direct primary care practice can be designed in different ways, but most opt out of insurance and offer a flat fee to patients for all primary care provided, said James A. Ellzy, MD, a family physician in Washington who serves on the American Academy of Family Physicians (AAFP) board of directors. A smaller number of practices operate a hybrid structure that includes both direct patients and fee-for-service patients.

About 3% of AAFP members are currently practicing direct primary care, and another 1% are currently converting, according to the AAFP 2018 Practice Profile Survey.

Nationally, about a third of survey respondents said they were learning about or considering a conversion to direct primary care, while another third said they were unfamiliar with the concept. The AAFP is working to educate physicians about the model, including holding an annual DPC summit.

But the move to direct primary care isn’t a sure bet. Success requires significant preparation, marketing, and structuring, experts say.

“There [can be] challenges in building a practice from scratch after you’ve had a fee-for-service practice,” Mr. Keese said. “If you’ve had a panel size of 2,500 or 3,000, and you’re looking at filling in 600 to 800 patients, it can take some time, which can cause some economic stress. But I think most people who go into direct primary care are excited and never look back.


 

Preparing for transition

When Rob Lamberts, MD, left his traditional practice in 2012, there were few leaders in direct primary care and not many resources available.

“I ended up just kind of figuring it out myself,” said Dr. Lamberts, an internist based in Augusta, Ga. “Over the past 6 1/2 years, I’ve built the practice to about 800 patients.”

Today, Dr. Lamberts is highly satisfied with his work and is helping local colleagues set up similar practices. He charges patients between $35 and $70 a month, depending on age, and offers a family fee between $150 and $175 for up to five members. Services include: extended physician access, office visits, discounted in-house labs, and discounted medications dispensed from his office.

“The amount of paperwork I have to do is substantially less,” Dr. Lamberts said. “My income is at least the same, if not a little more. My quality of life is tons better, and the quality of care is so much better.

Before making the jump to direct primary care, do your research and talk to other doctors about their experiences, Dr. Lamberts advised.

One important consideration is what type of direct primary care design to choose – the direct-to-consumer route or the direct-to-employer road. The first model targets patients as members, while the latter contracts with employers to provide services to their employees.

“There has been a surge in amount of interest in direct primary care to employers,” said Michael Tetreault, editor in chief for the DPC Journal, a news source that conducts data analytics on concierge medicine and DPC practices.

Reader surveys conducted by the DPC Journal found that a growing number of DPC physicians are looking to partner with local employers. Of 141 DPC physicians in 2019, 52% expressed an interest in employer partnerships, up from 35% in 2015, according to data provided by Mr. Tetreault.

One example of such growth is Nextera Healthcare, a network that started out with a handful of physicians about 10 years ago and now has more than 50, according to CEO and founder Clint Flanagan, MD.

The network contracts with employers across Colorado and eight other states to provide direct primary care services to their employees. Once affiliated, Nextera operates the marketing, sales, accounting, legal, and development side of the business. Most Nextera physicians have an average of 15 years practice experience, Dr. Flanagan said. Physicians receive most of the monthly revenue generated by their patients; Nextera retains a portion. Dr. Flanagan declined to specify the exact percentage retained.
 

Attracting patients, starting strong

For Dr. Hsieh, being well known in his community and having built a reputation as a family physician contributed to his success in direct primary care. In addition to taking on leadership roles in the health care community over the years, Dr. Hsieh regularly offers perspective for local media regarding medical topics, plays in a popular band at charity events, and teaches courses at two major universities in the area.

“When starting out in this practice, you really have to have built a reputation in town,” said Dr. Hsieh. “In this city, we’ve already had people try direct primary care who have failed because they came out of residency or people didn’t know who they were. You really have to have had a reputation of quality and service and patients should know about you.”

In many cases, physicians can bring their patients with them into direct primary care practice; however, some may not be able to based on their prior employment contract. Dr. Hsieh, for example, could not speak about his new practice or market the business until the day after he left his former practice, he said.

Dr. Lamberts said about 200 of his former patients initially followed him to direct primary care and another 100 have joined since. Before departing his former office, he gave a presentation to his patients about the direct primary care model and what the structure entailed.

Making patients aware of direct primary care and how it works is a top challenge to the model, Dr. Ellzy of the AAFP said. Some patients incorrectly believe that DPC covers all health services including hospitalizations and surgeries. Many DPC patients still carry insurance for hospitalizations as well as specialist visits.

“Part of it is understanding what direct primary care is and isn’t as you move from an insurance basis,” Dr. Ellzy said. “A lot of it is patient education, That’s one of the biggest issues.”
 

Strong team, alternate mindset

Putting in place an efficient, dedicated staff is also key to establishing a fruitful DPC practice, Dr. Hsieh noted. He credits his practice director, Jami Feitz, with keeping things running smoothly through patient education and advocacy. Ms. Feitz aids patients in navigating specialist visits, medication access issues, and payment.

“You can have the best business plan, you can have the best economics, you can even have the best reputation in town, but if you don’t have someone to run the logistics of your practice, you’re sunk,” Dr. Hsieh said. “As soon as you walk out of the exam room, that patient is going into that fragmented, complicated health care system. They need someone experienced with the special skills to help them through that process”

Dr. Lamberts adds that of all the shifts necessary for a prosperous direct primary care practice, a different mindset is among the most important for physicians.

“It’s a big change in philosophy,” he said. “You suddenly are focused on keeping patients away from the office rather than having a full office. You’re focused on keeping people well, rather than benefiting from people getting sick. That’s a challenge to lose the mindset and to suddenly celebrate if you have a day that’s not very busy or your office is empty. That’s a good thing.”
 

Direct primary care by the numbers

A 2018 survey by AAFP of 148 direct primary care physicians reveals how doctors are structuring their practices.

• 80% charge a fee to patients and do not bill any third-party payer.
• 14% engage with one or more third-party payers.
• 54% are male.
• 56% are greater than 15 years post residency.
• 20% are less than 7 years post residency.
• 72% of practices have been in operation less than 3 years.
• 11% of practices have been in operation less than 1 year.
• 54% of practices started from scratch.
• 34% of practices were converted from an existing practice.
• 57% of practices have employer-based contracts.
• 29% of practices are interested in employer-based contracts.
• 58% of practices supplement their income through other practice opportunities.
• 345 patients is the average panel size.
• 596 is the average target panel size.
• 91% of physicians would promote the model to others.

SOURCE: The American Academy of Family Physicians

agallegos@mdedge.com

After 30 years in a traditional family medicine practice, Jesse Hsieh, MD, was ready for a change.

Alicia Gallegos/MDedge News

Data entry and insurance paperwork had drastically reduced his time with patients, and practicing medicine was no longer enjoyable or meaningful, said Dr. Hsieh of Granger, Ind.

“I felt very strongly that we were not delivering the kind of care that could be the best for the patient,” he said. “I explored other ways I could continue to practice the way I wanted; spend time with patients, teach them about things, and not spend so much time with regulatory paperwork and insurance.”

The answer for Dr. Hsieh was direct primary care (DPC), a model that cuts out insurance and centers on unlimited physician access for a flat, membership fee. For $2,500 a year, Dr. Hsieh’s patients can schedule visits as often as they like and communicate with him as the need arises by phone, text, or email.

For Dr. Hsieh, the model allows for a more manageable panel size, ample time to spend with patients, and the ability to make a greater impact on their health.

“I’m practicing the way I did 30 years ago,” Dr. Hsieh said. “I’m spending more time with people, I can call the patient myself about their labs and results and take their questions. I spend a lot more time educating the patient.”

Dr. Hsieh is one of a growing number of physicians moving to direct primary care. In 2009, about 100 practices were providing direct primary care, according to Jay Keese, executive director for the Direct Primary Care Coalition. Today, about 1,000 practices in 48 states provide direct primary care to more than 300,000 patients.

A direct primary care practice can be designed in different ways, but most opt out of insurance and offer a flat fee to patients for all primary care provided, said James A. Ellzy, MD, a family physician in Washington who serves on the American Academy of Family Physicians (AAFP) board of directors. A smaller number of practices operate a hybrid structure that includes both direct patients and fee-for-service patients.

About 3% of AAFP members are currently practicing direct primary care, and another 1% are currently converting, according to the AAFP 2018 Practice Profile Survey.

Nationally, about a third of survey respondents said they were learning about or considering a conversion to direct primary care, while another third said they were unfamiliar with the concept. The AAFP is working to educate physicians about the model, including holding an annual DPC summit.

But the move to direct primary care isn’t a sure bet. Success requires significant preparation, marketing, and structuring, experts say.

“There [can be] challenges in building a practice from scratch after you’ve had a fee-for-service practice,” Mr. Keese said. “If you’ve had a panel size of 2,500 or 3,000, and you’re looking at filling in 600 to 800 patients, it can take some time, which can cause some economic stress. But I think most people who go into direct primary care are excited and never look back.


 

Preparing for transition

When Rob Lamberts, MD, left his traditional practice in 2012, there were few leaders in direct primary care and not many resources available.

“I ended up just kind of figuring it out myself,” said Dr. Lamberts, an internist based in Augusta, Ga. “Over the past 6 1/2 years, I’ve built the practice to about 800 patients.”

Today, Dr. Lamberts is highly satisfied with his work and is helping local colleagues set up similar practices. He charges patients between $35 and $70 a month, depending on age, and offers a family fee between $150 and $175 for up to five members. Services include: extended physician access, office visits, discounted in-house labs, and discounted medications dispensed from his office.

“The amount of paperwork I have to do is substantially less,” Dr. Lamberts said. “My income is at least the same, if not a little more. My quality of life is tons better, and the quality of care is so much better.

Before making the jump to direct primary care, do your research and talk to other doctors about their experiences, Dr. Lamberts advised.

One important consideration is what type of direct primary care design to choose – the direct-to-consumer route or the direct-to-employer road. The first model targets patients as members, while the latter contracts with employers to provide services to their employees.

“There has been a surge in amount of interest in direct primary care to employers,” said Michael Tetreault, editor in chief for the DPC Journal, a news source that conducts data analytics on concierge medicine and DPC practices.

Reader surveys conducted by the DPC Journal found that a growing number of DPC physicians are looking to partner with local employers. Of 141 DPC physicians in 2019, 52% expressed an interest in employer partnerships, up from 35% in 2015, according to data provided by Mr. Tetreault.

One example of such growth is Nextera Healthcare, a network that started out with a handful of physicians about 10 years ago and now has more than 50, according to CEO and founder Clint Flanagan, MD.

The network contracts with employers across Colorado and eight other states to provide direct primary care services to their employees. Once affiliated, Nextera operates the marketing, sales, accounting, legal, and development side of the business. Most Nextera physicians have an average of 15 years practice experience, Dr. Flanagan said. Physicians receive most of the monthly revenue generated by their patients; Nextera retains a portion. Dr. Flanagan declined to specify the exact percentage retained.
 

Attracting patients, starting strong

For Dr. Hsieh, being well known in his community and having built a reputation as a family physician contributed to his success in direct primary care. In addition to taking on leadership roles in the health care community over the years, Dr. Hsieh regularly offers perspective for local media regarding medical topics, plays in a popular band at charity events, and teaches courses at two major universities in the area.

“When starting out in this practice, you really have to have built a reputation in town,” said Dr. Hsieh. “In this city, we’ve already had people try direct primary care who have failed because they came out of residency or people didn’t know who they were. You really have to have had a reputation of quality and service and patients should know about you.”

In many cases, physicians can bring their patients with them into direct primary care practice; however, some may not be able to based on their prior employment contract. Dr. Hsieh, for example, could not speak about his new practice or market the business until the day after he left his former practice, he said.

Dr. Lamberts said about 200 of his former patients initially followed him to direct primary care and another 100 have joined since. Before departing his former office, he gave a presentation to his patients about the direct primary care model and what the structure entailed.

Making patients aware of direct primary care and how it works is a top challenge to the model, Dr. Ellzy of the AAFP said. Some patients incorrectly believe that DPC covers all health services including hospitalizations and surgeries. Many DPC patients still carry insurance for hospitalizations as well as specialist visits.

“Part of it is understanding what direct primary care is and isn’t as you move from an insurance basis,” Dr. Ellzy said. “A lot of it is patient education, That’s one of the biggest issues.”
 

Strong team, alternate mindset

Putting in place an efficient, dedicated staff is also key to establishing a fruitful DPC practice, Dr. Hsieh noted. He credits his practice director, Jami Feitz, with keeping things running smoothly through patient education and advocacy. Ms. Feitz aids patients in navigating specialist visits, medication access issues, and payment.

“You can have the best business plan, you can have the best economics, you can even have the best reputation in town, but if you don’t have someone to run the logistics of your practice, you’re sunk,” Dr. Hsieh said. “As soon as you walk out of the exam room, that patient is going into that fragmented, complicated health care system. They need someone experienced with the special skills to help them through that process”

Dr. Lamberts adds that of all the shifts necessary for a prosperous direct primary care practice, a different mindset is among the most important for physicians.

“It’s a big change in philosophy,” he said. “You suddenly are focused on keeping patients away from the office rather than having a full office. You’re focused on keeping people well, rather than benefiting from people getting sick. That’s a challenge to lose the mindset and to suddenly celebrate if you have a day that’s not very busy or your office is empty. That’s a good thing.”
 

Direct primary care by the numbers

A 2018 survey by AAFP of 148 direct primary care physicians reveals how doctors are structuring their practices.

• 80% charge a fee to patients and do not bill any third-party payer.
• 14% engage with one or more third-party payers.
• 54% are male.
• 56% are greater than 15 years post residency.
• 20% are less than 7 years post residency.
• 72% of practices have been in operation less than 3 years.
• 11% of practices have been in operation less than 1 year.
• 54% of practices started from scratch.
• 34% of practices were converted from an existing practice.
• 57% of practices have employer-based contracts.
• 29% of practices are interested in employer-based contracts.
• 58% of practices supplement their income through other practice opportunities.
• 345 patients is the average panel size.
• 596 is the average target panel size.
• 91% of physicians would promote the model to others.

SOURCE: The American Academy of Family Physicians

agallegos@mdedge.com

After 30 years in a traditional family medicine practice, Jesse Hsieh, MD, was ready for a change.

Alicia Gallegos/MDedge News

Data entry and insurance paperwork had drastically reduced his time with patients, and practicing medicine was no longer enjoyable or meaningful, said Dr. Hsieh of Granger, Ind.

“I felt very strongly that we were not delivering the kind of care that could be the best for the patient,” he said. “I explored other ways I could continue to practice the way I wanted; spend time with patients, teach them about things, and not spend so much time with regulatory paperwork and insurance.”

The answer for Dr. Hsieh was direct primary care (DPC), a model that cuts out insurance and centers on unlimited physician access for a flat, membership fee. For $2,500 a year, Dr. Hsieh’s patients can schedule visits as often as they like and communicate with him as the need arises by phone, text, or email.

For Dr. Hsieh, the model allows for a more manageable panel size, ample time to spend with patients, and the ability to make a greater impact on their health.

“I’m practicing the way I did 30 years ago,” Dr. Hsieh said. “I’m spending more time with people, I can call the patient myself about their labs and results and take their questions. I spend a lot more time educating the patient.”

Dr. Hsieh is one of a growing number of physicians moving to direct primary care. In 2009, about 100 practices were providing direct primary care, according to Jay Keese, executive director for the Direct Primary Care Coalition. Today, about 1,000 practices in 48 states provide direct primary care to more than 300,000 patients.

A direct primary care practice can be designed in different ways, but most opt out of insurance and offer a flat fee to patients for all primary care provided, said James A. Ellzy, MD, a family physician in Washington who serves on the American Academy of Family Physicians (AAFP) board of directors. A smaller number of practices operate a hybrid structure that includes both direct patients and fee-for-service patients.

About 3% of AAFP members are currently practicing direct primary care, and another 1% are currently converting, according to the AAFP 2018 Practice Profile Survey.

Nationally, about a third of survey respondents said they were learning about or considering a conversion to direct primary care, while another third said they were unfamiliar with the concept. The AAFP is working to educate physicians about the model, including holding an annual DPC summit.

But the move to direct primary care isn’t a sure bet. Success requires significant preparation, marketing, and structuring, experts say.

“There [can be] challenges in building a practice from scratch after you’ve had a fee-for-service practice,” Mr. Keese said. “If you’ve had a panel size of 2,500 or 3,000, and you’re looking at filling in 600 to 800 patients, it can take some time, which can cause some economic stress. But I think most people who go into direct primary care are excited and never look back.


 

Preparing for transition

When Rob Lamberts, MD, left his traditional practice in 2012, there were few leaders in direct primary care and not many resources available.

“I ended up just kind of figuring it out myself,” said Dr. Lamberts, an internist based in Augusta, Ga. “Over the past 6 1/2 years, I’ve built the practice to about 800 patients.”

Today, Dr. Lamberts is highly satisfied with his work and is helping local colleagues set up similar practices. He charges patients between $35 and $70 a month, depending on age, and offers a family fee between $150 and $175 for up to five members. Services include: extended physician access, office visits, discounted in-house labs, and discounted medications dispensed from his office.

“The amount of paperwork I have to do is substantially less,” Dr. Lamberts said. “My income is at least the same, if not a little more. My quality of life is tons better, and the quality of care is so much better.

Before making the jump to direct primary care, do your research and talk to other doctors about their experiences, Dr. Lamberts advised.

One important consideration is what type of direct primary care design to choose – the direct-to-consumer route or the direct-to-employer road. The first model targets patients as members, while the latter contracts with employers to provide services to their employees.

“There has been a surge in amount of interest in direct primary care to employers,” said Michael Tetreault, editor in chief for the DPC Journal, a news source that conducts data analytics on concierge medicine and DPC practices.

Reader surveys conducted by the DPC Journal found that a growing number of DPC physicians are looking to partner with local employers. Of 141 DPC physicians in 2019, 52% expressed an interest in employer partnerships, up from 35% in 2015, according to data provided by Mr. Tetreault.

One example of such growth is Nextera Healthcare, a network that started out with a handful of physicians about 10 years ago and now has more than 50, according to CEO and founder Clint Flanagan, MD.

The network contracts with employers across Colorado and eight other states to provide direct primary care services to their employees. Once affiliated, Nextera operates the marketing, sales, accounting, legal, and development side of the business. Most Nextera physicians have an average of 15 years practice experience, Dr. Flanagan said. Physicians receive most of the monthly revenue generated by their patients; Nextera retains a portion. Dr. Flanagan declined to specify the exact percentage retained.
 

Attracting patients, starting strong

For Dr. Hsieh, being well known in his community and having built a reputation as a family physician contributed to his success in direct primary care. In addition to taking on leadership roles in the health care community over the years, Dr. Hsieh regularly offers perspective for local media regarding medical topics, plays in a popular band at charity events, and teaches courses at two major universities in the area.

“When starting out in this practice, you really have to have built a reputation in town,” said Dr. Hsieh. “In this city, we’ve already had people try direct primary care who have failed because they came out of residency or people didn’t know who they were. You really have to have had a reputation of quality and service and patients should know about you.”

In many cases, physicians can bring their patients with them into direct primary care practice; however, some may not be able to based on their prior employment contract. Dr. Hsieh, for example, could not speak about his new practice or market the business until the day after he left his former practice, he said.

Dr. Lamberts said about 200 of his former patients initially followed him to direct primary care and another 100 have joined since. Before departing his former office, he gave a presentation to his patients about the direct primary care model and what the structure entailed.

Making patients aware of direct primary care and how it works is a top challenge to the model, Dr. Ellzy of the AAFP said. Some patients incorrectly believe that DPC covers all health services including hospitalizations and surgeries. Many DPC patients still carry insurance for hospitalizations as well as specialist visits.

“Part of it is understanding what direct primary care is and isn’t as you move from an insurance basis,” Dr. Ellzy said. “A lot of it is patient education, That’s one of the biggest issues.”
 

Strong team, alternate mindset

Putting in place an efficient, dedicated staff is also key to establishing a fruitful DPC practice, Dr. Hsieh noted. He credits his practice director, Jami Feitz, with keeping things running smoothly through patient education and advocacy. Ms. Feitz aids patients in navigating specialist visits, medication access issues, and payment.

“You can have the best business plan, you can have the best economics, you can even have the best reputation in town, but if you don’t have someone to run the logistics of your practice, you’re sunk,” Dr. Hsieh said. “As soon as you walk out of the exam room, that patient is going into that fragmented, complicated health care system. They need someone experienced with the special skills to help them through that process”

Dr. Lamberts adds that of all the shifts necessary for a prosperous direct primary care practice, a different mindset is among the most important for physicians.

“It’s a big change in philosophy,” he said. “You suddenly are focused on keeping patients away from the office rather than having a full office. You’re focused on keeping people well, rather than benefiting from people getting sick. That’s a challenge to lose the mindset and to suddenly celebrate if you have a day that’s not very busy or your office is empty. That’s a good thing.”
 

Direct primary care by the numbers

A 2018 survey by AAFP of 148 direct primary care physicians reveals how doctors are structuring their practices.

• 80% charge a fee to patients and do not bill any third-party payer.
• 14% engage with one or more third-party payers.
• 54% are male.
• 56% are greater than 15 years post residency.
• 20% are less than 7 years post residency.
• 72% of practices have been in operation less than 3 years.
• 11% of practices have been in operation less than 1 year.
• 54% of practices started from scratch.
• 34% of practices were converted from an existing practice.
• 57% of practices have employer-based contracts.
• 29% of practices are interested in employer-based contracts.
• 58% of practices supplement their income through other practice opportunities.
• 345 patients is the average panel size.
• 596 is the average target panel size.
• 91% of physicians would promote the model to others.

SOURCE: The American Academy of Family Physicians

agallegos@mdedge.com

A new Illinois law makes abortion a fundamental right and requires insurers to pay for the procedure as they would any other medical procedure.

The Illinois Reproductive Health Act repeals the Illinois Abortion Law of 1975 and the Partial-Birth Abortion Ban Act, two restrictive laws that have been largely blocked from enforcement for years by the courts. The replacement law removes criminal penalties for physicians who perform abortions, eliminates waiting periods before women can receive an abortion, and lifts a requirement that married women receive spousal consent before obtaining the procedure. Illinois Gov. JB Pritzker (D) signed the law on June 12.

“In a time when too many states across the nation are taking a step backward, Illinois is taking a giant step forward for women’s health,” Gov. Pritzker said in a statement. “Illinois is demonstrating what it means to affirm the rights of individuals to make the most personal and fundamental decisions of their lives, no matter your income level, race, ethnicity, or religion. When it comes to contraception, abortion, and reproductive care, this law puts the decision making where it belongs: in the hands of women and their doctors.”

As part of the law, private health insurance plans in Illinois are required to cover abortion. Previously, the plans were mandated to cover only contraception, infertility treatments, and maternity care. The law also states that a fertilized egg, embryo, or fetus does not have independent rights under Illinois law.

The law comes as states across the country are enacting more restrictive abortion measures. Recent laws in six states – Louisiana, Georgia, Kentucky, Mississippi, Missouri, and Ohio – bar abortions after a heartbeat is detected. A measure in Alabama meanwhile, prohibits abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and a Class C felony for attempting to perform an abortion. Analysts say those laws will likely lead to a review of Roe v. Wade by the Supreme Court later this year.

Also in June, the Department Health & Human Services said scientists are no longer allowed to use fetal tissue from abortions in research. In a statement, the agency said the decision comes amid a comprehensive review of all HHS research involving human fetal tissue from elective abortions to ensure consistency with statutes and regulations governing such research. The ban on fetal tissue research led to the cancellation of an existing HIV research contract between the federal government and the University of California, San Francisco, according to HHS.

“Promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration,” according to an HHS statement. “The audit and review helped inform the policy process that led to the administration’s decision to let the contract with UCSF expire and to discontinue intramural research – research conducted within the National Institutes of Health (NIH) – involving the use of human fetal tissue from elective abortion. Intramural research that requires new acquisition of fetal tissue from elective abortions will not be conducted.”

agallegos@mdedge.com

A new Illinois law makes abortion a fundamental right and requires insurers to pay for the procedure as they would any other medical procedure.

The Illinois Reproductive Health Act repeals the Illinois Abortion Law of 1975 and the Partial-Birth Abortion Ban Act, two restrictive laws that have been largely blocked from enforcement for years by the courts. The replacement law removes criminal penalties for physicians who perform abortions, eliminates waiting periods before women can receive an abortion, and lifts a requirement that married women receive spousal consent before obtaining the procedure. Illinois Gov. JB Pritzker (D) signed the law on June 12.

“In a time when too many states across the nation are taking a step backward, Illinois is taking a giant step forward for women’s health,” Gov. Pritzker said in a statement. “Illinois is demonstrating what it means to affirm the rights of individuals to make the most personal and fundamental decisions of their lives, no matter your income level, race, ethnicity, or religion. When it comes to contraception, abortion, and reproductive care, this law puts the decision making where it belongs: in the hands of women and their doctors.”

As part of the law, private health insurance plans in Illinois are required to cover abortion. Previously, the plans were mandated to cover only contraception, infertility treatments, and maternity care. The law also states that a fertilized egg, embryo, or fetus does not have independent rights under Illinois law.

The law comes as states across the country are enacting more restrictive abortion measures. Recent laws in six states – Louisiana, Georgia, Kentucky, Mississippi, Missouri, and Ohio – bar abortions after a heartbeat is detected. A measure in Alabama meanwhile, prohibits abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and a Class C felony for attempting to perform an abortion. Analysts say those laws will likely lead to a review of Roe v. Wade by the Supreme Court later this year.

Also in June, the Department Health & Human Services said scientists are no longer allowed to use fetal tissue from abortions in research. In a statement, the agency said the decision comes amid a comprehensive review of all HHS research involving human fetal tissue from elective abortions to ensure consistency with statutes and regulations governing such research. The ban on fetal tissue research led to the cancellation of an existing HIV research contract between the federal government and the University of California, San Francisco, according to HHS.

“Promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration,” according to an HHS statement. “The audit and review helped inform the policy process that led to the administration’s decision to let the contract with UCSF expire and to discontinue intramural research – research conducted within the National Institutes of Health (NIH) – involving the use of human fetal tissue from elective abortion. Intramural research that requires new acquisition of fetal tissue from elective abortions will not be conducted.”

agallegos@mdedge.com

A new Illinois law makes abortion a fundamental right and requires insurers to pay for the procedure as they would any other medical procedure.

The Illinois Reproductive Health Act repeals the Illinois Abortion Law of 1975 and the Partial-Birth Abortion Ban Act, two restrictive laws that have been largely blocked from enforcement for years by the courts. The replacement law removes criminal penalties for physicians who perform abortions, eliminates waiting periods before women can receive an abortion, and lifts a requirement that married women receive spousal consent before obtaining the procedure. Illinois Gov. JB Pritzker (D) signed the law on June 12.

“In a time when too many states across the nation are taking a step backward, Illinois is taking a giant step forward for women’s health,” Gov. Pritzker said in a statement. “Illinois is demonstrating what it means to affirm the rights of individuals to make the most personal and fundamental decisions of their lives, no matter your income level, race, ethnicity, or religion. When it comes to contraception, abortion, and reproductive care, this law puts the decision making where it belongs: in the hands of women and their doctors.”

As part of the law, private health insurance plans in Illinois are required to cover abortion. Previously, the plans were mandated to cover only contraception, infertility treatments, and maternity care. The law also states that a fertilized egg, embryo, or fetus does not have independent rights under Illinois law.

The law comes as states across the country are enacting more restrictive abortion measures. Recent laws in six states – Louisiana, Georgia, Kentucky, Mississippi, Missouri, and Ohio – bar abortions after a heartbeat is detected. A measure in Alabama meanwhile, prohibits abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and a Class C felony for attempting to perform an abortion. Analysts say those laws will likely lead to a review of Roe v. Wade by the Supreme Court later this year.

Also in June, the Department Health & Human Services said scientists are no longer allowed to use fetal tissue from abortions in research. In a statement, the agency said the decision comes amid a comprehensive review of all HHS research involving human fetal tissue from elective abortions to ensure consistency with statutes and regulations governing such research. The ban on fetal tissue research led to the cancellation of an existing HIV research contract between the federal government and the University of California, San Francisco, according to HHS.

“Promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration,” according to an HHS statement. “The audit and review helped inform the policy process that led to the administration’s decision to let the contract with UCSF expire and to discontinue intramural research – research conducted within the National Institutes of Health (NIH) – involving the use of human fetal tissue from elective abortion. Intramural research that requires new acquisition of fetal tissue from elective abortions will not be conducted.”

agallegos@mdedge.com

A district court in Texas has permanently barred the Affordable Care Act’s contraceptive mandate from being enforced, ruling that the requirement violates religious freedoms.

In a June 5, 2019, opinion, U.S. District Judge Reed O’Connor granted a permanent injunction on the contraceptive mandate, ruling that both the mandate and the accommodation process violate the Religious Freedom Restoration Act. The injunction applies to all individuals and employers – regardless of size or nonprofit status – that oppose contraceptive coverage based on religious beliefs.

In his ruling, Judge O’Connor said the contraceptive mandate substantially burdens the plaintiffs’ religious exercise.

“The point of the contraceptive mandate is to ensure all ACA-compliant insurance plans include cost-free coverage of all FDA [Food and Drug Administration]-approved contraceptive methods [and] the point of the individual mandate is to ensure individuals purchase ACA-compliant insurance plans,” Judge O’Conner wrote. “The result? The individual plaintiffs are forced out of either the health insurance market or their religious exercise. And by choosing to adhere to their religious beliefs, not only are the individual plaintiffs excluded from the insurance market, they are forced to violate federal law. That the contraceptive mandate systematically discriminates against the individual class by blocking members’ entrance into the marketplace – due to religious exercise – is a substantial burden of the highest order.”

The case, DeOtte v. Azar, started with an October 2018 legal challenge by several Texas residents and a business over having to comply with the Affordable Care Act mandate. The plaintiffs argued the requirement violates their religious freedom, and that the court should strike it down as unconstitutional. The current Justice Department has largely chosen not to defend the case, agreeing that forcing people and employers with religious objections to comply with the contraceptive mandate violates the Religious Freedom Restoration Act. In 2018, the department issued new rules expanding exemptions to the ACA’s contraceptive mandate on moral or religious grounds.

Legal challenges against the expanded exemptions continue through the courts. Judges in California and Pennsylvania have temporarily banned the rules from taking effect. Analysts say the final answer on the contraceptive mandate could come from the U.S. Supreme Court.

agallegos@mdedge.com

A district court in Texas has permanently barred the Affordable Care Act’s contraceptive mandate from being enforced, ruling that the requirement violates religious freedoms.

In a June 5, 2019, opinion, U.S. District Judge Reed O’Connor granted a permanent injunction on the contraceptive mandate, ruling that both the mandate and the accommodation process violate the Religious Freedom Restoration Act. The injunction applies to all individuals and employers – regardless of size or nonprofit status – that oppose contraceptive coverage based on religious beliefs.

In his ruling, Judge O’Connor said the contraceptive mandate substantially burdens the plaintiffs’ religious exercise.

“The point of the contraceptive mandate is to ensure all ACA-compliant insurance plans include cost-free coverage of all FDA [Food and Drug Administration]-approved contraceptive methods [and] the point of the individual mandate is to ensure individuals purchase ACA-compliant insurance plans,” Judge O’Conner wrote. “The result? The individual plaintiffs are forced out of either the health insurance market or their religious exercise. And by choosing to adhere to their religious beliefs, not only are the individual plaintiffs excluded from the insurance market, they are forced to violate federal law. That the contraceptive mandate systematically discriminates against the individual class by blocking members’ entrance into the marketplace – due to religious exercise – is a substantial burden of the highest order.”

The case, DeOtte v. Azar, started with an October 2018 legal challenge by several Texas residents and a business over having to comply with the Affordable Care Act mandate. The plaintiffs argued the requirement violates their religious freedom, and that the court should strike it down as unconstitutional. The current Justice Department has largely chosen not to defend the case, agreeing that forcing people and employers with religious objections to comply with the contraceptive mandate violates the Religious Freedom Restoration Act. In 2018, the department issued new rules expanding exemptions to the ACA’s contraceptive mandate on moral or religious grounds.

Legal challenges against the expanded exemptions continue through the courts. Judges in California and Pennsylvania have temporarily banned the rules from taking effect. Analysts say the final answer on the contraceptive mandate could come from the U.S. Supreme Court.

agallegos@mdedge.com

A district court in Texas has permanently barred the Affordable Care Act’s contraceptive mandate from being enforced, ruling that the requirement violates religious freedoms.

In a June 5, 2019, opinion, U.S. District Judge Reed O’Connor granted a permanent injunction on the contraceptive mandate, ruling that both the mandate and the accommodation process violate the Religious Freedom Restoration Act. The injunction applies to all individuals and employers – regardless of size or nonprofit status – that oppose contraceptive coverage based on religious beliefs.

In his ruling, Judge O’Connor said the contraceptive mandate substantially burdens the plaintiffs’ religious exercise.

“The point of the contraceptive mandate is to ensure all ACA-compliant insurance plans include cost-free coverage of all FDA [Food and Drug Administration]-approved contraceptive methods [and] the point of the individual mandate is to ensure individuals purchase ACA-compliant insurance plans,” Judge O’Conner wrote. “The result? The individual plaintiffs are forced out of either the health insurance market or their religious exercise. And by choosing to adhere to their religious beliefs, not only are the individual plaintiffs excluded from the insurance market, they are forced to violate federal law. That the contraceptive mandate systematically discriminates against the individual class by blocking members’ entrance into the marketplace – due to religious exercise – is a substantial burden of the highest order.”

The case, DeOtte v. Azar, started with an October 2018 legal challenge by several Texas residents and a business over having to comply with the Affordable Care Act mandate. The plaintiffs argued the requirement violates their religious freedom, and that the court should strike it down as unconstitutional. The current Justice Department has largely chosen not to defend the case, agreeing that forcing people and employers with religious objections to comply with the contraceptive mandate violates the Religious Freedom Restoration Act. In 2018, the department issued new rules expanding exemptions to the ACA’s contraceptive mandate on moral or religious grounds.

Legal challenges against the expanded exemptions continue through the courts. Judges in California and Pennsylvania have temporarily banned the rules from taking effect. Analysts say the final answer on the contraceptive mandate could come from the U.S. Supreme Court.

agallegos@mdedge.com

A study suggests that allowing patients to read their physician’s notes may help many of them better manage and adhere to their medications.

Lead authors Tom Delbanco, MD, and Jan Walker, RN, MBA, of Harvard University and Beth Israel Deaconess Medical Center, both in Boston, conducted an online survey in 2017 of 19,411 patients in three separate health systems who participated in the OpenNotes pilot, an initiative that provided patients access to online clinical notes about their care. Eligible survey participants were 18 years or older and had logged into their respective patient portal at least once in the last 12 months and had an ambulatory visit note available.

Of the patients surveyed, a combined 14% of patients from Beth Israel Deaconess Medical Center and Geisinger Health reported that reading their notes made them more likely to take their medications as prescribed, while 86% reported no change, according to the study published in the Annals of Internal Medicine. At the University of Washington, Seattle, 33% of patients rated notes as “extremely important” in assisting with medication regimens. (The wording and response categories used by the University of Washington were not the same as those used by the other sites.)

The majority of patients at all three sites reported that note reading helped them understand why a medication was prescribed, answered their questions, and made them feel more comfortable with and in control of their medications, according to the study.

Of patients with a primary language other than English, 75% reported that reading their clinical notes helped them understand why a medication was prescribed, compared with 64% of patients who spoke English as their primary language. Of patients with high school or less education, 74% reported that reading their notes helped answer their questions about their medications, compared with 53% of college graduates.

The researchers also found that about 8 out of 10 survey participants reported looking at their medication list on the patient portal at least once. Of those patients who checked the portal for their medications, 18% said that the list was not accurate, and 85% wanted to submit corrections online.

The authors concluded that although note sharing means a substantial change in the culture of medicine, the practice of inviting patients to review clinicians’ notes online is spreading rapidly.

“Reading visit notes may be important for sustained improvements in the use of medications over time in ambulatory care,” they noted.

agallegos@mdedge.com

SOURCE: Delbanco et. al. Ann Intern Med. 2019 May 28. doi: 0.7326/M18-3197

A study suggests that allowing patients to read their physician’s notes may help many of them better manage and adhere to their medications.

Lead authors Tom Delbanco, MD, and Jan Walker, RN, MBA, of Harvard University and Beth Israel Deaconess Medical Center, both in Boston, conducted an online survey in 2017 of 19,411 patients in three separate health systems who participated in the OpenNotes pilot, an initiative that provided patients access to online clinical notes about their care. Eligible survey participants were 18 years or older and had logged into their respective patient portal at least once in the last 12 months and had an ambulatory visit note available.

Of the patients surveyed, a combined 14% of patients from Beth Israel Deaconess Medical Center and Geisinger Health reported that reading their notes made them more likely to take their medications as prescribed, while 86% reported no change, according to the study published in the Annals of Internal Medicine. At the University of Washington, Seattle, 33% of patients rated notes as “extremely important” in assisting with medication regimens. (The wording and response categories used by the University of Washington were not the same as those used by the other sites.)

The majority of patients at all three sites reported that note reading helped them understand why a medication was prescribed, answered their questions, and made them feel more comfortable with and in control of their medications, according to the study.

Of patients with a primary language other than English, 75% reported that reading their clinical notes helped them understand why a medication was prescribed, compared with 64% of patients who spoke English as their primary language. Of patients with high school or less education, 74% reported that reading their notes helped answer their questions about their medications, compared with 53% of college graduates.

The researchers also found that about 8 out of 10 survey participants reported looking at their medication list on the patient portal at least once. Of those patients who checked the portal for their medications, 18% said that the list was not accurate, and 85% wanted to submit corrections online.

The authors concluded that although note sharing means a substantial change in the culture of medicine, the practice of inviting patients to review clinicians’ notes online is spreading rapidly.

“Reading visit notes may be important for sustained improvements in the use of medications over time in ambulatory care,” they noted.

agallegos@mdedge.com

SOURCE: Delbanco et. al. Ann Intern Med. 2019 May 28. doi: 0.7326/M18-3197

A study suggests that allowing patients to read their physician’s notes may help many of them better manage and adhere to their medications.

Lead authors Tom Delbanco, MD, and Jan Walker, RN, MBA, of Harvard University and Beth Israel Deaconess Medical Center, both in Boston, conducted an online survey in 2017 of 19,411 patients in three separate health systems who participated in the OpenNotes pilot, an initiative that provided patients access to online clinical notes about their care. Eligible survey participants were 18 years or older and had logged into their respective patient portal at least once in the last 12 months and had an ambulatory visit note available.

Of the patients surveyed, a combined 14% of patients from Beth Israel Deaconess Medical Center and Geisinger Health reported that reading their notes made them more likely to take their medications as prescribed, while 86% reported no change, according to the study published in the Annals of Internal Medicine. At the University of Washington, Seattle, 33% of patients rated notes as “extremely important” in assisting with medication regimens. (The wording and response categories used by the University of Washington were not the same as those used by the other sites.)

The majority of patients at all three sites reported that note reading helped them understand why a medication was prescribed, answered their questions, and made them feel more comfortable with and in control of their medications, according to the study.

Of patients with a primary language other than English, 75% reported that reading their clinical notes helped them understand why a medication was prescribed, compared with 64% of patients who spoke English as their primary language. Of patients with high school or less education, 74% reported that reading their notes helped answer their questions about their medications, compared with 53% of college graduates.

The researchers also found that about 8 out of 10 survey participants reported looking at their medication list on the patient portal at least once. Of those patients who checked the portal for their medications, 18% said that the list was not accurate, and 85% wanted to submit corrections online.

The authors concluded that although note sharing means a substantial change in the culture of medicine, the practice of inviting patients to review clinicians’ notes online is spreading rapidly.

“Reading visit notes may be important for sustained improvements in the use of medications over time in ambulatory care,” they noted.

agallegos@mdedge.com

SOURCE: Delbanco et. al. Ann Intern Med. 2019 May 28. doi: 0.7326/M18-3197