MDedge Infectious Disease

An experimental antiviral pill appears to work very well at keeping people who are at high risk of severe COVID-19 from being admitted to the hospital and dying, according to the drug’s maker, Pfizer.

The drug -- called Paxlovid -- was 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who were at high risk of severe complications. The company says it plans to ask the FDA to authorize the drug for emergency use.

The medication appears to work so well that Pfizer has stopped enrollment in the trial of the drug, which works by blocking an enzyme called a protease that the new coronavirus needs to make more copies of itself.

Stopping a clinical trial is a rare action that’s typically taken when a therapy appears to be very effective or clearly dangerous. In both those cases, it’s considered unethical to continue a clinical trial where people are randomly assigned either an active drug or a placebo, when safer or more effective options are available to them.

In this case, the company said in a news release that the move was recommended by an independent panel of advisers who are overseeing the trial, called a data safety monitoring committee, and done in consultation with the FDA.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, PhD, Pfizer chairman and chief executive officer. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In a randomized clinical trial that included more than 1,900 patients who tested positive for COVID-19 and were at risk for having severe complications for their infections, those who received Paxlovid within 3 days of the start of their symptoms were 89% less likely to be hospitalized than those who got a placebo pill -- three patients out of 389 who got the drug were hospitalized, compared with 27 out of 385 who got the placebo. Among patients who got the drug within 5 days of the start of their symptoms, six out of 607 were hospitalized within 28 days, compared to 41 out of 612 who got the placebo.

There were no deaths over the course of a month in patients who took Paxlovid, but 10 deaths in the group that got the placebo.

The news comes on the heels of an announcement in October by the drug company Merck that its experimental antiviral pill, molnupiravir, reduced the risk of hospitalization or death by 50% in patients with mild to moderate COVID, compared to a placebo.

The United Kingdom became the first country to authorize the use of molnupiravir, which is brand-named Lagevrio.

Stephen Griffin, PhD, an associate professor of medicine at the University of Leeds, hailed the success of both new antiviral pills.

“They both demonstrate that, with appropriate investment, the development of bespoke direct-acting antiviral drugs targeting SARS-CoV2 was eminently feasible and has ultimately proven far more successful than repurposing other drugs with questionable antiviral effects,” said Dr. Griffin, who was not involved in the development of either drug.

“The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection, and is also a vital element for the care of clinically vulnerable people who may be unable to either receive or respond to vaccines,” he said.

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

An experimental antiviral pill appears to work very well at keeping people who are at high risk of severe COVID-19 from being admitted to the hospital and dying, according to the drug’s maker, Pfizer.

The drug -- called Paxlovid -- was 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who were at high risk of severe complications. The company says it plans to ask the FDA to authorize the drug for emergency use.

The medication appears to work so well that Pfizer has stopped enrollment in the trial of the drug, which works by blocking an enzyme called a protease that the new coronavirus needs to make more copies of itself.

Stopping a clinical trial is a rare action that’s typically taken when a therapy appears to be very effective or clearly dangerous. In both those cases, it’s considered unethical to continue a clinical trial where people are randomly assigned either an active drug or a placebo, when safer or more effective options are available to them.

In this case, the company said in a news release that the move was recommended by an independent panel of advisers who are overseeing the trial, called a data safety monitoring committee, and done in consultation with the FDA.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, PhD, Pfizer chairman and chief executive officer. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In a randomized clinical trial that included more than 1,900 patients who tested positive for COVID-19 and were at risk for having severe complications for their infections, those who received Paxlovid within 3 days of the start of their symptoms were 89% less likely to be hospitalized than those who got a placebo pill -- three patients out of 389 who got the drug were hospitalized, compared with 27 out of 385 who got the placebo. Among patients who got the drug within 5 days of the start of their symptoms, six out of 607 were hospitalized within 28 days, compared to 41 out of 612 who got the placebo.

There were no deaths over the course of a month in patients who took Paxlovid, but 10 deaths in the group that got the placebo.

The news comes on the heels of an announcement in October by the drug company Merck that its experimental antiviral pill, molnupiravir, reduced the risk of hospitalization or death by 50% in patients with mild to moderate COVID, compared to a placebo.

The United Kingdom became the first country to authorize the use of molnupiravir, which is brand-named Lagevrio.

Stephen Griffin, PhD, an associate professor of medicine at the University of Leeds, hailed the success of both new antiviral pills.

“They both demonstrate that, with appropriate investment, the development of bespoke direct-acting antiviral drugs targeting SARS-CoV2 was eminently feasible and has ultimately proven far more successful than repurposing other drugs with questionable antiviral effects,” said Dr. Griffin, who was not involved in the development of either drug.

“The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection, and is also a vital element for the care of clinically vulnerable people who may be unable to either receive or respond to vaccines,” he said.

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

An experimental antiviral pill appears to work very well at keeping people who are at high risk of severe COVID-19 from being admitted to the hospital and dying, according to the drug’s maker, Pfizer.

The drug -- called Paxlovid -- was 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who were at high risk of severe complications. The company says it plans to ask the FDA to authorize the drug for emergency use.

The medication appears to work so well that Pfizer has stopped enrollment in the trial of the drug, which works by blocking an enzyme called a protease that the new coronavirus needs to make more copies of itself.

Stopping a clinical trial is a rare action that’s typically taken when a therapy appears to be very effective or clearly dangerous. In both those cases, it’s considered unethical to continue a clinical trial where people are randomly assigned either an active drug or a placebo, when safer or more effective options are available to them.

In this case, the company said in a news release that the move was recommended by an independent panel of advisers who are overseeing the trial, called a data safety monitoring committee, and done in consultation with the FDA.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, PhD, Pfizer chairman and chief executive officer. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In a randomized clinical trial that included more than 1,900 patients who tested positive for COVID-19 and were at risk for having severe complications for their infections, those who received Paxlovid within 3 days of the start of their symptoms were 89% less likely to be hospitalized than those who got a placebo pill -- three patients out of 389 who got the drug were hospitalized, compared with 27 out of 385 who got the placebo. Among patients who got the drug within 5 days of the start of their symptoms, six out of 607 were hospitalized within 28 days, compared to 41 out of 612 who got the placebo.

There were no deaths over the course of a month in patients who took Paxlovid, but 10 deaths in the group that got the placebo.

The news comes on the heels of an announcement in October by the drug company Merck that its experimental antiviral pill, molnupiravir, reduced the risk of hospitalization or death by 50% in patients with mild to moderate COVID, compared to a placebo.

The United Kingdom became the first country to authorize the use of molnupiravir, which is brand-named Lagevrio.

Stephen Griffin, PhD, an associate professor of medicine at the University of Leeds, hailed the success of both new antiviral pills.

“They both demonstrate that, with appropriate investment, the development of bespoke direct-acting antiviral drugs targeting SARS-CoV2 was eminently feasible and has ultimately proven far more successful than repurposing other drugs with questionable antiviral effects,” said Dr. Griffin, who was not involved in the development of either drug.

“The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection, and is also a vital element for the care of clinically vulnerable people who may be unable to either receive or respond to vaccines,” he said.

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

They went into hospitals with heart attacks, kidney failure or in a psychiatric crisis.

They left with COVID-19 — if they left at all.

More than 10,000 patients were diagnosed with COVID in a U.S. hospital last year after they were admitted for something else, according to federal and state records analyzed exclusively for KHN. The number is certainly an undercount, since it includes mostly patients 65 and older, plus California and Florida patients of all ages.

Yet in the scheme of things that can go wrong in a hospital, it is catastrophic: About 21% of the patients who contracted COVID in the hospital from April to September last year died, the data shows. In contrast, nearly 8% of other Medicare patients died in the hospital at the time.

Steven Johnson, 66, was expecting to get an infection cut out of his hip flesh and bone at Blake Medical Center in Bradenton, Fla., last November. The retired pharmacist had survived colon cancer and was meticulous to avoid contracting COVID. He could not have known that, from April through September, 8% of that hospital’s Medicare COVID patients were diagnosed with the virus after they were admitted for another concern.

Mr. Johnson had tested negative for COVID two days before he was admitted. After 13 days in the hospital, he tested positive, said his wife, Cindy Johnson, also a retired pharmacist.

Soon he was struggling to clear a glue-like phlegm from his lungs. A medical team could hardly control his pain. They prompted Cindy to share his final wishes. She asked: “Honey, do you want to be intubated?” He responded with an emphatic “no.” He died three days later.

After her husband tested positive, Cindy Johnson, trained in contact tracing, quickly got a COVID test. She tested negative. Then she thought about the large number of hospital staffers flowing into and out of his room — where he was often unmasked — and suspected a staff member had infected him. That the hospital, part of the HCA Healthcare chain, still has not mandated staff vaccinations is “appalling,” she said.

“I’m furious,” she said.

“How can they say on their website,” she asked, “that the safety precautions ‘we’ve put into place make our facilities among the safest possible places to receive healthcare at this time’?”

Blake Medical Center spokesperson Lisa Kirkland said the hospital is “strongly encouraging vaccination” and noted that it follows Centers for Disease Control and Prevention and federal and state guidelines to protect patients. President Joe Biden has called for all hospital employees to be vaccinated, but the requirement could face resistance in a dozen states, including Florida, that have banned vaccine mandates.

Overall, the rate of in-hospital spread among Medicare and other patients was lower than in other countries, including the United Kingdom, which makes such data public and openly discusses it. On average, about 1.7% of U.S. hospitalized COVID patients were diagnosed with the virus in U.S. hospitals, according to an analysis of Medicare records from April 1 to Sept. 30, 2020, provided by Dr. James Kennedy, founder of CDIMD, a Nashville-based consulting and data analytics company.

Yet the rate of infection was far higher in 38 hospitals where 5% or more of the Medicare COVID cases were documented as hospital-acquired. The data is from a challenging stretch last year when protective gear was in short supply and tests were scarce or slow to produce results. The Medicare data for the fourth quarter of 2020 and this year isn’t available yet, and the state data reflects April 1 through Dec. 31, 2020.

A KHN review of work-safety records, medical literature and interviews with staff at high-spread hospitals points to why the virus took hold: Hospital leaders were slow to appreciate its airborne nature, which made coughing patients hazardous to roommates and staff members, who often wore less-protective surgical masks instead of N95s. Hospitals failed to test every admitted patient, enabled by CDC guidance that leaves such testing to the “discretion of the facility.” Management often failed to inform workers when they’d been exposed to COVID and so were at risk of spreading it themselves.

Spread among patients and staffers seemed to go hand in hand. At Beaumont Hospital, Taylor, in Michigan, 139 employee COVID infections were logged between April 6 to Oct. 20 last year, a hospital inspection report shows. Nearly 7% of the Medicare patients with COVID tested positive after they were admitted to that hospital for something else, the federal data shows. A hospital spokesperson said tests were not available to screen all patients last year, resulting in some late diagnoses. He said all incoming patients are tested now.

Tracking COVID inside health facilities is no new task to federal officials, who publicly report new staff and resident cases weekly for each U.S. nursing home. Yet the Department of Health and Human Services reports data on COVID’s spread in hospitals only on a statewide basis, so patients are in the dark about which facilities have cases.

KHN commissioned analyses of hospital billing records, which are also used more broadly to spot various hospital-acquired infections. For COVID, the data has limitations. It can pick up some community-acquired cases that were slow to show up, as it can take two to 14 days from exposure to the virus for symptoms to appear, with the average being four to five days. The records do not account for cases picked up in an emergency room or diagnosed after a hospital patient was discharged.

Linda Moore, 71, tested positive at least 15 days into a hospital stay for spinal surgery, according to her daughter Trisha Tavolazzi. Her mother was at Havasu Regional Medical Center in Lake Havasu City, Ariz., which did not have a higher-than-average rate of internal spread last summer.

The hospital implemented “rigorous health and safety protocols to protect all of our patients” during the pandemic, said hospital spokesperson Corey Santoriello, who would not comment on Ms. Moore’s case, citing privacy laws.

Ms. Moore was airlifted to another hospital, where her condition only declined further, her daughter said. After the ventilator was removed, she clung to life fitfully for 5½ hours, as her daughter prayed for her mother to find her way to heaven.

“I asked her mom and her dad and her family and prayed to God, ‘Please just come show her the way,’” Ms. Tavolazzi said. “I relive it every day.”

When Ms. Tavolazzi sought answers from the hospital about where her mom got the virus, she said, she got none: “No one ever called me back.”
 

Two negative COVID tests, then ‘patient zero’

As the second surge of COVID subsided last September, doctors from the prestigious Brigham and Women’s Hospital published a reassuringstudy: With careful infection control, only two of 697 COVID patients acquired the virus within the Boston hospital. That is about 0.3% of patients --about six times lower than the overall Medicare rate. Brigham tested every patient it admitted, exceeding CDC recommendations. It was transparent and open about safety concerns.

But the study, published in the high-profile JAMA Network Open journal, conveyed the wrong message, according to Dr. Manoj Jain, an infectious-disease physician and adjunct professor at the Rollins School of Public Health at Emory University. COVID was spreading in hospitals, he said, and the study buried “the problem under the rug.”

Before the virtual ink on the study was dry, the virus began a stealthy streak through the elite hospital. It slipped in with a patient who tested negative twice -- but turned out to be positive. She was “patient zero” in an outbreak affecting 38 staffers and 14 patients, according to a study in Annals of Internal Medicine initially published Feb. 9.

That study’s authors sequenced the genome of the virus to confirm which cases were related and precisely how it traveled through the hospital.

As patients were moved from room to room in the early days of the outbreak, COVID spread among roommates 8 out of 9 times, likely through aerosol transmission, the study says. A survey of staff members revealed that those caring for coughing patients were more likely to get sick.

The virus also appeared to have breached the CDC-OK’d protective gear. Two staff members who had close patient contact while wearing a surgical mask and face shield still wound up infected. The findings suggested that more-protective N95 respirators could help safeguard staff.

Brigham and Women’s now tests every patient upon admission and again soon after. Nurses are encouraged to test again if they see a subtle sign of COVID, said Dr. Erica Shenoy, associate chief of the Infection Control Unit at Massachusetts General Hospital, who helped craft policy at Brigham.

She said nurses and environmental services workers are at the table for policymaking: “I personally make it a point to say, ‘Tell me what you’re thinking,’” Dr. Shenoy said. “‘There’s no retribution because we need to know.’”

CDC guidelines, though, left wide latitude on protective gear and testing. To this day, Dr. Shenoy said, hospitals employ a wide range of policies.

The CDC said in a statement that its guidelines “provide a comprehensive and layered approach to preventing transmission of SARS-CoV-2 in healthcare settings,” and include testing patients with “even mild symptoms” or recent exposure to someone with COVID.

Infection control policies are rarely apparent to patients or visitors, beyond whether they’re asked to wear a mask. But reviews of public records and interviews with more than a dozen people show that at hospitals with high rates of COVID spread, staff members were often alarmed by the lack of safety practices.
 

Nurses sound the alarm on COVID spread

As COVID crept into Florida in spring 2020, nurse Victoria Holland clashed with managers at Blake Medical Center in Bradenton, where Steven Johnson died.

She said managers suspended her early in the pandemic after taking part in a protest and “having a hissy fit” when she was denied a new N95 respirator before an “aerosol-generating” procedure. The CDC warns that such procedures can spread the virus through the air. Before the pandemic, nurses were trained to dispose of an N95 after each patient encounter.

When the suspension was over, Ms. Holland said, she felt unsafe. “They told us nothing,” she said. “It was all a little whisper between the doctors. You had potential COVIDs and you’d get a little surgical mask because [they didn’t] want to waste” an N95 unless they knew the patient was positive.

Ms. Holland said she quit in mid-April. Her nursing colleagues lodged a complaint with the Occupational Safety and Health Administration in late June alleging that staff “working around possible COVID-19 positive cases” had been denied PPE. Staff members protested outside the hospital in July and filed another OSHA complaint that said the hospital was allowing COVID-exposed employees to keep working.

Ms. Kirkland, the Blake spokesperson, said the hospital responded to OSHA and “no deficiencies were identified.”

The Medicare analysis shows that 22 of 273 patients with COVID, or 8%, were diagnosed with the virus after they were admitted to Blake. That’s about five times as high as the national average.

Ms. Kirkland said “there is no standard way for measuring COVID-19 hospital-associated transmissions” and “there is no evidence to suggest the risk of transmission at Blake Medical Center is different than what you would find at other hospitals.”

In Washington, D.C., 34 Medicare COVID patients contracted the virus at MedStar Washington Hospital Center, or nearly 6% of its total, the analysis shows.

Unhappy with the safety practices — which included gas sterilization and reuse of N95s — National Nurses United members protested on the hospital lawn in July 2020. At the protest, nurse Zoe Bendixen said one nurse had died of the virus and 50 had gotten sick: “[Nurses] can become a source for spreading the disease to other patients, co-workers and family members.”

Nurse Yuhana Gidey said she caught COVID after treating a patient who turned out to be infected. Another nurse, not managers doing contact tracing, told her she’d been exposed, she said.

Nurse Kimberly Walsh said in an interview there was an outbreak in a geriatric unit where she worked in September 2020. She said management blamed nurses for bringing the virus into the unit. But Ms. Walsh pointed to another problem: The hospital wasn’t COVID-testing patients coming in from nursing homes, where spread was rampant last year.

MedStar declined a request for an interview about its infection control practices and did not respond to specific questions.

While hospitals must track and publicly report rates of persistent infections like C. diff, antibiotic-resistant staph and surgical site infections, similar hospital-acquired COVID rates are not reported.

KHN examined a different source of data that Congress required hospitals to document about “hospital-acquired conditions.” The Medicare data, which notes whether each COVID case was “present on admission” or not, becomes available months after a hospitalization in obscure files that require a data-use agreement typically granted to researchers. KHN counted cases, as federal officials do, in some instances in which the documentation is deemed insufficient to categorize a case (see data methodology on the KHN website).

For this data, whether to deem a COVID case hospital-acquired lies with medical coders who review doctors’ notes and discharge summaries and ask doctors questions if the status is unclear, said Sue Bowman, senior director of coding policy and compliance at American Health Information Management Association.

She said medical coders are aware that the data is used for hospital quality measures and would be careful to review the contract tracing or other information in the medical record.

If a case was in the data KHN used, “that would mean it was acquired during the hospital stay either from a health care worker or another patient or maybe if a hospital allowed visitors, from a visitor,” Ms. Bowman said. “That would be a fair interpretation of the data.”

The high death rate for those diagnosed with COVID during a hospital stay — about 21% — mirrors the death rate for other Medicare COVID patients last year, when doctors had few proven methods to help patients. It also highlights the hazard unvaccinated staffers pose to patients, said Dr. Jain, the infectious-disease doctor. The American Hospital Association estimates that about 42% of U.S. hospitals have mandated that all staff members be vaccinated.

“We don’t need [unvaccinated staff] to be a threat to patients,” Dr. Jain said. “[Hospital] administration is too afraid to push the nursing staff, and the general public is clueless at what a threat a non-vaccinated person poses to a vulnerable population.”

Cindy Johnson said the hospital where she believes her husband contracted COVID faced minimal scrutiny in a state inspection, even after she said she reported that he caught COVID there. She explored suing, but an attorney told her it would be nearly impossible to win such a case. A 2021 state law requires proof of “at least gross negligence” to prevail in court. 

Ms. Johnson did ask a doctor who sees patients at the hospital for this: Please take down the big “OPEN & SAFE” sign outside. 

Within days, the sign was gone.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

They went into hospitals with heart attacks, kidney failure or in a psychiatric crisis.

They left with COVID-19 — if they left at all.

More than 10,000 patients were diagnosed with COVID in a U.S. hospital last year after they were admitted for something else, according to federal and state records analyzed exclusively for KHN. The number is certainly an undercount, since it includes mostly patients 65 and older, plus California and Florida patients of all ages.

Yet in the scheme of things that can go wrong in a hospital, it is catastrophic: About 21% of the patients who contracted COVID in the hospital from April to September last year died, the data shows. In contrast, nearly 8% of other Medicare patients died in the hospital at the time.

Steven Johnson, 66, was expecting to get an infection cut out of his hip flesh and bone at Blake Medical Center in Bradenton, Fla., last November. The retired pharmacist had survived colon cancer and was meticulous to avoid contracting COVID. He could not have known that, from April through September, 8% of that hospital’s Medicare COVID patients were diagnosed with the virus after they were admitted for another concern.

Mr. Johnson had tested negative for COVID two days before he was admitted. After 13 days in the hospital, he tested positive, said his wife, Cindy Johnson, also a retired pharmacist.

Soon he was struggling to clear a glue-like phlegm from his lungs. A medical team could hardly control his pain. They prompted Cindy to share his final wishes. She asked: “Honey, do you want to be intubated?” He responded with an emphatic “no.” He died three days later.

After her husband tested positive, Cindy Johnson, trained in contact tracing, quickly got a COVID test. She tested negative. Then she thought about the large number of hospital staffers flowing into and out of his room — where he was often unmasked — and suspected a staff member had infected him. That the hospital, part of the HCA Healthcare chain, still has not mandated staff vaccinations is “appalling,” she said.

“I’m furious,” she said.

“How can they say on their website,” she asked, “that the safety precautions ‘we’ve put into place make our facilities among the safest possible places to receive healthcare at this time’?”

Blake Medical Center spokesperson Lisa Kirkland said the hospital is “strongly encouraging vaccination” and noted that it follows Centers for Disease Control and Prevention and federal and state guidelines to protect patients. President Joe Biden has called for all hospital employees to be vaccinated, but the requirement could face resistance in a dozen states, including Florida, that have banned vaccine mandates.

Overall, the rate of in-hospital spread among Medicare and other patients was lower than in other countries, including the United Kingdom, which makes such data public and openly discusses it. On average, about 1.7% of U.S. hospitalized COVID patients were diagnosed with the virus in U.S. hospitals, according to an analysis of Medicare records from April 1 to Sept. 30, 2020, provided by Dr. James Kennedy, founder of CDIMD, a Nashville-based consulting and data analytics company.

Yet the rate of infection was far higher in 38 hospitals where 5% or more of the Medicare COVID cases were documented as hospital-acquired. The data is from a challenging stretch last year when protective gear was in short supply and tests were scarce or slow to produce results. The Medicare data for the fourth quarter of 2020 and this year isn’t available yet, and the state data reflects April 1 through Dec. 31, 2020.

A KHN review of work-safety records, medical literature and interviews with staff at high-spread hospitals points to why the virus took hold: Hospital leaders were slow to appreciate its airborne nature, which made coughing patients hazardous to roommates and staff members, who often wore less-protective surgical masks instead of N95s. Hospitals failed to test every admitted patient, enabled by CDC guidance that leaves such testing to the “discretion of the facility.” Management often failed to inform workers when they’d been exposed to COVID and so were at risk of spreading it themselves.

Spread among patients and staffers seemed to go hand in hand. At Beaumont Hospital, Taylor, in Michigan, 139 employee COVID infections were logged between April 6 to Oct. 20 last year, a hospital inspection report shows. Nearly 7% of the Medicare patients with COVID tested positive after they were admitted to that hospital for something else, the federal data shows. A hospital spokesperson said tests were not available to screen all patients last year, resulting in some late diagnoses. He said all incoming patients are tested now.

Tracking COVID inside health facilities is no new task to federal officials, who publicly report new staff and resident cases weekly for each U.S. nursing home. Yet the Department of Health and Human Services reports data on COVID’s spread in hospitals only on a statewide basis, so patients are in the dark about which facilities have cases.

KHN commissioned analyses of hospital billing records, which are also used more broadly to spot various hospital-acquired infections. For COVID, the data has limitations. It can pick up some community-acquired cases that were slow to show up, as it can take two to 14 days from exposure to the virus for symptoms to appear, with the average being four to five days. The records do not account for cases picked up in an emergency room or diagnosed after a hospital patient was discharged.

Linda Moore, 71, tested positive at least 15 days into a hospital stay for spinal surgery, according to her daughter Trisha Tavolazzi. Her mother was at Havasu Regional Medical Center in Lake Havasu City, Ariz., which did not have a higher-than-average rate of internal spread last summer.

The hospital implemented “rigorous health and safety protocols to protect all of our patients” during the pandemic, said hospital spokesperson Corey Santoriello, who would not comment on Ms. Moore’s case, citing privacy laws.

Ms. Moore was airlifted to another hospital, where her condition only declined further, her daughter said. After the ventilator was removed, she clung to life fitfully for 5½ hours, as her daughter prayed for her mother to find her way to heaven.

“I asked her mom and her dad and her family and prayed to God, ‘Please just come show her the way,’” Ms. Tavolazzi said. “I relive it every day.”

When Ms. Tavolazzi sought answers from the hospital about where her mom got the virus, she said, she got none: “No one ever called me back.”
 

Two negative COVID tests, then ‘patient zero’

As the second surge of COVID subsided last September, doctors from the prestigious Brigham and Women’s Hospital published a reassuringstudy: With careful infection control, only two of 697 COVID patients acquired the virus within the Boston hospital. That is about 0.3% of patients --about six times lower than the overall Medicare rate. Brigham tested every patient it admitted, exceeding CDC recommendations. It was transparent and open about safety concerns.

But the study, published in the high-profile JAMA Network Open journal, conveyed the wrong message, according to Dr. Manoj Jain, an infectious-disease physician and adjunct professor at the Rollins School of Public Health at Emory University. COVID was spreading in hospitals, he said, and the study buried “the problem under the rug.”

Before the virtual ink on the study was dry, the virus began a stealthy streak through the elite hospital. It slipped in with a patient who tested negative twice -- but turned out to be positive. She was “patient zero” in an outbreak affecting 38 staffers and 14 patients, according to a study in Annals of Internal Medicine initially published Feb. 9.

That study’s authors sequenced the genome of the virus to confirm which cases were related and precisely how it traveled through the hospital.

As patients were moved from room to room in the early days of the outbreak, COVID spread among roommates 8 out of 9 times, likely through aerosol transmission, the study says. A survey of staff members revealed that those caring for coughing patients were more likely to get sick.

The virus also appeared to have breached the CDC-OK’d protective gear. Two staff members who had close patient contact while wearing a surgical mask and face shield still wound up infected. The findings suggested that more-protective N95 respirators could help safeguard staff.

Brigham and Women’s now tests every patient upon admission and again soon after. Nurses are encouraged to test again if they see a subtle sign of COVID, said Dr. Erica Shenoy, associate chief of the Infection Control Unit at Massachusetts General Hospital, who helped craft policy at Brigham.

She said nurses and environmental services workers are at the table for policymaking: “I personally make it a point to say, ‘Tell me what you’re thinking,’” Dr. Shenoy said. “‘There’s no retribution because we need to know.’”

CDC guidelines, though, left wide latitude on protective gear and testing. To this day, Dr. Shenoy said, hospitals employ a wide range of policies.

The CDC said in a statement that its guidelines “provide a comprehensive and layered approach to preventing transmission of SARS-CoV-2 in healthcare settings,” and include testing patients with “even mild symptoms” or recent exposure to someone with COVID.

Infection control policies are rarely apparent to patients or visitors, beyond whether they’re asked to wear a mask. But reviews of public records and interviews with more than a dozen people show that at hospitals with high rates of COVID spread, staff members were often alarmed by the lack of safety practices.
 

Nurses sound the alarm on COVID spread

As COVID crept into Florida in spring 2020, nurse Victoria Holland clashed with managers at Blake Medical Center in Bradenton, where Steven Johnson died.

She said managers suspended her early in the pandemic after taking part in a protest and “having a hissy fit” when she was denied a new N95 respirator before an “aerosol-generating” procedure. The CDC warns that such procedures can spread the virus through the air. Before the pandemic, nurses were trained to dispose of an N95 after each patient encounter.

When the suspension was over, Ms. Holland said, she felt unsafe. “They told us nothing,” she said. “It was all a little whisper between the doctors. You had potential COVIDs and you’d get a little surgical mask because [they didn’t] want to waste” an N95 unless they knew the patient was positive.

Ms. Holland said she quit in mid-April. Her nursing colleagues lodged a complaint with the Occupational Safety and Health Administration in late June alleging that staff “working around possible COVID-19 positive cases” had been denied PPE. Staff members protested outside the hospital in July and filed another OSHA complaint that said the hospital was allowing COVID-exposed employees to keep working.

Ms. Kirkland, the Blake spokesperson, said the hospital responded to OSHA and “no deficiencies were identified.”

The Medicare analysis shows that 22 of 273 patients with COVID, or 8%, were diagnosed with the virus after they were admitted to Blake. That’s about five times as high as the national average.

Ms. Kirkland said “there is no standard way for measuring COVID-19 hospital-associated transmissions” and “there is no evidence to suggest the risk of transmission at Blake Medical Center is different than what you would find at other hospitals.”

In Washington, D.C., 34 Medicare COVID patients contracted the virus at MedStar Washington Hospital Center, or nearly 6% of its total, the analysis shows.

Unhappy with the safety practices — which included gas sterilization and reuse of N95s — National Nurses United members protested on the hospital lawn in July 2020. At the protest, nurse Zoe Bendixen said one nurse had died of the virus and 50 had gotten sick: “[Nurses] can become a source for spreading the disease to other patients, co-workers and family members.”

Nurse Yuhana Gidey said she caught COVID after treating a patient who turned out to be infected. Another nurse, not managers doing contact tracing, told her she’d been exposed, she said.

Nurse Kimberly Walsh said in an interview there was an outbreak in a geriatric unit where she worked in September 2020. She said management blamed nurses for bringing the virus into the unit. But Ms. Walsh pointed to another problem: The hospital wasn’t COVID-testing patients coming in from nursing homes, where spread was rampant last year.

MedStar declined a request for an interview about its infection control practices and did not respond to specific questions.

While hospitals must track and publicly report rates of persistent infections like C. diff, antibiotic-resistant staph and surgical site infections, similar hospital-acquired COVID rates are not reported.

KHN examined a different source of data that Congress required hospitals to document about “hospital-acquired conditions.” The Medicare data, which notes whether each COVID case was “present on admission” or not, becomes available months after a hospitalization in obscure files that require a data-use agreement typically granted to researchers. KHN counted cases, as federal officials do, in some instances in which the documentation is deemed insufficient to categorize a case (see data methodology on the KHN website).

For this data, whether to deem a COVID case hospital-acquired lies with medical coders who review doctors’ notes and discharge summaries and ask doctors questions if the status is unclear, said Sue Bowman, senior director of coding policy and compliance at American Health Information Management Association.

She said medical coders are aware that the data is used for hospital quality measures and would be careful to review the contract tracing or other information in the medical record.

If a case was in the data KHN used, “that would mean it was acquired during the hospital stay either from a health care worker or another patient or maybe if a hospital allowed visitors, from a visitor,” Ms. Bowman said. “That would be a fair interpretation of the data.”

The high death rate for those diagnosed with COVID during a hospital stay — about 21% — mirrors the death rate for other Medicare COVID patients last year, when doctors had few proven methods to help patients. It also highlights the hazard unvaccinated staffers pose to patients, said Dr. Jain, the infectious-disease doctor. The American Hospital Association estimates that about 42% of U.S. hospitals have mandated that all staff members be vaccinated.

“We don’t need [unvaccinated staff] to be a threat to patients,” Dr. Jain said. “[Hospital] administration is too afraid to push the nursing staff, and the general public is clueless at what a threat a non-vaccinated person poses to a vulnerable population.”

Cindy Johnson said the hospital where she believes her husband contracted COVID faced minimal scrutiny in a state inspection, even after she said she reported that he caught COVID there. She explored suing, but an attorney told her it would be nearly impossible to win such a case. A 2021 state law requires proof of “at least gross negligence” to prevail in court. 

Ms. Johnson did ask a doctor who sees patients at the hospital for this: Please take down the big “OPEN & SAFE” sign outside. 

Within days, the sign was gone.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

They went into hospitals with heart attacks, kidney failure or in a psychiatric crisis.

They left with COVID-19 — if they left at all.

More than 10,000 patients were diagnosed with COVID in a U.S. hospital last year after they were admitted for something else, according to federal and state records analyzed exclusively for KHN. The number is certainly an undercount, since it includes mostly patients 65 and older, plus California and Florida patients of all ages.

Yet in the scheme of things that can go wrong in a hospital, it is catastrophic: About 21% of the patients who contracted COVID in the hospital from April to September last year died, the data shows. In contrast, nearly 8% of other Medicare patients died in the hospital at the time.

Steven Johnson, 66, was expecting to get an infection cut out of his hip flesh and bone at Blake Medical Center in Bradenton, Fla., last November. The retired pharmacist had survived colon cancer and was meticulous to avoid contracting COVID. He could not have known that, from April through September, 8% of that hospital’s Medicare COVID patients were diagnosed with the virus after they were admitted for another concern.

Mr. Johnson had tested negative for COVID two days before he was admitted. After 13 days in the hospital, he tested positive, said his wife, Cindy Johnson, also a retired pharmacist.

Soon he was struggling to clear a glue-like phlegm from his lungs. A medical team could hardly control his pain. They prompted Cindy to share his final wishes. She asked: “Honey, do you want to be intubated?” He responded with an emphatic “no.” He died three days later.

After her husband tested positive, Cindy Johnson, trained in contact tracing, quickly got a COVID test. She tested negative. Then she thought about the large number of hospital staffers flowing into and out of his room — where he was often unmasked — and suspected a staff member had infected him. That the hospital, part of the HCA Healthcare chain, still has not mandated staff vaccinations is “appalling,” she said.

“I’m furious,” she said.

“How can they say on their website,” she asked, “that the safety precautions ‘we’ve put into place make our facilities among the safest possible places to receive healthcare at this time’?”

Blake Medical Center spokesperson Lisa Kirkland said the hospital is “strongly encouraging vaccination” and noted that it follows Centers for Disease Control and Prevention and federal and state guidelines to protect patients. President Joe Biden has called for all hospital employees to be vaccinated, but the requirement could face resistance in a dozen states, including Florida, that have banned vaccine mandates.

Overall, the rate of in-hospital spread among Medicare and other patients was lower than in other countries, including the United Kingdom, which makes such data public and openly discusses it. On average, about 1.7% of U.S. hospitalized COVID patients were diagnosed with the virus in U.S. hospitals, according to an analysis of Medicare records from April 1 to Sept. 30, 2020, provided by Dr. James Kennedy, founder of CDIMD, a Nashville-based consulting and data analytics company.

Yet the rate of infection was far higher in 38 hospitals where 5% or more of the Medicare COVID cases were documented as hospital-acquired. The data is from a challenging stretch last year when protective gear was in short supply and tests were scarce or slow to produce results. The Medicare data for the fourth quarter of 2020 and this year isn’t available yet, and the state data reflects April 1 through Dec. 31, 2020.

A KHN review of work-safety records, medical literature and interviews with staff at high-spread hospitals points to why the virus took hold: Hospital leaders were slow to appreciate its airborne nature, which made coughing patients hazardous to roommates and staff members, who often wore less-protective surgical masks instead of N95s. Hospitals failed to test every admitted patient, enabled by CDC guidance that leaves such testing to the “discretion of the facility.” Management often failed to inform workers when they’d been exposed to COVID and so were at risk of spreading it themselves.

Spread among patients and staffers seemed to go hand in hand. At Beaumont Hospital, Taylor, in Michigan, 139 employee COVID infections were logged between April 6 to Oct. 20 last year, a hospital inspection report shows. Nearly 7% of the Medicare patients with COVID tested positive after they were admitted to that hospital for something else, the federal data shows. A hospital spokesperson said tests were not available to screen all patients last year, resulting in some late diagnoses. He said all incoming patients are tested now.

Tracking COVID inside health facilities is no new task to federal officials, who publicly report new staff and resident cases weekly for each U.S. nursing home. Yet the Department of Health and Human Services reports data on COVID’s spread in hospitals only on a statewide basis, so patients are in the dark about which facilities have cases.

KHN commissioned analyses of hospital billing records, which are also used more broadly to spot various hospital-acquired infections. For COVID, the data has limitations. It can pick up some community-acquired cases that were slow to show up, as it can take two to 14 days from exposure to the virus for symptoms to appear, with the average being four to five days. The records do not account for cases picked up in an emergency room or diagnosed after a hospital patient was discharged.

Linda Moore, 71, tested positive at least 15 days into a hospital stay for spinal surgery, according to her daughter Trisha Tavolazzi. Her mother was at Havasu Regional Medical Center in Lake Havasu City, Ariz., which did not have a higher-than-average rate of internal spread last summer.

The hospital implemented “rigorous health and safety protocols to protect all of our patients” during the pandemic, said hospital spokesperson Corey Santoriello, who would not comment on Ms. Moore’s case, citing privacy laws.

Ms. Moore was airlifted to another hospital, where her condition only declined further, her daughter said. After the ventilator was removed, she clung to life fitfully for 5½ hours, as her daughter prayed for her mother to find her way to heaven.

“I asked her mom and her dad and her family and prayed to God, ‘Please just come show her the way,’” Ms. Tavolazzi said. “I relive it every day.”

When Ms. Tavolazzi sought answers from the hospital about where her mom got the virus, she said, she got none: “No one ever called me back.”
 

Two negative COVID tests, then ‘patient zero’

As the second surge of COVID subsided last September, doctors from the prestigious Brigham and Women’s Hospital published a reassuringstudy: With careful infection control, only two of 697 COVID patients acquired the virus within the Boston hospital. That is about 0.3% of patients --about six times lower than the overall Medicare rate. Brigham tested every patient it admitted, exceeding CDC recommendations. It was transparent and open about safety concerns.

But the study, published in the high-profile JAMA Network Open journal, conveyed the wrong message, according to Dr. Manoj Jain, an infectious-disease physician and adjunct professor at the Rollins School of Public Health at Emory University. COVID was spreading in hospitals, he said, and the study buried “the problem under the rug.”

Before the virtual ink on the study was dry, the virus began a stealthy streak through the elite hospital. It slipped in with a patient who tested negative twice -- but turned out to be positive. She was “patient zero” in an outbreak affecting 38 staffers and 14 patients, according to a study in Annals of Internal Medicine initially published Feb. 9.

That study’s authors sequenced the genome of the virus to confirm which cases were related and precisely how it traveled through the hospital.

As patients were moved from room to room in the early days of the outbreak, COVID spread among roommates 8 out of 9 times, likely through aerosol transmission, the study says. A survey of staff members revealed that those caring for coughing patients were more likely to get sick.

The virus also appeared to have breached the CDC-OK’d protective gear. Two staff members who had close patient contact while wearing a surgical mask and face shield still wound up infected. The findings suggested that more-protective N95 respirators could help safeguard staff.

Brigham and Women’s now tests every patient upon admission and again soon after. Nurses are encouraged to test again if they see a subtle sign of COVID, said Dr. Erica Shenoy, associate chief of the Infection Control Unit at Massachusetts General Hospital, who helped craft policy at Brigham.

She said nurses and environmental services workers are at the table for policymaking: “I personally make it a point to say, ‘Tell me what you’re thinking,’” Dr. Shenoy said. “‘There’s no retribution because we need to know.’”

CDC guidelines, though, left wide latitude on protective gear and testing. To this day, Dr. Shenoy said, hospitals employ a wide range of policies.

The CDC said in a statement that its guidelines “provide a comprehensive and layered approach to preventing transmission of SARS-CoV-2 in healthcare settings,” and include testing patients with “even mild symptoms” or recent exposure to someone with COVID.

Infection control policies are rarely apparent to patients or visitors, beyond whether they’re asked to wear a mask. But reviews of public records and interviews with more than a dozen people show that at hospitals with high rates of COVID spread, staff members were often alarmed by the lack of safety practices.
 

Nurses sound the alarm on COVID spread

As COVID crept into Florida in spring 2020, nurse Victoria Holland clashed with managers at Blake Medical Center in Bradenton, where Steven Johnson died.

She said managers suspended her early in the pandemic after taking part in a protest and “having a hissy fit” when she was denied a new N95 respirator before an “aerosol-generating” procedure. The CDC warns that such procedures can spread the virus through the air. Before the pandemic, nurses were trained to dispose of an N95 after each patient encounter.

When the suspension was over, Ms. Holland said, she felt unsafe. “They told us nothing,” she said. “It was all a little whisper between the doctors. You had potential COVIDs and you’d get a little surgical mask because [they didn’t] want to waste” an N95 unless they knew the patient was positive.

Ms. Holland said she quit in mid-April. Her nursing colleagues lodged a complaint with the Occupational Safety and Health Administration in late June alleging that staff “working around possible COVID-19 positive cases” had been denied PPE. Staff members protested outside the hospital in July and filed another OSHA complaint that said the hospital was allowing COVID-exposed employees to keep working.

Ms. Kirkland, the Blake spokesperson, said the hospital responded to OSHA and “no deficiencies were identified.”

The Medicare analysis shows that 22 of 273 patients with COVID, or 8%, were diagnosed with the virus after they were admitted to Blake. That’s about five times as high as the national average.

Ms. Kirkland said “there is no standard way for measuring COVID-19 hospital-associated transmissions” and “there is no evidence to suggest the risk of transmission at Blake Medical Center is different than what you would find at other hospitals.”

In Washington, D.C., 34 Medicare COVID patients contracted the virus at MedStar Washington Hospital Center, or nearly 6% of its total, the analysis shows.

Unhappy with the safety practices — which included gas sterilization and reuse of N95s — National Nurses United members protested on the hospital lawn in July 2020. At the protest, nurse Zoe Bendixen said one nurse had died of the virus and 50 had gotten sick: “[Nurses] can become a source for spreading the disease to other patients, co-workers and family members.”

Nurse Yuhana Gidey said she caught COVID after treating a patient who turned out to be infected. Another nurse, not managers doing contact tracing, told her she’d been exposed, she said.

Nurse Kimberly Walsh said in an interview there was an outbreak in a geriatric unit where she worked in September 2020. She said management blamed nurses for bringing the virus into the unit. But Ms. Walsh pointed to another problem: The hospital wasn’t COVID-testing patients coming in from nursing homes, where spread was rampant last year.

MedStar declined a request for an interview about its infection control practices and did not respond to specific questions.

While hospitals must track and publicly report rates of persistent infections like C. diff, antibiotic-resistant staph and surgical site infections, similar hospital-acquired COVID rates are not reported.

KHN examined a different source of data that Congress required hospitals to document about “hospital-acquired conditions.” The Medicare data, which notes whether each COVID case was “present on admission” or not, becomes available months after a hospitalization in obscure files that require a data-use agreement typically granted to researchers. KHN counted cases, as federal officials do, in some instances in which the documentation is deemed insufficient to categorize a case (see data methodology on the KHN website).

For this data, whether to deem a COVID case hospital-acquired lies with medical coders who review doctors’ notes and discharge summaries and ask doctors questions if the status is unclear, said Sue Bowman, senior director of coding policy and compliance at American Health Information Management Association.

She said medical coders are aware that the data is used for hospital quality measures and would be careful to review the contract tracing or other information in the medical record.

If a case was in the data KHN used, “that would mean it was acquired during the hospital stay either from a health care worker or another patient or maybe if a hospital allowed visitors, from a visitor,” Ms. Bowman said. “That would be a fair interpretation of the data.”

The high death rate for those diagnosed with COVID during a hospital stay — about 21% — mirrors the death rate for other Medicare COVID patients last year, when doctors had few proven methods to help patients. It also highlights the hazard unvaccinated staffers pose to patients, said Dr. Jain, the infectious-disease doctor. The American Hospital Association estimates that about 42% of U.S. hospitals have mandated that all staff members be vaccinated.

“We don’t need [unvaccinated staff] to be a threat to patients,” Dr. Jain said. “[Hospital] administration is too afraid to push the nursing staff, and the general public is clueless at what a threat a non-vaccinated person poses to a vulnerable population.”

Cindy Johnson said the hospital where she believes her husband contracted COVID faced minimal scrutiny in a state inspection, even after she said she reported that he caught COVID there. She explored suing, but an attorney told her it would be nearly impossible to win such a case. A 2021 state law requires proof of “at least gross negligence” to prevail in court. 

Ms. Johnson did ask a doctor who sees patients at the hospital for this: Please take down the big “OPEN & SAFE” sign outside. 

Within days, the sign was gone.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

A firestorm of controversy over access to HIV medications and protection against discriminatory insurance practices has been making its way through U.S. district courts for the past 3 years, pitting HIV patients against pharmacy benefits managers and, ostensibly, the healthcare industry itself.

The case, CVS Pharmacy Inc. v. Doe, scheduled for oral arguments before the Supreme Court of the United States (SCOTUS) in December, is a weighty one for patients with HIV and the practitioners caring for them.

At odds are whether or not mandatory mail-order requirements for specialty medications violate specific provisions of the Patient Protection and Affordable Care Act (ACA) and the Rehabilitation Act of 1973, both of which prohibit discrimination by programs that receive federal funds.

An amicus brief submitted on October 29 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School on behalf of five John Does and a number of medical practitioners and practitioner organizations underscores the degree to which advances in HIV treatment, viral suppression, and care linkage — not to mention the national mandate to end the AIDS epidemic by 2030 — might ultimately be affected.

“We decided to file the brief at the Supreme Court level because we wanted to make sure that the perspectives of people living with HIV, their providers, and advocates were in the record,” Maryanne Tomazic, a clinical instructor at CHLPI, toldthis news organization.

“It’s important for the court to consider why robust access to prescription drug coverage and pharmacy services are so important for people living with HIV, and why it’s not appropriate to compromise access to antiretroviral therapy,” she explained.
 

A bitter pill, regardless of who swallows it

CVS Pharmacy Inc. v. Doe focuses on a legal concept known as “disparate impact discrimination,” which refers to a policy that appears neutral but unintentionally discriminates against a protected class of people (eg, on the basis of sex, age, or ethnicity).

The Supreme Court’s decision in the case will address a central question: did CVS Pharmacy, Caremark, and Caremark Specialty Pharmacy (“CVS”) discriminate against the respondents by requiring that they obtain specialty medications (including those for HIV) by mail order or drop shipment for pickup, or, alternatively, pay out-of-network prices for these medications at non-CVS pharmacies?

The decision will also address whether the ACA’s inclusion of clause 504 of the Rehabilitation Act, which prohibits protected class discrimination, allows patients to challenge terms and conditions of their healthcare plans, a decision that has broad and far-reaching implications for insurers’ abilities to set plan restrictions and pricing.

A spokesperson for CVS declined to comment when contacted by this news organization but provided a link to an April 9, 2021 SCOTUS blog post about the filing. In its court filing, CVS contended that the program applies to all specialty medications (not just HIV) and simply reflects the cost/complexity of specialty medications.

Not everyone agrees that cost is the most important issue at play. Indeed, a critical take-away for practitioners is how mandated mail-order pharmacy programs can disrupt coordination of care.

“In the traditional model, the physician is talking to the pharmacists [or] talking with the patient, and you have kind of triangular communication model that helps not only the patient stay engaged in care but [also] allows the healthcare provider team to adjust the medication quickly without delay,” said Ms. Tomazic.

The John Doe statements in the original case highlight these concerns. They focus on how mandatory mail orders restrict highly personable relationships with local specialty pharmacists who are familiar with their patients’ medical histories as well as their medication dosing and adjustments and who regularly communicate with the complete care team on the patients’ behalf.

“JOHN DOE THREE and others depend on these types of long standing relationships with local pharmacists to maximize the benefits of HIV/AIDS medications and treat the complex and ever-changing needs of the HIV/AIDS patients,” wrote attorneys in the 2018 class action filing.

Other issues raised by the suit involve the following: privacy with respect to medication pickup; specialty care customer representatives’ lack of understanding and knowledge of HIV medications; incomplete prescription fills; late medication deliveries; exposure of medications to the elements; work and employment interruptions; and restrictions on early fills and reorders, which increase the risk for missed doses and potentially serious health problems, including interruptions in viral suppression and resistance.
 

Discrimination issues also raised

CHLPI’s amicus joins several others in support of the unique needs of persons with HIV, especially in Black and Hispanic/Latino communities, which are disproportionately affected by HIV.

A press release distributed by the National Association for the Advancement of Colored People Legal Defense and Educational Fund (LDF) reinforces the idea that not only are Black people more likely to have a disability other groups, owing to the country’s legacy of racial inequality, but also that they are likely to encounter unique forms of discrimination and specific barriers to full participation in society, further underscoring the need for disparate impact liability to address unfair policies and practices.

“Inequity in access to resources, including healthcare, further amplifies the instance and persistence of disabilities among Black people,” LDF attorneys wrote in the brief.

“We saw with COVID-19 that [mail-order prescription] programs can serve in a supportive role in access to care,” said Ms. Tomazic. “But we don’t want those programs to be mandated, and we don’t want to forget about communities where these kinds of programs are simply not a viable option,” she said.

Oral arguments in the case begin on December 7. A decision is expected some months later.

No relevant financial relationships have been disclosed.

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

A firestorm of controversy over access to HIV medications and protection against discriminatory insurance practices has been making its way through U.S. district courts for the past 3 years, pitting HIV patients against pharmacy benefits managers and, ostensibly, the healthcare industry itself.

The case, CVS Pharmacy Inc. v. Doe, scheduled for oral arguments before the Supreme Court of the United States (SCOTUS) in December, is a weighty one for patients with HIV and the practitioners caring for them.

At odds are whether or not mandatory mail-order requirements for specialty medications violate specific provisions of the Patient Protection and Affordable Care Act (ACA) and the Rehabilitation Act of 1973, both of which prohibit discrimination by programs that receive federal funds.

An amicus brief submitted on October 29 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School on behalf of five John Does and a number of medical practitioners and practitioner organizations underscores the degree to which advances in HIV treatment, viral suppression, and care linkage — not to mention the national mandate to end the AIDS epidemic by 2030 — might ultimately be affected.

“We decided to file the brief at the Supreme Court level because we wanted to make sure that the perspectives of people living with HIV, their providers, and advocates were in the record,” Maryanne Tomazic, a clinical instructor at CHLPI, toldthis news organization.

“It’s important for the court to consider why robust access to prescription drug coverage and pharmacy services are so important for people living with HIV, and why it’s not appropriate to compromise access to antiretroviral therapy,” she explained.
 

A bitter pill, regardless of who swallows it

CVS Pharmacy Inc. v. Doe focuses on a legal concept known as “disparate impact discrimination,” which refers to a policy that appears neutral but unintentionally discriminates against a protected class of people (eg, on the basis of sex, age, or ethnicity).

The Supreme Court’s decision in the case will address a central question: did CVS Pharmacy, Caremark, and Caremark Specialty Pharmacy (“CVS”) discriminate against the respondents by requiring that they obtain specialty medications (including those for HIV) by mail order or drop shipment for pickup, or, alternatively, pay out-of-network prices for these medications at non-CVS pharmacies?

The decision will also address whether the ACA’s inclusion of clause 504 of the Rehabilitation Act, which prohibits protected class discrimination, allows patients to challenge terms and conditions of their healthcare plans, a decision that has broad and far-reaching implications for insurers’ abilities to set plan restrictions and pricing.

A spokesperson for CVS declined to comment when contacted by this news organization but provided a link to an April 9, 2021 SCOTUS blog post about the filing. In its court filing, CVS contended that the program applies to all specialty medications (not just HIV) and simply reflects the cost/complexity of specialty medications.

Not everyone agrees that cost is the most important issue at play. Indeed, a critical take-away for practitioners is how mandated mail-order pharmacy programs can disrupt coordination of care.

“In the traditional model, the physician is talking to the pharmacists [or] talking with the patient, and you have kind of triangular communication model that helps not only the patient stay engaged in care but [also] allows the healthcare provider team to adjust the medication quickly without delay,” said Ms. Tomazic.

The John Doe statements in the original case highlight these concerns. They focus on how mandatory mail orders restrict highly personable relationships with local specialty pharmacists who are familiar with their patients’ medical histories as well as their medication dosing and adjustments and who regularly communicate with the complete care team on the patients’ behalf.

“JOHN DOE THREE and others depend on these types of long standing relationships with local pharmacists to maximize the benefits of HIV/AIDS medications and treat the complex and ever-changing needs of the HIV/AIDS patients,” wrote attorneys in the 2018 class action filing.

Other issues raised by the suit involve the following: privacy with respect to medication pickup; specialty care customer representatives’ lack of understanding and knowledge of HIV medications; incomplete prescription fills; late medication deliveries; exposure of medications to the elements; work and employment interruptions; and restrictions on early fills and reorders, which increase the risk for missed doses and potentially serious health problems, including interruptions in viral suppression and resistance.
 

Discrimination issues also raised

CHLPI’s amicus joins several others in support of the unique needs of persons with HIV, especially in Black and Hispanic/Latino communities, which are disproportionately affected by HIV.

A press release distributed by the National Association for the Advancement of Colored People Legal Defense and Educational Fund (LDF) reinforces the idea that not only are Black people more likely to have a disability other groups, owing to the country’s legacy of racial inequality, but also that they are likely to encounter unique forms of discrimination and specific barriers to full participation in society, further underscoring the need for disparate impact liability to address unfair policies and practices.

“Inequity in access to resources, including healthcare, further amplifies the instance and persistence of disabilities among Black people,” LDF attorneys wrote in the brief.

“We saw with COVID-19 that [mail-order prescription] programs can serve in a supportive role in access to care,” said Ms. Tomazic. “But we don’t want those programs to be mandated, and we don’t want to forget about communities where these kinds of programs are simply not a viable option,” she said.

Oral arguments in the case begin on December 7. A decision is expected some months later.

No relevant financial relationships have been disclosed.

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

A firestorm of controversy over access to HIV medications and protection against discriminatory insurance practices has been making its way through U.S. district courts for the past 3 years, pitting HIV patients against pharmacy benefits managers and, ostensibly, the healthcare industry itself.

The case, CVS Pharmacy Inc. v. Doe, scheduled for oral arguments before the Supreme Court of the United States (SCOTUS) in December, is a weighty one for patients with HIV and the practitioners caring for them.

At odds are whether or not mandatory mail-order requirements for specialty medications violate specific provisions of the Patient Protection and Affordable Care Act (ACA) and the Rehabilitation Act of 1973, both of which prohibit discrimination by programs that receive federal funds.

An amicus brief submitted on October 29 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School on behalf of five John Does and a number of medical practitioners and practitioner organizations underscores the degree to which advances in HIV treatment, viral suppression, and care linkage — not to mention the national mandate to end the AIDS epidemic by 2030 — might ultimately be affected.

“We decided to file the brief at the Supreme Court level because we wanted to make sure that the perspectives of people living with HIV, their providers, and advocates were in the record,” Maryanne Tomazic, a clinical instructor at CHLPI, toldthis news organization.

“It’s important for the court to consider why robust access to prescription drug coverage and pharmacy services are so important for people living with HIV, and why it’s not appropriate to compromise access to antiretroviral therapy,” she explained.
 

A bitter pill, regardless of who swallows it

CVS Pharmacy Inc. v. Doe focuses on a legal concept known as “disparate impact discrimination,” which refers to a policy that appears neutral but unintentionally discriminates against a protected class of people (eg, on the basis of sex, age, or ethnicity).

The Supreme Court’s decision in the case will address a central question: did CVS Pharmacy, Caremark, and Caremark Specialty Pharmacy (“CVS”) discriminate against the respondents by requiring that they obtain specialty medications (including those for HIV) by mail order or drop shipment for pickup, or, alternatively, pay out-of-network prices for these medications at non-CVS pharmacies?

The decision will also address whether the ACA’s inclusion of clause 504 of the Rehabilitation Act, which prohibits protected class discrimination, allows patients to challenge terms and conditions of their healthcare plans, a decision that has broad and far-reaching implications for insurers’ abilities to set plan restrictions and pricing.

A spokesperson for CVS declined to comment when contacted by this news organization but provided a link to an April 9, 2021 SCOTUS blog post about the filing. In its court filing, CVS contended that the program applies to all specialty medications (not just HIV) and simply reflects the cost/complexity of specialty medications.

Not everyone agrees that cost is the most important issue at play. Indeed, a critical take-away for practitioners is how mandated mail-order pharmacy programs can disrupt coordination of care.

“In the traditional model, the physician is talking to the pharmacists [or] talking with the patient, and you have kind of triangular communication model that helps not only the patient stay engaged in care but [also] allows the healthcare provider team to adjust the medication quickly without delay,” said Ms. Tomazic.

The John Doe statements in the original case highlight these concerns. They focus on how mandatory mail orders restrict highly personable relationships with local specialty pharmacists who are familiar with their patients’ medical histories as well as their medication dosing and adjustments and who regularly communicate with the complete care team on the patients’ behalf.

“JOHN DOE THREE and others depend on these types of long standing relationships with local pharmacists to maximize the benefits of HIV/AIDS medications and treat the complex and ever-changing needs of the HIV/AIDS patients,” wrote attorneys in the 2018 class action filing.

Other issues raised by the suit involve the following: privacy with respect to medication pickup; specialty care customer representatives’ lack of understanding and knowledge of HIV medications; incomplete prescription fills; late medication deliveries; exposure of medications to the elements; work and employment interruptions; and restrictions on early fills and reorders, which increase the risk for missed doses and potentially serious health problems, including interruptions in viral suppression and resistance.
 

Discrimination issues also raised

CHLPI’s amicus joins several others in support of the unique needs of persons with HIV, especially in Black and Hispanic/Latino communities, which are disproportionately affected by HIV.

A press release distributed by the National Association for the Advancement of Colored People Legal Defense and Educational Fund (LDF) reinforces the idea that not only are Black people more likely to have a disability other groups, owing to the country’s legacy of racial inequality, but also that they are likely to encounter unique forms of discrimination and specific barriers to full participation in society, further underscoring the need for disparate impact liability to address unfair policies and practices.

“Inequity in access to resources, including healthcare, further amplifies the instance and persistence of disabilities among Black people,” LDF attorneys wrote in the brief.

“We saw with COVID-19 that [mail-order prescription] programs can serve in a supportive role in access to care,” said Ms. Tomazic. “But we don’t want those programs to be mandated, and we don’t want to forget about communities where these kinds of programs are simply not a viable option,” she said.

Oral arguments in the case begin on December 7. A decision is expected some months later.

No relevant financial relationships have been disclosed.

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

Increased mental health needs, higher acuity from delayed appointments, and added questions and conversations surrounding COVID-19 are forcing primary care offices to rethink priorities in office visits.

Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.

The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.

More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.

Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.

In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.

“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
 

‘We’re going to be playing catch-up’

Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”

The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.

“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.

Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”

She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”

At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
 

Long COVID could overwhelm existing health care capacity

Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.

As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.

“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
 

Anxiety, depression ‘have gone off the charts’

Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”

Courtesy Dr. Danielle Loeb

“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”

Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.

COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.

“That really affects my ability to care for them,” they said.

Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.

To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.

Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.

“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
 

Rethinking workflow

Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.

“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.

“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.

Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.

“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.

Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.

“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.

As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.

That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.

Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.

Increased mental health needs, higher acuity from delayed appointments, and added questions and conversations surrounding COVID-19 are forcing primary care offices to rethink priorities in office visits.

Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.

The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.

More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.

Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.

In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.

“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
 

‘We’re going to be playing catch-up’

Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”

The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.

“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.

Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”

She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”

At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
 

Long COVID could overwhelm existing health care capacity

Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.

As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.

“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
 

Anxiety, depression ‘have gone off the charts’

Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”

Courtesy Dr. Danielle Loeb

“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”

Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.

COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.

“That really affects my ability to care for them,” they said.

Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.

To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.

Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.

“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
 

Rethinking workflow

Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.

“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.

“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.

Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.

“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.

Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.

“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.

As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.

That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.

Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.

Increased mental health needs, higher acuity from delayed appointments, and added questions and conversations surrounding COVID-19 are forcing primary care offices to rethink priorities in office visits.

Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.

The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.

More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.

Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.

In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.

“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
 

‘We’re going to be playing catch-up’

Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”

The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.

“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.

Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”

She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”

At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
 

Long COVID could overwhelm existing health care capacity

Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.

As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.

“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
 

Anxiety, depression ‘have gone off the charts’

Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”

Courtesy Dr. Danielle Loeb

“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”

Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.

COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.

“That really affects my ability to care for them,” they said.

Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.

To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.

Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.

“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
 

Rethinking workflow

Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.

“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.

“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.

Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.

“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.

Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.

“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.

As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.

That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.

Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.

The authors of a study purportedly showing that ivermectin could treat patients with SARS-CoV-2 have retracted their paper after acknowledging that their data were garbled.

The paper, “Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon,” appeared in the journal Viruses in May. According to the abstract: “A randomized controlled trial was conducted in 100 asymptomatic Lebanese subjects that have tested positive for SARS-CoV2. Fifty patients received standard preventive treatment, mainly supplements, and the experimental group received a single dose (according to body weight) of ivermectin, in addition to the same supplements the control group received.”

Results results results … and: “Ivermectin appears to be efficacious in providing clinical benefits in a randomized treatment of asymptomatic SARS-CoV-2-positive subjects, effectively resulting in fewer symptoms, lower viral load and reduced hospital admissions. However, larger-scale trials are warranted for this conclusion to be further cemented.”

However, in early October, the BBC reported — in a larger piece about the concerns about ivermectin-Covid-19 research — that the study “was found to have blocks of details of 11 patients that had been copied and pasted repeatedly – suggesting many of the trial’s apparent patients didn’t really exist.”

The study’s authors told the BBC that the ‘original set of data was rigged, sabotaged or mistakenly entered in the final file’ and that they have submitted a retraction to the scientific journal which published it.

That’s not quite what the retraction notice states: “The journal retracts the article, Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon [ 1 ], cited above. Following publication, the authors contacted the editorial office regarding an error between files used for the statistical analysis. Adhering to our complaints procedure, an investigation was conducted that confirmed the error reported by the authors.

This retraction was approved by the Editor in Chief of the journal. The authors agreed to this retraction.”

Ali Samaha, of Lebanese University in Beirut, and the lead author of the study, told us: “It was brought to our attention that we have used wrong file for our paper. We informed immediately the journal and we have run investigations. After revising the raw data we realised that a file that was used to train a research assistant was sent by mistake for analysis. Re-analysing the original data , the conclusions of the paper remained valid. For our transparency we asked for retraction.”

About that BBC report? Samaha said: “The BBC article was generated before the report of independent reviewers who confirmed an innocent mistake by using wrong file.”

Samaha added that he and his colleagues are now considering whether to resubmit the paper.

The article has been cited four times, according to Clarivate Analytics’ Web of Science — including in this meta-analysis published in June in the American Journal of Therapeutics , which concluded that: “Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using ivermectin. Using ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.”

That article was a social media darling, receiving more than 45,000 tweets and pickups in 90 news outlets, according to Altmetrics, which ranks it No. 7 among all papers published at that time.

A version of this article first appeared on Retraction Watch.

The authors of a study purportedly showing that ivermectin could treat patients with SARS-CoV-2 have retracted their paper after acknowledging that their data were garbled.

The paper, “Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon,” appeared in the journal Viruses in May. According to the abstract: “A randomized controlled trial was conducted in 100 asymptomatic Lebanese subjects that have tested positive for SARS-CoV2. Fifty patients received standard preventive treatment, mainly supplements, and the experimental group received a single dose (according to body weight) of ivermectin, in addition to the same supplements the control group received.”

Results results results … and: “Ivermectin appears to be efficacious in providing clinical benefits in a randomized treatment of asymptomatic SARS-CoV-2-positive subjects, effectively resulting in fewer symptoms, lower viral load and reduced hospital admissions. However, larger-scale trials are warranted for this conclusion to be further cemented.”

However, in early October, the BBC reported — in a larger piece about the concerns about ivermectin-Covid-19 research — that the study “was found to have blocks of details of 11 patients that had been copied and pasted repeatedly – suggesting many of the trial’s apparent patients didn’t really exist.”

The study’s authors told the BBC that the ‘original set of data was rigged, sabotaged or mistakenly entered in the final file’ and that they have submitted a retraction to the scientific journal which published it.

That’s not quite what the retraction notice states: “The journal retracts the article, Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon [ 1 ], cited above. Following publication, the authors contacted the editorial office regarding an error between files used for the statistical analysis. Adhering to our complaints procedure, an investigation was conducted that confirmed the error reported by the authors.

This retraction was approved by the Editor in Chief of the journal. The authors agreed to this retraction.”

Ali Samaha, of Lebanese University in Beirut, and the lead author of the study, told us: “It was brought to our attention that we have used wrong file for our paper. We informed immediately the journal and we have run investigations. After revising the raw data we realised that a file that was used to train a research assistant was sent by mistake for analysis. Re-analysing the original data , the conclusions of the paper remained valid. For our transparency we asked for retraction.”

About that BBC report? Samaha said: “The BBC article was generated before the report of independent reviewers who confirmed an innocent mistake by using wrong file.”

Samaha added that he and his colleagues are now considering whether to resubmit the paper.

The article has been cited four times, according to Clarivate Analytics’ Web of Science — including in this meta-analysis published in June in the American Journal of Therapeutics , which concluded that: “Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using ivermectin. Using ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.”

That article was a social media darling, receiving more than 45,000 tweets and pickups in 90 news outlets, according to Altmetrics, which ranks it No. 7 among all papers published at that time.

A version of this article first appeared on Retraction Watch.

The authors of a study purportedly showing that ivermectin could treat patients with SARS-CoV-2 have retracted their paper after acknowledging that their data were garbled.

The paper, “Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon,” appeared in the journal Viruses in May. According to the abstract: “A randomized controlled trial was conducted in 100 asymptomatic Lebanese subjects that have tested positive for SARS-CoV2. Fifty patients received standard preventive treatment, mainly supplements, and the experimental group received a single dose (according to body weight) of ivermectin, in addition to the same supplements the control group received.”

Results results results … and: “Ivermectin appears to be efficacious in providing clinical benefits in a randomized treatment of asymptomatic SARS-CoV-2-positive subjects, effectively resulting in fewer symptoms, lower viral load and reduced hospital admissions. However, larger-scale trials are warranted for this conclusion to be further cemented.”

However, in early October, the BBC reported — in a larger piece about the concerns about ivermectin-Covid-19 research — that the study “was found to have blocks of details of 11 patients that had been copied and pasted repeatedly – suggesting many of the trial’s apparent patients didn’t really exist.”

The study’s authors told the BBC that the ‘original set of data was rigged, sabotaged or mistakenly entered in the final file’ and that they have submitted a retraction to the scientific journal which published it.

That’s not quite what the retraction notice states: “The journal retracts the article, Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon [ 1 ], cited above. Following publication, the authors contacted the editorial office regarding an error between files used for the statistical analysis. Adhering to our complaints procedure, an investigation was conducted that confirmed the error reported by the authors.

This retraction was approved by the Editor in Chief of the journal. The authors agreed to this retraction.”

Ali Samaha, of Lebanese University in Beirut, and the lead author of the study, told us: “It was brought to our attention that we have used wrong file for our paper. We informed immediately the journal and we have run investigations. After revising the raw data we realised that a file that was used to train a research assistant was sent by mistake for analysis. Re-analysing the original data , the conclusions of the paper remained valid. For our transparency we asked for retraction.”

About that BBC report? Samaha said: “The BBC article was generated before the report of independent reviewers who confirmed an innocent mistake by using wrong file.”

Samaha added that he and his colleagues are now considering whether to resubmit the paper.

The article has been cited four times, according to Clarivate Analytics’ Web of Science — including in this meta-analysis published in June in the American Journal of Therapeutics , which concluded that: “Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using ivermectin. Using ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.”

That article was a social media darling, receiving more than 45,000 tweets and pickups in 90 news outlets, according to Altmetrics, which ranks it No. 7 among all papers published at that time.

A version of this article first appeared on Retraction Watch.

In early 2020, Justin Bullock, MD, MPH, did what few, if any, resident physicians have done: He published an honest account in the New England Journal of Medicine of a would-be suicide attempt during medical training.

In the article, Dr. Bullock matter-of-factly laid out how, in 2019, intern-year night shifts contributed to a depressive episode. For Dr. Bullock, who has a bipolar disorder, sleep dysregulation can be deadly. He had a plan for completing suicide, and this wouldn’t have been his first attempt. Thanks to his history and openness about his condition, Dr. Bullock had an experienced care team that helped him get to a psychiatric hospital before anything happened. While there for around 5 days, he wrote the bulk of the NEJM article.

The article took Dr. Bullock’s impact nationwide. In the medical world, where mental illness is a serious problem but still deeply stigmatized, Dr. Bullock’s unblinking honesty on the issue is still radical to many. On Twitter and in interviews, Dr. Bullock is an unapologetic advocate for accommodations for people in medicine with mental illness. “One of the things that inspired me to speak out early on is that I feel I stand in a place of so much privilege,” Dr. Bullock told this news organization. “I often feel this sense of ... ‘you have to speak up, Justin; no one else can.’ ”

Dr. Bullock’s activism is especially noteworthy, given that he is still establishing his career. In August, while an internal medicine resident at the University of California, San Francisco, he received a lifetime teaching award from UCSF because he had received three prior teaching awards; a recognition like this is considered rare someone so early in their career. Now in his final year of residency, he actively researches medical education, advocates for mental health support, and is working to become a leading voice on related issues.

“It seems to be working,” his older sister, Jacquis Mahoney, RN, said during a visit to the UCSF campus. Instead of any awkwardness, everyone is thrilled to learn that she is Justin’s sister. “There’s a lot of pride and excitement.”
 

Suicide attempts during medical training

Now 28, Dr. Bullock grew up in Detroit, with his mom and two older sisters. His father was incarcerated for much of Dr. Bullock’s childhood, in part because of his own bipolar disorder not being well controlled, Dr. Bullock said.

When he was younger, Dr. Bullock was the peacekeeper in the house between his two sisters, said Ms. Mahoney: “Justin was always very delicate and kind.”

He played soccer and ran track but also loved math and science. While outwardly accumulating an impressive resume, Dr. Bullock was internally struggling. In high school, he made what he now calls an “immature” attempt at suicide after coming out as gay to his family. While Dr. Bullock said he doesn’t necessarily dwell on the discrimination he has faced as a gay, Black man, his awareness of how others perceive and treat him because of his identity increases the background stress present in his daily life.

After high school, Dr. Bullock went to MIT in Boston, where he continued running and studied chemical-biological engineering. During college, Dr. Bullock thought he was going to have to withdraw from MIT because of his depression. Thankfully, he received counseling from student services and advice from a track coach who sat him down and talked about pragmatic solutions, like medication. “That was life-changing,” said Dr. Bullock.

When trying to decide between engineering and medicine, Dr. Bullock realized he preferred contemplating medical problems to engineering ones. So he applied to medical school. Dr. Bullock eventually ended up at UCSF, where he was selected to participate in the Program in Medical Education for the Urban Underserved, a 5-year track at the college for students committed to working with underserved communities.

By the time Dr. Bullock got to medical school, he was feeling good. In consultation with his psychiatrist, he thought it worthwhile to take a break from his medications. At that time, his diagnosis was major depressive disorder and he had only had one serious depressive episode, which didn’t necessarily indicate that he would need medication long-term, he said. 

Dr. Bullock loved everything about medical school. “One day when I was in my first year of med school, I called my mom and said: ‘It’s like science summer camp but every day!’” he recalled.

Despite his enthusiasm, though, he began feeling something troubling. Recognizing the symptoms of early depression, Dr. Bullock restarted his medication. But this time, the same SSRI only made things worse. He went from sleeping 8 hours to 90 minutes a night. He felt angry. One day, he went on a furious 22-mile run. Plus, within the first 6 months of moving to San Francisco, Dr. Bullock was stopped by the police three different times while riding his bike. He attributes this to his race, which has only further added to his stress. In September 2015, during his second year of medical school, Dr. Bullock attempted suicide again. This time, he was intubated in the ED and rushed to the ICU.

He was given a new diagnosis: bipolar disorder. He changed medications and lived for a time with Ms. Mahoney and his other sister, who moved from Chicago to California to be with him. “My family has helped me a lot,” he said.

Dr. Bullock was initially not sure whether he would be able to return to school after his attempted suicide. Overall, UCSF was extremely supportive, he said. That came as a relief. Medical school was a grounding force in his life, not a destabilizing one: “If I had been pushed out, it would have been really harmful to me.”

Then Dr. Bullock started residency. The sleep disruption that comes with the night shift – the resident rite of passage – triggered another episode. At first, Dr. Bullock was overly productive; his mind was active and alert after staying up all night. He worked on new research during the day instead of sleeping. 

Sleep disturbance is a hallmark symptom of bipolar disorder. “Justin should never be on a 24-hour call,” said Lisa Meeks, PhD, associate professor of psychiatry and family medicine at the University of Colorado at Denver, Aurora, and a leading scholar on disability advocacy for medical trainees. When he started residency, Dr. Bullock was open with his program director about his diagnosis and sought accommodations to go to therapy each week. But he didn’t try to get out of night shifts or 24-hour calls, despite his care team urging him to do so. “I have this sense of wanting to tough it out,” he said. He also felt guilty making his peers take on his share of those challenging shifts.

In December 2019, Dr. Bullock was voluntarily hospitalized for a few days and started writing the article that would later appear in NEJM. In January, a friend and UCSF medical student completed suicide. In March, the same month his NEJM article came out, Dr. Bullock attempted suicide again. This time, he quickly recognized that he was making a mistake and called an ambulance. “For me, as far as suicide attempts go, it’s the most positive one.”
 

Advocating for changes in medical training

Throughout his medical training, Dr. Bullock was always open about his struggles with his peers and with the administration. He shared his suicidal thoughts at a Mental Illness Among Us event during medical school. His story resonated with peers who were surprised that Dr. Bullock, who was thriving academically, could be struggling emotionally. 

During residency, he led small group discussions and gave lectures at the medical school, including a talk about his attempts to create institutional change at UCSF, such as his public fight against the college’s Fitness for Duty (FFD) assessment process. That discussion earned him an Outstanding Lecturer award. Because it was the third award he had received from the medical school, Dr. Bullock also automatically earned a lifetime teaching award. When he told his mom, a teacher herself, about the award, she joked: “Are you old enough for ‘lifetime’ anything?”

Dr. Bullock has also spoken out and actively fought against the processes within the medical community that prevent people from coming forward until it is too late. Physicians and trainees often fear that if they seek mental health treatment, they will have to disclose that treatment to a potential employer or licensing board and then be barred from practicing medicine. Because he has been open about his mental health for so long, Dr. Bullock feels that he is in a position to push back against these norms. For example, in June he coauthored another article, this time for the Journal of Hospital Medicine, describing the traumatizing FFD assessment that followed his March 2020 suicide attempt.

In that article, Dr. Bullock wrote how no mental health professional served on the UCSF Physician Well Being Committee – comprising physicians and lawyers who evaluate physician impairment or potential physician impairment – that evaluated him. Dr. Bullock was referred to an outside psychiatrist. He also describes how he was forced to release all of his psychiatric records and undergo extensive drug testing, despite having no history of substance abuse. To return to work, he had to sign a contract, agreeing to be monitored and to attend a specific kind of therapy.

While steps like these can, in the right circumstances, protect both the public and doctors-in-training in important ways, they can also “be very punitive and isolating for someone going through a mental health crisis,” said Dr. Meeks. There were also no Black physicians or lawyers on the committee evaluating Dr. Bullock. “That was really egregious, when you look back.” Dr. Meeks is a coauthor on Dr. Bullock’s JHM article and a mentor and previous student disability officer at UCSF. 

Dr. Bullock raised objections to UCSF administrators about how he felt that the committee was discriminating against him because of his mental illness despite assurances from the director of his program that there have never been any performance or professionalism concerns with him. He said the administrators told him he was the first person to question the FFD process. This isn’t surprising, given that all the power in such situations usually lies with the hospital and the administrators, whereas the resident or physician is worried about losing their job and their license, said Dr. Meeks.

Dr. Bullock contends that he’s in a unique position to speak out, considering his stellar academic and work records, openness about his mental illness before a crisis, access to quality mental health care, and extensive personal network among the UCSF administration. “I know that I hold power within my institution; I spoke out because I could,” Dr. Bullock said. In addition to writing an article about his experience, Dr. Bullock shared his story with a task force appointed by the medical staff president to review the Physician Well-Being Committee and the overall FFD process. Even before Dr. Bullock shared his story with the public, the task force had already been appointed as a result of the increased concern about physician mental health during the ongoing COVID-19 pandemic, Michelle Guy, MD, clinical professor of medicine at UCSF, told this news organization. 

Elizabeth Fernandez, a UCSF senior public information representative, declined to comment on Dr. Bullock’s specific experience as reported in the JHM. “As with every hospital accredited by the Joint Commission, UCSF Medical Center has a Physician Well Being Committee that provides resources for physicians who may need help with chemical dependency or mental illness,” Ms. Fernandez said.

“Our goal through this program is always, first, to provide the compassion and assistance our physicians need to address the issues they face and continue to pursue their careers. This program is entirely voluntary and is bound by federal and state laws and regulations to protect the confidentiality of its participants, while ensuring that – first and foremost – no one is harmed by the situation, including the participant.”
 

Overcoming stigma to change the system

All of the attention – from national media outlets such as Vox to struggling peers and others – is fulfilling, Dr. Bullock said. But it can also be overwhelming. “I have definitely been praised as ‘Black excellence,’ and that definitely has added to the pressure to keep going ... to keep pushing at times,” he said.

Ms. Mahoney added: “He’s willing to sacrifice himself in order to make a difference. He would be a sacrificial lamb” for the Black community, the gay community, or any minority community.

Despite these concerns and his past suicide attempts, colleagues feel that Dr. Bullock is in a strong place to make decisions. “I trust Justin to put the boundaries up when they are needed and to engage in a way that feels comfortable for him,” said Ms. Meeks. “He is someone who has incredible self-awareness.”

Dr. Bullock’s history isn’t just something he overcame: It’s something that makes him a better, more empathetic doctor, said Ms. Mahoney. He knows what it’s like to be hospitalized, to deal with the frustration of insurance, to navigate the complexity of the health care system as a patient, or to be facing a deep internal darkness. He “can genuinely hold that person’s hand and say: ‘I know what you’re going through and we’re going to work through this day by day,’ ” she said. “That is something he can bring that no other physician can bring.”

In his advocacy on Twitter, in lectures, and in conversations with UCSF administrators, Dr. Bullock is pushing for board licensing questions to be reformed so physicians are no longer penalized for seeking mental health treatment. He would also like residency programs to make it easier and less stigmatizing for trainees to receive accommodations for a disability or mental illness.

“They say one person can’t change a system,” said Dr. Meeks, “but I do think Justin is calling an awful lot of attention to the system and I do think there will be changes because of his advocacy.”

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

In early 2020, Justin Bullock, MD, MPH, did what few, if any, resident physicians have done: He published an honest account in the New England Journal of Medicine of a would-be suicide attempt during medical training.

In the article, Dr. Bullock matter-of-factly laid out how, in 2019, intern-year night shifts contributed to a depressive episode. For Dr. Bullock, who has a bipolar disorder, sleep dysregulation can be deadly. He had a plan for completing suicide, and this wouldn’t have been his first attempt. Thanks to his history and openness about his condition, Dr. Bullock had an experienced care team that helped him get to a psychiatric hospital before anything happened. While there for around 5 days, he wrote the bulk of the NEJM article.

The article took Dr. Bullock’s impact nationwide. In the medical world, where mental illness is a serious problem but still deeply stigmatized, Dr. Bullock’s unblinking honesty on the issue is still radical to many. On Twitter and in interviews, Dr. Bullock is an unapologetic advocate for accommodations for people in medicine with mental illness. “One of the things that inspired me to speak out early on is that I feel I stand in a place of so much privilege,” Dr. Bullock told this news organization. “I often feel this sense of ... ‘you have to speak up, Justin; no one else can.’ ”

Dr. Bullock’s activism is especially noteworthy, given that he is still establishing his career. In August, while an internal medicine resident at the University of California, San Francisco, he received a lifetime teaching award from UCSF because he had received three prior teaching awards; a recognition like this is considered rare someone so early in their career. Now in his final year of residency, he actively researches medical education, advocates for mental health support, and is working to become a leading voice on related issues.

“It seems to be working,” his older sister, Jacquis Mahoney, RN, said during a visit to the UCSF campus. Instead of any awkwardness, everyone is thrilled to learn that she is Justin’s sister. “There’s a lot of pride and excitement.”
 

Suicide attempts during medical training

Now 28, Dr. Bullock grew up in Detroit, with his mom and two older sisters. His father was incarcerated for much of Dr. Bullock’s childhood, in part because of his own bipolar disorder not being well controlled, Dr. Bullock said.

When he was younger, Dr. Bullock was the peacekeeper in the house between his two sisters, said Ms. Mahoney: “Justin was always very delicate and kind.”

He played soccer and ran track but also loved math and science. While outwardly accumulating an impressive resume, Dr. Bullock was internally struggling. In high school, he made what he now calls an “immature” attempt at suicide after coming out as gay to his family. While Dr. Bullock said he doesn’t necessarily dwell on the discrimination he has faced as a gay, Black man, his awareness of how others perceive and treat him because of his identity increases the background stress present in his daily life.

After high school, Dr. Bullock went to MIT in Boston, where he continued running and studied chemical-biological engineering. During college, Dr. Bullock thought he was going to have to withdraw from MIT because of his depression. Thankfully, he received counseling from student services and advice from a track coach who sat him down and talked about pragmatic solutions, like medication. “That was life-changing,” said Dr. Bullock.

When trying to decide between engineering and medicine, Dr. Bullock realized he preferred contemplating medical problems to engineering ones. So he applied to medical school. Dr. Bullock eventually ended up at UCSF, where he was selected to participate in the Program in Medical Education for the Urban Underserved, a 5-year track at the college for students committed to working with underserved communities.

By the time Dr. Bullock got to medical school, he was feeling good. In consultation with his psychiatrist, he thought it worthwhile to take a break from his medications. At that time, his diagnosis was major depressive disorder and he had only had one serious depressive episode, which didn’t necessarily indicate that he would need medication long-term, he said. 

Dr. Bullock loved everything about medical school. “One day when I was in my first year of med school, I called my mom and said: ‘It’s like science summer camp but every day!’” he recalled.

Despite his enthusiasm, though, he began feeling something troubling. Recognizing the symptoms of early depression, Dr. Bullock restarted his medication. But this time, the same SSRI only made things worse. He went from sleeping 8 hours to 90 minutes a night. He felt angry. One day, he went on a furious 22-mile run. Plus, within the first 6 months of moving to San Francisco, Dr. Bullock was stopped by the police three different times while riding his bike. He attributes this to his race, which has only further added to his stress. In September 2015, during his second year of medical school, Dr. Bullock attempted suicide again. This time, he was intubated in the ED and rushed to the ICU.

He was given a new diagnosis: bipolar disorder. He changed medications and lived for a time with Ms. Mahoney and his other sister, who moved from Chicago to California to be with him. “My family has helped me a lot,” he said.

Dr. Bullock was initially not sure whether he would be able to return to school after his attempted suicide. Overall, UCSF was extremely supportive, he said. That came as a relief. Medical school was a grounding force in his life, not a destabilizing one: “If I had been pushed out, it would have been really harmful to me.”

Then Dr. Bullock started residency. The sleep disruption that comes with the night shift – the resident rite of passage – triggered another episode. At first, Dr. Bullock was overly productive; his mind was active and alert after staying up all night. He worked on new research during the day instead of sleeping. 

Sleep disturbance is a hallmark symptom of bipolar disorder. “Justin should never be on a 24-hour call,” said Lisa Meeks, PhD, associate professor of psychiatry and family medicine at the University of Colorado at Denver, Aurora, and a leading scholar on disability advocacy for medical trainees. When he started residency, Dr. Bullock was open with his program director about his diagnosis and sought accommodations to go to therapy each week. But he didn’t try to get out of night shifts or 24-hour calls, despite his care team urging him to do so. “I have this sense of wanting to tough it out,” he said. He also felt guilty making his peers take on his share of those challenging shifts.

In December 2019, Dr. Bullock was voluntarily hospitalized for a few days and started writing the article that would later appear in NEJM. In January, a friend and UCSF medical student completed suicide. In March, the same month his NEJM article came out, Dr. Bullock attempted suicide again. This time, he quickly recognized that he was making a mistake and called an ambulance. “For me, as far as suicide attempts go, it’s the most positive one.”
 

Advocating for changes in medical training

Throughout his medical training, Dr. Bullock was always open about his struggles with his peers and with the administration. He shared his suicidal thoughts at a Mental Illness Among Us event during medical school. His story resonated with peers who were surprised that Dr. Bullock, who was thriving academically, could be struggling emotionally. 

During residency, he led small group discussions and gave lectures at the medical school, including a talk about his attempts to create institutional change at UCSF, such as his public fight against the college’s Fitness for Duty (FFD) assessment process. That discussion earned him an Outstanding Lecturer award. Because it was the third award he had received from the medical school, Dr. Bullock also automatically earned a lifetime teaching award. When he told his mom, a teacher herself, about the award, she joked: “Are you old enough for ‘lifetime’ anything?”

Dr. Bullock has also spoken out and actively fought against the processes within the medical community that prevent people from coming forward until it is too late. Physicians and trainees often fear that if they seek mental health treatment, they will have to disclose that treatment to a potential employer or licensing board and then be barred from practicing medicine. Because he has been open about his mental health for so long, Dr. Bullock feels that he is in a position to push back against these norms. For example, in June he coauthored another article, this time for the Journal of Hospital Medicine, describing the traumatizing FFD assessment that followed his March 2020 suicide attempt.

In that article, Dr. Bullock wrote how no mental health professional served on the UCSF Physician Well Being Committee – comprising physicians and lawyers who evaluate physician impairment or potential physician impairment – that evaluated him. Dr. Bullock was referred to an outside psychiatrist. He also describes how he was forced to release all of his psychiatric records and undergo extensive drug testing, despite having no history of substance abuse. To return to work, he had to sign a contract, agreeing to be monitored and to attend a specific kind of therapy.

While steps like these can, in the right circumstances, protect both the public and doctors-in-training in important ways, they can also “be very punitive and isolating for someone going through a mental health crisis,” said Dr. Meeks. There were also no Black physicians or lawyers on the committee evaluating Dr. Bullock. “That was really egregious, when you look back.” Dr. Meeks is a coauthor on Dr. Bullock’s JHM article and a mentor and previous student disability officer at UCSF. 

Dr. Bullock raised objections to UCSF administrators about how he felt that the committee was discriminating against him because of his mental illness despite assurances from the director of his program that there have never been any performance or professionalism concerns with him. He said the administrators told him he was the first person to question the FFD process. This isn’t surprising, given that all the power in such situations usually lies with the hospital and the administrators, whereas the resident or physician is worried about losing their job and their license, said Dr. Meeks.

Dr. Bullock contends that he’s in a unique position to speak out, considering his stellar academic and work records, openness about his mental illness before a crisis, access to quality mental health care, and extensive personal network among the UCSF administration. “I know that I hold power within my institution; I spoke out because I could,” Dr. Bullock said. In addition to writing an article about his experience, Dr. Bullock shared his story with a task force appointed by the medical staff president to review the Physician Well-Being Committee and the overall FFD process. Even before Dr. Bullock shared his story with the public, the task force had already been appointed as a result of the increased concern about physician mental health during the ongoing COVID-19 pandemic, Michelle Guy, MD, clinical professor of medicine at UCSF, told this news organization. 

Elizabeth Fernandez, a UCSF senior public information representative, declined to comment on Dr. Bullock’s specific experience as reported in the JHM. “As with every hospital accredited by the Joint Commission, UCSF Medical Center has a Physician Well Being Committee that provides resources for physicians who may need help with chemical dependency or mental illness,” Ms. Fernandez said.

“Our goal through this program is always, first, to provide the compassion and assistance our physicians need to address the issues they face and continue to pursue their careers. This program is entirely voluntary and is bound by federal and state laws and regulations to protect the confidentiality of its participants, while ensuring that – first and foremost – no one is harmed by the situation, including the participant.”
 

Overcoming stigma to change the system

All of the attention – from national media outlets such as Vox to struggling peers and others – is fulfilling, Dr. Bullock said. But it can also be overwhelming. “I have definitely been praised as ‘Black excellence,’ and that definitely has added to the pressure to keep going ... to keep pushing at times,” he said.

Ms. Mahoney added: “He’s willing to sacrifice himself in order to make a difference. He would be a sacrificial lamb” for the Black community, the gay community, or any minority community.

Despite these concerns and his past suicide attempts, colleagues feel that Dr. Bullock is in a strong place to make decisions. “I trust Justin to put the boundaries up when they are needed and to engage in a way that feels comfortable for him,” said Ms. Meeks. “He is someone who has incredible self-awareness.”

Dr. Bullock’s history isn’t just something he overcame: It’s something that makes him a better, more empathetic doctor, said Ms. Mahoney. He knows what it’s like to be hospitalized, to deal with the frustration of insurance, to navigate the complexity of the health care system as a patient, or to be facing a deep internal darkness. He “can genuinely hold that person’s hand and say: ‘I know what you’re going through and we’re going to work through this day by day,’ ” she said. “That is something he can bring that no other physician can bring.”

In his advocacy on Twitter, in lectures, and in conversations with UCSF administrators, Dr. Bullock is pushing for board licensing questions to be reformed so physicians are no longer penalized for seeking mental health treatment. He would also like residency programs to make it easier and less stigmatizing for trainees to receive accommodations for a disability or mental illness.

“They say one person can’t change a system,” said Dr. Meeks, “but I do think Justin is calling an awful lot of attention to the system and I do think there will be changes because of his advocacy.”

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

In early 2020, Justin Bullock, MD, MPH, did what few, if any, resident physicians have done: He published an honest account in the New England Journal of Medicine of a would-be suicide attempt during medical training.

In the article, Dr. Bullock matter-of-factly laid out how, in 2019, intern-year night shifts contributed to a depressive episode. For Dr. Bullock, who has a bipolar disorder, sleep dysregulation can be deadly. He had a plan for completing suicide, and this wouldn’t have been his first attempt. Thanks to his history and openness about his condition, Dr. Bullock had an experienced care team that helped him get to a psychiatric hospital before anything happened. While there for around 5 days, he wrote the bulk of the NEJM article.

The article took Dr. Bullock’s impact nationwide. In the medical world, where mental illness is a serious problem but still deeply stigmatized, Dr. Bullock’s unblinking honesty on the issue is still radical to many. On Twitter and in interviews, Dr. Bullock is an unapologetic advocate for accommodations for people in medicine with mental illness. “One of the things that inspired me to speak out early on is that I feel I stand in a place of so much privilege,” Dr. Bullock told this news organization. “I often feel this sense of ... ‘you have to speak up, Justin; no one else can.’ ”

Dr. Bullock’s activism is especially noteworthy, given that he is still establishing his career. In August, while an internal medicine resident at the University of California, San Francisco, he received a lifetime teaching award from UCSF because he had received three prior teaching awards; a recognition like this is considered rare someone so early in their career. Now in his final year of residency, he actively researches medical education, advocates for mental health support, and is working to become a leading voice on related issues.

“It seems to be working,” his older sister, Jacquis Mahoney, RN, said during a visit to the UCSF campus. Instead of any awkwardness, everyone is thrilled to learn that she is Justin’s sister. “There’s a lot of pride and excitement.”
 

Suicide attempts during medical training

Now 28, Dr. Bullock grew up in Detroit, with his mom and two older sisters. His father was incarcerated for much of Dr. Bullock’s childhood, in part because of his own bipolar disorder not being well controlled, Dr. Bullock said.

When he was younger, Dr. Bullock was the peacekeeper in the house between his two sisters, said Ms. Mahoney: “Justin was always very delicate and kind.”

He played soccer and ran track but also loved math and science. While outwardly accumulating an impressive resume, Dr. Bullock was internally struggling. In high school, he made what he now calls an “immature” attempt at suicide after coming out as gay to his family. While Dr. Bullock said he doesn’t necessarily dwell on the discrimination he has faced as a gay, Black man, his awareness of how others perceive and treat him because of his identity increases the background stress present in his daily life.

After high school, Dr. Bullock went to MIT in Boston, where he continued running and studied chemical-biological engineering. During college, Dr. Bullock thought he was going to have to withdraw from MIT because of his depression. Thankfully, he received counseling from student services and advice from a track coach who sat him down and talked about pragmatic solutions, like medication. “That was life-changing,” said Dr. Bullock.

When trying to decide between engineering and medicine, Dr. Bullock realized he preferred contemplating medical problems to engineering ones. So he applied to medical school. Dr. Bullock eventually ended up at UCSF, where he was selected to participate in the Program in Medical Education for the Urban Underserved, a 5-year track at the college for students committed to working with underserved communities.

By the time Dr. Bullock got to medical school, he was feeling good. In consultation with his psychiatrist, he thought it worthwhile to take a break from his medications. At that time, his diagnosis was major depressive disorder and he had only had one serious depressive episode, which didn’t necessarily indicate that he would need medication long-term, he said. 

Dr. Bullock loved everything about medical school. “One day when I was in my first year of med school, I called my mom and said: ‘It’s like science summer camp but every day!’” he recalled.

Despite his enthusiasm, though, he began feeling something troubling. Recognizing the symptoms of early depression, Dr. Bullock restarted his medication. But this time, the same SSRI only made things worse. He went from sleeping 8 hours to 90 minutes a night. He felt angry. One day, he went on a furious 22-mile run. Plus, within the first 6 months of moving to San Francisco, Dr. Bullock was stopped by the police three different times while riding his bike. He attributes this to his race, which has only further added to his stress. In September 2015, during his second year of medical school, Dr. Bullock attempted suicide again. This time, he was intubated in the ED and rushed to the ICU.

He was given a new diagnosis: bipolar disorder. He changed medications and lived for a time with Ms. Mahoney and his other sister, who moved from Chicago to California to be with him. “My family has helped me a lot,” he said.

Dr. Bullock was initially not sure whether he would be able to return to school after his attempted suicide. Overall, UCSF was extremely supportive, he said. That came as a relief. Medical school was a grounding force in his life, not a destabilizing one: “If I had been pushed out, it would have been really harmful to me.”

Then Dr. Bullock started residency. The sleep disruption that comes with the night shift – the resident rite of passage – triggered another episode. At first, Dr. Bullock was overly productive; his mind was active and alert after staying up all night. He worked on new research during the day instead of sleeping. 

Sleep disturbance is a hallmark symptom of bipolar disorder. “Justin should never be on a 24-hour call,” said Lisa Meeks, PhD, associate professor of psychiatry and family medicine at the University of Colorado at Denver, Aurora, and a leading scholar on disability advocacy for medical trainees. When he started residency, Dr. Bullock was open with his program director about his diagnosis and sought accommodations to go to therapy each week. But he didn’t try to get out of night shifts or 24-hour calls, despite his care team urging him to do so. “I have this sense of wanting to tough it out,” he said. He also felt guilty making his peers take on his share of those challenging shifts.

In December 2019, Dr. Bullock was voluntarily hospitalized for a few days and started writing the article that would later appear in NEJM. In January, a friend and UCSF medical student completed suicide. In March, the same month his NEJM article came out, Dr. Bullock attempted suicide again. This time, he quickly recognized that he was making a mistake and called an ambulance. “For me, as far as suicide attempts go, it’s the most positive one.”
 

Advocating for changes in medical training

Throughout his medical training, Dr. Bullock was always open about his struggles with his peers and with the administration. He shared his suicidal thoughts at a Mental Illness Among Us event during medical school. His story resonated with peers who were surprised that Dr. Bullock, who was thriving academically, could be struggling emotionally. 

During residency, he led small group discussions and gave lectures at the medical school, including a talk about his attempts to create institutional change at UCSF, such as his public fight against the college’s Fitness for Duty (FFD) assessment process. That discussion earned him an Outstanding Lecturer award. Because it was the third award he had received from the medical school, Dr. Bullock also automatically earned a lifetime teaching award. When he told his mom, a teacher herself, about the award, she joked: “Are you old enough for ‘lifetime’ anything?”

Dr. Bullock has also spoken out and actively fought against the processes within the medical community that prevent people from coming forward until it is too late. Physicians and trainees often fear that if they seek mental health treatment, they will have to disclose that treatment to a potential employer or licensing board and then be barred from practicing medicine. Because he has been open about his mental health for so long, Dr. Bullock feels that he is in a position to push back against these norms. For example, in June he coauthored another article, this time for the Journal of Hospital Medicine, describing the traumatizing FFD assessment that followed his March 2020 suicide attempt.

In that article, Dr. Bullock wrote how no mental health professional served on the UCSF Physician Well Being Committee – comprising physicians and lawyers who evaluate physician impairment or potential physician impairment – that evaluated him. Dr. Bullock was referred to an outside psychiatrist. He also describes how he was forced to release all of his psychiatric records and undergo extensive drug testing, despite having no history of substance abuse. To return to work, he had to sign a contract, agreeing to be monitored and to attend a specific kind of therapy.

While steps like these can, in the right circumstances, protect both the public and doctors-in-training in important ways, they can also “be very punitive and isolating for someone going through a mental health crisis,” said Dr. Meeks. There were also no Black physicians or lawyers on the committee evaluating Dr. Bullock. “That was really egregious, when you look back.” Dr. Meeks is a coauthor on Dr. Bullock’s JHM article and a mentor and previous student disability officer at UCSF. 

Dr. Bullock raised objections to UCSF administrators about how he felt that the committee was discriminating against him because of his mental illness despite assurances from the director of his program that there have never been any performance or professionalism concerns with him. He said the administrators told him he was the first person to question the FFD process. This isn’t surprising, given that all the power in such situations usually lies with the hospital and the administrators, whereas the resident or physician is worried about losing their job and their license, said Dr. Meeks.

Dr. Bullock contends that he’s in a unique position to speak out, considering his stellar academic and work records, openness about his mental illness before a crisis, access to quality mental health care, and extensive personal network among the UCSF administration. “I know that I hold power within my institution; I spoke out because I could,” Dr. Bullock said. In addition to writing an article about his experience, Dr. Bullock shared his story with a task force appointed by the medical staff president to review the Physician Well-Being Committee and the overall FFD process. Even before Dr. Bullock shared his story with the public, the task force had already been appointed as a result of the increased concern about physician mental health during the ongoing COVID-19 pandemic, Michelle Guy, MD, clinical professor of medicine at UCSF, told this news organization. 

Elizabeth Fernandez, a UCSF senior public information representative, declined to comment on Dr. Bullock’s specific experience as reported in the JHM. “As with every hospital accredited by the Joint Commission, UCSF Medical Center has a Physician Well Being Committee that provides resources for physicians who may need help with chemical dependency or mental illness,” Ms. Fernandez said.

“Our goal through this program is always, first, to provide the compassion and assistance our physicians need to address the issues they face and continue to pursue their careers. This program is entirely voluntary and is bound by federal and state laws and regulations to protect the confidentiality of its participants, while ensuring that – first and foremost – no one is harmed by the situation, including the participant.”
 

Overcoming stigma to change the system

All of the attention – from national media outlets such as Vox to struggling peers and others – is fulfilling, Dr. Bullock said. But it can also be overwhelming. “I have definitely been praised as ‘Black excellence,’ and that definitely has added to the pressure to keep going ... to keep pushing at times,” he said.

Ms. Mahoney added: “He’s willing to sacrifice himself in order to make a difference. He would be a sacrificial lamb” for the Black community, the gay community, or any minority community.

Despite these concerns and his past suicide attempts, colleagues feel that Dr. Bullock is in a strong place to make decisions. “I trust Justin to put the boundaries up when they are needed and to engage in a way that feels comfortable for him,” said Ms. Meeks. “He is someone who has incredible self-awareness.”

Dr. Bullock’s history isn’t just something he overcame: It’s something that makes him a better, more empathetic doctor, said Ms. Mahoney. He knows what it’s like to be hospitalized, to deal with the frustration of insurance, to navigate the complexity of the health care system as a patient, or to be facing a deep internal darkness. He “can genuinely hold that person’s hand and say: ‘I know what you’re going through and we’re going to work through this day by day,’ ” she said. “That is something he can bring that no other physician can bring.”

In his advocacy on Twitter, in lectures, and in conversations with UCSF administrators, Dr. Bullock is pushing for board licensing questions to be reformed so physicians are no longer penalized for seeking mental health treatment. He would also like residency programs to make it easier and less stigmatizing for trainees to receive accommodations for a disability or mental illness.

“They say one person can’t change a system,” said Dr. Meeks, “but I do think Justin is calling an awful lot of attention to the system and I do think there will be changes because of his advocacy.”

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

The Biden administration on Nov. 4 unveiled its rule to require most of the country’s larger employers to mandate workers be fully vaccinated against COVID-19, but set a Jan. 4 deadline, avoiding the busy holiday season.

The White House also shifted the time lines for earlier mandates applying to federal workers and contractors to Jan. 4. And the same deadline applies to a new separate rule for health care workers.

The new rules are meant to preempt “any inconsistent state or local laws,” including bans and limits on employers’ authority to require vaccination, masks, or testing, the White House said in a statement.

The rule on employers from the Occupational Safety and Health Administration will apply to organizations with 100 or more employees. These employers will need to make sure each worker is fully vaccinated or tests for COVID-19 on at least a weekly basis. The OSHA rule will also require that employers provide paid time for employees to get vaccinated and ensure that all unvaccinated workers wear a face mask in the workplace. This rule will cover 84 million employees. The OSHA rule will not apply to workplaces covered by either the Centers for Medicare & Medicaid Services rule or the federal contractor vaccination requirement

“The virus will not go away by itself, or because we wish it away: We have to act,” President Joe Biden said in a statement. “Vaccination is the single best pathway out of this pandemic.”

Mandates were not the preferred route to managing the pandemic, he said.

“Too many people remain unvaccinated for us to get out of this pandemic for good,” he said. “So I instituted requirements – and they are working.”

The White House said 70% percent of U.S. adults are now fully vaccinated – up from less than 1% when Mr. Biden took office in January.

The CMS vaccine rule is meant to cover more than 17 million workers and about 76,000 medical care sites, including hospitals, ambulatory surgery centers, nursing homes, dialysis facilities, home health agencies, and long-term care facilities. The rule will apply to employees whether their positions involve patient care or not.

Unlike the OSHA mandate, the one for health care workers will not offer the option of frequent COVID-19 testing instead of vaccination. There is a “higher bar” for health care workers, given their role in treating patients, so the mandate allows only for vaccination or limited exemptions, a senior administration official said on Nov. 3 during a call with reporters.

The CMS rule includes a “range of remedies,” including penalties and denial of payment for health care facilities that fail to meet the vaccine mandate. CMS could theoretically cut off hospitals and other medical organizations for failure to comply, but that would be a “last resort,” a senior administration official said. CMS will instead work with health care facilities to help them comply with the federal rule on vaccination of medical workers.

The new CMS rules apply only to Medicare- and Medicaid-certified centers and organizations. The rule does not directly apply to other health care entities, such as doctor’s offices, that are not regulated by CMS.

“Most states have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC,” CMS said in the rule.

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

The Biden administration on Nov. 4 unveiled its rule to require most of the country’s larger employers to mandate workers be fully vaccinated against COVID-19, but set a Jan. 4 deadline, avoiding the busy holiday season.

The White House also shifted the time lines for earlier mandates applying to federal workers and contractors to Jan. 4. And the same deadline applies to a new separate rule for health care workers.

The new rules are meant to preempt “any inconsistent state or local laws,” including bans and limits on employers’ authority to require vaccination, masks, or testing, the White House said in a statement.

The rule on employers from the Occupational Safety and Health Administration will apply to organizations with 100 or more employees. These employers will need to make sure each worker is fully vaccinated or tests for COVID-19 on at least a weekly basis. The OSHA rule will also require that employers provide paid time for employees to get vaccinated and ensure that all unvaccinated workers wear a face mask in the workplace. This rule will cover 84 million employees. The OSHA rule will not apply to workplaces covered by either the Centers for Medicare & Medicaid Services rule or the federal contractor vaccination requirement

“The virus will not go away by itself, or because we wish it away: We have to act,” President Joe Biden said in a statement. “Vaccination is the single best pathway out of this pandemic.”

Mandates were not the preferred route to managing the pandemic, he said.

“Too many people remain unvaccinated for us to get out of this pandemic for good,” he said. “So I instituted requirements – and they are working.”

The White House said 70% percent of U.S. adults are now fully vaccinated – up from less than 1% when Mr. Biden took office in January.

The CMS vaccine rule is meant to cover more than 17 million workers and about 76,000 medical care sites, including hospitals, ambulatory surgery centers, nursing homes, dialysis facilities, home health agencies, and long-term care facilities. The rule will apply to employees whether their positions involve patient care or not.

Unlike the OSHA mandate, the one for health care workers will not offer the option of frequent COVID-19 testing instead of vaccination. There is a “higher bar” for health care workers, given their role in treating patients, so the mandate allows only for vaccination or limited exemptions, a senior administration official said on Nov. 3 during a call with reporters.

The CMS rule includes a “range of remedies,” including penalties and denial of payment for health care facilities that fail to meet the vaccine mandate. CMS could theoretically cut off hospitals and other medical organizations for failure to comply, but that would be a “last resort,” a senior administration official said. CMS will instead work with health care facilities to help them comply with the federal rule on vaccination of medical workers.

The new CMS rules apply only to Medicare- and Medicaid-certified centers and organizations. The rule does not directly apply to other health care entities, such as doctor’s offices, that are not regulated by CMS.

“Most states have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC,” CMS said in the rule.

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

The Biden administration on Nov. 4 unveiled its rule to require most of the country’s larger employers to mandate workers be fully vaccinated against COVID-19, but set a Jan. 4 deadline, avoiding the busy holiday season.

The White House also shifted the time lines for earlier mandates applying to federal workers and contractors to Jan. 4. And the same deadline applies to a new separate rule for health care workers.

The new rules are meant to preempt “any inconsistent state or local laws,” including bans and limits on employers’ authority to require vaccination, masks, or testing, the White House said in a statement.

The rule on employers from the Occupational Safety and Health Administration will apply to organizations with 100 or more employees. These employers will need to make sure each worker is fully vaccinated or tests for COVID-19 on at least a weekly basis. The OSHA rule will also require that employers provide paid time for employees to get vaccinated and ensure that all unvaccinated workers wear a face mask in the workplace. This rule will cover 84 million employees. The OSHA rule will not apply to workplaces covered by either the Centers for Medicare & Medicaid Services rule or the federal contractor vaccination requirement

“The virus will not go away by itself, or because we wish it away: We have to act,” President Joe Biden said in a statement. “Vaccination is the single best pathway out of this pandemic.”

Mandates were not the preferred route to managing the pandemic, he said.

“Too many people remain unvaccinated for us to get out of this pandemic for good,” he said. “So I instituted requirements – and they are working.”

The White House said 70% percent of U.S. adults are now fully vaccinated – up from less than 1% when Mr. Biden took office in January.

The CMS vaccine rule is meant to cover more than 17 million workers and about 76,000 medical care sites, including hospitals, ambulatory surgery centers, nursing homes, dialysis facilities, home health agencies, and long-term care facilities. The rule will apply to employees whether their positions involve patient care or not.

Unlike the OSHA mandate, the one for health care workers will not offer the option of frequent COVID-19 testing instead of vaccination. There is a “higher bar” for health care workers, given their role in treating patients, so the mandate allows only for vaccination or limited exemptions, a senior administration official said on Nov. 3 during a call with reporters.

The CMS rule includes a “range of remedies,” including penalties and denial of payment for health care facilities that fail to meet the vaccine mandate. CMS could theoretically cut off hospitals and other medical organizations for failure to comply, but that would be a “last resort,” a senior administration official said. CMS will instead work with health care facilities to help them comply with the federal rule on vaccination of medical workers.

The new CMS rules apply only to Medicare- and Medicaid-certified centers and organizations. The rule does not directly apply to other health care entities, such as doctor’s offices, that are not regulated by CMS.

“Most states have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC,” CMS said in the rule.

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

No, Mr. Bond, I expect you to die

Movie watching usually requires a certain suspension of disbelief, and it’s safe to say James Bond movies require this more than most. Between the impossible gadgets and ludicrous doomsday plans, very few have ever stopped to consider the health risks of the James Bond universe.

Tumisu/Pixabay

Now, however, Bond, James Bond, has met his most formidable opponent: Wouter Graumans, a graduate student in epidemiology from the Netherlands. During a foray to Burkina Faso to study infectious diseases, Mr. Graumans came down with a case of food poisoning, which led him to wonder how 007 is able to trot across this big world of ours without contracting so much as a sinus infection.

Because Mr. Graumans is a man of science and conviction, mere speculation wasn’t enough. He and a group of coauthors wrote an entire paper on the health risks of the James Bond universe.

Doing so required watching over 3,000 minutes of numerous movies and analyzing Bond’s 86 total trips to 46 different countries based on current Centers for Disease Control and Prevention advice for travel to those countries. Time which, the authors state in the abstract, “could easily have been spent on more pressing societal issues or forms of relaxation that are more acceptable in academic circles.”

Naturally, Mr. Bond’s line of work entails exposure to unpleasant things, such as poison, dehydration, heatstroke, and dangerous wildlife (everything from ticks to crocodiles), though oddly enough he never succumbs to any of it. He’s also curiously immune to hangovers, despite rarely drinking anything nonalcoholic. There are also less obvious risks: For one, 007 rarely washes his hands. During one movie, he handles raw chicken to lure away a pack of crocodiles but fails to wash his hands afterward, leaving him at risk for multiple food-borne illnesses.

Of course, we must address the elephant in the bedroom: Mr. Bond’s numerous, er, encounters with women. One would imagine the biggest risk to those women would be from the various STDs that likely course through Bond’s body, but of the 27% who died shortly after … encountering … him, all involved violence, with disease playing no obvious role. Who knows, maybe he’s clean? Stranger things have happened.

The timing of this article may seem a bit suspicious. Was it a PR stunt by the studio? Rest assured, the authors addressed this, noting that they received no funding for the study, and that, “given the futility of its academic value, this is deemed entirely appropriate by all authors.” We love when a punchline writes itself.
 

How to see Atlanta on $688.35 a day

The world is always changing, so we have to change with it. This week, LOTME becomes a travel guide, and our first stop is the Big A, the Big Peach, Dogwood City, Empire City of the South, Wakanda.

There’s lots to do in Atlanta: Celebrate a World Series win, visit the College Football Hall of Fame or the World of Coca Cola, or take the Stranger Things/Upside Down film locations tour. Serious adventurers, however, get out of the city and go to Emory Decatur Hospital in – you guessed it – Decatur (unofficial motto: “Everything is Greater in Decatur”).

©Getty Images

Find the emergency room and ask for Taylor Davis, who will be your personal guide. She’ll show you how to check in at the desk, sit in the waiting room for 7 hours, and then leave without seeing any medical personnel or receiving any sort of attention whatsoever. All the things she did when she went there in July for a head injury.

Ms. Davis told Fox5 Atlanta: “I didn’t get my vitals taken, nobody called my name. I wasn’t seen at all.”

But wait! There’s more! By booking your trip through LOTMEgo* and using the code “Decatur,” you’ll get the Taylor Davis special, which includes a bill/cover charge for $688.35 from the hospital. An Emory Healthcare patient financial services employee told Ms. Davis that “you get charged before you are seen. Not for being seen.”

If all this has you ready to hop in your car (really?), then check out LOTMEgo* on Twittbook and InstaTok. You’ll also find trick-or-treating tips and discounts on haunted hospital tours.

*Does not actually exist

Breaking down the hot flash

Do you ever wonder why we scramble for cold things when we’re feeling nauseous? Whether it’s the cool air that needs to hit your face in the car or a cold, damp towel on the back of your neck, scientists think it could possibly be an evolutionary mechanism at the cellular level.

Piqsels

Motion sickness it’s actually a battle of body temperature, according to an article from LiveScience. Capillaries in the skin dilate, allowing for more blood flow near the skin’s surface and causing core temperature to fall. Once body temperature drops, the hypothalamus, which regulates temperature, tries to do its job by raising body temperature. Thus the hot flash!

The cold compress and cool air help fight the battle by counteracting the hypothalamus, but why the drop in body temperature to begin with?

There are a few theories. Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York, told LiveScience that the lack of oxygen needed in body tissue to survive at lower temperatures could be making it difficult to get oxygen to the body when a person is ill, and is “more likely an adaptive response influenced by poorly understood mechanisms at the cellular level.”

Another theory is that the nausea and body temperature shift is the body’s natural response to help people vomit.

Then there’s the theory of “defensive hypothermia,” which suggests that cold sweats are a possible mechanism to conserve energy so the body can fight off an intruder, which was supported by a 2014 study and a 2016 review.

It’s another one of the body’s many survival tricks.
 

Teachers were right: Pupils can do the math

Teachers liked to preach that we wouldn’t have calculators with us all the time, but that wound up not being true. Our phones have calculators at the press of a button. But maybe even calculators aren’t always needed because our pupils do more math than you think.

pxfuel

The pupil light reflex – constrict in light and dilate in darkness – is well known, but recent work shows that pupil size is also regulated by cognitive and perceptual factors. By presenting subjects with images of various numbers of dots and measuring pupil size, the investigators were able to show “that numerical information is intrinsically related to perception,” lead author Dr. Elisa Castaldi of Florence University noted in a written statement.

The researchers found that pupils are responsible for important survival techniques. Coauthor David Burr of the University of Sydney and the University of Florence gave an evolutionary perspective: “When we look around, we spontaneously perceive the form, size, movement and colour of a scene. Equally spontaneously, we perceive the number of items before us. This ability, shared with most other animals, is an evolutionary fundamental: It reveals immediately important quantities, such as how many apples there are on the tree, or how many enemies are attacking.”

Useful information, indeed, but our pupils seem to be more interested in the quantity of beers in the refrigerator.

No, Mr. Bond, I expect you to die

Movie watching usually requires a certain suspension of disbelief, and it’s safe to say James Bond movies require this more than most. Between the impossible gadgets and ludicrous doomsday plans, very few have ever stopped to consider the health risks of the James Bond universe.

Tumisu/Pixabay

Now, however, Bond, James Bond, has met his most formidable opponent: Wouter Graumans, a graduate student in epidemiology from the Netherlands. During a foray to Burkina Faso to study infectious diseases, Mr. Graumans came down with a case of food poisoning, which led him to wonder how 007 is able to trot across this big world of ours without contracting so much as a sinus infection.

Because Mr. Graumans is a man of science and conviction, mere speculation wasn’t enough. He and a group of coauthors wrote an entire paper on the health risks of the James Bond universe.

Doing so required watching over 3,000 minutes of numerous movies and analyzing Bond’s 86 total trips to 46 different countries based on current Centers for Disease Control and Prevention advice for travel to those countries. Time which, the authors state in the abstract, “could easily have been spent on more pressing societal issues or forms of relaxation that are more acceptable in academic circles.”

Naturally, Mr. Bond’s line of work entails exposure to unpleasant things, such as poison, dehydration, heatstroke, and dangerous wildlife (everything from ticks to crocodiles), though oddly enough he never succumbs to any of it. He’s also curiously immune to hangovers, despite rarely drinking anything nonalcoholic. There are also less obvious risks: For one, 007 rarely washes his hands. During one movie, he handles raw chicken to lure away a pack of crocodiles but fails to wash his hands afterward, leaving him at risk for multiple food-borne illnesses.

Of course, we must address the elephant in the bedroom: Mr. Bond’s numerous, er, encounters with women. One would imagine the biggest risk to those women would be from the various STDs that likely course through Bond’s body, but of the 27% who died shortly after … encountering … him, all involved violence, with disease playing no obvious role. Who knows, maybe he’s clean? Stranger things have happened.

The timing of this article may seem a bit suspicious. Was it a PR stunt by the studio? Rest assured, the authors addressed this, noting that they received no funding for the study, and that, “given the futility of its academic value, this is deemed entirely appropriate by all authors.” We love when a punchline writes itself.
 

How to see Atlanta on $688.35 a day

The world is always changing, so we have to change with it. This week, LOTME becomes a travel guide, and our first stop is the Big A, the Big Peach, Dogwood City, Empire City of the South, Wakanda.

There’s lots to do in Atlanta: Celebrate a World Series win, visit the College Football Hall of Fame or the World of Coca Cola, or take the Stranger Things/Upside Down film locations tour. Serious adventurers, however, get out of the city and go to Emory Decatur Hospital in – you guessed it – Decatur (unofficial motto: “Everything is Greater in Decatur”).

©Getty Images

Find the emergency room and ask for Taylor Davis, who will be your personal guide. She’ll show you how to check in at the desk, sit in the waiting room for 7 hours, and then leave without seeing any medical personnel or receiving any sort of attention whatsoever. All the things she did when she went there in July for a head injury.

Ms. Davis told Fox5 Atlanta: “I didn’t get my vitals taken, nobody called my name. I wasn’t seen at all.”

But wait! There’s more! By booking your trip through LOTMEgo* and using the code “Decatur,” you’ll get the Taylor Davis special, which includes a bill/cover charge for $688.35 from the hospital. An Emory Healthcare patient financial services employee told Ms. Davis that “you get charged before you are seen. Not for being seen.”

If all this has you ready to hop in your car (really?), then check out LOTMEgo* on Twittbook and InstaTok. You’ll also find trick-or-treating tips and discounts on haunted hospital tours.

*Does not actually exist

Breaking down the hot flash

Do you ever wonder why we scramble for cold things when we’re feeling nauseous? Whether it’s the cool air that needs to hit your face in the car or a cold, damp towel on the back of your neck, scientists think it could possibly be an evolutionary mechanism at the cellular level.

Piqsels

Motion sickness it’s actually a battle of body temperature, according to an article from LiveScience. Capillaries in the skin dilate, allowing for more blood flow near the skin’s surface and causing core temperature to fall. Once body temperature drops, the hypothalamus, which regulates temperature, tries to do its job by raising body temperature. Thus the hot flash!

The cold compress and cool air help fight the battle by counteracting the hypothalamus, but why the drop in body temperature to begin with?

There are a few theories. Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York, told LiveScience that the lack of oxygen needed in body tissue to survive at lower temperatures could be making it difficult to get oxygen to the body when a person is ill, and is “more likely an adaptive response influenced by poorly understood mechanisms at the cellular level.”

Another theory is that the nausea and body temperature shift is the body’s natural response to help people vomit.

Then there’s the theory of “defensive hypothermia,” which suggests that cold sweats are a possible mechanism to conserve energy so the body can fight off an intruder, which was supported by a 2014 study and a 2016 review.

It’s another one of the body’s many survival tricks.
 

Teachers were right: Pupils can do the math

Teachers liked to preach that we wouldn’t have calculators with us all the time, but that wound up not being true. Our phones have calculators at the press of a button. But maybe even calculators aren’t always needed because our pupils do more math than you think.

pxfuel

The pupil light reflex – constrict in light and dilate in darkness – is well known, but recent work shows that pupil size is also regulated by cognitive and perceptual factors. By presenting subjects with images of various numbers of dots and measuring pupil size, the investigators were able to show “that numerical information is intrinsically related to perception,” lead author Dr. Elisa Castaldi of Florence University noted in a written statement.

The researchers found that pupils are responsible for important survival techniques. Coauthor David Burr of the University of Sydney and the University of Florence gave an evolutionary perspective: “When we look around, we spontaneously perceive the form, size, movement and colour of a scene. Equally spontaneously, we perceive the number of items before us. This ability, shared with most other animals, is an evolutionary fundamental: It reveals immediately important quantities, such as how many apples there are on the tree, or how many enemies are attacking.”

Useful information, indeed, but our pupils seem to be more interested in the quantity of beers in the refrigerator.

No, Mr. Bond, I expect you to die

Movie watching usually requires a certain suspension of disbelief, and it’s safe to say James Bond movies require this more than most. Between the impossible gadgets and ludicrous doomsday plans, very few have ever stopped to consider the health risks of the James Bond universe.

Tumisu/Pixabay

Now, however, Bond, James Bond, has met his most formidable opponent: Wouter Graumans, a graduate student in epidemiology from the Netherlands. During a foray to Burkina Faso to study infectious diseases, Mr. Graumans came down with a case of food poisoning, which led him to wonder how 007 is able to trot across this big world of ours without contracting so much as a sinus infection.

Because Mr. Graumans is a man of science and conviction, mere speculation wasn’t enough. He and a group of coauthors wrote an entire paper on the health risks of the James Bond universe.

Doing so required watching over 3,000 minutes of numerous movies and analyzing Bond’s 86 total trips to 46 different countries based on current Centers for Disease Control and Prevention advice for travel to those countries. Time which, the authors state in the abstract, “could easily have been spent on more pressing societal issues or forms of relaxation that are more acceptable in academic circles.”

Naturally, Mr. Bond’s line of work entails exposure to unpleasant things, such as poison, dehydration, heatstroke, and dangerous wildlife (everything from ticks to crocodiles), though oddly enough he never succumbs to any of it. He’s also curiously immune to hangovers, despite rarely drinking anything nonalcoholic. There are also less obvious risks: For one, 007 rarely washes his hands. During one movie, he handles raw chicken to lure away a pack of crocodiles but fails to wash his hands afterward, leaving him at risk for multiple food-borne illnesses.

Of course, we must address the elephant in the bedroom: Mr. Bond’s numerous, er, encounters with women. One would imagine the biggest risk to those women would be from the various STDs that likely course through Bond’s body, but of the 27% who died shortly after … encountering … him, all involved violence, with disease playing no obvious role. Who knows, maybe he’s clean? Stranger things have happened.

The timing of this article may seem a bit suspicious. Was it a PR stunt by the studio? Rest assured, the authors addressed this, noting that they received no funding for the study, and that, “given the futility of its academic value, this is deemed entirely appropriate by all authors.” We love when a punchline writes itself.
 

How to see Atlanta on $688.35 a day

The world is always changing, so we have to change with it. This week, LOTME becomes a travel guide, and our first stop is the Big A, the Big Peach, Dogwood City, Empire City of the South, Wakanda.

There’s lots to do in Atlanta: Celebrate a World Series win, visit the College Football Hall of Fame or the World of Coca Cola, or take the Stranger Things/Upside Down film locations tour. Serious adventurers, however, get out of the city and go to Emory Decatur Hospital in – you guessed it – Decatur (unofficial motto: “Everything is Greater in Decatur”).

©Getty Images

Find the emergency room and ask for Taylor Davis, who will be your personal guide. She’ll show you how to check in at the desk, sit in the waiting room for 7 hours, and then leave without seeing any medical personnel or receiving any sort of attention whatsoever. All the things she did when she went there in July for a head injury.

Ms. Davis told Fox5 Atlanta: “I didn’t get my vitals taken, nobody called my name. I wasn’t seen at all.”

But wait! There’s more! By booking your trip through LOTMEgo* and using the code “Decatur,” you’ll get the Taylor Davis special, which includes a bill/cover charge for $688.35 from the hospital. An Emory Healthcare patient financial services employee told Ms. Davis that “you get charged before you are seen. Not for being seen.”

If all this has you ready to hop in your car (really?), then check out LOTMEgo* on Twittbook and InstaTok. You’ll also find trick-or-treating tips and discounts on haunted hospital tours.

*Does not actually exist

Breaking down the hot flash

Do you ever wonder why we scramble for cold things when we’re feeling nauseous? Whether it’s the cool air that needs to hit your face in the car or a cold, damp towel on the back of your neck, scientists think it could possibly be an evolutionary mechanism at the cellular level.

Piqsels

Motion sickness it’s actually a battle of body temperature, according to an article from LiveScience. Capillaries in the skin dilate, allowing for more blood flow near the skin’s surface and causing core temperature to fall. Once body temperature drops, the hypothalamus, which regulates temperature, tries to do its job by raising body temperature. Thus the hot flash!

The cold compress and cool air help fight the battle by counteracting the hypothalamus, but why the drop in body temperature to begin with?

There are a few theories. Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York, told LiveScience that the lack of oxygen needed in body tissue to survive at lower temperatures could be making it difficult to get oxygen to the body when a person is ill, and is “more likely an adaptive response influenced by poorly understood mechanisms at the cellular level.”

Another theory is that the nausea and body temperature shift is the body’s natural response to help people vomit.

Then there’s the theory of “defensive hypothermia,” which suggests that cold sweats are a possible mechanism to conserve energy so the body can fight off an intruder, which was supported by a 2014 study and a 2016 review.

It’s another one of the body’s many survival tricks.
 

Teachers were right: Pupils can do the math

Teachers liked to preach that we wouldn’t have calculators with us all the time, but that wound up not being true. Our phones have calculators at the press of a button. But maybe even calculators aren’t always needed because our pupils do more math than you think.

pxfuel

The pupil light reflex – constrict in light and dilate in darkness – is well known, but recent work shows that pupil size is also regulated by cognitive and perceptual factors. By presenting subjects with images of various numbers of dots and measuring pupil size, the investigators were able to show “that numerical information is intrinsically related to perception,” lead author Dr. Elisa Castaldi of Florence University noted in a written statement.

The researchers found that pupils are responsible for important survival techniques. Coauthor David Burr of the University of Sydney and the University of Florence gave an evolutionary perspective: “When we look around, we spontaneously perceive the form, size, movement and colour of a scene. Equally spontaneously, we perceive the number of items before us. This ability, shared with most other animals, is an evolutionary fundamental: It reveals immediately important quantities, such as how many apples there are on the tree, or how many enemies are attacking.”

Useful information, indeed, but our pupils seem to be more interested in the quantity of beers in the refrigerator.

The number of suicides in 2020 declined in comparison to 2019, despite an increase in some risk factors associated with suicidal behavior, including pandemic-related job loss, financial strain, and deteriorating mental health, according to new federal statistics.

The number of annual suicides in the United States increased steadily from 2003 through 2018, followed by a 2% decline between 2018 and 2019. There was concern that deaths due to suicide would increase in 2020, but this doesn’t appear to be the case.

The provisional numbers show 45,855 deaths by suicide in the United States in 2020 – 3% lower than in 2019 (47,511), and 5% below the 2018 peak of 48,344 suicides, report Sally Curtin, MA, and colleagues with the National Center for Health Statistics, part of the U.S. Centers for Disease Control and Prevention.

The data were published online Nov. 3 in the National Vital Statistics System (NVSS) Vital Statistics Rapid Release.

On a monthly basis, the number of suicides was lower in 2020 than in 2019 in March through October and December – with the largest drop happening in April 2020 at a time when deaths from COVID-19 were peaking, the authors note. In April 2020, suicide deaths were 14% lower than in April 2019 (3,468 vs. 4,029).

The provisional age-adjusted suicide rate was 3% lower in 2020 (13.5 per 100,000) than in 2019 (13.9 per 100,000). It was 2% lower among men (21.9 compared with 22.4), and 8% lower for women (5.5 compared with 6.0).

Suicide rates among younger adults aged 10 to 34 years rose slightly between 2019 and 2020 but was only significant in those 25 to 34, with a 5% increase between 2019 and 2020.

Individuals aged 35 to 74 years had significant declines in suicide with the largest drop in those aged 45 to 54 years and 55 to 64 years.

Women in all race and Hispanic-origin groups showed declines in suicide rates between 2019 and 2020, but the decline was significant only among non-Hispanic white women (10%).

Suicide rates declined for non-Hispanic white and non-Hispanic Asian men but increased among non-Hispanic black, non-Hispanic American Indian or Alaska Native, and Hispanic men.

This analysis is based on more than 99% of expected death records. Based on previous patterns between provisional and final data, these provisional findings are expected to be consistent with final 2020 data, the authors say.

The study had no commercial funding. The authors have disclosed no relevant financial relationships.

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

The number of suicides in 2020 declined in comparison to 2019, despite an increase in some risk factors associated with suicidal behavior, including pandemic-related job loss, financial strain, and deteriorating mental health, according to new federal statistics.

The number of annual suicides in the United States increased steadily from 2003 through 2018, followed by a 2% decline between 2018 and 2019. There was concern that deaths due to suicide would increase in 2020, but this doesn’t appear to be the case.

The provisional numbers show 45,855 deaths by suicide in the United States in 2020 – 3% lower than in 2019 (47,511), and 5% below the 2018 peak of 48,344 suicides, report Sally Curtin, MA, and colleagues with the National Center for Health Statistics, part of the U.S. Centers for Disease Control and Prevention.

The data were published online Nov. 3 in the National Vital Statistics System (NVSS) Vital Statistics Rapid Release.

On a monthly basis, the number of suicides was lower in 2020 than in 2019 in March through October and December – with the largest drop happening in April 2020 at a time when deaths from COVID-19 were peaking, the authors note. In April 2020, suicide deaths were 14% lower than in April 2019 (3,468 vs. 4,029).

The provisional age-adjusted suicide rate was 3% lower in 2020 (13.5 per 100,000) than in 2019 (13.9 per 100,000). It was 2% lower among men (21.9 compared with 22.4), and 8% lower for women (5.5 compared with 6.0).

Suicide rates among younger adults aged 10 to 34 years rose slightly between 2019 and 2020 but was only significant in those 25 to 34, with a 5% increase between 2019 and 2020.

Individuals aged 35 to 74 years had significant declines in suicide with the largest drop in those aged 45 to 54 years and 55 to 64 years.

Women in all race and Hispanic-origin groups showed declines in suicide rates between 2019 and 2020, but the decline was significant only among non-Hispanic white women (10%).

Suicide rates declined for non-Hispanic white and non-Hispanic Asian men but increased among non-Hispanic black, non-Hispanic American Indian or Alaska Native, and Hispanic men.

This analysis is based on more than 99% of expected death records. Based on previous patterns between provisional and final data, these provisional findings are expected to be consistent with final 2020 data, the authors say.

The study had no commercial funding. The authors have disclosed no relevant financial relationships.

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

The number of suicides in 2020 declined in comparison to 2019, despite an increase in some risk factors associated with suicidal behavior, including pandemic-related job loss, financial strain, and deteriorating mental health, according to new federal statistics.

The number of annual suicides in the United States increased steadily from 2003 through 2018, followed by a 2% decline between 2018 and 2019. There was concern that deaths due to suicide would increase in 2020, but this doesn’t appear to be the case.

The provisional numbers show 45,855 deaths by suicide in the United States in 2020 – 3% lower than in 2019 (47,511), and 5% below the 2018 peak of 48,344 suicides, report Sally Curtin, MA, and colleagues with the National Center for Health Statistics, part of the U.S. Centers for Disease Control and Prevention.

The data were published online Nov. 3 in the National Vital Statistics System (NVSS) Vital Statistics Rapid Release.

On a monthly basis, the number of suicides was lower in 2020 than in 2019 in March through October and December – with the largest drop happening in April 2020 at a time when deaths from COVID-19 were peaking, the authors note. In April 2020, suicide deaths were 14% lower than in April 2019 (3,468 vs. 4,029).

The provisional age-adjusted suicide rate was 3% lower in 2020 (13.5 per 100,000) than in 2019 (13.9 per 100,000). It was 2% lower among men (21.9 compared with 22.4), and 8% lower for women (5.5 compared with 6.0).

Suicide rates among younger adults aged 10 to 34 years rose slightly between 2019 and 2020 but was only significant in those 25 to 34, with a 5% increase between 2019 and 2020.

Individuals aged 35 to 74 years had significant declines in suicide with the largest drop in those aged 45 to 54 years and 55 to 64 years.

Women in all race and Hispanic-origin groups showed declines in suicide rates between 2019 and 2020, but the decline was significant only among non-Hispanic white women (10%).

Suicide rates declined for non-Hispanic white and non-Hispanic Asian men but increased among non-Hispanic black, non-Hispanic American Indian or Alaska Native, and Hispanic men.

This analysis is based on more than 99% of expected death records. Based on previous patterns between provisional and final data, these provisional findings are expected to be consistent with final 2020 data, the authors say.

The study had no commercial funding. The authors have disclosed no relevant financial relationships.

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

A psychiatrist was treating a couple individually, one of whom was HIV-positive. During a session, the infected partner revealed he was having sex with other men outside the relationship and not using safe sex practices.

“He was being treated for major depression and anxiety at the time,” explained the anonymous psychiatrist.  “I strongly encouraged him to tell his partner, but he was scared of doing so. He stated that they had not been using safe sex practices between the two of them, but he was willing to start at that point.”

At a session with the HIV-negative partner, the psychiatrist inquired about the couple’s current sex practices. The HIV-negative partner reported no changes and said the two continued to have sex without condoms, said the psychiatrist, who shared the experience in Medscape’s Ethics 2020 Survey open-ended questions.

“My dilemma now was whether or not to inform him about his partner’s ‘extracurricular sex behavior,’ the psychiatrist said. “Since he was now at greater risk of contracting HIV, I felt compelled to do something to intervene.”

What would you do in this situation?

Hearing about infidelity while treating two family members is a bothersome ethical quandary for many physicians, according to responses from the Ethics 2020 Report. When asked to share their toughest ethical dilemma, one internist for example, wrote, “I have couples as patients, and it is very challenging if they reveal infidelity or separate/divorce; I cannot reveal info to the spouse, but it makes me very uncomfortable caring for both.” Similarly, an obstetrician-gynecologist wrote about her experience counseling patients who reveal extramarital affairs.

“Women confide deeply with their gynecologist, and although I was not successful in rescuing 100% of them, the majority accepted my counseling and saved their marriages,” the anonymous ob/gyn wrote. “In every case in which my patient was willing to resume her marital relationship, I always ensured that she advised her spouse of the infidelity, and the couple was referred to a qualified provider for marriage counseling.”

When a sexually transmitted infection (STI) comes into play however, physicians describe a deeper level of internal conflict. A family physician wrote her top ethical dilemma was “Cheating spouses and STIs: how do you get the other spouse treated?” An ob-gyn stated that, “disclosure of STI status in couples when this may indicate infidelity,” was a frequent ethical issue in her specialty. Commenters on Medscape’s recent story, “The Secret I’ll Take to my Grave: Doc Reveals,” also raised the uncomfortable topic. One physician recalled a deaf female patient who requested in writing not to test for syphilis and not to discuss the issue with her husband. “Patient knew that she had syphilis, but she did not want her husband to know,” the physician wrote.    

It’s not uncommon for physicians to encounter such scenarios when treating long-term couples, especially in the digital era, said Shannon Dowler, MD, chief medical officer for North Carolina Medicaid and a family physician at the Buncombe County STI Clinic.

“This is definitely something I think we see more of in our age of ‘hookup apps’ and easier access to casual sexual connections than we did before,” said Dr. Dowler, who serves on the CDC Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment. 

The topic is particularly timely because of the pandemic’s impact on STI testing and the expected rise in sexually transmitted infection rates over the next year, Dr. Dowler notes.

“People weren’t necessarily coming in for routine screening or testing during the pandemic because they didn’t want to take a chance on being exposed to COVID,” she said. “But also, the reagent used for testing for certain types of transmitted infections was in short supply because they use that same reagent for the COVID test. We had shortages of STI testing in many parts of the country. I expect what we’re going to see over the next year are a lot of diagnoses that were missed during the pandemic and a lot of asymptomatic spread.”
 

What do the experts suggest?

Caring for spouses or two partners when an STI is discovered can be challenging for physicians, particularly in small towns where many people know each other, said Kenneth Goodman, PhD, founder and director of the Institute for Bioethics and Health Policy at the University of Miami.

“This can be a real challenge for family physicians and others in a small town,” he said. “If you discover one partner is positive for a sexually transmitted infection and the other is negative, then you’ve got a challenge to manage. The way to do that is to start with moral persuasion, namely you tell your patient, ‘You really need to disclose this. Because when he or she gets it, chances are, you’re going to be the prime suspect.’ “

Dr. Dowler, who practices in an STI clinic, said she once diagnosed a sexually transmitted infection in a patient who was married to one of Dowler’s coworkers. The patient would not allow the partner to be notified, she said. In this case, Dr. Dowler practiced expedited partner therapy (EPT), the clinical practice of treating sex partners of patients diagnosed with chlamydia or gonorrhea by giving the patient prescriptions or medications to take to the partner without having first examined the partner. The practice is legal to some extent in all states, Dr. Dowler said, but some states have different rules about how the practice can be utilized. 

Physicians are obligated to report communicable diseases to their local health department, Dr. Goodman said. The health department would then do contract tracing and be responsible for conveying the STI diagnosis to any relevant parties. Even so, Dr. Goodman said physicians have a moral obligation to strongly encourage patients to divulge the infection to their partner.

“Doctors should work on being persuasive to change behavior,” he said. “Tell your patients to do the right thing and follow up with them. You should tell patients they have a responsibility to disclose a sexually transmitted infection to any of their partners and a responsibility not to have unprotected sex. Doctors can be very powerful advocates for that.”

Dr. Dowler said if she is treating two partners, and one is diagnosed with a sexually transmitted infection, she generally asks the patient for their consent to disclose the diagnosis to the partner. She ensures a witness, usually a nurse, is present when she asks. If consent is refused, Dr. Dowler guides her treatment to be as protective as possible, she said. A helpful resource for patients is Tellyourpartner.org, a website that sends an anonymous text or email about infection exposure and provides guidance on treatment locations and options.

Of course, if the sexually transmitted infection is HIV, another set of rules apply. As of 2021, 35 states have laws that criminalize HIV exposure. Laws vary, but many hold patients criminally liable if they knowingly expose another party to HIV. Many states and some cities also have ‘partner notification’ laws that require health providers to disclose an HIV diagnosis to the patient’s sex partners or to report the names of sex partners to the health department, if known. 

However, case law on a physician’s duty to warn is mixed, and doctors’ responsibility for STI reporting and partner notification is determined by individual states. Making matters more complex is the fact that some states have recently changed their HIV control requirements, Dr. Dowler said. In North Carolina for example, patients living with HIV who have been virally suppressed for 6 months and who are adherent to medications, are no longer in violation of the control measure if they do not disclose their HIV diagnosis to sex partners or if they don’t wear a condom.

“This means physicians would not have to report a virally suppressed, adequately treated HIV-positive patient who is having unprotected sex or take measures to inform any known sex partners of the diagnosis,” she said. “The landscape is constantly changing so physicians have to be vigilant about their state public health statutes. It’s a tricky area. It takes an already complicated topic and makes it just a little more complicated.”
 

Consider drafting a policy

It’s a good idea to have a policy in place at your practice that addresses such ethical dilemmas before they occur, says Michael Heitt, PsyD, a clinical psychologist on the faculty of Loyola University Maryland in Baltimore, and a member of the Maryland Psychological Association’s Ethics Committee. Dr. Heitt developed a model of ethical reasoning called CLEAR Lenses, which stands for Clinical, Legal, Ethical, Administrative, and Risk management. The approach encourages clinicians to identify often competing factors in the decision-making process before choosing a course of action to take.

In the situation of an unfaithful spouse who contracted an STI for example, the physician should consider clinical issues such as the medical likelihood the unaware partner has the STI, and legal issues such as maintaining the confidentiality of all patient information and possible mandated reporting of STI data, Dr. Heitt said. The lenses overlap since confidentiality is also a key ethical issue, and other ethical issues involve the balance of helping the unaware spouse and not harming the infected spouse, he explained. Administrative issues might include how medical records are maintained and whether the physician documents information about patients’ family members in the medical record, while risk management elements may include informed consent, documentation, and consultation. 

“So, if the physician has a policy about how such matters are dealt with, and patients are informed about this when they come to the practice, this can guide the physician much more easily through this sticky situation,” Dr. Heitt said. “Documentation of the decision-making process in the medical record demonstrates the physician’s thought process should it ever be challenged in the future, and consultation with peers (while disguising the identity of the patients, of course) sets a foundation of what a ‘reasonable standard’ might be in such situations.”

There is also the conflict-avoidant approach, Dr. Heitt said, in which the physician could perform “routine” STI testing if the unaware spouse was due for an appointment soon.

“But of course, this is far from avoiding any conflict; it just kicks the can down the road as there will surely be conflict — and plenty of confusion — if the wife tests positive for an STI,” he said. “In most situations, it is usually best to be brave, do the hard work upfront, and deal with the tough situation then, rather than trying to avoid the probable inevitable difficult conversation.”

As for the psychiatrist who was treating the cheating HIV-positive partner, the physician ultimately convinced both patients to come in for a couple’s session. The doctor allowed for a 2-hour timeframe to encourage discussion of any conflicts and unresolved issues, the psychiatrist said. After several more couple’s sessions, it was apparent the HIV-positive partner wanted out of the relationship, according to the psychiatrist’s account. The physician referred them to a couples’ therapist for ongoing treatment.

“During that same session, the HIV positive partner disclosed his recent behaviors and, as a result, they decided not to have further sexual contact until they could explore this further in therapy,” the psychiatrist wrote. “At last communication the couple decided to end the relationship, and the HIV negative partner remained negative.”

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

A psychiatrist was treating a couple individually, one of whom was HIV-positive. During a session, the infected partner revealed he was having sex with other men outside the relationship and not using safe sex practices.

“He was being treated for major depression and anxiety at the time,” explained the anonymous psychiatrist.  “I strongly encouraged him to tell his partner, but he was scared of doing so. He stated that they had not been using safe sex practices between the two of them, but he was willing to start at that point.”

At a session with the HIV-negative partner, the psychiatrist inquired about the couple’s current sex practices. The HIV-negative partner reported no changes and said the two continued to have sex without condoms, said the psychiatrist, who shared the experience in Medscape’s Ethics 2020 Survey open-ended questions.

“My dilemma now was whether or not to inform him about his partner’s ‘extracurricular sex behavior,’ the psychiatrist said. “Since he was now at greater risk of contracting HIV, I felt compelled to do something to intervene.”

What would you do in this situation?

Hearing about infidelity while treating two family members is a bothersome ethical quandary for many physicians, according to responses from the Ethics 2020 Report. When asked to share their toughest ethical dilemma, one internist for example, wrote, “I have couples as patients, and it is very challenging if they reveal infidelity or separate/divorce; I cannot reveal info to the spouse, but it makes me very uncomfortable caring for both.” Similarly, an obstetrician-gynecologist wrote about her experience counseling patients who reveal extramarital affairs.

“Women confide deeply with their gynecologist, and although I was not successful in rescuing 100% of them, the majority accepted my counseling and saved their marriages,” the anonymous ob/gyn wrote. “In every case in which my patient was willing to resume her marital relationship, I always ensured that she advised her spouse of the infidelity, and the couple was referred to a qualified provider for marriage counseling.”

When a sexually transmitted infection (STI) comes into play however, physicians describe a deeper level of internal conflict. A family physician wrote her top ethical dilemma was “Cheating spouses and STIs: how do you get the other spouse treated?” An ob-gyn stated that, “disclosure of STI status in couples when this may indicate infidelity,” was a frequent ethical issue in her specialty. Commenters on Medscape’s recent story, “The Secret I’ll Take to my Grave: Doc Reveals,” also raised the uncomfortable topic. One physician recalled a deaf female patient who requested in writing not to test for syphilis and not to discuss the issue with her husband. “Patient knew that she had syphilis, but she did not want her husband to know,” the physician wrote.    

It’s not uncommon for physicians to encounter such scenarios when treating long-term couples, especially in the digital era, said Shannon Dowler, MD, chief medical officer for North Carolina Medicaid and a family physician at the Buncombe County STI Clinic.

“This is definitely something I think we see more of in our age of ‘hookup apps’ and easier access to casual sexual connections than we did before,” said Dr. Dowler, who serves on the CDC Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment. 

The topic is particularly timely because of the pandemic’s impact on STI testing and the expected rise in sexually transmitted infection rates over the next year, Dr. Dowler notes.

“People weren’t necessarily coming in for routine screening or testing during the pandemic because they didn’t want to take a chance on being exposed to COVID,” she said. “But also, the reagent used for testing for certain types of transmitted infections was in short supply because they use that same reagent for the COVID test. We had shortages of STI testing in many parts of the country. I expect what we’re going to see over the next year are a lot of diagnoses that were missed during the pandemic and a lot of asymptomatic spread.”
 

What do the experts suggest?

Caring for spouses or two partners when an STI is discovered can be challenging for physicians, particularly in small towns where many people know each other, said Kenneth Goodman, PhD, founder and director of the Institute for Bioethics and Health Policy at the University of Miami.

“This can be a real challenge for family physicians and others in a small town,” he said. “If you discover one partner is positive for a sexually transmitted infection and the other is negative, then you’ve got a challenge to manage. The way to do that is to start with moral persuasion, namely you tell your patient, ‘You really need to disclose this. Because when he or she gets it, chances are, you’re going to be the prime suspect.’ “

Dr. Dowler, who practices in an STI clinic, said she once diagnosed a sexually transmitted infection in a patient who was married to one of Dowler’s coworkers. The patient would not allow the partner to be notified, she said. In this case, Dr. Dowler practiced expedited partner therapy (EPT), the clinical practice of treating sex partners of patients diagnosed with chlamydia or gonorrhea by giving the patient prescriptions or medications to take to the partner without having first examined the partner. The practice is legal to some extent in all states, Dr. Dowler said, but some states have different rules about how the practice can be utilized. 

Physicians are obligated to report communicable diseases to their local health department, Dr. Goodman said. The health department would then do contract tracing and be responsible for conveying the STI diagnosis to any relevant parties. Even so, Dr. Goodman said physicians have a moral obligation to strongly encourage patients to divulge the infection to their partner.

“Doctors should work on being persuasive to change behavior,” he said. “Tell your patients to do the right thing and follow up with them. You should tell patients they have a responsibility to disclose a sexually transmitted infection to any of their partners and a responsibility not to have unprotected sex. Doctors can be very powerful advocates for that.”

Dr. Dowler said if she is treating two partners, and one is diagnosed with a sexually transmitted infection, she generally asks the patient for their consent to disclose the diagnosis to the partner. She ensures a witness, usually a nurse, is present when she asks. If consent is refused, Dr. Dowler guides her treatment to be as protective as possible, she said. A helpful resource for patients is Tellyourpartner.org, a website that sends an anonymous text or email about infection exposure and provides guidance on treatment locations and options.

Of course, if the sexually transmitted infection is HIV, another set of rules apply. As of 2021, 35 states have laws that criminalize HIV exposure. Laws vary, but many hold patients criminally liable if they knowingly expose another party to HIV. Many states and some cities also have ‘partner notification’ laws that require health providers to disclose an HIV diagnosis to the patient’s sex partners or to report the names of sex partners to the health department, if known. 

However, case law on a physician’s duty to warn is mixed, and doctors’ responsibility for STI reporting and partner notification is determined by individual states. Making matters more complex is the fact that some states have recently changed their HIV control requirements, Dr. Dowler said. In North Carolina for example, patients living with HIV who have been virally suppressed for 6 months and who are adherent to medications, are no longer in violation of the control measure if they do not disclose their HIV diagnosis to sex partners or if they don’t wear a condom.

“This means physicians would not have to report a virally suppressed, adequately treated HIV-positive patient who is having unprotected sex or take measures to inform any known sex partners of the diagnosis,” she said. “The landscape is constantly changing so physicians have to be vigilant about their state public health statutes. It’s a tricky area. It takes an already complicated topic and makes it just a little more complicated.”
 

Consider drafting a policy

It’s a good idea to have a policy in place at your practice that addresses such ethical dilemmas before they occur, says Michael Heitt, PsyD, a clinical psychologist on the faculty of Loyola University Maryland in Baltimore, and a member of the Maryland Psychological Association’s Ethics Committee. Dr. Heitt developed a model of ethical reasoning called CLEAR Lenses, which stands for Clinical, Legal, Ethical, Administrative, and Risk management. The approach encourages clinicians to identify often competing factors in the decision-making process before choosing a course of action to take.

In the situation of an unfaithful spouse who contracted an STI for example, the physician should consider clinical issues such as the medical likelihood the unaware partner has the STI, and legal issues such as maintaining the confidentiality of all patient information and possible mandated reporting of STI data, Dr. Heitt said. The lenses overlap since confidentiality is also a key ethical issue, and other ethical issues involve the balance of helping the unaware spouse and not harming the infected spouse, he explained. Administrative issues might include how medical records are maintained and whether the physician documents information about patients’ family members in the medical record, while risk management elements may include informed consent, documentation, and consultation. 

“So, if the physician has a policy about how such matters are dealt with, and patients are informed about this when they come to the practice, this can guide the physician much more easily through this sticky situation,” Dr. Heitt said. “Documentation of the decision-making process in the medical record demonstrates the physician’s thought process should it ever be challenged in the future, and consultation with peers (while disguising the identity of the patients, of course) sets a foundation of what a ‘reasonable standard’ might be in such situations.”

There is also the conflict-avoidant approach, Dr. Heitt said, in which the physician could perform “routine” STI testing if the unaware spouse was due for an appointment soon.

“But of course, this is far from avoiding any conflict; it just kicks the can down the road as there will surely be conflict — and plenty of confusion — if the wife tests positive for an STI,” he said. “In most situations, it is usually best to be brave, do the hard work upfront, and deal with the tough situation then, rather than trying to avoid the probable inevitable difficult conversation.”

As for the psychiatrist who was treating the cheating HIV-positive partner, the physician ultimately convinced both patients to come in for a couple’s session. The doctor allowed for a 2-hour timeframe to encourage discussion of any conflicts and unresolved issues, the psychiatrist said. After several more couple’s sessions, it was apparent the HIV-positive partner wanted out of the relationship, according to the psychiatrist’s account. The physician referred them to a couples’ therapist for ongoing treatment.

“During that same session, the HIV positive partner disclosed his recent behaviors and, as a result, they decided not to have further sexual contact until they could explore this further in therapy,” the psychiatrist wrote. “At last communication the couple decided to end the relationship, and the HIV negative partner remained negative.”

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

A psychiatrist was treating a couple individually, one of whom was HIV-positive. During a session, the infected partner revealed he was having sex with other men outside the relationship and not using safe sex practices.

“He was being treated for major depression and anxiety at the time,” explained the anonymous psychiatrist.  “I strongly encouraged him to tell his partner, but he was scared of doing so. He stated that they had not been using safe sex practices between the two of them, but he was willing to start at that point.”

At a session with the HIV-negative partner, the psychiatrist inquired about the couple’s current sex practices. The HIV-negative partner reported no changes and said the two continued to have sex without condoms, said the psychiatrist, who shared the experience in Medscape’s Ethics 2020 Survey open-ended questions.

“My dilemma now was whether or not to inform him about his partner’s ‘extracurricular sex behavior,’ the psychiatrist said. “Since he was now at greater risk of contracting HIV, I felt compelled to do something to intervene.”

What would you do in this situation?

Hearing about infidelity while treating two family members is a bothersome ethical quandary for many physicians, according to responses from the Ethics 2020 Report. When asked to share their toughest ethical dilemma, one internist for example, wrote, “I have couples as patients, and it is very challenging if they reveal infidelity or separate/divorce; I cannot reveal info to the spouse, but it makes me very uncomfortable caring for both.” Similarly, an obstetrician-gynecologist wrote about her experience counseling patients who reveal extramarital affairs.

“Women confide deeply with their gynecologist, and although I was not successful in rescuing 100% of them, the majority accepted my counseling and saved their marriages,” the anonymous ob/gyn wrote. “In every case in which my patient was willing to resume her marital relationship, I always ensured that she advised her spouse of the infidelity, and the couple was referred to a qualified provider for marriage counseling.”

When a sexually transmitted infection (STI) comes into play however, physicians describe a deeper level of internal conflict. A family physician wrote her top ethical dilemma was “Cheating spouses and STIs: how do you get the other spouse treated?” An ob-gyn stated that, “disclosure of STI status in couples when this may indicate infidelity,” was a frequent ethical issue in her specialty. Commenters on Medscape’s recent story, “The Secret I’ll Take to my Grave: Doc Reveals,” also raised the uncomfortable topic. One physician recalled a deaf female patient who requested in writing not to test for syphilis and not to discuss the issue with her husband. “Patient knew that she had syphilis, but she did not want her husband to know,” the physician wrote.    

It’s not uncommon for physicians to encounter such scenarios when treating long-term couples, especially in the digital era, said Shannon Dowler, MD, chief medical officer for North Carolina Medicaid and a family physician at the Buncombe County STI Clinic.

“This is definitely something I think we see more of in our age of ‘hookup apps’ and easier access to casual sexual connections than we did before,” said Dr. Dowler, who serves on the CDC Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment. 

The topic is particularly timely because of the pandemic’s impact on STI testing and the expected rise in sexually transmitted infection rates over the next year, Dr. Dowler notes.

“People weren’t necessarily coming in for routine screening or testing during the pandemic because they didn’t want to take a chance on being exposed to COVID,” she said. “But also, the reagent used for testing for certain types of transmitted infections was in short supply because they use that same reagent for the COVID test. We had shortages of STI testing in many parts of the country. I expect what we’re going to see over the next year are a lot of diagnoses that were missed during the pandemic and a lot of asymptomatic spread.”
 

What do the experts suggest?

Caring for spouses or two partners when an STI is discovered can be challenging for physicians, particularly in small towns where many people know each other, said Kenneth Goodman, PhD, founder and director of the Institute for Bioethics and Health Policy at the University of Miami.

“This can be a real challenge for family physicians and others in a small town,” he said. “If you discover one partner is positive for a sexually transmitted infection and the other is negative, then you’ve got a challenge to manage. The way to do that is to start with moral persuasion, namely you tell your patient, ‘You really need to disclose this. Because when he or she gets it, chances are, you’re going to be the prime suspect.’ “

Dr. Dowler, who practices in an STI clinic, said she once diagnosed a sexually transmitted infection in a patient who was married to one of Dowler’s coworkers. The patient would not allow the partner to be notified, she said. In this case, Dr. Dowler practiced expedited partner therapy (EPT), the clinical practice of treating sex partners of patients diagnosed with chlamydia or gonorrhea by giving the patient prescriptions or medications to take to the partner without having first examined the partner. The practice is legal to some extent in all states, Dr. Dowler said, but some states have different rules about how the practice can be utilized. 

Physicians are obligated to report communicable diseases to their local health department, Dr. Goodman said. The health department would then do contract tracing and be responsible for conveying the STI diagnosis to any relevant parties. Even so, Dr. Goodman said physicians have a moral obligation to strongly encourage patients to divulge the infection to their partner.

“Doctors should work on being persuasive to change behavior,” he said. “Tell your patients to do the right thing and follow up with them. You should tell patients they have a responsibility to disclose a sexually transmitted infection to any of their partners and a responsibility not to have unprotected sex. Doctors can be very powerful advocates for that.”

Dr. Dowler said if she is treating two partners, and one is diagnosed with a sexually transmitted infection, she generally asks the patient for their consent to disclose the diagnosis to the partner. She ensures a witness, usually a nurse, is present when she asks. If consent is refused, Dr. Dowler guides her treatment to be as protective as possible, she said. A helpful resource for patients is Tellyourpartner.org, a website that sends an anonymous text or email about infection exposure and provides guidance on treatment locations and options.

Of course, if the sexually transmitted infection is HIV, another set of rules apply. As of 2021, 35 states have laws that criminalize HIV exposure. Laws vary, but many hold patients criminally liable if they knowingly expose another party to HIV. Many states and some cities also have ‘partner notification’ laws that require health providers to disclose an HIV diagnosis to the patient’s sex partners or to report the names of sex partners to the health department, if known. 

However, case law on a physician’s duty to warn is mixed, and doctors’ responsibility for STI reporting and partner notification is determined by individual states. Making matters more complex is the fact that some states have recently changed their HIV control requirements, Dr. Dowler said. In North Carolina for example, patients living with HIV who have been virally suppressed for 6 months and who are adherent to medications, are no longer in violation of the control measure if they do not disclose their HIV diagnosis to sex partners or if they don’t wear a condom.

“This means physicians would not have to report a virally suppressed, adequately treated HIV-positive patient who is having unprotected sex or take measures to inform any known sex partners of the diagnosis,” she said. “The landscape is constantly changing so physicians have to be vigilant about their state public health statutes. It’s a tricky area. It takes an already complicated topic and makes it just a little more complicated.”
 

Consider drafting a policy

It’s a good idea to have a policy in place at your practice that addresses such ethical dilemmas before they occur, says Michael Heitt, PsyD, a clinical psychologist on the faculty of Loyola University Maryland in Baltimore, and a member of the Maryland Psychological Association’s Ethics Committee. Dr. Heitt developed a model of ethical reasoning called CLEAR Lenses, which stands for Clinical, Legal, Ethical, Administrative, and Risk management. The approach encourages clinicians to identify often competing factors in the decision-making process before choosing a course of action to take.

In the situation of an unfaithful spouse who contracted an STI for example, the physician should consider clinical issues such as the medical likelihood the unaware partner has the STI, and legal issues such as maintaining the confidentiality of all patient information and possible mandated reporting of STI data, Dr. Heitt said. The lenses overlap since confidentiality is also a key ethical issue, and other ethical issues involve the balance of helping the unaware spouse and not harming the infected spouse, he explained. Administrative issues might include how medical records are maintained and whether the physician documents information about patients’ family members in the medical record, while risk management elements may include informed consent, documentation, and consultation. 

“So, if the physician has a policy about how such matters are dealt with, and patients are informed about this when they come to the practice, this can guide the physician much more easily through this sticky situation,” Dr. Heitt said. “Documentation of the decision-making process in the medical record demonstrates the physician’s thought process should it ever be challenged in the future, and consultation with peers (while disguising the identity of the patients, of course) sets a foundation of what a ‘reasonable standard’ might be in such situations.”

There is also the conflict-avoidant approach, Dr. Heitt said, in which the physician could perform “routine” STI testing if the unaware spouse was due for an appointment soon.

“But of course, this is far from avoiding any conflict; it just kicks the can down the road as there will surely be conflict — and plenty of confusion — if the wife tests positive for an STI,” he said. “In most situations, it is usually best to be brave, do the hard work upfront, and deal with the tough situation then, rather than trying to avoid the probable inevitable difficult conversation.”

As for the psychiatrist who was treating the cheating HIV-positive partner, the physician ultimately convinced both patients to come in for a couple’s session. The doctor allowed for a 2-hour timeframe to encourage discussion of any conflicts and unresolved issues, the psychiatrist said. After several more couple’s sessions, it was apparent the HIV-positive partner wanted out of the relationship, according to the psychiatrist’s account. The physician referred them to a couples’ therapist for ongoing treatment.

“During that same session, the HIV positive partner disclosed his recent behaviors and, as a result, they decided not to have further sexual contact until they could explore this further in therapy,” the psychiatrist wrote. “At last communication the couple decided to end the relationship, and the HIV negative partner remained negative.”

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