Health 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.

In 2016, results from the LEADER trial of liraglutide in patients with type 2 diabetes helped jump-start awareness of the potential role of this new class of drugs, the glucagonlike peptide–1 receptor agonists, for reducing cardiovascular events. The randomized, placebo-controlled trial enrolled more than 9000 patients at more than 400 sites in over 30 countries, and took nearly 6 years from the start of patient enrollment to publication of the landmark results.

In December 2020, an independent team of researchers published results from a study with a design identical to LEADER, but used data that came not from a massive, global, years-long trial but from already-existing numbers culled from three large U.S. insurance claim databases. The result of this emulation using real-world data was virtually identical to what the actual trial showed, replicating both the direction and statistical significance of the original finding of the randomized, controlled trial (RCT).

What if research proved that this sort of RCT emulation could reliably be done on a regular basis? What might it mean for regulatory decisions on drugs and devices that historically have been based entirely on efficacy evidence from RCTs?
 

Making the most of a sea of observational data

Medicine in the United States has become increasingly awash in a sea of observational data collected from sources that include electronic health records, insurance claims, and increasingly, personal-health monitoring devices.

The Food and Drug Administration is now in the process of trying to figure out how it can legitimately harness this tsunami of real-world data to make efficacy decisions, essentially creating a new category of evidence to complement traditional data from randomized trials. It’s an opportunity that agency staff and their outside advisors have been keen to seize, especially given the soaring cost of prospective, randomized trials.

Recognition of this untapped resource in part led to a key initiative, among many others, included in the 21st Century Cures Act, passed in December 2016. Among the Act’s mandates was that, by the end of 2021, the FDA would issue guidance on when drug sponsors could use real-world evidence (RWE) to either help support a new indication for an already approved drug or help satisfy postapproval study requirements.

The initiative recognizes that this approach is not appropriate for initial drug approvals, which remain exclusively reliant on evidence from RCTs. Instead, it seems best suited to support expanding indications for already approved drugs.

Although FDA staff have made progress in identifying the challenges and broadening their understanding of how to best handle real-world data that come from observing patients in routine practice, agency leaders stress that this complex issue will likely not be fully resolved by their guidance to be published later this year. The FDA released a draft of the guidance in May 2019.
 

Can RWE be ‘credible and reliable?’

“Whether observational, nonrandomized data can become credible enough to use is what we’re talking about. These are possibilities that need to be explained and better understood,” said Robert Temple, MD, deputy director for clinical science of the FDA Center for Drug Evaluation and Research.

“Since the 1970s, the FDA has recognized historical controls as legitimate, so it’s possible [for RWE] to be credible. The big test is when is it credible and reliable enough [to assess efficacy]?” wondered Dr. Temple during a 2-day workshop on the topic held mid-February and organized by Duke University’s Margolis Center for Health Policy.

“We’re approaching an inflection point regarding how observational studies are generated and used, but our evidentiary standards will not lower, and it will be a case-by-case decision” by the agency as they review future RWE submissions, said John Concato, MD, the FDA’s associate director for real-world evidence, during the workshop.

“We are working toward guidance development, but also looking down the road to what we need to do to enable this,” said Dr. Concato. “It’s a complicated issue. If it was easy, it would have already been fixed.” He added that the agency will likely release a “portfolio” of guidance for submitting real-world data and RWE. Real-world data are raw information that, when analyzed, become RWE.

In short, the FDA seems headed toward guidance that won’t spell out a pathway that guarantees success using RWE but will at least open the door to consideration of this unprecedented application.
 

Not like flipping a switch

The guidance will not activate acceptance of RWE all at once. “It’s not like a light switch,” cautioned Adam Kroetsch, MPP, research director for biomedical innovation and regulatory policy at Duke-Margolis in Washington, D.C. “It’s an evolutionary process,” and the upcoming guidance will provide “just a little more clarity” on what sorts of best practices using RWE the FDA will find persuasive. “It’s hard for the FDA to clearly say what it’s looking for until they see some good examples,” Dr. Kroetsch said in an interview.

What will change is that drug sponsors can submit using RWE, and the FDA “will have a more open-minded view,” predicted Sebastian Schneeweiss, MD, ScD, a workshop participant and chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital in Boston. “For the first time, a law required [the FDA] to take a serious look” at observational data for efficacy assessment.

“The FDA has had a bias against using RWE for evidence of efficacy but has long used it to understand drug safety. Now the FDA is trying to wrap its arms around how to best use RWE” for efficacy decisions, said Joseph S. Ross, MD, another workshop participant and professor of medicine and public health at Yale University, New Haven, Conn.

The agency’s cautious approach is reassuring, Dr. Ross noted in an interview. “There was worry that the 21st Century Cures Act would open the door to allowing real-world data to be used in ways that weren’t very reliable. Very quickly, the FDA started trying to figure out the best ways to use these data in reasonable ways.”
 

Duplicating RCTs with RWE

To help better understand the potential use of RWE, the FDA sponsored several demonstration projects. Researchers presented results from three of these projects during the workshop in February. All three examined whether RWE, plugged into the design of an actual RCT, can produce roughly similar results when similar patients are used.

A generally consistent finding from the three demonstration projects was that “when the data are fit for purpose” the emulated or duplicated analyses with RWE “can come to similar conclusions” as the actual RCTs, said Dr. Schneeweiss, who leads one of the demonstration projects, RCT DUPLICATE.

At the workshop he reported results from RWE duplications of 20 different RCTs using insurance claims data from U.S. patients. The findings came from 10 duplications already reported in Circulation in December 2020 (including a duplication of the LEADER trial), and an additional 10 as yet unpublished RCT duplications. In the next few months, the researchers intend to assess a final group of 10 more RCT duplications.

Workshop participants also presented results from two other FDA demonstration projects: the OPERAND program run by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; and the CERSI program based at Yale and the Mayo Clinic in Rochester, Minn. Both are smaller in scale than RCT DUPLICATE, incorporate lab data in addition to claims data, and in some cases test how well RWE can emulate RCTs that are not yet completed.

Collectively, results from these demonstration projects suggest that RWE can successfully emulate the results of an RCT, said Dr. Ross, a coinvestigator on the CERSI study. But the CERSI findings also highlighted how an RCT can fall short of clinical relevance.

“One of our most important findings was that RCTs don’t always represent real-world practice,” he said. His group attempted to replicate the 5,000-patient GRADE trial of four different drug options added to metformin in patients with type 2 diabetes. One of the four options included insulin glargine (Lantus), and the attempt to emulate the study with RWE hit the bump that no relevant real-world patients in their US claims database actually received the formulation.

That means the GRADE trial “is almost meaningless. It doesn’t reflect real-world practice,” Dr. Ross noted.

Results from the three demonstration projects “highlight the gaps we still have,” summed up Dr. Kroetsch. “They show where we need better data” from observational sources that function as well as data from RCTs.

Still, the demonstration project results are “an important step forward in establishing the validity of real-world evidence,” commented David Kerr, MBChB, an endocrinologist and director of research and innovation at the Sansum Diabetes Research Institute in Santa Barbara, Calif.
 

‘Target trials’ tether RWE

The target trial approach to designing an observational study is a key tool for boosting reliability and applicability of the results. The idea is to create a well-designed trial that could be the basis for a conventional RCT, and then use observational data to flesh out the target trial instead of collecting data from prospectively enrolled patients.

Designing observational studies that emulate target trials allows causal inferences, said Miguel A. Hernán, MD, DrPH, a professor of biostatistics and epidemiology at the Harvard School of Public Health, Boston. Plugging real-world data into the framework of an appropriately designed target trial substantially cuts the risk of a biased analysis, he explained during the workshop.

However, the approach has limitations. The target trial must be a pragmatic trial, and the approach does not work for placebo-controlled trials, although it can accommodate a usual-care control arm. It also usually precludes patient blinding, testing treatments not used in routine practice, and close monitoring of patients in ways that are uncommon in usual care.

The target trial approach received broad endorsement during the workshop as the future for observational studies destined for efficacy consideration by the FDA.

“The idea of prespecifying a target trial is a really fantastic place to start,” commented Robert Ball, MD, deputy director of the FDA Office of Surveillance and Epidemiology. “There is still a whole set of questions once the trial is prespecified, but prespecification would be a fantastic step forward,” he said during the workshop.

Participants also endorsed other important steps to boost the value of observational studies for regulatory reviews, including preregistering the study on a site such as clinicaltrials.gov; being fully transparent about the origins of observational data; using data that match the needs of the target trial; not reviewing the data in advance to avoid cherry picking and gaming the analysis; and reporting neutral or negative results when they occur, something often not currently done for observational analyses.

But although there was clear progress and much agreement among thought leaders at the workshop, FDA representatives stressed caution in moving forward.
 

“No easy answer”

“With more experience, we can learn what works and what doesn’t work in generating valid results from observational studies,” said Dr. Concato. “Although the observational results have upside potential, we need to learn more. There is no easy answer, no checklist for fit-for-use data, no off-the-shelf study design, and no ideal analytic method.”

Dr. Concato acknowledged that the FDA’s goal is clear given the 2016 legislation. “The FDA is embracing our obligations under the 21st Century Cures Act to evaluate use of real-world data and real-world evidence.”

He also suggested that researchers “shy away from a false dichotomy of RCTs or observational studies and instead think about how and when RCTs and observational studies can be designed and conducted to yield trustworthy results.” Dr. Concato’s solution: “a taxonomy of interventional or noninterventional studies.”

“The FDA is under enormous pressure to embrace real-world evidence, both because of the economics of running RCTs and because of the availability of new observational data from electronic health records, wearable devices, claims, etc.,” said Dr. Kerr, who did not participate in the workshop but coauthored an editorial that calls for using real-world data in regulatory decisions for drugs and devices for diabetes. These factors create an “irresistible force” spurring the FDA to consider observational, noninterventional data.

“I think the FDA really wants this to go forward,” Dr. Kerr added in an interview. “The FDA keeps telling us that clinical trials do not have enough women or patients from minority groups. Real-world data is a way to address that. This will not be the death of RCTs, but this work shines a light on the deficiencies of RCTs and how the deficiencies can be dealt with.”

Dr. Kroetsch has reported no relevant financial relationships. Dr. Schneeweiss has reported being a consultant to and holding equity in Aetion and receiving research funding from the FDA. Dr. Ross has reported receiving research funding from the FDA, Johnson & Johnson, and Medtronic. Dr. Hernán has reported being a consultant for Cytel. Dr. Kerr has reported being a consultant for Ascensia, EOFlow, Lifecare, Merck, Novo Nordisk, Roche Diagnostics, and Voluntis. Dr. Temple, Dr. Concato, and Dr. Ball are FDA employees.

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

In 2016, results from the LEADER trial of liraglutide in patients with type 2 diabetes helped jump-start awareness of the potential role of this new class of drugs, the glucagonlike peptide–1 receptor agonists, for reducing cardiovascular events. The randomized, placebo-controlled trial enrolled more than 9000 patients at more than 400 sites in over 30 countries, and took nearly 6 years from the start of patient enrollment to publication of the landmark results.

In December 2020, an independent team of researchers published results from a study with a design identical to LEADER, but used data that came not from a massive, global, years-long trial but from already-existing numbers culled from three large U.S. insurance claim databases. The result of this emulation using real-world data was virtually identical to what the actual trial showed, replicating both the direction and statistical significance of the original finding of the randomized, controlled trial (RCT).

What if research proved that this sort of RCT emulation could reliably be done on a regular basis? What might it mean for regulatory decisions on drugs and devices that historically have been based entirely on efficacy evidence from RCTs?
 

Making the most of a sea of observational data

Medicine in the United States has become increasingly awash in a sea of observational data collected from sources that include electronic health records, insurance claims, and increasingly, personal-health monitoring devices.

The Food and Drug Administration is now in the process of trying to figure out how it can legitimately harness this tsunami of real-world data to make efficacy decisions, essentially creating a new category of evidence to complement traditional data from randomized trials. It’s an opportunity that agency staff and their outside advisors have been keen to seize, especially given the soaring cost of prospective, randomized trials.

Recognition of this untapped resource in part led to a key initiative, among many others, included in the 21st Century Cures Act, passed in December 2016. Among the Act’s mandates was that, by the end of 2021, the FDA would issue guidance on when drug sponsors could use real-world evidence (RWE) to either help support a new indication for an already approved drug or help satisfy postapproval study requirements.

The initiative recognizes that this approach is not appropriate for initial drug approvals, which remain exclusively reliant on evidence from RCTs. Instead, it seems best suited to support expanding indications for already approved drugs.

Although FDA staff have made progress in identifying the challenges and broadening their understanding of how to best handle real-world data that come from observing patients in routine practice, agency leaders stress that this complex issue will likely not be fully resolved by their guidance to be published later this year. The FDA released a draft of the guidance in May 2019.
 

Can RWE be ‘credible and reliable?’

“Whether observational, nonrandomized data can become credible enough to use is what we’re talking about. These are possibilities that need to be explained and better understood,” said Robert Temple, MD, deputy director for clinical science of the FDA Center for Drug Evaluation and Research.

“Since the 1970s, the FDA has recognized historical controls as legitimate, so it’s possible [for RWE] to be credible. The big test is when is it credible and reliable enough [to assess efficacy]?” wondered Dr. Temple during a 2-day workshop on the topic held mid-February and organized by Duke University’s Margolis Center for Health Policy.

“We’re approaching an inflection point regarding how observational studies are generated and used, but our evidentiary standards will not lower, and it will be a case-by-case decision” by the agency as they review future RWE submissions, said John Concato, MD, the FDA’s associate director for real-world evidence, during the workshop.

“We are working toward guidance development, but also looking down the road to what we need to do to enable this,” said Dr. Concato. “It’s a complicated issue. If it was easy, it would have already been fixed.” He added that the agency will likely release a “portfolio” of guidance for submitting real-world data and RWE. Real-world data are raw information that, when analyzed, become RWE.

In short, the FDA seems headed toward guidance that won’t spell out a pathway that guarantees success using RWE but will at least open the door to consideration of this unprecedented application.
 

Not like flipping a switch

The guidance will not activate acceptance of RWE all at once. “It’s not like a light switch,” cautioned Adam Kroetsch, MPP, research director for biomedical innovation and regulatory policy at Duke-Margolis in Washington, D.C. “It’s an evolutionary process,” and the upcoming guidance will provide “just a little more clarity” on what sorts of best practices using RWE the FDA will find persuasive. “It’s hard for the FDA to clearly say what it’s looking for until they see some good examples,” Dr. Kroetsch said in an interview.

What will change is that drug sponsors can submit using RWE, and the FDA “will have a more open-minded view,” predicted Sebastian Schneeweiss, MD, ScD, a workshop participant and chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital in Boston. “For the first time, a law required [the FDA] to take a serious look” at observational data for efficacy assessment.

“The FDA has had a bias against using RWE for evidence of efficacy but has long used it to understand drug safety. Now the FDA is trying to wrap its arms around how to best use RWE” for efficacy decisions, said Joseph S. Ross, MD, another workshop participant and professor of medicine and public health at Yale University, New Haven, Conn.

The agency’s cautious approach is reassuring, Dr. Ross noted in an interview. “There was worry that the 21st Century Cures Act would open the door to allowing real-world data to be used in ways that weren’t very reliable. Very quickly, the FDA started trying to figure out the best ways to use these data in reasonable ways.”
 

Duplicating RCTs with RWE

To help better understand the potential use of RWE, the FDA sponsored several demonstration projects. Researchers presented results from three of these projects during the workshop in February. All three examined whether RWE, plugged into the design of an actual RCT, can produce roughly similar results when similar patients are used.

A generally consistent finding from the three demonstration projects was that “when the data are fit for purpose” the emulated or duplicated analyses with RWE “can come to similar conclusions” as the actual RCTs, said Dr. Schneeweiss, who leads one of the demonstration projects, RCT DUPLICATE.

At the workshop he reported results from RWE duplications of 20 different RCTs using insurance claims data from U.S. patients. The findings came from 10 duplications already reported in Circulation in December 2020 (including a duplication of the LEADER trial), and an additional 10 as yet unpublished RCT duplications. In the next few months, the researchers intend to assess a final group of 10 more RCT duplications.

Workshop participants also presented results from two other FDA demonstration projects: the OPERAND program run by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; and the CERSI program based at Yale and the Mayo Clinic in Rochester, Minn. Both are smaller in scale than RCT DUPLICATE, incorporate lab data in addition to claims data, and in some cases test how well RWE can emulate RCTs that are not yet completed.

Collectively, results from these demonstration projects suggest that RWE can successfully emulate the results of an RCT, said Dr. Ross, a coinvestigator on the CERSI study. But the CERSI findings also highlighted how an RCT can fall short of clinical relevance.

“One of our most important findings was that RCTs don’t always represent real-world practice,” he said. His group attempted to replicate the 5,000-patient GRADE trial of four different drug options added to metformin in patients with type 2 diabetes. One of the four options included insulin glargine (Lantus), and the attempt to emulate the study with RWE hit the bump that no relevant real-world patients in their US claims database actually received the formulation.

That means the GRADE trial “is almost meaningless. It doesn’t reflect real-world practice,” Dr. Ross noted.

Results from the three demonstration projects “highlight the gaps we still have,” summed up Dr. Kroetsch. “They show where we need better data” from observational sources that function as well as data from RCTs.

Still, the demonstration project results are “an important step forward in establishing the validity of real-world evidence,” commented David Kerr, MBChB, an endocrinologist and director of research and innovation at the Sansum Diabetes Research Institute in Santa Barbara, Calif.
 

‘Target trials’ tether RWE

The target trial approach to designing an observational study is a key tool for boosting reliability and applicability of the results. The idea is to create a well-designed trial that could be the basis for a conventional RCT, and then use observational data to flesh out the target trial instead of collecting data from prospectively enrolled patients.

Designing observational studies that emulate target trials allows causal inferences, said Miguel A. Hernán, MD, DrPH, a professor of biostatistics and epidemiology at the Harvard School of Public Health, Boston. Plugging real-world data into the framework of an appropriately designed target trial substantially cuts the risk of a biased analysis, he explained during the workshop.

However, the approach has limitations. The target trial must be a pragmatic trial, and the approach does not work for placebo-controlled trials, although it can accommodate a usual-care control arm. It also usually precludes patient blinding, testing treatments not used in routine practice, and close monitoring of patients in ways that are uncommon in usual care.

The target trial approach received broad endorsement during the workshop as the future for observational studies destined for efficacy consideration by the FDA.

“The idea of prespecifying a target trial is a really fantastic place to start,” commented Robert Ball, MD, deputy director of the FDA Office of Surveillance and Epidemiology. “There is still a whole set of questions once the trial is prespecified, but prespecification would be a fantastic step forward,” he said during the workshop.

Participants also endorsed other important steps to boost the value of observational studies for regulatory reviews, including preregistering the study on a site such as clinicaltrials.gov; being fully transparent about the origins of observational data; using data that match the needs of the target trial; not reviewing the data in advance to avoid cherry picking and gaming the analysis; and reporting neutral or negative results when they occur, something often not currently done for observational analyses.

But although there was clear progress and much agreement among thought leaders at the workshop, FDA representatives stressed caution in moving forward.
 

“No easy answer”

“With more experience, we can learn what works and what doesn’t work in generating valid results from observational studies,” said Dr. Concato. “Although the observational results have upside potential, we need to learn more. There is no easy answer, no checklist for fit-for-use data, no off-the-shelf study design, and no ideal analytic method.”

Dr. Concato acknowledged that the FDA’s goal is clear given the 2016 legislation. “The FDA is embracing our obligations under the 21st Century Cures Act to evaluate use of real-world data and real-world evidence.”

He also suggested that researchers “shy away from a false dichotomy of RCTs or observational studies and instead think about how and when RCTs and observational studies can be designed and conducted to yield trustworthy results.” Dr. Concato’s solution: “a taxonomy of interventional or noninterventional studies.”

“The FDA is under enormous pressure to embrace real-world evidence, both because of the economics of running RCTs and because of the availability of new observational data from electronic health records, wearable devices, claims, etc.,” said Dr. Kerr, who did not participate in the workshop but coauthored an editorial that calls for using real-world data in regulatory decisions for drugs and devices for diabetes. These factors create an “irresistible force” spurring the FDA to consider observational, noninterventional data.

“I think the FDA really wants this to go forward,” Dr. Kerr added in an interview. “The FDA keeps telling us that clinical trials do not have enough women or patients from minority groups. Real-world data is a way to address that. This will not be the death of RCTs, but this work shines a light on the deficiencies of RCTs and how the deficiencies can be dealt with.”

Dr. Kroetsch has reported no relevant financial relationships. Dr. Schneeweiss has reported being a consultant to and holding equity in Aetion and receiving research funding from the FDA. Dr. Ross has reported receiving research funding from the FDA, Johnson & Johnson, and Medtronic. Dr. Hernán has reported being a consultant for Cytel. Dr. Kerr has reported being a consultant for Ascensia, EOFlow, Lifecare, Merck, Novo Nordisk, Roche Diagnostics, and Voluntis. Dr. Temple, Dr. Concato, and Dr. Ball are FDA employees.

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

In 2016, results from the LEADER trial of liraglutide in patients with type 2 diabetes helped jump-start awareness of the potential role of this new class of drugs, the glucagonlike peptide–1 receptor agonists, for reducing cardiovascular events. The randomized, placebo-controlled trial enrolled more than 9000 patients at more than 400 sites in over 30 countries, and took nearly 6 years from the start of patient enrollment to publication of the landmark results.

In December 2020, an independent team of researchers published results from a study with a design identical to LEADER, but used data that came not from a massive, global, years-long trial but from already-existing numbers culled from three large U.S. insurance claim databases. The result of this emulation using real-world data was virtually identical to what the actual trial showed, replicating both the direction and statistical significance of the original finding of the randomized, controlled trial (RCT).

What if research proved that this sort of RCT emulation could reliably be done on a regular basis? What might it mean for regulatory decisions on drugs and devices that historically have been based entirely on efficacy evidence from RCTs?
 

Making the most of a sea of observational data

Medicine in the United States has become increasingly awash in a sea of observational data collected from sources that include electronic health records, insurance claims, and increasingly, personal-health monitoring devices.

The Food and Drug Administration is now in the process of trying to figure out how it can legitimately harness this tsunami of real-world data to make efficacy decisions, essentially creating a new category of evidence to complement traditional data from randomized trials. It’s an opportunity that agency staff and their outside advisors have been keen to seize, especially given the soaring cost of prospective, randomized trials.

Recognition of this untapped resource in part led to a key initiative, among many others, included in the 21st Century Cures Act, passed in December 2016. Among the Act’s mandates was that, by the end of 2021, the FDA would issue guidance on when drug sponsors could use real-world evidence (RWE) to either help support a new indication for an already approved drug or help satisfy postapproval study requirements.

The initiative recognizes that this approach is not appropriate for initial drug approvals, which remain exclusively reliant on evidence from RCTs. Instead, it seems best suited to support expanding indications for already approved drugs.

Although FDA staff have made progress in identifying the challenges and broadening their understanding of how to best handle real-world data that come from observing patients in routine practice, agency leaders stress that this complex issue will likely not be fully resolved by their guidance to be published later this year. The FDA released a draft of the guidance in May 2019.
 

Can RWE be ‘credible and reliable?’

“Whether observational, nonrandomized data can become credible enough to use is what we’re talking about. These are possibilities that need to be explained and better understood,” said Robert Temple, MD, deputy director for clinical science of the FDA Center for Drug Evaluation and Research.

“Since the 1970s, the FDA has recognized historical controls as legitimate, so it’s possible [for RWE] to be credible. The big test is when is it credible and reliable enough [to assess efficacy]?” wondered Dr. Temple during a 2-day workshop on the topic held mid-February and organized by Duke University’s Margolis Center for Health Policy.

“We’re approaching an inflection point regarding how observational studies are generated and used, but our evidentiary standards will not lower, and it will be a case-by-case decision” by the agency as they review future RWE submissions, said John Concato, MD, the FDA’s associate director for real-world evidence, during the workshop.

“We are working toward guidance development, but also looking down the road to what we need to do to enable this,” said Dr. Concato. “It’s a complicated issue. If it was easy, it would have already been fixed.” He added that the agency will likely release a “portfolio” of guidance for submitting real-world data and RWE. Real-world data are raw information that, when analyzed, become RWE.

In short, the FDA seems headed toward guidance that won’t spell out a pathway that guarantees success using RWE but will at least open the door to consideration of this unprecedented application.
 

Not like flipping a switch

The guidance will not activate acceptance of RWE all at once. “It’s not like a light switch,” cautioned Adam Kroetsch, MPP, research director for biomedical innovation and regulatory policy at Duke-Margolis in Washington, D.C. “It’s an evolutionary process,” and the upcoming guidance will provide “just a little more clarity” on what sorts of best practices using RWE the FDA will find persuasive. “It’s hard for the FDA to clearly say what it’s looking for until they see some good examples,” Dr. Kroetsch said in an interview.

What will change is that drug sponsors can submit using RWE, and the FDA “will have a more open-minded view,” predicted Sebastian Schneeweiss, MD, ScD, a workshop participant and chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital in Boston. “For the first time, a law required [the FDA] to take a serious look” at observational data for efficacy assessment.

“The FDA has had a bias against using RWE for evidence of efficacy but has long used it to understand drug safety. Now the FDA is trying to wrap its arms around how to best use RWE” for efficacy decisions, said Joseph S. Ross, MD, another workshop participant and professor of medicine and public health at Yale University, New Haven, Conn.

The agency’s cautious approach is reassuring, Dr. Ross noted in an interview. “There was worry that the 21st Century Cures Act would open the door to allowing real-world data to be used in ways that weren’t very reliable. Very quickly, the FDA started trying to figure out the best ways to use these data in reasonable ways.”
 

Duplicating RCTs with RWE

To help better understand the potential use of RWE, the FDA sponsored several demonstration projects. Researchers presented results from three of these projects during the workshop in February. All three examined whether RWE, plugged into the design of an actual RCT, can produce roughly similar results when similar patients are used.

A generally consistent finding from the three demonstration projects was that “when the data are fit for purpose” the emulated or duplicated analyses with RWE “can come to similar conclusions” as the actual RCTs, said Dr. Schneeweiss, who leads one of the demonstration projects, RCT DUPLICATE.

At the workshop he reported results from RWE duplications of 20 different RCTs using insurance claims data from U.S. patients. The findings came from 10 duplications already reported in Circulation in December 2020 (including a duplication of the LEADER trial), and an additional 10 as yet unpublished RCT duplications. In the next few months, the researchers intend to assess a final group of 10 more RCT duplications.

Workshop participants also presented results from two other FDA demonstration projects: the OPERAND program run by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; and the CERSI program based at Yale and the Mayo Clinic in Rochester, Minn. Both are smaller in scale than RCT DUPLICATE, incorporate lab data in addition to claims data, and in some cases test how well RWE can emulate RCTs that are not yet completed.

Collectively, results from these demonstration projects suggest that RWE can successfully emulate the results of an RCT, said Dr. Ross, a coinvestigator on the CERSI study. But the CERSI findings also highlighted how an RCT can fall short of clinical relevance.

“One of our most important findings was that RCTs don’t always represent real-world practice,” he said. His group attempted to replicate the 5,000-patient GRADE trial of four different drug options added to metformin in patients with type 2 diabetes. One of the four options included insulin glargine (Lantus), and the attempt to emulate the study with RWE hit the bump that no relevant real-world patients in their US claims database actually received the formulation.

That means the GRADE trial “is almost meaningless. It doesn’t reflect real-world practice,” Dr. Ross noted.

Results from the three demonstration projects “highlight the gaps we still have,” summed up Dr. Kroetsch. “They show where we need better data” from observational sources that function as well as data from RCTs.

Still, the demonstration project results are “an important step forward in establishing the validity of real-world evidence,” commented David Kerr, MBChB, an endocrinologist and director of research and innovation at the Sansum Diabetes Research Institute in Santa Barbara, Calif.
 

‘Target trials’ tether RWE

The target trial approach to designing an observational study is a key tool for boosting reliability and applicability of the results. The idea is to create a well-designed trial that could be the basis for a conventional RCT, and then use observational data to flesh out the target trial instead of collecting data from prospectively enrolled patients.

Designing observational studies that emulate target trials allows causal inferences, said Miguel A. Hernán, MD, DrPH, a professor of biostatistics and epidemiology at the Harvard School of Public Health, Boston. Plugging real-world data into the framework of an appropriately designed target trial substantially cuts the risk of a biased analysis, he explained during the workshop.

However, the approach has limitations. The target trial must be a pragmatic trial, and the approach does not work for placebo-controlled trials, although it can accommodate a usual-care control arm. It also usually precludes patient blinding, testing treatments not used in routine practice, and close monitoring of patients in ways that are uncommon in usual care.

The target trial approach received broad endorsement during the workshop as the future for observational studies destined for efficacy consideration by the FDA.

“The idea of prespecifying a target trial is a really fantastic place to start,” commented Robert Ball, MD, deputy director of the FDA Office of Surveillance and Epidemiology. “There is still a whole set of questions once the trial is prespecified, but prespecification would be a fantastic step forward,” he said during the workshop.

Participants also endorsed other important steps to boost the value of observational studies for regulatory reviews, including preregistering the study on a site such as clinicaltrials.gov; being fully transparent about the origins of observational data; using data that match the needs of the target trial; not reviewing the data in advance to avoid cherry picking and gaming the analysis; and reporting neutral or negative results when they occur, something often not currently done for observational analyses.

But although there was clear progress and much agreement among thought leaders at the workshop, FDA representatives stressed caution in moving forward.
 

“No easy answer”

“With more experience, we can learn what works and what doesn’t work in generating valid results from observational studies,” said Dr. Concato. “Although the observational results have upside potential, we need to learn more. There is no easy answer, no checklist for fit-for-use data, no off-the-shelf study design, and no ideal analytic method.”

Dr. Concato acknowledged that the FDA’s goal is clear given the 2016 legislation. “The FDA is embracing our obligations under the 21st Century Cures Act to evaluate use of real-world data and real-world evidence.”

He also suggested that researchers “shy away from a false dichotomy of RCTs or observational studies and instead think about how and when RCTs and observational studies can be designed and conducted to yield trustworthy results.” Dr. Concato’s solution: “a taxonomy of interventional or noninterventional studies.”

“The FDA is under enormous pressure to embrace real-world evidence, both because of the economics of running RCTs and because of the availability of new observational data from electronic health records, wearable devices, claims, etc.,” said Dr. Kerr, who did not participate in the workshop but coauthored an editorial that calls for using real-world data in regulatory decisions for drugs and devices for diabetes. These factors create an “irresistible force” spurring the FDA to consider observational, noninterventional data.

“I think the FDA really wants this to go forward,” Dr. Kerr added in an interview. “The FDA keeps telling us that clinical trials do not have enough women or patients from minority groups. Real-world data is a way to address that. This will not be the death of RCTs, but this work shines a light on the deficiencies of RCTs and how the deficiencies can be dealt with.”

Dr. Kroetsch has reported no relevant financial relationships. Dr. Schneeweiss has reported being a consultant to and holding equity in Aetion and receiving research funding from the FDA. Dr. Ross has reported receiving research funding from the FDA, Johnson & Johnson, and Medtronic. Dr. Hernán has reported being a consultant for Cytel. Dr. Kerr has reported being a consultant for Ascensia, EOFlow, Lifecare, Merck, Novo Nordisk, Roche Diagnostics, and Voluntis. Dr. Temple, Dr. Concato, and Dr. Ball are FDA employees.

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

Federal guidance on indoor mask use may change soon, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said on May 9.

He was asked whether it’s time to start relaxing indoor mask requirements.

“I think so, and I think you’re going to probably be seeing that as we go along and as more people get vaccinated,” Dr. Fauci said on ABC News’s This Week.Nearly 150 million adults in the United States – or about 58% of the adult population – have received at least one COVID-19 vaccine dose, according to the latest CDC tally. About 113 million adults, or 44%, are considered fully vaccinated.

“The CDC will be, you know, almost in real time … updating their recommendations and their guidelines,” Dr. Fauci said.

In April, the CDC relaxed its guidance for those who have been vaccinated against COVID-19. Those who have gotten a shot don’t need to wear a mask outdoors or in small indoor gatherings with other vaccinated people, but both vaccinated and unvaccinated people are still advised to wear masks in indoor public spaces.

“We do need to start being more liberal as we get more people vaccinated,” Dr. Fauci said. “As you get more people vaccinated, the number of cases per day will absolutely go down.”

The United States is averaging about 43,000 cases per day, he said, adding that the cases need to be “much, much lower.” When the case numbers drop and vaccination numbers increase, the risk of infection will fall dramatically indoors and outdoors, he said.

Even after the pandemic, though, wearing masks could become a seasonal habit, Dr. Fauci said May 9 on NBC News’s Meet the Press.“I think people have gotten used to the fact that wearing masks, clearly if you look at the data, it diminishes respiratory diseases. We’ve had practically a nonexistent flu season this year,” he said.

“So it is conceivable that as we go on, a year or 2 or more from now, that during certain seasonal periods when you have respiratory-borne viruses like the flu, people might actually elect to wear masks to diminish the likelihood that you’ll spread these respiratory-borne diseases,” he said.

Dr. Fauci was asked about indoor mask guidelines on May 9 after former FDA Commissioner Scott Gottlieb, MD, said face mask requirements should be relaxed.

“Certainly outdoors, we shouldn’t be putting limits on gatherings anymore,” Dr. Gottlieb said on CBS News’s Face the Nation.“The states where prevalence is low, vaccination rates are high, we have good testing in place, and we’re identifying infections, I think we could start lifting these restrictions indoors as well, on a broad basis,” he said.

Lifting pandemic-related restrictions in areas where they’re no longer necessary could also encourage people to implement them again if cases increase during future surges, such as this fall or winter, Dr. Gottlieb said.

At the same time, Americans should continue to follow CDC guidance and wait for new guidelines before changing their indoor mask use, Jeffrey Zients, the White House COVID-19 response coordinator, said on CNN’s State of the Union on May 9.

“We all want to get back to a normal lifestyle,” he said. “I think we’re on the path to do that, but stay disciplined, and let’s take advantage of the new privilege of being vaccinated and not wearing masks outdoors, for example, unless you’re in a crowded place.”

Mr. Zients pointed to President Joe Biden’s goal for 70% of adults to receive at least one vaccine dose by July 4.

“As we all move toward that 70% goal, there will be more and more advantages to being vaccinated,” he said. “And if you’re not vaccinated, you’re not protected.”

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

Federal guidance on indoor mask use may change soon, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said on May 9.

He was asked whether it’s time to start relaxing indoor mask requirements.

“I think so, and I think you’re going to probably be seeing that as we go along and as more people get vaccinated,” Dr. Fauci said on ABC News’s This Week.Nearly 150 million adults in the United States – or about 58% of the adult population – have received at least one COVID-19 vaccine dose, according to the latest CDC tally. About 113 million adults, or 44%, are considered fully vaccinated.

“The CDC will be, you know, almost in real time … updating their recommendations and their guidelines,” Dr. Fauci said.

In April, the CDC relaxed its guidance for those who have been vaccinated against COVID-19. Those who have gotten a shot don’t need to wear a mask outdoors or in small indoor gatherings with other vaccinated people, but both vaccinated and unvaccinated people are still advised to wear masks in indoor public spaces.

“We do need to start being more liberal as we get more people vaccinated,” Dr. Fauci said. “As you get more people vaccinated, the number of cases per day will absolutely go down.”

The United States is averaging about 43,000 cases per day, he said, adding that the cases need to be “much, much lower.” When the case numbers drop and vaccination numbers increase, the risk of infection will fall dramatically indoors and outdoors, he said.

Even after the pandemic, though, wearing masks could become a seasonal habit, Dr. Fauci said May 9 on NBC News’s Meet the Press.“I think people have gotten used to the fact that wearing masks, clearly if you look at the data, it diminishes respiratory diseases. We’ve had practically a nonexistent flu season this year,” he said.

“So it is conceivable that as we go on, a year or 2 or more from now, that during certain seasonal periods when you have respiratory-borne viruses like the flu, people might actually elect to wear masks to diminish the likelihood that you’ll spread these respiratory-borne diseases,” he said.

Dr. Fauci was asked about indoor mask guidelines on May 9 after former FDA Commissioner Scott Gottlieb, MD, said face mask requirements should be relaxed.

“Certainly outdoors, we shouldn’t be putting limits on gatherings anymore,” Dr. Gottlieb said on CBS News’s Face the Nation.“The states where prevalence is low, vaccination rates are high, we have good testing in place, and we’re identifying infections, I think we could start lifting these restrictions indoors as well, on a broad basis,” he said.

Lifting pandemic-related restrictions in areas where they’re no longer necessary could also encourage people to implement them again if cases increase during future surges, such as this fall or winter, Dr. Gottlieb said.

At the same time, Americans should continue to follow CDC guidance and wait for new guidelines before changing their indoor mask use, Jeffrey Zients, the White House COVID-19 response coordinator, said on CNN’s State of the Union on May 9.

“We all want to get back to a normal lifestyle,” he said. “I think we’re on the path to do that, but stay disciplined, and let’s take advantage of the new privilege of being vaccinated and not wearing masks outdoors, for example, unless you’re in a crowded place.”

Mr. Zients pointed to President Joe Biden’s goal for 70% of adults to receive at least one vaccine dose by July 4.

“As we all move toward that 70% goal, there will be more and more advantages to being vaccinated,” he said. “And if you’re not vaccinated, you’re not protected.”

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

Federal guidance on indoor mask use may change soon, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said on May 9.

He was asked whether it’s time to start relaxing indoor mask requirements.

“I think so, and I think you’re going to probably be seeing that as we go along and as more people get vaccinated,” Dr. Fauci said on ABC News’s This Week.Nearly 150 million adults in the United States – or about 58% of the adult population – have received at least one COVID-19 vaccine dose, according to the latest CDC tally. About 113 million adults, or 44%, are considered fully vaccinated.

“The CDC will be, you know, almost in real time … updating their recommendations and their guidelines,” Dr. Fauci said.

In April, the CDC relaxed its guidance for those who have been vaccinated against COVID-19. Those who have gotten a shot don’t need to wear a mask outdoors or in small indoor gatherings with other vaccinated people, but both vaccinated and unvaccinated people are still advised to wear masks in indoor public spaces.

“We do need to start being more liberal as we get more people vaccinated,” Dr. Fauci said. “As you get more people vaccinated, the number of cases per day will absolutely go down.”

The United States is averaging about 43,000 cases per day, he said, adding that the cases need to be “much, much lower.” When the case numbers drop and vaccination numbers increase, the risk of infection will fall dramatically indoors and outdoors, he said.

Even after the pandemic, though, wearing masks could become a seasonal habit, Dr. Fauci said May 9 on NBC News’s Meet the Press.“I think people have gotten used to the fact that wearing masks, clearly if you look at the data, it diminishes respiratory diseases. We’ve had practically a nonexistent flu season this year,” he said.

“So it is conceivable that as we go on, a year or 2 or more from now, that during certain seasonal periods when you have respiratory-borne viruses like the flu, people might actually elect to wear masks to diminish the likelihood that you’ll spread these respiratory-borne diseases,” he said.

Dr. Fauci was asked about indoor mask guidelines on May 9 after former FDA Commissioner Scott Gottlieb, MD, said face mask requirements should be relaxed.

“Certainly outdoors, we shouldn’t be putting limits on gatherings anymore,” Dr. Gottlieb said on CBS News’s Face the Nation.“The states where prevalence is low, vaccination rates are high, we have good testing in place, and we’re identifying infections, I think we could start lifting these restrictions indoors as well, on a broad basis,” he said.

Lifting pandemic-related restrictions in areas where they’re no longer necessary could also encourage people to implement them again if cases increase during future surges, such as this fall or winter, Dr. Gottlieb said.

At the same time, Americans should continue to follow CDC guidance and wait for new guidelines before changing their indoor mask use, Jeffrey Zients, the White House COVID-19 response coordinator, said on CNN’s State of the Union on May 9.

“We all want to get back to a normal lifestyle,” he said. “I think we’re on the path to do that, but stay disciplined, and let’s take advantage of the new privilege of being vaccinated and not wearing masks outdoors, for example, unless you’re in a crowded place.”

Mr. Zients pointed to President Joe Biden’s goal for 70% of adults to receive at least one vaccine dose by July 4.

“As we all move toward that 70% goal, there will be more and more advantages to being vaccinated,” he said. “And if you’re not vaccinated, you’re not protected.”

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

The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.

Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.

But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.

The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.

The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.

“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.

Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.

Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.

“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”

The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”

Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.

The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”

The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.

Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”

The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.

Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.

“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.

The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.

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

The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.

Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.

But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.

The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.

The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.

“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.

Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.

Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.

“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”

The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”

Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.

The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”

The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.

Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”

The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.

Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.

“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.

The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.

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

The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.

Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.

But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.

The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.

The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.

“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.

Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.

Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.

“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”

The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”

Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.

The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”

The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.

Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”

The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.

Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.

“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.

The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.

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

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

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

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

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

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

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

Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.

Johnson & Johnson

Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.

Johnson & Johnson

Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.

Johnson & Johnson

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.

Health care–specific (eg, Healthgrades, Zocdoc, Vitals, WebMD) and general consumer websites (eg, Google, Yelp) are popular platforms for patients to find physicians, schedule appointments, and review physician experiences. Patients find ratings on these websites more trustworthy than standardized surveys distributed by hospitals, but many physicians do not trust the reviews on these sites. For example, in a survey of both physicians (n=828) and patients (n=494), 36% of physicians trusted online reviews compared to 57% of patients.¹ The objective of this study was to determine if health care–specific or general consumer websites more accurately reflect overall patient sentiment. This knowledge can help physicians who are seeking to improve the patient experience understand which websites have more accurate and trustworthy reviews.

Methods

A list of dermatologists from the top 10 most and least dermatologist–dense areas in the United States was compiled to examine different physician populations.² Equal numbers of male and female dermatologists were randomly selected from the most dense areas. All physicians were included from the least dense areas because of limited sample size. Ratings were collected from websites most likely to appear on the first page of a Google search for a physician name, as these are most likely to be seen by patients. Descriptive statistics were generated to describe the study population; mean and median physician rating (using a scale of 1–5); SD; and minimum, maximum, and interquartile ranges. Spearman correlation coefficients were generated to examine the strength of association between ratings from website pairs. P<.05 was considered statistically significant, with analyses performed in R (3.6.2) for Windows (the R Foundation).

Results

A total of 167 representative physicians were included in this analysis; 141 from the most dense areas, and 26 from the least dense areas. The lowest average ratings for the entire sample and most dermatologist–dense areas were found on Yelp (3.61 and 3.60, respectively), and the lowest ratings in the least dermatologist–dense areas were found on Google (3.45)(Table 1). Correlation coefficient values were lowest for Zocdoc and Healthgrades (0.263) and highest for Vitals and WebMD (0.963)(Table 2). The health care–specific sites were closer to the overall average (4.06) than the general consumer sites (eFigure).

Comment

Although dermatologist ratings on each site had a broad range, we found that patients typically expressed negative interactions on general consumer websites rather than health care–specific websites. When comparing the ratings of the same group of dermatologists across different sites, ratings on health care–specific sites had a higher degree of correlation, with physician ratings more similar between 2 health care–specific sites and less similar between a health care–specific and a general consumer website. This pattern was consistent in both dermatologist-dense and dermatologist-poor areas, despite patients having varying levels of access to dermatologic care and medical resources and potentially different regional preferences of consumer websites. Taken together, these findings imply that health care–specific websites more consistently reflect overall patient sentiment.

Although one 2016 study comparing reviews of dermatology practices on Zocdoc and Yelp also demonstrated lower average ratings on Yelp,³ our study suggests that this trend is not isolated to these 2 sites but can be seen when comparing many health care–specific sites vs general consumer sites.

Our study compared ratings of dermatologists among popular websites to understand those that are most representative of patient attitudes toward physicians. These findings are important because online reviews reflect the entire patient experience, not just the patient-physician interaction, which may explain why physician scores on standardized questionnaires, such as Press Ganey surveys, do not correlate well with their online reviews.⁴ In a study comparing 98 physicians with negative online ratings to 82 physicians in similar departments with positive ratings, there was no significant difference in scores on patient-physician interaction questions on the Press Ganey survey.⁵ However, physicians who received negative online reviews scored lower on Press Ganey questions related to nonphysician interactions (eg, office cleanliness, interactions with staff).

The current study was subject to several limitations. Our analysis included all physicians in our random selection without accounting for those physicians with a greater online presence who might be more cognizant of these ratings and try to manipulate them through a reputation-management company or public relations consultant.

Conclusion

Our study suggests that consumer websites are not primarily used by disgruntled patients wishing to express grievances; instead, on average, most physicians received positive reviews. Furthermore, health care–specific websites show a higher degree of concordance than and may more accurately reflect overall patient attitudes toward their physicians than general consumer sites. Reviews from these health care–specific sites may be more helpful than general consumer websites in allowing physicians to understand patient sentiment and improve patient experiences.

Health care–specific (eg, Healthgrades, Zocdoc, Vitals, WebMD) and general consumer websites (eg, Google, Yelp) are popular platforms for patients to find physicians, schedule appointments, and review physician experiences. Patients find ratings on these websites more trustworthy than standardized surveys distributed by hospitals, but many physicians do not trust the reviews on these sites. For example, in a survey of both physicians (n=828) and patients (n=494), 36% of physicians trusted online reviews compared to 57% of patients.¹ The objective of this study was to determine if health care–specific or general consumer websites more accurately reflect overall patient sentiment. This knowledge can help physicians who are seeking to improve the patient experience understand which websites have more accurate and trustworthy reviews.

Methods

A list of dermatologists from the top 10 most and least dermatologist–dense areas in the United States was compiled to examine different physician populations.² Equal numbers of male and female dermatologists were randomly selected from the most dense areas. All physicians were included from the least dense areas because of limited sample size. Ratings were collected from websites most likely to appear on the first page of a Google search for a physician name, as these are most likely to be seen by patients. Descriptive statistics were generated to describe the study population; mean and median physician rating (using a scale of 1–5); SD; and minimum, maximum, and interquartile ranges. Spearman correlation coefficients were generated to examine the strength of association between ratings from website pairs. P<.05 was considered statistically significant, with analyses performed in R (3.6.2) for Windows (the R Foundation).

Results

A total of 167 representative physicians were included in this analysis; 141 from the most dense areas, and 26 from the least dense areas. The lowest average ratings for the entire sample and most dermatologist–dense areas were found on Yelp (3.61 and 3.60, respectively), and the lowest ratings in the least dermatologist–dense areas were found on Google (3.45)(Table 1). Correlation coefficient values were lowest for Zocdoc and Healthgrades (0.263) and highest for Vitals and WebMD (0.963)(Table 2). The health care–specific sites were closer to the overall average (4.06) than the general consumer sites (eFigure).

Comment

Although dermatologist ratings on each site had a broad range, we found that patients typically expressed negative interactions on general consumer websites rather than health care–specific websites. When comparing the ratings of the same group of dermatologists across different sites, ratings on health care–specific sites had a higher degree of correlation, with physician ratings more similar between 2 health care–specific sites and less similar between a health care–specific and a general consumer website. This pattern was consistent in both dermatologist-dense and dermatologist-poor areas, despite patients having varying levels of access to dermatologic care and medical resources and potentially different regional preferences of consumer websites. Taken together, these findings imply that health care–specific websites more consistently reflect overall patient sentiment.

Although one 2016 study comparing reviews of dermatology practices on Zocdoc and Yelp also demonstrated lower average ratings on Yelp,³ our study suggests that this trend is not isolated to these 2 sites but can be seen when comparing many health care–specific sites vs general consumer sites.

Our study compared ratings of dermatologists among popular websites to understand those that are most representative of patient attitudes toward physicians. These findings are important because online reviews reflect the entire patient experience, not just the patient-physician interaction, which may explain why physician scores on standardized questionnaires, such as Press Ganey surveys, do not correlate well with their online reviews.⁴ In a study comparing 98 physicians with negative online ratings to 82 physicians in similar departments with positive ratings, there was no significant difference in scores on patient-physician interaction questions on the Press Ganey survey.⁵ However, physicians who received negative online reviews scored lower on Press Ganey questions related to nonphysician interactions (eg, office cleanliness, interactions with staff).

The current study was subject to several limitations. Our analysis included all physicians in our random selection without accounting for those physicians with a greater online presence who might be more cognizant of these ratings and try to manipulate them through a reputation-management company or public relations consultant.

Conclusion

Our study suggests that consumer websites are not primarily used by disgruntled patients wishing to express grievances; instead, on average, most physicians received positive reviews. Furthermore, health care–specific websites show a higher degree of concordance than and may more accurately reflect overall patient attitudes toward their physicians than general consumer sites. Reviews from these health care–specific sites may be more helpful than general consumer websites in allowing physicians to understand patient sentiment and improve patient experiences.

Health care–specific (eg, Healthgrades, Zocdoc, Vitals, WebMD) and general consumer websites (eg, Google, Yelp) are popular platforms for patients to find physicians, schedule appointments, and review physician experiences. Patients find ratings on these websites more trustworthy than standardized surveys distributed by hospitals, but many physicians do not trust the reviews on these sites. For example, in a survey of both physicians (n=828) and patients (n=494), 36% of physicians trusted online reviews compared to 57% of patients.¹ The objective of this study was to determine if health care–specific or general consumer websites more accurately reflect overall patient sentiment. This knowledge can help physicians who are seeking to improve the patient experience understand which websites have more accurate and trustworthy reviews.

Methods

A list of dermatologists from the top 10 most and least dermatologist–dense areas in the United States was compiled to examine different physician populations.² Equal numbers of male and female dermatologists were randomly selected from the most dense areas. All physicians were included from the least dense areas because of limited sample size. Ratings were collected from websites most likely to appear on the first page of a Google search for a physician name, as these are most likely to be seen by patients. Descriptive statistics were generated to describe the study population; mean and median physician rating (using a scale of 1–5); SD; and minimum, maximum, and interquartile ranges. Spearman correlation coefficients were generated to examine the strength of association between ratings from website pairs. P<.05 was considered statistically significant, with analyses performed in R (3.6.2) for Windows (the R Foundation).

Results

A total of 167 representative physicians were included in this analysis; 141 from the most dense areas, and 26 from the least dense areas. The lowest average ratings for the entire sample and most dermatologist–dense areas were found on Yelp (3.61 and 3.60, respectively), and the lowest ratings in the least dermatologist–dense areas were found on Google (3.45)(Table 1). Correlation coefficient values were lowest for Zocdoc and Healthgrades (0.263) and highest for Vitals and WebMD (0.963)(Table 2). The health care–specific sites were closer to the overall average (4.06) than the general consumer sites (eFigure).

Comment

Although dermatologist ratings on each site had a broad range, we found that patients typically expressed negative interactions on general consumer websites rather than health care–specific websites. When comparing the ratings of the same group of dermatologists across different sites, ratings on health care–specific sites had a higher degree of correlation, with physician ratings more similar between 2 health care–specific sites and less similar between a health care–specific and a general consumer website. This pattern was consistent in both dermatologist-dense and dermatologist-poor areas, despite patients having varying levels of access to dermatologic care and medical resources and potentially different regional preferences of consumer websites. Taken together, these findings imply that health care–specific websites more consistently reflect overall patient sentiment.

Although one 2016 study comparing reviews of dermatology practices on Zocdoc and Yelp also demonstrated lower average ratings on Yelp,³ our study suggests that this trend is not isolated to these 2 sites but can be seen when comparing many health care–specific sites vs general consumer sites.

Our study compared ratings of dermatologists among popular websites to understand those that are most representative of patient attitudes toward physicians. These findings are important because online reviews reflect the entire patient experience, not just the patient-physician interaction, which may explain why physician scores on standardized questionnaires, such as Press Ganey surveys, do not correlate well with their online reviews.⁴ In a study comparing 98 physicians with negative online ratings to 82 physicians in similar departments with positive ratings, there was no significant difference in scores on patient-physician interaction questions on the Press Ganey survey.⁵ However, physicians who received negative online reviews scored lower on Press Ganey questions related to nonphysician interactions (eg, office cleanliness, interactions with staff).

The current study was subject to several limitations. Our analysis included all physicians in our random selection without accounting for those physicians with a greater online presence who might be more cognizant of these ratings and try to manipulate them through a reputation-management company or public relations consultant.

Conclusion

Our study suggests that consumer websites are not primarily used by disgruntled patients wishing to express grievances; instead, on average, most physicians received positive reviews. Furthermore, health care–specific websites show a higher degree of concordance than and may more accurately reflect overall patient attitudes toward their physicians than general consumer sites. Reviews from these health care–specific sites may be more helpful than general consumer websites in allowing physicians to understand patient sentiment and improve patient experiences.

The list of medical comorbidities associated with high risk for severe COVID-19 now includes moderate to severe asthma, diabetes, and substance use disorders, according to the Centers for Disease Control and Prevention.

The CDC’s latest list consists of 17 conditions or groups of related conditions that may increase patients’ risk of developing severe outcomes of COVID-19, the CDC said on a web page intended for the general public.

On a separate page, the CDC defines severe outcomes “as hospitalization, admission to the intensive care unit, intubation or mechanical ventilation, or death.”

Asthma is included in the newly expanded list with other chronic lung diseases such as chronic obstructive pulmonary disease and cystic fibrosis; the list’s heart disease entry covers coronary artery disease, heart failure, cardiomyopathies, and hypertension, the CDC said.

[email protected]

The list of medical comorbidities associated with high risk for severe COVID-19 now includes moderate to severe asthma, diabetes, and substance use disorders, according to the Centers for Disease Control and Prevention.

The CDC’s latest list consists of 17 conditions or groups of related conditions that may increase patients’ risk of developing severe outcomes of COVID-19, the CDC said on a web page intended for the general public.

On a separate page, the CDC defines severe outcomes “as hospitalization, admission to the intensive care unit, intubation or mechanical ventilation, or death.”

Asthma is included in the newly expanded list with other chronic lung diseases such as chronic obstructive pulmonary disease and cystic fibrosis; the list’s heart disease entry covers coronary artery disease, heart failure, cardiomyopathies, and hypertension, the CDC said.

[email protected]

The list of medical comorbidities associated with high risk for severe COVID-19 now includes moderate to severe asthma, diabetes, and substance use disorders, according to the Centers for Disease Control and Prevention.

The CDC’s latest list consists of 17 conditions or groups of related conditions that may increase patients’ risk of developing severe outcomes of COVID-19, the CDC said on a web page intended for the general public.

On a separate page, the CDC defines severe outcomes “as hospitalization, admission to the intensive care unit, intubation or mechanical ventilation, or death.”

Asthma is included in the newly expanded list with other chronic lung diseases such as chronic obstructive pulmonary disease and cystic fibrosis; the list’s heart disease entry covers coronary artery disease, heart failure, cardiomyopathies, and hypertension, the CDC said.

[email protected]

From Mount Sinai Medical Center, Miami Beach, FL.

Abstract

Objective: To develop and implement a process for administering COVID-19 monoclonal antibody infusions for outpatients with mild or moderate COVID-19 at high risk for hospitalization, using multidisciplinary collaboration, US Food and Drug Administration (FDA) guidance, and infection prevention standards.

Methods: When monoclonal antibody therapy became available for mild or moderate COVID-19 outpatients via Emergency Use Authorization (EUA), our institution sought to provide this therapy option to our patients. We describe the process for planning, implementing, and maintaining a successful program for administering novel therapies based on FDA guidance and infection prevention standards. Key components of our implementation process were multidisciplinary planning involving decision makers and stakeholders; setting realistic goals in the process; team communication; and measuring and reporting quality improvement on a regular basis.

Results: A total of 790 COVID-19 monoclonal antibody infusions were administered from November 20, 2020 to March 5, 2021. Steps to minimize the likelihood of adverse drug reactions were implemented and a low incidence (< 1%) has occurred. There has been no concern from staff regarding infection during the process. Rarely, patients have raised cost-related concerns, typically due to incomplete communication regarding billing prior to the infusion. Patients, families, nursing staff, physicians, pharmacy, and hospital administration have expressed satisfaction with the program.

Conclusion: This process can provide a template for other hospitals or health care delivery facilities to provide novel therapies to patients with mild or moderate COVID-19 in a safe and effective manner.

Keywords: COVID-19; monoclonal antibody; infusion; emergency use authorization.

SARS-CoV-2 and the disease it causes, COVID-19, have transformed from scientific vernacular to common household terms. It began with a cluster of pneumonia cases of unknown etiology in December 2019 in Wuhan, China, with physicians there reporting a novel coronavirus strain (2019-nCoV), now referred to as SARS-CoV-2. Rapid spread of this virus resulted in the World Health Organization (WHO) declaring an international public health emergency. Since this time, the virus has evolved into a worldwide pandemic. COVID-19 has dramatically impacted our society, resulting in more than 2.63 million global deaths as of this writing, of which more than 527,000 deaths have occurred in the United States.¹ This novel virus has resulted in a flurry of literature, research, therapies, and collaboration across multiple disciplines in an effort to prevent, treat, and mitigate cases and complications of this disease.

On November 9, 2020, and November 21, 2020, the US Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUA) for 2 novel COVID-19 monoclonal therapies, bamlanivimab^2-3 and casirivimab/imdevimab,^3-4 respectively. The EUAs granted permission for these therapies to be administered for the treatment of mild to moderate COVID-19 in adult and pediatric patients (≥ 12 years and weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization. The therapies work by targeting the SARS-CoV-2 spike protein and subsequent attachment to human angiotensin-converting enzyme 2 receptors. Clinical trial data leading to the EUA demonstrated a reduction in viral load, safe outcome, and most importantly, fewer hospitalization and emergency room visits, as compared to the placebo group.^5-7 The use of monoclonal antibodies is not new and gained recognition during the Ebola crisis, when the monoclonal antibody to the Ebola virus showed a significant survival benefit.⁸ Providing monoclonal antibody therapy soon after symptom onset aligns with a shift from the onset of the pandemic to the current focus on the administration of pharmaceutical therapy early in the disease course. This shift prevents progression to severe COVID-19, with the goal of reducing patient mortality, hospitalizations, and strain on health care systems.

The availability of novel neutralizing monoclonal antibodies for COVID-19 led to discussions of how to incorporate these therapies as new options for patients. Our institution networked with colleagues from multiple disciplines to discuss processes and policies for the safe administration of the monoclonal antibody infusion therapies. Federal health leaders urge more use of monoclonal antibodies, but many hospitals have been unable to successfully implement infusions due to staff and logistical challenges.⁹ This article presents a viable process that hospitals can use to provide these novel therapies to outpatients with mild to moderate COVID-19.

The Mount Sinai Medical Center, Florida Experience

Mount Sinai Medical Center in Miami Beach, Florida, is the largest private, independent, not-for-profit teaching hospital in South Florida, comprising 672 licensed beds and supporting 150,000 emergency department (ED) visits annually. Per the EUA criteria for use, COVID-19 monoclonal antibody therapies are not authorized for patients who are hospitalized or who require oxygen therapy due to COVID-19. Therefore, options for outpatient administration needed to be evaluated. Directly following the first EUA press release, a task force of key stakeholders was assembled to brainstorm and develop a process to offer this therapy to the community. A multidisciplinary task force with representation from the ED, nursing, primary care, hospital medicine, pharmacy, risk management, billing, information technology, infection prevention, and senior level leadership participated (Table).

The task force reviewed institutional outpatient locations to determine whether offering this service would be feasible (eg, ED, ambulatory care facilities, cancer center). The ED was selected because it would offer the largest array of appointment times to meet the community needs with around-the-clock availability. While Mount Sinai Medical Center offers care in 3 emergency center locations in Aventura, Hialeah, and Miami Beach, it was determined to initiate the infusions at the main campus center in Miami Beach only. The main campus affords an onsite pharmacy with suitable staffing to prepare the anticipated volume of infusions in a timely manner, as both therapies have short stabilities following preparation. Thus, it was decided that patients from freestanding emergency centers in Aventura and Hialeah would be moved to the Miami Beach ED location to receive therapy. Operating at a single site also allowed for more rapid implementation, monitoring, and ability to make modifications more easily. Discussions for the possible expansion of COVID-19 monoclonal antibody infusions at satellite locations are underway.

On November 20, 2020, 11 days after the formation of the multidisciplinary task force, the first COVID-19 monoclonal infusion was successfully administered. Figure 1 depicts the timeline from assessment to program implementation. Critical to implementation was the involvement of decision makers from all necessary departments early in the planning process to ensure that standard operating procedures were followed and that the patients, community, and organization had a positive experience. This allowed for simultaneous planning of electronic health record (Epic; EHR) builds, departmental workflows, and staff education, as described in the following section. Figure 2 shows the patient safety activities included in the implementation process.

On the day of bamlanivimab EUA release, email communication was shared among hospital leadership with details of the press release. Departments were quickly involved to initiate a task force to assess if and how this therapy could be offered at Mount Sinai Medical Center. The following sections explain the role of each stakeholder and their essential role to operationalize these novel EUA treatment options. The task force was organized and led by our chief medical officer and chief nursing officer.

Information Technology

Medication Ordering and Documentation EHR and Smart Pumps. Early in the pandemic, the antimicrobial stewardship (ASP) clinical coordinator became the designated point person for pharmacy assessment of novel COVID-19 therapies. As such, this pharmacist began reviewing the bamlanivimab and, later, the casirivimab/imdevimab EUA Fact Sheet for Health Care Providers. All necessary elements for the complete and safe ordering and dispensing of the medication were developed and reviewed by pharmacy administration and ED nursing leadership for input, prior to submitting to the information technology team for implementation. Building the COVID-19 monoclonal medication records into the EHR allowed for detailed direction (ie, administration and preparation instructions) to be consistently applied. The medication records were also built into hospital smart pumps so that nurses could access prepopulated, accurate volumes and infusion rates to minimize errors.

Order Set Development. The pharmacy medication build was added to a comprehensive order set (Figure 3), which was then developed to guide prescribers and standardize the process around ordering of COVID-19 monoclonal therapies. While these therapies are new, oncology monoclonal therapies are regularly administered to outpatients at Mount Sinai Cancer Center. The cancer center was therefore consulted on their process surrounding best practices in administration of monoclonal antibody therapies. This included protocols for medications used in pretreatment and management of hypersensitivity reactions and potential adverse drug reactions of both COVID-19 monoclonal therapies. These medication orders were selected by default in the order set to ensure that all patients received premedications aimed at minimizing the risk of hypersensitivity reaction, and had as-needed medication orders, in the event a hypersensitivity reaction occurred. Reducing hypersensitivity reaction risk is important as well to increase the likelihood that the patient would receive full therapy, as management of this adverse drug reactions involves possible cessation of therapy depending on the level of severity. The pharmacy department also ensured these medications were stocked in ED automated dispensing cabinets to promote quick access. In addition to the aforementioned nursing orders, we added EUA criteria for use and hyperlinks to the Fact Sheets for Patients and Caregivers and Health Care Providers for each monoclonal therapy, and restricted ordering to ED physicians, nurse practitioners, and physician assistants.

The order set underwent multidisciplinary review by pharmacy administration, the chair of emergency medicine, physicians, and ED nursing leadership prior to presentation and approval by the Pharmacy and Therapeutics Committee. Lastly, at time of implementation, the order set was added to the ED preference list, preventing inpatient access. Additionally, as a patient safety action, free- standing orders of COVID-19 monoclonal therapies were disabled, so providers could only order therapies via the approved, comprehensive order set.

Preliminary Assessment Tool. A provider assessment tool was developed to document patient-specific EUA criteria for use during initial assessment (Figure 4). This tool serves as a checklist and is visible to the full multidisciplinary team in the patient’s EHR. It is used as a resource at the time of pharmacist verification and ED physician assessment to ensure criteria for use are met.

Patient Referral. Patients with symptoms or concerns of COVID-19 exposure can make physician appointments via telemedicine or in person at Mount Sinai Medical Center’s primary care and specialty offices. At the time of patient encounter, physicians suspecting a COVID-19 diagnosis will refer patients for outpatient COVID-19 polymerase chain reaction (PCR) laboratory testing, which has an approximate 24-hour turnaround to results. Physicians also assess whether the patient meets EUA criteria for use, pending results of testing. In the event a patient meets EUA criteria for use, the physician provides patient counseling and requests verbal consent. Following this, the physician enters a note in the EHR describing the patient’s condition, criteria for use evaluation, and the patient’s verbal agreement to therapy. This preliminary screening is beneficial to begin planning with both the patient and ED to minimize delays. Patients are notified of the results of their test once available. If the COVID-19 PCR test returns positive, the physician will call the ED at the main campus and schedule the patient for COVID-19 monoclonal therapy. As the desired timeframe for administering COVID-19 monoclonal therapies is within less than 10 days of symptom onset, timely scheduling of appointments is crucial. Infusion appointments are typically provided the same or next day. The patients are informed that they must bring documentation of their positive COVID-19 PCR test to their ED visit. Lastly, because patients are pretreated with medication that may potentially impair driving, they are instructed that they cannot drive themselves home; ride shares also are not allowed in order to limit the spread of infection.

Emergency Department

Patient Arrival and Screening. A COVID-19 patient can be evaluated in the ED 1 of 2 ways. The first option is via outpatient office referral, as described previously. Upon arrival to the ED, a second screening is performed to ensure the patient still meets EUA criteria for use and the positive COVID-19 PCR test result is confirmed. If the patient no longer meets criteria, the patient is triaged accordingly, including evaluation for higher-level care (eg, supplemental oxygen, hospital admission). The second optoion is via new patient walk-ins without outpatient physician referral (Figure 4). In these cases, an initial screening is performed, documenting EUA criteria for use in the preliminary assessment (Figure 5). Physicians will consider an outside COVID-19 test as valid, so long as documentation is readily available confirming a positive PCR result. Otherwise, an in-house COVID-19 PCR test will be performed, which has a 2-hour turnaround time.

Infusion Schedule. The ED offers a total of 16 COVID-19 monoclonal infusions slots daily. These are broken up into 4 infusion time blocks (eg, 8 am, 12 pm, 4 pm, 8 pm), with each infusion time block consisting of 4 available patient appointments. A list of scheduled infusions for the day is emailed to the pharmacy department every morning, and patients are instructed to arrive 1 hour prior to their appointment time. This allows time for patient registration, assessment, and pharmacy notification in advance of order entry. For logistical purposes, and as a patient safety initiative to reduce the likelihood of medication errors, each of the available COVID-19 monoclonal antibodies is offered on a designated day. Bamlanivimab is offered on Tuesday, Thursday, Saturday, and Sunday, while casirivimab/imdevimab is offered Monday, Wednesday, and Friday. This provides flexibility to adjust should supply deviate based on Department of Health allocation or should new therapy options within this class of medication become available.

Patient Education. Prior to administration of the monoclonal therapy, physician and nursing staff obtain a formal, written patient consent for therapy and provide patients with the option of participating in the institutional review board (IRB) approved study. Details of this are discussed in the risk management and IRB sections of the article. Nursing staff also provides the medication-specific Fact Sheet for Patients and Caregivers in either Spanish or English, which is also included as a hyperlink on the COVID-19 Monoclonal Antibody Order Set for ease of access. Interpreter services are available for patients who speak other languages. An ED decentralized pharmacist is also available onsite Monday through Friday from 12 pm to 8:30 pm to supplement education and serve as a resource for any questions.

Infusion Ordering. Once the patient is ready to begin therapy, the he/she is brought to a dedicated overflow area of the ED. There are few, if any, patients in this location, and it is adjacent to the main emergency center for easy access by the patients, nurses, pharmacists, and physicians. The physician then enters orders in the EHR using the COVID-19 Monoclonal Antibody Order Set (Figure 3). Three discrete questions were built into the medication order: (1) Was patient consent obtained? (2) Was the Fact Sheet for Patient/Caregiver provided to the patient? (3) Is the patient COVID-19 PCR-positive? These questions were built as hard stops so that the medication orders cannot be placed without a response. This serves as another double-check to ensure processes are followed and helps facilitate timely verification by the pharmacist.

Medication Administration. One nurse is dedicated to administering the monoclonal therapies scheduled at 8 am and 12 pm and another at 4 pm and 8 pm. Each appointment block is 4 hours in duration to allow adequate time for patient registration, infusion, and postinfusion observation. The nurse administers the premedications and COVID-19 monoclonal therapy, and observes the patient for the required 1-hour postadministration observation period. Nursing orders detailing monitoring parameters for mild, moderate, and severe reactions, along with associated medication orders to administer in the event they occur, are detailed in the nursing orders of the COVID-19 Monoclonal Antibody Order Set (Figure 3). Prior to administration, the nurse scans each medication and the patient’s wrist identification band, and documents the time of administration within the EHR medication administration report.

Pharmacy Department

Medication Receipt Process. Inventory is currently allocated biweekly from the state department of health and will soon be transitioning to a direct order system. The pharmacy technician in charge of deliveries notifies the pharmacy Antimicrobial Stewardship Program (ASP) clinical coordinator upon receipt of the monoclonal therapies. Bamlanivimab is supplied as 1 vial per dose, whereas casirivimab/imdevimab is supplied as 4 vials or 8 vials per dose, depending how it is shipped. To reduce the likelihood of medication errors, the ASP clinical coordinator assembles each of the casirivimab/imdevimab vials into kits, where 1 kit equals 1 dose. Labels are then affixed to each kit indicating the medication name, number of vials which equal a full dose, and pharmacist signature. The kits are stored in a dedicated refrigerator, and inventory logs are affixed to the outside of the refrigerator and updated daily. This inventory is also communicated daily to ED physician, nursing, and pharmacy leadership, as well as the director of patient safety, who reports weekly usage to the state Department of Health and Human Services. These weekly reports are used to determine allocation amounts.

Medication Verification and Delivery. The Mount Sinai Medical Center pharmacist staffing model consists of centralized order entry and specialized, decentralized positions. All orders are verified by the ED pharmacist when scheduled (not a 24/7 service) and by the designated pharmacist for all other times. At the time of medication verification, the pharmacist documents patient-specific EUA criteria for use and confirms that consent was obtained and the Fact Sheet for Patients/Caregivers was provided. A pharmacist intervention was developed to assist with this documentation. Pharmacists input smart text “.COVIDmonoclonal” and a drop-down menu of EUA criteria for use appears. The pharmacist reviews the patient care notes and medication order question responses to ascertain this information, contacting the ED prescriber if further clarification is required. This verification serves as another check to ensure processes put in place are followed. Lastly, intravenous preparation and delivery are electronically recorded in the EHR, and the medications require nursing signature at the time of delivery to ensure a formal chain of custody.

Risk Management

At Mount Sinai Medical Center, all EUA and investigational therapies require patient consent. Consistent with this requirement, a COVID-19 monoclonal specific consent was developed by risk management. This is provided to every patient receiving a COVID-19 monoclonal infusion, in addition to the FDA EUA Fact Sheet for Patients and Caregivers, and documented as part of their EHR. The questions providers must answer are built into the order set to ensure this process is followed and these patient safety checks are incorporated into the workflow.

Billing and Finance Department

In alignment with Mount Sinai Medical Center’s mission to provide high-quality health care to its diverse community through teaching, research, charity care, and financial responsibility, it was determined that this therapy would be provided to all patients regardless of insurance type, including those who are uninsured. The billing and finance department was consulted prior to this service being offered, to provide patients with accurate and pertinent information. The billing and finance department provided guidance on how to document patient encounters at time of registration to facilitate appropriate billing. At this time, the medication is free of charge, but nonmedication-related ED fees apply. This is explained to patients so there is a clear understanding prior to booking their appointment.

Infection Prevention

As patients receiving COVID-19 monoclonal therapies can transmit the virus to others, measures to ensure protection for other patients and staff are vital. To minimize exposure, specific nursing and physician staff from the ED are assigned to the treatment of these patients, and patients receive infusions and postobservation monitoring in a designated wing of the ED. Additionally, all staff who interact with these patients are required to don full personal protective equipment. This includes not only physicians and nurses but all specialties such as physician assistants, nurse practitioners, pharmacists, and laboratory technicians. Moreover, patients are not permitted to go home in a ride share and are counseled on Centers for Disease Control and Prevention quarantining following infusion.

Measurement of Process and Outcomes and Reporting

IRB approval was sought and obtained early during initiation of this service, allowing study consent to be offered to patients at the time general consent was obtained, which maximized patient recruitment and streamlined workflow. The study is a prospective observational research study to determine the impact of administration of COVID-19 monoclonal antibody therapy on length of symptoms, chronic illness, and rate of hospitalization. Most patients were eager to participate and offer their assistance to the scientific community during this pandemic.

Staff Education

In order to successfully implement this multidisciplinary EUA treatment option, comprehensive staff education was paramount after the workflow was developed. Prior to the first day of infusions, nurses and pharmacists were provided education during multiple huddle announcements. The pharmacy team also provided screen captures via email to the pharmacists so they could become familiar with the order set, intervention documentation, and location of the preliminary assessment of EUA criteria for use at the time of order verification. The emergency medicine department chair and chief medical officer also provided education via several virtual meetings and email to referring physicians (specialists and primary care) and residents in the emergency centers involved in COVID-19 monoclonal therapy-related patient care.

Factors Contributing to Success

We believe the reasons for continued success of this process are multifactorial and include the following key elements. Multidisciplinary planning, which included decision makers and all stakeholders, began at the time the idea was conceived. This allowed quick implementation of this service by efficiently navigating barriers to engaging impacted staff early on. Throughout this process, the authors set realistic step-wise goals. While navigating through the many details to implementation described, we also kept in mind the big picture, which was to provide this potentially lifesaving therapy to as many qualifying members of our community as possible. This included being flexible with the process and adapting when needed to achieve this ultimate goal. A focus on safety remained a priority to minimize possible errors and enhance patient and staff satisfaction. The optimization of the EHR streamlined workflow, provided point-of-care resources, and enhanced patient safety. Additionally, the target date set for implementation allowed staff and department leads adequate time to plan for and anticipate the changes. Serving only 1 patient on the first day allowed time for staff to experience this new process hands-on and provided opportunity for focused education. This team communication was essential to implementing this project, including staff training of processes and procedures prior to go-live. Early incorporation of IRB approval allowed the experience to be assessed and considered for contribution to the scientific literature to tackle this novel virus that has impacted our communities locally, nationally, and abroad. Moreover, continued measurement and reporting on a regular basis leads to performance improvement. The process outlined here can be adapted to incorporate other new therapies in the future, such as the recent February 9, 2021, EUA of the COVID-19 monoclonal antibody combination bamlanivimab and etesevimab.¹⁰

Conclusion

We administered 790 COVID-19 monoclonal antibody infusions between November 20, 2020 and March 5, 2021. Steps to minimize the likelihood of hypersensitivity reactions were implemented, and a low incidence (< 1%) has been observed. There has been no incidence of infection, concern from staff about infection prevention, or risk of infection during the processes. There have been very infrequent cost-related concerns raised by patients, typically due to incomplete communication regarding billing prior to the infusion. To address these issues, staff education has been provided to enhance patient instruction on this topic. The program has provided patient and family satisfaction, as well nursing, physician, pharmacist, clinical staff, and hospital administration pride and gratification. Setting up a new program to provide a 4-hour patient encounter to infuse therapy to high-risk patients with COVID-19 requires commitment and effort. This article describes the experience, ideas, and formula others may consider using to set up such a program. Through networking and formal phone calls and meetings about monoclonal antibody therapy, we have heard about other institutions who have not been able to institute this program due to various barriers to implementation. We hope our experience serves as a resource for others to provide this therapy to their patients and expand access in an effort to mitigate COVID-19 consequences and cases affecting our communities.

Corresponding author: Kathleen Jodoin, PharmD, BCPS, Mount Sinai Medical Center, 4300 Alton Rd, Miami Beach, FL 33140; [email protected].

Financial disclosures: None.

From Mount Sinai Medical Center, Miami Beach, FL.

Abstract

Objective: To develop and implement a process for administering COVID-19 monoclonal antibody infusions for outpatients with mild or moderate COVID-19 at high risk for hospitalization, using multidisciplinary collaboration, US Food and Drug Administration (FDA) guidance, and infection prevention standards.

Methods: When monoclonal antibody therapy became available for mild or moderate COVID-19 outpatients via Emergency Use Authorization (EUA), our institution sought to provide this therapy option to our patients. We describe the process for planning, implementing, and maintaining a successful program for administering novel therapies based on FDA guidance and infection prevention standards. Key components of our implementation process were multidisciplinary planning involving decision makers and stakeholders; setting realistic goals in the process; team communication; and measuring and reporting quality improvement on a regular basis.

Results: A total of 790 COVID-19 monoclonal antibody infusions were administered from November 20, 2020 to March 5, 2021. Steps to minimize the likelihood of adverse drug reactions were implemented and a low incidence (< 1%) has occurred. There has been no concern from staff regarding infection during the process. Rarely, patients have raised cost-related concerns, typically due to incomplete communication regarding billing prior to the infusion. Patients, families, nursing staff, physicians, pharmacy, and hospital administration have expressed satisfaction with the program.

Conclusion: This process can provide a template for other hospitals or health care delivery facilities to provide novel therapies to patients with mild or moderate COVID-19 in a safe and effective manner.

Keywords: COVID-19; monoclonal antibody; infusion; emergency use authorization.

SARS-CoV-2 and the disease it causes, COVID-19, have transformed from scientific vernacular to common household terms. It began with a cluster of pneumonia cases of unknown etiology in December 2019 in Wuhan, China, with physicians there reporting a novel coronavirus strain (2019-nCoV), now referred to as SARS-CoV-2. Rapid spread of this virus resulted in the World Health Organization (WHO) declaring an international public health emergency. Since this time, the virus has evolved into a worldwide pandemic. COVID-19 has dramatically impacted our society, resulting in more than 2.63 million global deaths as of this writing, of which more than 527,000 deaths have occurred in the United States.¹ This novel virus has resulted in a flurry of literature, research, therapies, and collaboration across multiple disciplines in an effort to prevent, treat, and mitigate cases and complications of this disease.

On November 9, 2020, and November 21, 2020, the US Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUA) for 2 novel COVID-19 monoclonal therapies, bamlanivimab^2-3 and casirivimab/imdevimab,^3-4 respectively. The EUAs granted permission for these therapies to be administered for the treatment of mild to moderate COVID-19 in adult and pediatric patients (≥ 12 years and weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization. The therapies work by targeting the SARS-CoV-2 spike protein and subsequent attachment to human angiotensin-converting enzyme 2 receptors. Clinical trial data leading to the EUA demonstrated a reduction in viral load, safe outcome, and most importantly, fewer hospitalization and emergency room visits, as compared to the placebo group.^5-7 The use of monoclonal antibodies is not new and gained recognition during the Ebola crisis, when the monoclonal antibody to the Ebola virus showed a significant survival benefit.⁸ Providing monoclonal antibody therapy soon after symptom onset aligns with a shift from the onset of the pandemic to the current focus on the administration of pharmaceutical therapy early in the disease course. This shift prevents progression to severe COVID-19, with the goal of reducing patient mortality, hospitalizations, and strain on health care systems.

The availability of novel neutralizing monoclonal antibodies for COVID-19 led to discussions of how to incorporate these therapies as new options for patients. Our institution networked with colleagues from multiple disciplines to discuss processes and policies for the safe administration of the monoclonal antibody infusion therapies. Federal health leaders urge more use of monoclonal antibodies, but many hospitals have been unable to successfully implement infusions due to staff and logistical challenges.⁹ This article presents a viable process that hospitals can use to provide these novel therapies to outpatients with mild to moderate COVID-19.

The Mount Sinai Medical Center, Florida Experience

Mount Sinai Medical Center in Miami Beach, Florida, is the largest private, independent, not-for-profit teaching hospital in South Florida, comprising 672 licensed beds and supporting 150,000 emergency department (ED) visits annually. Per the EUA criteria for use, COVID-19 monoclonal antibody therapies are not authorized for patients who are hospitalized or who require oxygen therapy due to COVID-19. Therefore, options for outpatient administration needed to be evaluated. Directly following the first EUA press release, a task force of key stakeholders was assembled to brainstorm and develop a process to offer this therapy to the community. A multidisciplinary task force with representation from the ED, nursing, primary care, hospital medicine, pharmacy, risk management, billing, information technology, infection prevention, and senior level leadership participated (Table).

The task force reviewed institutional outpatient locations to determine whether offering this service would be feasible (eg, ED, ambulatory care facilities, cancer center). The ED was selected because it would offer the largest array of appointment times to meet the community needs with around-the-clock availability. While Mount Sinai Medical Center offers care in 3 emergency center locations in Aventura, Hialeah, and Miami Beach, it was determined to initiate the infusions at the main campus center in Miami Beach only. The main campus affords an onsite pharmacy with suitable staffing to prepare the anticipated volume of infusions in a timely manner, as both therapies have short stabilities following preparation. Thus, it was decided that patients from freestanding emergency centers in Aventura and Hialeah would be moved to the Miami Beach ED location to receive therapy. Operating at a single site also allowed for more rapid implementation, monitoring, and ability to make modifications more easily. Discussions for the possible expansion of COVID-19 monoclonal antibody infusions at satellite locations are underway.

On November 20, 2020, 11 days after the formation of the multidisciplinary task force, the first COVID-19 monoclonal infusion was successfully administered. Figure 1 depicts the timeline from assessment to program implementation. Critical to implementation was the involvement of decision makers from all necessary departments early in the planning process to ensure that standard operating procedures were followed and that the patients, community, and organization had a positive experience. This allowed for simultaneous planning of electronic health record (Epic; EHR) builds, departmental workflows, and staff education, as described in the following section. Figure 2 shows the patient safety activities included in the implementation process.

On the day of bamlanivimab EUA release, email communication was shared among hospital leadership with details of the press release. Departments were quickly involved to initiate a task force to assess if and how this therapy could be offered at Mount Sinai Medical Center. The following sections explain the role of each stakeholder and their essential role to operationalize these novel EUA treatment options. The task force was organized and led by our chief medical officer and chief nursing officer.

Information Technology

Medication Ordering and Documentation EHR and Smart Pumps. Early in the pandemic, the antimicrobial stewardship (ASP) clinical coordinator became the designated point person for pharmacy assessment of novel COVID-19 therapies. As such, this pharmacist began reviewing the bamlanivimab and, later, the casirivimab/imdevimab EUA Fact Sheet for Health Care Providers. All necessary elements for the complete and safe ordering and dispensing of the medication were developed and reviewed by pharmacy administration and ED nursing leadership for input, prior to submitting to the information technology team for implementation. Building the COVID-19 monoclonal medication records into the EHR allowed for detailed direction (ie, administration and preparation instructions) to be consistently applied. The medication records were also built into hospital smart pumps so that nurses could access prepopulated, accurate volumes and infusion rates to minimize errors.

Order Set Development. The pharmacy medication build was added to a comprehensive order set (Figure 3), which was then developed to guide prescribers and standardize the process around ordering of COVID-19 monoclonal therapies. While these therapies are new, oncology monoclonal therapies are regularly administered to outpatients at Mount Sinai Cancer Center. The cancer center was therefore consulted on their process surrounding best practices in administration of monoclonal antibody therapies. This included protocols for medications used in pretreatment and management of hypersensitivity reactions and potential adverse drug reactions of both COVID-19 monoclonal therapies. These medication orders were selected by default in the order set to ensure that all patients received premedications aimed at minimizing the risk of hypersensitivity reaction, and had as-needed medication orders, in the event a hypersensitivity reaction occurred. Reducing hypersensitivity reaction risk is important as well to increase the likelihood that the patient would receive full therapy, as management of this adverse drug reactions involves possible cessation of therapy depending on the level of severity. The pharmacy department also ensured these medications were stocked in ED automated dispensing cabinets to promote quick access. In addition to the aforementioned nursing orders, we added EUA criteria for use and hyperlinks to the Fact Sheets for Patients and Caregivers and Health Care Providers for each monoclonal therapy, and restricted ordering to ED physicians, nurse practitioners, and physician assistants.

The order set underwent multidisciplinary review by pharmacy administration, the chair of emergency medicine, physicians, and ED nursing leadership prior to presentation and approval by the Pharmacy and Therapeutics Committee. Lastly, at time of implementation, the order set was added to the ED preference list, preventing inpatient access. Additionally, as a patient safety action, free- standing orders of COVID-19 monoclonal therapies were disabled, so providers could only order therapies via the approved, comprehensive order set.

Preliminary Assessment Tool. A provider assessment tool was developed to document patient-specific EUA criteria for use during initial assessment (Figure 4). This tool serves as a checklist and is visible to the full multidisciplinary team in the patient’s EHR. It is used as a resource at the time of pharmacist verification and ED physician assessment to ensure criteria for use are met.

Patient Referral. Patients with symptoms or concerns of COVID-19 exposure can make physician appointments via telemedicine or in person at Mount Sinai Medical Center’s primary care and specialty offices. At the time of patient encounter, physicians suspecting a COVID-19 diagnosis will refer patients for outpatient COVID-19 polymerase chain reaction (PCR) laboratory testing, which has an approximate 24-hour turnaround to results. Physicians also assess whether the patient meets EUA criteria for use, pending results of testing. In the event a patient meets EUA criteria for use, the physician provides patient counseling and requests verbal consent. Following this, the physician enters a note in the EHR describing the patient’s condition, criteria for use evaluation, and the patient’s verbal agreement to therapy. This preliminary screening is beneficial to begin planning with both the patient and ED to minimize delays. Patients are notified of the results of their test once available. If the COVID-19 PCR test returns positive, the physician will call the ED at the main campus and schedule the patient for COVID-19 monoclonal therapy. As the desired timeframe for administering COVID-19 monoclonal therapies is within less than 10 days of symptom onset, timely scheduling of appointments is crucial. Infusion appointments are typically provided the same or next day. The patients are informed that they must bring documentation of their positive COVID-19 PCR test to their ED visit. Lastly, because patients are pretreated with medication that may potentially impair driving, they are instructed that they cannot drive themselves home; ride shares also are not allowed in order to limit the spread of infection.

Emergency Department

Patient Arrival and Screening. A COVID-19 patient can be evaluated in the ED 1 of 2 ways. The first option is via outpatient office referral, as described previously. Upon arrival to the ED, a second screening is performed to ensure the patient still meets EUA criteria for use and the positive COVID-19 PCR test result is confirmed. If the patient no longer meets criteria, the patient is triaged accordingly, including evaluation for higher-level care (eg, supplemental oxygen, hospital admission). The second optoion is via new patient walk-ins without outpatient physician referral (Figure 4). In these cases, an initial screening is performed, documenting EUA criteria for use in the preliminary assessment (Figure 5). Physicians will consider an outside COVID-19 test as valid, so long as documentation is readily available confirming a positive PCR result. Otherwise, an in-house COVID-19 PCR test will be performed, which has a 2-hour turnaround time.

Infusion Schedule. The ED offers a total of 16 COVID-19 monoclonal infusions slots daily. These are broken up into 4 infusion time blocks (eg, 8 am, 12 pm, 4 pm, 8 pm), with each infusion time block consisting of 4 available patient appointments. A list of scheduled infusions for the day is emailed to the pharmacy department every morning, and patients are instructed to arrive 1 hour prior to their appointment time. This allows time for patient registration, assessment, and pharmacy notification in advance of order entry. For logistical purposes, and as a patient safety initiative to reduce the likelihood of medication errors, each of the available COVID-19 monoclonal antibodies is offered on a designated day. Bamlanivimab is offered on Tuesday, Thursday, Saturday, and Sunday, while casirivimab/imdevimab is offered Monday, Wednesday, and Friday. This provides flexibility to adjust should supply deviate based on Department of Health allocation or should new therapy options within this class of medication become available.

Patient Education. Prior to administration of the monoclonal therapy, physician and nursing staff obtain a formal, written patient consent for therapy and provide patients with the option of participating in the institutional review board (IRB) approved study. Details of this are discussed in the risk management and IRB sections of the article. Nursing staff also provides the medication-specific Fact Sheet for Patients and Caregivers in either Spanish or English, which is also included as a hyperlink on the COVID-19 Monoclonal Antibody Order Set for ease of access. Interpreter services are available for patients who speak other languages. An ED decentralized pharmacist is also available onsite Monday through Friday from 12 pm to 8:30 pm to supplement education and serve as a resource for any questions.

Infusion Ordering. Once the patient is ready to begin therapy, the he/she is brought to a dedicated overflow area of the ED. There are few, if any, patients in this location, and it is adjacent to the main emergency center for easy access by the patients, nurses, pharmacists, and physicians. The physician then enters orders in the EHR using the COVID-19 Monoclonal Antibody Order Set (Figure 3). Three discrete questions were built into the medication order: (1) Was patient consent obtained? (2) Was the Fact Sheet for Patient/Caregiver provided to the patient? (3) Is the patient COVID-19 PCR-positive? These questions were built as hard stops so that the medication orders cannot be placed without a response. This serves as another double-check to ensure processes are followed and helps facilitate timely verification by the pharmacist.

Medication Administration. One nurse is dedicated to administering the monoclonal therapies scheduled at 8 am and 12 pm and another at 4 pm and 8 pm. Each appointment block is 4 hours in duration to allow adequate time for patient registration, infusion, and postinfusion observation. The nurse administers the premedications and COVID-19 monoclonal therapy, and observes the patient for the required 1-hour postadministration observation period. Nursing orders detailing monitoring parameters for mild, moderate, and severe reactions, along with associated medication orders to administer in the event they occur, are detailed in the nursing orders of the COVID-19 Monoclonal Antibody Order Set (Figure 3). Prior to administration, the nurse scans each medication and the patient’s wrist identification band, and documents the time of administration within the EHR medication administration report.

Pharmacy Department

Medication Receipt Process. Inventory is currently allocated biweekly from the state department of health and will soon be transitioning to a direct order system. The pharmacy technician in charge of deliveries notifies the pharmacy Antimicrobial Stewardship Program (ASP) clinical coordinator upon receipt of the monoclonal therapies. Bamlanivimab is supplied as 1 vial per dose, whereas casirivimab/imdevimab is supplied as 4 vials or 8 vials per dose, depending how it is shipped. To reduce the likelihood of medication errors, the ASP clinical coordinator assembles each of the casirivimab/imdevimab vials into kits, where 1 kit equals 1 dose. Labels are then affixed to each kit indicating the medication name, number of vials which equal a full dose, and pharmacist signature. The kits are stored in a dedicated refrigerator, and inventory logs are affixed to the outside of the refrigerator and updated daily. This inventory is also communicated daily to ED physician, nursing, and pharmacy leadership, as well as the director of patient safety, who reports weekly usage to the state Department of Health and Human Services. These weekly reports are used to determine allocation amounts.

Medication Verification and Delivery. The Mount Sinai Medical Center pharmacist staffing model consists of centralized order entry and specialized, decentralized positions. All orders are verified by the ED pharmacist when scheduled (not a 24/7 service) and by the designated pharmacist for all other times. At the time of medication verification, the pharmacist documents patient-specific EUA criteria for use and confirms that consent was obtained and the Fact Sheet for Patients/Caregivers was provided. A pharmacist intervention was developed to assist with this documentation. Pharmacists input smart text “.COVIDmonoclonal” and a drop-down menu of EUA criteria for use appears. The pharmacist reviews the patient care notes and medication order question responses to ascertain this information, contacting the ED prescriber if further clarification is required. This verification serves as another check to ensure processes put in place are followed. Lastly, intravenous preparation and delivery are electronically recorded in the EHR, and the medications require nursing signature at the time of delivery to ensure a formal chain of custody.

Risk Management

At Mount Sinai Medical Center, all EUA and investigational therapies require patient consent. Consistent with this requirement, a COVID-19 monoclonal specific consent was developed by risk management. This is provided to every patient receiving a COVID-19 monoclonal infusion, in addition to the FDA EUA Fact Sheet for Patients and Caregivers, and documented as part of their EHR. The questions providers must answer are built into the order set to ensure this process is followed and these patient safety checks are incorporated into the workflow.

Billing and Finance Department

In alignment with Mount Sinai Medical Center’s mission to provide high-quality health care to its diverse community through teaching, research, charity care, and financial responsibility, it was determined that this therapy would be provided to all patients regardless of insurance type, including those who are uninsured. The billing and finance department was consulted prior to this service being offered, to provide patients with accurate and pertinent information. The billing and finance department provided guidance on how to document patient encounters at time of registration to facilitate appropriate billing. At this time, the medication is free of charge, but nonmedication-related ED fees apply. This is explained to patients so there is a clear understanding prior to booking their appointment.

Infection Prevention

As patients receiving COVID-19 monoclonal therapies can transmit the virus to others, measures to ensure protection for other patients and staff are vital. To minimize exposure, specific nursing and physician staff from the ED are assigned to the treatment of these patients, and patients receive infusions and postobservation monitoring in a designated wing of the ED. Additionally, all staff who interact with these patients are required to don full personal protective equipment. This includes not only physicians and nurses but all specialties such as physician assistants, nurse practitioners, pharmacists, and laboratory technicians. Moreover, patients are not permitted to go home in a ride share and are counseled on Centers for Disease Control and Prevention quarantining following infusion.

Measurement of Process and Outcomes and Reporting

IRB approval was sought and obtained early during initiation of this service, allowing study consent to be offered to patients at the time general consent was obtained, which maximized patient recruitment and streamlined workflow. The study is a prospective observational research study to determine the impact of administration of COVID-19 monoclonal antibody therapy on length of symptoms, chronic illness, and rate of hospitalization. Most patients were eager to participate and offer their assistance to the scientific community during this pandemic.

Staff Education

In order to successfully implement this multidisciplinary EUA treatment option, comprehensive staff education was paramount after the workflow was developed. Prior to the first day of infusions, nurses and pharmacists were provided education during multiple huddle announcements. The pharmacy team also provided screen captures via email to the pharmacists so they could become familiar with the order set, intervention documentation, and location of the preliminary assessment of EUA criteria for use at the time of order verification. The emergency medicine department chair and chief medical officer also provided education via several virtual meetings and email to referring physicians (specialists and primary care) and residents in the emergency centers involved in COVID-19 monoclonal therapy-related patient care.

Factors Contributing to Success

We believe the reasons for continued success of this process are multifactorial and include the following key elements. Multidisciplinary planning, which included decision makers and all stakeholders, began at the time the idea was conceived. This allowed quick implementation of this service by efficiently navigating barriers to engaging impacted staff early on. Throughout this process, the authors set realistic step-wise goals. While navigating through the many details to implementation described, we also kept in mind the big picture, which was to provide this potentially lifesaving therapy to as many qualifying members of our community as possible. This included being flexible with the process and adapting when needed to achieve this ultimate goal. A focus on safety remained a priority to minimize possible errors and enhance patient and staff satisfaction. The optimization of the EHR streamlined workflow, provided point-of-care resources, and enhanced patient safety. Additionally, the target date set for implementation allowed staff and department leads adequate time to plan for and anticipate the changes. Serving only 1 patient on the first day allowed time for staff to experience this new process hands-on and provided opportunity for focused education. This team communication was essential to implementing this project, including staff training of processes and procedures prior to go-live. Early incorporation of IRB approval allowed the experience to be assessed and considered for contribution to the scientific literature to tackle this novel virus that has impacted our communities locally, nationally, and abroad. Moreover, continued measurement and reporting on a regular basis leads to performance improvement. The process outlined here can be adapted to incorporate other new therapies in the future, such as the recent February 9, 2021, EUA of the COVID-19 monoclonal antibody combination bamlanivimab and etesevimab.¹⁰

Conclusion

We administered 790 COVID-19 monoclonal antibody infusions between November 20, 2020 and March 5, 2021. Steps to minimize the likelihood of hypersensitivity reactions were implemented, and a low incidence (< 1%) has been observed. There has been no incidence of infection, concern from staff about infection prevention, or risk of infection during the processes. There have been very infrequent cost-related concerns raised by patients, typically due to incomplete communication regarding billing prior to the infusion. To address these issues, staff education has been provided to enhance patient instruction on this topic. The program has provided patient and family satisfaction, as well nursing, physician, pharmacist, clinical staff, and hospital administration pride and gratification. Setting up a new program to provide a 4-hour patient encounter to infuse therapy to high-risk patients with COVID-19 requires commitment and effort. This article describes the experience, ideas, and formula others may consider using to set up such a program. Through networking and formal phone calls and meetings about monoclonal antibody therapy, we have heard about other institutions who have not been able to institute this program due to various barriers to implementation. We hope our experience serves as a resource for others to provide this therapy to their patients and expand access in an effort to mitigate COVID-19 consequences and cases affecting our communities.

Corresponding author: Kathleen Jodoin, PharmD, BCPS, Mount Sinai Medical Center, 4300 Alton Rd, Miami Beach, FL 33140; [email protected].

Financial disclosures: None.

From Mount Sinai Medical Center, Miami Beach, FL.

Abstract

Objective: To develop and implement a process for administering COVID-19 monoclonal antibody infusions for outpatients with mild or moderate COVID-19 at high risk for hospitalization, using multidisciplinary collaboration, US Food and Drug Administration (FDA) guidance, and infection prevention standards.

Methods: When monoclonal antibody therapy became available for mild or moderate COVID-19 outpatients via Emergency Use Authorization (EUA), our institution sought to provide this therapy option to our patients. We describe the process for planning, implementing, and maintaining a successful program for administering novel therapies based on FDA guidance and infection prevention standards. Key components of our implementation process were multidisciplinary planning involving decision makers and stakeholders; setting realistic goals in the process; team communication; and measuring and reporting quality improvement on a regular basis.

Results: A total of 790 COVID-19 monoclonal antibody infusions were administered from November 20, 2020 to March 5, 2021. Steps to minimize the likelihood of adverse drug reactions were implemented and a low incidence (< 1%) has occurred. There has been no concern from staff regarding infection during the process. Rarely, patients have raised cost-related concerns, typically due to incomplete communication regarding billing prior to the infusion. Patients, families, nursing staff, physicians, pharmacy, and hospital administration have expressed satisfaction with the program.

Conclusion: This process can provide a template for other hospitals or health care delivery facilities to provide novel therapies to patients with mild or moderate COVID-19 in a safe and effective manner.

Keywords: COVID-19; monoclonal antibody; infusion; emergency use authorization.

SARS-CoV-2 and the disease it causes, COVID-19, have transformed from scientific vernacular to common household terms. It began with a cluster of pneumonia cases of unknown etiology in December 2019 in Wuhan, China, with physicians there reporting a novel coronavirus strain (2019-nCoV), now referred to as SARS-CoV-2. Rapid spread of this virus resulted in the World Health Organization (WHO) declaring an international public health emergency. Since this time, the virus has evolved into a worldwide pandemic. COVID-19 has dramatically impacted our society, resulting in more than 2.63 million global deaths as of this writing, of which more than 527,000 deaths have occurred in the United States.¹ This novel virus has resulted in a flurry of literature, research, therapies, and collaboration across multiple disciplines in an effort to prevent, treat, and mitigate cases and complications of this disease.

On November 9, 2020, and November 21, 2020, the US Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUA) for 2 novel COVID-19 monoclonal therapies, bamlanivimab^2-3 and casirivimab/imdevimab,^3-4 respectively. The EUAs granted permission for these therapies to be administered for the treatment of mild to moderate COVID-19 in adult and pediatric patients (≥ 12 years and weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization. The therapies work by targeting the SARS-CoV-2 spike protein and subsequent attachment to human angiotensin-converting enzyme 2 receptors. Clinical trial data leading to the EUA demonstrated a reduction in viral load, safe outcome, and most importantly, fewer hospitalization and emergency room visits, as compared to the placebo group.^5-7 The use of monoclonal antibodies is not new and gained recognition during the Ebola crisis, when the monoclonal antibody to the Ebola virus showed a significant survival benefit.⁸ Providing monoclonal antibody therapy soon after symptom onset aligns with a shift from the onset of the pandemic to the current focus on the administration of pharmaceutical therapy early in the disease course. This shift prevents progression to severe COVID-19, with the goal of reducing patient mortality, hospitalizations, and strain on health care systems.

The availability of novel neutralizing monoclonal antibodies for COVID-19 led to discussions of how to incorporate these therapies as new options for patients. Our institution networked with colleagues from multiple disciplines to discuss processes and policies for the safe administration of the monoclonal antibody infusion therapies. Federal health leaders urge more use of monoclonal antibodies, but many hospitals have been unable to successfully implement infusions due to staff and logistical challenges.⁹ This article presents a viable process that hospitals can use to provide these novel therapies to outpatients with mild to moderate COVID-19.

The Mount Sinai Medical Center, Florida Experience

Mount Sinai Medical Center in Miami Beach, Florida, is the largest private, independent, not-for-profit teaching hospital in South Florida, comprising 672 licensed beds and supporting 150,000 emergency department (ED) visits annually. Per the EUA criteria for use, COVID-19 monoclonal antibody therapies are not authorized for patients who are hospitalized or who require oxygen therapy due to COVID-19. Therefore, options for outpatient administration needed to be evaluated. Directly following the first EUA press release, a task force of key stakeholders was assembled to brainstorm and develop a process to offer this therapy to the community. A multidisciplinary task force with representation from the ED, nursing, primary care, hospital medicine, pharmacy, risk management, billing, information technology, infection prevention, and senior level leadership participated (Table).

The task force reviewed institutional outpatient locations to determine whether offering this service would be feasible (eg, ED, ambulatory care facilities, cancer center). The ED was selected because it would offer the largest array of appointment times to meet the community needs with around-the-clock availability. While Mount Sinai Medical Center offers care in 3 emergency center locations in Aventura, Hialeah, and Miami Beach, it was determined to initiate the infusions at the main campus center in Miami Beach only. The main campus affords an onsite pharmacy with suitable staffing to prepare the anticipated volume of infusions in a timely manner, as both therapies have short stabilities following preparation. Thus, it was decided that patients from freestanding emergency centers in Aventura and Hialeah would be moved to the Miami Beach ED location to receive therapy. Operating at a single site also allowed for more rapid implementation, monitoring, and ability to make modifications more easily. Discussions for the possible expansion of COVID-19 monoclonal antibody infusions at satellite locations are underway.

On November 20, 2020, 11 days after the formation of the multidisciplinary task force, the first COVID-19 monoclonal infusion was successfully administered. Figure 1 depicts the timeline from assessment to program implementation. Critical to implementation was the involvement of decision makers from all necessary departments early in the planning process to ensure that standard operating procedures were followed and that the patients, community, and organization had a positive experience. This allowed for simultaneous planning of electronic health record (Epic; EHR) builds, departmental workflows, and staff education, as described in the following section. Figure 2 shows the patient safety activities included in the implementation process.

On the day of bamlanivimab EUA release, email communication was shared among hospital leadership with details of the press release. Departments were quickly involved to initiate a task force to assess if and how this therapy could be offered at Mount Sinai Medical Center. The following sections explain the role of each stakeholder and their essential role to operationalize these novel EUA treatment options. The task force was organized and led by our chief medical officer and chief nursing officer.

Information Technology

Medication Ordering and Documentation EHR and Smart Pumps. Early in the pandemic, the antimicrobial stewardship (ASP) clinical coordinator became the designated point person for pharmacy assessment of novel COVID-19 therapies. As such, this pharmacist began reviewing the bamlanivimab and, later, the casirivimab/imdevimab EUA Fact Sheet for Health Care Providers. All necessary elements for the complete and safe ordering and dispensing of the medication were developed and reviewed by pharmacy administration and ED nursing leadership for input, prior to submitting to the information technology team for implementation. Building the COVID-19 monoclonal medication records into the EHR allowed for detailed direction (ie, administration and preparation instructions) to be consistently applied. The medication records were also built into hospital smart pumps so that nurses could access prepopulated, accurate volumes and infusion rates to minimize errors.

Order Set Development. The pharmacy medication build was added to a comprehensive order set (Figure 3), which was then developed to guide prescribers and standardize the process around ordering of COVID-19 monoclonal therapies. While these therapies are new, oncology monoclonal therapies are regularly administered to outpatients at Mount Sinai Cancer Center. The cancer center was therefore consulted on their process surrounding best practices in administration of monoclonal antibody therapies. This included protocols for medications used in pretreatment and management of hypersensitivity reactions and potential adverse drug reactions of both COVID-19 monoclonal therapies. These medication orders were selected by default in the order set to ensure that all patients received premedications aimed at minimizing the risk of hypersensitivity reaction, and had as-needed medication orders, in the event a hypersensitivity reaction occurred. Reducing hypersensitivity reaction risk is important as well to increase the likelihood that the patient would receive full therapy, as management of this adverse drug reactions involves possible cessation of therapy depending on the level of severity. The pharmacy department also ensured these medications were stocked in ED automated dispensing cabinets to promote quick access. In addition to the aforementioned nursing orders, we added EUA criteria for use and hyperlinks to the Fact Sheets for Patients and Caregivers and Health Care Providers for each monoclonal therapy, and restricted ordering to ED physicians, nurse practitioners, and physician assistants.

The order set underwent multidisciplinary review by pharmacy administration, the chair of emergency medicine, physicians, and ED nursing leadership prior to presentation and approval by the Pharmacy and Therapeutics Committee. Lastly, at time of implementation, the order set was added to the ED preference list, preventing inpatient access. Additionally, as a patient safety action, free- standing orders of COVID-19 monoclonal therapies were disabled, so providers could only order therapies via the approved, comprehensive order set.

Preliminary Assessment Tool. A provider assessment tool was developed to document patient-specific EUA criteria for use during initial assessment (Figure 4). This tool serves as a checklist and is visible to the full multidisciplinary team in the patient’s EHR. It is used as a resource at the time of pharmacist verification and ED physician assessment to ensure criteria for use are met.

Patient Referral. Patients with symptoms or concerns of COVID-19 exposure can make physician appointments via telemedicine or in person at Mount Sinai Medical Center’s primary care and specialty offices. At the time of patient encounter, physicians suspecting a COVID-19 diagnosis will refer patients for outpatient COVID-19 polymerase chain reaction (PCR) laboratory testing, which has an approximate 24-hour turnaround to results. Physicians also assess whether the patient meets EUA criteria for use, pending results of testing. In the event a patient meets EUA criteria for use, the physician provides patient counseling and requests verbal consent. Following this, the physician enters a note in the EHR describing the patient’s condition, criteria for use evaluation, and the patient’s verbal agreement to therapy. This preliminary screening is beneficial to begin planning with both the patient and ED to minimize delays. Patients are notified of the results of their test once available. If the COVID-19 PCR test returns positive, the physician will call the ED at the main campus and schedule the patient for COVID-19 monoclonal therapy. As the desired timeframe for administering COVID-19 monoclonal therapies is within less than 10 days of symptom onset, timely scheduling of appointments is crucial. Infusion appointments are typically provided the same or next day. The patients are informed that they must bring documentation of their positive COVID-19 PCR test to their ED visit. Lastly, because patients are pretreated with medication that may potentially impair driving, they are instructed that they cannot drive themselves home; ride shares also are not allowed in order to limit the spread of infection.

Emergency Department

Patient Arrival and Screening. A COVID-19 patient can be evaluated in the ED 1 of 2 ways. The first option is via outpatient office referral, as described previously. Upon arrival to the ED, a second screening is performed to ensure the patient still meets EUA criteria for use and the positive COVID-19 PCR test result is confirmed. If the patient no longer meets criteria, the patient is triaged accordingly, including evaluation for higher-level care (eg, supplemental oxygen, hospital admission). The second optoion is via new patient walk-ins without outpatient physician referral (Figure 4). In these cases, an initial screening is performed, documenting EUA criteria for use in the preliminary assessment (Figure 5). Physicians will consider an outside COVID-19 test as valid, so long as documentation is readily available confirming a positive PCR result. Otherwise, an in-house COVID-19 PCR test will be performed, which has a 2-hour turnaround time.

Infusion Schedule. The ED offers a total of 16 COVID-19 monoclonal infusions slots daily. These are broken up into 4 infusion time blocks (eg, 8 am, 12 pm, 4 pm, 8 pm), with each infusion time block consisting of 4 available patient appointments. A list of scheduled infusions for the day is emailed to the pharmacy department every morning, and patients are instructed to arrive 1 hour prior to their appointment time. This allows time for patient registration, assessment, and pharmacy notification in advance of order entry. For logistical purposes, and as a patient safety initiative to reduce the likelihood of medication errors, each of the available COVID-19 monoclonal antibodies is offered on a designated day. Bamlanivimab is offered on Tuesday, Thursday, Saturday, and Sunday, while casirivimab/imdevimab is offered Monday, Wednesday, and Friday. This provides flexibility to adjust should supply deviate based on Department of Health allocation or should new therapy options within this class of medication become available.

Patient Education. Prior to administration of the monoclonal therapy, physician and nursing staff obtain a formal, written patient consent for therapy and provide patients with the option of participating in the institutional review board (IRB) approved study. Details of this are discussed in the risk management and IRB sections of the article. Nursing staff also provides the medication-specific Fact Sheet for Patients and Caregivers in either Spanish or English, which is also included as a hyperlink on the COVID-19 Monoclonal Antibody Order Set for ease of access. Interpreter services are available for patients who speak other languages. An ED decentralized pharmacist is also available onsite Monday through Friday from 12 pm to 8:30 pm to supplement education and serve as a resource for any questions.

Infusion Ordering. Once the patient is ready to begin therapy, the he/she is brought to a dedicated overflow area of the ED. There are few, if any, patients in this location, and it is adjacent to the main emergency center for easy access by the patients, nurses, pharmacists, and physicians. The physician then enters orders in the EHR using the COVID-19 Monoclonal Antibody Order Set (Figure 3). Three discrete questions were built into the medication order: (1) Was patient consent obtained? (2) Was the Fact Sheet for Patient/Caregiver provided to the patient? (3) Is the patient COVID-19 PCR-positive? These questions were built as hard stops so that the medication orders cannot be placed without a response. This serves as another double-check to ensure processes are followed and helps facilitate timely verification by the pharmacist.

Medication Administration. One nurse is dedicated to administering the monoclonal therapies scheduled at 8 am and 12 pm and another at 4 pm and 8 pm. Each appointment block is 4 hours in duration to allow adequate time for patient registration, infusion, and postinfusion observation. The nurse administers the premedications and COVID-19 monoclonal therapy, and observes the patient for the required 1-hour postadministration observation period. Nursing orders detailing monitoring parameters for mild, moderate, and severe reactions, along with associated medication orders to administer in the event they occur, are detailed in the nursing orders of the COVID-19 Monoclonal Antibody Order Set (Figure 3). Prior to administration, the nurse scans each medication and the patient’s wrist identification band, and documents the time of administration within the EHR medication administration report.

Pharmacy Department

Medication Receipt Process. Inventory is currently allocated biweekly from the state department of health and will soon be transitioning to a direct order system. The pharmacy technician in charge of deliveries notifies the pharmacy Antimicrobial Stewardship Program (ASP) clinical coordinator upon receipt of the monoclonal therapies. Bamlanivimab is supplied as 1 vial per dose, whereas casirivimab/imdevimab is supplied as 4 vials or 8 vials per dose, depending how it is shipped. To reduce the likelihood of medication errors, the ASP clinical coordinator assembles each of the casirivimab/imdevimab vials into kits, where 1 kit equals 1 dose. Labels are then affixed to each kit indicating the medication name, number of vials which equal a full dose, and pharmacist signature. The kits are stored in a dedicated refrigerator, and inventory logs are affixed to the outside of the refrigerator and updated daily. This inventory is also communicated daily to ED physician, nursing, and pharmacy leadership, as well as the director of patient safety, who reports weekly usage to the state Department of Health and Human Services. These weekly reports are used to determine allocation amounts.

Medication Verification and Delivery. The Mount Sinai Medical Center pharmacist staffing model consists of centralized order entry and specialized, decentralized positions. All orders are verified by the ED pharmacist when scheduled (not a 24/7 service) and by the designated pharmacist for all other times. At the time of medication verification, the pharmacist documents patient-specific EUA criteria for use and confirms that consent was obtained and the Fact Sheet for Patients/Caregivers was provided. A pharmacist intervention was developed to assist with this documentation. Pharmacists input smart text “.COVIDmonoclonal” and a drop-down menu of EUA criteria for use appears. The pharmacist reviews the patient care notes and medication order question responses to ascertain this information, contacting the ED prescriber if further clarification is required. This verification serves as another check to ensure processes put in place are followed. Lastly, intravenous preparation and delivery are electronically recorded in the EHR, and the medications require nursing signature at the time of delivery to ensure a formal chain of custody.

Risk Management

At Mount Sinai Medical Center, all EUA and investigational therapies require patient consent. Consistent with this requirement, a COVID-19 monoclonal specific consent was developed by risk management. This is provided to every patient receiving a COVID-19 monoclonal infusion, in addition to the FDA EUA Fact Sheet for Patients and Caregivers, and documented as part of their EHR. The questions providers must answer are built into the order set to ensure this process is followed and these patient safety checks are incorporated into the workflow.

Billing and Finance Department

In alignment with Mount Sinai Medical Center’s mission to provide high-quality health care to its diverse community through teaching, research, charity care, and financial responsibility, it was determined that this therapy would be provided to all patients regardless of insurance type, including those who are uninsured. The billing and finance department was consulted prior to this service being offered, to provide patients with accurate and pertinent information. The billing and finance department provided guidance on how to document patient encounters at time of registration to facilitate appropriate billing. At this time, the medication is free of charge, but nonmedication-related ED fees apply. This is explained to patients so there is a clear understanding prior to booking their appointment.

Infection Prevention

As patients receiving COVID-19 monoclonal therapies can transmit the virus to others, measures to ensure protection for other patients and staff are vital. To minimize exposure, specific nursing and physician staff from the ED are assigned to the treatment of these patients, and patients receive infusions and postobservation monitoring in a designated wing of the ED. Additionally, all staff who interact with these patients are required to don full personal protective equipment. This includes not only physicians and nurses but all specialties such as physician assistants, nurse practitioners, pharmacists, and laboratory technicians. Moreover, patients are not permitted to go home in a ride share and are counseled on Centers for Disease Control and Prevention quarantining following infusion.

Measurement of Process and Outcomes and Reporting

IRB approval was sought and obtained early during initiation of this service, allowing study consent to be offered to patients at the time general consent was obtained, which maximized patient recruitment and streamlined workflow. The study is a prospective observational research study to determine the impact of administration of COVID-19 monoclonal antibody therapy on length of symptoms, chronic illness, and rate of hospitalization. Most patients were eager to participate and offer their assistance to the scientific community during this pandemic.

Staff Education

In order to successfully implement this multidisciplinary EUA treatment option, comprehensive staff education was paramount after the workflow was developed. Prior to the first day of infusions, nurses and pharmacists were provided education during multiple huddle announcements. The pharmacy team also provided screen captures via email to the pharmacists so they could become familiar with the order set, intervention documentation, and location of the preliminary assessment of EUA criteria for use at the time of order verification. The emergency medicine department chair and chief medical officer also provided education via several virtual meetings and email to referring physicians (specialists and primary care) and residents in the emergency centers involved in COVID-19 monoclonal therapy-related patient care.

Factors Contributing to Success

We believe the reasons for continued success of this process are multifactorial and include the following key elements. Multidisciplinary planning, which included decision makers and all stakeholders, began at the time the idea was conceived. This allowed quick implementation of this service by efficiently navigating barriers to engaging impacted staff early on. Throughout this process, the authors set realistic step-wise goals. While navigating through the many details to implementation described, we also kept in mind the big picture, which was to provide this potentially lifesaving therapy to as many qualifying members of our community as possible. This included being flexible with the process and adapting when needed to achieve this ultimate goal. A focus on safety remained a priority to minimize possible errors and enhance patient and staff satisfaction. The optimization of the EHR streamlined workflow, provided point-of-care resources, and enhanced patient safety. Additionally, the target date set for implementation allowed staff and department leads adequate time to plan for and anticipate the changes. Serving only 1 patient on the first day allowed time for staff to experience this new process hands-on and provided opportunity for focused education. This team communication was essential to implementing this project, including staff training of processes and procedures prior to go-live. Early incorporation of IRB approval allowed the experience to be assessed and considered for contribution to the scientific literature to tackle this novel virus that has impacted our communities locally, nationally, and abroad. Moreover, continued measurement and reporting on a regular basis leads to performance improvement. The process outlined here can be adapted to incorporate other new therapies in the future, such as the recent February 9, 2021, EUA of the COVID-19 monoclonal antibody combination bamlanivimab and etesevimab.¹⁰

Conclusion

We administered 790 COVID-19 monoclonal antibody infusions between November 20, 2020 and March 5, 2021. Steps to minimize the likelihood of hypersensitivity reactions were implemented, and a low incidence (< 1%) has been observed. There has been no incidence of infection, concern from staff about infection prevention, or risk of infection during the processes. There have been very infrequent cost-related concerns raised by patients, typically due to incomplete communication regarding billing prior to the infusion. To address these issues, staff education has been provided to enhance patient instruction on this topic. The program has provided patient and family satisfaction, as well nursing, physician, pharmacist, clinical staff, and hospital administration pride and gratification. Setting up a new program to provide a 4-hour patient encounter to infuse therapy to high-risk patients with COVID-19 requires commitment and effort. This article describes the experience, ideas, and formula others may consider using to set up such a program. Through networking and formal phone calls and meetings about monoclonal antibody therapy, we have heard about other institutions who have not been able to institute this program due to various barriers to implementation. We hope our experience serves as a resource for others to provide this therapy to their patients and expand access in an effort to mitigate COVID-19 consequences and cases affecting our communities.

Corresponding author: Kathleen Jodoin, PharmD, BCPS, Mount Sinai Medical Center, 4300 Alton Rd, Miami Beach, FL 33140; [email protected].

Financial disclosures: None.