Clinical Psychiatry News

It took less than a day for physician groups to start pushing back at the Centers for Medicare & Medicaid Services over its new Medicaid block grant plan, which was introduced on Jan. 30.

Dubbed “Healthy Adult Opportunity,” the agency is offering all states the chance to participate in a block grant program through the 1115 waiver process.

According to a fact sheet issued by the agency, the program will focus on “adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan. Other very low-income parents, children, pregnant women, elderly adults, and people eligible on the basis of a disability will not be directly affected – except from the improvement that results from states reinvesting savings into strengthening their overall programs.”

States will be operating within a defined budget when participating in the program and expenditures exceeding that defined budget will not be eligible for additional federal funding. Budgets will be based on a state’s historic costs, as well as national and regional trends, and will be tied to inflation with the potential to have adjustments made for extraordinary events. States can set their baseline using the prior year’s total spending or a per-enrollee spending model.

A Jan. 30 letter to state Medicaid directors notes that states participating in the program “will be granted extensive flexibility to test alternative approaches to implementing their Medicaid programs, including the ability to make many ongoing program adjustments without the need for demonstration or state plan amendments that require prior approval.”

Among the activities states can engage in under this plan are adjusting cost-sharing requirements, adopting a closed formulary, and applying additional conditions of eligibility. Requests, if approved, will be approved for a 5-year initial period, with a renewal option of up to 10 years.

But physician groups are not seeing a benefit with this new block grant program.

“Moving to a block grant system will likely limit the ability of Medicaid patients to receive preventive and needed medical care from their family physicians, and it will only increase the health disparities that exist in these communities, worsen overall health outcomes, and ultimately increase costs,” Gary LeRoy, MD, president of the American Academy of Family Physicians, said in a statement.

The American Medical Association concurred.

“The AMA opposes caps on federal Medicaid funding, such as block grants, because they would increase the number of uninsured and undermine Medicaid’s role as an indispensable safety net,” Patrice Harris, MD, the AMA’s president, said in a statement. “The AMA supports flexibility in Medicaid and encourages CMS to work with states to develop and test new Medicaid models that best meet the needs and priorities of low-income patients. While encouraging flexibility, the AMA is mindful that expanding Medicaid has been a literal lifesaver for low-income patients. We need to find ways to build on this success. We look forward to reviewing the proposal in detail.”

Officials at the American College of Obstetricians and Gynecologists said the changes have the potential to harm women and children’s health, as well as negatively impact physician reimbursement and ultimately access to care.

“Limits on the federal contribution to the Medicaid program would negatively impact patients by forcing states to reduce the number of people who are eligible for Medicaid coverage, eliminate covered services, and increase beneficiary cost-sharing,” ACOG President Ted Anderson, MD, said in a statement. “ACOG is also concerned that this block grant opportunity could lower physician reimbursement for certain services, forcing providers out of the program and jeopardizing patients’ ability to access health care services. Given our nation’s stark rates of maternal mortality and severe maternal morbidity, we are alarmed by the Administration’s willingness to weaken physician payment in Medicaid.”

[email protected]

It took less than a day for physician groups to start pushing back at the Centers for Medicare & Medicaid Services over its new Medicaid block grant plan, which was introduced on Jan. 30.

Dubbed “Healthy Adult Opportunity,” the agency is offering all states the chance to participate in a block grant program through the 1115 waiver process.

According to a fact sheet issued by the agency, the program will focus on “adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan. Other very low-income parents, children, pregnant women, elderly adults, and people eligible on the basis of a disability will not be directly affected – except from the improvement that results from states reinvesting savings into strengthening their overall programs.”

States will be operating within a defined budget when participating in the program and expenditures exceeding that defined budget will not be eligible for additional federal funding. Budgets will be based on a state’s historic costs, as well as national and regional trends, and will be tied to inflation with the potential to have adjustments made for extraordinary events. States can set their baseline using the prior year’s total spending or a per-enrollee spending model.

A Jan. 30 letter to state Medicaid directors notes that states participating in the program “will be granted extensive flexibility to test alternative approaches to implementing their Medicaid programs, including the ability to make many ongoing program adjustments without the need for demonstration or state plan amendments that require prior approval.”

Among the activities states can engage in under this plan are adjusting cost-sharing requirements, adopting a closed formulary, and applying additional conditions of eligibility. Requests, if approved, will be approved for a 5-year initial period, with a renewal option of up to 10 years.

But physician groups are not seeing a benefit with this new block grant program.

“Moving to a block grant system will likely limit the ability of Medicaid patients to receive preventive and needed medical care from their family physicians, and it will only increase the health disparities that exist in these communities, worsen overall health outcomes, and ultimately increase costs,” Gary LeRoy, MD, president of the American Academy of Family Physicians, said in a statement.

The American Medical Association concurred.

“The AMA opposes caps on federal Medicaid funding, such as block grants, because they would increase the number of uninsured and undermine Medicaid’s role as an indispensable safety net,” Patrice Harris, MD, the AMA’s president, said in a statement. “The AMA supports flexibility in Medicaid and encourages CMS to work with states to develop and test new Medicaid models that best meet the needs and priorities of low-income patients. While encouraging flexibility, the AMA is mindful that expanding Medicaid has been a literal lifesaver for low-income patients. We need to find ways to build on this success. We look forward to reviewing the proposal in detail.”

Officials at the American College of Obstetricians and Gynecologists said the changes have the potential to harm women and children’s health, as well as negatively impact physician reimbursement and ultimately access to care.

“Limits on the federal contribution to the Medicaid program would negatively impact patients by forcing states to reduce the number of people who are eligible for Medicaid coverage, eliminate covered services, and increase beneficiary cost-sharing,” ACOG President Ted Anderson, MD, said in a statement. “ACOG is also concerned that this block grant opportunity could lower physician reimbursement for certain services, forcing providers out of the program and jeopardizing patients’ ability to access health care services. Given our nation’s stark rates of maternal mortality and severe maternal morbidity, we are alarmed by the Administration’s willingness to weaken physician payment in Medicaid.”

[email protected]

It took less than a day for physician groups to start pushing back at the Centers for Medicare & Medicaid Services over its new Medicaid block grant plan, which was introduced on Jan. 30.

Dubbed “Healthy Adult Opportunity,” the agency is offering all states the chance to participate in a block grant program through the 1115 waiver process.

According to a fact sheet issued by the agency, the program will focus on “adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan. Other very low-income parents, children, pregnant women, elderly adults, and people eligible on the basis of a disability will not be directly affected – except from the improvement that results from states reinvesting savings into strengthening their overall programs.”

States will be operating within a defined budget when participating in the program and expenditures exceeding that defined budget will not be eligible for additional federal funding. Budgets will be based on a state’s historic costs, as well as national and regional trends, and will be tied to inflation with the potential to have adjustments made for extraordinary events. States can set their baseline using the prior year’s total spending or a per-enrollee spending model.

A Jan. 30 letter to state Medicaid directors notes that states participating in the program “will be granted extensive flexibility to test alternative approaches to implementing their Medicaid programs, including the ability to make many ongoing program adjustments without the need for demonstration or state plan amendments that require prior approval.”

Among the activities states can engage in under this plan are adjusting cost-sharing requirements, adopting a closed formulary, and applying additional conditions of eligibility. Requests, if approved, will be approved for a 5-year initial period, with a renewal option of up to 10 years.

But physician groups are not seeing a benefit with this new block grant program.

“Moving to a block grant system will likely limit the ability of Medicaid patients to receive preventive and needed medical care from their family physicians, and it will only increase the health disparities that exist in these communities, worsen overall health outcomes, and ultimately increase costs,” Gary LeRoy, MD, president of the American Academy of Family Physicians, said in a statement.

The American Medical Association concurred.

“The AMA opposes caps on federal Medicaid funding, such as block grants, because they would increase the number of uninsured and undermine Medicaid’s role as an indispensable safety net,” Patrice Harris, MD, the AMA’s president, said in a statement. “The AMA supports flexibility in Medicaid and encourages CMS to work with states to develop and test new Medicaid models that best meet the needs and priorities of low-income patients. While encouraging flexibility, the AMA is mindful that expanding Medicaid has been a literal lifesaver for low-income patients. We need to find ways to build on this success. We look forward to reviewing the proposal in detail.”

Officials at the American College of Obstetricians and Gynecologists said the changes have the potential to harm women and children’s health, as well as negatively impact physician reimbursement and ultimately access to care.

“Limits on the federal contribution to the Medicaid program would negatively impact patients by forcing states to reduce the number of people who are eligible for Medicaid coverage, eliminate covered services, and increase beneficiary cost-sharing,” ACOG President Ted Anderson, MD, said in a statement. “ACOG is also concerned that this block grant opportunity could lower physician reimbursement for certain services, forcing providers out of the program and jeopardizing patients’ ability to access health care services. Given our nation’s stark rates of maternal mortality and severe maternal morbidity, we are alarmed by the Administration’s willingness to weaken physician payment in Medicaid.”

[email protected]

A number of years ago, a patient I was treating mentioned that she was not eating tomatoes. There had been stories in the news about people contracting bacterial infections from tomatoes, but I paused for a moment, then asked her: “Have there been any contaminated tomatoes here in Maryland?” There had not been and I was still happily eating salsa, but my patient thought about this differently: If disease-causing tomatoes were to come to our state, someone would be the first person to become ill. She did not want to take any risks. My patient, however, was a heavy smoker and already grappling with health issues that were caused by smoking, so I found her choice of what she should worry about and how it influenced her behavior to be perplexing. I realize it’s not the same; nicotine is an addiction, while tomatoes remain a choice for most of us, and it’s common for people to worry about very unlikely events even when we are surrounded by very real and statistically more probable threats to our well-being.

Today’s news reports are filled with stories about 2019 Novel Coronavirus (2019-nCoV), an illness that started in Wuhan, China; as of Jan. 31, 2020, there were 9,776 confirmed cases and 213 deaths. There have been an additional 118 cases reported outside of mainland China, including 6 in the United States, and no one outside of China has died.

The response to the virus has been remarkable: Wuhan, a city of more than 11 million inhabitants, is on lockdown, as are 15 other cities in China; 46 million people have been affected, the largest quarantine in human history. Travel is restricted in parts of China, airports all over the world are screening those who fly in from Wuhan, foreign governments are bringing their citizens home from Wuhan, and even Starbucks has temporarily closed half its stores in China. The economics of containing this virus are astounding.

In the meantime, the Centers for Disease Control and Prevention reports that, as of the week of Jan. 25, there have been 19 million cases of the flu in the United States. Of those stricken, 180,000 people have been hospitalized and 10,000 have died, including 68 pediatric patients. No cities are on lockdown, public transportation runs as usual, airports don’t screen passengers for flu symptoms, and Starbucks continues to serve vanilla lattes to any willing customer. Anxiety about illness is not new; we’ve seen it with SARS, Ebola, measles, and even around Chipotle’s food poisoning cases – to name just a few recent scares. We have also seen a lot of media on vaping-related deaths, and as of early January 2020, vaping-related illnesses affected 2,602 people with 59 deaths. It has been a topic of discussion among legislators, with an emphasis on either outlawing the flavoring that might appeal to younger people or simply outlawing e-cigarettes. No one, however, is talking about outlawing regular cigarettes, despite the fact that many people have switched from cigarettes to vaping products as a way to quit smoking. So, while vaping has caused 59 deaths since 2018, cigarettes are responsible for 480,000 fatalities a year in the United States and smokers live, on average, 10 years less than nonsmokers.

So what fuels anxiety about the latest health scare, and why aren’t we more anxious about the more common causes of premature mortality? Certainly, the newness and the unknown are factors in the coronavirus scare. It’s not certain how this illness was introduced into the human population, although one theory is that it started with the consumption of bats who carry the virus. It’s spreading fast, and in some people, it has been lethal. The incubation period is not known, or whether it is contagious before symptoms appear. Coronavirus is getting a lot of public health attention and the World Health Organization just announced that the virus is a public health emergency of international concern. On the televised news on Jan. 29, 2020, coronavirus was the top story in the United States, even though an impeachment trial is in progress for our country’s president.

The public health response of locking down cities may help contain the outbreak and prevent a global epidemic, although millions of people had already left Wuhan, so the heavy-handed attempt to prevent spread of the virus may well be too late. In the case of the Ebola virus – a much more lethal disease that was also thought to be introduced by bats – public health measures certainly curtailed global spread, and the epidemic of 2014-2016 was limited to 28,600 cases and 11,325 deaths, nearly all of them in West Africa.

Most of the things that cause people to die are not new and are not topics the media chooses to sensationalize. Dissemination of news has changed over the decades, with so much more of it, instant reports on social media, and competition for viewers that leads journalists to pull at our emotions. We might worry about getting food poisoning from romaine lettuce – if that is what the news is focusing on – but we don’t worry when we enter our cars, keep firearms in our homes, or light up cigarettes. And while we may, or may not, get flu shots and avoid those who have the flu, how and where we position both our anxiety and our resources does not always make sense. Certainly some people are predisposed to worry about both common and uncommon dangers, while others seem never to worry and engage in acts that many of us would consider dangerous. If we are looking for logic, it may be hard to find – there are those who would happily go bungee jumping but wouldn’t dream of leaving the house out without hand sanitizer.

The repercussions from this massive response to the Wuhan coronavirus are significant. For the millions of people on lockdown in China, each day gets emotionally harder; some may begin to have issues procuring food, and the financial losses for the economy will be significant. It’s not really possible to know yet if this response is warranted; we do know that infectious diseases can kill millions. The AIDS pandemic has taken the lives of 36 million people since 1981, and the influenza pandemic of 1918 resulted in an estimated 20 million to 50 million deaths after infecting 500 million people. Still, one might wonder if other, more mundane causes of morbidity and mortality – the ones that no longer garner our dread or make it to the front pages – might also be worthy of more hype and resources.

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

A number of years ago, a patient I was treating mentioned that she was not eating tomatoes. There had been stories in the news about people contracting bacterial infections from tomatoes, but I paused for a moment, then asked her: “Have there been any contaminated tomatoes here in Maryland?” There had not been and I was still happily eating salsa, but my patient thought about this differently: If disease-causing tomatoes were to come to our state, someone would be the first person to become ill. She did not want to take any risks. My patient, however, was a heavy smoker and already grappling with health issues that were caused by smoking, so I found her choice of what she should worry about and how it influenced her behavior to be perplexing. I realize it’s not the same; nicotine is an addiction, while tomatoes remain a choice for most of us, and it’s common for people to worry about very unlikely events even when we are surrounded by very real and statistically more probable threats to our well-being.

Today’s news reports are filled with stories about 2019 Novel Coronavirus (2019-nCoV), an illness that started in Wuhan, China; as of Jan. 31, 2020, there were 9,776 confirmed cases and 213 deaths. There have been an additional 118 cases reported outside of mainland China, including 6 in the United States, and no one outside of China has died.

The response to the virus has been remarkable: Wuhan, a city of more than 11 million inhabitants, is on lockdown, as are 15 other cities in China; 46 million people have been affected, the largest quarantine in human history. Travel is restricted in parts of China, airports all over the world are screening those who fly in from Wuhan, foreign governments are bringing their citizens home from Wuhan, and even Starbucks has temporarily closed half its stores in China. The economics of containing this virus are astounding.

In the meantime, the Centers for Disease Control and Prevention reports that, as of the week of Jan. 25, there have been 19 million cases of the flu in the United States. Of those stricken, 180,000 people have been hospitalized and 10,000 have died, including 68 pediatric patients. No cities are on lockdown, public transportation runs as usual, airports don’t screen passengers for flu symptoms, and Starbucks continues to serve vanilla lattes to any willing customer. Anxiety about illness is not new; we’ve seen it with SARS, Ebola, measles, and even around Chipotle’s food poisoning cases – to name just a few recent scares. We have also seen a lot of media on vaping-related deaths, and as of early January 2020, vaping-related illnesses affected 2,602 people with 59 deaths. It has been a topic of discussion among legislators, with an emphasis on either outlawing the flavoring that might appeal to younger people or simply outlawing e-cigarettes. No one, however, is talking about outlawing regular cigarettes, despite the fact that many people have switched from cigarettes to vaping products as a way to quit smoking. So, while vaping has caused 59 deaths since 2018, cigarettes are responsible for 480,000 fatalities a year in the United States and smokers live, on average, 10 years less than nonsmokers.

So what fuels anxiety about the latest health scare, and why aren’t we more anxious about the more common causes of premature mortality? Certainly, the newness and the unknown are factors in the coronavirus scare. It’s not certain how this illness was introduced into the human population, although one theory is that it started with the consumption of bats who carry the virus. It’s spreading fast, and in some people, it has been lethal. The incubation period is not known, or whether it is contagious before symptoms appear. Coronavirus is getting a lot of public health attention and the World Health Organization just announced that the virus is a public health emergency of international concern. On the televised news on Jan. 29, 2020, coronavirus was the top story in the United States, even though an impeachment trial is in progress for our country’s president.

The public health response of locking down cities may help contain the outbreak and prevent a global epidemic, although millions of people had already left Wuhan, so the heavy-handed attempt to prevent spread of the virus may well be too late. In the case of the Ebola virus – a much more lethal disease that was also thought to be introduced by bats – public health measures certainly curtailed global spread, and the epidemic of 2014-2016 was limited to 28,600 cases and 11,325 deaths, nearly all of them in West Africa.

Most of the things that cause people to die are not new and are not topics the media chooses to sensationalize. Dissemination of news has changed over the decades, with so much more of it, instant reports on social media, and competition for viewers that leads journalists to pull at our emotions. We might worry about getting food poisoning from romaine lettuce – if that is what the news is focusing on – but we don’t worry when we enter our cars, keep firearms in our homes, or light up cigarettes. And while we may, or may not, get flu shots and avoid those who have the flu, how and where we position both our anxiety and our resources does not always make sense. Certainly some people are predisposed to worry about both common and uncommon dangers, while others seem never to worry and engage in acts that many of us would consider dangerous. If we are looking for logic, it may be hard to find – there are those who would happily go bungee jumping but wouldn’t dream of leaving the house out without hand sanitizer.

The repercussions from this massive response to the Wuhan coronavirus are significant. For the millions of people on lockdown in China, each day gets emotionally harder; some may begin to have issues procuring food, and the financial losses for the economy will be significant. It’s not really possible to know yet if this response is warranted; we do know that infectious diseases can kill millions. The AIDS pandemic has taken the lives of 36 million people since 1981, and the influenza pandemic of 1918 resulted in an estimated 20 million to 50 million deaths after infecting 500 million people. Still, one might wonder if other, more mundane causes of morbidity and mortality – the ones that no longer garner our dread or make it to the front pages – might also be worthy of more hype and resources.

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

A number of years ago, a patient I was treating mentioned that she was not eating tomatoes. There had been stories in the news about people contracting bacterial infections from tomatoes, but I paused for a moment, then asked her: “Have there been any contaminated tomatoes here in Maryland?” There had not been and I was still happily eating salsa, but my patient thought about this differently: If disease-causing tomatoes were to come to our state, someone would be the first person to become ill. She did not want to take any risks. My patient, however, was a heavy smoker and already grappling with health issues that were caused by smoking, so I found her choice of what she should worry about and how it influenced her behavior to be perplexing. I realize it’s not the same; nicotine is an addiction, while tomatoes remain a choice for most of us, and it’s common for people to worry about very unlikely events even when we are surrounded by very real and statistically more probable threats to our well-being.

Today’s news reports are filled with stories about 2019 Novel Coronavirus (2019-nCoV), an illness that started in Wuhan, China; as of Jan. 31, 2020, there were 9,776 confirmed cases and 213 deaths. There have been an additional 118 cases reported outside of mainland China, including 6 in the United States, and no one outside of China has died.

The response to the virus has been remarkable: Wuhan, a city of more than 11 million inhabitants, is on lockdown, as are 15 other cities in China; 46 million people have been affected, the largest quarantine in human history. Travel is restricted in parts of China, airports all over the world are screening those who fly in from Wuhan, foreign governments are bringing their citizens home from Wuhan, and even Starbucks has temporarily closed half its stores in China. The economics of containing this virus are astounding.

In the meantime, the Centers for Disease Control and Prevention reports that, as of the week of Jan. 25, there have been 19 million cases of the flu in the United States. Of those stricken, 180,000 people have been hospitalized and 10,000 have died, including 68 pediatric patients. No cities are on lockdown, public transportation runs as usual, airports don’t screen passengers for flu symptoms, and Starbucks continues to serve vanilla lattes to any willing customer. Anxiety about illness is not new; we’ve seen it with SARS, Ebola, measles, and even around Chipotle’s food poisoning cases – to name just a few recent scares. We have also seen a lot of media on vaping-related deaths, and as of early January 2020, vaping-related illnesses affected 2,602 people with 59 deaths. It has been a topic of discussion among legislators, with an emphasis on either outlawing the flavoring that might appeal to younger people or simply outlawing e-cigarettes. No one, however, is talking about outlawing regular cigarettes, despite the fact that many people have switched from cigarettes to vaping products as a way to quit smoking. So, while vaping has caused 59 deaths since 2018, cigarettes are responsible for 480,000 fatalities a year in the United States and smokers live, on average, 10 years less than nonsmokers.

So what fuels anxiety about the latest health scare, and why aren’t we more anxious about the more common causes of premature mortality? Certainly, the newness and the unknown are factors in the coronavirus scare. It’s not certain how this illness was introduced into the human population, although one theory is that it started with the consumption of bats who carry the virus. It’s spreading fast, and in some people, it has been lethal. The incubation period is not known, or whether it is contagious before symptoms appear. Coronavirus is getting a lot of public health attention and the World Health Organization just announced that the virus is a public health emergency of international concern. On the televised news on Jan. 29, 2020, coronavirus was the top story in the United States, even though an impeachment trial is in progress for our country’s president.

The public health response of locking down cities may help contain the outbreak and prevent a global epidemic, although millions of people had already left Wuhan, so the heavy-handed attempt to prevent spread of the virus may well be too late. In the case of the Ebola virus – a much more lethal disease that was also thought to be introduced by bats – public health measures certainly curtailed global spread, and the epidemic of 2014-2016 was limited to 28,600 cases and 11,325 deaths, nearly all of them in West Africa.

Most of the things that cause people to die are not new and are not topics the media chooses to sensationalize. Dissemination of news has changed over the decades, with so much more of it, instant reports on social media, and competition for viewers that leads journalists to pull at our emotions. We might worry about getting food poisoning from romaine lettuce – if that is what the news is focusing on – but we don’t worry when we enter our cars, keep firearms in our homes, or light up cigarettes. And while we may, or may not, get flu shots and avoid those who have the flu, how and where we position both our anxiety and our resources does not always make sense. Certainly some people are predisposed to worry about both common and uncommon dangers, while others seem never to worry and engage in acts that many of us would consider dangerous. If we are looking for logic, it may be hard to find – there are those who would happily go bungee jumping but wouldn’t dream of leaving the house out without hand sanitizer.

The repercussions from this massive response to the Wuhan coronavirus are significant. For the millions of people on lockdown in China, each day gets emotionally harder; some may begin to have issues procuring food, and the financial losses for the economy will be significant. It’s not really possible to know yet if this response is warranted; we do know that infectious diseases can kill millions. The AIDS pandemic has taken the lives of 36 million people since 1981, and the influenza pandemic of 1918 resulted in an estimated 20 million to 50 million deaths after infecting 500 million people. Still, one might wonder if other, more mundane causes of morbidity and mortality – the ones that no longer garner our dread or make it to the front pages – might also be worthy of more hype and resources.

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

Trends in opioid prescribing and use from 2010 to 2016 offer some encouragement, but opioid-attributable deaths continued to increase over that period, according to the Centers for Disease Control and Prevention.

Prescribing rates dropped during that period, as did daily opioid dosage rates and the percentage of patients with high daily opioid dosages, Gail K. Strickler, PhD, of the Institute for Behavioral Health at Brandeis University in Waltham, Mass., and associates wrote in MMWR Surveillance Summaries.

Their analysis involved 11 of the 12 states (Washington was unable to provide data for the analysis) participating in the CDC’s Prescription Behavior Surveillance System, which uses data from the states’ prescription drug monitoring programs. The 11 states represented about 38% of the U.S. population in 2016.

The opioid prescribing rate fell in 10 of those 11 states, with declines varying from 3.4% in Idaho to 33.0% in Ohio. Prescribing went up in Texas by 11.3%, but the state only had data available for 2015 and 2016. Three other states – Delaware, Florida, and Idaho – were limited to data from 2012 to 2016, the investigators noted.

As for the other measures, all states showed declines for the mean daily opioid dosage. Texas had the smallest drop at 2.9% and Florida saw the largest, at 27.4%. All states also had reductions in the percentage of patients with high daily opioid dosage, with decreases varying from 5.7% in Idaho to 43.9% in Louisiana, Dr. Strickler and associates reported. A high daily dosage was defined as at least 90 morphine milligram equivalents for all class II-V opioid drugs.

“Despite these favorable trends ... opioid overdose deaths attributable to the most commonly prescribed opioids, the natural and semisynthetics (e.g., morphine and oxycodone), increased during 2010-2016,” they said.

It is possible that a change in mortality is lagging “behind changes in prescribing behaviors” or that “the trend in deaths related to these types of opioids has been driven by factors other than prescription opioid misuse rates, such as increasing mortality from heroin, which is frequently classified as morphine or found concomitantly with morphine postmortem, and a spike in deaths involving illicitly manufactured fentanyl combined with heroin and prescribed opioids since 2013,” the investigators suggested.

[email protected]

SOURCE: Strickler GK et al. MMWR Surveill Summ. 2020 Jan 31;69(1):1-14.

Trends in opioid prescribing and use from 2010 to 2016 offer some encouragement, but opioid-attributable deaths continued to increase over that period, according to the Centers for Disease Control and Prevention.

Prescribing rates dropped during that period, as did daily opioid dosage rates and the percentage of patients with high daily opioid dosages, Gail K. Strickler, PhD, of the Institute for Behavioral Health at Brandeis University in Waltham, Mass., and associates wrote in MMWR Surveillance Summaries.

Their analysis involved 11 of the 12 states (Washington was unable to provide data for the analysis) participating in the CDC’s Prescription Behavior Surveillance System, which uses data from the states’ prescription drug monitoring programs. The 11 states represented about 38% of the U.S. population in 2016.

The opioid prescribing rate fell in 10 of those 11 states, with declines varying from 3.4% in Idaho to 33.0% in Ohio. Prescribing went up in Texas by 11.3%, but the state only had data available for 2015 and 2016. Three other states – Delaware, Florida, and Idaho – were limited to data from 2012 to 2016, the investigators noted.

As for the other measures, all states showed declines for the mean daily opioid dosage. Texas had the smallest drop at 2.9% and Florida saw the largest, at 27.4%. All states also had reductions in the percentage of patients with high daily opioid dosage, with decreases varying from 5.7% in Idaho to 43.9% in Louisiana, Dr. Strickler and associates reported. A high daily dosage was defined as at least 90 morphine milligram equivalents for all class II-V opioid drugs.

“Despite these favorable trends ... opioid overdose deaths attributable to the most commonly prescribed opioids, the natural and semisynthetics (e.g., morphine and oxycodone), increased during 2010-2016,” they said.

It is possible that a change in mortality is lagging “behind changes in prescribing behaviors” or that “the trend in deaths related to these types of opioids has been driven by factors other than prescription opioid misuse rates, such as increasing mortality from heroin, which is frequently classified as morphine or found concomitantly with morphine postmortem, and a spike in deaths involving illicitly manufactured fentanyl combined with heroin and prescribed opioids since 2013,” the investigators suggested.

[email protected]

SOURCE: Strickler GK et al. MMWR Surveill Summ. 2020 Jan 31;69(1):1-14.

Trends in opioid prescribing and use from 2010 to 2016 offer some encouragement, but opioid-attributable deaths continued to increase over that period, according to the Centers for Disease Control and Prevention.

Prescribing rates dropped during that period, as did daily opioid dosage rates and the percentage of patients with high daily opioid dosages, Gail K. Strickler, PhD, of the Institute for Behavioral Health at Brandeis University in Waltham, Mass., and associates wrote in MMWR Surveillance Summaries.

Their analysis involved 11 of the 12 states (Washington was unable to provide data for the analysis) participating in the CDC’s Prescription Behavior Surveillance System, which uses data from the states’ prescription drug monitoring programs. The 11 states represented about 38% of the U.S. population in 2016.

The opioid prescribing rate fell in 10 of those 11 states, with declines varying from 3.4% in Idaho to 33.0% in Ohio. Prescribing went up in Texas by 11.3%, but the state only had data available for 2015 and 2016. Three other states – Delaware, Florida, and Idaho – were limited to data from 2012 to 2016, the investigators noted.

As for the other measures, all states showed declines for the mean daily opioid dosage. Texas had the smallest drop at 2.9% and Florida saw the largest, at 27.4%. All states also had reductions in the percentage of patients with high daily opioid dosage, with decreases varying from 5.7% in Idaho to 43.9% in Louisiana, Dr. Strickler and associates reported. A high daily dosage was defined as at least 90 morphine milligram equivalents for all class II-V opioid drugs.

“Despite these favorable trends ... opioid overdose deaths attributable to the most commonly prescribed opioids, the natural and semisynthetics (e.g., morphine and oxycodone), increased during 2010-2016,” they said.

It is possible that a change in mortality is lagging “behind changes in prescribing behaviors” or that “the trend in deaths related to these types of opioids has been driven by factors other than prescription opioid misuse rates, such as increasing mortality from heroin, which is frequently classified as morphine or found concomitantly with morphine postmortem, and a spike in deaths involving illicitly manufactured fentanyl combined with heroin and prescribed opioids since 2013,” the investigators suggested.

[email protected]

SOURCE: Strickler GK et al. MMWR Surveill Summ. 2020 Jan 31;69(1):1-14.

The plant compounds known as flavonols that are found in many fruits and vegetables may reduce risk of developing Alzheimer’s disease, results of a recent observational study suggest.

Chalffy/Getty Images

Onset of Alzheimer’s disease (AD) was inversely associated with intake of flavonols, a subclass of flavonoids with antioxidant and anti-inflammatory properties, according to the study authors.

The rate of developing AD was reduced by 50% among individuals reporting high intake of kaempferol, a flavonol plentiful in leafy green vegetables, and by 38% for high intake of the flavonols myricetin and isorhamnetin, researchers said in a report published in Neurology.

The findings are from the Rush Memory and Aging Project (MAP), a large, prospective study of older individuals in retirement communities and public housing in the Chicago area that has been ongoing since 1997.

“Although there is more work to be done, the associations that we observed are promising and deserve further study,” said Thomas M. Holland, MD, of the Rush Institute for Healthy Aging in Chicago, and coauthors.

Those associations between flavonol intake and AD help set the stage for U.S. POINTER and other randomized, controlled trials that seek to evaluate the effects of dietary interventions in a more rigorous way, according to Laura D. Baker, PhD, associate professor of internal medicine at Wake Forest University, Winston-Salem, N.C.

Michele G. Sullivan/MDedge News

“This kind of data helps us feel like we are looking in the right direction in the randomized, controlled trials,” Dr. Baker said in an interview.

Dr. Baker is an investigator in the U.S. POINTER study, which will in part evaluate the impact of the MIND diet, which has been shown to slow cognitive decline with age in a previously published MAP study.

However, in the absence of randomized, controlled trial data, Dr. Baker cautioned against “prematurely advocating” for specific dietary approaches when speaking to patients and caregivers now.

“What I say is, we know for sure that the standard American Heart Association diet has been shown in clinical trials to reduce the risk of heart disease, and in terms of brain health, if you can reduce risk of heart disease, you are protecting your brain,” she said in the interview.

The present MAP study linking a reduced rate of AD to flavonol consumption is believed to be the first of its kind, though two previous studies from the early 2000s did find inverse associations between incident AD and intake of flavonoids, of which flavonoids are just one subclass, said Dr. Holland and coinvestigators in their report.

Moreover, in a MAP study published in 2018, Martha Clare Morris, ScD, and coauthors concluded that consuming about a serving per day of green leafy vegetables and foods rich in kaempferol, among other nutrients and bioactive compounds, may help slow cognitive decline associated with aging.

To more specifically study the relationship between kaempferol and other flavonols and the development of AD, Dr. Holland and colleagues evaluated data for MAP participants who had completed a comprehensive food frequency questionnaire and underwent at least two evaluations to assess incidence of disease.

The mean age of the 921 individuals in the present analysis was 81 years, three-quarters were female, and over approximately 6 years of follow-up, 220 developed AD.

The rate of developing AD was 48% lower among participants reporting the highest total dietary intake of flavonols, compared with those reporting the lowest intake, Dr. Holland and coauthors reported.

Intake of the specific flavonols kaempferol, myricetin, and isorhamnetin were associated with incident AD reductions of 50%, 38%, and 38%, respectively. Another flavonol, quercetin, was by contrast not inversely associated with incident AD, according to the report.

Kaempferol was independently associated with AD in subsequent analyses, while there was no such independent association for myricetin, isorhamnetin, or quercetin, according to Dr. Holland and coinvestigators.

Further analyses of the data suggested the linkages between flavonols and AD were independent of lifestyle factors, dietary intakes, or cardiovascular conditions, they said in their report.

“Confirmation of these findings is warranted through other longitudinal epidemiologic studies and clinical trials, in addition to further elucidation of the biologic mechanisms,” they concluded.

The study was funded by grants from the National Institutes of Health and the USDA Agricultural Research Service. Dr. Holland and coauthors said that they had no disclosures relevant to their report.

SOURCE: Holland TM et al. Neurology. 2020 Jan 29. doi: 10.1212/WNL.0000000000008981.

The plant compounds known as flavonols that are found in many fruits and vegetables may reduce risk of developing Alzheimer’s disease, results of a recent observational study suggest.

Chalffy/Getty Images

Onset of Alzheimer’s disease (AD) was inversely associated with intake of flavonols, a subclass of flavonoids with antioxidant and anti-inflammatory properties, according to the study authors.

The rate of developing AD was reduced by 50% among individuals reporting high intake of kaempferol, a flavonol plentiful in leafy green vegetables, and by 38% for high intake of the flavonols myricetin and isorhamnetin, researchers said in a report published in Neurology.

The findings are from the Rush Memory and Aging Project (MAP), a large, prospective study of older individuals in retirement communities and public housing in the Chicago area that has been ongoing since 1997.

“Although there is more work to be done, the associations that we observed are promising and deserve further study,” said Thomas M. Holland, MD, of the Rush Institute for Healthy Aging in Chicago, and coauthors.

Those associations between flavonol intake and AD help set the stage for U.S. POINTER and other randomized, controlled trials that seek to evaluate the effects of dietary interventions in a more rigorous way, according to Laura D. Baker, PhD, associate professor of internal medicine at Wake Forest University, Winston-Salem, N.C.

Michele G. Sullivan/MDedge News

“This kind of data helps us feel like we are looking in the right direction in the randomized, controlled trials,” Dr. Baker said in an interview.

Dr. Baker is an investigator in the U.S. POINTER study, which will in part evaluate the impact of the MIND diet, which has been shown to slow cognitive decline with age in a previously published MAP study.

However, in the absence of randomized, controlled trial data, Dr. Baker cautioned against “prematurely advocating” for specific dietary approaches when speaking to patients and caregivers now.

“What I say is, we know for sure that the standard American Heart Association diet has been shown in clinical trials to reduce the risk of heart disease, and in terms of brain health, if you can reduce risk of heart disease, you are protecting your brain,” she said in the interview.

The present MAP study linking a reduced rate of AD to flavonol consumption is believed to be the first of its kind, though two previous studies from the early 2000s did find inverse associations between incident AD and intake of flavonoids, of which flavonoids are just one subclass, said Dr. Holland and coinvestigators in their report.

Moreover, in a MAP study published in 2018, Martha Clare Morris, ScD, and coauthors concluded that consuming about a serving per day of green leafy vegetables and foods rich in kaempferol, among other nutrients and bioactive compounds, may help slow cognitive decline associated with aging.

To more specifically study the relationship between kaempferol and other flavonols and the development of AD, Dr. Holland and colleagues evaluated data for MAP participants who had completed a comprehensive food frequency questionnaire and underwent at least two evaluations to assess incidence of disease.

The mean age of the 921 individuals in the present analysis was 81 years, three-quarters were female, and over approximately 6 years of follow-up, 220 developed AD.

The rate of developing AD was 48% lower among participants reporting the highest total dietary intake of flavonols, compared with those reporting the lowest intake, Dr. Holland and coauthors reported.

Intake of the specific flavonols kaempferol, myricetin, and isorhamnetin were associated with incident AD reductions of 50%, 38%, and 38%, respectively. Another flavonol, quercetin, was by contrast not inversely associated with incident AD, according to the report.

Kaempferol was independently associated with AD in subsequent analyses, while there was no such independent association for myricetin, isorhamnetin, or quercetin, according to Dr. Holland and coinvestigators.

Further analyses of the data suggested the linkages between flavonols and AD were independent of lifestyle factors, dietary intakes, or cardiovascular conditions, they said in their report.

“Confirmation of these findings is warranted through other longitudinal epidemiologic studies and clinical trials, in addition to further elucidation of the biologic mechanisms,” they concluded.

The study was funded by grants from the National Institutes of Health and the USDA Agricultural Research Service. Dr. Holland and coauthors said that they had no disclosures relevant to their report.

SOURCE: Holland TM et al. Neurology. 2020 Jan 29. doi: 10.1212/WNL.0000000000008981.

The plant compounds known as flavonols that are found in many fruits and vegetables may reduce risk of developing Alzheimer’s disease, results of a recent observational study suggest.

Chalffy/Getty Images

Onset of Alzheimer’s disease (AD) was inversely associated with intake of flavonols, a subclass of flavonoids with antioxidant and anti-inflammatory properties, according to the study authors.

The rate of developing AD was reduced by 50% among individuals reporting high intake of kaempferol, a flavonol plentiful in leafy green vegetables, and by 38% for high intake of the flavonols myricetin and isorhamnetin, researchers said in a report published in Neurology.

The findings are from the Rush Memory and Aging Project (MAP), a large, prospective study of older individuals in retirement communities and public housing in the Chicago area that has been ongoing since 1997.

“Although there is more work to be done, the associations that we observed are promising and deserve further study,” said Thomas M. Holland, MD, of the Rush Institute for Healthy Aging in Chicago, and coauthors.

Those associations between flavonol intake and AD help set the stage for U.S. POINTER and other randomized, controlled trials that seek to evaluate the effects of dietary interventions in a more rigorous way, according to Laura D. Baker, PhD, associate professor of internal medicine at Wake Forest University, Winston-Salem, N.C.

Michele G. Sullivan/MDedge News

“This kind of data helps us feel like we are looking in the right direction in the randomized, controlled trials,” Dr. Baker said in an interview.

Dr. Baker is an investigator in the U.S. POINTER study, which will in part evaluate the impact of the MIND diet, which has been shown to slow cognitive decline with age in a previously published MAP study.

However, in the absence of randomized, controlled trial data, Dr. Baker cautioned against “prematurely advocating” for specific dietary approaches when speaking to patients and caregivers now.

“What I say is, we know for sure that the standard American Heart Association diet has been shown in clinical trials to reduce the risk of heart disease, and in terms of brain health, if you can reduce risk of heart disease, you are protecting your brain,” she said in the interview.

The present MAP study linking a reduced rate of AD to flavonol consumption is believed to be the first of its kind, though two previous studies from the early 2000s did find inverse associations between incident AD and intake of flavonoids, of which flavonoids are just one subclass, said Dr. Holland and coinvestigators in their report.

Moreover, in a MAP study published in 2018, Martha Clare Morris, ScD, and coauthors concluded that consuming about a serving per day of green leafy vegetables and foods rich in kaempferol, among other nutrients and bioactive compounds, may help slow cognitive decline associated with aging.

To more specifically study the relationship between kaempferol and other flavonols and the development of AD, Dr. Holland and colleagues evaluated data for MAP participants who had completed a comprehensive food frequency questionnaire and underwent at least two evaluations to assess incidence of disease.

The mean age of the 921 individuals in the present analysis was 81 years, three-quarters were female, and over approximately 6 years of follow-up, 220 developed AD.

The rate of developing AD was 48% lower among participants reporting the highest total dietary intake of flavonols, compared with those reporting the lowest intake, Dr. Holland and coauthors reported.

Intake of the specific flavonols kaempferol, myricetin, and isorhamnetin were associated with incident AD reductions of 50%, 38%, and 38%, respectively. Another flavonol, quercetin, was by contrast not inversely associated with incident AD, according to the report.

Kaempferol was independently associated with AD in subsequent analyses, while there was no such independent association for myricetin, isorhamnetin, or quercetin, according to Dr. Holland and coinvestigators.

Further analyses of the data suggested the linkages between flavonols and AD were independent of lifestyle factors, dietary intakes, or cardiovascular conditions, they said in their report.

“Confirmation of these findings is warranted through other longitudinal epidemiologic studies and clinical trials, in addition to further elucidation of the biologic mechanisms,” they concluded.

The study was funded by grants from the National Institutes of Health and the USDA Agricultural Research Service. Dr. Holland and coauthors said that they had no disclosures relevant to their report.

SOURCE: Holland TM et al. Neurology. 2020 Jan 29. doi: 10.1212/WNL.0000000000008981.

Although the last decade has brought appropriate increased interest in the diagnosis and treatment of postpartum depression, with screening initiatives across more than 40 states in place and even new medications being brought to market for treatment, far less attention has been given to diagnosis and treatment of a particularly serious psychiatric illness: postpartum psychosis.

Postpartum psychosis is relatively rare, with an incidence of 1 in 1,000 births, but it is one of the most serious complications of modern obstetrics. Clinically, women can experience rapid mood changes, most often with the presentation that is consistent with a manic-like psychosis, with associated symptoms of delusional thinking, hallucinations, paranoia and either depression or elation, or an amalgam of these so-called “mixed symptoms.” Onset of symptoms typically is early, within 72 hours as is classically described, but may have a somewhat later time of onset in some women.

Many investigators have studied risk factors for postpartum psychosis, and it has been well established that a history of mood disorder, particularly bipolar disorder, is one of the strongest predictors of risk for postpartum psychosis. Women with histories of postpartum psychosis are at very high risk of recurrence, with as many as 70%-90% of women experiencing recurrence if not prophylaxed with an appropriate agent. From a clinical point of view, women with postpartum psychosis typically are hospitalized, given that this is both a psychiatric and potential obstetrical emergency. In fact, the data would suggest that although postpartum suicide and infanticide are not common, they can be a tragic concomitant of postpartum psychosis (Am J Psychiatry. 2016 Dec 1;173[12]:1179-88).

A great amount of interest has been placed on the etiology of postpartum psychosis, as it’s a dramatic presentation with very rapid onset in the acute postpartum period. A rich evidence base with respect to an algorithm of treatment that maximizes likelihood of full recovery or sustaining of euthymia after recovery is limited. Few studies have looked systematically at the optimum way to treat postpartum psychosis. Clinical wisdom has dictated that, given the dramatic symptoms with which these patients present, most patients are treated with lithium and an antipsychotic medication as if they have a manic-like psychosis. It may take brief or extended periods of time for patients to stabilize. Once they are stabilized, one of the most challenging questions for clinicians is how long to treat. Again, an evidence base clearly informing this question is lacking.

Over the years, many clinicians have treated patients with postpartum psychosis as if they have bipolar disorder, given the index presentation of the illness, so some of these patients are treated with antimanic drugs indefinitely. However, clinical experience from several centers that treat women with postpartum psychosis suggests that in remitted patients, a proportion of them may be able to taper and discontinue treatment, then sustain well-being for protracted periods.

One obstacle with respect to treatment of postpartum psychosis derives from the short length of stay after delivery for many women. Some women who present with symptoms of postpartum psychosis in the first 24-48 hours frequently are managed with direct admission to an inpatient psychiatric service. But others may not develop symptoms until they are home, which may place both mother and newborn at risk.

Given that the risk for recurrent postpartum psychosis is so great (70%-90%), women with histories of postpartum psychosis invariably are prophylaxed with mood stabilizer prior to delivery in a subsequent pregnancy. In our own center, we have published on the value of such prophylactic intervention, not just in women with postpartum psychosis, but in women with bipolar disorder, who are, as noted, at great risk for developing postpartum psychotic symptoms (Am J Psychiatry. 1995 Nov;152[11]:1641-5.)

Although postpartum psychosis may be rare, over the last 3 decades we have seen a substantial number of women with postpartum psychosis and have been fascinated with the spectrum of symptoms with which some women with postpartum psychotic illness present. We also have been impressed with the time required for some women to recompensate from their illness and the course of their disorder after they have seemingly remitted. Some women appear to be able to discontinue treatment as noted above; others, particularly if there is any history of bipolar disorder, need to be maintained on treatment with mood stabilizer indefinitely.

To better understand the phenomenology of postpartum psychosis, as well as the longitudinal course of the illness, in 2019, the Mass General Hospital Postpartum Psychosis Project (MGHP3) was established. The project is conducted as a hospital-based registry where women with histories of postpartum psychosis over the last decade are invited to participate in an in-depth interview to understand both symptoms and course of underlying illness. This is complemented by obtaining a sample of saliva, which is used for genetic testing to try to identify a genetic underpinning associated with postpartum psychosis, as the question of genetic etiology of postpartum psychosis is still an open one.

As part of the MGHP3 project, clinicians across the country are able to contact perinatal psychiatrists in our center with expertise in the treatment of postpartum psychosis. Our psychiatrists also can counsel clinicians on issues regarding long-term management of postpartum psychosis because for many, knowledge of precisely how to manage this disorder or the follow-up treatment may be incomplete.

From a clinical point of view, the relevant questions really include not only acute treatment, which has already been outlined, but also the issue of duration of treatment. While some patients may be able to taper and discontinue treatment after, for example, a year of being totally well, to date we are unable to know who those patients are. We tend to be more conservative in our own center and treat patients with puerperal psychosis for a more protracted period of time, usually over several years. We also ask women about their family history of bipolar disorder or postpartum psychosis. Depending on the clinical course (if the patient really has sustained euthymia), we consider slow taper and ultimate discontinuation. As always, treatment decisions are tailored to individual clinical history, course, and patient wishes.

Postpartum psychosis remains one of the most serious illnesses that we find in reproductive psychiatry, and incomplete attention has been given to this devastating illness, which we read about periodically in newspapers and magazines. Greater understanding of postpartum psychosis will lead to a more precision-like psychiatric approach, tailoring treatment to the invariable heterogeneity of this illness.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Although the last decade has brought appropriate increased interest in the diagnosis and treatment of postpartum depression, with screening initiatives across more than 40 states in place and even new medications being brought to market for treatment, far less attention has been given to diagnosis and treatment of a particularly serious psychiatric illness: postpartum psychosis.

Postpartum psychosis is relatively rare, with an incidence of 1 in 1,000 births, but it is one of the most serious complications of modern obstetrics. Clinically, women can experience rapid mood changes, most often with the presentation that is consistent with a manic-like psychosis, with associated symptoms of delusional thinking, hallucinations, paranoia and either depression or elation, or an amalgam of these so-called “mixed symptoms.” Onset of symptoms typically is early, within 72 hours as is classically described, but may have a somewhat later time of onset in some women.

Many investigators have studied risk factors for postpartum psychosis, and it has been well established that a history of mood disorder, particularly bipolar disorder, is one of the strongest predictors of risk for postpartum psychosis. Women with histories of postpartum psychosis are at very high risk of recurrence, with as many as 70%-90% of women experiencing recurrence if not prophylaxed with an appropriate agent. From a clinical point of view, women with postpartum psychosis typically are hospitalized, given that this is both a psychiatric and potential obstetrical emergency. In fact, the data would suggest that although postpartum suicide and infanticide are not common, they can be a tragic concomitant of postpartum psychosis (Am J Psychiatry. 2016 Dec 1;173[12]:1179-88).

A great amount of interest has been placed on the etiology of postpartum psychosis, as it’s a dramatic presentation with very rapid onset in the acute postpartum period. A rich evidence base with respect to an algorithm of treatment that maximizes likelihood of full recovery or sustaining of euthymia after recovery is limited. Few studies have looked systematically at the optimum way to treat postpartum psychosis. Clinical wisdom has dictated that, given the dramatic symptoms with which these patients present, most patients are treated with lithium and an antipsychotic medication as if they have a manic-like psychosis. It may take brief or extended periods of time for patients to stabilize. Once they are stabilized, one of the most challenging questions for clinicians is how long to treat. Again, an evidence base clearly informing this question is lacking.

Over the years, many clinicians have treated patients with postpartum psychosis as if they have bipolar disorder, given the index presentation of the illness, so some of these patients are treated with antimanic drugs indefinitely. However, clinical experience from several centers that treat women with postpartum psychosis suggests that in remitted patients, a proportion of them may be able to taper and discontinue treatment, then sustain well-being for protracted periods.

One obstacle with respect to treatment of postpartum psychosis derives from the short length of stay after delivery for many women. Some women who present with symptoms of postpartum psychosis in the first 24-48 hours frequently are managed with direct admission to an inpatient psychiatric service. But others may not develop symptoms until they are home, which may place both mother and newborn at risk.

Given that the risk for recurrent postpartum psychosis is so great (70%-90%), women with histories of postpartum psychosis invariably are prophylaxed with mood stabilizer prior to delivery in a subsequent pregnancy. In our own center, we have published on the value of such prophylactic intervention, not just in women with postpartum psychosis, but in women with bipolar disorder, who are, as noted, at great risk for developing postpartum psychotic symptoms (Am J Psychiatry. 1995 Nov;152[11]:1641-5.)

Although postpartum psychosis may be rare, over the last 3 decades we have seen a substantial number of women with postpartum psychosis and have been fascinated with the spectrum of symptoms with which some women with postpartum psychotic illness present. We also have been impressed with the time required for some women to recompensate from their illness and the course of their disorder after they have seemingly remitted. Some women appear to be able to discontinue treatment as noted above; others, particularly if there is any history of bipolar disorder, need to be maintained on treatment with mood stabilizer indefinitely.

To better understand the phenomenology of postpartum psychosis, as well as the longitudinal course of the illness, in 2019, the Mass General Hospital Postpartum Psychosis Project (MGHP3) was established. The project is conducted as a hospital-based registry where women with histories of postpartum psychosis over the last decade are invited to participate in an in-depth interview to understand both symptoms and course of underlying illness. This is complemented by obtaining a sample of saliva, which is used for genetic testing to try to identify a genetic underpinning associated with postpartum psychosis, as the question of genetic etiology of postpartum psychosis is still an open one.

As part of the MGHP3 project, clinicians across the country are able to contact perinatal psychiatrists in our center with expertise in the treatment of postpartum psychosis. Our psychiatrists also can counsel clinicians on issues regarding long-term management of postpartum psychosis because for many, knowledge of precisely how to manage this disorder or the follow-up treatment may be incomplete.

From a clinical point of view, the relevant questions really include not only acute treatment, which has already been outlined, but also the issue of duration of treatment. While some patients may be able to taper and discontinue treatment after, for example, a year of being totally well, to date we are unable to know who those patients are. We tend to be more conservative in our own center and treat patients with puerperal psychosis for a more protracted period of time, usually over several years. We also ask women about their family history of bipolar disorder or postpartum psychosis. Depending on the clinical course (if the patient really has sustained euthymia), we consider slow taper and ultimate discontinuation. As always, treatment decisions are tailored to individual clinical history, course, and patient wishes.

Postpartum psychosis remains one of the most serious illnesses that we find in reproductive psychiatry, and incomplete attention has been given to this devastating illness, which we read about periodically in newspapers and magazines. Greater understanding of postpartum psychosis will lead to a more precision-like psychiatric approach, tailoring treatment to the invariable heterogeneity of this illness.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Although the last decade has brought appropriate increased interest in the diagnosis and treatment of postpartum depression, with screening initiatives across more than 40 states in place and even new medications being brought to market for treatment, far less attention has been given to diagnosis and treatment of a particularly serious psychiatric illness: postpartum psychosis.

Postpartum psychosis is relatively rare, with an incidence of 1 in 1,000 births, but it is one of the most serious complications of modern obstetrics. Clinically, women can experience rapid mood changes, most often with the presentation that is consistent with a manic-like psychosis, with associated symptoms of delusional thinking, hallucinations, paranoia and either depression or elation, or an amalgam of these so-called “mixed symptoms.” Onset of symptoms typically is early, within 72 hours as is classically described, but may have a somewhat later time of onset in some women.

Many investigators have studied risk factors for postpartum psychosis, and it has been well established that a history of mood disorder, particularly bipolar disorder, is one of the strongest predictors of risk for postpartum psychosis. Women with histories of postpartum psychosis are at very high risk of recurrence, with as many as 70%-90% of women experiencing recurrence if not prophylaxed with an appropriate agent. From a clinical point of view, women with postpartum psychosis typically are hospitalized, given that this is both a psychiatric and potential obstetrical emergency. In fact, the data would suggest that although postpartum suicide and infanticide are not common, they can be a tragic concomitant of postpartum psychosis (Am J Psychiatry. 2016 Dec 1;173[12]:1179-88).

A great amount of interest has been placed on the etiology of postpartum psychosis, as it’s a dramatic presentation with very rapid onset in the acute postpartum period. A rich evidence base with respect to an algorithm of treatment that maximizes likelihood of full recovery or sustaining of euthymia after recovery is limited. Few studies have looked systematically at the optimum way to treat postpartum psychosis. Clinical wisdom has dictated that, given the dramatic symptoms with which these patients present, most patients are treated with lithium and an antipsychotic medication as if they have a manic-like psychosis. It may take brief or extended periods of time for patients to stabilize. Once they are stabilized, one of the most challenging questions for clinicians is how long to treat. Again, an evidence base clearly informing this question is lacking.

Over the years, many clinicians have treated patients with postpartum psychosis as if they have bipolar disorder, given the index presentation of the illness, so some of these patients are treated with antimanic drugs indefinitely. However, clinical experience from several centers that treat women with postpartum psychosis suggests that in remitted patients, a proportion of them may be able to taper and discontinue treatment, then sustain well-being for protracted periods.

One obstacle with respect to treatment of postpartum psychosis derives from the short length of stay after delivery for many women. Some women who present with symptoms of postpartum psychosis in the first 24-48 hours frequently are managed with direct admission to an inpatient psychiatric service. But others may not develop symptoms until they are home, which may place both mother and newborn at risk.

Given that the risk for recurrent postpartum psychosis is so great (70%-90%), women with histories of postpartum psychosis invariably are prophylaxed with mood stabilizer prior to delivery in a subsequent pregnancy. In our own center, we have published on the value of such prophylactic intervention, not just in women with postpartum psychosis, but in women with bipolar disorder, who are, as noted, at great risk for developing postpartum psychotic symptoms (Am J Psychiatry. 1995 Nov;152[11]:1641-5.)

Although postpartum psychosis may be rare, over the last 3 decades we have seen a substantial number of women with postpartum psychosis and have been fascinated with the spectrum of symptoms with which some women with postpartum psychotic illness present. We also have been impressed with the time required for some women to recompensate from their illness and the course of their disorder after they have seemingly remitted. Some women appear to be able to discontinue treatment as noted above; others, particularly if there is any history of bipolar disorder, need to be maintained on treatment with mood stabilizer indefinitely.

To better understand the phenomenology of postpartum psychosis, as well as the longitudinal course of the illness, in 2019, the Mass General Hospital Postpartum Psychosis Project (MGHP3) was established. The project is conducted as a hospital-based registry where women with histories of postpartum psychosis over the last decade are invited to participate in an in-depth interview to understand both symptoms and course of underlying illness. This is complemented by obtaining a sample of saliva, which is used for genetic testing to try to identify a genetic underpinning associated with postpartum psychosis, as the question of genetic etiology of postpartum psychosis is still an open one.

As part of the MGHP3 project, clinicians across the country are able to contact perinatal psychiatrists in our center with expertise in the treatment of postpartum psychosis. Our psychiatrists also can counsel clinicians on issues regarding long-term management of postpartum psychosis because for many, knowledge of precisely how to manage this disorder or the follow-up treatment may be incomplete.

From a clinical point of view, the relevant questions really include not only acute treatment, which has already been outlined, but also the issue of duration of treatment. While some patients may be able to taper and discontinue treatment after, for example, a year of being totally well, to date we are unable to know who those patients are. We tend to be more conservative in our own center and treat patients with puerperal psychosis for a more protracted period of time, usually over several years. We also ask women about their family history of bipolar disorder or postpartum psychosis. Depending on the clinical course (if the patient really has sustained euthymia), we consider slow taper and ultimate discontinuation. As always, treatment decisions are tailored to individual clinical history, course, and patient wishes.

Postpartum psychosis remains one of the most serious illnesses that we find in reproductive psychiatry, and incomplete attention has been given to this devastating illness, which we read about periodically in newspapers and magazines. Greater understanding of postpartum psychosis will lead to a more precision-like psychiatric approach, tailoring treatment to the invariable heterogeneity of this illness.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

If you’ve knocked yourself out to earn a Merit-Based Incentive Payment System (MIPS) bonus payment, it’s pretty safe to say that getting a 1.68% payment boost probably didn’t feel like a “win” that was worth the effort.

And although it saved you from having a negative 5% payment adjustment, many physicians don’t feel that it was worth the effort.

On Jan. 6, the Centers for Medicare & Medicaid Services announced the 2020 payouts for MIPS.

Based on 2018 participation, the bonus for those who scored a perfect 100 is only a 1.68% boost in Medicare reimbursement, slightly lower than last year’s 1.88%. This decline comes as no surprise as the agency leader admits: “As the program matures, we expect that the increases in the performance thresholds in future program years will create a smaller distribution of positive payment adjustments.” Overall, more than 97% of participants avoided having a negative 5% payment adjustment.

Indeed, these bonus monies are based on a short-term appropriation of extra funds from Congress. After these temporary funds are no longer available, there will be little, if any, monies to distribute as the program is based on a “losers-feed-the-winners” construct.

It may be very tempting for many physicians to decide to ignore MIPS, with the rationale that 1.68% is not worth the effort. But don’t let your foot off the gas pedal yet, since the penalty for not participating in 2020 is a substantial 9%. Physicians should make sure that they, at minimum, achieve the 45 points necessary to avoid that pitfall this reporting year.

However, it is certainly time to reconsider efforts to participate at the highest level.
 

Should you or shouldn’t you bother with MIPS?

Let’s say you have $75,000 in revenue from Medicare Part B per year. Depending on the services you offer in your practice, that equates to 500-750 encounters with Medicare beneficiaries per year. (A reminder that MIPS affects only Part B; Medicare Advantage plans do not partake in the program.)

The recent announcement reveals that perfection would equate to an additional $1,260 per year. That’s only if you received the full 100 points; if you were simply an “exceptional performer,” the government will allot an additional $157. That’s less than you get paid for a single office visit.

The difference between perfection and compliance is approximately $1,000. Failure to participate, however, knocks $6,750 off your bottom line. Clearly, that’s a substantial financial loss that would affect most practices. Obviously, the numbers change if you have higher – or lower – Medicare revenue, but it’s important to do the math.

Why? Physicians are spending a significant amount of money to comply with the program requirements. This includes substantial payments to registries – typically $200 to >$1,000 per year – to report the quality measures for the program; electronic health record (EHR) systems, many of which require additional funding for the “upgrade” to a MIPS-compatible system, are also a sizable investment.

These hard costs pale in comparison with the time spent on understanding the ever-changing requirements of the program and the process by which your practice will implement them. Take, for example, something as innocuous as the required “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

You first must understand the elements of the measure: What is a “referral loop?” When do we need to generate one? To whom shall it be sent? What needs to be included in “health information?” What is the electronic address to which we should route the information? How do we obtain that address? Then you must determine how your EHR system captures and reports it.

Only then comes the hard part: How are we going to implement this? That’s only one of more than a dozen required elements: six quality measures, two (to four) improvement activities, and four promoting interoperability requirements. Each one of these elements has a host of requirements, all listed on multipage specification sheets.

The government does not seem to be listening. John Cullen, MD, president of the American Academy of Family Physicians, testified at the Senate Finance Committee in May 2019 that MIPS “has created a burdensome and extremely complex program that has increased practice costs ... ” Yet, later that year, CMS issued another hefty ruling that outlines significant changes to the program, despite the fact that it’s in its fourth performance year.
 

Turning frustration into action

Frustration or even anger may be one reaction, but now is an opportune time to determine your investment in the program. At a minimum, it’s vital to understand and meet the threshold to avoid the penalty. It’s been shifting to date, but it’s now set at 9% for perpetuity.

First, it’s crucial to check on your participation status. CMS revealed that the participation database was recently corrected for so-called inconsistencies, so it pays to double-check. It only takes seconds: Insert your NPI in the QPP Participation Status Tool to determine your eligibility for 2020.

In 2020, the threshold to avoid the penalty is 45 points. To get the 45 points, practices must participate in two improvement activities, which is not difficult as there are 118 options. That will garner 15 points. Then there are 45 points available from the quality category; you need at least 30 to reach the 45-point threshold for penalty avoidance.
 

Smart MIPS hacks that can help you

To obtain the additional 30 points, turn your attention to the quality category. There are 268 quality measures; choose at least six to measure. If you report directly from your EHR system, you’ll get a bonus point for each reported measure, plus one just for trying. (There are a few other opportunities for bonus points, such as improving your scores over last year.) Those bonus points give you a base with which to work, but getting to 45 will require effort to report successfully on at least a couple of the measures.

The quality category has a total of 100 points available, which are converted to 45 toward your composite score. Since you need 30 to reach that magical 45 (if 15 were attained from improvement activities), that means you must come up with 75 points in the quality category. Between the bonus points and measuring a handful of measures successfully through the year, you’ll achieve this threshold.

There are two other categories in the program: promoting interoperability (PI) and cost. The PI category mirrors the old “meaningful use” program; however, it has become increasingly difficult over the years. If you think that you can meet the required elements, you can pick up 25 more points toward your composite score.

Cost is a bit of an unknown, as the scoring is based on a retrospective review of your claims. You’ll likely pick up a few more points on this 15-point category, but there’s no method to determine performance until after the reporting period. Therefore, be cautious about relying on this category.

The best MIPS hack, however, is if you are a small practice. CMS – remarkably – defines a “small practice” as 15 or fewer eligible professionals. If you qualify under this paradigm, you have multiple options to ease compliance:

Apply for a “hardship exemption” simply on the basis of being small; the exemption relates to the promoting operability category, shifting those points to the quality category.

Gain three points per quality measure, regardless of data completeness; this compares to just one point for other physicians.

Capture all of the points available from the Improvement Activities category by confirming participation with just a single activity. (This also applies to all physicians in rural or Health Professional Shortage Areas.)

In the event that you don’t qualify as a “small practice” or you’re still falling short of the requirements, CMS allows for the ultimate “out”: You can apply for exemption on the basis of an “extreme and uncontrollable circumstance.” The applications for these exceptions open this summer.

Unless you qualify for the program exemption, it’s important to keep pace with the program to ensure that you reach the 45-point threshold. It may not, however, be worthwhile to gear up for all 100 points unless your estimate of the potential return – and what it costs you to get there – reveals otherwise. MIPS is not going anywhere; the program is written into the law.

But that doesn’t mean that CMS can’t make tweaks and updates. Hopefully, the revisions won’t create even more administrative burden as the program is quickly turning into a big stick with only a small carrot at the end.

Elizabeth Woodcock is president of Woodcock & Associates in Atlanta. She has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

If you’ve knocked yourself out to earn a Merit-Based Incentive Payment System (MIPS) bonus payment, it’s pretty safe to say that getting a 1.68% payment boost probably didn’t feel like a “win” that was worth the effort.

And although it saved you from having a negative 5% payment adjustment, many physicians don’t feel that it was worth the effort.

On Jan. 6, the Centers for Medicare & Medicaid Services announced the 2020 payouts for MIPS.

Based on 2018 participation, the bonus for those who scored a perfect 100 is only a 1.68% boost in Medicare reimbursement, slightly lower than last year’s 1.88%. This decline comes as no surprise as the agency leader admits: “As the program matures, we expect that the increases in the performance thresholds in future program years will create a smaller distribution of positive payment adjustments.” Overall, more than 97% of participants avoided having a negative 5% payment adjustment.

Indeed, these bonus monies are based on a short-term appropriation of extra funds from Congress. After these temporary funds are no longer available, there will be little, if any, monies to distribute as the program is based on a “losers-feed-the-winners” construct.

It may be very tempting for many physicians to decide to ignore MIPS, with the rationale that 1.68% is not worth the effort. But don’t let your foot off the gas pedal yet, since the penalty for not participating in 2020 is a substantial 9%. Physicians should make sure that they, at minimum, achieve the 45 points necessary to avoid that pitfall this reporting year.

However, it is certainly time to reconsider efforts to participate at the highest level.
 

Should you or shouldn’t you bother with MIPS?

Let’s say you have $75,000 in revenue from Medicare Part B per year. Depending on the services you offer in your practice, that equates to 500-750 encounters with Medicare beneficiaries per year. (A reminder that MIPS affects only Part B; Medicare Advantage plans do not partake in the program.)

The recent announcement reveals that perfection would equate to an additional $1,260 per year. That’s only if you received the full 100 points; if you were simply an “exceptional performer,” the government will allot an additional $157. That’s less than you get paid for a single office visit.

The difference between perfection and compliance is approximately $1,000. Failure to participate, however, knocks $6,750 off your bottom line. Clearly, that’s a substantial financial loss that would affect most practices. Obviously, the numbers change if you have higher – or lower – Medicare revenue, but it’s important to do the math.

Why? Physicians are spending a significant amount of money to comply with the program requirements. This includes substantial payments to registries – typically $200 to >$1,000 per year – to report the quality measures for the program; electronic health record (EHR) systems, many of which require additional funding for the “upgrade” to a MIPS-compatible system, are also a sizable investment.

These hard costs pale in comparison with the time spent on understanding the ever-changing requirements of the program and the process by which your practice will implement them. Take, for example, something as innocuous as the required “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

You first must understand the elements of the measure: What is a “referral loop?” When do we need to generate one? To whom shall it be sent? What needs to be included in “health information?” What is the electronic address to which we should route the information? How do we obtain that address? Then you must determine how your EHR system captures and reports it.

Only then comes the hard part: How are we going to implement this? That’s only one of more than a dozen required elements: six quality measures, two (to four) improvement activities, and four promoting interoperability requirements. Each one of these elements has a host of requirements, all listed on multipage specification sheets.

The government does not seem to be listening. John Cullen, MD, president of the American Academy of Family Physicians, testified at the Senate Finance Committee in May 2019 that MIPS “has created a burdensome and extremely complex program that has increased practice costs ... ” Yet, later that year, CMS issued another hefty ruling that outlines significant changes to the program, despite the fact that it’s in its fourth performance year.
 

Turning frustration into action

Frustration or even anger may be one reaction, but now is an opportune time to determine your investment in the program. At a minimum, it’s vital to understand and meet the threshold to avoid the penalty. It’s been shifting to date, but it’s now set at 9% for perpetuity.

First, it’s crucial to check on your participation status. CMS revealed that the participation database was recently corrected for so-called inconsistencies, so it pays to double-check. It only takes seconds: Insert your NPI in the QPP Participation Status Tool to determine your eligibility for 2020.

In 2020, the threshold to avoid the penalty is 45 points. To get the 45 points, practices must participate in two improvement activities, which is not difficult as there are 118 options. That will garner 15 points. Then there are 45 points available from the quality category; you need at least 30 to reach the 45-point threshold for penalty avoidance.
 

Smart MIPS hacks that can help you

To obtain the additional 30 points, turn your attention to the quality category. There are 268 quality measures; choose at least six to measure. If you report directly from your EHR system, you’ll get a bonus point for each reported measure, plus one just for trying. (There are a few other opportunities for bonus points, such as improving your scores over last year.) Those bonus points give you a base with which to work, but getting to 45 will require effort to report successfully on at least a couple of the measures.

The quality category has a total of 100 points available, which are converted to 45 toward your composite score. Since you need 30 to reach that magical 45 (if 15 were attained from improvement activities), that means you must come up with 75 points in the quality category. Between the bonus points and measuring a handful of measures successfully through the year, you’ll achieve this threshold.

There are two other categories in the program: promoting interoperability (PI) and cost. The PI category mirrors the old “meaningful use” program; however, it has become increasingly difficult over the years. If you think that you can meet the required elements, you can pick up 25 more points toward your composite score.

Cost is a bit of an unknown, as the scoring is based on a retrospective review of your claims. You’ll likely pick up a few more points on this 15-point category, but there’s no method to determine performance until after the reporting period. Therefore, be cautious about relying on this category.

The best MIPS hack, however, is if you are a small practice. CMS – remarkably – defines a “small practice” as 15 or fewer eligible professionals. If you qualify under this paradigm, you have multiple options to ease compliance:

Apply for a “hardship exemption” simply on the basis of being small; the exemption relates to the promoting operability category, shifting those points to the quality category.

Gain three points per quality measure, regardless of data completeness; this compares to just one point for other physicians.

Capture all of the points available from the Improvement Activities category by confirming participation with just a single activity. (This also applies to all physicians in rural or Health Professional Shortage Areas.)

In the event that you don’t qualify as a “small practice” or you’re still falling short of the requirements, CMS allows for the ultimate “out”: You can apply for exemption on the basis of an “extreme and uncontrollable circumstance.” The applications for these exceptions open this summer.

Unless you qualify for the program exemption, it’s important to keep pace with the program to ensure that you reach the 45-point threshold. It may not, however, be worthwhile to gear up for all 100 points unless your estimate of the potential return – and what it costs you to get there – reveals otherwise. MIPS is not going anywhere; the program is written into the law.

But that doesn’t mean that CMS can’t make tweaks and updates. Hopefully, the revisions won’t create even more administrative burden as the program is quickly turning into a big stick with only a small carrot at the end.

Elizabeth Woodcock is president of Woodcock & Associates in Atlanta. She has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

If you’ve knocked yourself out to earn a Merit-Based Incentive Payment System (MIPS) bonus payment, it’s pretty safe to say that getting a 1.68% payment boost probably didn’t feel like a “win” that was worth the effort.

And although it saved you from having a negative 5% payment adjustment, many physicians don’t feel that it was worth the effort.

On Jan. 6, the Centers for Medicare & Medicaid Services announced the 2020 payouts for MIPS.

Based on 2018 participation, the bonus for those who scored a perfect 100 is only a 1.68% boost in Medicare reimbursement, slightly lower than last year’s 1.88%. This decline comes as no surprise as the agency leader admits: “As the program matures, we expect that the increases in the performance thresholds in future program years will create a smaller distribution of positive payment adjustments.” Overall, more than 97% of participants avoided having a negative 5% payment adjustment.

Indeed, these bonus monies are based on a short-term appropriation of extra funds from Congress. After these temporary funds are no longer available, there will be little, if any, monies to distribute as the program is based on a “losers-feed-the-winners” construct.

It may be very tempting for many physicians to decide to ignore MIPS, with the rationale that 1.68% is not worth the effort. But don’t let your foot off the gas pedal yet, since the penalty for not participating in 2020 is a substantial 9%. Physicians should make sure that they, at minimum, achieve the 45 points necessary to avoid that pitfall this reporting year.

However, it is certainly time to reconsider efforts to participate at the highest level.
 

Should you or shouldn’t you bother with MIPS?

Let’s say you have $75,000 in revenue from Medicare Part B per year. Depending on the services you offer in your practice, that equates to 500-750 encounters with Medicare beneficiaries per year. (A reminder that MIPS affects only Part B; Medicare Advantage plans do not partake in the program.)

The recent announcement reveals that perfection would equate to an additional $1,260 per year. That’s only if you received the full 100 points; if you were simply an “exceptional performer,” the government will allot an additional $157. That’s less than you get paid for a single office visit.

The difference between perfection and compliance is approximately $1,000. Failure to participate, however, knocks $6,750 off your bottom line. Clearly, that’s a substantial financial loss that would affect most practices. Obviously, the numbers change if you have higher – or lower – Medicare revenue, but it’s important to do the math.

Why? Physicians are spending a significant amount of money to comply with the program requirements. This includes substantial payments to registries – typically $200 to >$1,000 per year – to report the quality measures for the program; electronic health record (EHR) systems, many of which require additional funding for the “upgrade” to a MIPS-compatible system, are also a sizable investment.

These hard costs pale in comparison with the time spent on understanding the ever-changing requirements of the program and the process by which your practice will implement them. Take, for example, something as innocuous as the required “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

You first must understand the elements of the measure: What is a “referral loop?” When do we need to generate one? To whom shall it be sent? What needs to be included in “health information?” What is the electronic address to which we should route the information? How do we obtain that address? Then you must determine how your EHR system captures and reports it.

Only then comes the hard part: How are we going to implement this? That’s only one of more than a dozen required elements: six quality measures, two (to four) improvement activities, and four promoting interoperability requirements. Each one of these elements has a host of requirements, all listed on multipage specification sheets.

The government does not seem to be listening. John Cullen, MD, president of the American Academy of Family Physicians, testified at the Senate Finance Committee in May 2019 that MIPS “has created a burdensome and extremely complex program that has increased practice costs ... ” Yet, later that year, CMS issued another hefty ruling that outlines significant changes to the program, despite the fact that it’s in its fourth performance year.
 

Turning frustration into action

Frustration or even anger may be one reaction, but now is an opportune time to determine your investment in the program. At a minimum, it’s vital to understand and meet the threshold to avoid the penalty. It’s been shifting to date, but it’s now set at 9% for perpetuity.

First, it’s crucial to check on your participation status. CMS revealed that the participation database was recently corrected for so-called inconsistencies, so it pays to double-check. It only takes seconds: Insert your NPI in the QPP Participation Status Tool to determine your eligibility for 2020.

In 2020, the threshold to avoid the penalty is 45 points. To get the 45 points, practices must participate in two improvement activities, which is not difficult as there are 118 options. That will garner 15 points. Then there are 45 points available from the quality category; you need at least 30 to reach the 45-point threshold for penalty avoidance.
 

Smart MIPS hacks that can help you

To obtain the additional 30 points, turn your attention to the quality category. There are 268 quality measures; choose at least six to measure. If you report directly from your EHR system, you’ll get a bonus point for each reported measure, plus one just for trying. (There are a few other opportunities for bonus points, such as improving your scores over last year.) Those bonus points give you a base with which to work, but getting to 45 will require effort to report successfully on at least a couple of the measures.

The quality category has a total of 100 points available, which are converted to 45 toward your composite score. Since you need 30 to reach that magical 45 (if 15 were attained from improvement activities), that means you must come up with 75 points in the quality category. Between the bonus points and measuring a handful of measures successfully through the year, you’ll achieve this threshold.

There are two other categories in the program: promoting interoperability (PI) and cost. The PI category mirrors the old “meaningful use” program; however, it has become increasingly difficult over the years. If you think that you can meet the required elements, you can pick up 25 more points toward your composite score.

Cost is a bit of an unknown, as the scoring is based on a retrospective review of your claims. You’ll likely pick up a few more points on this 15-point category, but there’s no method to determine performance until after the reporting period. Therefore, be cautious about relying on this category.

The best MIPS hack, however, is if you are a small practice. CMS – remarkably – defines a “small practice” as 15 or fewer eligible professionals. If you qualify under this paradigm, you have multiple options to ease compliance:

Apply for a “hardship exemption” simply on the basis of being small; the exemption relates to the promoting operability category, shifting those points to the quality category.

Gain three points per quality measure, regardless of data completeness; this compares to just one point for other physicians.

Capture all of the points available from the Improvement Activities category by confirming participation with just a single activity. (This also applies to all physicians in rural or Health Professional Shortage Areas.)

In the event that you don’t qualify as a “small practice” or you’re still falling short of the requirements, CMS allows for the ultimate “out”: You can apply for exemption on the basis of an “extreme and uncontrollable circumstance.” The applications for these exceptions open this summer.

Unless you qualify for the program exemption, it’s important to keep pace with the program to ensure that you reach the 45-point threshold. It may not, however, be worthwhile to gear up for all 100 points unless your estimate of the potential return – and what it costs you to get there – reveals otherwise. MIPS is not going anywhere; the program is written into the law.

But that doesn’t mean that CMS can’t make tweaks and updates. Hopefully, the revisions won’t create even more administrative burden as the program is quickly turning into a big stick with only a small carrot at the end.

Elizabeth Woodcock is president of Woodcock & Associates in Atlanta. She has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

The cost of health care is keeping more Americans from seeing a doctor, even as the number of individuals with insurance coverage increases, according to a new study.

“Despite short-term gains owing to the [Affordable Care Act], over the past 20 years the portion of adults aged 18-64 years unable to see a physician owing to the cost increased, mostly because of an increase among persons with insurance,” Laura Hawks, MD, of Cambridge (Mass.) Health Alliance and Harvard Medical School in Boston and colleagues wrote in a new research report published in JAMA Internal Medicine.

“In 2017, nearly one-fifth of individuals with any chronic condition (diabetes, obesity, or cardiovascular disease) said they were unable to see a physician owing to cost,” they continued.

Researchers examined 20 years of data (January 1998 through December 2017) from the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System to identify trends in unmet need for physician and preventive services.

Among adults aged 18-64 years who responded to the survey in 1998 and 2017, uninsurance decreased by 2.1 percentage points, falling from 16.9% to 14.8%. But at the same time, the portion of adults who were unable to see a physician because of cost rose by 2.7 percentage points, from 11.4% to 15.7%. Looking specifically at adults who had insurance coverage, the researchers found that cost was a barrier for 11.5% of them in 2017, up from 7.1% in 1998.

These results come against a backdrop of growing medical costs, increasing deductibles and copayments, an increasing use of cost containment measures like prior authorization, and narrow provider networks in the wake of the transition to value-based payment structures, the authors noted.

“Our finding that financial access to physician care worsened is concerning,” Dr. Hawks and her colleagues wrote. “Persons with conditions such as diabetes, hypertension, cardiovascular disease, and poor health status risk substantial harms if they forgo physician care. Financial barriers to care have been associated with increased hospitalizations and worse health outcomes in patients with cardiovascular disease and hypertension and increased morbidity among patients with diabetes.”

One of the trends highlighted by the study authors is the growing number of employers offering plans with a high deductible.

“Enrollment in a high-deductible health plan, which has become increasingly common in the last decade, a trend uninterrupted by the ACA, is associated with forgoing needed care, especially among those of lower socioeconomic status,” the authors wrote. “Other changes in insurance benefit design, such as imposing tiered copayments and coinsurance obligations, eliminating coverage for some services (e.g., eyeglasses) and narrowing provider networks (which can force some patients to go out-of-network for care) may also have undermined the affordability of care.”

There was some positive news among the findings, however.

“The main encouraging finding from our analysis is the increase in the proportion of persons – both insured and uninsured – receiving cholesterol checks and flu shots,” Dr. Hawk and her colleagues wrote, adding that this increase “may be attributable to the increasing implementation of quality metrics, financial incentives, and improved systems for the delivery of these services.”

However, not all preventive services that had cost barriers eliminated under the ACA saw improvement, such as cancer screening. They note that the proportion of women who did not receive mammography increased during the study period and then plateaued, but did not improve following the implementation of the ACA. The authors described the reasons for this as “unclear.”

Dr. Hawks received funding support from an Institutional National Research Service award and from Cambridge Health Alliance, her employer. Other authors reported membership in Physicians for a National Health Program.

[email protected]

SOURCE: Hawks L et al. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6538.

The cost of health care is keeping more Americans from seeing a doctor, even as the number of individuals with insurance coverage increases, according to a new study.

“Despite short-term gains owing to the [Affordable Care Act], over the past 20 years the portion of adults aged 18-64 years unable to see a physician owing to the cost increased, mostly because of an increase among persons with insurance,” Laura Hawks, MD, of Cambridge (Mass.) Health Alliance and Harvard Medical School in Boston and colleagues wrote in a new research report published in JAMA Internal Medicine.

“In 2017, nearly one-fifth of individuals with any chronic condition (diabetes, obesity, or cardiovascular disease) said they were unable to see a physician owing to cost,” they continued.

Researchers examined 20 years of data (January 1998 through December 2017) from the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System to identify trends in unmet need for physician and preventive services.

Among adults aged 18-64 years who responded to the survey in 1998 and 2017, uninsurance decreased by 2.1 percentage points, falling from 16.9% to 14.8%. But at the same time, the portion of adults who were unable to see a physician because of cost rose by 2.7 percentage points, from 11.4% to 15.7%. Looking specifically at adults who had insurance coverage, the researchers found that cost was a barrier for 11.5% of them in 2017, up from 7.1% in 1998.

These results come against a backdrop of growing medical costs, increasing deductibles and copayments, an increasing use of cost containment measures like prior authorization, and narrow provider networks in the wake of the transition to value-based payment structures, the authors noted.

“Our finding that financial access to physician care worsened is concerning,” Dr. Hawks and her colleagues wrote. “Persons with conditions such as diabetes, hypertension, cardiovascular disease, and poor health status risk substantial harms if they forgo physician care. Financial barriers to care have been associated with increased hospitalizations and worse health outcomes in patients with cardiovascular disease and hypertension and increased morbidity among patients with diabetes.”

One of the trends highlighted by the study authors is the growing number of employers offering plans with a high deductible.

“Enrollment in a high-deductible health plan, which has become increasingly common in the last decade, a trend uninterrupted by the ACA, is associated with forgoing needed care, especially among those of lower socioeconomic status,” the authors wrote. “Other changes in insurance benefit design, such as imposing tiered copayments and coinsurance obligations, eliminating coverage for some services (e.g., eyeglasses) and narrowing provider networks (which can force some patients to go out-of-network for care) may also have undermined the affordability of care.”

There was some positive news among the findings, however.

“The main encouraging finding from our analysis is the increase in the proportion of persons – both insured and uninsured – receiving cholesterol checks and flu shots,” Dr. Hawk and her colleagues wrote, adding that this increase “may be attributable to the increasing implementation of quality metrics, financial incentives, and improved systems for the delivery of these services.”

However, not all preventive services that had cost barriers eliminated under the ACA saw improvement, such as cancer screening. They note that the proportion of women who did not receive mammography increased during the study period and then plateaued, but did not improve following the implementation of the ACA. The authors described the reasons for this as “unclear.”

Dr. Hawks received funding support from an Institutional National Research Service award and from Cambridge Health Alliance, her employer. Other authors reported membership in Physicians for a National Health Program.

[email protected]

SOURCE: Hawks L et al. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6538.

The cost of health care is keeping more Americans from seeing a doctor, even as the number of individuals with insurance coverage increases, according to a new study.

“Despite short-term gains owing to the [Affordable Care Act], over the past 20 years the portion of adults aged 18-64 years unable to see a physician owing to the cost increased, mostly because of an increase among persons with insurance,” Laura Hawks, MD, of Cambridge (Mass.) Health Alliance and Harvard Medical School in Boston and colleagues wrote in a new research report published in JAMA Internal Medicine.

“In 2017, nearly one-fifth of individuals with any chronic condition (diabetes, obesity, or cardiovascular disease) said they were unable to see a physician owing to cost,” they continued.

Researchers examined 20 years of data (January 1998 through December 2017) from the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System to identify trends in unmet need for physician and preventive services.

Among adults aged 18-64 years who responded to the survey in 1998 and 2017, uninsurance decreased by 2.1 percentage points, falling from 16.9% to 14.8%. But at the same time, the portion of adults who were unable to see a physician because of cost rose by 2.7 percentage points, from 11.4% to 15.7%. Looking specifically at adults who had insurance coverage, the researchers found that cost was a barrier for 11.5% of them in 2017, up from 7.1% in 1998.

These results come against a backdrop of growing medical costs, increasing deductibles and copayments, an increasing use of cost containment measures like prior authorization, and narrow provider networks in the wake of the transition to value-based payment structures, the authors noted.

“Our finding that financial access to physician care worsened is concerning,” Dr. Hawks and her colleagues wrote. “Persons with conditions such as diabetes, hypertension, cardiovascular disease, and poor health status risk substantial harms if they forgo physician care. Financial barriers to care have been associated with increased hospitalizations and worse health outcomes in patients with cardiovascular disease and hypertension and increased morbidity among patients with diabetes.”

One of the trends highlighted by the study authors is the growing number of employers offering plans with a high deductible.

“Enrollment in a high-deductible health plan, which has become increasingly common in the last decade, a trend uninterrupted by the ACA, is associated with forgoing needed care, especially among those of lower socioeconomic status,” the authors wrote. “Other changes in insurance benefit design, such as imposing tiered copayments and coinsurance obligations, eliminating coverage for some services (e.g., eyeglasses) and narrowing provider networks (which can force some patients to go out-of-network for care) may also have undermined the affordability of care.”

There was some positive news among the findings, however.

“The main encouraging finding from our analysis is the increase in the proportion of persons – both insured and uninsured – receiving cholesterol checks and flu shots,” Dr. Hawk and her colleagues wrote, adding that this increase “may be attributable to the increasing implementation of quality metrics, financial incentives, and improved systems for the delivery of these services.”

However, not all preventive services that had cost barriers eliminated under the ACA saw improvement, such as cancer screening. They note that the proportion of women who did not receive mammography increased during the study period and then plateaued, but did not improve following the implementation of the ACA. The authors described the reasons for this as “unclear.”

Dr. Hawks received funding support from an Institutional National Research Service award and from Cambridge Health Alliance, her employer. Other authors reported membership in Physicians for a National Health Program.

[email protected]

SOURCE: Hawks L et al. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6538.

For many years now, we have been lamenting the shortage of psychiatrists practicing in the United States. At this point, we must identify possible solutions.^1,2 Currently, the shortage of practicing psychiatrists in the United States could be as high as 45,000.³ The major problem is that the number of psychiatry residency positions will not increase in the foreseeable future, thus generating more psychiatrists is not an option.

Medicare pays about $150,000 per residency slot per year. To solve the mental health access problem, $27 billion (45,000 x $150,000 x 4 years)* would be required from Medicare, which is not feasible.⁴ The national average starting salary for psychiatrists from 2018-2019 was about $273,000 (much lower in academic institutions), according to Merritt Hawkins, the physician recruiting firm. That salary is modest, compared with those offered in other medical specialties. For this reason, many graduates choose other lucrative specialties. And we know that increasing the salaries of psychiatrists alone would not lead more people to choose psychiatry. On paper, it may say they work a 40-hour week, but they end up working 60 hours a week.

To make matters worse, family medicine and internal medicine doctors generally would rather not deal with people with mental illness and do “cherry-picking and lemon-dropping.” While many patients present to primary care with mental health issues, lack of time and education in psychiatric disorders and treatment hinder these physicians. In short, the mental health field cannot count on primary care physicians.

Meanwhile, there are thousands of unmatched residency graduates. In light of those realities, perhaps psychiatry residency programs could provide these unmatched graduates with 6 months of training and use them to supplement the workforce. These medical doctors, or “physician associates,” could be paired with a few psychiatrists to do clinical and administrative work. With one in four individuals having mental health issues, and more and more people seeking help because of increasing awareness and the benefits that accompanied the Affordable Care Act (ACA), physician associates might ease the workload of psychiatrists so that they can deliver better care to more people. We must take advantage of these two trends: The surge in unmatched graduates and “shrinking shrinks,” or the decline in the psychiatric workforce pool. (The Royal College of Physicians has established a category of clinicians called physician associates,⁵ but they are comparable to physician assistants in the United States. As you will see, the construct I am proposing is different.)

The current landscape

Currently, psychiatrists are under a lot of pressure to see a certain number of patients. Patients consistently complain that psychiatrists spend a maximum of 15 minutes with them, that the visits are interrupted by phone calls, and that they are not being heard and helped. Burnout, a silent epidemic among physicians, is relatively prevalent in psychiatry.⁶ Hence, some psychiatrists are reducing their hours and retiring early. Psychiatry has the third-oldest workforce, with 59% of current psychiatrists aged 55 years or older.⁷ A better pay/work ratio and work/life balance would enable psychiatrists to enjoy more fulfilling careers.

Many psychiatrists are spending a lot of their time in research, administration, and the classroom. In addition to those issues, the United States currently has a broken mental health care system.⁸ Finally, the medical practice landscape has changed dramatically in recent years, and those changes undermine both the effectiveness and well-being of clinicians.

The historical landscape

Some people proudly refer to the deinstitutionalization of mental asylums and state mental hospitals in the United States. But where have these patients gone? According to a U.S. Justice Department report, 2,220,300 adults were incarcerated in U.S. federal and state prisons and county jails in 2013.⁹ In addition, 4,751,400 adults in 2013 were on probation or parole. The percentages of inmates in state and federal prisons and local jails with a psychiatric diagnosis were 56%, 45%, and 64%, respectively.

I work at the Maryland correctional institutions, part of the Maryland Department of Public Safety and Correctional Services. One thing that I consistently hear from several correctional officers is “had these inmates received timely help and care, they wouldn’t have ended up behind bars.” Because of the criminalization of mental illness, in 44 states, the number of people with mental illness is higher in a jail or prison than in the largest state psychiatric hospital, according to the Treatment Advocacy Center. We have to be responsible for many of the inmates currently in correctional facilities for committing crimes related to mental health problems. In Maryland, a small state, there are 30,000 inmates in jails, and state and federal prison. The average cost of a meal is $1.36, thus $1.36 x 3 meals x 30,000 inmates = $122,400.00 for food alone for 1 day – this average does not take other expenses into account. By using money and manpower wisely and taking care of individuals’ mental health problems before they commit crimes, better outcomes could be achieved.

I used to work for MedOptions Inc. doing psychiatry consults at nursing homes and assisted-living facilities. Because of the shortage of psychiatrists and nurse practitioners, especially in the suburbs and rural areas, those patients could not be seen in a timely manner even for their 3-month routine follow-ups. As my colleagues and I have written previously, many elderly individuals with major neurocognitive disorders are not on the Food and Drug Administration­–approved cognitive enhancers, such as donepezil, galantamine, and memantine.¹⁰ Instead, those patients are on benzodiazepines, which are associated with cognitive impairments, and increased risk of pneumonia and falls. Benzodiazepines also can cause and/or worsen disinhibited behavior. Also, in those settings, crisis situations often are addressed days to weeks later because of the doctor shortage. This situation is going to get worse, because this patient population is growing.
 

Child and geriatric psychiatry shortages

Child and geriatric psychiatrist shortages are even higher than those in general psychiatry.¹¹ Many years of training and low salaries are a few of the reasons some choose not to do a fellowship. These residency graduates would rather join a practice at an attending salary than at a fellow’s salary, which requires an additional 1 to 2 years of training. Student loans of $100,000–$500,000 after residency also discourage some from pursuing fellowship opportunities. We need to consider models such as 2 years of residency with 2 years of a child psychiatry fellowship or 3 years of residency with 1 year of geriatric psychiatry fellowship. Working as an adult attending physician (50% of the time) and concurrently doing a fellowship (50% of the time) while receiving an attending salary might motivate more people to complete a fellowship.

In specialties such as radiology, international medical graduates (IMGs) who have completed residency training in radiology in other countries can complete a radiology fellowship in a particular area for several years and can practice in the United States as board-eligible certified MDs. Likewise, in line with the model proposed here, we could provide unmatched graduates who have no residency training with 3 to 4 years of child psychiatry and geriatric psychiatry training in addition to some adult psychiatry training.

Implementation of such a model might take care of the shortage of child and geriatric psychiatrists. In 2015, there were 56 geriatric psychiatry fellowship programs; 54 positions were filled, and 51 fellows completed training.¹² “It appears that a reasonable percentage of IMGs who obtain a fellowship in geriatric psychiatry do not have an intent of pursuing a career in the field,” Marc H. Zisselman, MD, former geriatric psychiatry fellowship director and currently with the Einstein Medical Center in Philadelphia, told me in 2016. These numbers are not at all sufficient to take care of the nation’s unmet need. Hence, implementing alternate strategies is imperative.
 

Administrative tasks and care

What consumes a psychiatrist’s time and leads to burnout? The answer has to do with administrative tasks at work. Administrative tasks are not an effective use of time for an MD who has spent more than a decade in medical school, residency, and fellowship training. Although electronic medical record (EMR) systems are considered a major advancement, engaging in the process throughout the day is associated with exhaustion.

Many physicians feel that EMRs have slowed them down, and some are not well-equipped to use them in quick and efficient ways. EMRs also have led to physicians making minimal eye contact in interviews with patients. Patients often complain: “I am talking, and the doctor is looking at the computer and typing.” Patients consider this behavior to be unprofessional and rude. In a survey of 57 U.S. physicians in family medicine, internal medicine, cardiology, and orthopedics, results showed that during the work day, 27% of their time was spent on direct clinical face time with patients and 49.2% was spent on EMR and desk work. While in the examination room with patients, physicians spent 52.9% of their time on direct clinical face time and 37.0% on EMR and desk work. Outside office hours, physicians spend up to 2 hours of personal time each night doing additional computer and other clerical work.¹³

Several EMR software systems, such as CareLogic, Cerner, Epic,NextGen, PointClickCare, and Sunrise, are used in the United States. The U.S. Veterans Affairs Medical Centers (VAMCs) use the computerized patient record system (CPRS) across the country. VA clinicians find CPRS extremely useful when they move from one VAMC to another. Likewise, hospitals and universities may use one software system such as the CPRS and thus, when clinicians change jobs, they find it hard to adapt to the new system.

Because psychiatrists are wasting a lot of time doing administrative tasks, they might be unable to do a good job with regard to making the right diagnoses and prescribing the best treatments.When I ask patients what are they diagnosed with, they tell me: “It depends on who you ask,” or “I’ve been diagnosed with everything.” This shows that we are not doing a good job or something is not right.

Currently, psychiatrists do not have the time and/or interest to make the right diagnoses and provide adequate psychoeducation for their patients. This also could be attributable to a variety of factors, including, but not limited to, time constraints, cynicism, and apathy. Time constraints also lead to the gross underutilization¹⁴ of relapse prevention strategies such as long-acting injectables and medications that can prevent suicide, such as lithium and clozapine.¹⁵

Other factors that undermine good care include not participating in continuing medical education (CME) and not staying up to date with the literature. For example, haloperidol continues to be one of the most frequently prescribed (probably, the most common) antipsychotic, although it is clearly neurotoxic^16,17 and other safer options are available.¹⁸ Board certification and maintenance of certification (MOC) are not synonymous with good clinical practice. Many physicians are finding it hard to complete daily documentation, let alone time for MOC. For a variety of reasons, many are not maintaining certification, and this number is likely to increase. Think about how much time is devoted to the one-to-one interview with the patient and direct patient care during the 15-minute medical check appointment and the hour-long new evaluation. In some clinics, psychiatrists are asked to see more than 25 patients in 4 hours. Some U.S.-based psychiatrists see 65 inpatients and initiate 10 new evaluations in a single day. Under those kinds of time constraints, how can we provide quality care?
 

A model that would address the shortage

Overall, 7,826 PGY-1 applicants were unmatched in 2019, according to data from the 2019 Main Residency Match.¹⁹ Psychiatry residency programs could give these unmatched graduates 6 months of training (arbitrary duration) in psychiatry, which is not at all difficult with the program modules that are available.²⁰ We could use them as physician associates as a major contributor to our workforce to complete administrative and other clinical tasks.

Administrative tasks are not necessarily negative, as all psychiatrists have done administrative tasks as medical students, residents, and fellows. However, at this point, administrative tasks are not an effective use of a psychiatrist’s time. Those physician associates could be paired with two to three psychiatrists to do administrative tasks (for making daytime and overnight phone calls; handling prescriptions, prior authorizations, and medication orders, especially over-the-counter and comfort medications in the inpatient units; doing chart reviews; ordering and checking laboratory tests; collecting collateral information from previous clinicians and records; printing medication education pamphlets; faxing; corresponding with insurance companies/utilization review; performing documentation; billing; and taking care of other clinical and administrative paperwork).

In addition, physician associates could collect information using rating scales such as the 9-item Patient Health Questionnaire for measurement-based care²¹ and Geriatric Depression Scale, both of which are currently not used in psychiatric practice because of time constraints and lack of manpower. Keep in mind that these individuals are medical doctors and could do a good job with these kinds of tasks. Most of them already have clinical experience in the United States and know the health care system. These MDs could conduct an initial interview (what medical students, residents, and fellows do) and present to the attending psychiatrist. Psychiatrists could then focus on the follow-up interview; diagnoses and treatment; major medical decision making, including shared decision making (patients feel that they are not part of the treatment plan); and seeing more patients, which is a more effective use of their time. This training would give these physician associates a chance to work as doctors and make a living. These MDs have completed medical school training after passing Medical College Admission Test – equivalent exams in their countries. They have passed all steps of the U.S. Medical Licensing Examination and have received Educational Commission for Foreign Medical Graduates certification. Some have even completed residency programs in their home countries.

Some U.S. states already have implemented these kinds of programs. In Arkansas, Kansas, and Missouri,^22,23 legislators have passed laws allowing unmatched graduates who have not completed a residency program to work in medically underserved areas with a collaborating physician. These physicians must directly supervise the new doctors for at least a month before they can see patients on their own. Another proposal that has been suggested to address the psychiatrist shortage is employing physician assistants to provide care.^24-26

The model proposed here is comparable to postdoctoral fellow-principal investigator and resident-attending collaborative work. At hospitals, a certified nurse assistant helps patients with health care needs under the supervision of a nurse. Similarly, a physician associate could help a psychiatrist under his or her supervision. In the Sheppard Pratt Health System in Baltimore, where I worked previously, for example, nurses dictate and prepare discharge summaries for the attending physician with whom they work. These are the kinds of tasks that physician associates could do as well.

The wait time to get a new evaluation with a psychiatrist is enormous. The policy is that a new patient admitted to an inpatient unit must be seen within 24 hours. With this model, the physician associates could see patients within a few hours, take care of their most immediate needs, take a history and conduct a physical, and write an admission note for the attending psychiatrist to sign. Currently, the outpatient practice is so busy that psychiatrists do not have the time to read the discharge summaries of patients referred to them after a recent hospitalization, which often leads to poor aftercare. The physician associates could read the discharge summaries and provide pertinent information to the attending psychiatrists.

In the inpatient units and emergency departments, nurses and social workers see patients before the attending physician, present patient information to the attending psychiatrist, and document their findings. It is redundant for the physician to write the same narrative again. Rather, the physician could add an addendum to the nurse’s or social worker’s notes and sign off. This would save a lot of time.

Numerous well-designed studies support the adoption of collaborative care models as one means of providing quality psychiatric care to larger populations.^27,28 The American Psychiatric Association (APA) is currently training 3,500 psychiatrists in collaborative care through the Centers for Medicare and Medicaid Services’ Transforming Clinical Practice Initiative.^29,30 Despite this training and the services provided by the nurse practitioners and physician assistants, the shortage of psychiatrists has not been adequately addressed. Hence, we need to think outside the box to find other potential pragmatic solutions.

Simply increasing the hours of work or the number of nurse practitioners or physician assistants already in practice is not going to solve the problem completely. The model proposed here and previously³¹ is likely to improve the quality of care that we now provide. This model should not be seen as exploiting these unmatched medical graduates and setting up a two-tiered health care system. The salary for these physicians would be a small percentage (5%-10%; these are arbitrary percentages) from the reimbursement of the attending psychiatrist. This model would not affect the salary of the attending psychiatrists; with this model, they would be able to see 25%-50% more patients (again, arbitrary percentages) with the help and support from these physician associates.
 

Potential barriers to implementation

There could be inherent barriers and complications to implementation of this model that are difficult to foresee at this point. Nurse practitioners (222,000 plus) and physician assistants (83,000 plus) have a fixed and structured curriculum, have national examining boards and national organizations with recertification requirements, and are licensed as independent practitioners, at least as far as CME is concerned.

Physician associates would need a standardized curriculum and examinations to validate what they have studied and learned. This process might be an important part of the credentialing of these individuals, as well as evaluation of cultural competency. If this model is to successfully lead to formation of a specific clinical group, it might need its own specific identity, national organization, national standards of competency, national certification and recertification processes, and national conference and CME or at least a subsection in a national behavioral and medical health organization, such as the APA or the American Academy of Child and Adolescent Psychiatry.

It would be desirable to “field test” the physician associate concept to clarify implementation difficulties, including the ones described above, that could arise. The cost of implementation of this program should not be of much concern; the 6-month training could be on a volunteer basis, or a small stipend might be paid by graduate medical education funding. This model could prove to be rewarding long term, save trillions of health care dollars, and allow us to provide exceptional and timely care.
 

Conclusion

The 2020 Mental Health America annual State of Mental Health in America report found that more than 70% of youth with severe major depressive disorder were in need of treatment in 2017. The percentage of adults with any mental illness who did not receive treatment stood at about 57.2%.³² Meanwhile, from 1999 through 2014, the age-adjusted suicide rate in the United States increased 24%.³³ More individuals are seeking help because of increased awareness.^34,35 In light of the access to services afforded by the ACA, physician associates might ease the workload of psychiatrists and enable them to deliver better care to more people. We would not necessarily have to use the term “physician associate” and could generate better terminologies later. In short, let’s tap into the pools of unmatched graduates and shrinking shrinks! If this model is successful, it could be used in other specialties and countries. The stakes for our patients have never been higher.

References

1. Bishop TF et al. Health Aff. 2016;35(7):1271-7.

2. National Council Medical Director Institute. The psychiatric shortage: Causes and solutions. 2017. Washington: National Council for Behavioral Health.

3. Satiani A et al. Psychiatric Serv. 2018;69:710-3.

4. Carlat D. Psychiatric Times. 2010 Aug 3;27(8).

5. McCartney M. BMJ. 2017;359:j5022.

6. Maslach C and Leiter MP. World Psychiatry. 2016 Jun 5;15:103-11.

7. Merritt Hawkins. “The silent shortage: A white paper examining supply, demand and recruitment trends in psychiatry.” 2018.

8. Sederer LI and Sharfstein SS. JAMA. 2014 Sep 24;312:1195-6.

9. James DJ and Glaze LE. Mental health problems of prison and jail inmates. 2006 Sep. U.S. Justice Department, Bureau of Justice Statistics Special Report.

10. Koola MM et al. J Geriatr Care Res. 2018;5(2):57-67.

11. Buckley PF and Nasrallah HA. Curr Psychiatr. 2016;15:23-4.

12. American Medical Association Database. Open Residency and Fellowship Positions.

13. Sinsky C et al. Ann Intern Med. 2016;165:753-60.

14. Koola MM. Curr Psychiatr. 2017 Mar. 16(3):19-20,47,e1.

15. Koola MM and Sebastian J. HSOA J Psychiatry Depress Anxiety. 2016;(2):1-11.

16. Nasrallah HA and Chen AT. Ann Clin Psychiatry. 2017 Aug;29(3):195-202.

17. Nasrallah HA. Curr Psychiatr. 2013 Jul;7-8.

18. Chen AT and Nasrallah HA. Schizophr Res. 2019 Jun;208:1-7.

19. National Resident Matching Program, Results and Data: 2019 Main Residency Match. National Resident Matching Program, Washington, 2019.

20. Masters KJ. J Physician Assist Educ. 2015 Sep;26(3):136-43.

21. Koola MM et al. J Nerv Ment Dis. 2011;199(12):989-90.

22. “New Missouri licensing offers ‘Band-Aid’ for physician shortages.” Kansas City Business Journal. Updated 2017 May 16.

23. “After earning an MD, she’s headed back to school – to become a nurse.” STAT. 2016 Nov 8.

24. Keizer TB and Trangle MA. Acad Psychiatry. 2015 Dec;39(6):691-4.

25. Miller JG and Peterson DJ. Acad Psychiatry. 2015 Dec;39(6):685-6.

26. Smith MS. Curr Psychiatr. 2019 Sep;18(9):17-24.

27. Osofsky HJ et al. Acad Psychiatry. 2016 Oct;40(5):747-54.

28. Dreier-Wolfgramm A et al. Z Gerontol Geriatr. 2017 May;50(Suppl 2):68-77.

29. Huang H and Barkil-Oteo A. Psychosomatics. 2015 Nov-Dec;56(6):658-61.

30. Raney L et al. Fam Syst Health. 2014 Jun;32(2):147-8.

31. Koola MM. Curr Psychiatr. 2016 Dec. 15(12):33-4.

32. Mental Health America. State of Mental Health in America 2020.

33. Curtin SC et al. NCHS Data Brief. 2016 Apr;(241):1-8.

34. Kelly DL et al. Ann Intern Med. 2020;172(2):167-8.

35. Miller JP and Nasrallah HA. Curr Psychiatr. 2015;14(12):45-6.

Dr. Koola is an associate professor in the department of psychiatry and behavioral health at Stony Brook (N.Y.) University. His main area of interest is novel therapeutic discovery in the treatment of schizophrenia. He has a particular interest in improving the health care delivery system for people with psychiatric illness. Dr. Koola declared no conflicts of interest. He can be reached at [email protected].

*This commentary was updated 2/2/2020.

For many years now, we have been lamenting the shortage of psychiatrists practicing in the United States. At this point, we must identify possible solutions.^1,2 Currently, the shortage of practicing psychiatrists in the United States could be as high as 45,000.³ The major problem is that the number of psychiatry residency positions will not increase in the foreseeable future, thus generating more psychiatrists is not an option.

Medicare pays about $150,000 per residency slot per year. To solve the mental health access problem, $27 billion (45,000 x $150,000 x 4 years)* would be required from Medicare, which is not feasible.⁴ The national average starting salary for psychiatrists from 2018-2019 was about $273,000 (much lower in academic institutions), according to Merritt Hawkins, the physician recruiting firm. That salary is modest, compared with those offered in other medical specialties. For this reason, many graduates choose other lucrative specialties. And we know that increasing the salaries of psychiatrists alone would not lead more people to choose psychiatry. On paper, it may say they work a 40-hour week, but they end up working 60 hours a week.

To make matters worse, family medicine and internal medicine doctors generally would rather not deal with people with mental illness and do “cherry-picking and lemon-dropping.” While many patients present to primary care with mental health issues, lack of time and education in psychiatric disorders and treatment hinder these physicians. In short, the mental health field cannot count on primary care physicians.

Meanwhile, there are thousands of unmatched residency graduates. In light of those realities, perhaps psychiatry residency programs could provide these unmatched graduates with 6 months of training and use them to supplement the workforce. These medical doctors, or “physician associates,” could be paired with a few psychiatrists to do clinical and administrative work. With one in four individuals having mental health issues, and more and more people seeking help because of increasing awareness and the benefits that accompanied the Affordable Care Act (ACA), physician associates might ease the workload of psychiatrists so that they can deliver better care to more people. We must take advantage of these two trends: The surge in unmatched graduates and “shrinking shrinks,” or the decline in the psychiatric workforce pool. (The Royal College of Physicians has established a category of clinicians called physician associates,⁵ but they are comparable to physician assistants in the United States. As you will see, the construct I am proposing is different.)

The current landscape

Currently, psychiatrists are under a lot of pressure to see a certain number of patients. Patients consistently complain that psychiatrists spend a maximum of 15 minutes with them, that the visits are interrupted by phone calls, and that they are not being heard and helped. Burnout, a silent epidemic among physicians, is relatively prevalent in psychiatry.⁶ Hence, some psychiatrists are reducing their hours and retiring early. Psychiatry has the third-oldest workforce, with 59% of current psychiatrists aged 55 years or older.⁷ A better pay/work ratio and work/life balance would enable psychiatrists to enjoy more fulfilling careers.

Many psychiatrists are spending a lot of their time in research, administration, and the classroom. In addition to those issues, the United States currently has a broken mental health care system.⁸ Finally, the medical practice landscape has changed dramatically in recent years, and those changes undermine both the effectiveness and well-being of clinicians.

The historical landscape

Some people proudly refer to the deinstitutionalization of mental asylums and state mental hospitals in the United States. But where have these patients gone? According to a U.S. Justice Department report, 2,220,300 adults were incarcerated in U.S. federal and state prisons and county jails in 2013.⁹ In addition, 4,751,400 adults in 2013 were on probation or parole. The percentages of inmates in state and federal prisons and local jails with a psychiatric diagnosis were 56%, 45%, and 64%, respectively.

I work at the Maryland correctional institutions, part of the Maryland Department of Public Safety and Correctional Services. One thing that I consistently hear from several correctional officers is “had these inmates received timely help and care, they wouldn’t have ended up behind bars.” Because of the criminalization of mental illness, in 44 states, the number of people with mental illness is higher in a jail or prison than in the largest state psychiatric hospital, according to the Treatment Advocacy Center. We have to be responsible for many of the inmates currently in correctional facilities for committing crimes related to mental health problems. In Maryland, a small state, there are 30,000 inmates in jails, and state and federal prison. The average cost of a meal is $1.36, thus $1.36 x 3 meals x 30,000 inmates = $122,400.00 for food alone for 1 day – this average does not take other expenses into account. By using money and manpower wisely and taking care of individuals’ mental health problems before they commit crimes, better outcomes could be achieved.

I used to work for MedOptions Inc. doing psychiatry consults at nursing homes and assisted-living facilities. Because of the shortage of psychiatrists and nurse practitioners, especially in the suburbs and rural areas, those patients could not be seen in a timely manner even for their 3-month routine follow-ups. As my colleagues and I have written previously, many elderly individuals with major neurocognitive disorders are not on the Food and Drug Administration­–approved cognitive enhancers, such as donepezil, galantamine, and memantine.¹⁰ Instead, those patients are on benzodiazepines, which are associated with cognitive impairments, and increased risk of pneumonia and falls. Benzodiazepines also can cause and/or worsen disinhibited behavior. Also, in those settings, crisis situations often are addressed days to weeks later because of the doctor shortage. This situation is going to get worse, because this patient population is growing.
 

Child and geriatric psychiatry shortages

Child and geriatric psychiatrist shortages are even higher than those in general psychiatry.¹¹ Many years of training and low salaries are a few of the reasons some choose not to do a fellowship. These residency graduates would rather join a practice at an attending salary than at a fellow’s salary, which requires an additional 1 to 2 years of training. Student loans of $100,000–$500,000 after residency also discourage some from pursuing fellowship opportunities. We need to consider models such as 2 years of residency with 2 years of a child psychiatry fellowship or 3 years of residency with 1 year of geriatric psychiatry fellowship. Working as an adult attending physician (50% of the time) and concurrently doing a fellowship (50% of the time) while receiving an attending salary might motivate more people to complete a fellowship.

In specialties such as radiology, international medical graduates (IMGs) who have completed residency training in radiology in other countries can complete a radiology fellowship in a particular area for several years and can practice in the United States as board-eligible certified MDs. Likewise, in line with the model proposed here, we could provide unmatched graduates who have no residency training with 3 to 4 years of child psychiatry and geriatric psychiatry training in addition to some adult psychiatry training.

Implementation of such a model might take care of the shortage of child and geriatric psychiatrists. In 2015, there were 56 geriatric psychiatry fellowship programs; 54 positions were filled, and 51 fellows completed training.¹² “It appears that a reasonable percentage of IMGs who obtain a fellowship in geriatric psychiatry do not have an intent of pursuing a career in the field,” Marc H. Zisselman, MD, former geriatric psychiatry fellowship director and currently with the Einstein Medical Center in Philadelphia, told me in 2016. These numbers are not at all sufficient to take care of the nation’s unmet need. Hence, implementing alternate strategies is imperative.
 

Administrative tasks and care

What consumes a psychiatrist’s time and leads to burnout? The answer has to do with administrative tasks at work. Administrative tasks are not an effective use of time for an MD who has spent more than a decade in medical school, residency, and fellowship training. Although electronic medical record (EMR) systems are considered a major advancement, engaging in the process throughout the day is associated with exhaustion.

Many physicians feel that EMRs have slowed them down, and some are not well-equipped to use them in quick and efficient ways. EMRs also have led to physicians making minimal eye contact in interviews with patients. Patients often complain: “I am talking, and the doctor is looking at the computer and typing.” Patients consider this behavior to be unprofessional and rude. In a survey of 57 U.S. physicians in family medicine, internal medicine, cardiology, and orthopedics, results showed that during the work day, 27% of their time was spent on direct clinical face time with patients and 49.2% was spent on EMR and desk work. While in the examination room with patients, physicians spent 52.9% of their time on direct clinical face time and 37.0% on EMR and desk work. Outside office hours, physicians spend up to 2 hours of personal time each night doing additional computer and other clerical work.¹³

Several EMR software systems, such as CareLogic, Cerner, Epic,NextGen, PointClickCare, and Sunrise, are used in the United States. The U.S. Veterans Affairs Medical Centers (VAMCs) use the computerized patient record system (CPRS) across the country. VA clinicians find CPRS extremely useful when they move from one VAMC to another. Likewise, hospitals and universities may use one software system such as the CPRS and thus, when clinicians change jobs, they find it hard to adapt to the new system.

Because psychiatrists are wasting a lot of time doing administrative tasks, they might be unable to do a good job with regard to making the right diagnoses and prescribing the best treatments.When I ask patients what are they diagnosed with, they tell me: “It depends on who you ask,” or “I’ve been diagnosed with everything.” This shows that we are not doing a good job or something is not right.

Currently, psychiatrists do not have the time and/or interest to make the right diagnoses and provide adequate psychoeducation for their patients. This also could be attributable to a variety of factors, including, but not limited to, time constraints, cynicism, and apathy. Time constraints also lead to the gross underutilization¹⁴ of relapse prevention strategies such as long-acting injectables and medications that can prevent suicide, such as lithium and clozapine.¹⁵

Other factors that undermine good care include not participating in continuing medical education (CME) and not staying up to date with the literature. For example, haloperidol continues to be one of the most frequently prescribed (probably, the most common) antipsychotic, although it is clearly neurotoxic^16,17 and other safer options are available.¹⁸ Board certification and maintenance of certification (MOC) are not synonymous with good clinical practice. Many physicians are finding it hard to complete daily documentation, let alone time for MOC. For a variety of reasons, many are not maintaining certification, and this number is likely to increase. Think about how much time is devoted to the one-to-one interview with the patient and direct patient care during the 15-minute medical check appointment and the hour-long new evaluation. In some clinics, psychiatrists are asked to see more than 25 patients in 4 hours. Some U.S.-based psychiatrists see 65 inpatients and initiate 10 new evaluations in a single day. Under those kinds of time constraints, how can we provide quality care?
 

A model that would address the shortage

Overall, 7,826 PGY-1 applicants were unmatched in 2019, according to data from the 2019 Main Residency Match.¹⁹ Psychiatry residency programs could give these unmatched graduates 6 months of training (arbitrary duration) in psychiatry, which is not at all difficult with the program modules that are available.²⁰ We could use them as physician associates as a major contributor to our workforce to complete administrative and other clinical tasks.

Administrative tasks are not necessarily negative, as all psychiatrists have done administrative tasks as medical students, residents, and fellows. However, at this point, administrative tasks are not an effective use of a psychiatrist’s time. Those physician associates could be paired with two to three psychiatrists to do administrative tasks (for making daytime and overnight phone calls; handling prescriptions, prior authorizations, and medication orders, especially over-the-counter and comfort medications in the inpatient units; doing chart reviews; ordering and checking laboratory tests; collecting collateral information from previous clinicians and records; printing medication education pamphlets; faxing; corresponding with insurance companies/utilization review; performing documentation; billing; and taking care of other clinical and administrative paperwork).

In addition, physician associates could collect information using rating scales such as the 9-item Patient Health Questionnaire for measurement-based care²¹ and Geriatric Depression Scale, both of which are currently not used in psychiatric practice because of time constraints and lack of manpower. Keep in mind that these individuals are medical doctors and could do a good job with these kinds of tasks. Most of them already have clinical experience in the United States and know the health care system. These MDs could conduct an initial interview (what medical students, residents, and fellows do) and present to the attending psychiatrist. Psychiatrists could then focus on the follow-up interview; diagnoses and treatment; major medical decision making, including shared decision making (patients feel that they are not part of the treatment plan); and seeing more patients, which is a more effective use of their time. This training would give these physician associates a chance to work as doctors and make a living. These MDs have completed medical school training after passing Medical College Admission Test – equivalent exams in their countries. They have passed all steps of the U.S. Medical Licensing Examination and have received Educational Commission for Foreign Medical Graduates certification. Some have even completed residency programs in their home countries.

Some U.S. states already have implemented these kinds of programs. In Arkansas, Kansas, and Missouri,^22,23 legislators have passed laws allowing unmatched graduates who have not completed a residency program to work in medically underserved areas with a collaborating physician. These physicians must directly supervise the new doctors for at least a month before they can see patients on their own. Another proposal that has been suggested to address the psychiatrist shortage is employing physician assistants to provide care.^24-26

The model proposed here is comparable to postdoctoral fellow-principal investigator and resident-attending collaborative work. At hospitals, a certified nurse assistant helps patients with health care needs under the supervision of a nurse. Similarly, a physician associate could help a psychiatrist under his or her supervision. In the Sheppard Pratt Health System in Baltimore, where I worked previously, for example, nurses dictate and prepare discharge summaries for the attending physician with whom they work. These are the kinds of tasks that physician associates could do as well.

The wait time to get a new evaluation with a psychiatrist is enormous. The policy is that a new patient admitted to an inpatient unit must be seen within 24 hours. With this model, the physician associates could see patients within a few hours, take care of their most immediate needs, take a history and conduct a physical, and write an admission note for the attending psychiatrist to sign. Currently, the outpatient practice is so busy that psychiatrists do not have the time to read the discharge summaries of patients referred to them after a recent hospitalization, which often leads to poor aftercare. The physician associates could read the discharge summaries and provide pertinent information to the attending psychiatrists.

In the inpatient units and emergency departments, nurses and social workers see patients before the attending physician, present patient information to the attending psychiatrist, and document their findings. It is redundant for the physician to write the same narrative again. Rather, the physician could add an addendum to the nurse’s or social worker’s notes and sign off. This would save a lot of time.

Numerous well-designed studies support the adoption of collaborative care models as one means of providing quality psychiatric care to larger populations.^27,28 The American Psychiatric Association (APA) is currently training 3,500 psychiatrists in collaborative care through the Centers for Medicare and Medicaid Services’ Transforming Clinical Practice Initiative.^29,30 Despite this training and the services provided by the nurse practitioners and physician assistants, the shortage of psychiatrists has not been adequately addressed. Hence, we need to think outside the box to find other potential pragmatic solutions.

Simply increasing the hours of work or the number of nurse practitioners or physician assistants already in practice is not going to solve the problem completely. The model proposed here and previously³¹ is likely to improve the quality of care that we now provide. This model should not be seen as exploiting these unmatched medical graduates and setting up a two-tiered health care system. The salary for these physicians would be a small percentage (5%-10%; these are arbitrary percentages) from the reimbursement of the attending psychiatrist. This model would not affect the salary of the attending psychiatrists; with this model, they would be able to see 25%-50% more patients (again, arbitrary percentages) with the help and support from these physician associates.
 

Potential barriers to implementation

There could be inherent barriers and complications to implementation of this model that are difficult to foresee at this point. Nurse practitioners (222,000 plus) and physician assistants (83,000 plus) have a fixed and structured curriculum, have national examining boards and national organizations with recertification requirements, and are licensed as independent practitioners, at least as far as CME is concerned.

Physician associates would need a standardized curriculum and examinations to validate what they have studied and learned. This process might be an important part of the credentialing of these individuals, as well as evaluation of cultural competency. If this model is to successfully lead to formation of a specific clinical group, it might need its own specific identity, national organization, national standards of competency, national certification and recertification processes, and national conference and CME or at least a subsection in a national behavioral and medical health organization, such as the APA or the American Academy of Child and Adolescent Psychiatry.

It would be desirable to “field test” the physician associate concept to clarify implementation difficulties, including the ones described above, that could arise. The cost of implementation of this program should not be of much concern; the 6-month training could be on a volunteer basis, or a small stipend might be paid by graduate medical education funding. This model could prove to be rewarding long term, save trillions of health care dollars, and allow us to provide exceptional and timely care.
 

Conclusion

The 2020 Mental Health America annual State of Mental Health in America report found that more than 70% of youth with severe major depressive disorder were in need of treatment in 2017. The percentage of adults with any mental illness who did not receive treatment stood at about 57.2%.³² Meanwhile, from 1999 through 2014, the age-adjusted suicide rate in the United States increased 24%.³³ More individuals are seeking help because of increased awareness.^34,35 In light of the access to services afforded by the ACA, physician associates might ease the workload of psychiatrists and enable them to deliver better care to more people. We would not necessarily have to use the term “physician associate” and could generate better terminologies later. In short, let’s tap into the pools of unmatched graduates and shrinking shrinks! If this model is successful, it could be used in other specialties and countries. The stakes for our patients have never been higher.

References

1. Bishop TF et al. Health Aff. 2016;35(7):1271-7.

2. National Council Medical Director Institute. The psychiatric shortage: Causes and solutions. 2017. Washington: National Council for Behavioral Health.

3. Satiani A et al. Psychiatric Serv. 2018;69:710-3.

4. Carlat D. Psychiatric Times. 2010 Aug 3;27(8).

5. McCartney M. BMJ. 2017;359:j5022.

6. Maslach C and Leiter MP. World Psychiatry. 2016 Jun 5;15:103-11.

7. Merritt Hawkins. “The silent shortage: A white paper examining supply, demand and recruitment trends in psychiatry.” 2018.

8. Sederer LI and Sharfstein SS. JAMA. 2014 Sep 24;312:1195-6.

9. James DJ and Glaze LE. Mental health problems of prison and jail inmates. 2006 Sep. U.S. Justice Department, Bureau of Justice Statistics Special Report.

10. Koola MM et al. J Geriatr Care Res. 2018;5(2):57-67.

11. Buckley PF and Nasrallah HA. Curr Psychiatr. 2016;15:23-4.

12. American Medical Association Database. Open Residency and Fellowship Positions.

13. Sinsky C et al. Ann Intern Med. 2016;165:753-60.

14. Koola MM. Curr Psychiatr. 2017 Mar. 16(3):19-20,47,e1.

15. Koola MM and Sebastian J. HSOA J Psychiatry Depress Anxiety. 2016;(2):1-11.

16. Nasrallah HA and Chen AT. Ann Clin Psychiatry. 2017 Aug;29(3):195-202.

17. Nasrallah HA. Curr Psychiatr. 2013 Jul;7-8.

18. Chen AT and Nasrallah HA. Schizophr Res. 2019 Jun;208:1-7.

19. National Resident Matching Program, Results and Data: 2019 Main Residency Match. National Resident Matching Program, Washington, 2019.

20. Masters KJ. J Physician Assist Educ. 2015 Sep;26(3):136-43.

21. Koola MM et al. J Nerv Ment Dis. 2011;199(12):989-90.

22. “New Missouri licensing offers ‘Band-Aid’ for physician shortages.” Kansas City Business Journal. Updated 2017 May 16.

23. “After earning an MD, she’s headed back to school – to become a nurse.” STAT. 2016 Nov 8.

24. Keizer TB and Trangle MA. Acad Psychiatry. 2015 Dec;39(6):691-4.

25. Miller JG and Peterson DJ. Acad Psychiatry. 2015 Dec;39(6):685-6.

26. Smith MS. Curr Psychiatr. 2019 Sep;18(9):17-24.

27. Osofsky HJ et al. Acad Psychiatry. 2016 Oct;40(5):747-54.

28. Dreier-Wolfgramm A et al. Z Gerontol Geriatr. 2017 May;50(Suppl 2):68-77.

29. Huang H and Barkil-Oteo A. Psychosomatics. 2015 Nov-Dec;56(6):658-61.

30. Raney L et al. Fam Syst Health. 2014 Jun;32(2):147-8.

31. Koola MM. Curr Psychiatr. 2016 Dec. 15(12):33-4.

32. Mental Health America. State of Mental Health in America 2020.

33. Curtin SC et al. NCHS Data Brief. 2016 Apr;(241):1-8.

34. Kelly DL et al. Ann Intern Med. 2020;172(2):167-8.

35. Miller JP and Nasrallah HA. Curr Psychiatr. 2015;14(12):45-6.

Dr. Koola is an associate professor in the department of psychiatry and behavioral health at Stony Brook (N.Y.) University. His main area of interest is novel therapeutic discovery in the treatment of schizophrenia. He has a particular interest in improving the health care delivery system for people with psychiatric illness. Dr. Koola declared no conflicts of interest. He can be reached at [email protected].

*This commentary was updated 2/2/2020.

For many years now, we have been lamenting the shortage of psychiatrists practicing in the United States. At this point, we must identify possible solutions.^1,2 Currently, the shortage of practicing psychiatrists in the United States could be as high as 45,000.³ The major problem is that the number of psychiatry residency positions will not increase in the foreseeable future, thus generating more psychiatrists is not an option.

Medicare pays about $150,000 per residency slot per year. To solve the mental health access problem, $27 billion (45,000 x $150,000 x 4 years)* would be required from Medicare, which is not feasible.⁴ The national average starting salary for psychiatrists from 2018-2019 was about $273,000 (much lower in academic institutions), according to Merritt Hawkins, the physician recruiting firm. That salary is modest, compared with those offered in other medical specialties. For this reason, many graduates choose other lucrative specialties. And we know that increasing the salaries of psychiatrists alone would not lead more people to choose psychiatry. On paper, it may say they work a 40-hour week, but they end up working 60 hours a week.

To make matters worse, family medicine and internal medicine doctors generally would rather not deal with people with mental illness and do “cherry-picking and lemon-dropping.” While many patients present to primary care with mental health issues, lack of time and education in psychiatric disorders and treatment hinder these physicians. In short, the mental health field cannot count on primary care physicians.

Meanwhile, there are thousands of unmatched residency graduates. In light of those realities, perhaps psychiatry residency programs could provide these unmatched graduates with 6 months of training and use them to supplement the workforce. These medical doctors, or “physician associates,” could be paired with a few psychiatrists to do clinical and administrative work. With one in four individuals having mental health issues, and more and more people seeking help because of increasing awareness and the benefits that accompanied the Affordable Care Act (ACA), physician associates might ease the workload of psychiatrists so that they can deliver better care to more people. We must take advantage of these two trends: The surge in unmatched graduates and “shrinking shrinks,” or the decline in the psychiatric workforce pool. (The Royal College of Physicians has established a category of clinicians called physician associates,⁵ but they are comparable to physician assistants in the United States. As you will see, the construct I am proposing is different.)

The current landscape

Currently, psychiatrists are under a lot of pressure to see a certain number of patients. Patients consistently complain that psychiatrists spend a maximum of 15 minutes with them, that the visits are interrupted by phone calls, and that they are not being heard and helped. Burnout, a silent epidemic among physicians, is relatively prevalent in psychiatry.⁶ Hence, some psychiatrists are reducing their hours and retiring early. Psychiatry has the third-oldest workforce, with 59% of current psychiatrists aged 55 years or older.⁷ A better pay/work ratio and work/life balance would enable psychiatrists to enjoy more fulfilling careers.

Many psychiatrists are spending a lot of their time in research, administration, and the classroom. In addition to those issues, the United States currently has a broken mental health care system.⁸ Finally, the medical practice landscape has changed dramatically in recent years, and those changes undermine both the effectiveness and well-being of clinicians.

The historical landscape

Some people proudly refer to the deinstitutionalization of mental asylums and state mental hospitals in the United States. But where have these patients gone? According to a U.S. Justice Department report, 2,220,300 adults were incarcerated in U.S. federal and state prisons and county jails in 2013.⁹ In addition, 4,751,400 adults in 2013 were on probation or parole. The percentages of inmates in state and federal prisons and local jails with a psychiatric diagnosis were 56%, 45%, and 64%, respectively.

I work at the Maryland correctional institutions, part of the Maryland Department of Public Safety and Correctional Services. One thing that I consistently hear from several correctional officers is “had these inmates received timely help and care, they wouldn’t have ended up behind bars.” Because of the criminalization of mental illness, in 44 states, the number of people with mental illness is higher in a jail or prison than in the largest state psychiatric hospital, according to the Treatment Advocacy Center. We have to be responsible for many of the inmates currently in correctional facilities for committing crimes related to mental health problems. In Maryland, a small state, there are 30,000 inmates in jails, and state and federal prison. The average cost of a meal is $1.36, thus $1.36 x 3 meals x 30,000 inmates = $122,400.00 for food alone for 1 day – this average does not take other expenses into account. By using money and manpower wisely and taking care of individuals’ mental health problems before they commit crimes, better outcomes could be achieved.

I used to work for MedOptions Inc. doing psychiatry consults at nursing homes and assisted-living facilities. Because of the shortage of psychiatrists and nurse practitioners, especially in the suburbs and rural areas, those patients could not be seen in a timely manner even for their 3-month routine follow-ups. As my colleagues and I have written previously, many elderly individuals with major neurocognitive disorders are not on the Food and Drug Administration­–approved cognitive enhancers, such as donepezil, galantamine, and memantine.¹⁰ Instead, those patients are on benzodiazepines, which are associated with cognitive impairments, and increased risk of pneumonia and falls. Benzodiazepines also can cause and/or worsen disinhibited behavior. Also, in those settings, crisis situations often are addressed days to weeks later because of the doctor shortage. This situation is going to get worse, because this patient population is growing.
 

Child and geriatric psychiatry shortages

Child and geriatric psychiatrist shortages are even higher than those in general psychiatry.¹¹ Many years of training and low salaries are a few of the reasons some choose not to do a fellowship. These residency graduates would rather join a practice at an attending salary than at a fellow’s salary, which requires an additional 1 to 2 years of training. Student loans of $100,000–$500,000 after residency also discourage some from pursuing fellowship opportunities. We need to consider models such as 2 years of residency with 2 years of a child psychiatry fellowship or 3 years of residency with 1 year of geriatric psychiatry fellowship. Working as an adult attending physician (50% of the time) and concurrently doing a fellowship (50% of the time) while receiving an attending salary might motivate more people to complete a fellowship.

In specialties such as radiology, international medical graduates (IMGs) who have completed residency training in radiology in other countries can complete a radiology fellowship in a particular area for several years and can practice in the United States as board-eligible certified MDs. Likewise, in line with the model proposed here, we could provide unmatched graduates who have no residency training with 3 to 4 years of child psychiatry and geriatric psychiatry training in addition to some adult psychiatry training.

Implementation of such a model might take care of the shortage of child and geriatric psychiatrists. In 2015, there were 56 geriatric psychiatry fellowship programs; 54 positions were filled, and 51 fellows completed training.¹² “It appears that a reasonable percentage of IMGs who obtain a fellowship in geriatric psychiatry do not have an intent of pursuing a career in the field,” Marc H. Zisselman, MD, former geriatric psychiatry fellowship director and currently with the Einstein Medical Center in Philadelphia, told me in 2016. These numbers are not at all sufficient to take care of the nation’s unmet need. Hence, implementing alternate strategies is imperative.
 

Administrative tasks and care

What consumes a psychiatrist’s time and leads to burnout? The answer has to do with administrative tasks at work. Administrative tasks are not an effective use of time for an MD who has spent more than a decade in medical school, residency, and fellowship training. Although electronic medical record (EMR) systems are considered a major advancement, engaging in the process throughout the day is associated with exhaustion.

Many physicians feel that EMRs have slowed them down, and some are not well-equipped to use them in quick and efficient ways. EMRs also have led to physicians making minimal eye contact in interviews with patients. Patients often complain: “I am talking, and the doctor is looking at the computer and typing.” Patients consider this behavior to be unprofessional and rude. In a survey of 57 U.S. physicians in family medicine, internal medicine, cardiology, and orthopedics, results showed that during the work day, 27% of their time was spent on direct clinical face time with patients and 49.2% was spent on EMR and desk work. While in the examination room with patients, physicians spent 52.9% of their time on direct clinical face time and 37.0% on EMR and desk work. Outside office hours, physicians spend up to 2 hours of personal time each night doing additional computer and other clerical work.¹³

Several EMR software systems, such as CareLogic, Cerner, Epic,NextGen, PointClickCare, and Sunrise, are used in the United States. The U.S. Veterans Affairs Medical Centers (VAMCs) use the computerized patient record system (CPRS) across the country. VA clinicians find CPRS extremely useful when they move from one VAMC to another. Likewise, hospitals and universities may use one software system such as the CPRS and thus, when clinicians change jobs, they find it hard to adapt to the new system.

Because psychiatrists are wasting a lot of time doing administrative tasks, they might be unable to do a good job with regard to making the right diagnoses and prescribing the best treatments.When I ask patients what are they diagnosed with, they tell me: “It depends on who you ask,” or “I’ve been diagnosed with everything.” This shows that we are not doing a good job or something is not right.

Currently, psychiatrists do not have the time and/or interest to make the right diagnoses and provide adequate psychoeducation for their patients. This also could be attributable to a variety of factors, including, but not limited to, time constraints, cynicism, and apathy. Time constraints also lead to the gross underutilization¹⁴ of relapse prevention strategies such as long-acting injectables and medications that can prevent suicide, such as lithium and clozapine.¹⁵

Other factors that undermine good care include not participating in continuing medical education (CME) and not staying up to date with the literature. For example, haloperidol continues to be one of the most frequently prescribed (probably, the most common) antipsychotic, although it is clearly neurotoxic^16,17 and other safer options are available.¹⁸ Board certification and maintenance of certification (MOC) are not synonymous with good clinical practice. Many physicians are finding it hard to complete daily documentation, let alone time for MOC. For a variety of reasons, many are not maintaining certification, and this number is likely to increase. Think about how much time is devoted to the one-to-one interview with the patient and direct patient care during the 15-minute medical check appointment and the hour-long new evaluation. In some clinics, psychiatrists are asked to see more than 25 patients in 4 hours. Some U.S.-based psychiatrists see 65 inpatients and initiate 10 new evaluations in a single day. Under those kinds of time constraints, how can we provide quality care?
 

A model that would address the shortage

Overall, 7,826 PGY-1 applicants were unmatched in 2019, according to data from the 2019 Main Residency Match.¹⁹ Psychiatry residency programs could give these unmatched graduates 6 months of training (arbitrary duration) in psychiatry, which is not at all difficult with the program modules that are available.²⁰ We could use them as physician associates as a major contributor to our workforce to complete administrative and other clinical tasks.

Administrative tasks are not necessarily negative, as all psychiatrists have done administrative tasks as medical students, residents, and fellows. However, at this point, administrative tasks are not an effective use of a psychiatrist’s time. Those physician associates could be paired with two to three psychiatrists to do administrative tasks (for making daytime and overnight phone calls; handling prescriptions, prior authorizations, and medication orders, especially over-the-counter and comfort medications in the inpatient units; doing chart reviews; ordering and checking laboratory tests; collecting collateral information from previous clinicians and records; printing medication education pamphlets; faxing; corresponding with insurance companies/utilization review; performing documentation; billing; and taking care of other clinical and administrative paperwork).

In addition, physician associates could collect information using rating scales such as the 9-item Patient Health Questionnaire for measurement-based care²¹ and Geriatric Depression Scale, both of which are currently not used in psychiatric practice because of time constraints and lack of manpower. Keep in mind that these individuals are medical doctors and could do a good job with these kinds of tasks. Most of them already have clinical experience in the United States and know the health care system. These MDs could conduct an initial interview (what medical students, residents, and fellows do) and present to the attending psychiatrist. Psychiatrists could then focus on the follow-up interview; diagnoses and treatment; major medical decision making, including shared decision making (patients feel that they are not part of the treatment plan); and seeing more patients, which is a more effective use of their time. This training would give these physician associates a chance to work as doctors and make a living. These MDs have completed medical school training after passing Medical College Admission Test – equivalent exams in their countries. They have passed all steps of the U.S. Medical Licensing Examination and have received Educational Commission for Foreign Medical Graduates certification. Some have even completed residency programs in their home countries.

Some U.S. states already have implemented these kinds of programs. In Arkansas, Kansas, and Missouri,^22,23 legislators have passed laws allowing unmatched graduates who have not completed a residency program to work in medically underserved areas with a collaborating physician. These physicians must directly supervise the new doctors for at least a month before they can see patients on their own. Another proposal that has been suggested to address the psychiatrist shortage is employing physician assistants to provide care.^24-26

The model proposed here is comparable to postdoctoral fellow-principal investigator and resident-attending collaborative work. At hospitals, a certified nurse assistant helps patients with health care needs under the supervision of a nurse. Similarly, a physician associate could help a psychiatrist under his or her supervision. In the Sheppard Pratt Health System in Baltimore, where I worked previously, for example, nurses dictate and prepare discharge summaries for the attending physician with whom they work. These are the kinds of tasks that physician associates could do as well.

The wait time to get a new evaluation with a psychiatrist is enormous. The policy is that a new patient admitted to an inpatient unit must be seen within 24 hours. With this model, the physician associates could see patients within a few hours, take care of their most immediate needs, take a history and conduct a physical, and write an admission note for the attending psychiatrist to sign. Currently, the outpatient practice is so busy that psychiatrists do not have the time to read the discharge summaries of patients referred to them after a recent hospitalization, which often leads to poor aftercare. The physician associates could read the discharge summaries and provide pertinent information to the attending psychiatrists.

In the inpatient units and emergency departments, nurses and social workers see patients before the attending physician, present patient information to the attending psychiatrist, and document their findings. It is redundant for the physician to write the same narrative again. Rather, the physician could add an addendum to the nurse’s or social worker’s notes and sign off. This would save a lot of time.

Numerous well-designed studies support the adoption of collaborative care models as one means of providing quality psychiatric care to larger populations.^27,28 The American Psychiatric Association (APA) is currently training 3,500 psychiatrists in collaborative care through the Centers for Medicare and Medicaid Services’ Transforming Clinical Practice Initiative.^29,30 Despite this training and the services provided by the nurse practitioners and physician assistants, the shortage of psychiatrists has not been adequately addressed. Hence, we need to think outside the box to find other potential pragmatic solutions.

Simply increasing the hours of work or the number of nurse practitioners or physician assistants already in practice is not going to solve the problem completely. The model proposed here and previously³¹ is likely to improve the quality of care that we now provide. This model should not be seen as exploiting these unmatched medical graduates and setting up a two-tiered health care system. The salary for these physicians would be a small percentage (5%-10%; these are arbitrary percentages) from the reimbursement of the attending psychiatrist. This model would not affect the salary of the attending psychiatrists; with this model, they would be able to see 25%-50% more patients (again, arbitrary percentages) with the help and support from these physician associates.
 

Potential barriers to implementation

There could be inherent barriers and complications to implementation of this model that are difficult to foresee at this point. Nurse practitioners (222,000 plus) and physician assistants (83,000 plus) have a fixed and structured curriculum, have national examining boards and national organizations with recertification requirements, and are licensed as independent practitioners, at least as far as CME is concerned.

Physician associates would need a standardized curriculum and examinations to validate what they have studied and learned. This process might be an important part of the credentialing of these individuals, as well as evaluation of cultural competency. If this model is to successfully lead to formation of a specific clinical group, it might need its own specific identity, national organization, national standards of competency, national certification and recertification processes, and national conference and CME or at least a subsection in a national behavioral and medical health organization, such as the APA or the American Academy of Child and Adolescent Psychiatry.

It would be desirable to “field test” the physician associate concept to clarify implementation difficulties, including the ones described above, that could arise. The cost of implementation of this program should not be of much concern; the 6-month training could be on a volunteer basis, or a small stipend might be paid by graduate medical education funding. This model could prove to be rewarding long term, save trillions of health care dollars, and allow us to provide exceptional and timely care.
 

Conclusion

The 2020 Mental Health America annual State of Mental Health in America report found that more than 70% of youth with severe major depressive disorder were in need of treatment in 2017. The percentage of adults with any mental illness who did not receive treatment stood at about 57.2%.³² Meanwhile, from 1999 through 2014, the age-adjusted suicide rate in the United States increased 24%.³³ More individuals are seeking help because of increased awareness.^34,35 In light of the access to services afforded by the ACA, physician associates might ease the workload of psychiatrists and enable them to deliver better care to more people. We would not necessarily have to use the term “physician associate” and could generate better terminologies later. In short, let’s tap into the pools of unmatched graduates and shrinking shrinks! If this model is successful, it could be used in other specialties and countries. The stakes for our patients have never been higher.

References

1. Bishop TF et al. Health Aff. 2016;35(7):1271-7.

2. National Council Medical Director Institute. The psychiatric shortage: Causes and solutions. 2017. Washington: National Council for Behavioral Health.

3. Satiani A et al. Psychiatric Serv. 2018;69:710-3.

4. Carlat D. Psychiatric Times. 2010 Aug 3;27(8).

5. McCartney M. BMJ. 2017;359:j5022.

6. Maslach C and Leiter MP. World Psychiatry. 2016 Jun 5;15:103-11.

7. Merritt Hawkins. “The silent shortage: A white paper examining supply, demand and recruitment trends in psychiatry.” 2018.

8. Sederer LI and Sharfstein SS. JAMA. 2014 Sep 24;312:1195-6.

9. James DJ and Glaze LE. Mental health problems of prison and jail inmates. 2006 Sep. U.S. Justice Department, Bureau of Justice Statistics Special Report.

10. Koola MM et al. J Geriatr Care Res. 2018;5(2):57-67.

11. Buckley PF and Nasrallah HA. Curr Psychiatr. 2016;15:23-4.

12. American Medical Association Database. Open Residency and Fellowship Positions.

13. Sinsky C et al. Ann Intern Med. 2016;165:753-60.

14. Koola MM. Curr Psychiatr. 2017 Mar. 16(3):19-20,47,e1.

15. Koola MM and Sebastian J. HSOA J Psychiatry Depress Anxiety. 2016;(2):1-11.

16. Nasrallah HA and Chen AT. Ann Clin Psychiatry. 2017 Aug;29(3):195-202.

17. Nasrallah HA. Curr Psychiatr. 2013 Jul;7-8.

18. Chen AT and Nasrallah HA. Schizophr Res. 2019 Jun;208:1-7.

19. National Resident Matching Program, Results and Data: 2019 Main Residency Match. National Resident Matching Program, Washington, 2019.

20. Masters KJ. J Physician Assist Educ. 2015 Sep;26(3):136-43.

21. Koola MM et al. J Nerv Ment Dis. 2011;199(12):989-90.

22. “New Missouri licensing offers ‘Band-Aid’ for physician shortages.” Kansas City Business Journal. Updated 2017 May 16.

23. “After earning an MD, she’s headed back to school – to become a nurse.” STAT. 2016 Nov 8.

24. Keizer TB and Trangle MA. Acad Psychiatry. 2015 Dec;39(6):691-4.

25. Miller JG and Peterson DJ. Acad Psychiatry. 2015 Dec;39(6):685-6.

26. Smith MS. Curr Psychiatr. 2019 Sep;18(9):17-24.

27. Osofsky HJ et al. Acad Psychiatry. 2016 Oct;40(5):747-54.

28. Dreier-Wolfgramm A et al. Z Gerontol Geriatr. 2017 May;50(Suppl 2):68-77.

29. Huang H and Barkil-Oteo A. Psychosomatics. 2015 Nov-Dec;56(6):658-61.

30. Raney L et al. Fam Syst Health. 2014 Jun;32(2):147-8.

31. Koola MM. Curr Psychiatr. 2016 Dec. 15(12):33-4.

32. Mental Health America. State of Mental Health in America 2020.

33. Curtin SC et al. NCHS Data Brief. 2016 Apr;(241):1-8.

34. Kelly DL et al. Ann Intern Med. 2020;172(2):167-8.

35. Miller JP and Nasrallah HA. Curr Psychiatr. 2015;14(12):45-6.

Dr. Koola is an associate professor in the department of psychiatry and behavioral health at Stony Brook (N.Y.) University. His main area of interest is novel therapeutic discovery in the treatment of schizophrenia. He has a particular interest in improving the health care delivery system for people with psychiatric illness. Dr. Koola declared no conflicts of interest. He can be reached at [email protected].

*This commentary was updated 2/2/2020.

A group of leading medical journal editors is seeking to improve the completeness and transparency of financial disclosure reporting with a proposed new disclosure form that puts more onus on readers to decide whether relationships and activities should influence how they view published papers.

The proposed changes are described in an editorial published simultaneously today in the Annals of Internal Medicine, British Medical Journal, Journal of the American Medical Association, The Lancet, New England Journal of Medicine, and several other journals whose editors are members of the International Committee of Medical Journal Editors (ICMJE).

“While no approach to disclosure will be perfect or foolproof, we hope the changes we propose will help promote transparency and trust,” the editorial stated (Ann Intern Med. 2020 Jan 27. doi: 10.7326/M19-3933).

The ICMJE adopted its currently used electronic form – the “ICMJE Form for the Disclosure of Potential Conflicts of Interest” – 10 years ago in an effort to create some uniformity amidst a patchwork of differing disclosure requirements for authors.

It’s not known how many journals outside of the ICMJE’s member journals routinely use the disclosure form, but the organization’s website houses an extensive list of journals whose editors or publishers have requested to be listed as following the ICMJE’s recommendations for editing, reporting, and publishing, including those concerning disclosures. The ICMJE does not “certify” journals. The full set of recommendations was updated in December 2019.

Most authors are committed to transparent reporting, but “opinions differ over which relationships or activities to report,” the editorial stated.

An author might choose to omit an item that others deem important because of a difference in opinion regarding “relevance,” confusion over definitions, or a simple oversight. Some authors may be “concerned that readers will interpret the listing of any item as a ‘potential conflict of interest’ as indicative of problematic influence and wrongdoing,” the editorial stated.

The revised form, like the current one, asks authors to disclose relationships and activities that are directly related to the reported work, as well as those that are topically related (within the broadly defined field addressed in the work). But unlike the current form, the new version provides a checklist of relationships and activities and asks authors to check ‘yes’ or ‘no’ for each one (and to name them when the answer is ‘yes’).

Items in the checklist include grants, payments/honoraria for lectures, patents issued or planned, stock/stock options, and leadership or fiduciary roles in committees, boards, or societies.

The proposed new form makes no mention of “potential conflicts of interest” or “relevancy,” per say. Authors aren’t asked to determine what might be interpreted as a potential conflict of interest, but instead are asked for a “complete listing” of what readers may find “pertinent” to their work.

“We’re trying to move away from calling everything a [potential] ‘conflict,’ ” Darren B. Taichman, MD, PhD, secretary of ICMJE and executive editor of the Annals of Internal Medicine, said in an interview. “We want to remove for authors the concern or stigma, if you will, that anything listed on a form implies that there is something wrong, because that’s just not true. … We want readers to decide what relationships are important as they interpret the work.”

Dr. Taichman said in the interview that the ICMJE’s updating of the form was more a function of “good housekeeping” and continuous appreciation of disclosure as an important issue, rather than any one specific issue, such as concern over a “relevancy” approach to disclosures.

The ICMJE is seeking feedback about its proposed form, which is available with a link for providing comments, at www.icmje.org.

Broader national efforts

Editors and others have been increasingly moving, however, toward asking for more complete disclosures where authors aren’t asked to judge “relevancy” and where readers can make decisions on their own. The American Society of Clinical Oncology, which produces the Journal of Clinical Oncology (JCO) as well as practice guidelines and continuing medical education programs, moved about 5 years ago to a system of general disclosure that asks physicians and others to disclose all financial interests and industry relationships, with no qualifiers.

Earlier in January 2020, the Accreditation Council for Continuing Medical Education issued proposed revisions to its Standards for Integrity and Independence in Accredited Continuing Education. These revisions, which are open for comment, require CME providers to collect disclosure information about all financial relationships of speakers and presenters. It’s up to the CME provider to then determine which relationships are relevant, according to the proposed document.

More change is on the way, as disclosure issues are being deliberated nationally in the wake of a highly publicized disclosure failure at Memorial Sloan Kettering Cancer Center in 2018. Chief medical officer José Baselga, MD, PhD, failed to report millions of dollars of industry payments and ownership interests in journal articles he wrote or cowrote over several years.

In February 2019, leaders from journals, academia, medical societies, and other institutions gathered in Washington for a closed-door meeting to hash out various disclosure related issues.

Hosted by the Association of American Medical Colleges and cosponsored by Memorial Sloan Kettering Cancer Center, ASCO, JAMA, and the Council of Medical Specialty Societies, the meeting led to a series of working groups that are creating additional recommendations “due out soon in 2020,” Heather Pierce, senior director of science policy and regulatory counsel for the AAMC, said in an interview.

Among the questions being discussed: What disclosures should be verified and who should do so? How can disclosures be made more complete and easier for researchers? And, “most importantly,” said Ms. Pierce, how can policy requirements across each of these sectors be aligned so that there’s more coordination and oversight – and with it, public trust?

Some critics of current disclosure policies have called for more reporting of compensation amounts, and Ms. Pierce said that this has been part of cross-sector discussions.

The ICMJE’s proposed form invites, but does not require, authors to indicate what payments were made to them or their institutions. “Part of this is due to the fact that it’s hard to define, let alone agree on, what’s an important amount,” Dr. Taichman said.

A push for registries

The ICMJE is also aiming to make the disclosure process more efficient for authors – and to eliminate inconsistent and incomplete disclosures – by accepting disclosures from web-based repositories, according to the editorial. Repositories allow authors to maintain an inventory of their relationships and activities and then create electronic disclosures that are tailored to the requirements of the ICMJE, medical societies, and other entities.

The AAMC-run repository, called Convey, is consistent with ICMJE reporting requirements and other criteria (e.g., there are no fees for individuals to enter, store, or export their data), but the development of other repositories may be helpful “for meeting regional, linguistic, and regulatory needs” of authors across the world, the editorial stated.

The Annals of Internal Medicine and the New England Journal of Medicine are both currently collecting disclosures through Convey. The platform was born from discussions that followed a 2009 Institute of Medicine report on conflicts of interest.

Signers of the ICMJE editorial include representatives of the National Library of Medicine and the World Association of Medical Editors, in addition to editors in chief and other leaders of the ICMJE member journals.

A group of leading medical journal editors is seeking to improve the completeness and transparency of financial disclosure reporting with a proposed new disclosure form that puts more onus on readers to decide whether relationships and activities should influence how they view published papers.

The proposed changes are described in an editorial published simultaneously today in the Annals of Internal Medicine, British Medical Journal, Journal of the American Medical Association, The Lancet, New England Journal of Medicine, and several other journals whose editors are members of the International Committee of Medical Journal Editors (ICMJE).

“While no approach to disclosure will be perfect or foolproof, we hope the changes we propose will help promote transparency and trust,” the editorial stated (Ann Intern Med. 2020 Jan 27. doi: 10.7326/M19-3933).

The ICMJE adopted its currently used electronic form – the “ICMJE Form for the Disclosure of Potential Conflicts of Interest” – 10 years ago in an effort to create some uniformity amidst a patchwork of differing disclosure requirements for authors.

It’s not known how many journals outside of the ICMJE’s member journals routinely use the disclosure form, but the organization’s website houses an extensive list of journals whose editors or publishers have requested to be listed as following the ICMJE’s recommendations for editing, reporting, and publishing, including those concerning disclosures. The ICMJE does not “certify” journals. The full set of recommendations was updated in December 2019.

Most authors are committed to transparent reporting, but “opinions differ over which relationships or activities to report,” the editorial stated.

An author might choose to omit an item that others deem important because of a difference in opinion regarding “relevance,” confusion over definitions, or a simple oversight. Some authors may be “concerned that readers will interpret the listing of any item as a ‘potential conflict of interest’ as indicative of problematic influence and wrongdoing,” the editorial stated.

The revised form, like the current one, asks authors to disclose relationships and activities that are directly related to the reported work, as well as those that are topically related (within the broadly defined field addressed in the work). But unlike the current form, the new version provides a checklist of relationships and activities and asks authors to check ‘yes’ or ‘no’ for each one (and to name them when the answer is ‘yes’).

Items in the checklist include grants, payments/honoraria for lectures, patents issued or planned, stock/stock options, and leadership or fiduciary roles in committees, boards, or societies.

The proposed new form makes no mention of “potential conflicts of interest” or “relevancy,” per say. Authors aren’t asked to determine what might be interpreted as a potential conflict of interest, but instead are asked for a “complete listing” of what readers may find “pertinent” to their work.

“We’re trying to move away from calling everything a [potential] ‘conflict,’ ” Darren B. Taichman, MD, PhD, secretary of ICMJE and executive editor of the Annals of Internal Medicine, said in an interview. “We want to remove for authors the concern or stigma, if you will, that anything listed on a form implies that there is something wrong, because that’s just not true. … We want readers to decide what relationships are important as they interpret the work.”

Dr. Taichman said in the interview that the ICMJE’s updating of the form was more a function of “good housekeeping” and continuous appreciation of disclosure as an important issue, rather than any one specific issue, such as concern over a “relevancy” approach to disclosures.

The ICMJE is seeking feedback about its proposed form, which is available with a link for providing comments, at www.icmje.org.

Broader national efforts

Editors and others have been increasingly moving, however, toward asking for more complete disclosures where authors aren’t asked to judge “relevancy” and where readers can make decisions on their own. The American Society of Clinical Oncology, which produces the Journal of Clinical Oncology (JCO) as well as practice guidelines and continuing medical education programs, moved about 5 years ago to a system of general disclosure that asks physicians and others to disclose all financial interests and industry relationships, with no qualifiers.

Earlier in January 2020, the Accreditation Council for Continuing Medical Education issued proposed revisions to its Standards for Integrity and Independence in Accredited Continuing Education. These revisions, which are open for comment, require CME providers to collect disclosure information about all financial relationships of speakers and presenters. It’s up to the CME provider to then determine which relationships are relevant, according to the proposed document.

More change is on the way, as disclosure issues are being deliberated nationally in the wake of a highly publicized disclosure failure at Memorial Sloan Kettering Cancer Center in 2018. Chief medical officer José Baselga, MD, PhD, failed to report millions of dollars of industry payments and ownership interests in journal articles he wrote or cowrote over several years.

In February 2019, leaders from journals, academia, medical societies, and other institutions gathered in Washington for a closed-door meeting to hash out various disclosure related issues.

Hosted by the Association of American Medical Colleges and cosponsored by Memorial Sloan Kettering Cancer Center, ASCO, JAMA, and the Council of Medical Specialty Societies, the meeting led to a series of working groups that are creating additional recommendations “due out soon in 2020,” Heather Pierce, senior director of science policy and regulatory counsel for the AAMC, said in an interview.

Among the questions being discussed: What disclosures should be verified and who should do so? How can disclosures be made more complete and easier for researchers? And, “most importantly,” said Ms. Pierce, how can policy requirements across each of these sectors be aligned so that there’s more coordination and oversight – and with it, public trust?

Some critics of current disclosure policies have called for more reporting of compensation amounts, and Ms. Pierce said that this has been part of cross-sector discussions.

The ICMJE’s proposed form invites, but does not require, authors to indicate what payments were made to them or their institutions. “Part of this is due to the fact that it’s hard to define, let alone agree on, what’s an important amount,” Dr. Taichman said.

A push for registries

The ICMJE is also aiming to make the disclosure process more efficient for authors – and to eliminate inconsistent and incomplete disclosures – by accepting disclosures from web-based repositories, according to the editorial. Repositories allow authors to maintain an inventory of their relationships and activities and then create electronic disclosures that are tailored to the requirements of the ICMJE, medical societies, and other entities.

The AAMC-run repository, called Convey, is consistent with ICMJE reporting requirements and other criteria (e.g., there are no fees for individuals to enter, store, or export their data), but the development of other repositories may be helpful “for meeting regional, linguistic, and regulatory needs” of authors across the world, the editorial stated.

The Annals of Internal Medicine and the New England Journal of Medicine are both currently collecting disclosures through Convey. The platform was born from discussions that followed a 2009 Institute of Medicine report on conflicts of interest.

Signers of the ICMJE editorial include representatives of the National Library of Medicine and the World Association of Medical Editors, in addition to editors in chief and other leaders of the ICMJE member journals.

A group of leading medical journal editors is seeking to improve the completeness and transparency of financial disclosure reporting with a proposed new disclosure form that puts more onus on readers to decide whether relationships and activities should influence how they view published papers.

The proposed changes are described in an editorial published simultaneously today in the Annals of Internal Medicine, British Medical Journal, Journal of the American Medical Association, The Lancet, New England Journal of Medicine, and several other journals whose editors are members of the International Committee of Medical Journal Editors (ICMJE).

“While no approach to disclosure will be perfect or foolproof, we hope the changes we propose will help promote transparency and trust,” the editorial stated (Ann Intern Med. 2020 Jan 27. doi: 10.7326/M19-3933).

The ICMJE adopted its currently used electronic form – the “ICMJE Form for the Disclosure of Potential Conflicts of Interest” – 10 years ago in an effort to create some uniformity amidst a patchwork of differing disclosure requirements for authors.

It’s not known how many journals outside of the ICMJE’s member journals routinely use the disclosure form, but the organization’s website houses an extensive list of journals whose editors or publishers have requested to be listed as following the ICMJE’s recommendations for editing, reporting, and publishing, including those concerning disclosures. The ICMJE does not “certify” journals. The full set of recommendations was updated in December 2019.

Most authors are committed to transparent reporting, but “opinions differ over which relationships or activities to report,” the editorial stated.

An author might choose to omit an item that others deem important because of a difference in opinion regarding “relevance,” confusion over definitions, or a simple oversight. Some authors may be “concerned that readers will interpret the listing of any item as a ‘potential conflict of interest’ as indicative of problematic influence and wrongdoing,” the editorial stated.

The revised form, like the current one, asks authors to disclose relationships and activities that are directly related to the reported work, as well as those that are topically related (within the broadly defined field addressed in the work). But unlike the current form, the new version provides a checklist of relationships and activities and asks authors to check ‘yes’ or ‘no’ for each one (and to name them when the answer is ‘yes’).

Items in the checklist include grants, payments/honoraria for lectures, patents issued or planned, stock/stock options, and leadership or fiduciary roles in committees, boards, or societies.

The proposed new form makes no mention of “potential conflicts of interest” or “relevancy,” per say. Authors aren’t asked to determine what might be interpreted as a potential conflict of interest, but instead are asked for a “complete listing” of what readers may find “pertinent” to their work.

“We’re trying to move away from calling everything a [potential] ‘conflict,’ ” Darren B. Taichman, MD, PhD, secretary of ICMJE and executive editor of the Annals of Internal Medicine, said in an interview. “We want to remove for authors the concern or stigma, if you will, that anything listed on a form implies that there is something wrong, because that’s just not true. … We want readers to decide what relationships are important as they interpret the work.”

Dr. Taichman said in the interview that the ICMJE’s updating of the form was more a function of “good housekeeping” and continuous appreciation of disclosure as an important issue, rather than any one specific issue, such as concern over a “relevancy” approach to disclosures.

The ICMJE is seeking feedback about its proposed form, which is available with a link for providing comments, at www.icmje.org.

Broader national efforts

Editors and others have been increasingly moving, however, toward asking for more complete disclosures where authors aren’t asked to judge “relevancy” and where readers can make decisions on their own. The American Society of Clinical Oncology, which produces the Journal of Clinical Oncology (JCO) as well as practice guidelines and continuing medical education programs, moved about 5 years ago to a system of general disclosure that asks physicians and others to disclose all financial interests and industry relationships, with no qualifiers.

Earlier in January 2020, the Accreditation Council for Continuing Medical Education issued proposed revisions to its Standards for Integrity and Independence in Accredited Continuing Education. These revisions, which are open for comment, require CME providers to collect disclosure information about all financial relationships of speakers and presenters. It’s up to the CME provider to then determine which relationships are relevant, according to the proposed document.

More change is on the way, as disclosure issues are being deliberated nationally in the wake of a highly publicized disclosure failure at Memorial Sloan Kettering Cancer Center in 2018. Chief medical officer José Baselga, MD, PhD, failed to report millions of dollars of industry payments and ownership interests in journal articles he wrote or cowrote over several years.

In February 2019, leaders from journals, academia, medical societies, and other institutions gathered in Washington for a closed-door meeting to hash out various disclosure related issues.

Hosted by the Association of American Medical Colleges and cosponsored by Memorial Sloan Kettering Cancer Center, ASCO, JAMA, and the Council of Medical Specialty Societies, the meeting led to a series of working groups that are creating additional recommendations “due out soon in 2020,” Heather Pierce, senior director of science policy and regulatory counsel for the AAMC, said in an interview.

Among the questions being discussed: What disclosures should be verified and who should do so? How can disclosures be made more complete and easier for researchers? And, “most importantly,” said Ms. Pierce, how can policy requirements across each of these sectors be aligned so that there’s more coordination and oversight – and with it, public trust?

Some critics of current disclosure policies have called for more reporting of compensation amounts, and Ms. Pierce said that this has been part of cross-sector discussions.

The ICMJE’s proposed form invites, but does not require, authors to indicate what payments were made to them or their institutions. “Part of this is due to the fact that it’s hard to define, let alone agree on, what’s an important amount,” Dr. Taichman said.

A push for registries

The ICMJE is also aiming to make the disclosure process more efficient for authors – and to eliminate inconsistent and incomplete disclosures – by accepting disclosures from web-based repositories, according to the editorial. Repositories allow authors to maintain an inventory of their relationships and activities and then create electronic disclosures that are tailored to the requirements of the ICMJE, medical societies, and other entities.

The AAMC-run repository, called Convey, is consistent with ICMJE reporting requirements and other criteria (e.g., there are no fees for individuals to enter, store, or export their data), but the development of other repositories may be helpful “for meeting regional, linguistic, and regulatory needs” of authors across the world, the editorial stated.

The Annals of Internal Medicine and the New England Journal of Medicine are both currently collecting disclosures through Convey. The platform was born from discussions that followed a 2009 Institute of Medicine report on conflicts of interest.

Signers of the ICMJE editorial include representatives of the National Library of Medicine and the World Association of Medical Editors, in addition to editors in chief and other leaders of the ICMJE member journals.

Modafinil exposure during pregnancy was associated with an approximately tripled risk of congenital malformations in a large Danish registry-based study.

Modafinil (Provigil) is commonly prescribed to address daytime sleepiness in narcolepsy and multiple sclerosis. An interim postmarketing safety analysis showed increased rates of major malformation in modafinil-exposed pregnancies, so the manufacturer issued an alert advising health care professionals of this safety signal in June 2019, wrote Per Damkier, MD, PhD, corresponding author of a JAMA research letter reporting the Danish study results. The postmarketing study had shown a major malformation rate of about 15% in modafinil-exposed pregnancies, much higher than the 3% background rate.

Dr. Damkier and Anne Broe, MD, PhD, both of the department of clinical biochemistry and pharmacology at Odense (Denmark) University Hospital, compared outcomes for pregnant women who were prescribed modafinil at any point during the first trimester of pregnancy with those who were prescribed an active comparator, methylphenidate, as well as with those who had neither exposure. Methylphenidate is not associated with congenital malformations and is used for indications similar to modafinil.

Looking at all pregnancies for whom complete records existed in Danish health registries between 2004 and 2017, the investigators found 49 modafinil-exposed pregnancies, 963 methylphenidate-exposed pregnancies, and 828,644 pregnancies with neither exposure.

Six major congenital malformations occurred in the modafinil-exposed group for an absolute risk of 12%. Major malformations occurred in 43 (4.5%) of the methylphenidate-exposed group and 32,466 (3.9%) of the unexposed group.

Using the extensive data available in public registries, the authors were able to perform logistic regression to adjust for concomitant use of other psychotropic medication; comorbidities such as diabetes and hypertension; and demographic and anthropometric measures such as maternal age, smoking status, and body mass index.

After this statistical adjustment, the researchers found that modafinil exposure during the first trimester of pregnancy was associated with an odds ratio of 3.4 (95% confidence interval, 1.2-9.7) for major congenital malformation, compared with first-trimester methylphenidate exposure. Compared with the unexposed cohort, modafinil-exposed pregnancies had an adjusted odds ratio of 2.7 (95% CI, 1.1-6.9) for major congenital malformation.

A total of 13 (27%) women who took modafinil had multiple sclerosis, but the authors excluded women who’d received a prescription for the multiple sclerosis drug teriflunomide (Aubagio), a known teratogen. Sleep disorders were reported for 39% of modafinil users, compared with 4.5% of methylphenidate users. Rates of psychoactive drug use were 41% for the modafinil group and 30% for the methylphenidate group.

The authors acknowledged the possibility of residual confounders affecting their results, and of the statistical problems with the very small sample size of modafinil-exposed pregnancies. Also, actual medication use – rather than prescription redemption – wasn’t captured in the study.

The study was partially funded by the Novo Nordisk Foundation. The authors reported no conflicts of interest.

[email protected]

SOURCE: Damkier P, Broe A. JAMA. 2020;323(4):374-6.

Modafinil exposure during pregnancy was associated with an approximately tripled risk of congenital malformations in a large Danish registry-based study.

Modafinil (Provigil) is commonly prescribed to address daytime sleepiness in narcolepsy and multiple sclerosis. An interim postmarketing safety analysis showed increased rates of major malformation in modafinil-exposed pregnancies, so the manufacturer issued an alert advising health care professionals of this safety signal in June 2019, wrote Per Damkier, MD, PhD, corresponding author of a JAMA research letter reporting the Danish study results. The postmarketing study had shown a major malformation rate of about 15% in modafinil-exposed pregnancies, much higher than the 3% background rate.

Dr. Damkier and Anne Broe, MD, PhD, both of the department of clinical biochemistry and pharmacology at Odense (Denmark) University Hospital, compared outcomes for pregnant women who were prescribed modafinil at any point during the first trimester of pregnancy with those who were prescribed an active comparator, methylphenidate, as well as with those who had neither exposure. Methylphenidate is not associated with congenital malformations and is used for indications similar to modafinil.

Looking at all pregnancies for whom complete records existed in Danish health registries between 2004 and 2017, the investigators found 49 modafinil-exposed pregnancies, 963 methylphenidate-exposed pregnancies, and 828,644 pregnancies with neither exposure.

Six major congenital malformations occurred in the modafinil-exposed group for an absolute risk of 12%. Major malformations occurred in 43 (4.5%) of the methylphenidate-exposed group and 32,466 (3.9%) of the unexposed group.

Using the extensive data available in public registries, the authors were able to perform logistic regression to adjust for concomitant use of other psychotropic medication; comorbidities such as diabetes and hypertension; and demographic and anthropometric measures such as maternal age, smoking status, and body mass index.

After this statistical adjustment, the researchers found that modafinil exposure during the first trimester of pregnancy was associated with an odds ratio of 3.4 (95% confidence interval, 1.2-9.7) for major congenital malformation, compared with first-trimester methylphenidate exposure. Compared with the unexposed cohort, modafinil-exposed pregnancies had an adjusted odds ratio of 2.7 (95% CI, 1.1-6.9) for major congenital malformation.

A total of 13 (27%) women who took modafinil had multiple sclerosis, but the authors excluded women who’d received a prescription for the multiple sclerosis drug teriflunomide (Aubagio), a known teratogen. Sleep disorders were reported for 39% of modafinil users, compared with 4.5% of methylphenidate users. Rates of psychoactive drug use were 41% for the modafinil group and 30% for the methylphenidate group.

The authors acknowledged the possibility of residual confounders affecting their results, and of the statistical problems with the very small sample size of modafinil-exposed pregnancies. Also, actual medication use – rather than prescription redemption – wasn’t captured in the study.

The study was partially funded by the Novo Nordisk Foundation. The authors reported no conflicts of interest.

[email protected]

SOURCE: Damkier P, Broe A. JAMA. 2020;323(4):374-6.

Modafinil exposure during pregnancy was associated with an approximately tripled risk of congenital malformations in a large Danish registry-based study.

Modafinil (Provigil) is commonly prescribed to address daytime sleepiness in narcolepsy and multiple sclerosis. An interim postmarketing safety analysis showed increased rates of major malformation in modafinil-exposed pregnancies, so the manufacturer issued an alert advising health care professionals of this safety signal in June 2019, wrote Per Damkier, MD, PhD, corresponding author of a JAMA research letter reporting the Danish study results. The postmarketing study had shown a major malformation rate of about 15% in modafinil-exposed pregnancies, much higher than the 3% background rate.

Dr. Damkier and Anne Broe, MD, PhD, both of the department of clinical biochemistry and pharmacology at Odense (Denmark) University Hospital, compared outcomes for pregnant women who were prescribed modafinil at any point during the first trimester of pregnancy with those who were prescribed an active comparator, methylphenidate, as well as with those who had neither exposure. Methylphenidate is not associated with congenital malformations and is used for indications similar to modafinil.

Looking at all pregnancies for whom complete records existed in Danish health registries between 2004 and 2017, the investigators found 49 modafinil-exposed pregnancies, 963 methylphenidate-exposed pregnancies, and 828,644 pregnancies with neither exposure.

Six major congenital malformations occurred in the modafinil-exposed group for an absolute risk of 12%. Major malformations occurred in 43 (4.5%) of the methylphenidate-exposed group and 32,466 (3.9%) of the unexposed group.

Using the extensive data available in public registries, the authors were able to perform logistic regression to adjust for concomitant use of other psychotropic medication; comorbidities such as diabetes and hypertension; and demographic and anthropometric measures such as maternal age, smoking status, and body mass index.

After this statistical adjustment, the researchers found that modafinil exposure during the first trimester of pregnancy was associated with an odds ratio of 3.4 (95% confidence interval, 1.2-9.7) for major congenital malformation, compared with first-trimester methylphenidate exposure. Compared with the unexposed cohort, modafinil-exposed pregnancies had an adjusted odds ratio of 2.7 (95% CI, 1.1-6.9) for major congenital malformation.

A total of 13 (27%) women who took modafinil had multiple sclerosis, but the authors excluded women who’d received a prescription for the multiple sclerosis drug teriflunomide (Aubagio), a known teratogen. Sleep disorders were reported for 39% of modafinil users, compared with 4.5% of methylphenidate users. Rates of psychoactive drug use were 41% for the modafinil group and 30% for the methylphenidate group.

The authors acknowledged the possibility of residual confounders affecting their results, and of the statistical problems with the very small sample size of modafinil-exposed pregnancies. Also, actual medication use – rather than prescription redemption – wasn’t captured in the study.

The study was partially funded by the Novo Nordisk Foundation. The authors reported no conflicts of interest.

[email protected]

SOURCE: Damkier P, Broe A. JAMA. 2020;323(4):374-6.