Clinical Psychiatry News

On March 3 of this year, Bryant Cameron Webb, MD, JD, won two-thirds of the vote in Virginia’s Democratic primary race. In November, he’ll compete against Republican Bob Good to represent the state’s 5th Congressional District. If he succeeds, he will become the first Black physician ever elected to a seat in Congress.

Courtesy Dr. Bryant Cameron Webb

The political and social unrest across the United States in recent months has resulted in millions of people becoming more proactive: from sports arenas to the halls of Congress, the rally cry of Black Lives Matter has echoed like never before after the killing of George Floyd and Breonna Taylor at the hands of law enforcement. Dr. Webb, a practicing internist and professor at the University of Virginia, Charlottesville, is among many physicians joining the cause. If elected, he hopes to bring a unique perspective to Washington and advocate for racial equity to help combat systemic racist policies that result in health disparities.

“For me as a professor at UVA in both public health sciences and in medicine, I have a lot to bring to this moment,” he commented, “real expertise on issues that are critical to the nation. Beyond my passion for health and wellness, I have a passion for justice.”

Dr. Webb also believes that serving in Congress is a way to help his patients. “I balance the work of direct patient care and patient advocacy in different spaces,” said the Spotsylvania County native. “Working in Congress is patient advocacy to me. It’s where I can be at my highest use to the people I take care of. It is different from direct patient care. I think this [unique] background that I have is needed in Congress.”

Dr. Webb has never held an elected office before, and he’s looking to get elected in a district that voted for President Trump in the past election. He knows challenges lie ahead.
 

A calling

The field of medicine called for Dr. Webb at an early age. He credits his family doctor, a Black man, for inspiring him. “With six kids in our family, we saw the doctor frequently. Dr. Yarboro was a young Black man just a few years out of residency. My mom had supreme confidence in him, and he made us feel at ease. So I wanted to be a doctor ever since I was 5 or 6 years old.”

Dr. Webb earned a bachelor’s degree from the University of Virginia in 2005. He entered medical school at Wake Forest University, Winston-Salem, N.C., the following year. Following his third year of medical training, he heeded another calling: He took time off to attend law school. He enrolled in Loyola University of Chicago School of Law and earned his juris doctorate in 2012.

The move may seem an unexpected turn. But Dr. Webb feels his law degree enhances his work. “I think that it’s because I’m so steeped in the legal resources that folks need to navigate. I think I am able to provide better care. ... It’s a complement and helpful to me professionally, whether it’s fighting with an insurance company or with a prescription drug company.”

After law school, Dr. Webb finished his medical training at Wake Forest and moved north, where he completed an internal medicine residency at New York–Presbyterian Hospital. Then came yet another twist in Dr. Webb’s unconventional career path: in 2016, he was selected by President Obama as a White House fellow. He spent the next 2 years in Washington, where he worked on Mr. Obama’s My Brother’s Keeper Task Force, an initiative that addresses opportunity gaps faced by boys and young men of color.

Adeze Enekwechi, MD, president of Impaq and associate professor at the George Washington University, Washington, worked with Dr. Webb at the White House. “This is the place where he will have the most impact. We’ve been talking and writing about health equity ever since our time [there]. Not everybody can speak that language. Being an African American male physician and an attorney can really help drive change by being the right person at the table.”
 

Why here? Why now?

Dr. Webb sees patients 2-3 days a week on alternating weeks and knows well the concerns of people who struggle with health. Now he’s ready to have those conversations on a larger platform. “As a Black physician, it’s about bringing that healer mindset to these problems. It’s not about just going there to brow beat people or add to that divisive nature in Congress. You acknowledge that the problems exist, and then bridge,” he said, hoping that bridging party divides can be a catalyst for healing.

Carla Boutin-Foster, MD, associate dean, office of diversity education and research at the State University of New York, Brooklyn, has mentored Dr. Webb since 2013. With his credentials, confidence, and persistence, she believes, he will be a great representative of the medical community in D.C. “You need someone who respects the Constitution. When policy needs to be developed, you need a healer, someone who understands the science of vaccines. This is something Cam has been groomed for. It’s something he has been living and practicing for years.”

The killing of George Floyd and the uprising that ensued has opened the dialogue about racial inequality in America. Health care is not immune to racial bias, and the effects are palatable. One survey conducted by the Larry A. Green Center, in collaboration with the Primary Care Collaborative and 3rd Conversation, found that more than 40% of clinicians say Mr. Floyd’s demise has become a topic of concern among patients of all demographics.

When it comes to racism, Dr. Webb understands that he plays a critical role in moving America forward. “We have so many voices that are powerful and important in the highest level of legislation. We have to use those voices to root out the injustices in our society, like in the Breonna Taylor case. We have to do so because that is how you achieve the American dream,” he said.

The social determinants of health – or “ZIP-code risk” – has been proven to influence health outcomes, yet few physicians screen for them during patient visits. For Dr. Webb, discussing things like housing security and interpersonal violence are critical to providing care.

One of Dr. Webb’s biggest supporters is his wife of 11 years, Leigh Ann Webb, MD, MBA, an emergency medicine physician and assistant professor of emergency medicine at UVA. “He is an effective leader and a consensus builder,” she said of her husband, with whom she has two children. “There has always been something very unique and special about him and the way he engages the world. We need more thoughtful, intelligent people like him to help our country move forward.”

In addition to being the director of health policy and equity at UVA this fall, Dr. Webb plans to teach a course at UVA centered around the social determinants of health called Place Matters. “The focus is on understanding how education and housing and food insecurity all come together to cause illness,” he said. “Health doesn’t happen in hospitals and clinics. It happens in the community.”

A version of this article originally appeared on Medscape.com.

On March 3 of this year, Bryant Cameron Webb, MD, JD, won two-thirds of the vote in Virginia’s Democratic primary race. In November, he’ll compete against Republican Bob Good to represent the state’s 5th Congressional District. If he succeeds, he will become the first Black physician ever elected to a seat in Congress.

Courtesy Dr. Bryant Cameron Webb

The political and social unrest across the United States in recent months has resulted in millions of people becoming more proactive: from sports arenas to the halls of Congress, the rally cry of Black Lives Matter has echoed like never before after the killing of George Floyd and Breonna Taylor at the hands of law enforcement. Dr. Webb, a practicing internist and professor at the University of Virginia, Charlottesville, is among many physicians joining the cause. If elected, he hopes to bring a unique perspective to Washington and advocate for racial equity to help combat systemic racist policies that result in health disparities.

“For me as a professor at UVA in both public health sciences and in medicine, I have a lot to bring to this moment,” he commented, “real expertise on issues that are critical to the nation. Beyond my passion for health and wellness, I have a passion for justice.”

Dr. Webb also believes that serving in Congress is a way to help his patients. “I balance the work of direct patient care and patient advocacy in different spaces,” said the Spotsylvania County native. “Working in Congress is patient advocacy to me. It’s where I can be at my highest use to the people I take care of. It is different from direct patient care. I think this [unique] background that I have is needed in Congress.”

Dr. Webb has never held an elected office before, and he’s looking to get elected in a district that voted for President Trump in the past election. He knows challenges lie ahead.
 

A calling

The field of medicine called for Dr. Webb at an early age. He credits his family doctor, a Black man, for inspiring him. “With six kids in our family, we saw the doctor frequently. Dr. Yarboro was a young Black man just a few years out of residency. My mom had supreme confidence in him, and he made us feel at ease. So I wanted to be a doctor ever since I was 5 or 6 years old.”

Dr. Webb earned a bachelor’s degree from the University of Virginia in 2005. He entered medical school at Wake Forest University, Winston-Salem, N.C., the following year. Following his third year of medical training, he heeded another calling: He took time off to attend law school. He enrolled in Loyola University of Chicago School of Law and earned his juris doctorate in 2012.

The move may seem an unexpected turn. But Dr. Webb feels his law degree enhances his work. “I think that it’s because I’m so steeped in the legal resources that folks need to navigate. I think I am able to provide better care. ... It’s a complement and helpful to me professionally, whether it’s fighting with an insurance company or with a prescription drug company.”

After law school, Dr. Webb finished his medical training at Wake Forest and moved north, where he completed an internal medicine residency at New York–Presbyterian Hospital. Then came yet another twist in Dr. Webb’s unconventional career path: in 2016, he was selected by President Obama as a White House fellow. He spent the next 2 years in Washington, where he worked on Mr. Obama’s My Brother’s Keeper Task Force, an initiative that addresses opportunity gaps faced by boys and young men of color.

Adeze Enekwechi, MD, president of Impaq and associate professor at the George Washington University, Washington, worked with Dr. Webb at the White House. “This is the place where he will have the most impact. We’ve been talking and writing about health equity ever since our time [there]. Not everybody can speak that language. Being an African American male physician and an attorney can really help drive change by being the right person at the table.”
 

Why here? Why now?

Dr. Webb sees patients 2-3 days a week on alternating weeks and knows well the concerns of people who struggle with health. Now he’s ready to have those conversations on a larger platform. “As a Black physician, it’s about bringing that healer mindset to these problems. It’s not about just going there to brow beat people or add to that divisive nature in Congress. You acknowledge that the problems exist, and then bridge,” he said, hoping that bridging party divides can be a catalyst for healing.

Carla Boutin-Foster, MD, associate dean, office of diversity education and research at the State University of New York, Brooklyn, has mentored Dr. Webb since 2013. With his credentials, confidence, and persistence, she believes, he will be a great representative of the medical community in D.C. “You need someone who respects the Constitution. When policy needs to be developed, you need a healer, someone who understands the science of vaccines. This is something Cam has been groomed for. It’s something he has been living and practicing for years.”

The killing of George Floyd and the uprising that ensued has opened the dialogue about racial inequality in America. Health care is not immune to racial bias, and the effects are palatable. One survey conducted by the Larry A. Green Center, in collaboration with the Primary Care Collaborative and 3rd Conversation, found that more than 40% of clinicians say Mr. Floyd’s demise has become a topic of concern among patients of all demographics.

When it comes to racism, Dr. Webb understands that he plays a critical role in moving America forward. “We have so many voices that are powerful and important in the highest level of legislation. We have to use those voices to root out the injustices in our society, like in the Breonna Taylor case. We have to do so because that is how you achieve the American dream,” he said.

The social determinants of health – or “ZIP-code risk” – has been proven to influence health outcomes, yet few physicians screen for them during patient visits. For Dr. Webb, discussing things like housing security and interpersonal violence are critical to providing care.

One of Dr. Webb’s biggest supporters is his wife of 11 years, Leigh Ann Webb, MD, MBA, an emergency medicine physician and assistant professor of emergency medicine at UVA. “He is an effective leader and a consensus builder,” she said of her husband, with whom she has two children. “There has always been something very unique and special about him and the way he engages the world. We need more thoughtful, intelligent people like him to help our country move forward.”

In addition to being the director of health policy and equity at UVA this fall, Dr. Webb plans to teach a course at UVA centered around the social determinants of health called Place Matters. “The focus is on understanding how education and housing and food insecurity all come together to cause illness,” he said. “Health doesn’t happen in hospitals and clinics. It happens in the community.”

A version of this article originally appeared on Medscape.com.

On March 3 of this year, Bryant Cameron Webb, MD, JD, won two-thirds of the vote in Virginia’s Democratic primary race. In November, he’ll compete against Republican Bob Good to represent the state’s 5th Congressional District. If he succeeds, he will become the first Black physician ever elected to a seat in Congress.

Courtesy Dr. Bryant Cameron Webb

The political and social unrest across the United States in recent months has resulted in millions of people becoming more proactive: from sports arenas to the halls of Congress, the rally cry of Black Lives Matter has echoed like never before after the killing of George Floyd and Breonna Taylor at the hands of law enforcement. Dr. Webb, a practicing internist and professor at the University of Virginia, Charlottesville, is among many physicians joining the cause. If elected, he hopes to bring a unique perspective to Washington and advocate for racial equity to help combat systemic racist policies that result in health disparities.

“For me as a professor at UVA in both public health sciences and in medicine, I have a lot to bring to this moment,” he commented, “real expertise on issues that are critical to the nation. Beyond my passion for health and wellness, I have a passion for justice.”

Dr. Webb also believes that serving in Congress is a way to help his patients. “I balance the work of direct patient care and patient advocacy in different spaces,” said the Spotsylvania County native. “Working in Congress is patient advocacy to me. It’s where I can be at my highest use to the people I take care of. It is different from direct patient care. I think this [unique] background that I have is needed in Congress.”

Dr. Webb has never held an elected office before, and he’s looking to get elected in a district that voted for President Trump in the past election. He knows challenges lie ahead.
 

A calling

The field of medicine called for Dr. Webb at an early age. He credits his family doctor, a Black man, for inspiring him. “With six kids in our family, we saw the doctor frequently. Dr. Yarboro was a young Black man just a few years out of residency. My mom had supreme confidence in him, and he made us feel at ease. So I wanted to be a doctor ever since I was 5 or 6 years old.”

Dr. Webb earned a bachelor’s degree from the University of Virginia in 2005. He entered medical school at Wake Forest University, Winston-Salem, N.C., the following year. Following his third year of medical training, he heeded another calling: He took time off to attend law school. He enrolled in Loyola University of Chicago School of Law and earned his juris doctorate in 2012.

The move may seem an unexpected turn. But Dr. Webb feels his law degree enhances his work. “I think that it’s because I’m so steeped in the legal resources that folks need to navigate. I think I am able to provide better care. ... It’s a complement and helpful to me professionally, whether it’s fighting with an insurance company or with a prescription drug company.”

After law school, Dr. Webb finished his medical training at Wake Forest and moved north, where he completed an internal medicine residency at New York–Presbyterian Hospital. Then came yet another twist in Dr. Webb’s unconventional career path: in 2016, he was selected by President Obama as a White House fellow. He spent the next 2 years in Washington, where he worked on Mr. Obama’s My Brother’s Keeper Task Force, an initiative that addresses opportunity gaps faced by boys and young men of color.

Adeze Enekwechi, MD, president of Impaq and associate professor at the George Washington University, Washington, worked with Dr. Webb at the White House. “This is the place where he will have the most impact. We’ve been talking and writing about health equity ever since our time [there]. Not everybody can speak that language. Being an African American male physician and an attorney can really help drive change by being the right person at the table.”
 

Why here? Why now?

Dr. Webb sees patients 2-3 days a week on alternating weeks and knows well the concerns of people who struggle with health. Now he’s ready to have those conversations on a larger platform. “As a Black physician, it’s about bringing that healer mindset to these problems. It’s not about just going there to brow beat people or add to that divisive nature in Congress. You acknowledge that the problems exist, and then bridge,” he said, hoping that bridging party divides can be a catalyst for healing.

Carla Boutin-Foster, MD, associate dean, office of diversity education and research at the State University of New York, Brooklyn, has mentored Dr. Webb since 2013. With his credentials, confidence, and persistence, she believes, he will be a great representative of the medical community in D.C. “You need someone who respects the Constitution. When policy needs to be developed, you need a healer, someone who understands the science of vaccines. This is something Cam has been groomed for. It’s something he has been living and practicing for years.”

The killing of George Floyd and the uprising that ensued has opened the dialogue about racial inequality in America. Health care is not immune to racial bias, and the effects are palatable. One survey conducted by the Larry A. Green Center, in collaboration with the Primary Care Collaborative and 3rd Conversation, found that more than 40% of clinicians say Mr. Floyd’s demise has become a topic of concern among patients of all demographics.

When it comes to racism, Dr. Webb understands that he plays a critical role in moving America forward. “We have so many voices that are powerful and important in the highest level of legislation. We have to use those voices to root out the injustices in our society, like in the Breonna Taylor case. We have to do so because that is how you achieve the American dream,” he said.

The social determinants of health – or “ZIP-code risk” – has been proven to influence health outcomes, yet few physicians screen for them during patient visits. For Dr. Webb, discussing things like housing security and interpersonal violence are critical to providing care.

One of Dr. Webb’s biggest supporters is his wife of 11 years, Leigh Ann Webb, MD, MBA, an emergency medicine physician and assistant professor of emergency medicine at UVA. “He is an effective leader and a consensus builder,” she said of her husband, with whom she has two children. “There has always been something very unique and special about him and the way he engages the world. We need more thoughtful, intelligent people like him to help our country move forward.”

In addition to being the director of health policy and equity at UVA this fall, Dr. Webb plans to teach a course at UVA centered around the social determinants of health called Place Matters. “The focus is on understanding how education and housing and food insecurity all come together to cause illness,” he said. “Health doesn’t happen in hospitals and clinics. It happens in the community.”

A version of this article originally appeared on Medscape.com.

On Feb. 27, 2018, I got an email from the Heritage Foundation that alerted me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”

Supreme Court of the United States

I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”

Few people took that case very seriously – barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat to the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.

Democrats are raising alarms about the future of the law without Ms. Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.

“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”

Ms. Ginsburg’s death could throw an already chaotic general election campaign during a pandemic into even more turmoil. But in the longer term, her absence from the bench could accelerate a trend underway to get cases to the Supreme Court toward invalidating the ACA and rolling back reproductive freedoms for women.

Let’s take them one at a time.
 

The ACA under fire – again

The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.

Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.

Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to Mr. O’Connor to suggest that perhaps the entire law need not fall.

Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.

While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case, now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Mr. Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Mr. Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.

But without Ms. Ginsburg, the case could wind up in a 4-4 tie, even if Mr. Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ms. Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.

At least 20 million Americans – and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.

Adult children under age 26 years would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.

But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals, and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.

A new Democratic president could not drop the lawsuit because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.

As Nicholas Bagley, a law professor at the University of Michigan, Ann Arbor, who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”
 

Reproductive rights

A woman’s right to abortion – and even to birth control – also has been hanging by a thread at the high court for more than a decade. This past term, Mr. Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Mr. Roberts argued.

Ms. Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly 3 decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.

Adding a justice opposed to abortion to the bench – which is what Trump has promised his supporters – would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.

But not only is abortion on the line: The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.

And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.

For Ms. Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.

“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’ ” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’ ”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

On Feb. 27, 2018, I got an email from the Heritage Foundation that alerted me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”

Supreme Court of the United States

I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”

Few people took that case very seriously – barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat to the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.

Democrats are raising alarms about the future of the law without Ms. Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.

“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”

Ms. Ginsburg’s death could throw an already chaotic general election campaign during a pandemic into even more turmoil. But in the longer term, her absence from the bench could accelerate a trend underway to get cases to the Supreme Court toward invalidating the ACA and rolling back reproductive freedoms for women.

Let’s take them one at a time.
 

The ACA under fire – again

The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.

Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.

Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to Mr. O’Connor to suggest that perhaps the entire law need not fall.

Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.

While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case, now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Mr. Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Mr. Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.

But without Ms. Ginsburg, the case could wind up in a 4-4 tie, even if Mr. Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ms. Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.

At least 20 million Americans – and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.

Adult children under age 26 years would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.

But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals, and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.

A new Democratic president could not drop the lawsuit because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.

As Nicholas Bagley, a law professor at the University of Michigan, Ann Arbor, who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”
 

Reproductive rights

A woman’s right to abortion – and even to birth control – also has been hanging by a thread at the high court for more than a decade. This past term, Mr. Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Mr. Roberts argued.

Ms. Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly 3 decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.

Adding a justice opposed to abortion to the bench – which is what Trump has promised his supporters – would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.

But not only is abortion on the line: The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.

And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.

For Ms. Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.

“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’ ” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’ ”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

On Feb. 27, 2018, I got an email from the Heritage Foundation that alerted me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”

Supreme Court of the United States

I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”

Few people took that case very seriously – barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat to the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.

Democrats are raising alarms about the future of the law without Ms. Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.

“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”

Ms. Ginsburg’s death could throw an already chaotic general election campaign during a pandemic into even more turmoil. But in the longer term, her absence from the bench could accelerate a trend underway to get cases to the Supreme Court toward invalidating the ACA and rolling back reproductive freedoms for women.

Let’s take them one at a time.
 

The ACA under fire – again

The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.

Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.

Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to Mr. O’Connor to suggest that perhaps the entire law need not fall.

Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.

While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case, now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Mr. Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Mr. Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.

But without Ms. Ginsburg, the case could wind up in a 4-4 tie, even if Mr. Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ms. Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.

At least 20 million Americans – and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.

Adult children under age 26 years would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.

But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals, and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.

A new Democratic president could not drop the lawsuit because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.

As Nicholas Bagley, a law professor at the University of Michigan, Ann Arbor, who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”
 

Reproductive rights

A woman’s right to abortion – and even to birth control – also has been hanging by a thread at the high court for more than a decade. This past term, Mr. Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Mr. Roberts argued.

Ms. Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly 3 decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.

Adding a justice opposed to abortion to the bench – which is what Trump has promised his supporters – would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.

But not only is abortion on the line: The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.

And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.

For Ms. Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.

“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’ ” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’ ”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

The American College of Physicians and the American Academy of Family Physicians recently authored a guideline regarding the treatment of acute, non–low back, musculoskeletal injuries in adults in the outpatient setting. While their recommendations mirror what most clinicians currently do in their medical practices, they don’t address the multiple components of pain that include sensory, emotional, cognitive, and behavioral processes in addition to the physical discomfort.

According to the authors, musculoskeletal injuries result in more than 65 million medical visits a year with an annual estimated cost of $176.1 billion in 2010.

In summary, the guideline, which was published in the Annals of Internal Medicine, is based on a review of the best available evidence. The research reviewed by the guideline authors showed favorable results with topical NSAIDs, oral NSAIDs, oral acetaminophen, acupressure, and transcutaneous electrical nerve stimulation in reducing pain and/or improving function. The guideline authors “recommend that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with topical [NSAIDs] with or without gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient’s treatment satisfaction (Grade: strong recommendation; moderate-certainty evidence).” Additionally, the guideline recommends against treating acute pain from non–low back, musculoskeletal injuries with opioids, including tramadol (Grade: conditional recommendation; low-certainty evidence).

The guideline also mentions improving function in relation to decreasing pain, which can be multifactorial.

Treating pain requires a multipronged approach. Many patients require more than one therapy to treat their pain, such as NSAIDs plus physical therapy. The ACP and AAFP did not make any recommendations for combination therapies in this guideline.

When physical therapy is needed

Nonopioid pain medications can do a great job of reducing a patient’s physical discomfort, which the evidence for these guideline demonstrates. However, much of the dysfunction caused by musculoskeletal injuries will not improve by reducing the pain alone. Physical therapy, exercise, and mobilization did not show a significant benefit in reducing symptoms in the systematic review and meta-analysis of randomized trials that appeared alongside the guideline. The type of pain, however, was not evaluated in relation to the effectiveness of these treatments. A fractured bone, for example, may heal just fine with casting and pain management, without the need for additional therapies. However, the muscles surrounding that bone can atrophy and become weak from not being used. Physical therapy may be needed to restrengthen those muscles. Therefore, a multifaceted approach is often needed, even for uncomplicated conditions.

Mental pain often comes with physical pain, and this is an aspect of care that is often neglected. It can be quite devastating for patients to not be able to do the things they were previously able to do. While this is easily recognized in professional athletes when they can no longer play, it is not so readily apparent with a mother who is just trying to take care of her kids. As doctors, especially those of us in family medicine, we should be addressing more than just physical pain.

Patients can also do activities that exacerbate their pain. As doctors, we need to be asking questions that help us determine whether a patient’s pain is caused by a particular action. Maybe that increase in shoulder pain is due to nothing more than lifting something heavy rather than a failure in a prescribed medication. Pain diaries are helpful, and clinicians don’t use them often enough.
 

How pain affects mental health

Acute injuries can also lead to disability. Many patients become quite distressed about being unable to work. They often need Famiy & Medical Leave Act forms filled out, and this task usually falls to the primary care doctor. In addition to assessing the pain, we need to be evaluating, at each visit, a patient’s level of functioning and their ability to do their job.

Every patient responds to pain differently, and it is important to evaluate patients’ mindsets regarding theirs. A patient may be in severe pain and may try to ignore it for a variety of reasons. A patient may “catastrophize” their pain, believing only the worst outcome will happen to them. Helping patients set appropriate expectations and having a positive mindset can help.

Overall, the new recommendations are a great tool as a guideline, but they are not complete enough to be the only ones used in managing acute, non–low back, musculoskeletal pain in adults.

They are very important for clinicians who may be prescribing opioid medications for patients with this type of pain. Amid an opioid crisis, it is the responsibility of every doctor to prescribe these medications appropriately. The evidence clearly shows they provide little benefit and place patients at risk of addiction.

We should all be following these recommendations as the baseline of care for acute pain. However, we need to delve deeper and manage all the components involved. We would be ignoring very real suffering in our patients if we limited our focus to only the physical discomfort.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Rutgers RWJ Medical School.

SOURCE: Ann Intern Med. 2020 Aug 18. doi: 10.7326/M19-3602.

The American College of Physicians and the American Academy of Family Physicians recently authored a guideline regarding the treatment of acute, non–low back, musculoskeletal injuries in adults in the outpatient setting. While their recommendations mirror what most clinicians currently do in their medical practices, they don’t address the multiple components of pain that include sensory, emotional, cognitive, and behavioral processes in addition to the physical discomfort.

According to the authors, musculoskeletal injuries result in more than 65 million medical visits a year with an annual estimated cost of $176.1 billion in 2010.

In summary, the guideline, which was published in the Annals of Internal Medicine, is based on a review of the best available evidence. The research reviewed by the guideline authors showed favorable results with topical NSAIDs, oral NSAIDs, oral acetaminophen, acupressure, and transcutaneous electrical nerve stimulation in reducing pain and/or improving function. The guideline authors “recommend that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with topical [NSAIDs] with or without gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient’s treatment satisfaction (Grade: strong recommendation; moderate-certainty evidence).” Additionally, the guideline recommends against treating acute pain from non–low back, musculoskeletal injuries with opioids, including tramadol (Grade: conditional recommendation; low-certainty evidence).

The guideline also mentions improving function in relation to decreasing pain, which can be multifactorial.

Treating pain requires a multipronged approach. Many patients require more than one therapy to treat their pain, such as NSAIDs plus physical therapy. The ACP and AAFP did not make any recommendations for combination therapies in this guideline.

When physical therapy is needed

Nonopioid pain medications can do a great job of reducing a patient’s physical discomfort, which the evidence for these guideline demonstrates. However, much of the dysfunction caused by musculoskeletal injuries will not improve by reducing the pain alone. Physical therapy, exercise, and mobilization did not show a significant benefit in reducing symptoms in the systematic review and meta-analysis of randomized trials that appeared alongside the guideline. The type of pain, however, was not evaluated in relation to the effectiveness of these treatments. A fractured bone, for example, may heal just fine with casting and pain management, without the need for additional therapies. However, the muscles surrounding that bone can atrophy and become weak from not being used. Physical therapy may be needed to restrengthen those muscles. Therefore, a multifaceted approach is often needed, even for uncomplicated conditions.

Mental pain often comes with physical pain, and this is an aspect of care that is often neglected. It can be quite devastating for patients to not be able to do the things they were previously able to do. While this is easily recognized in professional athletes when they can no longer play, it is not so readily apparent with a mother who is just trying to take care of her kids. As doctors, especially those of us in family medicine, we should be addressing more than just physical pain.

Patients can also do activities that exacerbate their pain. As doctors, we need to be asking questions that help us determine whether a patient’s pain is caused by a particular action. Maybe that increase in shoulder pain is due to nothing more than lifting something heavy rather than a failure in a prescribed medication. Pain diaries are helpful, and clinicians don’t use them often enough.
 

How pain affects mental health

Acute injuries can also lead to disability. Many patients become quite distressed about being unable to work. They often need Famiy & Medical Leave Act forms filled out, and this task usually falls to the primary care doctor. In addition to assessing the pain, we need to be evaluating, at each visit, a patient’s level of functioning and their ability to do their job.

Every patient responds to pain differently, and it is important to evaluate patients’ mindsets regarding theirs. A patient may be in severe pain and may try to ignore it for a variety of reasons. A patient may “catastrophize” their pain, believing only the worst outcome will happen to them. Helping patients set appropriate expectations and having a positive mindset can help.

Overall, the new recommendations are a great tool as a guideline, but they are not complete enough to be the only ones used in managing acute, non–low back, musculoskeletal pain in adults.

They are very important for clinicians who may be prescribing opioid medications for patients with this type of pain. Amid an opioid crisis, it is the responsibility of every doctor to prescribe these medications appropriately. The evidence clearly shows they provide little benefit and place patients at risk of addiction.

We should all be following these recommendations as the baseline of care for acute pain. However, we need to delve deeper and manage all the components involved. We would be ignoring very real suffering in our patients if we limited our focus to only the physical discomfort.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Rutgers RWJ Medical School.

SOURCE: Ann Intern Med. 2020 Aug 18. doi: 10.7326/M19-3602.

The American College of Physicians and the American Academy of Family Physicians recently authored a guideline regarding the treatment of acute, non–low back, musculoskeletal injuries in adults in the outpatient setting. While their recommendations mirror what most clinicians currently do in their medical practices, they don’t address the multiple components of pain that include sensory, emotional, cognitive, and behavioral processes in addition to the physical discomfort.

According to the authors, musculoskeletal injuries result in more than 65 million medical visits a year with an annual estimated cost of $176.1 billion in 2010.

In summary, the guideline, which was published in the Annals of Internal Medicine, is based on a review of the best available evidence. The research reviewed by the guideline authors showed favorable results with topical NSAIDs, oral NSAIDs, oral acetaminophen, acupressure, and transcutaneous electrical nerve stimulation in reducing pain and/or improving function. The guideline authors “recommend that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with topical [NSAIDs] with or without gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient’s treatment satisfaction (Grade: strong recommendation; moderate-certainty evidence).” Additionally, the guideline recommends against treating acute pain from non–low back, musculoskeletal injuries with opioids, including tramadol (Grade: conditional recommendation; low-certainty evidence).

The guideline also mentions improving function in relation to decreasing pain, which can be multifactorial.

Treating pain requires a multipronged approach. Many patients require more than one therapy to treat their pain, such as NSAIDs plus physical therapy. The ACP and AAFP did not make any recommendations for combination therapies in this guideline.

When physical therapy is needed

Nonopioid pain medications can do a great job of reducing a patient’s physical discomfort, which the evidence for these guideline demonstrates. However, much of the dysfunction caused by musculoskeletal injuries will not improve by reducing the pain alone. Physical therapy, exercise, and mobilization did not show a significant benefit in reducing symptoms in the systematic review and meta-analysis of randomized trials that appeared alongside the guideline. The type of pain, however, was not evaluated in relation to the effectiveness of these treatments. A fractured bone, for example, may heal just fine with casting and pain management, without the need for additional therapies. However, the muscles surrounding that bone can atrophy and become weak from not being used. Physical therapy may be needed to restrengthen those muscles. Therefore, a multifaceted approach is often needed, even for uncomplicated conditions.

Mental pain often comes with physical pain, and this is an aspect of care that is often neglected. It can be quite devastating for patients to not be able to do the things they were previously able to do. While this is easily recognized in professional athletes when they can no longer play, it is not so readily apparent with a mother who is just trying to take care of her kids. As doctors, especially those of us in family medicine, we should be addressing more than just physical pain.

Patients can also do activities that exacerbate their pain. As doctors, we need to be asking questions that help us determine whether a patient’s pain is caused by a particular action. Maybe that increase in shoulder pain is due to nothing more than lifting something heavy rather than a failure in a prescribed medication. Pain diaries are helpful, and clinicians don’t use them often enough.
 

How pain affects mental health

Acute injuries can also lead to disability. Many patients become quite distressed about being unable to work. They often need Famiy & Medical Leave Act forms filled out, and this task usually falls to the primary care doctor. In addition to assessing the pain, we need to be evaluating, at each visit, a patient’s level of functioning and their ability to do their job.

Every patient responds to pain differently, and it is important to evaluate patients’ mindsets regarding theirs. A patient may be in severe pain and may try to ignore it for a variety of reasons. A patient may “catastrophize” their pain, believing only the worst outcome will happen to them. Helping patients set appropriate expectations and having a positive mindset can help.

Overall, the new recommendations are a great tool as a guideline, but they are not complete enough to be the only ones used in managing acute, non–low back, musculoskeletal pain in adults.

They are very important for clinicians who may be prescribing opioid medications for patients with this type of pain. Amid an opioid crisis, it is the responsibility of every doctor to prescribe these medications appropriately. The evidence clearly shows they provide little benefit and place patients at risk of addiction.

We should all be following these recommendations as the baseline of care for acute pain. However, we need to delve deeper and manage all the components involved. We would be ignoring very real suffering in our patients if we limited our focus to only the physical discomfort.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Rutgers RWJ Medical School.

SOURCE: Ann Intern Med. 2020 Aug 18. doi: 10.7326/M19-3602.

Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.

But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.

Some good news has made primary care and some other physicians happy.

The government’s proposal includes significant changes to reimbursement for all physicians. Most important, the government is boosting rates for the office/outpatient evaluation and management (E/M) codes, combined with simplifying coding requirements.

Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.

According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.

The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.

These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.

If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.

The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.

For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.

Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.

The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.

A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.

The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.

Other key changes include the following:

• The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
• Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
• Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
• A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.

Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.

The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.

Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.

CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.

MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.

The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.

CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.

The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.

Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.

Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.

The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.

If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).

This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
 

A version of this article originally appeared on Medscape.com.

Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.

But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.

Some good news has made primary care and some other physicians happy.

The government’s proposal includes significant changes to reimbursement for all physicians. Most important, the government is boosting rates for the office/outpatient evaluation and management (E/M) codes, combined with simplifying coding requirements.

Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.

According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.

The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.

These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.

If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.

The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.

For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.

Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.

The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.

A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.

The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.

Other key changes include the following:

• The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
• Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
• Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
• A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.

Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.

The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.

Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.

CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.

MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.

The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.

CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.

The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.

Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.

Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.

The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.

If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).

This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
 

A version of this article originally appeared on Medscape.com.

Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.

But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.

Some good news has made primary care and some other physicians happy.

The government’s proposal includes significant changes to reimbursement for all physicians. Most important, the government is boosting rates for the office/outpatient evaluation and management (E/M) codes, combined with simplifying coding requirements.

Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.

According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.

The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.

These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.

If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.

The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.

For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.

Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.

The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.

A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.

The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.

Other key changes include the following:

• The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
• Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
• Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
• A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.

Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.

The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.

Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.

CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.

MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.

The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.

CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.

The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.

Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.

Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.

The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.

If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).

This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
 

A version of this article originally appeared on Medscape.com.

Individuals with major depressive disorder (MDD) have an increased heart rate – a finding that may have the potential to identify individuals at risk for the disorder and predict treatment response, early research suggests.

enot-poloskun/Getty Images

Using the rapid-action of the novel antidepressant ketamine and the latest wearable 24-hour electrocardiogram (ECG) technology, investigators found that heart rate could distinguish MDD patients from healthy individuals.

They also found that patients with MDD with the highest resting heart rate had a greater treatment response. In fact, on average, depressed patients had a heart rate that was roughly 10-15 beats per minute higher than healthy controls.

The innovative design of the proof-of-concept study “allowed us to see that average resting heart rate may change quite suddenly to reflect the change in mood,” lead investigator Carmen Schiweck, PhD, Goethe University, Frankfurt am Main, Germany, said in an interview.

These results could have “exciting implications for treatment selection,” and the researchers plan to assess the potential for heart rate to act as an early warning system for depression, they noted.

The findings were presented at the 33rd European College of Neuropsychopharmacology (ECNP) Congress, which was held online this year because of the COVID-19 pandemic.

Identifying trait markers

There have been recent attempts to assess heart rate or heart rate variability (HRV) in patients with MDD to identify trait markers, which are present regardless of the disease phase, or state markers, which are present only during a depressive phase.

However, heart rate and HRV are “highly variable” over a 24-hour cycle, a fact that has been ignored by recent classification efforts, the researchers noted. Moreover, most commonly used antidepressants have a long onset of action, which makes studying their impact on the heart rate challenging.

The researchers’ goal was to determine whether heart rate and HRV could be used as trait markers to distinguish MDD patients from healthy individuals and, through the use of ketamine, whether they can also act as state markers for depression.

For the study, 16 treatment-resistant patients with MDD and 16 age- and sex-matched healthy controls wore a portable ECG device for 4 consecutive days and 3 nights. Heart rate and HRV data were subsequently averaged to obtain a 24-hour ECG.

Participants then received a single infusion of intravenous ketamine for 40 minutes. After waiting for 1 hour, the patients resumed ECG recording for an additional 4 days, with changes in mood assessed using the Hamilton Rating Scale for Depression (HAM-D).

Results showed that, compared with the control group, patients with MDD had a significantly higher 24-hour heart rate (P < .001) and a significantly lower HRV, as measured by the root mean square of successive differences (P < .001).

The investigators also found a reduction in heart rate amplitude, which indicates “significant blunting of circadian rhythm variation throughout the day and less recovery at night.”
 

Ninety percent accuracy

Harmonic and binary regression showed that heart rate was able to identify those with MDD versus those in the control group, particularly using nighttime readings, with 90.6% accuracy. The data correctly identified 14 (87.5%) patients and 15 (93.8%) members of the control group.

Following treatment, heart rate decreased significantly among the MDD group (P < .001), but there was no significant change in HRV (P = .295).

There was a significant positive association between baseline heart rate and response to treatment on the HAM-D (r = .55; P = .046), which suggested better outcomes in patients with a higher heart rate.

Interestingly, while heart rate was positively correlated with depression severity before treatment (r = .59; P = .03), this relationship disappeared following treatment (r = –0.04; P = .90), suggesting heart rate changes were not linked to depression states.

While heart rate levels may be useful as a trait marker and, potentially, for predicting response to antidepressant treatment, they did not show potential as a state marker, the investigators noted.

They suggested that, while the results need to be confirmed in longitudinal studies, approval of a ketamine nasal spray “may open up new avenues to conceive treatment paradigms, as explored in this study.”

However, “this is a small proof-of-concept study,” the investigators acknowledged. They also point out that only six of the patients with MDD had a reduction in HAM-D scores of at least 30% in response to treatment.

Future research plans

Dr. Schiweck said in an interview that her team was able to identify differences in heart rate and HRV in MDD patients that were not observed in other studies because portable at-home devices allowed them to monitor heart rate continuously over days.

The use of ketamine may also have been advantageous because the Netherlands Study of Depression and Anxiety (NESDA), which was published in 2010, clearly showed that “traditional antidepressants,” in particular tricyclic antidepressants, have a strong influence on heart rate and HRV, Dr. Schiweck said.

The team next wants to replicate their study in patients who take nonketamine antidepressants and then remit, because most of the recent studies “just assess patients who are remitted and patients who are currently depressed, but it’s a cross-sectional study design,” said Schiweck.

“If we can follow up the same patients over time then we might really know if it is possible to use heart rate as a state marker for depression,” she added. “That’s what we tried to do with ketamine, but our study was very, very small.”

She noted that the investigators would also like to assess individuals who are “very stressed” and may show some depressive symptoms but don’t yet have a diagnosis of depression.

Mind-body link

Commenting on the findings, Brenda W.J.H. Penninx, MD, PhD, professor of psychiatric epidemiology at the VU University Medical Center in Amsterdam, said the concept of higher heart rate and lower HRV in depression “is indicative of more sympathetic drive and less parasympathetic drive of the autonomic nervous system.”

“That fits with the overall thought that depression is a state with more continuous exposure to stress overactivation of the body, which can be reflected in the [hypothalamic-pituitary-adrenal] axis, leading to higher levels of cortisol stress hormone. But it can also be reflected in the parasympathetic and sympathetic activation of the autonomic nervous system,” she said.

Dr. Penninx, who was also the principal investigator of the NESDA study, was not involved with the current research.

She noted that the NESDA study showed that, when patients with depressive disorder are compared with a healthy controls group, they have a higher heart rate and lower HRV. “But if we then divide people into medicated and nonmedicated people ... then we see that these deviations are only seen in people using medication,” she added.

“Our findings indicate that at least the use of antidepressants is having quite a large impact on autonomic nervous system dysregulation,” Dr. Penninx said. The difference with the current study, she pointed out, is that “it examines the problem over a completely different time scale.”

Although this offers advantages, the current study did not have the large patient numbers that were included in the NESDA study and “they were not clearly able to distinguish the effect of disease from medication,” noted Dr. Penninx.

In addition, this is not an easy area to investigate because there are multiple factors that can mitigate results, including the psychiatric state of the patient, use of medications for both mental illness and cardiometabolic disease, and a patient’s age and gender.

Still, the study clearly illustrates the importance of the interplay between mental health and somatic health and that there is “a very clear indication that we don’t need to separate those,” Dr. Penninx said.

The study was funded by a TGO-IWT Grant from Belgium. The study authors and Dr. Penninx have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Individuals with major depressive disorder (MDD) have an increased heart rate – a finding that may have the potential to identify individuals at risk for the disorder and predict treatment response, early research suggests.

enot-poloskun/Getty Images

Using the rapid-action of the novel antidepressant ketamine and the latest wearable 24-hour electrocardiogram (ECG) technology, investigators found that heart rate could distinguish MDD patients from healthy individuals.

They also found that patients with MDD with the highest resting heart rate had a greater treatment response. In fact, on average, depressed patients had a heart rate that was roughly 10-15 beats per minute higher than healthy controls.

The innovative design of the proof-of-concept study “allowed us to see that average resting heart rate may change quite suddenly to reflect the change in mood,” lead investigator Carmen Schiweck, PhD, Goethe University, Frankfurt am Main, Germany, said in an interview.

These results could have “exciting implications for treatment selection,” and the researchers plan to assess the potential for heart rate to act as an early warning system for depression, they noted.

The findings were presented at the 33rd European College of Neuropsychopharmacology (ECNP) Congress, which was held online this year because of the COVID-19 pandemic.

Identifying trait markers

There have been recent attempts to assess heart rate or heart rate variability (HRV) in patients with MDD to identify trait markers, which are present regardless of the disease phase, or state markers, which are present only during a depressive phase.

However, heart rate and HRV are “highly variable” over a 24-hour cycle, a fact that has been ignored by recent classification efforts, the researchers noted. Moreover, most commonly used antidepressants have a long onset of action, which makes studying their impact on the heart rate challenging.

The researchers’ goal was to determine whether heart rate and HRV could be used as trait markers to distinguish MDD patients from healthy individuals and, through the use of ketamine, whether they can also act as state markers for depression.

For the study, 16 treatment-resistant patients with MDD and 16 age- and sex-matched healthy controls wore a portable ECG device for 4 consecutive days and 3 nights. Heart rate and HRV data were subsequently averaged to obtain a 24-hour ECG.

Participants then received a single infusion of intravenous ketamine for 40 minutes. After waiting for 1 hour, the patients resumed ECG recording for an additional 4 days, with changes in mood assessed using the Hamilton Rating Scale for Depression (HAM-D).

Results showed that, compared with the control group, patients with MDD had a significantly higher 24-hour heart rate (P < .001) and a significantly lower HRV, as measured by the root mean square of successive differences (P < .001).

The investigators also found a reduction in heart rate amplitude, which indicates “significant blunting of circadian rhythm variation throughout the day and less recovery at night.”
 

Ninety percent accuracy

Harmonic and binary regression showed that heart rate was able to identify those with MDD versus those in the control group, particularly using nighttime readings, with 90.6% accuracy. The data correctly identified 14 (87.5%) patients and 15 (93.8%) members of the control group.

Following treatment, heart rate decreased significantly among the MDD group (P < .001), but there was no significant change in HRV (P = .295).

There was a significant positive association between baseline heart rate and response to treatment on the HAM-D (r = .55; P = .046), which suggested better outcomes in patients with a higher heart rate.

Interestingly, while heart rate was positively correlated with depression severity before treatment (r = .59; P = .03), this relationship disappeared following treatment (r = –0.04; P = .90), suggesting heart rate changes were not linked to depression states.

While heart rate levels may be useful as a trait marker and, potentially, for predicting response to antidepressant treatment, they did not show potential as a state marker, the investigators noted.

They suggested that, while the results need to be confirmed in longitudinal studies, approval of a ketamine nasal spray “may open up new avenues to conceive treatment paradigms, as explored in this study.”

However, “this is a small proof-of-concept study,” the investigators acknowledged. They also point out that only six of the patients with MDD had a reduction in HAM-D scores of at least 30% in response to treatment.

Future research plans

Dr. Schiweck said in an interview that her team was able to identify differences in heart rate and HRV in MDD patients that were not observed in other studies because portable at-home devices allowed them to monitor heart rate continuously over days.

The use of ketamine may also have been advantageous because the Netherlands Study of Depression and Anxiety (NESDA), which was published in 2010, clearly showed that “traditional antidepressants,” in particular tricyclic antidepressants, have a strong influence on heart rate and HRV, Dr. Schiweck said.

The team next wants to replicate their study in patients who take nonketamine antidepressants and then remit, because most of the recent studies “just assess patients who are remitted and patients who are currently depressed, but it’s a cross-sectional study design,” said Schiweck.

“If we can follow up the same patients over time then we might really know if it is possible to use heart rate as a state marker for depression,” she added. “That’s what we tried to do with ketamine, but our study was very, very small.”

She noted that the investigators would also like to assess individuals who are “very stressed” and may show some depressive symptoms but don’t yet have a diagnosis of depression.

Mind-body link

Commenting on the findings, Brenda W.J.H. Penninx, MD, PhD, professor of psychiatric epidemiology at the VU University Medical Center in Amsterdam, said the concept of higher heart rate and lower HRV in depression “is indicative of more sympathetic drive and less parasympathetic drive of the autonomic nervous system.”

“That fits with the overall thought that depression is a state with more continuous exposure to stress overactivation of the body, which can be reflected in the [hypothalamic-pituitary-adrenal] axis, leading to higher levels of cortisol stress hormone. But it can also be reflected in the parasympathetic and sympathetic activation of the autonomic nervous system,” she said.

Dr. Penninx, who was also the principal investigator of the NESDA study, was not involved with the current research.

She noted that the NESDA study showed that, when patients with depressive disorder are compared with a healthy controls group, they have a higher heart rate and lower HRV. “But if we then divide people into medicated and nonmedicated people ... then we see that these deviations are only seen in people using medication,” she added.

“Our findings indicate that at least the use of antidepressants is having quite a large impact on autonomic nervous system dysregulation,” Dr. Penninx said. The difference with the current study, she pointed out, is that “it examines the problem over a completely different time scale.”

Although this offers advantages, the current study did not have the large patient numbers that were included in the NESDA study and “they were not clearly able to distinguish the effect of disease from medication,” noted Dr. Penninx.

In addition, this is not an easy area to investigate because there are multiple factors that can mitigate results, including the psychiatric state of the patient, use of medications for both mental illness and cardiometabolic disease, and a patient’s age and gender.

Still, the study clearly illustrates the importance of the interplay between mental health and somatic health and that there is “a very clear indication that we don’t need to separate those,” Dr. Penninx said.

The study was funded by a TGO-IWT Grant from Belgium. The study authors and Dr. Penninx have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Individuals with major depressive disorder (MDD) have an increased heart rate – a finding that may have the potential to identify individuals at risk for the disorder and predict treatment response, early research suggests.

enot-poloskun/Getty Images

Using the rapid-action of the novel antidepressant ketamine and the latest wearable 24-hour electrocardiogram (ECG) technology, investigators found that heart rate could distinguish MDD patients from healthy individuals.

They also found that patients with MDD with the highest resting heart rate had a greater treatment response. In fact, on average, depressed patients had a heart rate that was roughly 10-15 beats per minute higher than healthy controls.

The innovative design of the proof-of-concept study “allowed us to see that average resting heart rate may change quite suddenly to reflect the change in mood,” lead investigator Carmen Schiweck, PhD, Goethe University, Frankfurt am Main, Germany, said in an interview.

These results could have “exciting implications for treatment selection,” and the researchers plan to assess the potential for heart rate to act as an early warning system for depression, they noted.

The findings were presented at the 33rd European College of Neuropsychopharmacology (ECNP) Congress, which was held online this year because of the COVID-19 pandemic.

Identifying trait markers

There have been recent attempts to assess heart rate or heart rate variability (HRV) in patients with MDD to identify trait markers, which are present regardless of the disease phase, or state markers, which are present only during a depressive phase.

However, heart rate and HRV are “highly variable” over a 24-hour cycle, a fact that has been ignored by recent classification efforts, the researchers noted. Moreover, most commonly used antidepressants have a long onset of action, which makes studying their impact on the heart rate challenging.

The researchers’ goal was to determine whether heart rate and HRV could be used as trait markers to distinguish MDD patients from healthy individuals and, through the use of ketamine, whether they can also act as state markers for depression.

For the study, 16 treatment-resistant patients with MDD and 16 age- and sex-matched healthy controls wore a portable ECG device for 4 consecutive days and 3 nights. Heart rate and HRV data were subsequently averaged to obtain a 24-hour ECG.

Participants then received a single infusion of intravenous ketamine for 40 minutes. After waiting for 1 hour, the patients resumed ECG recording for an additional 4 days, with changes in mood assessed using the Hamilton Rating Scale for Depression (HAM-D).

Results showed that, compared with the control group, patients with MDD had a significantly higher 24-hour heart rate (P < .001) and a significantly lower HRV, as measured by the root mean square of successive differences (P < .001).

The investigators also found a reduction in heart rate amplitude, which indicates “significant blunting of circadian rhythm variation throughout the day and less recovery at night.”
 

Ninety percent accuracy

Harmonic and binary regression showed that heart rate was able to identify those with MDD versus those in the control group, particularly using nighttime readings, with 90.6% accuracy. The data correctly identified 14 (87.5%) patients and 15 (93.8%) members of the control group.

Following treatment, heart rate decreased significantly among the MDD group (P < .001), but there was no significant change in HRV (P = .295).

There was a significant positive association between baseline heart rate and response to treatment on the HAM-D (r = .55; P = .046), which suggested better outcomes in patients with a higher heart rate.

Interestingly, while heart rate was positively correlated with depression severity before treatment (r = .59; P = .03), this relationship disappeared following treatment (r = –0.04; P = .90), suggesting heart rate changes were not linked to depression states.

While heart rate levels may be useful as a trait marker and, potentially, for predicting response to antidepressant treatment, they did not show potential as a state marker, the investigators noted.

They suggested that, while the results need to be confirmed in longitudinal studies, approval of a ketamine nasal spray “may open up new avenues to conceive treatment paradigms, as explored in this study.”

However, “this is a small proof-of-concept study,” the investigators acknowledged. They also point out that only six of the patients with MDD had a reduction in HAM-D scores of at least 30% in response to treatment.

Future research plans

Dr. Schiweck said in an interview that her team was able to identify differences in heart rate and HRV in MDD patients that were not observed in other studies because portable at-home devices allowed them to monitor heart rate continuously over days.

The use of ketamine may also have been advantageous because the Netherlands Study of Depression and Anxiety (NESDA), which was published in 2010, clearly showed that “traditional antidepressants,” in particular tricyclic antidepressants, have a strong influence on heart rate and HRV, Dr. Schiweck said.

The team next wants to replicate their study in patients who take nonketamine antidepressants and then remit, because most of the recent studies “just assess patients who are remitted and patients who are currently depressed, but it’s a cross-sectional study design,” said Schiweck.

“If we can follow up the same patients over time then we might really know if it is possible to use heart rate as a state marker for depression,” she added. “That’s what we tried to do with ketamine, but our study was very, very small.”

She noted that the investigators would also like to assess individuals who are “very stressed” and may show some depressive symptoms but don’t yet have a diagnosis of depression.

Mind-body link

Commenting on the findings, Brenda W.J.H. Penninx, MD, PhD, professor of psychiatric epidemiology at the VU University Medical Center in Amsterdam, said the concept of higher heart rate and lower HRV in depression “is indicative of more sympathetic drive and less parasympathetic drive of the autonomic nervous system.”

“That fits with the overall thought that depression is a state with more continuous exposure to stress overactivation of the body, which can be reflected in the [hypothalamic-pituitary-adrenal] axis, leading to higher levels of cortisol stress hormone. But it can also be reflected in the parasympathetic and sympathetic activation of the autonomic nervous system,” she said.

Dr. Penninx, who was also the principal investigator of the NESDA study, was not involved with the current research.

She noted that the NESDA study showed that, when patients with depressive disorder are compared with a healthy controls group, they have a higher heart rate and lower HRV. “But if we then divide people into medicated and nonmedicated people ... then we see that these deviations are only seen in people using medication,” she added.

“Our findings indicate that at least the use of antidepressants is having quite a large impact on autonomic nervous system dysregulation,” Dr. Penninx said. The difference with the current study, she pointed out, is that “it examines the problem over a completely different time scale.”

Although this offers advantages, the current study did not have the large patient numbers that were included in the NESDA study and “they were not clearly able to distinguish the effect of disease from medication,” noted Dr. Penninx.

In addition, this is not an easy area to investigate because there are multiple factors that can mitigate results, including the psychiatric state of the patient, use of medications for both mental illness and cardiometabolic disease, and a patient’s age and gender.

Still, the study clearly illustrates the importance of the interplay between mental health and somatic health and that there is “a very clear indication that we don’t need to separate those,” Dr. Penninx said.

The study was funded by a TGO-IWT Grant from Belgium. The study authors and Dr. Penninx have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Having low serum vitamin D levels was an independent risk factor for having symptomatic COVID-19 with respiratory distress requiring admission to intensive care – as opposed to having mild COVID-19 – and for not surviving, in a new study from Italy.

“Our data give strong observational support to previous suggestions that reduced vitamin D levels may favor the appearance of severe respiratory dysfunction and increase the mortality risk in patients affected with COVID-19,” the researchers report.

Luigi Gennari, MD, PhD, Department of Medicine, Surgery, and Neurosciences, University of Siena, Italy, presented these findings during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

Gennari told Medscape Medical News that this analysis suggests determining vitamin D levels (25 hydroxyvitamin D) in people testing positive for SARS-Cov-2 infection might help predict their risk of severe disease.

However, further research is needed to explore whether vitamin D supplements could prevent the risk of respiratory failure in patients with SARS-Cov-2 infection, he stressed.

In the meantime, Gennari said: “I believe that, particularly in the winter season (when the solar ultraviolet-B (UVB) radiation exposure does not allow the skin to synthesize vitamin D in most countries), the use of vitamin D supplementation and correction of vitamin D deficiency might be of major relevance for the reduction of the clinical burden of the ongoing and future outbreaks of SARS-CoV-2 infection.

Invited to comment, David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, who was not involved with the study, agrees.

“I think this body of work suggests that people should be taking supplements if they cannot increase sun exposure on a sustained basis,” Meltzer said. “The abstract supports multiple prior findings that suggest that higher vitamin D levels are associated with improved outcomes.”

And JoAnn E. Manson, MD, DrPH, of Harvard Medical School and Brigham and Women’s Hospital, who was not involved with the research but has spoken about the topic in a video report for Medscape, said: “We know from several studies that a low vitamin D level is associated with a higher risk of having COVID-19 and severe illness, but correlation does not prove causation.”

“I think that improving vitamin D status is a promising way to reduce the risk of severe illness, but we need randomized controlled trials to prove cause and effect,” she told Medscape Medical News.

103 patients with severe COVID-19, 52 with mild COVID-19, 206 controls

Gennari said several lines of evidence suggest that vitamin D deficiency might be a risk factor for COVID-19 severity.

Countries with lower average levels of vitamin D or lower UVB radiation exposure have higher COVID-19 mortality, and “demographic groups known to be at higher risk of vitamin D deficiency (such as black individuals, the elderly, nursing home residents, and those with obesity and diabetes) are at high risk of COVID-19 hospitalization/mortality, he noted.

There is a high prevalence of vitamin D deficiency in Italy, where mortality rates from COVID-19 have been particularly high.

To examine the relationship between vitamin D levels and COVID-19 severity/mortality, the researchers studied three groups:

• 103 symptomatic patients with COVID-19 with respiratory insufficiency who were admitted to a Milan hospital from March 9 to April 30.
• 52 patients with mild COVID-19, recruited from patients and staff from a nearby nursing home who had a positive test for COVID-19.
• 206 healthy controls, matched 2:1 with symptomatic patients of the same age, weight, and gender, from 3174 patients who had vitamin D measured during a routine check-up from January to March 2020.

Patients in the hospitalized group had lower mean vitamin D levels (18.2 ng/mL) than those with mild COVID-19 (30.3 ng/mL) or those in the control group (25.4 ng/mL).

Patients with symptomatic versus mild COVID-19 were slightly older and more likely to have at least one comorbidity and less likely to be taking a vitamin D supplement at baseline (30% vs 79%).

Among symptomatic patients, mean vitamin D levels were inversely associated with interleukin (IL)-6 and C-reactive protein, “both of which are a direct expression of the inflammatory status,” Gennari noted.

About half of the hospitalized patients (49) were admitted to a ward and discharged after a mean stay of 16 days (none died).

The other 54 hospitalized patients were admitted to the intensive care unit with severe acute respiratory distress; 38 patients received continuous positive airway pressure (CPAP) and 16 patients received endotracheal intubation.

Of the 54 patients admitted to ICU, 19 patients died from respiratory distress after a mean of 19 days, “consistent with the literature,” and the other 35 patients were discharged after a mean of 21 days.

Patients with severe COVID-19 who were admitted to the ICU, as opposed to a ward, were more likely to be male, have at least one comorbidity, have higher baseline IL-6 levels and neutrophil counts, and lower lymphocyte and platelet counts.

They also had lower mean vitamin D levels (14.4 vs 22.4 ng/mL) and were more likely to have vitamin D deficiency (vitamin D <20 ng/mL; 80% vs. 45%).  

Patients admitted to ICU who died had lower baseline vitamin D levels than those who survived (13.2 vs. 19.3 ng/mL).

Vitamin D levels were inversely associated with respiratory distress requiring ICU admission (odds ratio, 1.06; P = .038) and with mortality (OR, 1.18, P = 029), independent of IL-6 levels and other comorbidities.

“That vitamin D levels are associated with improved outcomes independent of IL-6 could reflect that IL-6 is an imperfect measure of the inflammatory process or that vitamin D is related to outcomes for other reasons, such as enhancement of innate or adaptive immunity,” said Meltzer.

He added that “this is not to exclude the possibility that vitamin D has important immunomodulatory effects.”

Gennari, Meltzer, and Manson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Having low serum vitamin D levels was an independent risk factor for having symptomatic COVID-19 with respiratory distress requiring admission to intensive care – as opposed to having mild COVID-19 – and for not surviving, in a new study from Italy.

“Our data give strong observational support to previous suggestions that reduced vitamin D levels may favor the appearance of severe respiratory dysfunction and increase the mortality risk in patients affected with COVID-19,” the researchers report.

Luigi Gennari, MD, PhD, Department of Medicine, Surgery, and Neurosciences, University of Siena, Italy, presented these findings during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

Gennari told Medscape Medical News that this analysis suggests determining vitamin D levels (25 hydroxyvitamin D) in people testing positive for SARS-Cov-2 infection might help predict their risk of severe disease.

However, further research is needed to explore whether vitamin D supplements could prevent the risk of respiratory failure in patients with SARS-Cov-2 infection, he stressed.

In the meantime, Gennari said: “I believe that, particularly in the winter season (when the solar ultraviolet-B (UVB) radiation exposure does not allow the skin to synthesize vitamin D in most countries), the use of vitamin D supplementation and correction of vitamin D deficiency might be of major relevance for the reduction of the clinical burden of the ongoing and future outbreaks of SARS-CoV-2 infection.

Invited to comment, David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, who was not involved with the study, agrees.

“I think this body of work suggests that people should be taking supplements if they cannot increase sun exposure on a sustained basis,” Meltzer said. “The abstract supports multiple prior findings that suggest that higher vitamin D levels are associated with improved outcomes.”

And JoAnn E. Manson, MD, DrPH, of Harvard Medical School and Brigham and Women’s Hospital, who was not involved with the research but has spoken about the topic in a video report for Medscape, said: “We know from several studies that a low vitamin D level is associated with a higher risk of having COVID-19 and severe illness, but correlation does not prove causation.”

“I think that improving vitamin D status is a promising way to reduce the risk of severe illness, but we need randomized controlled trials to prove cause and effect,” she told Medscape Medical News.

103 patients with severe COVID-19, 52 with mild COVID-19, 206 controls

Gennari said several lines of evidence suggest that vitamin D deficiency might be a risk factor for COVID-19 severity.

Countries with lower average levels of vitamin D or lower UVB radiation exposure have higher COVID-19 mortality, and “demographic groups known to be at higher risk of vitamin D deficiency (such as black individuals, the elderly, nursing home residents, and those with obesity and diabetes) are at high risk of COVID-19 hospitalization/mortality, he noted.

There is a high prevalence of vitamin D deficiency in Italy, where mortality rates from COVID-19 have been particularly high.

To examine the relationship between vitamin D levels and COVID-19 severity/mortality, the researchers studied three groups:

• 103 symptomatic patients with COVID-19 with respiratory insufficiency who were admitted to a Milan hospital from March 9 to April 30.
• 52 patients with mild COVID-19, recruited from patients and staff from a nearby nursing home who had a positive test for COVID-19.
• 206 healthy controls, matched 2:1 with symptomatic patients of the same age, weight, and gender, from 3174 patients who had vitamin D measured during a routine check-up from January to March 2020.

Patients in the hospitalized group had lower mean vitamin D levels (18.2 ng/mL) than those with mild COVID-19 (30.3 ng/mL) or those in the control group (25.4 ng/mL).

Patients with symptomatic versus mild COVID-19 were slightly older and more likely to have at least one comorbidity and less likely to be taking a vitamin D supplement at baseline (30% vs 79%).

Among symptomatic patients, mean vitamin D levels were inversely associated with interleukin (IL)-6 and C-reactive protein, “both of which are a direct expression of the inflammatory status,” Gennari noted.

About half of the hospitalized patients (49) were admitted to a ward and discharged after a mean stay of 16 days (none died).

The other 54 hospitalized patients were admitted to the intensive care unit with severe acute respiratory distress; 38 patients received continuous positive airway pressure (CPAP) and 16 patients received endotracheal intubation.

Of the 54 patients admitted to ICU, 19 patients died from respiratory distress after a mean of 19 days, “consistent with the literature,” and the other 35 patients were discharged after a mean of 21 days.

Patients with severe COVID-19 who were admitted to the ICU, as opposed to a ward, were more likely to be male, have at least one comorbidity, have higher baseline IL-6 levels and neutrophil counts, and lower lymphocyte and platelet counts.

They also had lower mean vitamin D levels (14.4 vs 22.4 ng/mL) and were more likely to have vitamin D deficiency (vitamin D <20 ng/mL; 80% vs. 45%).  

Patients admitted to ICU who died had lower baseline vitamin D levels than those who survived (13.2 vs. 19.3 ng/mL).

Vitamin D levels were inversely associated with respiratory distress requiring ICU admission (odds ratio, 1.06; P = .038) and with mortality (OR, 1.18, P = 029), independent of IL-6 levels and other comorbidities.

“That vitamin D levels are associated with improved outcomes independent of IL-6 could reflect that IL-6 is an imperfect measure of the inflammatory process or that vitamin D is related to outcomes for other reasons, such as enhancement of innate or adaptive immunity,” said Meltzer.

He added that “this is not to exclude the possibility that vitamin D has important immunomodulatory effects.”

Gennari, Meltzer, and Manson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Having low serum vitamin D levels was an independent risk factor for having symptomatic COVID-19 with respiratory distress requiring admission to intensive care – as opposed to having mild COVID-19 – and for not surviving, in a new study from Italy.

“Our data give strong observational support to previous suggestions that reduced vitamin D levels may favor the appearance of severe respiratory dysfunction and increase the mortality risk in patients affected with COVID-19,” the researchers report.

Luigi Gennari, MD, PhD, Department of Medicine, Surgery, and Neurosciences, University of Siena, Italy, presented these findings during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

Gennari told Medscape Medical News that this analysis suggests determining vitamin D levels (25 hydroxyvitamin D) in people testing positive for SARS-Cov-2 infection might help predict their risk of severe disease.

However, further research is needed to explore whether vitamin D supplements could prevent the risk of respiratory failure in patients with SARS-Cov-2 infection, he stressed.

In the meantime, Gennari said: “I believe that, particularly in the winter season (when the solar ultraviolet-B (UVB) radiation exposure does not allow the skin to synthesize vitamin D in most countries), the use of vitamin D supplementation and correction of vitamin D deficiency might be of major relevance for the reduction of the clinical burden of the ongoing and future outbreaks of SARS-CoV-2 infection.

Invited to comment, David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, who was not involved with the study, agrees.

“I think this body of work suggests that people should be taking supplements if they cannot increase sun exposure on a sustained basis,” Meltzer said. “The abstract supports multiple prior findings that suggest that higher vitamin D levels are associated with improved outcomes.”

And JoAnn E. Manson, MD, DrPH, of Harvard Medical School and Brigham and Women’s Hospital, who was not involved with the research but has spoken about the topic in a video report for Medscape, said: “We know from several studies that a low vitamin D level is associated with a higher risk of having COVID-19 and severe illness, but correlation does not prove causation.”

“I think that improving vitamin D status is a promising way to reduce the risk of severe illness, but we need randomized controlled trials to prove cause and effect,” she told Medscape Medical News.

103 patients with severe COVID-19, 52 with mild COVID-19, 206 controls

Gennari said several lines of evidence suggest that vitamin D deficiency might be a risk factor for COVID-19 severity.

Countries with lower average levels of vitamin D or lower UVB radiation exposure have higher COVID-19 mortality, and “demographic groups known to be at higher risk of vitamin D deficiency (such as black individuals, the elderly, nursing home residents, and those with obesity and diabetes) are at high risk of COVID-19 hospitalization/mortality, he noted.

There is a high prevalence of vitamin D deficiency in Italy, where mortality rates from COVID-19 have been particularly high.

To examine the relationship between vitamin D levels and COVID-19 severity/mortality, the researchers studied three groups:

• 103 symptomatic patients with COVID-19 with respiratory insufficiency who were admitted to a Milan hospital from March 9 to April 30.
• 52 patients with mild COVID-19, recruited from patients and staff from a nearby nursing home who had a positive test for COVID-19.
• 206 healthy controls, matched 2:1 with symptomatic patients of the same age, weight, and gender, from 3174 patients who had vitamin D measured during a routine check-up from January to March 2020.

Patients in the hospitalized group had lower mean vitamin D levels (18.2 ng/mL) than those with mild COVID-19 (30.3 ng/mL) or those in the control group (25.4 ng/mL).

Patients with symptomatic versus mild COVID-19 were slightly older and more likely to have at least one comorbidity and less likely to be taking a vitamin D supplement at baseline (30% vs 79%).

Among symptomatic patients, mean vitamin D levels were inversely associated with interleukin (IL)-6 and C-reactive protein, “both of which are a direct expression of the inflammatory status,” Gennari noted.

About half of the hospitalized patients (49) were admitted to a ward and discharged after a mean stay of 16 days (none died).

The other 54 hospitalized patients were admitted to the intensive care unit with severe acute respiratory distress; 38 patients received continuous positive airway pressure (CPAP) and 16 patients received endotracheal intubation.

Of the 54 patients admitted to ICU, 19 patients died from respiratory distress after a mean of 19 days, “consistent with the literature,” and the other 35 patients were discharged after a mean of 21 days.

Patients with severe COVID-19 who were admitted to the ICU, as opposed to a ward, were more likely to be male, have at least one comorbidity, have higher baseline IL-6 levels and neutrophil counts, and lower lymphocyte and platelet counts.

They also had lower mean vitamin D levels (14.4 vs 22.4 ng/mL) and were more likely to have vitamin D deficiency (vitamin D <20 ng/mL; 80% vs. 45%).  

Patients admitted to ICU who died had lower baseline vitamin D levels than those who survived (13.2 vs. 19.3 ng/mL).

Vitamin D levels were inversely associated with respiratory distress requiring ICU admission (odds ratio, 1.06; P = .038) and with mortality (OR, 1.18, P = 029), independent of IL-6 levels and other comorbidities.

“That vitamin D levels are associated with improved outcomes independent of IL-6 could reflect that IL-6 is an imperfect measure of the inflammatory process or that vitamin D is related to outcomes for other reasons, such as enhancement of innate or adaptive immunity,” said Meltzer.

He added that “this is not to exclude the possibility that vitamin D has important immunomodulatory effects.”

Gennari, Meltzer, and Manson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

In a recent study published in the Journal of the American Medical Informatics Association that used EHR logs, researchers found that “Clinicians with the highest volume of patient call messages have almost 4 times the odds of burnout compared with clinicians with the fewest.” And they discovered that “No other workload measures were significantly associated with burnout.” Like the majority of papers I skim through, it states the obvious. Doesn’t it makes sense that the busiest of providers should be more vulnerable to stress related symptoms? But is that really true for every provider? Being “busy” doesn’t guarantee that you are productive nor does it mean that the stuff you are doing while you are busy is fulfilling or rewarding either emotionally or financially. Certainly, slogging through a long list of patient call messages at the end of the day does qualify as being busy, but it is more likely to generate anger and frustration than it is fulfillment.

Yuri_Arcurs/DigitalVision/Getty Images

Just because you have a large practice, does that mean that you will necessarily have more messages to review and calls to return than a provider with a smaller practice. Maybe you manage your practice and your time so well that you actually have fewer messages and calls to return and, therefore, are less vulnerable to burnout.

There are three general strategies that you might be employing that result in fewer messages and calls that require your response. It may be that you have developed a handbook of frequently asked questions and trained your staff to use it as a reference in a way that reduces the number of messages that filter to you. Creating this triage book and finding the right personnel took time, but it didn’t necessarily mean that you had to hire staff with extensive training, which can be expensive. In-house training of raw talent that has demonstrated common sense and good communication skills can be cost effective and rewarding. You probably already have discovered that continued attention to quality control is an important part of this strategy. Included in your handbook you may have included a clearcut triage system for the questions that the staff can’t answer. Is it a question you must answer (a) as soon as you finish with this patient, (b) before lunch, or (c) at the end of the day? (Category (c) is of course strongly discouraged).

The second general group of strategies you may be using to keep your calls and messages to a minimum is anticipatory guidance. As you wrap up each visit, are you anticipating what calls it might generate? This of course depends on the nature of the problem and the personality of the patient. From your experience you can probably predict most of the questions that are likely going to crop up after the patient arrives home. Preemptively answering these before patients leave and providing a personalized handout that you discuss with them may easily be saving you two or three calls a day. Because you can’t anticipate every question, you have found that promising a follow-up call in a day or 2 encourages the patients to hold their questions and wait for you or your assistant to call.

Finally, you may have discovered long ago that in many cases it is easier and more efficient to see the patient rather than having your staff spend half their time building and maintaining a communication wall around you. This is particularly true if, during the initial contact with your office, the patients have made it clear that they would like to be seen. This strategy is based on commons sense, but for many physicians and their office staff it may require a dramatic shift in attitude. You may have needed to become more comfortable squeezing in short visits at which the goal is to simply begin the dual processes of anxiety relief and diagnosis. In the beginning, you may have had to frequently remind your staff that their primary goal is patient satisfaction and not protecting you from seeing “too many” patients. Ironically, by being over protective, they may have been contributing to burnout when simply cutting to the chase and having the patient come in to be seen would have generated fewer stress-producing calls and messages.

There are different kinds of busy, and there are strategies to minimize the kind of busy that leads to burnout. Enabling a system that generates an excess of patient messages is looking for trouble.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

In a recent study published in the Journal of the American Medical Informatics Association that used EHR logs, researchers found that “Clinicians with the highest volume of patient call messages have almost 4 times the odds of burnout compared with clinicians with the fewest.” And they discovered that “No other workload measures were significantly associated with burnout.” Like the majority of papers I skim through, it states the obvious. Doesn’t it makes sense that the busiest of providers should be more vulnerable to stress related symptoms? But is that really true for every provider? Being “busy” doesn’t guarantee that you are productive nor does it mean that the stuff you are doing while you are busy is fulfilling or rewarding either emotionally or financially. Certainly, slogging through a long list of patient call messages at the end of the day does qualify as being busy, but it is more likely to generate anger and frustration than it is fulfillment.

Yuri_Arcurs/DigitalVision/Getty Images

Just because you have a large practice, does that mean that you will necessarily have more messages to review and calls to return than a provider with a smaller practice. Maybe you manage your practice and your time so well that you actually have fewer messages and calls to return and, therefore, are less vulnerable to burnout.

There are three general strategies that you might be employing that result in fewer messages and calls that require your response. It may be that you have developed a handbook of frequently asked questions and trained your staff to use it as a reference in a way that reduces the number of messages that filter to you. Creating this triage book and finding the right personnel took time, but it didn’t necessarily mean that you had to hire staff with extensive training, which can be expensive. In-house training of raw talent that has demonstrated common sense and good communication skills can be cost effective and rewarding. You probably already have discovered that continued attention to quality control is an important part of this strategy. Included in your handbook you may have included a clearcut triage system for the questions that the staff can’t answer. Is it a question you must answer (a) as soon as you finish with this patient, (b) before lunch, or (c) at the end of the day? (Category (c) is of course strongly discouraged).

The second general group of strategies you may be using to keep your calls and messages to a minimum is anticipatory guidance. As you wrap up each visit, are you anticipating what calls it might generate? This of course depends on the nature of the problem and the personality of the patient. From your experience you can probably predict most of the questions that are likely going to crop up after the patient arrives home. Preemptively answering these before patients leave and providing a personalized handout that you discuss with them may easily be saving you two or three calls a day. Because you can’t anticipate every question, you have found that promising a follow-up call in a day or 2 encourages the patients to hold their questions and wait for you or your assistant to call.

Finally, you may have discovered long ago that in many cases it is easier and more efficient to see the patient rather than having your staff spend half their time building and maintaining a communication wall around you. This is particularly true if, during the initial contact with your office, the patients have made it clear that they would like to be seen. This strategy is based on commons sense, but for many physicians and their office staff it may require a dramatic shift in attitude. You may have needed to become more comfortable squeezing in short visits at which the goal is to simply begin the dual processes of anxiety relief and diagnosis. In the beginning, you may have had to frequently remind your staff that their primary goal is patient satisfaction and not protecting you from seeing “too many” patients. Ironically, by being over protective, they may have been contributing to burnout when simply cutting to the chase and having the patient come in to be seen would have generated fewer stress-producing calls and messages.

There are different kinds of busy, and there are strategies to minimize the kind of busy that leads to burnout. Enabling a system that generates an excess of patient messages is looking for trouble.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

In a recent study published in the Journal of the American Medical Informatics Association that used EHR logs, researchers found that “Clinicians with the highest volume of patient call messages have almost 4 times the odds of burnout compared with clinicians with the fewest.” And they discovered that “No other workload measures were significantly associated with burnout.” Like the majority of papers I skim through, it states the obvious. Doesn’t it makes sense that the busiest of providers should be more vulnerable to stress related symptoms? But is that really true for every provider? Being “busy” doesn’t guarantee that you are productive nor does it mean that the stuff you are doing while you are busy is fulfilling or rewarding either emotionally or financially. Certainly, slogging through a long list of patient call messages at the end of the day does qualify as being busy, but it is more likely to generate anger and frustration than it is fulfillment.

Yuri_Arcurs/DigitalVision/Getty Images

Just because you have a large practice, does that mean that you will necessarily have more messages to review and calls to return than a provider with a smaller practice. Maybe you manage your practice and your time so well that you actually have fewer messages and calls to return and, therefore, are less vulnerable to burnout.

There are three general strategies that you might be employing that result in fewer messages and calls that require your response. It may be that you have developed a handbook of frequently asked questions and trained your staff to use it as a reference in a way that reduces the number of messages that filter to you. Creating this triage book and finding the right personnel took time, but it didn’t necessarily mean that you had to hire staff with extensive training, which can be expensive. In-house training of raw talent that has demonstrated common sense and good communication skills can be cost effective and rewarding. You probably already have discovered that continued attention to quality control is an important part of this strategy. Included in your handbook you may have included a clearcut triage system for the questions that the staff can’t answer. Is it a question you must answer (a) as soon as you finish with this patient, (b) before lunch, or (c) at the end of the day? (Category (c) is of course strongly discouraged).

The second general group of strategies you may be using to keep your calls and messages to a minimum is anticipatory guidance. As you wrap up each visit, are you anticipating what calls it might generate? This of course depends on the nature of the problem and the personality of the patient. From your experience you can probably predict most of the questions that are likely going to crop up after the patient arrives home. Preemptively answering these before patients leave and providing a personalized handout that you discuss with them may easily be saving you two or three calls a day. Because you can’t anticipate every question, you have found that promising a follow-up call in a day or 2 encourages the patients to hold their questions and wait for you or your assistant to call.

Finally, you may have discovered long ago that in many cases it is easier and more efficient to see the patient rather than having your staff spend half their time building and maintaining a communication wall around you. This is particularly true if, during the initial contact with your office, the patients have made it clear that they would like to be seen. This strategy is based on commons sense, but for many physicians and their office staff it may require a dramatic shift in attitude. You may have needed to become more comfortable squeezing in short visits at which the goal is to simply begin the dual processes of anxiety relief and diagnosis. In the beginning, you may have had to frequently remind your staff that their primary goal is patient satisfaction and not protecting you from seeing “too many” patients. Ironically, by being over protective, they may have been contributing to burnout when simply cutting to the chase and having the patient come in to be seen would have generated fewer stress-producing calls and messages.

There are different kinds of busy, and there are strategies to minimize the kind of busy that leads to burnout. Enabling a system that generates an excess of patient messages is looking for trouble.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.

Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.

But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.

The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.

Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.

“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a  health consultant who has worked with Colorado on its importation proposal.

Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.

Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.

The DeSantis administration did not respond to requests for comment.

Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”

The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.

The proposal would regulate how states set up their own programs for importing drugs from Canada.

Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.

The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.

But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.

“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”

Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.

Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.

For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.

About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.

The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.

The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.

The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.

Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”

The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.

Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.

The second program would be geared to the broader state population.

In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.

“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.

Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.

Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.

Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.

However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.

Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.

“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.

Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.

Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.

“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald. 

Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.

Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.

But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.

The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.

Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.

“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a  health consultant who has worked with Colorado on its importation proposal.

Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.

Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.

The DeSantis administration did not respond to requests for comment.

Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”

The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.

The proposal would regulate how states set up their own programs for importing drugs from Canada.

Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.

The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.

But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.

“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”

Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.

Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.

For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.

About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.

The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.

The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.

The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.

Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”

The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.

Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.

The second program would be geared to the broader state population.

In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.

“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.

Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.

Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.

Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.

However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.

Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.

“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.

Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.

Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.

“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald. 

Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.

Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.

But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.

The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.

Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.

“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a  health consultant who has worked with Colorado on its importation proposal.

Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.

Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.

The DeSantis administration did not respond to requests for comment.

Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”

The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.

The proposal would regulate how states set up their own programs for importing drugs from Canada.

Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.

The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.

But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.

“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”

Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.

Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.

For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.

About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.

The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.

The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.

The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.

Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”

The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.

Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.

The second program would be geared to the broader state population.

In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.

“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.

Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.

Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.

Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.

However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.

Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.

“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.

Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.

Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.

“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald. 

Almost a quarter of adults in the United States are very concerned about access to health care during the COVID-19 pandemic, according to the results of a survey conducted Aug. 7-26.

Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.

At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.

When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.

Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:

• Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
• Frequently washing hands: 74.7% very, 1.6% not at all.
• Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
• Wearing a face mask in public: 75.7% very, 3.5% not at all.

The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.

[email protected]

Almost a quarter of adults in the United States are very concerned about access to health care during the COVID-19 pandemic, according to the results of a survey conducted Aug. 7-26.

Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.

At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.

When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.

Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:

• Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
• Frequently washing hands: 74.7% very, 1.6% not at all.
• Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
• Wearing a face mask in public: 75.7% very, 3.5% not at all.

The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.

[email protected]

Almost a quarter of adults in the United States are very concerned about access to health care during the COVID-19 pandemic, according to the results of a survey conducted Aug. 7-26.

Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.

At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.

When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.

Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:

• Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
• Frequently washing hands: 74.7% very, 1.6% not at all.
• Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
• Wearing a face mask in public: 75.7% very, 3.5% not at all.

The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.

[email protected]

Three previously described clinical phenotypes of obstructive sleep apnea (OSA) have been validated in a large and diverse Hispanic/Latino community-based population for the first time, according to findings presented at the virtual annual meeting of the Associated Professional Sleep Societies.

The three OSA symptom profiles present in this population – labeled “minimally symptomatic,” “disturbed sleep,” and “daytime sleepiness” – are consistent with recent findings from the Sleep Apnea Global Interdisciplinary Consortium, which were published in Sleep, but there are notable differences in the prevalence of these clusters, with the minimally symptomatic cluster much more prevalent than in prior research, reported Kevin Gonzalez, of the University of California, San Diego.

“Other biopsychosocial factors may be contributing to OSA phenotypes among Hispanics and Latinos,” Mr. Gonzalez said in his presentation. Prior research to characterize the heterogeneity of sleep apnea has not included a diverse Latino population, he emphasized.

The adults studied were aged 18-74 years and participants in the multisite Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a comprehensive study of Hispanic/Latino health and disease in the United States. Their respiratory events were measured overnight in HCHS/SOL sleep reading centers with an ARES Unicorder 5.2, B-Alert. Sleep patterns and risk factors were assessed using the Sleep Heart Health Study Sleep Habits Questionnaire and the Epworth Sleepiness Scale.

Participants meeting the criteria for moderate to severe OSA (with an Apnea Hypopnea Index of 15 or above) were included in the analysis (n = 1,623). Their average age was 52.4 ± 13.9 years, and 34.1% were female.

To identify phenotype clusters, investigators performed a latent class analysis using 15 common OSA symptoms and a survey weighted to adjust for selection bias. The three clusters offering the “best” fit for the data aligned with the previously reported phenotypes and identified daytime sleepiness in 15.3%, disturbed sleep (insomnia-like symptoms) in 37.7%, and minimally symptomatic (a low symptom profile) in 46.9%.

These phenotypes were reported in the European Respiratory Journal in 2014 in a cluster analysis of data from a sleep apnea cohort in Iceland and later replicated in the analysis of data from the Sleep Apnea Global Interdisciplinary Consortium published in Sleep in 2018. The consortium study also added two additional phenotypes, labeled “upper airway symptoms dominant” and “sleepiness dominant.”

The prevalence of a “minimally symptomatic group” in the new analysis of the Hispanics/Latinos in the United States is much higher than reported in these prior studies, at least partly, the investigators believed, because the “prior studies were clinical samples, and the people who were minimally symptomatic didn’t get to the sleep centers,” Mr. Gonzalez said in an interview after the meeting.

Patients with a phenotype of daytime sleepiness – the most common phenotype in prior research – constituted only a minority in the Hispanic/Latino population, he said.

Alberto Ramos, MD, of the University of Miami and the principal investigator, said in an interview that the research team is currently analyzing “if and how these different [phenotypic] clusters could affect the incidence of comorbidities” recorded in the HCHS/SOL study, such as hypertension, diabetes, cardiovascular disease, and cognitive decline.

For now, he said, the findings suggest that OSA may be especially underrecognized in Hispanics and Latinos and that there is more research to be done to better identify and stratify patients with varying symptomatology for more personalized treatment and for clinical trial selection. “Maybe we should expand our criteria ... broaden our [recognition] of the presentation of sleep apnea and the symptoms associated with it, not only in Hispanics but maybe in the general population,” Dr. Ramos said.

In commenting on the study, Krishna M. Sundar, MD, FCCP, director of the Sleep-Wake Center at the University of Utah, Salt Lake City, said that insomnia and daytime sleepiness are “key associations with obstructive sleep apnea and may predict different outcomes with untreated OSA.” Such heterogeneity is “only beginning to be appreciated,” he said. “The expression of OSA with these symptoms points to how OSA impacts quality of life” and how symptomatology in addition to Apnea Hypopnea Index “may be an important determinant of treatment benefit and compliance.”

The investigators reported no relevant disclosures. Dr. Sundar said that he is cofounder of Hypnoscure, software for population management of sleep apnea, but with no monies received.
 

Three previously described clinical phenotypes of obstructive sleep apnea (OSA) have been validated in a large and diverse Hispanic/Latino community-based population for the first time, according to findings presented at the virtual annual meeting of the Associated Professional Sleep Societies.

The three OSA symptom profiles present in this population – labeled “minimally symptomatic,” “disturbed sleep,” and “daytime sleepiness” – are consistent with recent findings from the Sleep Apnea Global Interdisciplinary Consortium, which were published in Sleep, but there are notable differences in the prevalence of these clusters, with the minimally symptomatic cluster much more prevalent than in prior research, reported Kevin Gonzalez, of the University of California, San Diego.

“Other biopsychosocial factors may be contributing to OSA phenotypes among Hispanics and Latinos,” Mr. Gonzalez said in his presentation. Prior research to characterize the heterogeneity of sleep apnea has not included a diverse Latino population, he emphasized.

The adults studied were aged 18-74 years and participants in the multisite Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a comprehensive study of Hispanic/Latino health and disease in the United States. Their respiratory events were measured overnight in HCHS/SOL sleep reading centers with an ARES Unicorder 5.2, B-Alert. Sleep patterns and risk factors were assessed using the Sleep Heart Health Study Sleep Habits Questionnaire and the Epworth Sleepiness Scale.

Participants meeting the criteria for moderate to severe OSA (with an Apnea Hypopnea Index of 15 or above) were included in the analysis (n = 1,623). Their average age was 52.4 ± 13.9 years, and 34.1% were female.

To identify phenotype clusters, investigators performed a latent class analysis using 15 common OSA symptoms and a survey weighted to adjust for selection bias. The three clusters offering the “best” fit for the data aligned with the previously reported phenotypes and identified daytime sleepiness in 15.3%, disturbed sleep (insomnia-like symptoms) in 37.7%, and minimally symptomatic (a low symptom profile) in 46.9%.

These phenotypes were reported in the European Respiratory Journal in 2014 in a cluster analysis of data from a sleep apnea cohort in Iceland and later replicated in the analysis of data from the Sleep Apnea Global Interdisciplinary Consortium published in Sleep in 2018. The consortium study also added two additional phenotypes, labeled “upper airway symptoms dominant” and “sleepiness dominant.”

The prevalence of a “minimally symptomatic group” in the new analysis of the Hispanics/Latinos in the United States is much higher than reported in these prior studies, at least partly, the investigators believed, because the “prior studies were clinical samples, and the people who were minimally symptomatic didn’t get to the sleep centers,” Mr. Gonzalez said in an interview after the meeting.

Patients with a phenotype of daytime sleepiness – the most common phenotype in prior research – constituted only a minority in the Hispanic/Latino population, he said.

Alberto Ramos, MD, of the University of Miami and the principal investigator, said in an interview that the research team is currently analyzing “if and how these different [phenotypic] clusters could affect the incidence of comorbidities” recorded in the HCHS/SOL study, such as hypertension, diabetes, cardiovascular disease, and cognitive decline.

For now, he said, the findings suggest that OSA may be especially underrecognized in Hispanics and Latinos and that there is more research to be done to better identify and stratify patients with varying symptomatology for more personalized treatment and for clinical trial selection. “Maybe we should expand our criteria ... broaden our [recognition] of the presentation of sleep apnea and the symptoms associated with it, not only in Hispanics but maybe in the general population,” Dr. Ramos said.

In commenting on the study, Krishna M. Sundar, MD, FCCP, director of the Sleep-Wake Center at the University of Utah, Salt Lake City, said that insomnia and daytime sleepiness are “key associations with obstructive sleep apnea and may predict different outcomes with untreated OSA.” Such heterogeneity is “only beginning to be appreciated,” he said. “The expression of OSA with these symptoms points to how OSA impacts quality of life” and how symptomatology in addition to Apnea Hypopnea Index “may be an important determinant of treatment benefit and compliance.”

The investigators reported no relevant disclosures. Dr. Sundar said that he is cofounder of Hypnoscure, software for population management of sleep apnea, but with no monies received.
 

Three previously described clinical phenotypes of obstructive sleep apnea (OSA) have been validated in a large and diverse Hispanic/Latino community-based population for the first time, according to findings presented at the virtual annual meeting of the Associated Professional Sleep Societies.

The three OSA symptom profiles present in this population – labeled “minimally symptomatic,” “disturbed sleep,” and “daytime sleepiness” – are consistent with recent findings from the Sleep Apnea Global Interdisciplinary Consortium, which were published in Sleep, but there are notable differences in the prevalence of these clusters, with the minimally symptomatic cluster much more prevalent than in prior research, reported Kevin Gonzalez, of the University of California, San Diego.

“Other biopsychosocial factors may be contributing to OSA phenotypes among Hispanics and Latinos,” Mr. Gonzalez said in his presentation. Prior research to characterize the heterogeneity of sleep apnea has not included a diverse Latino population, he emphasized.

The adults studied were aged 18-74 years and participants in the multisite Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a comprehensive study of Hispanic/Latino health and disease in the United States. Their respiratory events were measured overnight in HCHS/SOL sleep reading centers with an ARES Unicorder 5.2, B-Alert. Sleep patterns and risk factors were assessed using the Sleep Heart Health Study Sleep Habits Questionnaire and the Epworth Sleepiness Scale.

Participants meeting the criteria for moderate to severe OSA (with an Apnea Hypopnea Index of 15 or above) were included in the analysis (n = 1,623). Their average age was 52.4 ± 13.9 years, and 34.1% were female.

To identify phenotype clusters, investigators performed a latent class analysis using 15 common OSA symptoms and a survey weighted to adjust for selection bias. The three clusters offering the “best” fit for the data aligned with the previously reported phenotypes and identified daytime sleepiness in 15.3%, disturbed sleep (insomnia-like symptoms) in 37.7%, and minimally symptomatic (a low symptom profile) in 46.9%.

These phenotypes were reported in the European Respiratory Journal in 2014 in a cluster analysis of data from a sleep apnea cohort in Iceland and later replicated in the analysis of data from the Sleep Apnea Global Interdisciplinary Consortium published in Sleep in 2018. The consortium study also added two additional phenotypes, labeled “upper airway symptoms dominant” and “sleepiness dominant.”

The prevalence of a “minimally symptomatic group” in the new analysis of the Hispanics/Latinos in the United States is much higher than reported in these prior studies, at least partly, the investigators believed, because the “prior studies were clinical samples, and the people who were minimally symptomatic didn’t get to the sleep centers,” Mr. Gonzalez said in an interview after the meeting.

Patients with a phenotype of daytime sleepiness – the most common phenotype in prior research – constituted only a minority in the Hispanic/Latino population, he said.

Alberto Ramos, MD, of the University of Miami and the principal investigator, said in an interview that the research team is currently analyzing “if and how these different [phenotypic] clusters could affect the incidence of comorbidities” recorded in the HCHS/SOL study, such as hypertension, diabetes, cardiovascular disease, and cognitive decline.

For now, he said, the findings suggest that OSA may be especially underrecognized in Hispanics and Latinos and that there is more research to be done to better identify and stratify patients with varying symptomatology for more personalized treatment and for clinical trial selection. “Maybe we should expand our criteria ... broaden our [recognition] of the presentation of sleep apnea and the symptoms associated with it, not only in Hispanics but maybe in the general population,” Dr. Ramos said.

In commenting on the study, Krishna M. Sundar, MD, FCCP, director of the Sleep-Wake Center at the University of Utah, Salt Lake City, said that insomnia and daytime sleepiness are “key associations with obstructive sleep apnea and may predict different outcomes with untreated OSA.” Such heterogeneity is “only beginning to be appreciated,” he said. “The expression of OSA with these symptoms points to how OSA impacts quality of life” and how symptomatology in addition to Apnea Hypopnea Index “may be an important determinant of treatment benefit and compliance.”

The investigators reported no relevant disclosures. Dr. Sundar said that he is cofounder of Hypnoscure, software for population management of sleep apnea, but with no monies received.