Health Policy

Fed up with personal attacks on the nation’s top infectious disease expert, scores of leading scientists and physicians have signed an open letter defending Anthony Fauci, MD, for his years of service to the public and his leadership on the pandemic.

“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.

Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.

“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.

Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).

At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”

Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
 

‘Sagacious counsel’

The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.

“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.

“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.

“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”

“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.

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

Fed up with personal attacks on the nation’s top infectious disease expert, scores of leading scientists and physicians have signed an open letter defending Anthony Fauci, MD, for his years of service to the public and his leadership on the pandemic.

“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.

Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.

“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.

Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).

At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”

Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
 

‘Sagacious counsel’

The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.

“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.

“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.

“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”

“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.

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

Fed up with personal attacks on the nation’s top infectious disease expert, scores of leading scientists and physicians have signed an open letter defending Anthony Fauci, MD, for his years of service to the public and his leadership on the pandemic.

“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.

Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.

“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.

Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).

At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”

Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
 

‘Sagacious counsel’

The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.

“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.

“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.

“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”

“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.

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

The CDC is preparing to update its COVID-19 mask recommendations to emphasize the use of N95 and KN95 masks that better filter the virus, Director Rochelle Walensky, MD, said on Jan. 12.

“We are preparing an update to the info on our mask website to best reflect the options that are available to people and the different levels of protection different masks provide, and we want to provide Americans the best and most updated information to choose what mask is going to be right for them,” she said at a White House news briefing.

While the higher-quality masks provide better protection, they can be uncomfortable to wear, expensive, and harder to find. That’s why Dr. Walensky added an important caveat.

“Any mask is better than no mask, and we do encourage all Americans to wear a well-fitting mask to protect themselves and prevent the spread of COVID-19. That recommendation is not going to change,” she said.

“Most importantly, the best mask that you wear is the one you will wear and the one you can keep on all day long and tolerate in public indoor settings.”

Meanwhile, the World Health Organization was more focused on vaccines.

WHO officials stressed on Jan. 12 that global vaccine distribution is first priority in defeating the highly contagious Omicron variant, as well as other variants that may evolve. 

The WHO’s Technical Advisory Group on COVID-19 Vaccine Composition – a group of experts assessing how COVID-19 vaccines perform against Omicron and other emerging variants – says there is an “urgent need” for broader access to vaccines, along with reviewing and updating current vaccines as needed to ensure protection. 

The WHO also disputed the idea that COVID-19 could become endemic in one largely vaccinated nation, while the rest of the world remains unprotected. 

“It is up to us how this pandemic unfolds,” Maria Van Kerkhove, PhD, the WHO’s technical lead on COVID-19 response, said at a news briefing. 

The WHO has a goal of vaccinating 70% of the population of every country by the middle of the year.

But right now, 90 countries have yet to reach 40% vaccination rates, and 36 of those countries have less than 10% of their populations vaccinated, according to WHO Director General Tedros Adhanom Ghebreyesus, PhD.

A staggering 85% of the African population has not received a first dose.

But progress is being made, Dr. Ghebreyesus said at the briefing. 

The WHO said there were over 15 million COVID-19 cases reported last week – the most ever in a single week – and this is likely an underestimate. 

The Omicron variant, first identified in South Africa 2 months ago and now found on all seven continents, is “rapidly replacing Delta in almost all countries,” Dr. Ghebreyesus said.

Dr. Walensky said this week’s U.S. daily average COVID-19 case count was 751,000, an increase of 47% from last week. The average daily hospital admissions this week is 19,800, an increase of 33%. Deaths are up 40%, reaching 1,600 per day.

But she also reported new data that supports other research showing Omicron may produce less severe disease. Kaiser Permanente Southern California released a study on Jan. 11 showing that, compared with Delta infections, Omicron was associated with a 53% reduction in hospitalizations, a 74% reduction in intensive care unit admissions, and a 91% lower risk of death.

In the study, no patients with Omicron required mechanical ventilation. The strain now accounts for 98% of cases nationwide.

But Dr. Walensky warned the lower disease severity is not enough to make up for the sheer number of cases that continue to overwhelm hospital systems.

“While we are seeing early evidence that Omicron is less severe than Delta and that those infected are less likely to require hospitalization, it’s important to note that Omicron continues to be much more transmissible than Delta,” she said. “The sudden rise in cases due to Omicron is resulting in unprecedented daily case counts, sickness, absenteeism, and strains on our health care system.”

A version of this article first appeared on WebMD.com.

The CDC is preparing to update its COVID-19 mask recommendations to emphasize the use of N95 and KN95 masks that better filter the virus, Director Rochelle Walensky, MD, said on Jan. 12.

“We are preparing an update to the info on our mask website to best reflect the options that are available to people and the different levels of protection different masks provide, and we want to provide Americans the best and most updated information to choose what mask is going to be right for them,” she said at a White House news briefing.

While the higher-quality masks provide better protection, they can be uncomfortable to wear, expensive, and harder to find. That’s why Dr. Walensky added an important caveat.

“Any mask is better than no mask, and we do encourage all Americans to wear a well-fitting mask to protect themselves and prevent the spread of COVID-19. That recommendation is not going to change,” she said.

“Most importantly, the best mask that you wear is the one you will wear and the one you can keep on all day long and tolerate in public indoor settings.”

Meanwhile, the World Health Organization was more focused on vaccines.

WHO officials stressed on Jan. 12 that global vaccine distribution is first priority in defeating the highly contagious Omicron variant, as well as other variants that may evolve. 

The WHO’s Technical Advisory Group on COVID-19 Vaccine Composition – a group of experts assessing how COVID-19 vaccines perform against Omicron and other emerging variants – says there is an “urgent need” for broader access to vaccines, along with reviewing and updating current vaccines as needed to ensure protection. 

The WHO also disputed the idea that COVID-19 could become endemic in one largely vaccinated nation, while the rest of the world remains unprotected. 

“It is up to us how this pandemic unfolds,” Maria Van Kerkhove, PhD, the WHO’s technical lead on COVID-19 response, said at a news briefing. 

The WHO has a goal of vaccinating 70% of the population of every country by the middle of the year.

But right now, 90 countries have yet to reach 40% vaccination rates, and 36 of those countries have less than 10% of their populations vaccinated, according to WHO Director General Tedros Adhanom Ghebreyesus, PhD.

A staggering 85% of the African population has not received a first dose.

But progress is being made, Dr. Ghebreyesus said at the briefing. 

The WHO said there were over 15 million COVID-19 cases reported last week – the most ever in a single week – and this is likely an underestimate. 

The Omicron variant, first identified in South Africa 2 months ago and now found on all seven continents, is “rapidly replacing Delta in almost all countries,” Dr. Ghebreyesus said.

Dr. Walensky said this week’s U.S. daily average COVID-19 case count was 751,000, an increase of 47% from last week. The average daily hospital admissions this week is 19,800, an increase of 33%. Deaths are up 40%, reaching 1,600 per day.

But she also reported new data that supports other research showing Omicron may produce less severe disease. Kaiser Permanente Southern California released a study on Jan. 11 showing that, compared with Delta infections, Omicron was associated with a 53% reduction in hospitalizations, a 74% reduction in intensive care unit admissions, and a 91% lower risk of death.

In the study, no patients with Omicron required mechanical ventilation. The strain now accounts for 98% of cases nationwide.

But Dr. Walensky warned the lower disease severity is not enough to make up for the sheer number of cases that continue to overwhelm hospital systems.

“While we are seeing early evidence that Omicron is less severe than Delta and that those infected are less likely to require hospitalization, it’s important to note that Omicron continues to be much more transmissible than Delta,” she said. “The sudden rise in cases due to Omicron is resulting in unprecedented daily case counts, sickness, absenteeism, and strains on our health care system.”

A version of this article first appeared on WebMD.com.

The CDC is preparing to update its COVID-19 mask recommendations to emphasize the use of N95 and KN95 masks that better filter the virus, Director Rochelle Walensky, MD, said on Jan. 12.

“We are preparing an update to the info on our mask website to best reflect the options that are available to people and the different levels of protection different masks provide, and we want to provide Americans the best and most updated information to choose what mask is going to be right for them,” she said at a White House news briefing.

While the higher-quality masks provide better protection, they can be uncomfortable to wear, expensive, and harder to find. That’s why Dr. Walensky added an important caveat.

“Any mask is better than no mask, and we do encourage all Americans to wear a well-fitting mask to protect themselves and prevent the spread of COVID-19. That recommendation is not going to change,” she said.

“Most importantly, the best mask that you wear is the one you will wear and the one you can keep on all day long and tolerate in public indoor settings.”

Meanwhile, the World Health Organization was more focused on vaccines.

WHO officials stressed on Jan. 12 that global vaccine distribution is first priority in defeating the highly contagious Omicron variant, as well as other variants that may evolve. 

The WHO’s Technical Advisory Group on COVID-19 Vaccine Composition – a group of experts assessing how COVID-19 vaccines perform against Omicron and other emerging variants – says there is an “urgent need” for broader access to vaccines, along with reviewing and updating current vaccines as needed to ensure protection. 

The WHO also disputed the idea that COVID-19 could become endemic in one largely vaccinated nation, while the rest of the world remains unprotected. 

“It is up to us how this pandemic unfolds,” Maria Van Kerkhove, PhD, the WHO’s technical lead on COVID-19 response, said at a news briefing. 

The WHO has a goal of vaccinating 70% of the population of every country by the middle of the year.

But right now, 90 countries have yet to reach 40% vaccination rates, and 36 of those countries have less than 10% of their populations vaccinated, according to WHO Director General Tedros Adhanom Ghebreyesus, PhD.

A staggering 85% of the African population has not received a first dose.

But progress is being made, Dr. Ghebreyesus said at the briefing. 

The WHO said there were over 15 million COVID-19 cases reported last week – the most ever in a single week – and this is likely an underestimate. 

The Omicron variant, first identified in South Africa 2 months ago and now found on all seven continents, is “rapidly replacing Delta in almost all countries,” Dr. Ghebreyesus said.

Dr. Walensky said this week’s U.S. daily average COVID-19 case count was 751,000, an increase of 47% from last week. The average daily hospital admissions this week is 19,800, an increase of 33%. Deaths are up 40%, reaching 1,600 per day.

But she also reported new data that supports other research showing Omicron may produce less severe disease. Kaiser Permanente Southern California released a study on Jan. 11 showing that, compared with Delta infections, Omicron was associated with a 53% reduction in hospitalizations, a 74% reduction in intensive care unit admissions, and a 91% lower risk of death.

In the study, no patients with Omicron required mechanical ventilation. The strain now accounts for 98% of cases nationwide.

But Dr. Walensky warned the lower disease severity is not enough to make up for the sheer number of cases that continue to overwhelm hospital systems.

“While we are seeing early evidence that Omicron is less severe than Delta and that those infected are less likely to require hospitalization, it’s important to note that Omicron continues to be much more transmissible than Delta,” she said. “The sudden rise in cases due to Omicron is resulting in unprecedented daily case counts, sickness, absenteeism, and strains on our health care system.”

A version of this article first appeared on WebMD.com.

The Centers for Disease Control and Prevention’s recently updated guidance on isolating and testing were tied to the public’s increased interest in testing, Director Rochelle Walenksy, MD, said during a White House briefing Jan. 5.

Health officials recently shortened the recommended COVID-19 isolation and quarantine period from 10 days to 5, creating confusion amid an outbreak of the highly transmissible Omicron variant, which now accounts for 95% of cases in the United States.

Then, in slightly updated guidance, the CDC recommended using an at-home antigen test after 5 days of isolation if possible, even though these tests having aren’t as sensitive to the Omicron variant, according to the FDA.

“After we released our recs early last week, it became very clear people were interested in using the rapid test, though not authorized for this purpose after the end of their isolation period,” Dr. Walensky said. “We then provided guidance on how they should be used.”

“If that test is negative, people really do need to understand they must continue to wear their mask for those 5 days,” Dr. Walensky said.

But for many, the CDC guidelines are murky and seem to always change.

“Nearly 2 years into this pandemic, with Omicron cases surging across the country, the American people should be able to count on the Centers for Disease Control and Prevention for timely, accurate, clear guidance to protect themselves, their loved ones, and their communities,” American Medical Association president Gerald Harmon, MD, said in a statement. “Instead, the new recommendations on quarantine and isolation are not only confusing, but are risking further spread of the virus.”

About 31% of people remain infectious 5 days after a positive COVID-19 test, Dr. Harmon said, quoting the CDC’s own rationale for changing its guidance.

“With hundreds of thousands of new cases daily and more than a million positive reported cases on January 3, tens of thousands – potentially hundreds of thousands of people – could return to work and school infectious if they follow the CDC’s new guidance on ending isolation after 5 days without a negative test,” he said. “Physicians are concerned that these recommendations put our patients at risk and could further overwhelm our health care system.”

Instead, Dr. Harmon said a negative test should be required for ending isolation.

“Reemerging without knowing one’s status unnecessarily risks further transmission of the virus,” he said.

Meanwhile, also during the White House briefing, officials said that early data continue to show that Omicron infections are less severe than those from other variants, but skyrocketing cases will still put a strain on the health care system.

“The big caveat is we should not be complacent,” presidential Chief Medical Adviser Anthony Fauci, MD, said a White House briefing Jan. 5.

He added that Omicron “could still stress our hospital system because a certain proportion of a large volume of cases, no matter what, are going to be severe.”

Cases continue to increase greatly. This week’s 7-day daily average of infections is 491,700 -- an increase of 98% over last week, Dr. Walensky said. Hospitalizations, while lagging behind case numbers, are still rising significantly: The daily average is 14,800 admissions, up 63% from last week. Daily deaths this week are 1,200, an increase of only 5%.

Dr. Walensky continues to encourage vaccinations, boosters, and other precautions.

“Vaccines and boosters are protecting people from the severe and tragic outcomes that can occur from COVID-19 infection,” she said. “Get vaccinated and get boosted if eligible, wear a mask, stay home when you’re sick, and take a test if you have symptoms or are looking for greater reassurance before you gather with others.”

A version of this article first appeared on WebMD.com.

The Centers for Disease Control and Prevention’s recently updated guidance on isolating and testing were tied to the public’s increased interest in testing, Director Rochelle Walenksy, MD, said during a White House briefing Jan. 5.

Health officials recently shortened the recommended COVID-19 isolation and quarantine period from 10 days to 5, creating confusion amid an outbreak of the highly transmissible Omicron variant, which now accounts for 95% of cases in the United States.

Then, in slightly updated guidance, the CDC recommended using an at-home antigen test after 5 days of isolation if possible, even though these tests having aren’t as sensitive to the Omicron variant, according to the FDA.

“After we released our recs early last week, it became very clear people were interested in using the rapid test, though not authorized for this purpose after the end of their isolation period,” Dr. Walensky said. “We then provided guidance on how they should be used.”

“If that test is negative, people really do need to understand they must continue to wear their mask for those 5 days,” Dr. Walensky said.

But for many, the CDC guidelines are murky and seem to always change.

“Nearly 2 years into this pandemic, with Omicron cases surging across the country, the American people should be able to count on the Centers for Disease Control and Prevention for timely, accurate, clear guidance to protect themselves, their loved ones, and their communities,” American Medical Association president Gerald Harmon, MD, said in a statement. “Instead, the new recommendations on quarantine and isolation are not only confusing, but are risking further spread of the virus.”

About 31% of people remain infectious 5 days after a positive COVID-19 test, Dr. Harmon said, quoting the CDC’s own rationale for changing its guidance.

“With hundreds of thousands of new cases daily and more than a million positive reported cases on January 3, tens of thousands – potentially hundreds of thousands of people – could return to work and school infectious if they follow the CDC’s new guidance on ending isolation after 5 days without a negative test,” he said. “Physicians are concerned that these recommendations put our patients at risk and could further overwhelm our health care system.”

Instead, Dr. Harmon said a negative test should be required for ending isolation.

“Reemerging without knowing one’s status unnecessarily risks further transmission of the virus,” he said.

Meanwhile, also during the White House briefing, officials said that early data continue to show that Omicron infections are less severe than those from other variants, but skyrocketing cases will still put a strain on the health care system.

“The big caveat is we should not be complacent,” presidential Chief Medical Adviser Anthony Fauci, MD, said a White House briefing Jan. 5.

He added that Omicron “could still stress our hospital system because a certain proportion of a large volume of cases, no matter what, are going to be severe.”

Cases continue to increase greatly. This week’s 7-day daily average of infections is 491,700 -- an increase of 98% over last week, Dr. Walensky said. Hospitalizations, while lagging behind case numbers, are still rising significantly: The daily average is 14,800 admissions, up 63% from last week. Daily deaths this week are 1,200, an increase of only 5%.

Dr. Walensky continues to encourage vaccinations, boosters, and other precautions.

“Vaccines and boosters are protecting people from the severe and tragic outcomes that can occur from COVID-19 infection,” she said. “Get vaccinated and get boosted if eligible, wear a mask, stay home when you’re sick, and take a test if you have symptoms or are looking for greater reassurance before you gather with others.”

A version of this article first appeared on WebMD.com.

The Centers for Disease Control and Prevention’s recently updated guidance on isolating and testing were tied to the public’s increased interest in testing, Director Rochelle Walenksy, MD, said during a White House briefing Jan. 5.

Health officials recently shortened the recommended COVID-19 isolation and quarantine period from 10 days to 5, creating confusion amid an outbreak of the highly transmissible Omicron variant, which now accounts for 95% of cases in the United States.

Then, in slightly updated guidance, the CDC recommended using an at-home antigen test after 5 days of isolation if possible, even though these tests having aren’t as sensitive to the Omicron variant, according to the FDA.

“After we released our recs early last week, it became very clear people were interested in using the rapid test, though not authorized for this purpose after the end of their isolation period,” Dr. Walensky said. “We then provided guidance on how they should be used.”

“If that test is negative, people really do need to understand they must continue to wear their mask for those 5 days,” Dr. Walensky said.

But for many, the CDC guidelines are murky and seem to always change.

“Nearly 2 years into this pandemic, with Omicron cases surging across the country, the American people should be able to count on the Centers for Disease Control and Prevention for timely, accurate, clear guidance to protect themselves, their loved ones, and their communities,” American Medical Association president Gerald Harmon, MD, said in a statement. “Instead, the new recommendations on quarantine and isolation are not only confusing, but are risking further spread of the virus.”

About 31% of people remain infectious 5 days after a positive COVID-19 test, Dr. Harmon said, quoting the CDC’s own rationale for changing its guidance.

“With hundreds of thousands of new cases daily and more than a million positive reported cases on January 3, tens of thousands – potentially hundreds of thousands of people – could return to work and school infectious if they follow the CDC’s new guidance on ending isolation after 5 days without a negative test,” he said. “Physicians are concerned that these recommendations put our patients at risk and could further overwhelm our health care system.”

Instead, Dr. Harmon said a negative test should be required for ending isolation.

“Reemerging without knowing one’s status unnecessarily risks further transmission of the virus,” he said.

Meanwhile, also during the White House briefing, officials said that early data continue to show that Omicron infections are less severe than those from other variants, but skyrocketing cases will still put a strain on the health care system.

“The big caveat is we should not be complacent,” presidential Chief Medical Adviser Anthony Fauci, MD, said a White House briefing Jan. 5.

He added that Omicron “could still stress our hospital system because a certain proportion of a large volume of cases, no matter what, are going to be severe.”

Cases continue to increase greatly. This week’s 7-day daily average of infections is 491,700 -- an increase of 98% over last week, Dr. Walensky said. Hospitalizations, while lagging behind case numbers, are still rising significantly: The daily average is 14,800 admissions, up 63% from last week. Daily deaths this week are 1,200, an increase of only 5%.

Dr. Walensky continues to encourage vaccinations, boosters, and other precautions.

“Vaccines and boosters are protecting people from the severe and tragic outcomes that can occur from COVID-19 infection,” she said. “Get vaccinated and get boosted if eligible, wear a mask, stay home when you’re sick, and take a test if you have symptoms or are looking for greater reassurance before you gather with others.”

A version of this article first appeared on WebMD.com.

The Food and Drug Administration on Jan. 3 authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.

The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.

What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
 

A lower risk of myocarditis?

Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”

“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.

The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.

“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.

Dr. Marks also pointed out that most cases of myocarditis clear up quickly.

“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.

“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”

He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.

Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.

Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.

Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.

The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
 

Mixing and matching vaccines

Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.

“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.

Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
 

‘It’s not too late’

No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.

“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.

“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”

A version of this article first appeared on WebMD.com.

The Food and Drug Administration on Jan. 3 authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.

The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.

What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
 

A lower risk of myocarditis?

Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”

“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.

The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.

“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.

Dr. Marks also pointed out that most cases of myocarditis clear up quickly.

“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.

“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”

He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.

Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.

Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.

Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.

The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
 

Mixing and matching vaccines

Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.

“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.

Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
 

‘It’s not too late’

No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.

“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.

“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”

A version of this article first appeared on WebMD.com.

The Food and Drug Administration on Jan. 3 authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.

The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.

What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
 

A lower risk of myocarditis?

Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”

“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.

The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.

“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.

Dr. Marks also pointed out that most cases of myocarditis clear up quickly.

“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.

“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”

He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.

Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.

Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.

Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.

The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
 

Mixing and matching vaccines

Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.

“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.

Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
 

‘It’s not too late’

No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.

“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.

“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”

A version of this article first appeared on WebMD.com.

Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.

Catherine Hackett/Frontline Medical News

Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.

Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.

Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.

Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.

Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.

In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”

The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.

People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.

“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.

“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.

Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.

Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.

“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
 

‘Work to do’ on opioids

Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.

There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.

Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.

“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.

Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.

“So I know we have work to do,” Dr. Califf said.

Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.

At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.

Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.

While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.

The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.

Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.

Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.

Question on accelerated approvals

The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.

The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.

The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.

At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.

“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.

Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”

Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.

But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.

“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
 

Worries about the medical supply chain

Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.

Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.

This committee will soon release a report with specific recommendations, Dr. Califf said.

“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”

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

Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.

Catherine Hackett/Frontline Medical News

Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.

Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.

Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.

Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.

Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.

In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”

The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.

People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.

“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.

“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.

Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.

Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.

“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
 

‘Work to do’ on opioids

Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.

There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.

Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.

“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.

Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.

“So I know we have work to do,” Dr. Califf said.

Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.

At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.

Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.

While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.

The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.

Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.

Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.

Question on accelerated approvals

The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.

The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.

The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.

At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.

“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.

Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”

Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.

But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.

“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
 

Worries about the medical supply chain

Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.

Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.

This committee will soon release a report with specific recommendations, Dr. Califf said.

“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”

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

Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.

Catherine Hackett/Frontline Medical News

Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.

Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.

Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.

Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.

Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.

In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”

The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.

People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.

“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.

“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.

Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.

Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.

“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
 

‘Work to do’ on opioids

Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.

There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.

Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.

“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.

Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.

“So I know we have work to do,” Dr. Califf said.

Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.

At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.

Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.

While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.

The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.

Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.

Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.

Question on accelerated approvals

The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.

The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.

The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.

At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.

“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.

Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”

Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.

But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.

“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
 

Worries about the medical supply chain

Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.

Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.

This committee will soon release a report with specific recommendations, Dr. Califf said.

“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”

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

A recent study examined projected career earnings between the genders in a largely community-based physician population, finding a difference of about $2 million in career earnings. That a gender pay gap exists in medicine is not news – but the manner in which this study was done, the investigators’ ability to control for a number of confounding variables, and the size of the study group (over 80,000) are newsworthy.

Some of the key findings include that gender pay gaps start with your first job, and you never close the gap, even as you gain experience and efficiency. Also, the more highly remunerated your specialty, the larger the gap. The gender pay gap joins a growing list of inequities within health care. Although physician compensation is not the most important, given that nearly all physicians are well-paid, and we have much more significant inequities that lead to direct patient harm, the reasons for this discrepancy warrant further consideration.

When I was first being educated about social inequity as part of work in social determinants of health, I made the error of using “inequality” and “inequity” interchangeably. The subtle yet important difference between the two terms was quickly described to me. Inequality is a gastroenterologist getting paid more money to do a colonoscopy than a family physician. Inequity is a female gastroenterologist getting paid less than a male gastroenterologist. Global Health Europe boldly identifies that “inequity is the result of failure.” In looking at the inequity inherent in the gender pay gap, I consider what failed and why.

I’m currently making a major career change, leaving an executive leadership position to return to full-time clinical practice. There is a significant pay decrease that will accompany this change because I am in a primary care specialty. Beyond that, I am considering two employment contracts from different systems to do a similar clinical role.

One of the questions my husband asked was which will pay more over the long run. This is difficult to discern because the compensation formula each health system uses is different, even though they are based on standard national benchmarking data. It is possible that women, in general, are like I am and look for factors other than compensation to make a job decision – assuming, like I do, that it will be close enough to not matter or is generally fair. In fact, while compensation is most certainly a consideration for me, once I determined that it was likely to be in the same ballpark, I stopped comparing. Even as the sole breadwinner in our family, I take this (probably faulty) approach.
 

It’s time to reconsider how we pay physicians

Women may be more likely to gloss over compensation details that men evaluate and negotiate carefully. To change this, women must first take responsibility for being an active, informed, and engaged part of compensation negotiations. In addition, employers who value gender pay equity must negotiate in good faith, keeping in mind the well-described vulnerabilities in discussions about pay. Finally, male and female mentors and leaders should actively coach female physicians on how to approach these conversations with confidence and skill.

In primary care, female physicians spend, on average, about 15% more time with their patients during a visit. Despite spending as much time in clinic seeing patients per week, they see fewer patients, thereby generating less revenue. For compensation plans that are based on productivity, the extra time spent costs money. In this case, it costs the female physicians lost compensation.

The way in which women are more likely to practice medicine, which includes the amount of time they spend with patients, may affect clinical outcomes without directly increasing productivity. A 2017 study demonstrated that elderly patients had lower rates of mortality and readmission when cared for by a female rather than a male physician. These findings require health systems to critically evaluate what compensation plans value and to promote an appropriate balance between quality of care, quantity of care, and style of care.

Although I’ve seen gender pay inequity as blatant as two different salaries for physicians doing the same work – one male and one female – I think this is uncommon. Like many forms of inequity, the outputs are often related to a failed system rather than solely a series of individual failures. Making compensation formulas gender-blind is an important step – but it is only the first step, not the last. Recognizing that the structure of a compensation formula may be biased toward a style of medical practice more likely to be espoused by one gender is necessary as well.

The data, including the findings of this recent study, clearly identify the gender pay gap that exists in medicine, as it does in many other fields, and that it is not explainable solely by differences in specialties, work hours, family status, or title.

To address the inequity, it is imperative that women engage with employers and leaders to both understand and develop skills around effective and appropriate compensation negotiation. Recognizing that compensation plans, especially those built on productivity models, may fail to place adequate value on gender-specific practice styles.

Jennifer Frank is a family physician, physician leader, wife, and mother in Northeast Wisconsin.

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

A recent study examined projected career earnings between the genders in a largely community-based physician population, finding a difference of about $2 million in career earnings. That a gender pay gap exists in medicine is not news – but the manner in which this study was done, the investigators’ ability to control for a number of confounding variables, and the size of the study group (over 80,000) are newsworthy.

Some of the key findings include that gender pay gaps start with your first job, and you never close the gap, even as you gain experience and efficiency. Also, the more highly remunerated your specialty, the larger the gap. The gender pay gap joins a growing list of inequities within health care. Although physician compensation is not the most important, given that nearly all physicians are well-paid, and we have much more significant inequities that lead to direct patient harm, the reasons for this discrepancy warrant further consideration.

When I was first being educated about social inequity as part of work in social determinants of health, I made the error of using “inequality” and “inequity” interchangeably. The subtle yet important difference between the two terms was quickly described to me. Inequality is a gastroenterologist getting paid more money to do a colonoscopy than a family physician. Inequity is a female gastroenterologist getting paid less than a male gastroenterologist. Global Health Europe boldly identifies that “inequity is the result of failure.” In looking at the inequity inherent in the gender pay gap, I consider what failed and why.

I’m currently making a major career change, leaving an executive leadership position to return to full-time clinical practice. There is a significant pay decrease that will accompany this change because I am in a primary care specialty. Beyond that, I am considering two employment contracts from different systems to do a similar clinical role.

One of the questions my husband asked was which will pay more over the long run. This is difficult to discern because the compensation formula each health system uses is different, even though they are based on standard national benchmarking data. It is possible that women, in general, are like I am and look for factors other than compensation to make a job decision – assuming, like I do, that it will be close enough to not matter or is generally fair. In fact, while compensation is most certainly a consideration for me, once I determined that it was likely to be in the same ballpark, I stopped comparing. Even as the sole breadwinner in our family, I take this (probably faulty) approach.
 

It’s time to reconsider how we pay physicians

Women may be more likely to gloss over compensation details that men evaluate and negotiate carefully. To change this, women must first take responsibility for being an active, informed, and engaged part of compensation negotiations. In addition, employers who value gender pay equity must negotiate in good faith, keeping in mind the well-described vulnerabilities in discussions about pay. Finally, male and female mentors and leaders should actively coach female physicians on how to approach these conversations with confidence and skill.

In primary care, female physicians spend, on average, about 15% more time with their patients during a visit. Despite spending as much time in clinic seeing patients per week, they see fewer patients, thereby generating less revenue. For compensation plans that are based on productivity, the extra time spent costs money. In this case, it costs the female physicians lost compensation.

The way in which women are more likely to practice medicine, which includes the amount of time they spend with patients, may affect clinical outcomes without directly increasing productivity. A 2017 study demonstrated that elderly patients had lower rates of mortality and readmission when cared for by a female rather than a male physician. These findings require health systems to critically evaluate what compensation plans value and to promote an appropriate balance between quality of care, quantity of care, and style of care.

Although I’ve seen gender pay inequity as blatant as two different salaries for physicians doing the same work – one male and one female – I think this is uncommon. Like many forms of inequity, the outputs are often related to a failed system rather than solely a series of individual failures. Making compensation formulas gender-blind is an important step – but it is only the first step, not the last. Recognizing that the structure of a compensation formula may be biased toward a style of medical practice more likely to be espoused by one gender is necessary as well.

The data, including the findings of this recent study, clearly identify the gender pay gap that exists in medicine, as it does in many other fields, and that it is not explainable solely by differences in specialties, work hours, family status, or title.

To address the inequity, it is imperative that women engage with employers and leaders to both understand and develop skills around effective and appropriate compensation negotiation. Recognizing that compensation plans, especially those built on productivity models, may fail to place adequate value on gender-specific practice styles.

Jennifer Frank is a family physician, physician leader, wife, and mother in Northeast Wisconsin.

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

A recent study examined projected career earnings between the genders in a largely community-based physician population, finding a difference of about $2 million in career earnings. That a gender pay gap exists in medicine is not news – but the manner in which this study was done, the investigators’ ability to control for a number of confounding variables, and the size of the study group (over 80,000) are newsworthy.

Some of the key findings include that gender pay gaps start with your first job, and you never close the gap, even as you gain experience and efficiency. Also, the more highly remunerated your specialty, the larger the gap. The gender pay gap joins a growing list of inequities within health care. Although physician compensation is not the most important, given that nearly all physicians are well-paid, and we have much more significant inequities that lead to direct patient harm, the reasons for this discrepancy warrant further consideration.

When I was first being educated about social inequity as part of work in social determinants of health, I made the error of using “inequality” and “inequity” interchangeably. The subtle yet important difference between the two terms was quickly described to me. Inequality is a gastroenterologist getting paid more money to do a colonoscopy than a family physician. Inequity is a female gastroenterologist getting paid less than a male gastroenterologist. Global Health Europe boldly identifies that “inequity is the result of failure.” In looking at the inequity inherent in the gender pay gap, I consider what failed and why.

I’m currently making a major career change, leaving an executive leadership position to return to full-time clinical practice. There is a significant pay decrease that will accompany this change because I am in a primary care specialty. Beyond that, I am considering two employment contracts from different systems to do a similar clinical role.

One of the questions my husband asked was which will pay more over the long run. This is difficult to discern because the compensation formula each health system uses is different, even though they are based on standard national benchmarking data. It is possible that women, in general, are like I am and look for factors other than compensation to make a job decision – assuming, like I do, that it will be close enough to not matter or is generally fair. In fact, while compensation is most certainly a consideration for me, once I determined that it was likely to be in the same ballpark, I stopped comparing. Even as the sole breadwinner in our family, I take this (probably faulty) approach.
 

It’s time to reconsider how we pay physicians

Women may be more likely to gloss over compensation details that men evaluate and negotiate carefully. To change this, women must first take responsibility for being an active, informed, and engaged part of compensation negotiations. In addition, employers who value gender pay equity must negotiate in good faith, keeping in mind the well-described vulnerabilities in discussions about pay. Finally, male and female mentors and leaders should actively coach female physicians on how to approach these conversations with confidence and skill.

In primary care, female physicians spend, on average, about 15% more time with their patients during a visit. Despite spending as much time in clinic seeing patients per week, they see fewer patients, thereby generating less revenue. For compensation plans that are based on productivity, the extra time spent costs money. In this case, it costs the female physicians lost compensation.

The way in which women are more likely to practice medicine, which includes the amount of time they spend with patients, may affect clinical outcomes without directly increasing productivity. A 2017 study demonstrated that elderly patients had lower rates of mortality and readmission when cared for by a female rather than a male physician. These findings require health systems to critically evaluate what compensation plans value and to promote an appropriate balance between quality of care, quantity of care, and style of care.

Although I’ve seen gender pay inequity as blatant as two different salaries for physicians doing the same work – one male and one female – I think this is uncommon. Like many forms of inequity, the outputs are often related to a failed system rather than solely a series of individual failures. Making compensation formulas gender-blind is an important step – but it is only the first step, not the last. Recognizing that the structure of a compensation formula may be biased toward a style of medical practice more likely to be espoused by one gender is necessary as well.

The data, including the findings of this recent study, clearly identify the gender pay gap that exists in medicine, as it does in many other fields, and that it is not explainable solely by differences in specialties, work hours, family status, or title.

To address the inequity, it is imperative that women engage with employers and leaders to both understand and develop skills around effective and appropriate compensation negotiation. Recognizing that compensation plans, especially those built on productivity models, may fail to place adequate value on gender-specific practice styles.

Jennifer Frank is a family physician, physician leader, wife, and mother in Northeast Wisconsin.

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

Thousands of health care professionals who separate from active duty each year now have a route to stay in federal health care jobs, including open positions in US Department of Veterans Affairs (VA) hospitals. President Biden signed the Hire Veteran Health Heroes Act of 2021 into law on November 30, saying, “This new program will build upon existing efforts to create a pipeline for former military health professionals….to allow those professionals to continue their service to each other and to our nation.”

Senators Mike Braun (R, Indiana) and Maggie Hassan (D, New Hampshire) introduced the bill last March; Representatives Robert Latta (Ohio-05) and Kathleen Rice (New York-04) introduced companion legislation in the House.

The Act serves multiple purposes, including to retain the critical experience of doctors, nurses, pharmacists, technicians, and physical therapists who understand the challenges service members face; to give those professionals continued employment; and to fill empty staff positions. Two years ago, the VA Inspector General said staff shortages are a root cause of many of the problems in veterans’ care.

 The bill directs the VA to create a program to recruit military medical personnel who are within 1 year of completing their military service. On average, 13,000 active-duty medical department members separate from the military each year at the end of enlistments or contracts, or through retirement. But until now, there has been no formal program to actively recruit them to stay.

The Act requires VA leaders to work with US Department of Defense officials to identify, refer, and transition service members who have critically needed skills. Moreover, the bill specifically mandates that if a member of the Armed Forces expresses an interest in working in a health care occupation within the VA, the VA Secretary “shall refer the member to a recruiter of the Department for consideration of open positions in the specialty and geography of interest to the member.”

Senator Hassan, in an official statement, said, “[W]e must always ensure that veterans have the support and resources that they need to succeed, and a critical way to do that is by expanding employment opportunities for our nation’s heroes and strengthening their health care.”

In his remarks, President Biden said, “For both our veterans and our military medical personnel, service isn’t just what they do, it’s who they are.”

Thousands of health care professionals who separate from active duty each year now have a route to stay in federal health care jobs, including open positions in US Department of Veterans Affairs (VA) hospitals. President Biden signed the Hire Veteran Health Heroes Act of 2021 into law on November 30, saying, “This new program will build upon existing efforts to create a pipeline for former military health professionals….to allow those professionals to continue their service to each other and to our nation.”

Senators Mike Braun (R, Indiana) and Maggie Hassan (D, New Hampshire) introduced the bill last March; Representatives Robert Latta (Ohio-05) and Kathleen Rice (New York-04) introduced companion legislation in the House.

The Act serves multiple purposes, including to retain the critical experience of doctors, nurses, pharmacists, technicians, and physical therapists who understand the challenges service members face; to give those professionals continued employment; and to fill empty staff positions. Two years ago, the VA Inspector General said staff shortages are a root cause of many of the problems in veterans’ care.

 The bill directs the VA to create a program to recruit military medical personnel who are within 1 year of completing their military service. On average, 13,000 active-duty medical department members separate from the military each year at the end of enlistments or contracts, or through retirement. But until now, there has been no formal program to actively recruit them to stay.

The Act requires VA leaders to work with US Department of Defense officials to identify, refer, and transition service members who have critically needed skills. Moreover, the bill specifically mandates that if a member of the Armed Forces expresses an interest in working in a health care occupation within the VA, the VA Secretary “shall refer the member to a recruiter of the Department for consideration of open positions in the specialty and geography of interest to the member.”

Senator Hassan, in an official statement, said, “[W]e must always ensure that veterans have the support and resources that they need to succeed, and a critical way to do that is by expanding employment opportunities for our nation’s heroes and strengthening their health care.”

In his remarks, President Biden said, “For both our veterans and our military medical personnel, service isn’t just what they do, it’s who they are.”

Thousands of health care professionals who separate from active duty each year now have a route to stay in federal health care jobs, including open positions in US Department of Veterans Affairs (VA) hospitals. President Biden signed the Hire Veteran Health Heroes Act of 2021 into law on November 30, saying, “This new program will build upon existing efforts to create a pipeline for former military health professionals….to allow those professionals to continue their service to each other and to our nation.”

Senators Mike Braun (R, Indiana) and Maggie Hassan (D, New Hampshire) introduced the bill last March; Representatives Robert Latta (Ohio-05) and Kathleen Rice (New York-04) introduced companion legislation in the House.

The Act serves multiple purposes, including to retain the critical experience of doctors, nurses, pharmacists, technicians, and physical therapists who understand the challenges service members face; to give those professionals continued employment; and to fill empty staff positions. Two years ago, the VA Inspector General said staff shortages are a root cause of many of the problems in veterans’ care.

 The bill directs the VA to create a program to recruit military medical personnel who are within 1 year of completing their military service. On average, 13,000 active-duty medical department members separate from the military each year at the end of enlistments or contracts, or through retirement. But until now, there has been no formal program to actively recruit them to stay.

The Act requires VA leaders to work with US Department of Defense officials to identify, refer, and transition service members who have critically needed skills. Moreover, the bill specifically mandates that if a member of the Armed Forces expresses an interest in working in a health care occupation within the VA, the VA Secretary “shall refer the member to a recruiter of the Department for consideration of open positions in the specialty and geography of interest to the member.”

Senator Hassan, in an official statement, said, “[W]e must always ensure that veterans have the support and resources that they need to succeed, and a critical way to do that is by expanding employment opportunities for our nation’s heroes and strengthening their health care.”

In his remarks, President Biden said, “For both our veterans and our military medical personnel, service isn’t just what they do, it’s who they are.”

Starting Dec. 8, the Centers for Disease Control and Prevention recommends all clinicians talk to their sexually active adolescent and adult patients about HIV pre-exposure prophylaxis (PrEP) at least once and prescribe the prevention pills to anyone who asks for them, whether or not you understand their need for it.

“PrEP is a part of good primary care,” Demetre Daskalakis, MD, CDC’s director of the division of HIV/AIDS prevention, said in an interview. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”

The expanded recommendation comes as part of the 2021 update to the U.S. Public Health Service’s PrEP prescribing guidelines. It’s the third iteration since the Food and Drug Administration approved the first HIV prevention pill in 2012, and the first to include guidance on how to prescribe and monitor an injectable version of PrEP, which the FDA may approve as early as December 2021.

There are currently two pills, Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences and generic) and Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences). The pills have been found to be up to 99% effective in preventing HIV acquisition. The new injectable cabotegravir appears to be even more effective.

The broadened guidance is part of an effort from the country’s top health officials to expand PrEP prescribing from infectious disease specialists and sexual health clinics to health care professionals, including gynecologists, internal medicine physicians, and family practice clinicians. It appears to be necessary. In 2020, just 25% of the 1.2 million Americans who could benefit from PrEP were taking it, according to CDC data.

But those rates belie stark disparities in PrEP use by race and gender. The vast majority of those using PrEP are White Americans and men. About 66% of White Americans who could benefit from PrEP used it in 2020, and more than a quarter of the men who could benefit used it. By contrast, just 16% of Latinx people who could benefit had a prescription. And fewer than 1 in 10 Black Americans, who make up nearly half of those with indications for PrEP, had a prescription. The same was true for the women who could benefit.

Researchers and data from early PrEP demonstration projects have documented that clinicians are less likely to refer or prescribe the HIV prevention pills to Black people, especially the Black cisgender and transgender women and same-gender-loving men who bear the disproportionate burden of new cases in the United States, as well as fail to prescribe the medication to people who inject drugs.
 

Normalizing PrEP in primary care

When Courtney Sherman, DNP, APRN, first heard about PrEP in the early 2010s, she joked that her reaction was: “You’re ridiculous. You’re making that up. That’s not real.”

Ms. Sherman is now launching a tele-PrEP program from CAN Community Health, a nonprofit network of community health centers in southern Florida. The tele-PrEP program is meant to serve people in Florida and beyond, to increase access to the pill in areas with few health care professionals, or clinicians unwilling to prescribe it.

“When I go other places, I can’t do what I do for a living without getting some sort of bizarre comment or look,” she said. But the looks don’t just come from family, friends, or her children’s teachers. They come from colleagues, too. “What I’ve learned is that anybody – anybody – can be impacted [by HIV] and the illusion that ‘those people who live over there do things that me and my kind don’t do’ is just garbage.”

That’s the PrEP stigma that the universal PrEP counseling in the guidelines is meant to override, said Dr. Daskalakis. Going forward, he said that informing people about PrEP should be treated as normally as counseling people about smoking.

“You can change the blank: You talk to all adolescents and adults about not smoking,” he said. “This is: ‘Tell adolescents and adults about ways you can prevent HIV, and PrEP is one of them.’ ”

The guidelines also simplify for monitoring lab levels for the current daily pills, checking creatinine clearance levels twice a year in people older than age 50 and once a year in those younger than 50 taking the oral pills. Dr. Daskalakis said that should ease the burden of monitoring PrEP patients for health care professionals with busy caseloads.

It’s a move that drew praise from Shawnika Hull, PhD, assistant professor of health communications at Rutgers University, New Brunswick, N.J.. Dr. Hull’s recent data showed that clinicians who espoused more biased racial views were also less likely to prescribe PrEP to Black women who asked for it.

“Public health practitioners and scientists have been advocating for this as a strategy, as one way to address several ongoing barriers to PrEP specifically but also equity in PrEP,” said Dr. Hull. “This sort of universal provision of information is really an important strategy to try to undo some of the deeply intertwined barriers to uptake.”
 

‘Don’t grill them’

The updated guidelines keep the number and proportion of Americans who could benefit from PrEP the same: 1.2 million Americans, with nearly half of those Black. And the reasons people would qualify for PrEP remain the same: inconsistent condom use, sharing injection drug equipment, and a STI diagnosis in the last 6 months. There are also 57 jurisdictions, including seven rural states, where dating and having sex carries an increased risk of acquiring HIV because of high rates of untreated HIV in the community.

That’s why the other big change in the update is guidance to prescribe PrEP to whoever asks for it, whether the patient divulges their risk or not. Or as Dr. Daskalakis puts it: “If someone asks for PrEP, don’t grill them.”

There are lots of reasons that someone might ask for PrEP without divulging their risk behaviors, said Dr. Daskalakis, who was an infectious disease doctor in New York back in 2012 (and a member of the FDA committee) when the first pill for PrEP was approved. He said he’s seen this particularly with women who ask about it. Asking for PrEP ends up being an “ice breaker” to discussing the woman’s sexual and injection drug use history, which can then improve the kinds of tests and vaccinations clinicians suggest for her.

“So many women will open the door and say, ‘I want to do this,’ and not necessarily want to go into the details,” he said. “Now, will they go into the details later? Absolutely. That’s how you create trust and connection.”
 

A mandate and a guideline

Leisha McKinley-Beach, MPH, a member of the U.S. Women and PrEP Working Group, has been urging greater funding and mandates to expand PrEP to women since the first pill was approved. And still, Ms. McKinley-Beach said she recently met a woman who worked for a community group scheduling PrEP appointments for gay men. But the woman didn’t know that she, too, could take it. 

The American Academy of Family Physicians recommends health care professionals offer PrEP to those who can benefit. The American College of Obstetricians and Gynecologists have a 2014 committee opinion stating that PrEP “may be a useful tool for women at highest risk of HIV acquisition.”

But the ACOG opinion is not a recommendation, stating that it “should not be construed as dictating an exclusive course of treatment or procedure to be followed.” Ms. McKinley-Beach said she hopes that the new CDC guidelines will prompt ACOG and other professional organizations to issue statements to include PrEP education in all health assessments. A spokesperson for ACOG said that the organization had not seen the new CDC guidelines and had no statement on them, but pointed out that the 2014 committee opinion is one of the “highest level of documents we produce.

“We have failed for nearly a decade to raise awareness that PrEP is also a prevention strategy for women,” Ms. McKinley-Beach said in an interview. “In many ways, we’re still back in 2012 as it relates to women.”

Dr. Hull reported having done previous research funded by Gilead Sciences and having received consulting fees from Gilead Sciences in 2018. Ms. McKinley-Beach reported receiving honoraria from ViiV Healthcare. Ms. Sherman and Dr. Daskalakis disclosed no relevant financial relationships.

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

Starting Dec. 8, the Centers for Disease Control and Prevention recommends all clinicians talk to their sexually active adolescent and adult patients about HIV pre-exposure prophylaxis (PrEP) at least once and prescribe the prevention pills to anyone who asks for them, whether or not you understand their need for it.

“PrEP is a part of good primary care,” Demetre Daskalakis, MD, CDC’s director of the division of HIV/AIDS prevention, said in an interview. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”

The expanded recommendation comes as part of the 2021 update to the U.S. Public Health Service’s PrEP prescribing guidelines. It’s the third iteration since the Food and Drug Administration approved the first HIV prevention pill in 2012, and the first to include guidance on how to prescribe and monitor an injectable version of PrEP, which the FDA may approve as early as December 2021.

There are currently two pills, Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences and generic) and Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences). The pills have been found to be up to 99% effective in preventing HIV acquisition. The new injectable cabotegravir appears to be even more effective.

The broadened guidance is part of an effort from the country’s top health officials to expand PrEP prescribing from infectious disease specialists and sexual health clinics to health care professionals, including gynecologists, internal medicine physicians, and family practice clinicians. It appears to be necessary. In 2020, just 25% of the 1.2 million Americans who could benefit from PrEP were taking it, according to CDC data.

But those rates belie stark disparities in PrEP use by race and gender. The vast majority of those using PrEP are White Americans and men. About 66% of White Americans who could benefit from PrEP used it in 2020, and more than a quarter of the men who could benefit used it. By contrast, just 16% of Latinx people who could benefit had a prescription. And fewer than 1 in 10 Black Americans, who make up nearly half of those with indications for PrEP, had a prescription. The same was true for the women who could benefit.

Researchers and data from early PrEP demonstration projects have documented that clinicians are less likely to refer or prescribe the HIV prevention pills to Black people, especially the Black cisgender and transgender women and same-gender-loving men who bear the disproportionate burden of new cases in the United States, as well as fail to prescribe the medication to people who inject drugs.
 

Normalizing PrEP in primary care

When Courtney Sherman, DNP, APRN, first heard about PrEP in the early 2010s, she joked that her reaction was: “You’re ridiculous. You’re making that up. That’s not real.”

Ms. Sherman is now launching a tele-PrEP program from CAN Community Health, a nonprofit network of community health centers in southern Florida. The tele-PrEP program is meant to serve people in Florida and beyond, to increase access to the pill in areas with few health care professionals, or clinicians unwilling to prescribe it.

“When I go other places, I can’t do what I do for a living without getting some sort of bizarre comment or look,” she said. But the looks don’t just come from family, friends, or her children’s teachers. They come from colleagues, too. “What I’ve learned is that anybody – anybody – can be impacted [by HIV] and the illusion that ‘those people who live over there do things that me and my kind don’t do’ is just garbage.”

That’s the PrEP stigma that the universal PrEP counseling in the guidelines is meant to override, said Dr. Daskalakis. Going forward, he said that informing people about PrEP should be treated as normally as counseling people about smoking.

“You can change the blank: You talk to all adolescents and adults about not smoking,” he said. “This is: ‘Tell adolescents and adults about ways you can prevent HIV, and PrEP is one of them.’ ”

The guidelines also simplify for monitoring lab levels for the current daily pills, checking creatinine clearance levels twice a year in people older than age 50 and once a year in those younger than 50 taking the oral pills. Dr. Daskalakis said that should ease the burden of monitoring PrEP patients for health care professionals with busy caseloads.

It’s a move that drew praise from Shawnika Hull, PhD, assistant professor of health communications at Rutgers University, New Brunswick, N.J.. Dr. Hull’s recent data showed that clinicians who espoused more biased racial views were also less likely to prescribe PrEP to Black women who asked for it.

“Public health practitioners and scientists have been advocating for this as a strategy, as one way to address several ongoing barriers to PrEP specifically but also equity in PrEP,” said Dr. Hull. “This sort of universal provision of information is really an important strategy to try to undo some of the deeply intertwined barriers to uptake.”
 

‘Don’t grill them’

The updated guidelines keep the number and proportion of Americans who could benefit from PrEP the same: 1.2 million Americans, with nearly half of those Black. And the reasons people would qualify for PrEP remain the same: inconsistent condom use, sharing injection drug equipment, and a STI diagnosis in the last 6 months. There are also 57 jurisdictions, including seven rural states, where dating and having sex carries an increased risk of acquiring HIV because of high rates of untreated HIV in the community.

That’s why the other big change in the update is guidance to prescribe PrEP to whoever asks for it, whether the patient divulges their risk or not. Or as Dr. Daskalakis puts it: “If someone asks for PrEP, don’t grill them.”

There are lots of reasons that someone might ask for PrEP without divulging their risk behaviors, said Dr. Daskalakis, who was an infectious disease doctor in New York back in 2012 (and a member of the FDA committee) when the first pill for PrEP was approved. He said he’s seen this particularly with women who ask about it. Asking for PrEP ends up being an “ice breaker” to discussing the woman’s sexual and injection drug use history, which can then improve the kinds of tests and vaccinations clinicians suggest for her.

“So many women will open the door and say, ‘I want to do this,’ and not necessarily want to go into the details,” he said. “Now, will they go into the details later? Absolutely. That’s how you create trust and connection.”
 

A mandate and a guideline

Leisha McKinley-Beach, MPH, a member of the U.S. Women and PrEP Working Group, has been urging greater funding and mandates to expand PrEP to women since the first pill was approved. And still, Ms. McKinley-Beach said she recently met a woman who worked for a community group scheduling PrEP appointments for gay men. But the woman didn’t know that she, too, could take it. 

The American Academy of Family Physicians recommends health care professionals offer PrEP to those who can benefit. The American College of Obstetricians and Gynecologists have a 2014 committee opinion stating that PrEP “may be a useful tool for women at highest risk of HIV acquisition.”

But the ACOG opinion is not a recommendation, stating that it “should not be construed as dictating an exclusive course of treatment or procedure to be followed.” Ms. McKinley-Beach said she hopes that the new CDC guidelines will prompt ACOG and other professional organizations to issue statements to include PrEP education in all health assessments. A spokesperson for ACOG said that the organization had not seen the new CDC guidelines and had no statement on them, but pointed out that the 2014 committee opinion is one of the “highest level of documents we produce.

“We have failed for nearly a decade to raise awareness that PrEP is also a prevention strategy for women,” Ms. McKinley-Beach said in an interview. “In many ways, we’re still back in 2012 as it relates to women.”

Dr. Hull reported having done previous research funded by Gilead Sciences and having received consulting fees from Gilead Sciences in 2018. Ms. McKinley-Beach reported receiving honoraria from ViiV Healthcare. Ms. Sherman and Dr. Daskalakis disclosed no relevant financial relationships.

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

Starting Dec. 8, the Centers for Disease Control and Prevention recommends all clinicians talk to their sexually active adolescent and adult patients about HIV pre-exposure prophylaxis (PrEP) at least once and prescribe the prevention pills to anyone who asks for them, whether or not you understand their need for it.

“PrEP is a part of good primary care,” Demetre Daskalakis, MD, CDC’s director of the division of HIV/AIDS prevention, said in an interview. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”

The expanded recommendation comes as part of the 2021 update to the U.S. Public Health Service’s PrEP prescribing guidelines. It’s the third iteration since the Food and Drug Administration approved the first HIV prevention pill in 2012, and the first to include guidance on how to prescribe and monitor an injectable version of PrEP, which the FDA may approve as early as December 2021.

There are currently two pills, Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences and generic) and Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences). The pills have been found to be up to 99% effective in preventing HIV acquisition. The new injectable cabotegravir appears to be even more effective.

The broadened guidance is part of an effort from the country’s top health officials to expand PrEP prescribing from infectious disease specialists and sexual health clinics to health care professionals, including gynecologists, internal medicine physicians, and family practice clinicians. It appears to be necessary. In 2020, just 25% of the 1.2 million Americans who could benefit from PrEP were taking it, according to CDC data.

But those rates belie stark disparities in PrEP use by race and gender. The vast majority of those using PrEP are White Americans and men. About 66% of White Americans who could benefit from PrEP used it in 2020, and more than a quarter of the men who could benefit used it. By contrast, just 16% of Latinx people who could benefit had a prescription. And fewer than 1 in 10 Black Americans, who make up nearly half of those with indications for PrEP, had a prescription. The same was true for the women who could benefit.

Researchers and data from early PrEP demonstration projects have documented that clinicians are less likely to refer or prescribe the HIV prevention pills to Black people, especially the Black cisgender and transgender women and same-gender-loving men who bear the disproportionate burden of new cases in the United States, as well as fail to prescribe the medication to people who inject drugs.
 

Normalizing PrEP in primary care

When Courtney Sherman, DNP, APRN, first heard about PrEP in the early 2010s, she joked that her reaction was: “You’re ridiculous. You’re making that up. That’s not real.”

Ms. Sherman is now launching a tele-PrEP program from CAN Community Health, a nonprofit network of community health centers in southern Florida. The tele-PrEP program is meant to serve people in Florida and beyond, to increase access to the pill in areas with few health care professionals, or clinicians unwilling to prescribe it.

“When I go other places, I can’t do what I do for a living without getting some sort of bizarre comment or look,” she said. But the looks don’t just come from family, friends, or her children’s teachers. They come from colleagues, too. “What I’ve learned is that anybody – anybody – can be impacted [by HIV] and the illusion that ‘those people who live over there do things that me and my kind don’t do’ is just garbage.”

That’s the PrEP stigma that the universal PrEP counseling in the guidelines is meant to override, said Dr. Daskalakis. Going forward, he said that informing people about PrEP should be treated as normally as counseling people about smoking.

“You can change the blank: You talk to all adolescents and adults about not smoking,” he said. “This is: ‘Tell adolescents and adults about ways you can prevent HIV, and PrEP is one of them.’ ”

The guidelines also simplify for monitoring lab levels for the current daily pills, checking creatinine clearance levels twice a year in people older than age 50 and once a year in those younger than 50 taking the oral pills. Dr. Daskalakis said that should ease the burden of monitoring PrEP patients for health care professionals with busy caseloads.

It’s a move that drew praise from Shawnika Hull, PhD, assistant professor of health communications at Rutgers University, New Brunswick, N.J.. Dr. Hull’s recent data showed that clinicians who espoused more biased racial views were also less likely to prescribe PrEP to Black women who asked for it.

“Public health practitioners and scientists have been advocating for this as a strategy, as one way to address several ongoing barriers to PrEP specifically but also equity in PrEP,” said Dr. Hull. “This sort of universal provision of information is really an important strategy to try to undo some of the deeply intertwined barriers to uptake.”
 

‘Don’t grill them’

The updated guidelines keep the number and proportion of Americans who could benefit from PrEP the same: 1.2 million Americans, with nearly half of those Black. And the reasons people would qualify for PrEP remain the same: inconsistent condom use, sharing injection drug equipment, and a STI diagnosis in the last 6 months. There are also 57 jurisdictions, including seven rural states, where dating and having sex carries an increased risk of acquiring HIV because of high rates of untreated HIV in the community.

That’s why the other big change in the update is guidance to prescribe PrEP to whoever asks for it, whether the patient divulges their risk or not. Or as Dr. Daskalakis puts it: “If someone asks for PrEP, don’t grill them.”

There are lots of reasons that someone might ask for PrEP without divulging their risk behaviors, said Dr. Daskalakis, who was an infectious disease doctor in New York back in 2012 (and a member of the FDA committee) when the first pill for PrEP was approved. He said he’s seen this particularly with women who ask about it. Asking for PrEP ends up being an “ice breaker” to discussing the woman’s sexual and injection drug use history, which can then improve the kinds of tests and vaccinations clinicians suggest for her.

“So many women will open the door and say, ‘I want to do this,’ and not necessarily want to go into the details,” he said. “Now, will they go into the details later? Absolutely. That’s how you create trust and connection.”
 

A mandate and a guideline

Leisha McKinley-Beach, MPH, a member of the U.S. Women and PrEP Working Group, has been urging greater funding and mandates to expand PrEP to women since the first pill was approved. And still, Ms. McKinley-Beach said she recently met a woman who worked for a community group scheduling PrEP appointments for gay men. But the woman didn’t know that she, too, could take it. 

The American Academy of Family Physicians recommends health care professionals offer PrEP to those who can benefit. The American College of Obstetricians and Gynecologists have a 2014 committee opinion stating that PrEP “may be a useful tool for women at highest risk of HIV acquisition.”

But the ACOG opinion is not a recommendation, stating that it “should not be construed as dictating an exclusive course of treatment or procedure to be followed.” Ms. McKinley-Beach said she hopes that the new CDC guidelines will prompt ACOG and other professional organizations to issue statements to include PrEP education in all health assessments. A spokesperson for ACOG said that the organization had not seen the new CDC guidelines and had no statement on them, but pointed out that the 2014 committee opinion is one of the “highest level of documents we produce.

“We have failed for nearly a decade to raise awareness that PrEP is also a prevention strategy for women,” Ms. McKinley-Beach said in an interview. “In many ways, we’re still back in 2012 as it relates to women.”

Dr. Hull reported having done previous research funded by Gilead Sciences and having received consulting fees from Gilead Sciences in 2018. Ms. McKinley-Beach reported receiving honoraria from ViiV Healthcare. Ms. Sherman and Dr. Daskalakis disclosed no relevant financial relationships.

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

It’s called the Momnibus—the Black Maternal Health Momnibus Act of 2021 (HR 959) with 12 bills addressing “every dimension of the maternal health crisis in America.” The first bill in the Momnibus to pass Congress is the Protecting Moms Who Served act, which sets up a $15 million maternal care program within the US Department of Veterans Affairs (VA). “There has never been a comprehensive evaluation of how our nation’s growing maternal mortality crisis is impacting our women veterans, even though they may be at higher risk due to their service,” said Sen. Tammy Duckworth (D-IL), a co-sponsor of the Momnibus. The bill has passed Congress and awaits President Biden’s signature.

Rep. Lauren Underwood (D-IL) along with Rep. Alma Adams (D- NC-12), Sen. Cory Booker D-NJ), and members of the Black Maternal Health Caucus reintroduced the bill (first introduced last year). According to Rep. Underwood, the act would codify and strengthen the VA maternity care coordination programs. It also will require the US Government Accountability Office to report the deaths of pregnant and postpartum veterans and to focus on any racial or ethnic disparities. The bill passed overwhelmingly, 414 to 9 and awaits President Biden’s signature.

The Momnibus’s cute name represents a very serious purpose. “Maternal mortality has historically been used as a key indicator of the health of a population,” say researchers from National Vital Statistics Reports. But American mothers are dying at the highest rate in the developed world, and the numbers have been rising dramatically. Between 1987, when the Centers for Disease Control and Prevention (CDC) launched the Pregnancy Mortality Surveillance System in 2017, the latest year for available data, the number of reported pregnancy-related deaths in the United States rose steadily from 7.2 deaths per 100,000 live births to 17.3 per 100,000.

The maternal morbidity crisis is particularly stark among certain groups of women. Black women are acutely at risk, dying at 3 to 4 times the rate of White women (41.7 deaths per 100,000 live births), and one-third higher than the next highest risk group, Native American women (28.3 deaths per 100,000 live births).

But just how accurate have the data been? The study published in National Vital Statistics Report found that using a checkbox for “cause of death” specifying maternal death identified more than triple the number of maternal deaths. Without the checkbox item, maternal mortality rates in 2015 and 2016 would have been reported as 8.7 deaths per 100,000 live births, compared with 8.9 in 2002. With the checkbox, the rate would be reported as 20.9 per 100,000 live births in 2015 and 21.8/100,000 in 2016.

The CDC states that the reasons for the rising numbers are unclear; advances in identification have improved over time, for one. But by and large, the women are dying of preventable causes, such as hypertension, diabetes mellitus, and chronic heart disease. Nearly 60% of maternal deaths are deemed preventable.

Black and other minority women, though, may be dying of biases. Researchers from Beth Israel and Harvard cite studies that have found racial and ethnic disparities in obstetric care delivery. Non-Hispanic Blacks women, Hispanic women, and Asian women, for instance, have lower odds of labor induction when compared with that of White women. The odds of receiving an episiotomy are lower in non-Hispanic Black and Hispanic women. The Listening to Mothers survey III found that 24% of participants perceived discrimination during birth hospitalization, predominantly among Black or Hispanic women and uninsured women.

A maternal health equity advocacy group, 4Kira4Moms, was founded by the husband of Kira Johnson who died of hemorrhage following a routine scheduled cesarean section. In the recovery room, her catheter began turning pink with blood. For 10 hours, her husband said, he and her family begged the medical staff for help but were told his wife was not a priority. Thus, the Momnibus also contains the Kira Johnson Act, which will establish funding for community-based groups to provide Black pregnant women with more support.

Among other changes, the Momnibus will:

• Make critical investments in social determinants of health that influence maternal health outcomes, such as housing, transportation, and nutrition;
• Provide funding to community-based organizations that are working to improve maternal health outcomes and promote equity;
• Comprehensively study the unique maternal health risks facing pregnant and postpartum veterans and support VA maternity care coordination programs;
• Support mothers with mental health conditions and substance use disorders; and
• Promote innovative payment models to incentivize high-quality maternity care and nonclinical perinatal support

A variety of recent bills in Congress address maternal health. The Mothers and Offspring Mortality and Morbidity Awareness (MOMMA) Act, for instance, also would specifically address maternal health disparities by improving data collection and reporting, improving maternal care, and advancing respectful, equitable care. It also would extend Medicaid and the Children’s Health Insurance Program coverage. Katie Shea Barrett, MPH, executive director of March for Moms, a coalition of families, health care practitioners, policy makers, and partners advocating for mothers’ and families’ health, notes in an essay for thehill.com that Medicaid coverage ends about 60 days postpartum, although half of the maternal deaths happen between 42 days and 1 year postpartum. 

She writes: “[W]e have to directly address the disproportionate impact of maternal mortality on women of color by training providers in offering care that is culturally competent and free of implicit bias. Health systems must be aware and respectful of cultural norms when providing care and be mindful of buying into stereotypes based on race, ethnicity, and even underlying medical conditions like diabetes, which often lead to perceived discrimination and perpetuate systems of injustice.”

In April, Vice President Kamala Harris called for sweeping action to curb racial inequities in pregnancy and childbirth. In an email Q&A with STAT, she said, “With every day that goes by and every woman who dies, the need for action grows more urgent.”

It’s called the Momnibus—the Black Maternal Health Momnibus Act of 2021 (HR 959) with 12 bills addressing “every dimension of the maternal health crisis in America.” The first bill in the Momnibus to pass Congress is the Protecting Moms Who Served act, which sets up a $15 million maternal care program within the US Department of Veterans Affairs (VA). “There has never been a comprehensive evaluation of how our nation’s growing maternal mortality crisis is impacting our women veterans, even though they may be at higher risk due to their service,” said Sen. Tammy Duckworth (D-IL), a co-sponsor of the Momnibus. The bill has passed Congress and awaits President Biden’s signature.

Rep. Lauren Underwood (D-IL) along with Rep. Alma Adams (D- NC-12), Sen. Cory Booker D-NJ), and members of the Black Maternal Health Caucus reintroduced the bill (first introduced last year). According to Rep. Underwood, the act would codify and strengthen the VA maternity care coordination programs. It also will require the US Government Accountability Office to report the deaths of pregnant and postpartum veterans and to focus on any racial or ethnic disparities. The bill passed overwhelmingly, 414 to 9 and awaits President Biden’s signature.

The Momnibus’s cute name represents a very serious purpose. “Maternal mortality has historically been used as a key indicator of the health of a population,” say researchers from National Vital Statistics Reports. But American mothers are dying at the highest rate in the developed world, and the numbers have been rising dramatically. Between 1987, when the Centers for Disease Control and Prevention (CDC) launched the Pregnancy Mortality Surveillance System in 2017, the latest year for available data, the number of reported pregnancy-related deaths in the United States rose steadily from 7.2 deaths per 100,000 live births to 17.3 per 100,000.

The maternal morbidity crisis is particularly stark among certain groups of women. Black women are acutely at risk, dying at 3 to 4 times the rate of White women (41.7 deaths per 100,000 live births), and one-third higher than the next highest risk group, Native American women (28.3 deaths per 100,000 live births).

But just how accurate have the data been? The study published in National Vital Statistics Report found that using a checkbox for “cause of death” specifying maternal death identified more than triple the number of maternal deaths. Without the checkbox item, maternal mortality rates in 2015 and 2016 would have been reported as 8.7 deaths per 100,000 live births, compared with 8.9 in 2002. With the checkbox, the rate would be reported as 20.9 per 100,000 live births in 2015 and 21.8/100,000 in 2016.

The CDC states that the reasons for the rising numbers are unclear; advances in identification have improved over time, for one. But by and large, the women are dying of preventable causes, such as hypertension, diabetes mellitus, and chronic heart disease. Nearly 60% of maternal deaths are deemed preventable.

Black and other minority women, though, may be dying of biases. Researchers from Beth Israel and Harvard cite studies that have found racial and ethnic disparities in obstetric care delivery. Non-Hispanic Blacks women, Hispanic women, and Asian women, for instance, have lower odds of labor induction when compared with that of White women. The odds of receiving an episiotomy are lower in non-Hispanic Black and Hispanic women. The Listening to Mothers survey III found that 24% of participants perceived discrimination during birth hospitalization, predominantly among Black or Hispanic women and uninsured women.

A maternal health equity advocacy group, 4Kira4Moms, was founded by the husband of Kira Johnson who died of hemorrhage following a routine scheduled cesarean section. In the recovery room, her catheter began turning pink with blood. For 10 hours, her husband said, he and her family begged the medical staff for help but were told his wife was not a priority. Thus, the Momnibus also contains the Kira Johnson Act, which will establish funding for community-based groups to provide Black pregnant women with more support.

Among other changes, the Momnibus will:

• Make critical investments in social determinants of health that influence maternal health outcomes, such as housing, transportation, and nutrition;
• Provide funding to community-based organizations that are working to improve maternal health outcomes and promote equity;
• Comprehensively study the unique maternal health risks facing pregnant and postpartum veterans and support VA maternity care coordination programs;
• Support mothers with mental health conditions and substance use disorders; and
• Promote innovative payment models to incentivize high-quality maternity care and nonclinical perinatal support

A variety of recent bills in Congress address maternal health. The Mothers and Offspring Mortality and Morbidity Awareness (MOMMA) Act, for instance, also would specifically address maternal health disparities by improving data collection and reporting, improving maternal care, and advancing respectful, equitable care. It also would extend Medicaid and the Children’s Health Insurance Program coverage. Katie Shea Barrett, MPH, executive director of March for Moms, a coalition of families, health care practitioners, policy makers, and partners advocating for mothers’ and families’ health, notes in an essay for thehill.com that Medicaid coverage ends about 60 days postpartum, although half of the maternal deaths happen between 42 days and 1 year postpartum. 

She writes: “[W]e have to directly address the disproportionate impact of maternal mortality on women of color by training providers in offering care that is culturally competent and free of implicit bias. Health systems must be aware and respectful of cultural norms when providing care and be mindful of buying into stereotypes based on race, ethnicity, and even underlying medical conditions like diabetes, which often lead to perceived discrimination and perpetuate systems of injustice.”

In April, Vice President Kamala Harris called for sweeping action to curb racial inequities in pregnancy and childbirth. In an email Q&A with STAT, she said, “With every day that goes by and every woman who dies, the need for action grows more urgent.”

It’s called the Momnibus—the Black Maternal Health Momnibus Act of 2021 (HR 959) with 12 bills addressing “every dimension of the maternal health crisis in America.” The first bill in the Momnibus to pass Congress is the Protecting Moms Who Served act, which sets up a $15 million maternal care program within the US Department of Veterans Affairs (VA). “There has never been a comprehensive evaluation of how our nation’s growing maternal mortality crisis is impacting our women veterans, even though they may be at higher risk due to their service,” said Sen. Tammy Duckworth (D-IL), a co-sponsor of the Momnibus. The bill has passed Congress and awaits President Biden’s signature.

Rep. Lauren Underwood (D-IL) along with Rep. Alma Adams (D- NC-12), Sen. Cory Booker D-NJ), and members of the Black Maternal Health Caucus reintroduced the bill (first introduced last year). According to Rep. Underwood, the act would codify and strengthen the VA maternity care coordination programs. It also will require the US Government Accountability Office to report the deaths of pregnant and postpartum veterans and to focus on any racial or ethnic disparities. The bill passed overwhelmingly, 414 to 9 and awaits President Biden’s signature.

The Momnibus’s cute name represents a very serious purpose. “Maternal mortality has historically been used as a key indicator of the health of a population,” say researchers from National Vital Statistics Reports. But American mothers are dying at the highest rate in the developed world, and the numbers have been rising dramatically. Between 1987, when the Centers for Disease Control and Prevention (CDC) launched the Pregnancy Mortality Surveillance System in 2017, the latest year for available data, the number of reported pregnancy-related deaths in the United States rose steadily from 7.2 deaths per 100,000 live births to 17.3 per 100,000.

The maternal morbidity crisis is particularly stark among certain groups of women. Black women are acutely at risk, dying at 3 to 4 times the rate of White women (41.7 deaths per 100,000 live births), and one-third higher than the next highest risk group, Native American women (28.3 deaths per 100,000 live births).

But just how accurate have the data been? The study published in National Vital Statistics Report found that using a checkbox for “cause of death” specifying maternal death identified more than triple the number of maternal deaths. Without the checkbox item, maternal mortality rates in 2015 and 2016 would have been reported as 8.7 deaths per 100,000 live births, compared with 8.9 in 2002. With the checkbox, the rate would be reported as 20.9 per 100,000 live births in 2015 and 21.8/100,000 in 2016.

The CDC states that the reasons for the rising numbers are unclear; advances in identification have improved over time, for one. But by and large, the women are dying of preventable causes, such as hypertension, diabetes mellitus, and chronic heart disease. Nearly 60% of maternal deaths are deemed preventable.

Black and other minority women, though, may be dying of biases. Researchers from Beth Israel and Harvard cite studies that have found racial and ethnic disparities in obstetric care delivery. Non-Hispanic Blacks women, Hispanic women, and Asian women, for instance, have lower odds of labor induction when compared with that of White women. The odds of receiving an episiotomy are lower in non-Hispanic Black and Hispanic women. The Listening to Mothers survey III found that 24% of participants perceived discrimination during birth hospitalization, predominantly among Black or Hispanic women and uninsured women.

A maternal health equity advocacy group, 4Kira4Moms, was founded by the husband of Kira Johnson who died of hemorrhage following a routine scheduled cesarean section. In the recovery room, her catheter began turning pink with blood. For 10 hours, her husband said, he and her family begged the medical staff for help but were told his wife was not a priority. Thus, the Momnibus also contains the Kira Johnson Act, which will establish funding for community-based groups to provide Black pregnant women with more support.

Among other changes, the Momnibus will:

• Make critical investments in social determinants of health that influence maternal health outcomes, such as housing, transportation, and nutrition;
• Provide funding to community-based organizations that are working to improve maternal health outcomes and promote equity;
• Comprehensively study the unique maternal health risks facing pregnant and postpartum veterans and support VA maternity care coordination programs;
• Support mothers with mental health conditions and substance use disorders; and
• Promote innovative payment models to incentivize high-quality maternity care and nonclinical perinatal support

A variety of recent bills in Congress address maternal health. The Mothers and Offspring Mortality and Morbidity Awareness (MOMMA) Act, for instance, also would specifically address maternal health disparities by improving data collection and reporting, improving maternal care, and advancing respectful, equitable care. It also would extend Medicaid and the Children’s Health Insurance Program coverage. Katie Shea Barrett, MPH, executive director of March for Moms, a coalition of families, health care practitioners, policy makers, and partners advocating for mothers’ and families’ health, notes in an essay for thehill.com that Medicaid coverage ends about 60 days postpartum, although half of the maternal deaths happen between 42 days and 1 year postpartum. 

She writes: “[W]e have to directly address the disproportionate impact of maternal mortality on women of color by training providers in offering care that is culturally competent and free of implicit bias. Health systems must be aware and respectful of cultural norms when providing care and be mindful of buying into stereotypes based on race, ethnicity, and even underlying medical conditions like diabetes, which often lead to perceived discrimination and perpetuate systems of injustice.”

In April, Vice President Kamala Harris called for sweeping action to curb racial inequities in pregnancy and childbirth. In an email Q&A with STAT, she said, “With every day that goes by and every woman who dies, the need for action grows more urgent.”

From Pacific Lutheran School of Nursing, Tacoma, WA.

Objective: This quality improvement project aimed to enhance The Olympia Free Clinic’s (TOFC) data availability using International Classification of Diseases (ICD) code entry into the electronic health record (EHR). Prior to this project, TOFC lacked quality diagnosis data. This project strived to answer questions like “How many TOFC patients have diabetes?”

Methods: A new system was implemented for inputting ICD codes into Practice Fusion, the clinic’s EHR. During the initial phase, TOFC’s 21 volunteer providers entered the codes associated with the appropriate diagnosis for each of 157 encounters using a simplified map of options, including a map of the 20 most common diagnoses and a more comprehensive 60-code map.

Results: An EHR report found that 128 new diagnoses were entered during project implementation, hypertension being the most common diagnosis, followed by depression, then posttraumatic stress disorder.

Conclusion: The knowledge of patient diagnoses enabled the clinic to make more-informed decisions.

Keywords: free clinic, data, quality improvement, electronic health record, International Classification of Diseases

Data creates a starting point, a goal, background, understanding of needs and context, and allows for tracking and improvement over time. This quality improvement (QI) project for The Olympia Free Clinic (TOFC) implemented a new system for tracking patient diagnoses. The 21 primary TOFC providers were encouraged to input mapped International Statistical Classification of Diseases and Related Health Problems (ICD) codes into the electronic health record (EHR). The clinic’s providers consisted of mostly retired, but some actively practicing, medical doctors, doctors of osteopathy, nurse practitioners, physician assistants, and psychiatrists.

Previous to this project, the clinic lacked any concrete data on patient demographics or diagnoses. For example, the clinic was unable to accurately answer the National Association of Free and Charitable Clinics’ questions about how many patients TOFC providers saw with diabetes, hypertension, asthma, and hyperlipidemia.¹ Additionally, the needs of the clinic and its population were based on educated guesses.

Purpose

The project enlisted 21 volunteer providers to record diagnoses through ICD codes on the approximately 2000 active patients between March 22, 2021, and June 15, 2021. Tracking patient diagnoses improves clinic data, outcomes, and decision-making. By working on data improvement, the clinic can better understand its patient population and their needs, enhance clinical care, create better outcomes, make informed decisions, and raise eligibility for grants. The clinic was at a turning point as they reevaluated their mission statement and decided whether they would continue to focus on acute ailments or expand to formally manage chronic diseases as well. This decision needed to be made with knowledge, understanding, and context, which diagnosis data can provide. For example, the knowledge that the clinic’s 3 most common diagnoses are chronic conditions demonstrated that an official shift in their mission may have been warranted.

Literature Review

QI projects are effective and common in the free clinic setting.^2-4 To the author’s knowledge, no literature to date shows the implementation of a system to better track diagnoses using a free clinic’s EHR with ICD codes.

Data bring value to clinics in many ways. It can also lead to more informed and better distribution of resources, such as preventative health and social services, patient education, and medical inventory.⁴

The focus of the US health care system is shifting to a value-based system under the Patient Protection and Affordable Care Act.⁵ Outcome measurements and improvement play a key role in this.⁶ Without knowing diagnoses, we cannot effectively track outcomes and have no data on which to base improvements. Insurance and reimbursement requirements typically hold health care facilities accountable for making these outcomes and improvements a reality.^5,6 Free clinics, however, lack these motivations, which explains why a free clinic may be deficient in data and tracking methods. Tracking diagnosis codes will, going forward, allow TOFC to see outcomes and trends over time, track the effectiveness of the treatments, and change course if need be.⁶

TOFC fully implemented the EHR in 2018, giving the clinic better capabilities for pulling reports and tracking data. Although there were growing pains, many TOFC providers were already familiar with ICD codes, which, along with an EHR, provide a system to easily retrieve, store, and analyze diagnoses for evidence-based and informed decision-making.⁷ This made using ICD codes and the EHR an obvious choice to track patient diagnoses. However, most of the providers were not putting them in ICD codes before this project was implemented. Instead, diagnoses were typed in the notes and, therefore, not easy to generate in a report without having to open each chart for each individual encounter and combing through the notes. To make matters worse, providers were never trained on how to enter the codes in the EHR, and most providers saw no reason to, because the clinic does not bill for services.

Methods

A needs assessment determined that TOFC lacked data. This QI project used a combination of primary and secondary continuous quality improvement data.⁸ The primary data came from pulling the reports on Practice Fusion to see how many times each diagnosis code was put in during the implementation phase of this project. Secondary data came from interviewing the providers and asking whether they put in the diagnosis codes.

ICD diagnosis entry

Practice Fusion is the EHR TOFC uses and was therefore the platform for this QI project. Two ICD maps were created, which incorporated both International Classification of Diseases, Ninth Revision (ICD-9) and International Classification of Diseases, Tenth Revision (ICD-10) codes. There are tens of thousands of ICD codes in existence, but because TOFC is a free clinic that does not bill or receive reimbursement, the codes did not need to be as specific as they do in a paid clinic. Therefore, the maps put all the variations of each disease into a single category. For example, every patient with diabetes would receive the same ICD code regardless of whether their diabetes was controlled, uncontrolled, or any other variation. The goal of simplifying the codes was to improve compliance with ICD code entry and make reports easier to generate. The maps allowed the options to be simplified and, therefore, more user friendly for both the providers and the data collectors pulling reports. As some ICD-9 codes were already being used, these codes were incorporated so providers could keep using what they were already familiar with. To create the map, generic ICD codes were selected to represent each disease.

An initial survey was conducted prior to implementation with 10 providers, 2 nurses, and 2 staff members, asking which diagnoses they thought were seen most often in the clinic. Based off those answers, a map was created with the 20 most commonly used ICD codes, which can be seen in the Table. A more comprehensive map was also created, with 61 encompassing diagnoses.

Surveys

Surveys were conducted after the project was completed with willing and available providers and staff members in order to assess the utility of the project as well as to ensure future improvements and sustainability of the system.

Provider surveys

Do you currently input mapped ICD-10 codes when you chart for each encounter?

Yes No

If yes, do you intend to continue inputting the ICD codes in your encounters in the future?

Yes No

If no to either question above, please explain:

Do you have any recommendations for making it easier to input ICD codes or another way to track patients’ diagnoses?

Staff surveys

Is this data helpful for your role?

Yes No

If yes, how will you use this data?

Results

During the implementation phase, hypertension was the most common diagnosis seen at TOFC, accounting for 35 of 131 (27%) top 20 diagnoses entered. Depression was second, accounting for about 20% of diagnoses. Posttraumatic stress disorder was the third most common, making up 18% of diagnoses. There were 157 encounters during the implementation phase and 128 ICD diagnoses entered into the chart during this time period, suggesting that most encounters had a corresponding diagnosis code entered. See the Table for more details.

Provider surveys

Six providers answered the survey questions. Four answered “yes” to both questions and 2 answered “no” to both questions. Reasons cited for why they did not input the ICD codes included not remembering to enter the codes or not remembering how to enter the codes. Recommendations for making it easier included incorporating the diagnosis in the assessment section of the EHR instead of standing alone as its own section, replacing ICD-9 codes with ICD-10 codes on the maps, making more specific codes for options, like typing more mental health diagnoses, and implementing more training on how to enter the codes.

Staff surveys

Three of 4 staff members responded to the survey. All 3 indicated that the data collected from this project assisted in their role. Stated uses for this data included grant applications and funding; community education, such as presentations and outreach; program development and monitoring; quality improvement; supply purchasing (eg, medications in stock to treat most commonly seen conditions), scheduling clinics and providers; allocating resources and supplies; and accepting or rejecting medical supply donations.

Discussion

Before this project, 668 of the top 20 most common diagnosis codes were entered from when TOFC introduced use of the EHR in the clinic in 2017, until the beginning of the implementation phase of this project in March 2021. During the 3 months of the implementation phase, 131 diagnoses were entered, representing almost 20% of the amount that were entered in 3 and a half years. Pulling the reports for these 20 diagnoses took less than 1 hour. During the needs assessment phase of this project, diagnoses for 3 months were extracted from the EHR by combing through provider notes and extracting the data from the notes—a process that took 11 hours.

Knowledge of diagnoses and the reasons for clinic attendance help the clinic make decisions about staffing, resources, and services. The TOFC board of directors used this data to assist with the decision of whether or not to change the clinic’s mission to include primary care as an official clinic function. The original purpose of the clinic was to address acute issues for people who lacked the resources for medical care. For example, a homeless person with an abscess could come to the clinic and have the abscess drained and treated. The results of this project illustrate that, in reality, most of the diagnoses actually seen in the clinic are more chronic in nature and require consistent, ongoing care. For instance, the project identified 52 clinic patients receiving consistent diabetic care. This type of data can help the clinic determine whether it should accept diabetes-associated donations and whether it needs to recruit a volunteer diabetes educator. Generally, this data can help guide other decisions as well, like what medications should be kept in the pharmacy, whether there are certain specialists the clinic should seek to partner with, and whether the clinic should embark on any particular education campaigns. By inputting ICD codes, diagnosis data are easily obtained to assist with future decisions.

A limitation of this project was that the reports could only be pulled within a certain time frame if the start date of the diagnosis was specified. As most providers did not indicate a start date with their entered diagnosis code, the only way to compare the before and after was to count the total before and the total after the implementation time frame. In other words, comparison reports could not be pulled retroactively, so some data on the less common diagnosis codes are missing from this paper, as reports for the comprehensive map were not pulled ahead of time. Providers may have omitted the start date when entering the diagnosis codes because many of these patients had their diagnoses for years—seeing different providers each time—so starting the diagnosis at that particular encounter did not make sense. Additionally, during training, although how to enter the start date was demonstrated, the emphasis and priority was placed on actually entering the ICD code, in an effort to keep the process simple and increase participation.

Conclusion

Evidence-based care and informed decision-making require data. In a free clinic, this can be difficult to obtain due to limited staffing and the absence of billing and insurance requirements. ICD codes and EHRs are powerful tools to collect data and information about clinic needs. This project improved TOFC’s knowledge about what kind of patients and diagnoses they see.

Corresponding author: Sarah M. Shanahan, MSN, RN, Pacific Lutheran University School of Nursing, Ramstad, Room 214, Tacoma, WA 98447; slmarble94@gmail.com.

Financial disclosures: None.

From Pacific Lutheran School of Nursing, Tacoma, WA.

Objective: This quality improvement project aimed to enhance The Olympia Free Clinic’s (TOFC) data availability using International Classification of Diseases (ICD) code entry into the electronic health record (EHR). Prior to this project, TOFC lacked quality diagnosis data. This project strived to answer questions like “How many TOFC patients have diabetes?”

Methods: A new system was implemented for inputting ICD codes into Practice Fusion, the clinic’s EHR. During the initial phase, TOFC’s 21 volunteer providers entered the codes associated with the appropriate diagnosis for each of 157 encounters using a simplified map of options, including a map of the 20 most common diagnoses and a more comprehensive 60-code map.

Results: An EHR report found that 128 new diagnoses were entered during project implementation, hypertension being the most common diagnosis, followed by depression, then posttraumatic stress disorder.

Conclusion: The knowledge of patient diagnoses enabled the clinic to make more-informed decisions.

Keywords: free clinic, data, quality improvement, electronic health record, International Classification of Diseases

Data creates a starting point, a goal, background, understanding of needs and context, and allows for tracking and improvement over time. This quality improvement (QI) project for The Olympia Free Clinic (TOFC) implemented a new system for tracking patient diagnoses. The 21 primary TOFC providers were encouraged to input mapped International Statistical Classification of Diseases and Related Health Problems (ICD) codes into the electronic health record (EHR). The clinic’s providers consisted of mostly retired, but some actively practicing, medical doctors, doctors of osteopathy, nurse practitioners, physician assistants, and psychiatrists.

Previous to this project, the clinic lacked any concrete data on patient demographics or diagnoses. For example, the clinic was unable to accurately answer the National Association of Free and Charitable Clinics’ questions about how many patients TOFC providers saw with diabetes, hypertension, asthma, and hyperlipidemia.¹ Additionally, the needs of the clinic and its population were based on educated guesses.

Purpose

The project enlisted 21 volunteer providers to record diagnoses through ICD codes on the approximately 2000 active patients between March 22, 2021, and June 15, 2021. Tracking patient diagnoses improves clinic data, outcomes, and decision-making. By working on data improvement, the clinic can better understand its patient population and their needs, enhance clinical care, create better outcomes, make informed decisions, and raise eligibility for grants. The clinic was at a turning point as they reevaluated their mission statement and decided whether they would continue to focus on acute ailments or expand to formally manage chronic diseases as well. This decision needed to be made with knowledge, understanding, and context, which diagnosis data can provide. For example, the knowledge that the clinic’s 3 most common diagnoses are chronic conditions demonstrated that an official shift in their mission may have been warranted.

Literature Review

QI projects are effective and common in the free clinic setting.^2-4 To the author’s knowledge, no literature to date shows the implementation of a system to better track diagnoses using a free clinic’s EHR with ICD codes.

Data bring value to clinics in many ways. It can also lead to more informed and better distribution of resources, such as preventative health and social services, patient education, and medical inventory.⁴

The focus of the US health care system is shifting to a value-based system under the Patient Protection and Affordable Care Act.⁵ Outcome measurements and improvement play a key role in this.⁶ Without knowing diagnoses, we cannot effectively track outcomes and have no data on which to base improvements. Insurance and reimbursement requirements typically hold health care facilities accountable for making these outcomes and improvements a reality.^5,6 Free clinics, however, lack these motivations, which explains why a free clinic may be deficient in data and tracking methods. Tracking diagnosis codes will, going forward, allow TOFC to see outcomes and trends over time, track the effectiveness of the treatments, and change course if need be.⁶

TOFC fully implemented the EHR in 2018, giving the clinic better capabilities for pulling reports and tracking data. Although there were growing pains, many TOFC providers were already familiar with ICD codes, which, along with an EHR, provide a system to easily retrieve, store, and analyze diagnoses for evidence-based and informed decision-making.⁷ This made using ICD codes and the EHR an obvious choice to track patient diagnoses. However, most of the providers were not putting them in ICD codes before this project was implemented. Instead, diagnoses were typed in the notes and, therefore, not easy to generate in a report without having to open each chart for each individual encounter and combing through the notes. To make matters worse, providers were never trained on how to enter the codes in the EHR, and most providers saw no reason to, because the clinic does not bill for services.

Methods

A needs assessment determined that TOFC lacked data. This QI project used a combination of primary and secondary continuous quality improvement data.⁸ The primary data came from pulling the reports on Practice Fusion to see how many times each diagnosis code was put in during the implementation phase of this project. Secondary data came from interviewing the providers and asking whether they put in the diagnosis codes.

ICD diagnosis entry

Practice Fusion is the EHR TOFC uses and was therefore the platform for this QI project. Two ICD maps were created, which incorporated both International Classification of Diseases, Ninth Revision (ICD-9) and International Classification of Diseases, Tenth Revision (ICD-10) codes. There are tens of thousands of ICD codes in existence, but because TOFC is a free clinic that does not bill or receive reimbursement, the codes did not need to be as specific as they do in a paid clinic. Therefore, the maps put all the variations of each disease into a single category. For example, every patient with diabetes would receive the same ICD code regardless of whether their diabetes was controlled, uncontrolled, or any other variation. The goal of simplifying the codes was to improve compliance with ICD code entry and make reports easier to generate. The maps allowed the options to be simplified and, therefore, more user friendly for both the providers and the data collectors pulling reports. As some ICD-9 codes were already being used, these codes were incorporated so providers could keep using what they were already familiar with. To create the map, generic ICD codes were selected to represent each disease.

An initial survey was conducted prior to implementation with 10 providers, 2 nurses, and 2 staff members, asking which diagnoses they thought were seen most often in the clinic. Based off those answers, a map was created with the 20 most commonly used ICD codes, which can be seen in the Table. A more comprehensive map was also created, with 61 encompassing diagnoses.

Surveys

Surveys were conducted after the project was completed with willing and available providers and staff members in order to assess the utility of the project as well as to ensure future improvements and sustainability of the system.

Provider surveys

Do you currently input mapped ICD-10 codes when you chart for each encounter?

Yes No

If yes, do you intend to continue inputting the ICD codes in your encounters in the future?

Yes No

If no to either question above, please explain:

Do you have any recommendations for making it easier to input ICD codes or another way to track patients’ diagnoses?

Staff surveys

Is this data helpful for your role?

Yes No

If yes, how will you use this data?

Results

During the implementation phase, hypertension was the most common diagnosis seen at TOFC, accounting for 35 of 131 (27%) top 20 diagnoses entered. Depression was second, accounting for about 20% of diagnoses. Posttraumatic stress disorder was the third most common, making up 18% of diagnoses. There were 157 encounters during the implementation phase and 128 ICD diagnoses entered into the chart during this time period, suggesting that most encounters had a corresponding diagnosis code entered. See the Table for more details.

Provider surveys

Six providers answered the survey questions. Four answered “yes” to both questions and 2 answered “no” to both questions. Reasons cited for why they did not input the ICD codes included not remembering to enter the codes or not remembering how to enter the codes. Recommendations for making it easier included incorporating the diagnosis in the assessment section of the EHR instead of standing alone as its own section, replacing ICD-9 codes with ICD-10 codes on the maps, making more specific codes for options, like typing more mental health diagnoses, and implementing more training on how to enter the codes.

Staff surveys

Three of 4 staff members responded to the survey. All 3 indicated that the data collected from this project assisted in their role. Stated uses for this data included grant applications and funding; community education, such as presentations and outreach; program development and monitoring; quality improvement; supply purchasing (eg, medications in stock to treat most commonly seen conditions), scheduling clinics and providers; allocating resources and supplies; and accepting or rejecting medical supply donations.

Discussion

Before this project, 668 of the top 20 most common diagnosis codes were entered from when TOFC introduced use of the EHR in the clinic in 2017, until the beginning of the implementation phase of this project in March 2021. During the 3 months of the implementation phase, 131 diagnoses were entered, representing almost 20% of the amount that were entered in 3 and a half years. Pulling the reports for these 20 diagnoses took less than 1 hour. During the needs assessment phase of this project, diagnoses for 3 months were extracted from the EHR by combing through provider notes and extracting the data from the notes—a process that took 11 hours.

Knowledge of diagnoses and the reasons for clinic attendance help the clinic make decisions about staffing, resources, and services. The TOFC board of directors used this data to assist with the decision of whether or not to change the clinic’s mission to include primary care as an official clinic function. The original purpose of the clinic was to address acute issues for people who lacked the resources for medical care. For example, a homeless person with an abscess could come to the clinic and have the abscess drained and treated. The results of this project illustrate that, in reality, most of the diagnoses actually seen in the clinic are more chronic in nature and require consistent, ongoing care. For instance, the project identified 52 clinic patients receiving consistent diabetic care. This type of data can help the clinic determine whether it should accept diabetes-associated donations and whether it needs to recruit a volunteer diabetes educator. Generally, this data can help guide other decisions as well, like what medications should be kept in the pharmacy, whether there are certain specialists the clinic should seek to partner with, and whether the clinic should embark on any particular education campaigns. By inputting ICD codes, diagnosis data are easily obtained to assist with future decisions.

A limitation of this project was that the reports could only be pulled within a certain time frame if the start date of the diagnosis was specified. As most providers did not indicate a start date with their entered diagnosis code, the only way to compare the before and after was to count the total before and the total after the implementation time frame. In other words, comparison reports could not be pulled retroactively, so some data on the less common diagnosis codes are missing from this paper, as reports for the comprehensive map were not pulled ahead of time. Providers may have omitted the start date when entering the diagnosis codes because many of these patients had their diagnoses for years—seeing different providers each time—so starting the diagnosis at that particular encounter did not make sense. Additionally, during training, although how to enter the start date was demonstrated, the emphasis and priority was placed on actually entering the ICD code, in an effort to keep the process simple and increase participation.

Conclusion

Evidence-based care and informed decision-making require data. In a free clinic, this can be difficult to obtain due to limited staffing and the absence of billing and insurance requirements. ICD codes and EHRs are powerful tools to collect data and information about clinic needs. This project improved TOFC’s knowledge about what kind of patients and diagnoses they see.

Corresponding author: Sarah M. Shanahan, MSN, RN, Pacific Lutheran University School of Nursing, Ramstad, Room 214, Tacoma, WA 98447; slmarble94@gmail.com.

Financial disclosures: None.

From Pacific Lutheran School of Nursing, Tacoma, WA.

Objective: This quality improvement project aimed to enhance The Olympia Free Clinic’s (TOFC) data availability using International Classification of Diseases (ICD) code entry into the electronic health record (EHR). Prior to this project, TOFC lacked quality diagnosis data. This project strived to answer questions like “How many TOFC patients have diabetes?”

Methods: A new system was implemented for inputting ICD codes into Practice Fusion, the clinic’s EHR. During the initial phase, TOFC’s 21 volunteer providers entered the codes associated with the appropriate diagnosis for each of 157 encounters using a simplified map of options, including a map of the 20 most common diagnoses and a more comprehensive 60-code map.

Results: An EHR report found that 128 new diagnoses were entered during project implementation, hypertension being the most common diagnosis, followed by depression, then posttraumatic stress disorder.

Conclusion: The knowledge of patient diagnoses enabled the clinic to make more-informed decisions.

Keywords: free clinic, data, quality improvement, electronic health record, International Classification of Diseases

Data creates a starting point, a goal, background, understanding of needs and context, and allows for tracking and improvement over time. This quality improvement (QI) project for The Olympia Free Clinic (TOFC) implemented a new system for tracking patient diagnoses. The 21 primary TOFC providers were encouraged to input mapped International Statistical Classification of Diseases and Related Health Problems (ICD) codes into the electronic health record (EHR). The clinic’s providers consisted of mostly retired, but some actively practicing, medical doctors, doctors of osteopathy, nurse practitioners, physician assistants, and psychiatrists.

Previous to this project, the clinic lacked any concrete data on patient demographics or diagnoses. For example, the clinic was unable to accurately answer the National Association of Free and Charitable Clinics’ questions about how many patients TOFC providers saw with diabetes, hypertension, asthma, and hyperlipidemia.¹ Additionally, the needs of the clinic and its population were based on educated guesses.

Purpose

The project enlisted 21 volunteer providers to record diagnoses through ICD codes on the approximately 2000 active patients between March 22, 2021, and June 15, 2021. Tracking patient diagnoses improves clinic data, outcomes, and decision-making. By working on data improvement, the clinic can better understand its patient population and their needs, enhance clinical care, create better outcomes, make informed decisions, and raise eligibility for grants. The clinic was at a turning point as they reevaluated their mission statement and decided whether they would continue to focus on acute ailments or expand to formally manage chronic diseases as well. This decision needed to be made with knowledge, understanding, and context, which diagnosis data can provide. For example, the knowledge that the clinic’s 3 most common diagnoses are chronic conditions demonstrated that an official shift in their mission may have been warranted.

Literature Review

QI projects are effective and common in the free clinic setting.^2-4 To the author’s knowledge, no literature to date shows the implementation of a system to better track diagnoses using a free clinic’s EHR with ICD codes.

Data bring value to clinics in many ways. It can also lead to more informed and better distribution of resources, such as preventative health and social services, patient education, and medical inventory.⁴

The focus of the US health care system is shifting to a value-based system under the Patient Protection and Affordable Care Act.⁵ Outcome measurements and improvement play a key role in this.⁶ Without knowing diagnoses, we cannot effectively track outcomes and have no data on which to base improvements. Insurance and reimbursement requirements typically hold health care facilities accountable for making these outcomes and improvements a reality.^5,6 Free clinics, however, lack these motivations, which explains why a free clinic may be deficient in data and tracking methods. Tracking diagnosis codes will, going forward, allow TOFC to see outcomes and trends over time, track the effectiveness of the treatments, and change course if need be.⁶

TOFC fully implemented the EHR in 2018, giving the clinic better capabilities for pulling reports and tracking data. Although there were growing pains, many TOFC providers were already familiar with ICD codes, which, along with an EHR, provide a system to easily retrieve, store, and analyze diagnoses for evidence-based and informed decision-making.⁷ This made using ICD codes and the EHR an obvious choice to track patient diagnoses. However, most of the providers were not putting them in ICD codes before this project was implemented. Instead, diagnoses were typed in the notes and, therefore, not easy to generate in a report without having to open each chart for each individual encounter and combing through the notes. To make matters worse, providers were never trained on how to enter the codes in the EHR, and most providers saw no reason to, because the clinic does not bill for services.

Methods

A needs assessment determined that TOFC lacked data. This QI project used a combination of primary and secondary continuous quality improvement data.⁸ The primary data came from pulling the reports on Practice Fusion to see how many times each diagnosis code was put in during the implementation phase of this project. Secondary data came from interviewing the providers and asking whether they put in the diagnosis codes.

ICD diagnosis entry

Practice Fusion is the EHR TOFC uses and was therefore the platform for this QI project. Two ICD maps were created, which incorporated both International Classification of Diseases, Ninth Revision (ICD-9) and International Classification of Diseases, Tenth Revision (ICD-10) codes. There are tens of thousands of ICD codes in existence, but because TOFC is a free clinic that does not bill or receive reimbursement, the codes did not need to be as specific as they do in a paid clinic. Therefore, the maps put all the variations of each disease into a single category. For example, every patient with diabetes would receive the same ICD code regardless of whether their diabetes was controlled, uncontrolled, or any other variation. The goal of simplifying the codes was to improve compliance with ICD code entry and make reports easier to generate. The maps allowed the options to be simplified and, therefore, more user friendly for both the providers and the data collectors pulling reports. As some ICD-9 codes were already being used, these codes were incorporated so providers could keep using what they were already familiar with. To create the map, generic ICD codes were selected to represent each disease.

An initial survey was conducted prior to implementation with 10 providers, 2 nurses, and 2 staff members, asking which diagnoses they thought were seen most often in the clinic. Based off those answers, a map was created with the 20 most commonly used ICD codes, which can be seen in the Table. A more comprehensive map was also created, with 61 encompassing diagnoses.

Surveys

Surveys were conducted after the project was completed with willing and available providers and staff members in order to assess the utility of the project as well as to ensure future improvements and sustainability of the system.

Provider surveys

Do you currently input mapped ICD-10 codes when you chart for each encounter?

Yes No

If yes, do you intend to continue inputting the ICD codes in your encounters in the future?

Yes No

If no to either question above, please explain:

Do you have any recommendations for making it easier to input ICD codes or another way to track patients’ diagnoses?

Staff surveys

Is this data helpful for your role?

Yes No

If yes, how will you use this data?

Results

During the implementation phase, hypertension was the most common diagnosis seen at TOFC, accounting for 35 of 131 (27%) top 20 diagnoses entered. Depression was second, accounting for about 20% of diagnoses. Posttraumatic stress disorder was the third most common, making up 18% of diagnoses. There were 157 encounters during the implementation phase and 128 ICD diagnoses entered into the chart during this time period, suggesting that most encounters had a corresponding diagnosis code entered. See the Table for more details.

Provider surveys

Six providers answered the survey questions. Four answered “yes” to both questions and 2 answered “no” to both questions. Reasons cited for why they did not input the ICD codes included not remembering to enter the codes or not remembering how to enter the codes. Recommendations for making it easier included incorporating the diagnosis in the assessment section of the EHR instead of standing alone as its own section, replacing ICD-9 codes with ICD-10 codes on the maps, making more specific codes for options, like typing more mental health diagnoses, and implementing more training on how to enter the codes.

Staff surveys

Three of 4 staff members responded to the survey. All 3 indicated that the data collected from this project assisted in their role. Stated uses for this data included grant applications and funding; community education, such as presentations and outreach; program development and monitoring; quality improvement; supply purchasing (eg, medications in stock to treat most commonly seen conditions), scheduling clinics and providers; allocating resources and supplies; and accepting or rejecting medical supply donations.

Discussion

Before this project, 668 of the top 20 most common diagnosis codes were entered from when TOFC introduced use of the EHR in the clinic in 2017, until the beginning of the implementation phase of this project in March 2021. During the 3 months of the implementation phase, 131 diagnoses were entered, representing almost 20% of the amount that were entered in 3 and a half years. Pulling the reports for these 20 diagnoses took less than 1 hour. During the needs assessment phase of this project, diagnoses for 3 months were extracted from the EHR by combing through provider notes and extracting the data from the notes—a process that took 11 hours.

Knowledge of diagnoses and the reasons for clinic attendance help the clinic make decisions about staffing, resources, and services. The TOFC board of directors used this data to assist with the decision of whether or not to change the clinic’s mission to include primary care as an official clinic function. The original purpose of the clinic was to address acute issues for people who lacked the resources for medical care. For example, a homeless person with an abscess could come to the clinic and have the abscess drained and treated. The results of this project illustrate that, in reality, most of the diagnoses actually seen in the clinic are more chronic in nature and require consistent, ongoing care. For instance, the project identified 52 clinic patients receiving consistent diabetic care. This type of data can help the clinic determine whether it should accept diabetes-associated donations and whether it needs to recruit a volunteer diabetes educator. Generally, this data can help guide other decisions as well, like what medications should be kept in the pharmacy, whether there are certain specialists the clinic should seek to partner with, and whether the clinic should embark on any particular education campaigns. By inputting ICD codes, diagnosis data are easily obtained to assist with future decisions.

A limitation of this project was that the reports could only be pulled within a certain time frame if the start date of the diagnosis was specified. As most providers did not indicate a start date with their entered diagnosis code, the only way to compare the before and after was to count the total before and the total after the implementation time frame. In other words, comparison reports could not be pulled retroactively, so some data on the less common diagnosis codes are missing from this paper, as reports for the comprehensive map were not pulled ahead of time. Providers may have omitted the start date when entering the diagnosis codes because many of these patients had their diagnoses for years—seeing different providers each time—so starting the diagnosis at that particular encounter did not make sense. Additionally, during training, although how to enter the start date was demonstrated, the emphasis and priority was placed on actually entering the ICD code, in an effort to keep the process simple and increase participation.

Conclusion

Evidence-based care and informed decision-making require data. In a free clinic, this can be difficult to obtain due to limited staffing and the absence of billing and insurance requirements. ICD codes and EHRs are powerful tools to collect data and information about clinic needs. This project improved TOFC’s knowledge about what kind of patients and diagnoses they see.

Corresponding author: Sarah M. Shanahan, MSN, RN, Pacific Lutheran University School of Nursing, Ramstad, Room 214, Tacoma, WA 98447; slmarble94@gmail.com.

Financial disclosures: None.