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HHS to inject billions into mental health, substance use disorders
The U.S. Department of Health and Human Services will inject billions of dollars into programs designed to address mental health and substance use disorders, including $3 billion released to states as of May 18, said federal officials.
The American Rescue Plan, a COVID-relief package signed into law in March, contained the money, which will be divided equally between the Community Mental Health Services Block Grant Program and the Substance Abuse Prevention and Treatment Block Grant Program, said Tom Coderre, Acting Assistant Secretary for Mental Health and Substance Use, in a call with reporters.
The award amounts will vary by state.
The mental health program helps states and territories provide services for children with serious emotional issues and adults with serious mental illness.
The substance use program provides money to plan, implement, and evaluate prevention, intervention, treatment, and recovery services.
, which fueled an increase in anxiety, depression, and overdose, said Assistant Secretary for Health Rachel Levine, MD, on the call.
“We know multiple stressors during the pandemic – isolation, sickness, grief, job loss, food instability, and loss of routines – have devastated many Americans and presented the unprecedented behavioral health challenges across the nation,” said Dr. Levine.
The HHS also announced that it is re-establishing a Behavioral Health Coordinating Council (BHCC). Dr. Levine and Mr. Coderre will serve as cochairs of the Council, which will coordinate action-oriented approaches to addressing the HHS’s behavioral health efforts.
However, in 2014, the U.S. Government Accountability Office criticized the BHCC for only focusing on the HHS, and noted the lack of coordination across the federal government’s various efforts to address mental health.
‘A huge step forward’
The American Psychiatric Association welcomed the new money and the return of the council.
“In the wake of the pandemic an unprecedented, and as of yet untold, number of Americans are faced with mental health and substance use disorders, particularly in communities impacted by structural racism,” said APA President Vivian Pender, MD, in a statement. “With the creation of this Council and this investment in mental health, the administration is taking a huge step forward.”
APA CEO and Medical Director Saul Levin, MD, MPA, added: “This Council has great potential to ease the challenges we face as we begin to recover from the pandemic’s impact on our society, and [the] APA looks forward to assisting in their efforts.”
HHS Secretary Xavier Becerra noted in a statement that the COVID-19 pandemic “has made clear the need to invest resources in our nation’s mental health and address the inequities that still exist around behavioral health care.” He added, “This national problem calls for department-wide coordination to address the issue.”
Dr. Levine said the Council “will assure the right prioritization and guidelines are in place to provide pathways to prevention, intervention, treatment, and recovery services.”
A version of this article first appeared on Medscape.com.
The U.S. Department of Health and Human Services will inject billions of dollars into programs designed to address mental health and substance use disorders, including $3 billion released to states as of May 18, said federal officials.
The American Rescue Plan, a COVID-relief package signed into law in March, contained the money, which will be divided equally between the Community Mental Health Services Block Grant Program and the Substance Abuse Prevention and Treatment Block Grant Program, said Tom Coderre, Acting Assistant Secretary for Mental Health and Substance Use, in a call with reporters.
The award amounts will vary by state.
The mental health program helps states and territories provide services for children with serious emotional issues and adults with serious mental illness.
The substance use program provides money to plan, implement, and evaluate prevention, intervention, treatment, and recovery services.
, which fueled an increase in anxiety, depression, and overdose, said Assistant Secretary for Health Rachel Levine, MD, on the call.
“We know multiple stressors during the pandemic – isolation, sickness, grief, job loss, food instability, and loss of routines – have devastated many Americans and presented the unprecedented behavioral health challenges across the nation,” said Dr. Levine.
The HHS also announced that it is re-establishing a Behavioral Health Coordinating Council (BHCC). Dr. Levine and Mr. Coderre will serve as cochairs of the Council, which will coordinate action-oriented approaches to addressing the HHS’s behavioral health efforts.
However, in 2014, the U.S. Government Accountability Office criticized the BHCC for only focusing on the HHS, and noted the lack of coordination across the federal government’s various efforts to address mental health.
‘A huge step forward’
The American Psychiatric Association welcomed the new money and the return of the council.
“In the wake of the pandemic an unprecedented, and as of yet untold, number of Americans are faced with mental health and substance use disorders, particularly in communities impacted by structural racism,” said APA President Vivian Pender, MD, in a statement. “With the creation of this Council and this investment in mental health, the administration is taking a huge step forward.”
APA CEO and Medical Director Saul Levin, MD, MPA, added: “This Council has great potential to ease the challenges we face as we begin to recover from the pandemic’s impact on our society, and [the] APA looks forward to assisting in their efforts.”
HHS Secretary Xavier Becerra noted in a statement that the COVID-19 pandemic “has made clear the need to invest resources in our nation’s mental health and address the inequities that still exist around behavioral health care.” He added, “This national problem calls for department-wide coordination to address the issue.”
Dr. Levine said the Council “will assure the right prioritization and guidelines are in place to provide pathways to prevention, intervention, treatment, and recovery services.”
A version of this article first appeared on Medscape.com.
The U.S. Department of Health and Human Services will inject billions of dollars into programs designed to address mental health and substance use disorders, including $3 billion released to states as of May 18, said federal officials.
The American Rescue Plan, a COVID-relief package signed into law in March, contained the money, which will be divided equally between the Community Mental Health Services Block Grant Program and the Substance Abuse Prevention and Treatment Block Grant Program, said Tom Coderre, Acting Assistant Secretary for Mental Health and Substance Use, in a call with reporters.
The award amounts will vary by state.
The mental health program helps states and territories provide services for children with serious emotional issues and adults with serious mental illness.
The substance use program provides money to plan, implement, and evaluate prevention, intervention, treatment, and recovery services.
, which fueled an increase in anxiety, depression, and overdose, said Assistant Secretary for Health Rachel Levine, MD, on the call.
“We know multiple stressors during the pandemic – isolation, sickness, grief, job loss, food instability, and loss of routines – have devastated many Americans and presented the unprecedented behavioral health challenges across the nation,” said Dr. Levine.
The HHS also announced that it is re-establishing a Behavioral Health Coordinating Council (BHCC). Dr. Levine and Mr. Coderre will serve as cochairs of the Council, which will coordinate action-oriented approaches to addressing the HHS’s behavioral health efforts.
However, in 2014, the U.S. Government Accountability Office criticized the BHCC for only focusing on the HHS, and noted the lack of coordination across the federal government’s various efforts to address mental health.
‘A huge step forward’
The American Psychiatric Association welcomed the new money and the return of the council.
“In the wake of the pandemic an unprecedented, and as of yet untold, number of Americans are faced with mental health and substance use disorders, particularly in communities impacted by structural racism,” said APA President Vivian Pender, MD, in a statement. “With the creation of this Council and this investment in mental health, the administration is taking a huge step forward.”
APA CEO and Medical Director Saul Levin, MD, MPA, added: “This Council has great potential to ease the challenges we face as we begin to recover from the pandemic’s impact on our society, and [the] APA looks forward to assisting in their efforts.”
HHS Secretary Xavier Becerra noted in a statement that the COVID-19 pandemic “has made clear the need to invest resources in our nation’s mental health and address the inequities that still exist around behavioral health care.” He added, “This national problem calls for department-wide coordination to address the issue.”
Dr. Levine said the Council “will assure the right prioritization and guidelines are in place to provide pathways to prevention, intervention, treatment, and recovery services.”
A version of this article first appeared on Medscape.com.
HHS prohibits discrimination against LGBTQ patients: Action reverses Trump-era policy
The Biden administration is reversing a Trump-era policy that allowed health care providers to bar services to lesbian, gay, bisexual, transgender, or queer (LGBTQ) patients.
The U.S. Department of Health and Human Services gave notice on Monday that it would interpret the Affordable Care Act’s Section 1557 – which bars discrimination on the basis of sex – to include discrimination on the basis of sexual orientation or gender identity. The department said its position is consistent with a June 2020 U.S. Supreme Court ruling in Bostock v. Clayton County, GA. The ruling determined that the Civil Rights Act’s prohibition of employment discrimination on the basis of sex includes sexual orientation and gender identity.
“The mission of our Department is to enhance the health and well-being of all Americans, no matter their gender identity or sexual orientation,” said HHS Assistant Secretary for Health Rachel Levine, MD, in a statement released Monday.
“All people need access to health care services to fix a broken bone, protect their heart health, and screen for cancer risk,” she said. “No one should be discriminated against when seeking medical services because of who they are.”
Many physician organizations applauded the decision.
“The Biden administration did the right thing by terminating a short-lived effort to allow discrimination based on gender or sexual orientation when seeking health care,” said Susan R. Bailey, MD, president of the American Medical Association, in a statement.
When, in 2019, the Trump administration proposed to allow providers to deny care to LGBTQ people, the AMA said in a letter to the HHS that its interpretation “was contrary to the intent and the plain language of the law.”
Now, said Bailey, the AMA welcomes the Biden administration’s interpretation. It “is a victory for health equity and ends a dismal chapter in which a federal agency sought to remove civil rights protections,” she said.
An alliance of patient groups – including the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Epilepsy Foundation, the National Multiple Sclerosis Society, and the National Organization for Rare Disorders – also applauded the new policy. “This community already faces significant health disparities,” the groups noted in a statement. People with chronic illness such as HIV and cancer “need to be able to access care quickly and without fear of discrimination,” they said.
The groups had filed a friend of the court brief in a case against the Trump administration rule.
“We welcome this positive step to ensure access is preserved without hindrance, as intended by the health care law,” they said.
Twenty-two states and Washington, D.C. – led by former California Attorney General Xavier Becerra, who is now HHS secretary – sued the Trump administration in July 2020, aiming to overturn the rule.
Chase Strangio, deputy director for Trans Justice with the American Civil Liberties Union LGBTQ & HIV Project, noted that the HHS announcement was crucial in the face of efforts in multiple states to bar health care for transgender youth. “The Biden administration has affirmed what courts have said for decades: Discrimination against LGBTQ people is against the law. It also affirms what transgender people have long said: Gender-affirming care is life-saving care,” he said in a statement.
Lambda Legal, which led another lawsuit against the Trump administration rule, said it welcomed the HHS action but noted in a statement by the organization’s senior attorney, Omar Gonzalez-Pagan, that it “does not address significant aspects of the Trump-era rule that we and others have challenged in court.”
The Trump rule also “limited the remedies available to people who face health disparities, limited access to health care for people with Limited English Proficiency, unlawfully incorporated religious exemptions, and dramatically reduced the number of health care entities and insurance subject to the rule, all of which today’s action does not address,” said Gonzalez-Pagan.
“We encourage Secretary Xavier Becerra and the Biden administration to take additional steps to ensure that all LGBTQ people are completely covered wherever and whenever they may encounter discrimination during some of the most delicate and precarious moments of their lives: When seeking health care,” he said.
A version of this article first appeared on Medscape.com.
The Biden administration is reversing a Trump-era policy that allowed health care providers to bar services to lesbian, gay, bisexual, transgender, or queer (LGBTQ) patients.
The U.S. Department of Health and Human Services gave notice on Monday that it would interpret the Affordable Care Act’s Section 1557 – which bars discrimination on the basis of sex – to include discrimination on the basis of sexual orientation or gender identity. The department said its position is consistent with a June 2020 U.S. Supreme Court ruling in Bostock v. Clayton County, GA. The ruling determined that the Civil Rights Act’s prohibition of employment discrimination on the basis of sex includes sexual orientation and gender identity.
“The mission of our Department is to enhance the health and well-being of all Americans, no matter their gender identity or sexual orientation,” said HHS Assistant Secretary for Health Rachel Levine, MD, in a statement released Monday.
“All people need access to health care services to fix a broken bone, protect their heart health, and screen for cancer risk,” she said. “No one should be discriminated against when seeking medical services because of who they are.”
Many physician organizations applauded the decision.
“The Biden administration did the right thing by terminating a short-lived effort to allow discrimination based on gender or sexual orientation when seeking health care,” said Susan R. Bailey, MD, president of the American Medical Association, in a statement.
When, in 2019, the Trump administration proposed to allow providers to deny care to LGBTQ people, the AMA said in a letter to the HHS that its interpretation “was contrary to the intent and the plain language of the law.”
Now, said Bailey, the AMA welcomes the Biden administration’s interpretation. It “is a victory for health equity and ends a dismal chapter in which a federal agency sought to remove civil rights protections,” she said.
An alliance of patient groups – including the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Epilepsy Foundation, the National Multiple Sclerosis Society, and the National Organization for Rare Disorders – also applauded the new policy. “This community already faces significant health disparities,” the groups noted in a statement. People with chronic illness such as HIV and cancer “need to be able to access care quickly and without fear of discrimination,” they said.
The groups had filed a friend of the court brief in a case against the Trump administration rule.
“We welcome this positive step to ensure access is preserved without hindrance, as intended by the health care law,” they said.
Twenty-two states and Washington, D.C. – led by former California Attorney General Xavier Becerra, who is now HHS secretary – sued the Trump administration in July 2020, aiming to overturn the rule.
Chase Strangio, deputy director for Trans Justice with the American Civil Liberties Union LGBTQ & HIV Project, noted that the HHS announcement was crucial in the face of efforts in multiple states to bar health care for transgender youth. “The Biden administration has affirmed what courts have said for decades: Discrimination against LGBTQ people is against the law. It also affirms what transgender people have long said: Gender-affirming care is life-saving care,” he said in a statement.
Lambda Legal, which led another lawsuit against the Trump administration rule, said it welcomed the HHS action but noted in a statement by the organization’s senior attorney, Omar Gonzalez-Pagan, that it “does not address significant aspects of the Trump-era rule that we and others have challenged in court.”
The Trump rule also “limited the remedies available to people who face health disparities, limited access to health care for people with Limited English Proficiency, unlawfully incorporated religious exemptions, and dramatically reduced the number of health care entities and insurance subject to the rule, all of which today’s action does not address,” said Gonzalez-Pagan.
“We encourage Secretary Xavier Becerra and the Biden administration to take additional steps to ensure that all LGBTQ people are completely covered wherever and whenever they may encounter discrimination during some of the most delicate and precarious moments of their lives: When seeking health care,” he said.
A version of this article first appeared on Medscape.com.
The Biden administration is reversing a Trump-era policy that allowed health care providers to bar services to lesbian, gay, bisexual, transgender, or queer (LGBTQ) patients.
The U.S. Department of Health and Human Services gave notice on Monday that it would interpret the Affordable Care Act’s Section 1557 – which bars discrimination on the basis of sex – to include discrimination on the basis of sexual orientation or gender identity. The department said its position is consistent with a June 2020 U.S. Supreme Court ruling in Bostock v. Clayton County, GA. The ruling determined that the Civil Rights Act’s prohibition of employment discrimination on the basis of sex includes sexual orientation and gender identity.
“The mission of our Department is to enhance the health and well-being of all Americans, no matter their gender identity or sexual orientation,” said HHS Assistant Secretary for Health Rachel Levine, MD, in a statement released Monday.
“All people need access to health care services to fix a broken bone, protect their heart health, and screen for cancer risk,” she said. “No one should be discriminated against when seeking medical services because of who they are.”
Many physician organizations applauded the decision.
“The Biden administration did the right thing by terminating a short-lived effort to allow discrimination based on gender or sexual orientation when seeking health care,” said Susan R. Bailey, MD, president of the American Medical Association, in a statement.
When, in 2019, the Trump administration proposed to allow providers to deny care to LGBTQ people, the AMA said in a letter to the HHS that its interpretation “was contrary to the intent and the plain language of the law.”
Now, said Bailey, the AMA welcomes the Biden administration’s interpretation. It “is a victory for health equity and ends a dismal chapter in which a federal agency sought to remove civil rights protections,” she said.
An alliance of patient groups – including the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Epilepsy Foundation, the National Multiple Sclerosis Society, and the National Organization for Rare Disorders – also applauded the new policy. “This community already faces significant health disparities,” the groups noted in a statement. People with chronic illness such as HIV and cancer “need to be able to access care quickly and without fear of discrimination,” they said.
The groups had filed a friend of the court brief in a case against the Trump administration rule.
“We welcome this positive step to ensure access is preserved without hindrance, as intended by the health care law,” they said.
Twenty-two states and Washington, D.C. – led by former California Attorney General Xavier Becerra, who is now HHS secretary – sued the Trump administration in July 2020, aiming to overturn the rule.
Chase Strangio, deputy director for Trans Justice with the American Civil Liberties Union LGBTQ & HIV Project, noted that the HHS announcement was crucial in the face of efforts in multiple states to bar health care for transgender youth. “The Biden administration has affirmed what courts have said for decades: Discrimination against LGBTQ people is against the law. It also affirms what transgender people have long said: Gender-affirming care is life-saving care,” he said in a statement.
Lambda Legal, which led another lawsuit against the Trump administration rule, said it welcomed the HHS action but noted in a statement by the organization’s senior attorney, Omar Gonzalez-Pagan, that it “does not address significant aspects of the Trump-era rule that we and others have challenged in court.”
The Trump rule also “limited the remedies available to people who face health disparities, limited access to health care for people with Limited English Proficiency, unlawfully incorporated religious exemptions, and dramatically reduced the number of health care entities and insurance subject to the rule, all of which today’s action does not address,” said Gonzalez-Pagan.
“We encourage Secretary Xavier Becerra and the Biden administration to take additional steps to ensure that all LGBTQ people are completely covered wherever and whenever they may encounter discrimination during some of the most delicate and precarious moments of their lives: When seeking health care,” he said.
A version of this article first appeared on Medscape.com.
Small clinics, practices key to COVID-19 vaccine success: State officials
Primary care physicians and providers in small offices and clinics are going to be key to ensuring that the remaining half of the nation receives a COVID-19 vaccination, state health officials said Wednesday, and the federal government will soon start shipping smaller packages of the Pfizer/BioNTech vaccine that can be more readily used by individual doctors.
According to the Centers for Disease Control and Prevention, as of April 21, more than 215 million doses have been administered. About 40% – 134 million Americans – have had at least one dose of a vaccine.
Among those who still haven’t received a shot are people who don’t have the time, may be homebound, or who have questions about the vaccine, or might say they will never be vaccinated, said Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials and director of the Maine Center for Disease Control and Prevention, on a call with reporters.
Especially for those who fall into the “not-ever” category, state officials “are working to find trusted messengers like doctors” who can connect with these individuals and give them information, he said.
Primary care physicians’ offices and other small practice settings are “where we are most likely to reach many of the remaining 50%,” Steven Stack, MD, MBA, FACEP, commissioner of the Kentucky Department for Public Health, said on the briefing.
State officials also “need to support all people to consult their personal physicians in whom they have confidence and trust to be informed of the benefits of COVID vaccination and the safety of this vaccination,” he said, adding that “this is the way we put this pandemic in the rearview mirror and move on with our lives.”
Dr. Stack said the federal government is starting by working with Pfizer to slim down its packages from 1,170 doses to 450 doses. That should happen before June, said Dr. Stack, adding that state health officials will be able to distribute the smaller packages “more widely and to smaller settings.”
Ideally, packaging for all vaccines will get down to single-dose, pre-filled syringes, he said. But that is a “journey” that the federal government has just begun, said Dr. Stack.
The White House had not responded to a request from this news organization for comment by press time.
Having vaccines onsite in a physician’s office is important, Dr. Stack said, adding that doctors “need to reach people in their persuadable moment.”
Bringing pediatricians on board
Illinois state health officials have begun a process that will let pediatricians have weekly vaccination clinics and also have vaccine on hand to meet patients in the moment, said Ngozi Ezike, MD, director of the Illinois Department of Public Health, on the briefing.
She said the distribution can start even before the Pfizer vaccine is shipped in smaller packages – and as soon as the Food and Drug Administration authorizes the vaccine for adolescents. Pfizer applied for emergency use approval for children aged 12-15 on April 9.
Local health departments will store the vaccine in their ultra-cold freezers. Pediatricians will identify how many people they hope to vaccinate each week and receive the doses on Monday, with the understanding that they must use the vaccine within 5 days, said Dr. Ezike.
The aim is to support vaccination clinics but also to ensure doctors have “doses on hand,” so that a parent or adolescent could opt for vaccination during a visit.
Although estimating the number of doses required will be difficult and likely involve some waste, Dr. Ezike said it’s important to be able to offer a vaccine in the office instead of having to refer someone elsewhere.
A version of this article first appeared on Medscape.com.
Primary care physicians and providers in small offices and clinics are going to be key to ensuring that the remaining half of the nation receives a COVID-19 vaccination, state health officials said Wednesday, and the federal government will soon start shipping smaller packages of the Pfizer/BioNTech vaccine that can be more readily used by individual doctors.
According to the Centers for Disease Control and Prevention, as of April 21, more than 215 million doses have been administered. About 40% – 134 million Americans – have had at least one dose of a vaccine.
Among those who still haven’t received a shot are people who don’t have the time, may be homebound, or who have questions about the vaccine, or might say they will never be vaccinated, said Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials and director of the Maine Center for Disease Control and Prevention, on a call with reporters.
Especially for those who fall into the “not-ever” category, state officials “are working to find trusted messengers like doctors” who can connect with these individuals and give them information, he said.
Primary care physicians’ offices and other small practice settings are “where we are most likely to reach many of the remaining 50%,” Steven Stack, MD, MBA, FACEP, commissioner of the Kentucky Department for Public Health, said on the briefing.
State officials also “need to support all people to consult their personal physicians in whom they have confidence and trust to be informed of the benefits of COVID vaccination and the safety of this vaccination,” he said, adding that “this is the way we put this pandemic in the rearview mirror and move on with our lives.”
Dr. Stack said the federal government is starting by working with Pfizer to slim down its packages from 1,170 doses to 450 doses. That should happen before June, said Dr. Stack, adding that state health officials will be able to distribute the smaller packages “more widely and to smaller settings.”
Ideally, packaging for all vaccines will get down to single-dose, pre-filled syringes, he said. But that is a “journey” that the federal government has just begun, said Dr. Stack.
The White House had not responded to a request from this news organization for comment by press time.
Having vaccines onsite in a physician’s office is important, Dr. Stack said, adding that doctors “need to reach people in their persuadable moment.”
Bringing pediatricians on board
Illinois state health officials have begun a process that will let pediatricians have weekly vaccination clinics and also have vaccine on hand to meet patients in the moment, said Ngozi Ezike, MD, director of the Illinois Department of Public Health, on the briefing.
She said the distribution can start even before the Pfizer vaccine is shipped in smaller packages – and as soon as the Food and Drug Administration authorizes the vaccine for adolescents. Pfizer applied for emergency use approval for children aged 12-15 on April 9.
Local health departments will store the vaccine in their ultra-cold freezers. Pediatricians will identify how many people they hope to vaccinate each week and receive the doses on Monday, with the understanding that they must use the vaccine within 5 days, said Dr. Ezike.
The aim is to support vaccination clinics but also to ensure doctors have “doses on hand,” so that a parent or adolescent could opt for vaccination during a visit.
Although estimating the number of doses required will be difficult and likely involve some waste, Dr. Ezike said it’s important to be able to offer a vaccine in the office instead of having to refer someone elsewhere.
A version of this article first appeared on Medscape.com.
Primary care physicians and providers in small offices and clinics are going to be key to ensuring that the remaining half of the nation receives a COVID-19 vaccination, state health officials said Wednesday, and the federal government will soon start shipping smaller packages of the Pfizer/BioNTech vaccine that can be more readily used by individual doctors.
According to the Centers for Disease Control and Prevention, as of April 21, more than 215 million doses have been administered. About 40% – 134 million Americans – have had at least one dose of a vaccine.
Among those who still haven’t received a shot are people who don’t have the time, may be homebound, or who have questions about the vaccine, or might say they will never be vaccinated, said Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials and director of the Maine Center for Disease Control and Prevention, on a call with reporters.
Especially for those who fall into the “not-ever” category, state officials “are working to find trusted messengers like doctors” who can connect with these individuals and give them information, he said.
Primary care physicians’ offices and other small practice settings are “where we are most likely to reach many of the remaining 50%,” Steven Stack, MD, MBA, FACEP, commissioner of the Kentucky Department for Public Health, said on the briefing.
State officials also “need to support all people to consult their personal physicians in whom they have confidence and trust to be informed of the benefits of COVID vaccination and the safety of this vaccination,” he said, adding that “this is the way we put this pandemic in the rearview mirror and move on with our lives.”
Dr. Stack said the federal government is starting by working with Pfizer to slim down its packages from 1,170 doses to 450 doses. That should happen before June, said Dr. Stack, adding that state health officials will be able to distribute the smaller packages “more widely and to smaller settings.”
Ideally, packaging for all vaccines will get down to single-dose, pre-filled syringes, he said. But that is a “journey” that the federal government has just begun, said Dr. Stack.
The White House had not responded to a request from this news organization for comment by press time.
Having vaccines onsite in a physician’s office is important, Dr. Stack said, adding that doctors “need to reach people in their persuadable moment.”
Bringing pediatricians on board
Illinois state health officials have begun a process that will let pediatricians have weekly vaccination clinics and also have vaccine on hand to meet patients in the moment, said Ngozi Ezike, MD, director of the Illinois Department of Public Health, on the briefing.
She said the distribution can start even before the Pfizer vaccine is shipped in smaller packages – and as soon as the Food and Drug Administration authorizes the vaccine for adolescents. Pfizer applied for emergency use approval for children aged 12-15 on April 9.
Local health departments will store the vaccine in their ultra-cold freezers. Pediatricians will identify how many people they hope to vaccinate each week and receive the doses on Monday, with the understanding that they must use the vaccine within 5 days, said Dr. Ezike.
The aim is to support vaccination clinics but also to ensure doctors have “doses on hand,” so that a parent or adolescent could opt for vaccination during a visit.
Although estimating the number of doses required will be difficult and likely involve some waste, Dr. Ezike said it’s important to be able to offer a vaccine in the office instead of having to refer someone elsewhere.
A version of this article first appeared on Medscape.com.
Percentage of doctors who are Black barely changed in 120 years
according to a new study.
In 1900, 1.3% of physicians were Black. In 1940, 2.8% of physicians were Black, and by 2018 – when almost 13% of the population was Black – 5.4% of doctors were Black, reports Dan Ly, MD, PhD, MPP, an assistant professor of medicine at the University of California, Los Angeles, in a study published online April 19, 2021, in the Journal of General Internal Medicine.
The proportion of male Black physicians was 2.7% in 1940 and 2.6% in 2018.
Dr. Ly also found a significant wage gap. The median income earned by White doctors was $50,000 more than the median income of Black physicians in 2018. Dr. Ly based his findings on the U.S. Census Decennial Census long form, accessed via IPUMS, a free database funded by the National Institutes of Health and other organizations.
“If we care about the health of the population, particularly the health of Black patients, we should care about how small the proportion of our physicians who are Black is and the extremely slow progress we have made as a medical system in increasing that proportion,” Dr. Ly said in an interview.
Dr. Ly said he took on this research in part because previous studies have shown that Black patients are more likely to seek preventive care from Black doctors. Thus, increasing the numbers of Black physicians could narrow gaps in life expectancy between Whites and Blacks.
He also wanted to see whether progress had been made as a result of various medical organizations and the Association of American Medical Colleges undertaking initiatives to increase workforce diversity. There has been “very, very little” progress, he said.
Norma Poll-Hunter, PhD, the AAMC’s senior director of workforce diversity, said Dr. Ly’s report “was not surprising at all.”
The AAMC reported in 2014 that the number of Black men who apply to and matriculate into medical schools has been declining since 1978. That year, there were 1,410 Black male applicants and 542 Black enrollees. In 2014, there were 1,337 applicants and 515 enrollees.
Since 2014, Black male enrollment has increased slightly, rising from 2.4% in the 2014-2015 school year to 2.9% in the 2019-2020 year, the AAMC reported last year.
In addition, among other historically underrepresented minorities, “we really have seen very small progress” despite the increase in the number of medical schools, Dr. Poll-Hunter said in an interview.
The AAMC and the National Medical Association consider the lack of Black male applicants and matriculants to be a national crisis. The two groups started an alliance in 2020 aimed at finding ways to amplify and support Black men’s interest in medicine and the biomedical sciences and to “develop systems-based solutions to address exclusionary practices that create barriers for Black men and prevent them from having equitable opportunities to successfully enroll in medical school.”
Solutions include requiring medical school admissions committees and application screeners to undergo implicit bias awareness and mitigation training, adopting holistic admissions reviews, and incentivizing institutions of higher learning to partner with Black communities in urban and rural school systems to establish K-12 health sciences academies, said NMA President Leon McDougle, MD, MPH.
“There are the systems factors, and racism is a big one that we have to tackle,” said Dr. Poll-Hunter.
Diversity isn’t just about numbers, said Dr. McDougle, a professor of family medicine and associate dean for diversity and inclusion at Ohio State University, Columbus. “We know that medical school graduates who are African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native are more likely to serve those communities as practicing physicians.
“The COVID-19 pandemic highlighted the urgent need for more African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native physicians,” he said. “Inadequate access to culturally competent care has exacerbated existing health disparities, resulting in death and hospitalization rates up to three to four times the rates of European American or White people.”
Dr. Poll-Hunter also said that studies have shown that diversity in the classroom creates a more enriched learning environment and increases civic mindedness and cognitive complexity, “as well as helps us understand people who are different than ourselves.”
The diversity goal “is not about quotas, it’s about excellence,” she said. “We know that there’s talent that exists, and we want to make sure that everyone has an opportunity to be successful.”
Dr. Ly has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new study.
In 1900, 1.3% of physicians were Black. In 1940, 2.8% of physicians were Black, and by 2018 – when almost 13% of the population was Black – 5.4% of doctors were Black, reports Dan Ly, MD, PhD, MPP, an assistant professor of medicine at the University of California, Los Angeles, in a study published online April 19, 2021, in the Journal of General Internal Medicine.
The proportion of male Black physicians was 2.7% in 1940 and 2.6% in 2018.
Dr. Ly also found a significant wage gap. The median income earned by White doctors was $50,000 more than the median income of Black physicians in 2018. Dr. Ly based his findings on the U.S. Census Decennial Census long form, accessed via IPUMS, a free database funded by the National Institutes of Health and other organizations.
“If we care about the health of the population, particularly the health of Black patients, we should care about how small the proportion of our physicians who are Black is and the extremely slow progress we have made as a medical system in increasing that proportion,” Dr. Ly said in an interview.
Dr. Ly said he took on this research in part because previous studies have shown that Black patients are more likely to seek preventive care from Black doctors. Thus, increasing the numbers of Black physicians could narrow gaps in life expectancy between Whites and Blacks.
He also wanted to see whether progress had been made as a result of various medical organizations and the Association of American Medical Colleges undertaking initiatives to increase workforce diversity. There has been “very, very little” progress, he said.
Norma Poll-Hunter, PhD, the AAMC’s senior director of workforce diversity, said Dr. Ly’s report “was not surprising at all.”
The AAMC reported in 2014 that the number of Black men who apply to and matriculate into medical schools has been declining since 1978. That year, there were 1,410 Black male applicants and 542 Black enrollees. In 2014, there were 1,337 applicants and 515 enrollees.
Since 2014, Black male enrollment has increased slightly, rising from 2.4% in the 2014-2015 school year to 2.9% in the 2019-2020 year, the AAMC reported last year.
In addition, among other historically underrepresented minorities, “we really have seen very small progress” despite the increase in the number of medical schools, Dr. Poll-Hunter said in an interview.
The AAMC and the National Medical Association consider the lack of Black male applicants and matriculants to be a national crisis. The two groups started an alliance in 2020 aimed at finding ways to amplify and support Black men’s interest in medicine and the biomedical sciences and to “develop systems-based solutions to address exclusionary practices that create barriers for Black men and prevent them from having equitable opportunities to successfully enroll in medical school.”
Solutions include requiring medical school admissions committees and application screeners to undergo implicit bias awareness and mitigation training, adopting holistic admissions reviews, and incentivizing institutions of higher learning to partner with Black communities in urban and rural school systems to establish K-12 health sciences academies, said NMA President Leon McDougle, MD, MPH.
“There are the systems factors, and racism is a big one that we have to tackle,” said Dr. Poll-Hunter.
Diversity isn’t just about numbers, said Dr. McDougle, a professor of family medicine and associate dean for diversity and inclusion at Ohio State University, Columbus. “We know that medical school graduates who are African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native are more likely to serve those communities as practicing physicians.
“The COVID-19 pandemic highlighted the urgent need for more African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native physicians,” he said. “Inadequate access to culturally competent care has exacerbated existing health disparities, resulting in death and hospitalization rates up to three to four times the rates of European American or White people.”
Dr. Poll-Hunter also said that studies have shown that diversity in the classroom creates a more enriched learning environment and increases civic mindedness and cognitive complexity, “as well as helps us understand people who are different than ourselves.”
The diversity goal “is not about quotas, it’s about excellence,” she said. “We know that there’s talent that exists, and we want to make sure that everyone has an opportunity to be successful.”
Dr. Ly has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new study.
In 1900, 1.3% of physicians were Black. In 1940, 2.8% of physicians were Black, and by 2018 – when almost 13% of the population was Black – 5.4% of doctors were Black, reports Dan Ly, MD, PhD, MPP, an assistant professor of medicine at the University of California, Los Angeles, in a study published online April 19, 2021, in the Journal of General Internal Medicine.
The proportion of male Black physicians was 2.7% in 1940 and 2.6% in 2018.
Dr. Ly also found a significant wage gap. The median income earned by White doctors was $50,000 more than the median income of Black physicians in 2018. Dr. Ly based his findings on the U.S. Census Decennial Census long form, accessed via IPUMS, a free database funded by the National Institutes of Health and other organizations.
“If we care about the health of the population, particularly the health of Black patients, we should care about how small the proportion of our physicians who are Black is and the extremely slow progress we have made as a medical system in increasing that proportion,” Dr. Ly said in an interview.
Dr. Ly said he took on this research in part because previous studies have shown that Black patients are more likely to seek preventive care from Black doctors. Thus, increasing the numbers of Black physicians could narrow gaps in life expectancy between Whites and Blacks.
He also wanted to see whether progress had been made as a result of various medical organizations and the Association of American Medical Colleges undertaking initiatives to increase workforce diversity. There has been “very, very little” progress, he said.
Norma Poll-Hunter, PhD, the AAMC’s senior director of workforce diversity, said Dr. Ly’s report “was not surprising at all.”
The AAMC reported in 2014 that the number of Black men who apply to and matriculate into medical schools has been declining since 1978. That year, there were 1,410 Black male applicants and 542 Black enrollees. In 2014, there were 1,337 applicants and 515 enrollees.
Since 2014, Black male enrollment has increased slightly, rising from 2.4% in the 2014-2015 school year to 2.9% in the 2019-2020 year, the AAMC reported last year.
In addition, among other historically underrepresented minorities, “we really have seen very small progress” despite the increase in the number of medical schools, Dr. Poll-Hunter said in an interview.
The AAMC and the National Medical Association consider the lack of Black male applicants and matriculants to be a national crisis. The two groups started an alliance in 2020 aimed at finding ways to amplify and support Black men’s interest in medicine and the biomedical sciences and to “develop systems-based solutions to address exclusionary practices that create barriers for Black men and prevent them from having equitable opportunities to successfully enroll in medical school.”
Solutions include requiring medical school admissions committees and application screeners to undergo implicit bias awareness and mitigation training, adopting holistic admissions reviews, and incentivizing institutions of higher learning to partner with Black communities in urban and rural school systems to establish K-12 health sciences academies, said NMA President Leon McDougle, MD, MPH.
“There are the systems factors, and racism is a big one that we have to tackle,” said Dr. Poll-Hunter.
Diversity isn’t just about numbers, said Dr. McDougle, a professor of family medicine and associate dean for diversity and inclusion at Ohio State University, Columbus. “We know that medical school graduates who are African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native are more likely to serve those communities as practicing physicians.
“The COVID-19 pandemic highlighted the urgent need for more African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native physicians,” he said. “Inadequate access to culturally competent care has exacerbated existing health disparities, resulting in death and hospitalization rates up to three to four times the rates of European American or White people.”
Dr. Poll-Hunter also said that studies have shown that diversity in the classroom creates a more enriched learning environment and increases civic mindedness and cognitive complexity, “as well as helps us understand people who are different than ourselves.”
The diversity goal “is not about quotas, it’s about excellence,” she said. “We know that there’s talent that exists, and we want to make sure that everyone has an opportunity to be successful.”
Dr. Ly has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
HHS proposes overturning Title X ‘gag’ rule
The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.
HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.
Medical organizations and reproductive health specialists lauded the move.
“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”
“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”
HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.
HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.
The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.
The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.
The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.
The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”
Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.
March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.
“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.
The Title X program does not pay for abortions, however.
The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”
The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”
The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.
The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.
Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.
A version of this article first appeared on Medscape.com.
The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.
HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.
Medical organizations and reproductive health specialists lauded the move.
“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”
“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”
HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.
HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.
The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.
The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.
The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.
The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”
Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.
March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.
“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.
The Title X program does not pay for abortions, however.
The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”
The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”
The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.
The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.
Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.
A version of this article first appeared on Medscape.com.
The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.
HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.
Medical organizations and reproductive health specialists lauded the move.
“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”
“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”
HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.
HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.
The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.
The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.
The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.
The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”
Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.
March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.
“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.
The Title X program does not pay for abortions, however.
The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”
The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”
The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.
The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.
Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.
A version of this article first appeared on Medscape.com.
Feds let Illinois extend postpartum Medicaid coverage: HHS encourages other states to follow suit
The federal government has approved a request by Illinois to extend postpartum Medicaid coverage to a full year from the current standard of 60 days.
Health & Human Services Secretary Xavier Becerra announced the approval at a press briefing on April 12, noting that it was occurring during Black Maternal Health Week. The coverage extension is aimed at decreasing maternal morbidity and mortality, particularly among women of color.
Black women are two times more likely to die from a pregnancy-related cause than White women, according to HHS. Mr. Becerra noted that, in the United States, 52% of pregnancy-related deaths take place up to 1 year post partum, and that in Illinois the figure is 80%.
“The continuity of coverage available through this action will help new mothers manage chronic conditions like hypertension and diabetes, and it will provide access to behavioral health and other mental health care services,” he said.
Continuing Medicaid coverage for new mothers has been backed by the American Medical Association, is a priority of the American College of Obstetricians and Gynecologists, and has been promoted by Republicans and Democrats in Congress and state legislatures.
Illinois is the first state to seek and win approval to extend its Medicaid coverage from the current 60-days postbirth requirement. The program was granted through an existing section 1115 waiver program. It begins today and is authorized through Dec. 31, 2025. The state estimates that some 2,500 women with incomes up to 208% of the federal poverty level will receive the year of continuous Medicaid coverage. Illinois will evaluate whether the extension improves women’s health and if it benefits the Medicaid program overall.
However, the recently passed coronavirus rescue package creates a new process that lets states more easily expand postpartum coverage, but they must act by April 2022. Mr. Becerra said the federal government is encouraging more states to follow Illinois’ lead in extending postpartum eligibility by taking advantage of the new process.
States won’t get extra money – they will receive the regular per capita–based federal match if they extend Medicaid coverage through this pathway. Even so, Mr. Becerra said there has been much interest.
“I hope that we begin to see states not only express interest but actually submit their proposals on how they would do this,” Mr. Becerra said.
Medicaid has become one of the key providers of maternal health care in the United States, as it covers 4 in 10 births, according to the Kaiser Family Foundation. But postpartum coverage after the 60-day federal requirement is a patchwork. In 38 states (plus Washington, D.C.) that have expanded Medicaid under the Affordable Care Act, mothers who earn up to 138% of the federal poverty level can continue on Medicaid; for those who earn more than that, they can get coverage through the ACA.
In the 12 states that did not expand Medicaid, new mothers have to seek Medicaid coverage after 60 days as parents, and the income limits are strict. In Texas, for example, a married mother with a newborn loses Medicaid coverage 2 months after giving birth if she and her partner have an annual income above $3,733, reports the Kaiser Family Foundation.
Coverage disruptions are harmful to mothers, said Mr. Becerra. HHS data shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months postpartum and that disruptions in coverage often lead to delayed care and less preventive care.
Mr. Becerra also announced that the Health Resources and Services Administration will make $12 million available over 4 years for the Rural Maternity and Obstetrics Management Strategies program. Applicants for the new funds will be required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.
A version of this article first appeared on Medscape.com.
The federal government has approved a request by Illinois to extend postpartum Medicaid coverage to a full year from the current standard of 60 days.
Health & Human Services Secretary Xavier Becerra announced the approval at a press briefing on April 12, noting that it was occurring during Black Maternal Health Week. The coverage extension is aimed at decreasing maternal morbidity and mortality, particularly among women of color.
Black women are two times more likely to die from a pregnancy-related cause than White women, according to HHS. Mr. Becerra noted that, in the United States, 52% of pregnancy-related deaths take place up to 1 year post partum, and that in Illinois the figure is 80%.
“The continuity of coverage available through this action will help new mothers manage chronic conditions like hypertension and diabetes, and it will provide access to behavioral health and other mental health care services,” he said.
Continuing Medicaid coverage for new mothers has been backed by the American Medical Association, is a priority of the American College of Obstetricians and Gynecologists, and has been promoted by Republicans and Democrats in Congress and state legislatures.
Illinois is the first state to seek and win approval to extend its Medicaid coverage from the current 60-days postbirth requirement. The program was granted through an existing section 1115 waiver program. It begins today and is authorized through Dec. 31, 2025. The state estimates that some 2,500 women with incomes up to 208% of the federal poverty level will receive the year of continuous Medicaid coverage. Illinois will evaluate whether the extension improves women’s health and if it benefits the Medicaid program overall.
However, the recently passed coronavirus rescue package creates a new process that lets states more easily expand postpartum coverage, but they must act by April 2022. Mr. Becerra said the federal government is encouraging more states to follow Illinois’ lead in extending postpartum eligibility by taking advantage of the new process.
States won’t get extra money – they will receive the regular per capita–based federal match if they extend Medicaid coverage through this pathway. Even so, Mr. Becerra said there has been much interest.
“I hope that we begin to see states not only express interest but actually submit their proposals on how they would do this,” Mr. Becerra said.
Medicaid has become one of the key providers of maternal health care in the United States, as it covers 4 in 10 births, according to the Kaiser Family Foundation. But postpartum coverage after the 60-day federal requirement is a patchwork. In 38 states (plus Washington, D.C.) that have expanded Medicaid under the Affordable Care Act, mothers who earn up to 138% of the federal poverty level can continue on Medicaid; for those who earn more than that, they can get coverage through the ACA.
In the 12 states that did not expand Medicaid, new mothers have to seek Medicaid coverage after 60 days as parents, and the income limits are strict. In Texas, for example, a married mother with a newborn loses Medicaid coverage 2 months after giving birth if she and her partner have an annual income above $3,733, reports the Kaiser Family Foundation.
Coverage disruptions are harmful to mothers, said Mr. Becerra. HHS data shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months postpartum and that disruptions in coverage often lead to delayed care and less preventive care.
Mr. Becerra also announced that the Health Resources and Services Administration will make $12 million available over 4 years for the Rural Maternity and Obstetrics Management Strategies program. Applicants for the new funds will be required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.
A version of this article first appeared on Medscape.com.
The federal government has approved a request by Illinois to extend postpartum Medicaid coverage to a full year from the current standard of 60 days.
Health & Human Services Secretary Xavier Becerra announced the approval at a press briefing on April 12, noting that it was occurring during Black Maternal Health Week. The coverage extension is aimed at decreasing maternal morbidity and mortality, particularly among women of color.
Black women are two times more likely to die from a pregnancy-related cause than White women, according to HHS. Mr. Becerra noted that, in the United States, 52% of pregnancy-related deaths take place up to 1 year post partum, and that in Illinois the figure is 80%.
“The continuity of coverage available through this action will help new mothers manage chronic conditions like hypertension and diabetes, and it will provide access to behavioral health and other mental health care services,” he said.
Continuing Medicaid coverage for new mothers has been backed by the American Medical Association, is a priority of the American College of Obstetricians and Gynecologists, and has been promoted by Republicans and Democrats in Congress and state legislatures.
Illinois is the first state to seek and win approval to extend its Medicaid coverage from the current 60-days postbirth requirement. The program was granted through an existing section 1115 waiver program. It begins today and is authorized through Dec. 31, 2025. The state estimates that some 2,500 women with incomes up to 208% of the federal poverty level will receive the year of continuous Medicaid coverage. Illinois will evaluate whether the extension improves women’s health and if it benefits the Medicaid program overall.
However, the recently passed coronavirus rescue package creates a new process that lets states more easily expand postpartum coverage, but they must act by April 2022. Mr. Becerra said the federal government is encouraging more states to follow Illinois’ lead in extending postpartum eligibility by taking advantage of the new process.
States won’t get extra money – they will receive the regular per capita–based federal match if they extend Medicaid coverage through this pathway. Even so, Mr. Becerra said there has been much interest.
“I hope that we begin to see states not only express interest but actually submit their proposals on how they would do this,” Mr. Becerra said.
Medicaid has become one of the key providers of maternal health care in the United States, as it covers 4 in 10 births, according to the Kaiser Family Foundation. But postpartum coverage after the 60-day federal requirement is a patchwork. In 38 states (plus Washington, D.C.) that have expanded Medicaid under the Affordable Care Act, mothers who earn up to 138% of the federal poverty level can continue on Medicaid; for those who earn more than that, they can get coverage through the ACA.
In the 12 states that did not expand Medicaid, new mothers have to seek Medicaid coverage after 60 days as parents, and the income limits are strict. In Texas, for example, a married mother with a newborn loses Medicaid coverage 2 months after giving birth if she and her partner have an annual income above $3,733, reports the Kaiser Family Foundation.
Coverage disruptions are harmful to mothers, said Mr. Becerra. HHS data shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months postpartum and that disruptions in coverage often lead to delayed care and less preventive care.
Mr. Becerra also announced that the Health Resources and Services Administration will make $12 million available over 4 years for the Rural Maternity and Obstetrics Management Strategies program. Applicants for the new funds will be required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.
A version of this article first appeared on Medscape.com.
Detroit cardiologists prevail in retaliation suit against Tenet
After losing at arbitration, as well as in federal court and partially on appeal, Tenet Healthcare is refusing to comment on whether it will continue to battle two Detroit-area cardiologists whom the hospital corporation fired from leadership positions in 2018.
The cardiologists were awarded $10.6 million from an arbitrator, who found that Detroit Medical Center (DMC) and its parent, Tenet, retaliated against Amir Kaki, MD, and Mahir Elder, MD, when the doctors repeatedly reported concerns about patient safety and potential fraud.
The award was made public when it was upheld in federal court in February 2021 and was partially upheld on appeal days later by the Sixth Circuit Court of Appeals.
The Sixth Circuit Court of Appeals denied Tenet’s motion to bar Dr. Kaki and Dr. Elder from returning to work with full privileges but said it would continue to consider the overall appeal. Tenet argued that it needed to keep the cardiologists out of DMC because of “behavioral issues.”
Those allegations are “complete nonsense,” said the cardiologists’ attorney, Deborah Gordon, of Bloomfield Hills, Mich. The alleged problems regarding Dr. Kaki and Dr. Elder were examined by an arbitrator, who “found that all of those complaints were unsubstantiated,” Ms. Gordon said in an interview.
In her final ruling, arbitrator Mary Beth Kelly wrote, “Both Kaki and Elder testified credibly regarding the humiliation, the emotional distress and the reputational damage they have suffered to their national reputations.”
A spokesperson for Tenet and DMC said the organizations had no further comment.
Ms. Gordon said she believes it’s unlikely Tenet will prevail in the Sixth Circuit Court of Appeals, noting that the court already had examined the merits of the case to determine whether Dr. Kaki and Dr. Elder could go back to work. In the court’s opinion, shared in an interview, nothing substantive in Tenet’s appeal prevented the doctors from returning to the hospital, she said.
As of now, both cardiologists have 1 year of privileges at the DMC-affiliated hospitals. Only Dr. Kaki has returned to work, said Ms. Gordon. Neither is speaking to the media, she said.
From respected to reviled
Both Dr. Kaki and Dr. Elder were respected at DMC, according to court filings.
Dr. Kaki was recruited from Weill Cornell Medical College by a Detroit mayor because of his expertise in interventional cardiology. He had staff privileges at DMC beginning in 2012 and was a clinical associate professor and assistant program director of the interventional cardiology fellowship program at Wayne State University in Detroit. He became director of the cardiac catheterization services unit at the new DMC Heart Hospital at Harper-Hutzel Hospital in Detroit in 2014, and 4 years later was appointed director of the facility’s anticoagulation clinic. Dr. Kaki was nominated for and completed Tenet’s Leadership Academy.
Dr. Elder was a clinical professor and assistant fellowship director at Wayne State and was a clinical professor of medicine at Michigan State University. Beginning in 2008, he held directorships at DMC’s cardiac care unit, ambulatory services program, cardiac CT angiogram program, PERT program, and carotid stenting program. Dr. Elder was voted Teacher of the Year for 10 consecutive years by DMC cardiology fellows.
The two doctors aimed high when it came to quality of care and ethics, according to legal filings. Over the years, Dr. Kaki and Dr. Elder repeatedly reported what they considered to be egregious violations of patient safety and of Medicare and Medicaid fraud laws. The clinicians complained about unsterile surgical instruments and the removal of a stat laboratory from the cardiac catheterization unit, noting that the removal would cause delays that would endanger lives.
At peer review meetings, as well as with administrators, they flagged colleagues who they said were performing unnecessary or dangerous procedures solely to generate revenue. At least one doctor falsified records of such a procedure after a patient died, alleged Dr. Kaki and Dr. Elder.
Tenet hired outside attorneys in the fall of 2018, telling Dr. Kaki and Dr. Elder that the legal team would investigate their complaints. However, the investigation was a sham: Filings allege that the investigation was used instead to build a case against Dr. Kaki and Dr. Elder and that Tenet leadership used the inquiry to pressure the cardiologists to resign.
They refused, and in October 2018, they were fired from their leadership positions. DMC and Tenet then held a press conference in which they said that Dr. Kaki and Dr. Elder had been dismissed for “violations” of the “Tenet Standards of Conduct.”
Cardiologists push back
Dr. Kaki and Dr. Elder, however, were not willing to just walk away. They sought reinstatement through an internal DMC appeals panel of their peers. The clinicians who participated on that panel ruled that neither firing was justified.
But DMC’s governing board voted in April 2020 to deny privileges to both cardiologists.
Tenet continued a campaign of retaliation, according to legal filings, by not paying the clinicians for being on call, by removing them from peer review committees, and by prohibiting them from teaching or giving lectures. DMC refused to give Dr. Kaki his personnel record, stating that he was never an employee when he was in the leadership position. Dr. Kaki sued, and a Wayne County Circuit Court judge granted his motion to get his file. DMC and Tenet appealed that ruling but lost.
Eventually, Ms. Gordon sued DMC and Tenet in federal court, alleging the hospital retaliated against the cardiologists, interfered with their ability to earn a living by disparaging them, refused to renew their privileges in 2019, and committed violations under multiple federal and state statutes, including the False Claims Act and the Fair Labor Standards Act.
Tenet successfully argued that the case should go to arbitration.
Arbitrator Mary Beth Kelly, though, ruled in December 2020 that the vast majority of the complaints compiled against the two physicians in the external investigation were not verified or supported and that Tenet and DMC had retaliated against Dr. Kaki and Dr. Elder.
For that harm, Ms. Kelly awarded each clinician $1 million, according to the final ruling shared in an interview.
In addition, she awarded Dr. Kaki $2.3 million in back pay and 2 years of front pay (slightly more than $1 million). She awarded Dr. Elder $2.3 million in back pay and $2.1 million in front pay for 4 years, noting that “his strong association with DMC may make it more difficult for him to successfully transition into the situation he enjoyed prior to termination and nonrenewal.”
The clinicians also were awarded legal fees of $623,816 and court costs of $110,673.
“Wholesale retrial”
To secure the award, Ms. Gordon had to seek a ruling from the U.S. District Court for Eastern Michigan. Tenet asked that court to overturn the arbitrator’s award and to keep it sealed from public view.
In his February ruling, Judge Arthur J. Tarnow wrote that Tenet and DMC “not only attempt to relitigate the legal issues, but also endeavor to introduce a factual counternarrative unmoored from the findings of the Arbitrator and including evidence which the Arbitrator specifically found inadmissible.
“By seeking a wholesale retrial of their case after forcing plaintiffs to arbitrate in the first place,” Tenet and DMC basically ignored the goal of arbitration, which is to relieve judicial congestion and provide a faster and cheaper alternative to litigation, he wrote.
Judge Tarnow also warned Tenet and DMC against taking too long to reinstate privileges for Dr. Kaki and Dr. Elder. If they “continue to delay the restoration of plaintiffs’ privileges in the hopes of a different result on appeal, they will be in violation of this Order,” said the judge.
Tenet, however, tried one more avenue to block the cardiologists from getting privileges, appealing to the Sixth Circuit, which again ordered the company to grant the 1-year privileges.
A version of this article first appeared on Medscape.com.
After losing at arbitration, as well as in federal court and partially on appeal, Tenet Healthcare is refusing to comment on whether it will continue to battle two Detroit-area cardiologists whom the hospital corporation fired from leadership positions in 2018.
The cardiologists were awarded $10.6 million from an arbitrator, who found that Detroit Medical Center (DMC) and its parent, Tenet, retaliated against Amir Kaki, MD, and Mahir Elder, MD, when the doctors repeatedly reported concerns about patient safety and potential fraud.
The award was made public when it was upheld in federal court in February 2021 and was partially upheld on appeal days later by the Sixth Circuit Court of Appeals.
The Sixth Circuit Court of Appeals denied Tenet’s motion to bar Dr. Kaki and Dr. Elder from returning to work with full privileges but said it would continue to consider the overall appeal. Tenet argued that it needed to keep the cardiologists out of DMC because of “behavioral issues.”
Those allegations are “complete nonsense,” said the cardiologists’ attorney, Deborah Gordon, of Bloomfield Hills, Mich. The alleged problems regarding Dr. Kaki and Dr. Elder were examined by an arbitrator, who “found that all of those complaints were unsubstantiated,” Ms. Gordon said in an interview.
In her final ruling, arbitrator Mary Beth Kelly wrote, “Both Kaki and Elder testified credibly regarding the humiliation, the emotional distress and the reputational damage they have suffered to their national reputations.”
A spokesperson for Tenet and DMC said the organizations had no further comment.
Ms. Gordon said she believes it’s unlikely Tenet will prevail in the Sixth Circuit Court of Appeals, noting that the court already had examined the merits of the case to determine whether Dr. Kaki and Dr. Elder could go back to work. In the court’s opinion, shared in an interview, nothing substantive in Tenet’s appeal prevented the doctors from returning to the hospital, she said.
As of now, both cardiologists have 1 year of privileges at the DMC-affiliated hospitals. Only Dr. Kaki has returned to work, said Ms. Gordon. Neither is speaking to the media, she said.
From respected to reviled
Both Dr. Kaki and Dr. Elder were respected at DMC, according to court filings.
Dr. Kaki was recruited from Weill Cornell Medical College by a Detroit mayor because of his expertise in interventional cardiology. He had staff privileges at DMC beginning in 2012 and was a clinical associate professor and assistant program director of the interventional cardiology fellowship program at Wayne State University in Detroit. He became director of the cardiac catheterization services unit at the new DMC Heart Hospital at Harper-Hutzel Hospital in Detroit in 2014, and 4 years later was appointed director of the facility’s anticoagulation clinic. Dr. Kaki was nominated for and completed Tenet’s Leadership Academy.
Dr. Elder was a clinical professor and assistant fellowship director at Wayne State and was a clinical professor of medicine at Michigan State University. Beginning in 2008, he held directorships at DMC’s cardiac care unit, ambulatory services program, cardiac CT angiogram program, PERT program, and carotid stenting program. Dr. Elder was voted Teacher of the Year for 10 consecutive years by DMC cardiology fellows.
The two doctors aimed high when it came to quality of care and ethics, according to legal filings. Over the years, Dr. Kaki and Dr. Elder repeatedly reported what they considered to be egregious violations of patient safety and of Medicare and Medicaid fraud laws. The clinicians complained about unsterile surgical instruments and the removal of a stat laboratory from the cardiac catheterization unit, noting that the removal would cause delays that would endanger lives.
At peer review meetings, as well as with administrators, they flagged colleagues who they said were performing unnecessary or dangerous procedures solely to generate revenue. At least one doctor falsified records of such a procedure after a patient died, alleged Dr. Kaki and Dr. Elder.
Tenet hired outside attorneys in the fall of 2018, telling Dr. Kaki and Dr. Elder that the legal team would investigate their complaints. However, the investigation was a sham: Filings allege that the investigation was used instead to build a case against Dr. Kaki and Dr. Elder and that Tenet leadership used the inquiry to pressure the cardiologists to resign.
They refused, and in October 2018, they were fired from their leadership positions. DMC and Tenet then held a press conference in which they said that Dr. Kaki and Dr. Elder had been dismissed for “violations” of the “Tenet Standards of Conduct.”
Cardiologists push back
Dr. Kaki and Dr. Elder, however, were not willing to just walk away. They sought reinstatement through an internal DMC appeals panel of their peers. The clinicians who participated on that panel ruled that neither firing was justified.
But DMC’s governing board voted in April 2020 to deny privileges to both cardiologists.
Tenet continued a campaign of retaliation, according to legal filings, by not paying the clinicians for being on call, by removing them from peer review committees, and by prohibiting them from teaching or giving lectures. DMC refused to give Dr. Kaki his personnel record, stating that he was never an employee when he was in the leadership position. Dr. Kaki sued, and a Wayne County Circuit Court judge granted his motion to get his file. DMC and Tenet appealed that ruling but lost.
Eventually, Ms. Gordon sued DMC and Tenet in federal court, alleging the hospital retaliated against the cardiologists, interfered with their ability to earn a living by disparaging them, refused to renew their privileges in 2019, and committed violations under multiple federal and state statutes, including the False Claims Act and the Fair Labor Standards Act.
Tenet successfully argued that the case should go to arbitration.
Arbitrator Mary Beth Kelly, though, ruled in December 2020 that the vast majority of the complaints compiled against the two physicians in the external investigation were not verified or supported and that Tenet and DMC had retaliated against Dr. Kaki and Dr. Elder.
For that harm, Ms. Kelly awarded each clinician $1 million, according to the final ruling shared in an interview.
In addition, she awarded Dr. Kaki $2.3 million in back pay and 2 years of front pay (slightly more than $1 million). She awarded Dr. Elder $2.3 million in back pay and $2.1 million in front pay for 4 years, noting that “his strong association with DMC may make it more difficult for him to successfully transition into the situation he enjoyed prior to termination and nonrenewal.”
The clinicians also were awarded legal fees of $623,816 and court costs of $110,673.
“Wholesale retrial”
To secure the award, Ms. Gordon had to seek a ruling from the U.S. District Court for Eastern Michigan. Tenet asked that court to overturn the arbitrator’s award and to keep it sealed from public view.
In his February ruling, Judge Arthur J. Tarnow wrote that Tenet and DMC “not only attempt to relitigate the legal issues, but also endeavor to introduce a factual counternarrative unmoored from the findings of the Arbitrator and including evidence which the Arbitrator specifically found inadmissible.
“By seeking a wholesale retrial of their case after forcing plaintiffs to arbitrate in the first place,” Tenet and DMC basically ignored the goal of arbitration, which is to relieve judicial congestion and provide a faster and cheaper alternative to litigation, he wrote.
Judge Tarnow also warned Tenet and DMC against taking too long to reinstate privileges for Dr. Kaki and Dr. Elder. If they “continue to delay the restoration of plaintiffs’ privileges in the hopes of a different result on appeal, they will be in violation of this Order,” said the judge.
Tenet, however, tried one more avenue to block the cardiologists from getting privileges, appealing to the Sixth Circuit, which again ordered the company to grant the 1-year privileges.
A version of this article first appeared on Medscape.com.
After losing at arbitration, as well as in federal court and partially on appeal, Tenet Healthcare is refusing to comment on whether it will continue to battle two Detroit-area cardiologists whom the hospital corporation fired from leadership positions in 2018.
The cardiologists were awarded $10.6 million from an arbitrator, who found that Detroit Medical Center (DMC) and its parent, Tenet, retaliated against Amir Kaki, MD, and Mahir Elder, MD, when the doctors repeatedly reported concerns about patient safety and potential fraud.
The award was made public when it was upheld in federal court in February 2021 and was partially upheld on appeal days later by the Sixth Circuit Court of Appeals.
The Sixth Circuit Court of Appeals denied Tenet’s motion to bar Dr. Kaki and Dr. Elder from returning to work with full privileges but said it would continue to consider the overall appeal. Tenet argued that it needed to keep the cardiologists out of DMC because of “behavioral issues.”
Those allegations are “complete nonsense,” said the cardiologists’ attorney, Deborah Gordon, of Bloomfield Hills, Mich. The alleged problems regarding Dr. Kaki and Dr. Elder were examined by an arbitrator, who “found that all of those complaints were unsubstantiated,” Ms. Gordon said in an interview.
In her final ruling, arbitrator Mary Beth Kelly wrote, “Both Kaki and Elder testified credibly regarding the humiliation, the emotional distress and the reputational damage they have suffered to their national reputations.”
A spokesperson for Tenet and DMC said the organizations had no further comment.
Ms. Gordon said she believes it’s unlikely Tenet will prevail in the Sixth Circuit Court of Appeals, noting that the court already had examined the merits of the case to determine whether Dr. Kaki and Dr. Elder could go back to work. In the court’s opinion, shared in an interview, nothing substantive in Tenet’s appeal prevented the doctors from returning to the hospital, she said.
As of now, both cardiologists have 1 year of privileges at the DMC-affiliated hospitals. Only Dr. Kaki has returned to work, said Ms. Gordon. Neither is speaking to the media, she said.
From respected to reviled
Both Dr. Kaki and Dr. Elder were respected at DMC, according to court filings.
Dr. Kaki was recruited from Weill Cornell Medical College by a Detroit mayor because of his expertise in interventional cardiology. He had staff privileges at DMC beginning in 2012 and was a clinical associate professor and assistant program director of the interventional cardiology fellowship program at Wayne State University in Detroit. He became director of the cardiac catheterization services unit at the new DMC Heart Hospital at Harper-Hutzel Hospital in Detroit in 2014, and 4 years later was appointed director of the facility’s anticoagulation clinic. Dr. Kaki was nominated for and completed Tenet’s Leadership Academy.
Dr. Elder was a clinical professor and assistant fellowship director at Wayne State and was a clinical professor of medicine at Michigan State University. Beginning in 2008, he held directorships at DMC’s cardiac care unit, ambulatory services program, cardiac CT angiogram program, PERT program, and carotid stenting program. Dr. Elder was voted Teacher of the Year for 10 consecutive years by DMC cardiology fellows.
The two doctors aimed high when it came to quality of care and ethics, according to legal filings. Over the years, Dr. Kaki and Dr. Elder repeatedly reported what they considered to be egregious violations of patient safety and of Medicare and Medicaid fraud laws. The clinicians complained about unsterile surgical instruments and the removal of a stat laboratory from the cardiac catheterization unit, noting that the removal would cause delays that would endanger lives.
At peer review meetings, as well as with administrators, they flagged colleagues who they said were performing unnecessary or dangerous procedures solely to generate revenue. At least one doctor falsified records of such a procedure after a patient died, alleged Dr. Kaki and Dr. Elder.
Tenet hired outside attorneys in the fall of 2018, telling Dr. Kaki and Dr. Elder that the legal team would investigate their complaints. However, the investigation was a sham: Filings allege that the investigation was used instead to build a case against Dr. Kaki and Dr. Elder and that Tenet leadership used the inquiry to pressure the cardiologists to resign.
They refused, and in October 2018, they were fired from their leadership positions. DMC and Tenet then held a press conference in which they said that Dr. Kaki and Dr. Elder had been dismissed for “violations” of the “Tenet Standards of Conduct.”
Cardiologists push back
Dr. Kaki and Dr. Elder, however, were not willing to just walk away. They sought reinstatement through an internal DMC appeals panel of their peers. The clinicians who participated on that panel ruled that neither firing was justified.
But DMC’s governing board voted in April 2020 to deny privileges to both cardiologists.
Tenet continued a campaign of retaliation, according to legal filings, by not paying the clinicians for being on call, by removing them from peer review committees, and by prohibiting them from teaching or giving lectures. DMC refused to give Dr. Kaki his personnel record, stating that he was never an employee when he was in the leadership position. Dr. Kaki sued, and a Wayne County Circuit Court judge granted his motion to get his file. DMC and Tenet appealed that ruling but lost.
Eventually, Ms. Gordon sued DMC and Tenet in federal court, alleging the hospital retaliated against the cardiologists, interfered with their ability to earn a living by disparaging them, refused to renew their privileges in 2019, and committed violations under multiple federal and state statutes, including the False Claims Act and the Fair Labor Standards Act.
Tenet successfully argued that the case should go to arbitration.
Arbitrator Mary Beth Kelly, though, ruled in December 2020 that the vast majority of the complaints compiled against the two physicians in the external investigation were not verified or supported and that Tenet and DMC had retaliated against Dr. Kaki and Dr. Elder.
For that harm, Ms. Kelly awarded each clinician $1 million, according to the final ruling shared in an interview.
In addition, she awarded Dr. Kaki $2.3 million in back pay and 2 years of front pay (slightly more than $1 million). She awarded Dr. Elder $2.3 million in back pay and $2.1 million in front pay for 4 years, noting that “his strong association with DMC may make it more difficult for him to successfully transition into the situation he enjoyed prior to termination and nonrenewal.”
The clinicians also were awarded legal fees of $623,816 and court costs of $110,673.
“Wholesale retrial”
To secure the award, Ms. Gordon had to seek a ruling from the U.S. District Court for Eastern Michigan. Tenet asked that court to overturn the arbitrator’s award and to keep it sealed from public view.
In his February ruling, Judge Arthur J. Tarnow wrote that Tenet and DMC “not only attempt to relitigate the legal issues, but also endeavor to introduce a factual counternarrative unmoored from the findings of the Arbitrator and including evidence which the Arbitrator specifically found inadmissible.
“By seeking a wholesale retrial of their case after forcing plaintiffs to arbitrate in the first place,” Tenet and DMC basically ignored the goal of arbitration, which is to relieve judicial congestion and provide a faster and cheaper alternative to litigation, he wrote.
Judge Tarnow also warned Tenet and DMC against taking too long to reinstate privileges for Dr. Kaki and Dr. Elder. If they “continue to delay the restoration of plaintiffs’ privileges in the hopes of a different result on appeal, they will be in violation of this Order,” said the judge.
Tenet, however, tried one more avenue to block the cardiologists from getting privileges, appealing to the Sixth Circuit, which again ordered the company to grant the 1-year privileges.
A version of this article first appeared on Medscape.com.
Senate confirms Murthy as Surgeon General
Seven Republicans – Bill Cassidy (La.), Susan Collins (Maine), Roger Marshall (Kan.), Susan Murkowski (Alaska), Rob Portman (Ohio), Mitt Romney (Utah), and Dan Sullivan (Alaska) – joined all the Democrats and independents in the 57-43 vote approving Dr. Murthy’s nomination.
Dr. Murthy, 43, previously served as the 19th Surgeon General, from December 2014 to April 2017, when he was asked to step down by President Donald J. Trump.
Surgeons General serve 4-year terms.
During his first tenure, Dr. Murthy issued the first-ever Surgeon General’s report on the crisis of addiction and issued a call to action to doctors to help battle the opioid crisis.
When Dr. Murthy was nominated by President-elect Joseph R. Biden Jr. in December, he was acting as cochair of the incoming administration’s COVID-19 transition advisory board.
Early in 2020, before the COVID-19 pandemic hit, Dr. Murthy published a timely book: “Together: The Healing Power of Human Connection in a Sometimes Lonely World”.
He earned his bachelor’s degree from Harvard and his MD and MBA degrees from Yale. He completed his internal medicine residency at Brigham and Women’s Hospital in Boston, where he also served as a hospitalist, and later joined Harvard Medical School as a faculty member in internal medicine.
He is married to Alice Chen, MD. The couple have two children.
A version of this article first appeared on WebMD.com.
Seven Republicans – Bill Cassidy (La.), Susan Collins (Maine), Roger Marshall (Kan.), Susan Murkowski (Alaska), Rob Portman (Ohio), Mitt Romney (Utah), and Dan Sullivan (Alaska) – joined all the Democrats and independents in the 57-43 vote approving Dr. Murthy’s nomination.
Dr. Murthy, 43, previously served as the 19th Surgeon General, from December 2014 to April 2017, when he was asked to step down by President Donald J. Trump.
Surgeons General serve 4-year terms.
During his first tenure, Dr. Murthy issued the first-ever Surgeon General’s report on the crisis of addiction and issued a call to action to doctors to help battle the opioid crisis.
When Dr. Murthy was nominated by President-elect Joseph R. Biden Jr. in December, he was acting as cochair of the incoming administration’s COVID-19 transition advisory board.
Early in 2020, before the COVID-19 pandemic hit, Dr. Murthy published a timely book: “Together: The Healing Power of Human Connection in a Sometimes Lonely World”.
He earned his bachelor’s degree from Harvard and his MD and MBA degrees from Yale. He completed his internal medicine residency at Brigham and Women’s Hospital in Boston, where he also served as a hospitalist, and later joined Harvard Medical School as a faculty member in internal medicine.
He is married to Alice Chen, MD. The couple have two children.
A version of this article first appeared on WebMD.com.
Seven Republicans – Bill Cassidy (La.), Susan Collins (Maine), Roger Marshall (Kan.), Susan Murkowski (Alaska), Rob Portman (Ohio), Mitt Romney (Utah), and Dan Sullivan (Alaska) – joined all the Democrats and independents in the 57-43 vote approving Dr. Murthy’s nomination.
Dr. Murthy, 43, previously served as the 19th Surgeon General, from December 2014 to April 2017, when he was asked to step down by President Donald J. Trump.
Surgeons General serve 4-year terms.
During his first tenure, Dr. Murthy issued the first-ever Surgeon General’s report on the crisis of addiction and issued a call to action to doctors to help battle the opioid crisis.
When Dr. Murthy was nominated by President-elect Joseph R. Biden Jr. in December, he was acting as cochair of the incoming administration’s COVID-19 transition advisory board.
Early in 2020, before the COVID-19 pandemic hit, Dr. Murthy published a timely book: “Together: The Healing Power of Human Connection in a Sometimes Lonely World”.
He earned his bachelor’s degree from Harvard and his MD and MBA degrees from Yale. He completed his internal medicine residency at Brigham and Women’s Hospital in Boston, where he also served as a hospitalist, and later joined Harvard Medical School as a faculty member in internal medicine.
He is married to Alice Chen, MD. The couple have two children.
A version of this article first appeared on WebMD.com.
Journal to retract psych paper after plagiarism allegations, editor steps down
A medical journal is retracting a paper after a psychiatrist alleged that the managing editor closely copied and published her withdrawn work and claimed it for his own.
In addition, the managing editor, Gary VandenBos, PhD, has resigned at the journal’s request, according to an email sent to the paper’s original author, psychiatrist Amy Barnhorst, MD, vice chair for community mental health at the University of California, Davis, and coauthor and UC Davis colleague Rocco Pallin, MPH.
Dr. Barnhorst shared emails – from the journal’s publisher, Springer Publishing Company, and from the editor in chief, Morgan Sammons, PhD – with this news organization.
The retraction is the end of a saga that began when Dr. Barnhorst and Dr. Pallin submitted a paper, at Dr. VandenBos’s request, to the Journal of Health Service Psychology, published by Springer.
As previously reported by this news organization, Dr. Barnhorst and Dr. Pallin eventually decided to withdraw the paper and were later notified by Dr. VandenBos that he’d published a similar article under his own authorship. Michael O. Miller, a retired judge who trained as a psychologist, was listed as a coauthor.
The two women – acknowledged experts in the article’s subject matter on how physicians can talk to patients about gun violence – immediately notified Dr. Sammons and Springer Publishing when they saw the published piece, saying they believed it plagiarized their original submission.
According to the e-mail Springer sent to Dr. Barnhorst, the publisher investigated and said that it would “be retracting the article shortly.”
The retraction notice will state: “The Editor in Chief and the authors, Dr. VandenBos and Mr. Miller, have retracted this article, as it significantly overlaps with an unpublished manuscript by Amy Barnhorst and Rocco Pallin.” It also states that “[Dr.] VandenBos accepts full responsibility for the overlap.”
The original article will still be available, but it will be marked as “retracted” and feature a link to the retraction notice.
Dr. Barnhorst, who garnered at least 40,000 likes when she tweeted about the alleged theft of her work, said in an interview that she and Dr. Pallin are “glad to see that the investigation is complete and the retraction has been issued.”
“At least we can now submit it to a new journal in a version that appropriately represents our work and expertise,” said Dr. Barnhorst. “I still have no idea how or why this happened, nor how much of it was intentional and on whose part, but I guess I never will!”
Editor removed
When contacted by this news organization to comment on the retraction and removal of Dr. VandenBos as managing editor, Dr. Sammons said it was not possible because, “I treat such correspondence as confidential.”
Dr. Sammons said he could “confirm that our investigation is reaching its conclusion and my colleagues at Springer Nature would be happy to contact you when we can provide a further update.”
Springer spokesperson Anne Korn also would not comment beyond saying, “The conclusion of our investigation is still in progress and may take a little additional time.”
In the letter sent to Dr. Barnhorst and Dr. Pallin, Dr. Sammons said he had “asked for and accepted the resignation of Dr. VandenBos,” and that the resignation will be announced “in the upcoming print issue of our journal.”
Dr. Sammons said he also notified the dean of the University of Arizona College of Law that Mr. Miller, who held a position at the school, was not aware of the original submission by the two women. Even so, the school suspended Mr. Miller’s academic appointment, according to Dr. Sammons’ letter.
The editor in chief also said that, while “[Dr.] VandenBos’ errors were substantial and had substantial consequences, my investigation did not find any intent to plagiarize your work.”
He apologized again to Dr. Barnhorst and Dr. Pallin, though, adding, “I and my associate editors have initiated a revision of our publications processes to ensure that errors such as the above do not occur in the future, and I apologize again that this lapse affected you and your scholarly work.”
A version of this article first appeared on Medscape.com.
A medical journal is retracting a paper after a psychiatrist alleged that the managing editor closely copied and published her withdrawn work and claimed it for his own.
In addition, the managing editor, Gary VandenBos, PhD, has resigned at the journal’s request, according to an email sent to the paper’s original author, psychiatrist Amy Barnhorst, MD, vice chair for community mental health at the University of California, Davis, and coauthor and UC Davis colleague Rocco Pallin, MPH.
Dr. Barnhorst shared emails – from the journal’s publisher, Springer Publishing Company, and from the editor in chief, Morgan Sammons, PhD – with this news organization.
The retraction is the end of a saga that began when Dr. Barnhorst and Dr. Pallin submitted a paper, at Dr. VandenBos’s request, to the Journal of Health Service Psychology, published by Springer.
As previously reported by this news organization, Dr. Barnhorst and Dr. Pallin eventually decided to withdraw the paper and were later notified by Dr. VandenBos that he’d published a similar article under his own authorship. Michael O. Miller, a retired judge who trained as a psychologist, was listed as a coauthor.
The two women – acknowledged experts in the article’s subject matter on how physicians can talk to patients about gun violence – immediately notified Dr. Sammons and Springer Publishing when they saw the published piece, saying they believed it plagiarized their original submission.
According to the e-mail Springer sent to Dr. Barnhorst, the publisher investigated and said that it would “be retracting the article shortly.”
The retraction notice will state: “The Editor in Chief and the authors, Dr. VandenBos and Mr. Miller, have retracted this article, as it significantly overlaps with an unpublished manuscript by Amy Barnhorst and Rocco Pallin.” It also states that “[Dr.] VandenBos accepts full responsibility for the overlap.”
The original article will still be available, but it will be marked as “retracted” and feature a link to the retraction notice.
Dr. Barnhorst, who garnered at least 40,000 likes when she tweeted about the alleged theft of her work, said in an interview that she and Dr. Pallin are “glad to see that the investigation is complete and the retraction has been issued.”
“At least we can now submit it to a new journal in a version that appropriately represents our work and expertise,” said Dr. Barnhorst. “I still have no idea how or why this happened, nor how much of it was intentional and on whose part, but I guess I never will!”
Editor removed
When contacted by this news organization to comment on the retraction and removal of Dr. VandenBos as managing editor, Dr. Sammons said it was not possible because, “I treat such correspondence as confidential.”
Dr. Sammons said he could “confirm that our investigation is reaching its conclusion and my colleagues at Springer Nature would be happy to contact you when we can provide a further update.”
Springer spokesperson Anne Korn also would not comment beyond saying, “The conclusion of our investigation is still in progress and may take a little additional time.”
In the letter sent to Dr. Barnhorst and Dr. Pallin, Dr. Sammons said he had “asked for and accepted the resignation of Dr. VandenBos,” and that the resignation will be announced “in the upcoming print issue of our journal.”
Dr. Sammons said he also notified the dean of the University of Arizona College of Law that Mr. Miller, who held a position at the school, was not aware of the original submission by the two women. Even so, the school suspended Mr. Miller’s academic appointment, according to Dr. Sammons’ letter.
The editor in chief also said that, while “[Dr.] VandenBos’ errors were substantial and had substantial consequences, my investigation did not find any intent to plagiarize your work.”
He apologized again to Dr. Barnhorst and Dr. Pallin, though, adding, “I and my associate editors have initiated a revision of our publications processes to ensure that errors such as the above do not occur in the future, and I apologize again that this lapse affected you and your scholarly work.”
A version of this article first appeared on Medscape.com.
A medical journal is retracting a paper after a psychiatrist alleged that the managing editor closely copied and published her withdrawn work and claimed it for his own.
In addition, the managing editor, Gary VandenBos, PhD, has resigned at the journal’s request, according to an email sent to the paper’s original author, psychiatrist Amy Barnhorst, MD, vice chair for community mental health at the University of California, Davis, and coauthor and UC Davis colleague Rocco Pallin, MPH.
Dr. Barnhorst shared emails – from the journal’s publisher, Springer Publishing Company, and from the editor in chief, Morgan Sammons, PhD – with this news organization.
The retraction is the end of a saga that began when Dr. Barnhorst and Dr. Pallin submitted a paper, at Dr. VandenBos’s request, to the Journal of Health Service Psychology, published by Springer.
As previously reported by this news organization, Dr. Barnhorst and Dr. Pallin eventually decided to withdraw the paper and were later notified by Dr. VandenBos that he’d published a similar article under his own authorship. Michael O. Miller, a retired judge who trained as a psychologist, was listed as a coauthor.
The two women – acknowledged experts in the article’s subject matter on how physicians can talk to patients about gun violence – immediately notified Dr. Sammons and Springer Publishing when they saw the published piece, saying they believed it plagiarized their original submission.
According to the e-mail Springer sent to Dr. Barnhorst, the publisher investigated and said that it would “be retracting the article shortly.”
The retraction notice will state: “The Editor in Chief and the authors, Dr. VandenBos and Mr. Miller, have retracted this article, as it significantly overlaps with an unpublished manuscript by Amy Barnhorst and Rocco Pallin.” It also states that “[Dr.] VandenBos accepts full responsibility for the overlap.”
The original article will still be available, but it will be marked as “retracted” and feature a link to the retraction notice.
Dr. Barnhorst, who garnered at least 40,000 likes when she tweeted about the alleged theft of her work, said in an interview that she and Dr. Pallin are “glad to see that the investigation is complete and the retraction has been issued.”
“At least we can now submit it to a new journal in a version that appropriately represents our work and expertise,” said Dr. Barnhorst. “I still have no idea how or why this happened, nor how much of it was intentional and on whose part, but I guess I never will!”
Editor removed
When contacted by this news organization to comment on the retraction and removal of Dr. VandenBos as managing editor, Dr. Sammons said it was not possible because, “I treat such correspondence as confidential.”
Dr. Sammons said he could “confirm that our investigation is reaching its conclusion and my colleagues at Springer Nature would be happy to contact you when we can provide a further update.”
Springer spokesperson Anne Korn also would not comment beyond saying, “The conclusion of our investigation is still in progress and may take a little additional time.”
In the letter sent to Dr. Barnhorst and Dr. Pallin, Dr. Sammons said he had “asked for and accepted the resignation of Dr. VandenBos,” and that the resignation will be announced “in the upcoming print issue of our journal.”
Dr. Sammons said he also notified the dean of the University of Arizona College of Law that Mr. Miller, who held a position at the school, was not aware of the original submission by the two women. Even so, the school suspended Mr. Miller’s academic appointment, according to Dr. Sammons’ letter.
The editor in chief also said that, while “[Dr.] VandenBos’ errors were substantial and had substantial consequences, my investigation did not find any intent to plagiarize your work.”
He apologized again to Dr. Barnhorst and Dr. Pallin, though, adding, “I and my associate editors have initiated a revision of our publications processes to ensure that errors such as the above do not occur in the future, and I apologize again that this lapse affected you and your scholarly work.”
A version of this article first appeared on Medscape.com.
Rollout of COVID-19 monoclonal antibodies lacked unified plan: expert panel
Monoclonal antibodies (mAbs) to treat COVID-19 are in ample supply, but scant evidence on their effectiveness, paltry reimbursement, and a lack of a planned infrastructure to administer them has led to major underutilization of these potentially useful therapies, according to a new report from The National Academies of Sciences, Engineering, and Medicine.
The 35-page report described missed opportunities to work with states and hospitals to establish trust with clinicians and patients and to set up an infusion infrastructure to funnel patients to sites. Though the therapies still need more study, they should be an option for the right patient at the right time, said the National Academies experts in their report, Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
“No potentially eligible patient should be left uninformed, and no eligible patient should be denied access, if there are doses available and the patient and doctor agree it is a reasonable course,” they concluded. The report also noted that underuse, and in particular underuse by members of vulnerable and underserved communities “raises concerns about exacerbating already dramatic health disparities.”
The federal government has spent $375 million on Eli Lilly’s bamlanivimab and $450 million on Regeneron’s casirivimab plus imdevimab cocktail, and agreed last month to spend as much as $2.6 billion more on up to 1.25 million additional doses.
Some 785,000 doses of the two therapeutics have been produced and about a half million have been distributed to states. But about three quarters have gone unused. The U.S. Department of Health & Human Services has launched an online treatment locater to try to spur interest in the therapies.
But the federal government hasn’t addressed some of the basic barriers to use of the monoclonals, said the National Academies experts.
“Lack of awareness, interest, and confidence in COVID-19 mAb therapies among patients and providers are major issues,” they said in the report. Patients who have tested positive might not want to travel to an infusion site, while others might not have access to health care or only seek such treatments when it’s too late. Some who are eligible might not have the time, resources, or transportation to go to a site and sit through a 2-hour treatment.
In addition, “the supply and availability of infusion centers and personnel was identified as a greater constraint than the supply of COVID-19 mAbs,” said the report.
Cost a big impediment
While the federal government has covered the cost of the therapies, hospitals and patients inevitably incur related costs.
“The fragmented payment system in the United States has not provided adequate support to cover the spectrum of costs associated with COVID-19 mAb therapies,” said the report. That is compounded by chronic underfunding and restrictions on federally qualified health centers for community health, the report said.
Patients may have to pay for testing, office visits, follow-up appointments, transportation to and from the infusion site, and potentially a copay for the administration of the drug.
While Medicare pays hospitals $309 per infusion, that might not be enough, especially if a hospital or other site had to build out a new infusion center, the report shows. For clinicians, the administrative payment under Medicare Part B does “not cover the total practice cost to furnish infusion services, resulting in a substantial cost-reimbursement disparity,” the report states.
In addition, there are no specific codes for observing patients during the 2-hour procedure.
“The established Medicare payment rate for furnishing COVID-19 mAb therapies does not cover the cost associated with coordinating care for those patients, nor does it justify the risk and opportunity costs associated with investing in infrastructure modifications to safely integrate COVID-19 patients into existing facilities or building temporary infusion capacity,” the report concluded.
More data needed
The U.S. Food and Drug Administration issued emergency-use authorizations (EUAs) for the two monoclonal therapies based on phase 2 trial data, and that leaves a lot of uncertainty, noted the National Academies.
In trials, both therapies reduced COVID-19-related hospitalizations and emergency room visits within 28 days after treatment among patients at high risk of progression, compared with those who received placebo.
But clinicians aren’t certain about who should use the monoclonals, said the report. The underuse has in turn led to trouble collecting data – either through ongoing trials or in starting new trials.
The National Academies recommended allocating the monoclonal antibodies in a way that would give rise to better data collection to inform clinicians. Payers could support the development of a core data platform or registry, or Medicare could develop pilot trials, said the report.
Lilly and UnitedHealth Group are collaborating on a study in high-risk Medicare patients, according to Reuters. Patients who test positive will be given bamlanivimab at home.
“Building infusion capacity and developing the evidence base about the impact of COVID-19 mAbs on clinical outcomes other than hospitalization, including mortality, are the most promising strategies for increasing effective utilization moving forward,” stated the National Academies report.
A version of this article first appeared on Medscape.com.
Monoclonal antibodies (mAbs) to treat COVID-19 are in ample supply, but scant evidence on their effectiveness, paltry reimbursement, and a lack of a planned infrastructure to administer them has led to major underutilization of these potentially useful therapies, according to a new report from The National Academies of Sciences, Engineering, and Medicine.
The 35-page report described missed opportunities to work with states and hospitals to establish trust with clinicians and patients and to set up an infusion infrastructure to funnel patients to sites. Though the therapies still need more study, they should be an option for the right patient at the right time, said the National Academies experts in their report, Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
“No potentially eligible patient should be left uninformed, and no eligible patient should be denied access, if there are doses available and the patient and doctor agree it is a reasonable course,” they concluded. The report also noted that underuse, and in particular underuse by members of vulnerable and underserved communities “raises concerns about exacerbating already dramatic health disparities.”
The federal government has spent $375 million on Eli Lilly’s bamlanivimab and $450 million on Regeneron’s casirivimab plus imdevimab cocktail, and agreed last month to spend as much as $2.6 billion more on up to 1.25 million additional doses.
Some 785,000 doses of the two therapeutics have been produced and about a half million have been distributed to states. But about three quarters have gone unused. The U.S. Department of Health & Human Services has launched an online treatment locater to try to spur interest in the therapies.
But the federal government hasn’t addressed some of the basic barriers to use of the monoclonals, said the National Academies experts.
“Lack of awareness, interest, and confidence in COVID-19 mAb therapies among patients and providers are major issues,” they said in the report. Patients who have tested positive might not want to travel to an infusion site, while others might not have access to health care or only seek such treatments when it’s too late. Some who are eligible might not have the time, resources, or transportation to go to a site and sit through a 2-hour treatment.
In addition, “the supply and availability of infusion centers and personnel was identified as a greater constraint than the supply of COVID-19 mAbs,” said the report.
Cost a big impediment
While the federal government has covered the cost of the therapies, hospitals and patients inevitably incur related costs.
“The fragmented payment system in the United States has not provided adequate support to cover the spectrum of costs associated with COVID-19 mAb therapies,” said the report. That is compounded by chronic underfunding and restrictions on federally qualified health centers for community health, the report said.
Patients may have to pay for testing, office visits, follow-up appointments, transportation to and from the infusion site, and potentially a copay for the administration of the drug.
While Medicare pays hospitals $309 per infusion, that might not be enough, especially if a hospital or other site had to build out a new infusion center, the report shows. For clinicians, the administrative payment under Medicare Part B does “not cover the total practice cost to furnish infusion services, resulting in a substantial cost-reimbursement disparity,” the report states.
In addition, there are no specific codes for observing patients during the 2-hour procedure.
“The established Medicare payment rate for furnishing COVID-19 mAb therapies does not cover the cost associated with coordinating care for those patients, nor does it justify the risk and opportunity costs associated with investing in infrastructure modifications to safely integrate COVID-19 patients into existing facilities or building temporary infusion capacity,” the report concluded.
More data needed
The U.S. Food and Drug Administration issued emergency-use authorizations (EUAs) for the two monoclonal therapies based on phase 2 trial data, and that leaves a lot of uncertainty, noted the National Academies.
In trials, both therapies reduced COVID-19-related hospitalizations and emergency room visits within 28 days after treatment among patients at high risk of progression, compared with those who received placebo.
But clinicians aren’t certain about who should use the monoclonals, said the report. The underuse has in turn led to trouble collecting data – either through ongoing trials or in starting new trials.
The National Academies recommended allocating the monoclonal antibodies in a way that would give rise to better data collection to inform clinicians. Payers could support the development of a core data platform or registry, or Medicare could develop pilot trials, said the report.
Lilly and UnitedHealth Group are collaborating on a study in high-risk Medicare patients, according to Reuters. Patients who test positive will be given bamlanivimab at home.
“Building infusion capacity and developing the evidence base about the impact of COVID-19 mAbs on clinical outcomes other than hospitalization, including mortality, are the most promising strategies for increasing effective utilization moving forward,” stated the National Academies report.
A version of this article first appeared on Medscape.com.
Monoclonal antibodies (mAbs) to treat COVID-19 are in ample supply, but scant evidence on their effectiveness, paltry reimbursement, and a lack of a planned infrastructure to administer them has led to major underutilization of these potentially useful therapies, according to a new report from The National Academies of Sciences, Engineering, and Medicine.
The 35-page report described missed opportunities to work with states and hospitals to establish trust with clinicians and patients and to set up an infusion infrastructure to funnel patients to sites. Though the therapies still need more study, they should be an option for the right patient at the right time, said the National Academies experts in their report, Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
“No potentially eligible patient should be left uninformed, and no eligible patient should be denied access, if there are doses available and the patient and doctor agree it is a reasonable course,” they concluded. The report also noted that underuse, and in particular underuse by members of vulnerable and underserved communities “raises concerns about exacerbating already dramatic health disparities.”
The federal government has spent $375 million on Eli Lilly’s bamlanivimab and $450 million on Regeneron’s casirivimab plus imdevimab cocktail, and agreed last month to spend as much as $2.6 billion more on up to 1.25 million additional doses.
Some 785,000 doses of the two therapeutics have been produced and about a half million have been distributed to states. But about three quarters have gone unused. The U.S. Department of Health & Human Services has launched an online treatment locater to try to spur interest in the therapies.
But the federal government hasn’t addressed some of the basic barriers to use of the monoclonals, said the National Academies experts.
“Lack of awareness, interest, and confidence in COVID-19 mAb therapies among patients and providers are major issues,” they said in the report. Patients who have tested positive might not want to travel to an infusion site, while others might not have access to health care or only seek such treatments when it’s too late. Some who are eligible might not have the time, resources, or transportation to go to a site and sit through a 2-hour treatment.
In addition, “the supply and availability of infusion centers and personnel was identified as a greater constraint than the supply of COVID-19 mAbs,” said the report.
Cost a big impediment
While the federal government has covered the cost of the therapies, hospitals and patients inevitably incur related costs.
“The fragmented payment system in the United States has not provided adequate support to cover the spectrum of costs associated with COVID-19 mAb therapies,” said the report. That is compounded by chronic underfunding and restrictions on federally qualified health centers for community health, the report said.
Patients may have to pay for testing, office visits, follow-up appointments, transportation to and from the infusion site, and potentially a copay for the administration of the drug.
While Medicare pays hospitals $309 per infusion, that might not be enough, especially if a hospital or other site had to build out a new infusion center, the report shows. For clinicians, the administrative payment under Medicare Part B does “not cover the total practice cost to furnish infusion services, resulting in a substantial cost-reimbursement disparity,” the report states.
In addition, there are no specific codes for observing patients during the 2-hour procedure.
“The established Medicare payment rate for furnishing COVID-19 mAb therapies does not cover the cost associated with coordinating care for those patients, nor does it justify the risk and opportunity costs associated with investing in infrastructure modifications to safely integrate COVID-19 patients into existing facilities or building temporary infusion capacity,” the report concluded.
More data needed
The U.S. Food and Drug Administration issued emergency-use authorizations (EUAs) for the two monoclonal therapies based on phase 2 trial data, and that leaves a lot of uncertainty, noted the National Academies.
In trials, both therapies reduced COVID-19-related hospitalizations and emergency room visits within 28 days after treatment among patients at high risk of progression, compared with those who received placebo.
But clinicians aren’t certain about who should use the monoclonals, said the report. The underuse has in turn led to trouble collecting data – either through ongoing trials or in starting new trials.
The National Academies recommended allocating the monoclonal antibodies in a way that would give rise to better data collection to inform clinicians. Payers could support the development of a core data platform or registry, or Medicare could develop pilot trials, said the report.
Lilly and UnitedHealth Group are collaborating on a study in high-risk Medicare patients, according to Reuters. Patients who test positive will be given bamlanivimab at home.
“Building infusion capacity and developing the evidence base about the impact of COVID-19 mAbs on clinical outcomes other than hospitalization, including mortality, are the most promising strategies for increasing effective utilization moving forward,” stated the National Academies report.
A version of this article first appeared on Medscape.com.