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The National Institutes of Health has dropped its recommendation against the inexpensive antiparasitic drug ivermectin for treatment of COVID-19, and the agency now advises it can’t recommend for or against its use, leaving the decision to physicians and their patients.

“Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of COVID-19,” according to new NIH guidance released last week.

Passionate arguments have been waged for and against the drug’s use.

The NIH update disappointed members of the Front Line COVID-19 Critical Care Alliance (FLCCC), which outlined its case for endorsing ivermectin in a public statement Jan. 18. Point by point, the group of 10 physicians argued against each limitation that drove the NIH’s ruling.

The group’s members said that, although grateful the recommendation against the drug was dropped, a neutral approach is not acceptable as total U.S. deaths surpassed 400,000 since last spring – and currently approach 4,000 a day. Results from research are enough to support its use, and the drug will immediately save lives, they say.

“Patients do not have time to wait,” they write, “and we as health care providers in society do not have that time either.”

NIH, which in August had recommended against ivermectin’s use, invited the group to present evidence to its treatment guidance panel on Jan. 6 to detail the emerging science surrounding ivermectin. The group cited rapidly growing evidence of the drug’s effectiveness.

Pierre Kory, MD, president/cofounder of FLCCC and a pulmonary and critical care specialist at Aurora St. Luke’s Medical Center in Milwaukee, also spoke before a Senate panel on Dec. 8 in a widely shared impassioned video, touting ivermectin as a COVID-19 “miracle” drug, a term he said he doesn’t use lightly.

Dr. Kory pleaded with the NIH to consider the emerging data. “Please, I’m just asking that they review our manuscript,” he told the senators.

“We have immense amounts of data to show that ivermectin must be implemented and implemented now,” he said.
 

Some draw parallels to hydroxychloroquine

Critics have said there’s not enough data to institute a protocol, and some draw parallels to another repurposed drug – hydroxychloroquine (HCQ) – which was once considered a promising treatment for COVID-19, based on flawed and incomplete evidence, and now is not recommended.

Paul Sax, MD, a professor of medicine at Harvard and clinical director of the HIV program and division of infectious diseases at Brigham and Women’s Hospital in Boston, wrote in a blog post earlier this month in the New England Journal of Medicine Journal Watch that ivermectin has more robust evidence for it than HCQ ever did.

“But we’re not quite yet at the ‘practice changing’ level,” he writes. “Results from at least five randomized clinical trials are expected soon that might further inform the decision.”

He said the best argument for the drug is seen in this explanation of a meta-analysis of studies of between 100 and 500 patients by Andrew Hill, MD, with the department of pharmacology, University of Liverpool (England).

Dr. Sax advises against two biases in considering ivermectin. One is assuming that because HCQ failed, other antiparasitic drugs will too.

The second bias to avoid, he says, is discounting studies done in low- and middle-income countries because “they weren’t done in the right places.”

“That’s not just bias,” he says. “It’s also snobbery.”

Ivermectin has been approved by the U.S. Food and Drug Administration for treatment of onchocerciasis (river blindness) and strongyloidiasis, but is not FDA-approved for the treatment of any viral infection. It also is sometimes used to treat animals.

In dropping the recommendation against ivermectin, the NIH gave it the same neutral declaration as monoclonal antibodies and convalescent plasma.
 

Some physicians say they won’t prescribe it

Some physicians say they won’t be recommending it to their COVID-19 patients.

Amesh Adalja, MD, an infectious disease expert and senior scholar at the Johns Hopkins University Center for Health Security in Baltimore,said in an interview that the NIH update hasn’t changed his mind and he isn’t prescribing it for his patients.

He said although “there’s enough of a signal” that he would like to see more data, “we haven’t seen anything in terms of a really robust study.”

He noted that the Infectious Diseases Society of America has 15 recommendations for COVID-19 treatment “and not one of them has to do with ivermectin.”

He added, “It’s not enough to see if it works, but we need to see who it works in and when it works in them.”

He also acknowledged that “some prominent physicians” are recommending it.

Among them is Paul Marik, MD, endowed professor of medicine and chief of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk. A cofounder of FLCCC, Dr. Marik has championed ivermectin and developed a protocol for its use to prevent and treat COVID-19.

The data surrounding ivermectin have met with hope, criticism, and warnings.

Australian researchers published a study ahead of print in Antiviral Research that found ivermectin inhibited the replication of SARS-CoV-2 in a laboratory setting.

The study concluded that the drug resulted post infection in a 5,000-fold reduction in viral RNA at 48 hours. After that study, however, the FDA in April warned consumers not to self-medicate with ivermectin products intended for animals.

The NIH acknowledged that several randomized trials and retrospective studies of ivermectin use in patients with COVID-19 have now been published in peer-reviewed journals or on preprint servers.

“Some clinical studies showed no benefits or worsening of disease after ivermectin use, whereas others reported shorter time to resolution of disease manifestations attributed to COVID-19, greater reduction in inflammatory markers, shorter time to viral clearance, or lower mortality rates in patients who received ivermectin than in patients who received comparator drugs or placebo,” the NIH guidance reads.

The NIH acknowledges limitations: the studies have been small; doses of ivermectin have varied; some patients were taking other medications at the same time (including doxycycline, hydroxychloroquine, azithromycin, zinc, and corticosteroids, which may be potential confounders); and patients’ severity of COVID was not always clearly described in the studies.

Nasia Safdar, MD, medical director of infection prevention at the University of Wisconsin Hospital in Madison, told this news organization she agrees more research is needed before ivermectin is recommended by regulatory bodies for COVID-19.

That said, Dr. Safdar added, “in individual circumstances if a physician is confronted with a patient in dire straits and you’re not sure what to do, might you consider it? I think after a discussion with the patient, perhaps, but the level of evidence certainly doesn’t rise to the level of a policy.”

A downside of recommending a treatment without conclusive data, even if harm isn’t the primary concern, she said, is that supplies could dwindle for its intended use in other diseases. Also, premature approval can limit the robust research needed to see not only whether it works better for prevention or treatment, but also if it’s effective depending on patient populations and the severity of COVID-19.

Dr. Adalja and Dr. Safdar have disclosed no relevant financial relationships.

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

The National Institutes of Health has dropped its recommendation against the inexpensive antiparasitic drug ivermectin for treatment of COVID-19, and the agency now advises it can’t recommend for or against its use, leaving the decision to physicians and their patients.

“Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of COVID-19,” according to new NIH guidance released last week.

Passionate arguments have been waged for and against the drug’s use.

The NIH update disappointed members of the Front Line COVID-19 Critical Care Alliance (FLCCC), which outlined its case for endorsing ivermectin in a public statement Jan. 18. Point by point, the group of 10 physicians argued against each limitation that drove the NIH’s ruling.

The group’s members said that, although grateful the recommendation against the drug was dropped, a neutral approach is not acceptable as total U.S. deaths surpassed 400,000 since last spring – and currently approach 4,000 a day. Results from research are enough to support its use, and the drug will immediately save lives, they say.

“Patients do not have time to wait,” they write, “and we as health care providers in society do not have that time either.”

NIH, which in August had recommended against ivermectin’s use, invited the group to present evidence to its treatment guidance panel on Jan. 6 to detail the emerging science surrounding ivermectin. The group cited rapidly growing evidence of the drug’s effectiveness.

Pierre Kory, MD, president/cofounder of FLCCC and a pulmonary and critical care specialist at Aurora St. Luke’s Medical Center in Milwaukee, also spoke before a Senate panel on Dec. 8 in a widely shared impassioned video, touting ivermectin as a COVID-19 “miracle” drug, a term he said he doesn’t use lightly.

Dr. Kory pleaded with the NIH to consider the emerging data. “Please, I’m just asking that they review our manuscript,” he told the senators.

“We have immense amounts of data to show that ivermectin must be implemented and implemented now,” he said.
 

Some draw parallels to hydroxychloroquine

Critics have said there’s not enough data to institute a protocol, and some draw parallels to another repurposed drug – hydroxychloroquine (HCQ) – which was once considered a promising treatment for COVID-19, based on flawed and incomplete evidence, and now is not recommended.

Paul Sax, MD, a professor of medicine at Harvard and clinical director of the HIV program and division of infectious diseases at Brigham and Women’s Hospital in Boston, wrote in a blog post earlier this month in the New England Journal of Medicine Journal Watch that ivermectin has more robust evidence for it than HCQ ever did.

“But we’re not quite yet at the ‘practice changing’ level,” he writes. “Results from at least five randomized clinical trials are expected soon that might further inform the decision.”

He said the best argument for the drug is seen in this explanation of a meta-analysis of studies of between 100 and 500 patients by Andrew Hill, MD, with the department of pharmacology, University of Liverpool (England).

Dr. Sax advises against two biases in considering ivermectin. One is assuming that because HCQ failed, other antiparasitic drugs will too.

The second bias to avoid, he says, is discounting studies done in low- and middle-income countries because “they weren’t done in the right places.”

“That’s not just bias,” he says. “It’s also snobbery.”

Ivermectin has been approved by the U.S. Food and Drug Administration for treatment of onchocerciasis (river blindness) and strongyloidiasis, but is not FDA-approved for the treatment of any viral infection. It also is sometimes used to treat animals.

In dropping the recommendation against ivermectin, the NIH gave it the same neutral declaration as monoclonal antibodies and convalescent plasma.
 

Some physicians say they won’t prescribe it

Some physicians say they won’t be recommending it to their COVID-19 patients.

Amesh Adalja, MD, an infectious disease expert and senior scholar at the Johns Hopkins University Center for Health Security in Baltimore,said in an interview that the NIH update hasn’t changed his mind and he isn’t prescribing it for his patients.

He said although “there’s enough of a signal” that he would like to see more data, “we haven’t seen anything in terms of a really robust study.”

He noted that the Infectious Diseases Society of America has 15 recommendations for COVID-19 treatment “and not one of them has to do with ivermectin.”

He added, “It’s not enough to see if it works, but we need to see who it works in and when it works in them.”

He also acknowledged that “some prominent physicians” are recommending it.

Among them is Paul Marik, MD, endowed professor of medicine and chief of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk. A cofounder of FLCCC, Dr. Marik has championed ivermectin and developed a protocol for its use to prevent and treat COVID-19.

The data surrounding ivermectin have met with hope, criticism, and warnings.

Australian researchers published a study ahead of print in Antiviral Research that found ivermectin inhibited the replication of SARS-CoV-2 in a laboratory setting.

The study concluded that the drug resulted post infection in a 5,000-fold reduction in viral RNA at 48 hours. After that study, however, the FDA in April warned consumers not to self-medicate with ivermectin products intended for animals.

The NIH acknowledged that several randomized trials and retrospective studies of ivermectin use in patients with COVID-19 have now been published in peer-reviewed journals or on preprint servers.

“Some clinical studies showed no benefits or worsening of disease after ivermectin use, whereas others reported shorter time to resolution of disease manifestations attributed to COVID-19, greater reduction in inflammatory markers, shorter time to viral clearance, or lower mortality rates in patients who received ivermectin than in patients who received comparator drugs or placebo,” the NIH guidance reads.

The NIH acknowledges limitations: the studies have been small; doses of ivermectin have varied; some patients were taking other medications at the same time (including doxycycline, hydroxychloroquine, azithromycin, zinc, and corticosteroids, which may be potential confounders); and patients’ severity of COVID was not always clearly described in the studies.

Nasia Safdar, MD, medical director of infection prevention at the University of Wisconsin Hospital in Madison, told this news organization she agrees more research is needed before ivermectin is recommended by regulatory bodies for COVID-19.

That said, Dr. Safdar added, “in individual circumstances if a physician is confronted with a patient in dire straits and you’re not sure what to do, might you consider it? I think after a discussion with the patient, perhaps, but the level of evidence certainly doesn’t rise to the level of a policy.”

A downside of recommending a treatment without conclusive data, even if harm isn’t the primary concern, she said, is that supplies could dwindle for its intended use in other diseases. Also, premature approval can limit the robust research needed to see not only whether it works better for prevention or treatment, but also if it’s effective depending on patient populations and the severity of COVID-19.

Dr. Adalja and Dr. Safdar have disclosed no relevant financial relationships.

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

The National Institutes of Health has dropped its recommendation against the inexpensive antiparasitic drug ivermectin for treatment of COVID-19, and the agency now advises it can’t recommend for or against its use, leaving the decision to physicians and their patients.

“Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of COVID-19,” according to new NIH guidance released last week.

Passionate arguments have been waged for and against the drug’s use.

The NIH update disappointed members of the Front Line COVID-19 Critical Care Alliance (FLCCC), which outlined its case for endorsing ivermectin in a public statement Jan. 18. Point by point, the group of 10 physicians argued against each limitation that drove the NIH’s ruling.

The group’s members said that, although grateful the recommendation against the drug was dropped, a neutral approach is not acceptable as total U.S. deaths surpassed 400,000 since last spring – and currently approach 4,000 a day. Results from research are enough to support its use, and the drug will immediately save lives, they say.

“Patients do not have time to wait,” they write, “and we as health care providers in society do not have that time either.”

NIH, which in August had recommended against ivermectin’s use, invited the group to present evidence to its treatment guidance panel on Jan. 6 to detail the emerging science surrounding ivermectin. The group cited rapidly growing evidence of the drug’s effectiveness.

Pierre Kory, MD, president/cofounder of FLCCC and a pulmonary and critical care specialist at Aurora St. Luke’s Medical Center in Milwaukee, also spoke before a Senate panel on Dec. 8 in a widely shared impassioned video, touting ivermectin as a COVID-19 “miracle” drug, a term he said he doesn’t use lightly.

Dr. Kory pleaded with the NIH to consider the emerging data. “Please, I’m just asking that they review our manuscript,” he told the senators.

“We have immense amounts of data to show that ivermectin must be implemented and implemented now,” he said.
 

Some draw parallels to hydroxychloroquine

Critics have said there’s not enough data to institute a protocol, and some draw parallels to another repurposed drug – hydroxychloroquine (HCQ) – which was once considered a promising treatment for COVID-19, based on flawed and incomplete evidence, and now is not recommended.

Paul Sax, MD, a professor of medicine at Harvard and clinical director of the HIV program and division of infectious diseases at Brigham and Women’s Hospital in Boston, wrote in a blog post earlier this month in the New England Journal of Medicine Journal Watch that ivermectin has more robust evidence for it than HCQ ever did.

“But we’re not quite yet at the ‘practice changing’ level,” he writes. “Results from at least five randomized clinical trials are expected soon that might further inform the decision.”

He said the best argument for the drug is seen in this explanation of a meta-analysis of studies of between 100 and 500 patients by Andrew Hill, MD, with the department of pharmacology, University of Liverpool (England).

Dr. Sax advises against two biases in considering ivermectin. One is assuming that because HCQ failed, other antiparasitic drugs will too.

The second bias to avoid, he says, is discounting studies done in low- and middle-income countries because “they weren’t done in the right places.”

“That’s not just bias,” he says. “It’s also snobbery.”

Ivermectin has been approved by the U.S. Food and Drug Administration for treatment of onchocerciasis (river blindness) and strongyloidiasis, but is not FDA-approved for the treatment of any viral infection. It also is sometimes used to treat animals.

In dropping the recommendation against ivermectin, the NIH gave it the same neutral declaration as monoclonal antibodies and convalescent plasma.
 

Some physicians say they won’t prescribe it

Some physicians say they won’t be recommending it to their COVID-19 patients.

Amesh Adalja, MD, an infectious disease expert and senior scholar at the Johns Hopkins University Center for Health Security in Baltimore,said in an interview that the NIH update hasn’t changed his mind and he isn’t prescribing it for his patients.

He said although “there’s enough of a signal” that he would like to see more data, “we haven’t seen anything in terms of a really robust study.”

He noted that the Infectious Diseases Society of America has 15 recommendations for COVID-19 treatment “and not one of them has to do with ivermectin.”

He added, “It’s not enough to see if it works, but we need to see who it works in and when it works in them.”

He also acknowledged that “some prominent physicians” are recommending it.

Among them is Paul Marik, MD, endowed professor of medicine and chief of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk. A cofounder of FLCCC, Dr. Marik has championed ivermectin and developed a protocol for its use to prevent and treat COVID-19.

The data surrounding ivermectin have met with hope, criticism, and warnings.

Australian researchers published a study ahead of print in Antiviral Research that found ivermectin inhibited the replication of SARS-CoV-2 in a laboratory setting.

The study concluded that the drug resulted post infection in a 5,000-fold reduction in viral RNA at 48 hours. After that study, however, the FDA in April warned consumers not to self-medicate with ivermectin products intended for animals.

The NIH acknowledged that several randomized trials and retrospective studies of ivermectin use in patients with COVID-19 have now been published in peer-reviewed journals or on preprint servers.

“Some clinical studies showed no benefits or worsening of disease after ivermectin use, whereas others reported shorter time to resolution of disease manifestations attributed to COVID-19, greater reduction in inflammatory markers, shorter time to viral clearance, or lower mortality rates in patients who received ivermectin than in patients who received comparator drugs or placebo,” the NIH guidance reads.

The NIH acknowledges limitations: the studies have been small; doses of ivermectin have varied; some patients were taking other medications at the same time (including doxycycline, hydroxychloroquine, azithromycin, zinc, and corticosteroids, which may be potential confounders); and patients’ severity of COVID was not always clearly described in the studies.

Nasia Safdar, MD, medical director of infection prevention at the University of Wisconsin Hospital in Madison, told this news organization she agrees more research is needed before ivermectin is recommended by regulatory bodies for COVID-19.

That said, Dr. Safdar added, “in individual circumstances if a physician is confronted with a patient in dire straits and you’re not sure what to do, might you consider it? I think after a discussion with the patient, perhaps, but the level of evidence certainly doesn’t rise to the level of a policy.”

A downside of recommending a treatment without conclusive data, even if harm isn’t the primary concern, she said, is that supplies could dwindle for its intended use in other diseases. Also, premature approval can limit the robust research needed to see not only whether it works better for prevention or treatment, but also if it’s effective depending on patient populations and the severity of COVID-19.

Dr. Adalja and Dr. Safdar have disclosed no relevant financial relationships.

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

In the midst of a pandemic, the biggest changes health care leaders reported in their medical practices last year revolved around staffing, cost and revenue, practice transformation, information technology, and operations, according to a December 2020 report from the Medical Group Management Association.

The report was assembled from the results of weekly Stat polls by MGMA, which consists of 15,000 group practices representing more than 350,000 physicians. During the course of the year, more than 4,800 practice leaders were surveyed, but the individual polls had far fewer respondents.

The 2020 data represents snapshots from different points in the developing public health crisis. Still, much of what practices experienced earlier in the pandemic continues to apply, and it’s likely to persist this year as long as the coronavirus spreads and its toll deepens.

One top-line conclusion of the report: the economic pain felt by practices has resulted in layoffs, furloughs, and/or reduced compensation for providers and staff.

In the May 19 weekly survey, 82% of respondents said some or all of their providers’ compensation had been affected by the crisis. About 62% said every provider had been affected. Provider compensation was cut in several ways, including reduced hours and salaries, reduced or eliminated bonuses, and lower allowances for continuing medical education.

About 61% of health care leaders said in the June 26 poll that their own compensation had decreased.

In the following week’s survey, one in three managers said their organization had reduced staff compensation. Nearly all of the respondents in this category predicted the salary reductions would be temporary.

As of March 17, early in the pandemic, 40% of health care leaders said they were experiencing staff shortages. An April 21 poll found that 53% of health care leaders were taking steps to address their providers’ and staffers’ mental health.

“The mental and emotional toll on everyone continues to be a concern, as public health authorities continue to report alarming numbers of new [COVID-19] cases, hospitalizations, and deaths,” MGMA commented.
 

Telehealth and remote monitoring

Nearly all of the health care leaders surveyed on March 31 reported that their practices had expanded telehealth access because of COVID-19. The percentage of patient visits handled remotely had dropped substantially by the fall, according to a Harvard University/Commonwealth Fund/Phreesia survey. Still, it remains significantly higher than it was before the pandemic.

“At the end of 2020, telemedicine continues to play a vital role in everyday practice operations and long-term planning,” the MGMA report said. One indication of this, the association said, is that health care leaders are recognizing new best practices in specialty telemedicine, such as pediatrics and ob.gyn.

According to an April 28 poll, the top three coding/billing challenges for telehealth and telephone visits amid COVID-19 were inconsistent payer rules, pay parity and accuracy, and documentation of virtual visits.

While the Centers for Medicare & Medicaid Services has loosened its regulations to allow reimbursement of telehealth in all locations and at the same level as in-person visits, most of those changes will not last beyond the public health crisis without new legislation.

More health care leaders are considering the use of remote patient monitoring, MGMA said, but only 21% of practices offered such services as of Sept. 15. The report drew a connection between these plans and the current challenge of deferred care.

In the July 21 poll, 87% of health care leaders reported that safety concerns were the top reason that patients deferred care amid COVID-19. The MGMA report quoted JaeLynn Williams, CEO of Air Methods, which provides helicopter ambulance services, as saying that many people are staying home even when they face life-threatening conditions such as chest pain, drug symptoms, inflamed appendix, and gallbladder pain.
 

Operational issues

Overall, MGMA said, practices that have taken a financial risk have done better during the pandemic than fee-for-service practices because their monthly capitation revenue has continued unabated. In contrast, “most groups’ struggles to sustain visits and procedures meant less revenue and lower compensation,” the report said.

In the August 18 survey, one in three health care leaders reported their practices were changing their operational metrics and how often they looked at those measures because of the pandemic. “Practice managers are asking for dashboard data in weeks instead of months to measure the drop in charges and forecast the resulting change in collections,” MGMA noted. “The type of data practice managers are asking for has also changed.”

Among the new metrics that practices are interested in, according to an MGMA article, are measures that track telehealth visits, the productivity of staff working at home, and the number of ancillary services and procedures that new patients might need based on historical data.

Nearly all health care leaders surveyed on Aug. 11 said the cost of obtaining personal protective equipment had increased during 2020. MGMA said it expects this situation to worsen if the pandemic lasts through the summer of 2021.

While everyone is talking about the botched launch of the COVID-19 vaccination campaign, there were also problems with flu vaccination in 2020. In the Sept. 25 poll, 34% of health care leaders reported their practices were experiencing delays in getting the flu vaccine.
 

Looking ahead

Looking further ahead, the report recommended that practices make plans to boost staff morale by restoring bonuses.

In addition, MGMA suggested that physician groups reassess their space needs. “The equation is simple – fewer nonclinical staff members at your facility means you should repurpose that office space or consider finding a better fit for your new real estate needs in 2021.”

Finally, MGMA noted that the practices expanding rather than contracting their business are those increasing their value-based revenues by taking on more risk. For those groups, “growing the patient panel can help [them] seek better rates in contract negotiations.”

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

In the midst of a pandemic, the biggest changes health care leaders reported in their medical practices last year revolved around staffing, cost and revenue, practice transformation, information technology, and operations, according to a December 2020 report from the Medical Group Management Association.

The report was assembled from the results of weekly Stat polls by MGMA, which consists of 15,000 group practices representing more than 350,000 physicians. During the course of the year, more than 4,800 practice leaders were surveyed, but the individual polls had far fewer respondents.

The 2020 data represents snapshots from different points in the developing public health crisis. Still, much of what practices experienced earlier in the pandemic continues to apply, and it’s likely to persist this year as long as the coronavirus spreads and its toll deepens.

One top-line conclusion of the report: the economic pain felt by practices has resulted in layoffs, furloughs, and/or reduced compensation for providers and staff.

In the May 19 weekly survey, 82% of respondents said some or all of their providers’ compensation had been affected by the crisis. About 62% said every provider had been affected. Provider compensation was cut in several ways, including reduced hours and salaries, reduced or eliminated bonuses, and lower allowances for continuing medical education.

About 61% of health care leaders said in the June 26 poll that their own compensation had decreased.

In the following week’s survey, one in three managers said their organization had reduced staff compensation. Nearly all of the respondents in this category predicted the salary reductions would be temporary.

As of March 17, early in the pandemic, 40% of health care leaders said they were experiencing staff shortages. An April 21 poll found that 53% of health care leaders were taking steps to address their providers’ and staffers’ mental health.

“The mental and emotional toll on everyone continues to be a concern, as public health authorities continue to report alarming numbers of new [COVID-19] cases, hospitalizations, and deaths,” MGMA commented.
 

Telehealth and remote monitoring

Nearly all of the health care leaders surveyed on March 31 reported that their practices had expanded telehealth access because of COVID-19. The percentage of patient visits handled remotely had dropped substantially by the fall, according to a Harvard University/Commonwealth Fund/Phreesia survey. Still, it remains significantly higher than it was before the pandemic.

“At the end of 2020, telemedicine continues to play a vital role in everyday practice operations and long-term planning,” the MGMA report said. One indication of this, the association said, is that health care leaders are recognizing new best practices in specialty telemedicine, such as pediatrics and ob.gyn.

According to an April 28 poll, the top three coding/billing challenges for telehealth and telephone visits amid COVID-19 were inconsistent payer rules, pay parity and accuracy, and documentation of virtual visits.

While the Centers for Medicare & Medicaid Services has loosened its regulations to allow reimbursement of telehealth in all locations and at the same level as in-person visits, most of those changes will not last beyond the public health crisis without new legislation.

More health care leaders are considering the use of remote patient monitoring, MGMA said, but only 21% of practices offered such services as of Sept. 15. The report drew a connection between these plans and the current challenge of deferred care.

In the July 21 poll, 87% of health care leaders reported that safety concerns were the top reason that patients deferred care amid COVID-19. The MGMA report quoted JaeLynn Williams, CEO of Air Methods, which provides helicopter ambulance services, as saying that many people are staying home even when they face life-threatening conditions such as chest pain, drug symptoms, inflamed appendix, and gallbladder pain.
 

Operational issues

Overall, MGMA said, practices that have taken a financial risk have done better during the pandemic than fee-for-service practices because their monthly capitation revenue has continued unabated. In contrast, “most groups’ struggles to sustain visits and procedures meant less revenue and lower compensation,” the report said.

In the August 18 survey, one in three health care leaders reported their practices were changing their operational metrics and how often they looked at those measures because of the pandemic. “Practice managers are asking for dashboard data in weeks instead of months to measure the drop in charges and forecast the resulting change in collections,” MGMA noted. “The type of data practice managers are asking for has also changed.”

Among the new metrics that practices are interested in, according to an MGMA article, are measures that track telehealth visits, the productivity of staff working at home, and the number of ancillary services and procedures that new patients might need based on historical data.

Nearly all health care leaders surveyed on Aug. 11 said the cost of obtaining personal protective equipment had increased during 2020. MGMA said it expects this situation to worsen if the pandemic lasts through the summer of 2021.

While everyone is talking about the botched launch of the COVID-19 vaccination campaign, there were also problems with flu vaccination in 2020. In the Sept. 25 poll, 34% of health care leaders reported their practices were experiencing delays in getting the flu vaccine.
 

Looking ahead

Looking further ahead, the report recommended that practices make plans to boost staff morale by restoring bonuses.

In addition, MGMA suggested that physician groups reassess their space needs. “The equation is simple – fewer nonclinical staff members at your facility means you should repurpose that office space or consider finding a better fit for your new real estate needs in 2021.”

Finally, MGMA noted that the practices expanding rather than contracting their business are those increasing their value-based revenues by taking on more risk. For those groups, “growing the patient panel can help [them] seek better rates in contract negotiations.”

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

In the midst of a pandemic, the biggest changes health care leaders reported in their medical practices last year revolved around staffing, cost and revenue, practice transformation, information technology, and operations, according to a December 2020 report from the Medical Group Management Association.

The report was assembled from the results of weekly Stat polls by MGMA, which consists of 15,000 group practices representing more than 350,000 physicians. During the course of the year, more than 4,800 practice leaders were surveyed, but the individual polls had far fewer respondents.

The 2020 data represents snapshots from different points in the developing public health crisis. Still, much of what practices experienced earlier in the pandemic continues to apply, and it’s likely to persist this year as long as the coronavirus spreads and its toll deepens.

One top-line conclusion of the report: the economic pain felt by practices has resulted in layoffs, furloughs, and/or reduced compensation for providers and staff.

In the May 19 weekly survey, 82% of respondents said some or all of their providers’ compensation had been affected by the crisis. About 62% said every provider had been affected. Provider compensation was cut in several ways, including reduced hours and salaries, reduced or eliminated bonuses, and lower allowances for continuing medical education.

About 61% of health care leaders said in the June 26 poll that their own compensation had decreased.

In the following week’s survey, one in three managers said their organization had reduced staff compensation. Nearly all of the respondents in this category predicted the salary reductions would be temporary.

As of March 17, early in the pandemic, 40% of health care leaders said they were experiencing staff shortages. An April 21 poll found that 53% of health care leaders were taking steps to address their providers’ and staffers’ mental health.

“The mental and emotional toll on everyone continues to be a concern, as public health authorities continue to report alarming numbers of new [COVID-19] cases, hospitalizations, and deaths,” MGMA commented.
 

Telehealth and remote monitoring

Nearly all of the health care leaders surveyed on March 31 reported that their practices had expanded telehealth access because of COVID-19. The percentage of patient visits handled remotely had dropped substantially by the fall, according to a Harvard University/Commonwealth Fund/Phreesia survey. Still, it remains significantly higher than it was before the pandemic.

“At the end of 2020, telemedicine continues to play a vital role in everyday practice operations and long-term planning,” the MGMA report said. One indication of this, the association said, is that health care leaders are recognizing new best practices in specialty telemedicine, such as pediatrics and ob.gyn.

According to an April 28 poll, the top three coding/billing challenges for telehealth and telephone visits amid COVID-19 were inconsistent payer rules, pay parity and accuracy, and documentation of virtual visits.

While the Centers for Medicare & Medicaid Services has loosened its regulations to allow reimbursement of telehealth in all locations and at the same level as in-person visits, most of those changes will not last beyond the public health crisis without new legislation.

More health care leaders are considering the use of remote patient monitoring, MGMA said, but only 21% of practices offered such services as of Sept. 15. The report drew a connection between these plans and the current challenge of deferred care.

In the July 21 poll, 87% of health care leaders reported that safety concerns were the top reason that patients deferred care amid COVID-19. The MGMA report quoted JaeLynn Williams, CEO of Air Methods, which provides helicopter ambulance services, as saying that many people are staying home even when they face life-threatening conditions such as chest pain, drug symptoms, inflamed appendix, and gallbladder pain.
 

Operational issues

Overall, MGMA said, practices that have taken a financial risk have done better during the pandemic than fee-for-service practices because their monthly capitation revenue has continued unabated. In contrast, “most groups’ struggles to sustain visits and procedures meant less revenue and lower compensation,” the report said.

In the August 18 survey, one in three health care leaders reported their practices were changing their operational metrics and how often they looked at those measures because of the pandemic. “Practice managers are asking for dashboard data in weeks instead of months to measure the drop in charges and forecast the resulting change in collections,” MGMA noted. “The type of data practice managers are asking for has also changed.”

Among the new metrics that practices are interested in, according to an MGMA article, are measures that track telehealth visits, the productivity of staff working at home, and the number of ancillary services and procedures that new patients might need based on historical data.

Nearly all health care leaders surveyed on Aug. 11 said the cost of obtaining personal protective equipment had increased during 2020. MGMA said it expects this situation to worsen if the pandemic lasts through the summer of 2021.

While everyone is talking about the botched launch of the COVID-19 vaccination campaign, there were also problems with flu vaccination in 2020. In the Sept. 25 poll, 34% of health care leaders reported their practices were experiencing delays in getting the flu vaccine.
 

Looking ahead

Looking further ahead, the report recommended that practices make plans to boost staff morale by restoring bonuses.

In addition, MGMA suggested that physician groups reassess their space needs. “The equation is simple – fewer nonclinical staff members at your facility means you should repurpose that office space or consider finding a better fit for your new real estate needs in 2021.”

Finally, MGMA noted that the practices expanding rather than contracting their business are those increasing their value-based revenues by taking on more risk. For those groups, “growing the patient panel can help [them] seek better rates in contract negotiations.”

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

President Joe Biden signed 10 new executive orders on his second day in office that are designed to help roll out his broader plan to fight COVID-19.

Whitehouse.gov

“For the past year, we couldn’t rely on the federal government to act with the urgency and focus and coordination we needed, and we have seen the tragic cost of that failure,” Mr. Biden said in remarks from the White House, unveiling his 198-page National Strategy for the COVID-19 Response and Pandemic Preparedness.

He said as many as 500,000 Americans will have died by February. “It’s going to take months for us to turn things around,” he said.

“Our national strategy is comprehensive – it’s based on science, not politics; it’s based on truth, not denial,” Mr. Biden said. He also promised to restore public trust, in part by having scientists and public health experts speak to the public. “That’s why you’ll be hearing a lot more from Dr. Fauci again, not from the president,” he said, adding that the experts will be “free from political interference.”

While the president’s executive orders can help accomplish some of the plan’s proposals, the majority will require new funding from Congress and will be included in the $1.9 trillion American Rescue package that Mr. Biden hopes legislators will approve.
 

Ten new orders

The 10 new pandemic-related orders Biden signed on Jan. 21 follow two he signed on his first day in office.

One establishes a COVID-19 Response Office responsible for coordinating the pandemic response across all federal departments and agencies and also reestablishes the White House Directorate on Global Health Security and Biodefense, which was disabled by the Trump administration.

The other order requires masks and physical distancing in all federal buildings, on all federal lands, and by federal employees and contractors.

Among the new orders will be directives that:

• Require individuals to also wear masks in airports and planes, and when using other modes of public transportation including trains, boats, and intercity buses, and also require international travelers to produce proof of a recent negative COVID-19 test prior to entry and to quarantine after entry.
• Federal agencies use all powers, including the Defense Production Act, to accelerate manufacturing and delivery of supplies such as N95 masks, gowns, gloves, swabs, reagents, pipette tips, rapid test kits, and nitrocellulose material for rapid antigen tests, and all equipment and material needed to accelerate manufacture, delivery, and administration of COVID-19 vaccine.
• Create a Pandemic Testing Board to expand supply and access, to promote more surge capacity, and to ensure equitable access to tests.
• Facilitate discovery, development, and trials of potential COVID-19 treatments, as well as expand access to programs that can meet the long-term health needs of those recovering from the disease.
• Facilitate more and better data sharing that will allow businesses, schools, hospitals, and individuals to make real-time decisions based on spread in their community.
• Direct the Education and Health & Human Services departments to provide schools and child-care operations guidance on how to reopen and operate safely.
• Direct the Occupational Safety and Health Administration (OSHA) to immediately release clear guidance for employers to help keep workers safe and to enforce health and safety requirements.

The plan also sets goals for vaccination – including 100 million shots in the administration’s first 100 days. President Biden had already previewed his goals for vaccination, including setting up mass vaccination sites and mobile vaccination sites. During his remarks, Mr. Biden said that he had already directed the Federal Emergency Management Agency (FEMA) to begin setting up the vaccination centers.

The administration is also going to look into improving reimbursement for giving vaccines. As a start, the HHS will ask the Centers for Medicare & Medicaid Services to consider if a higher rate “may more accurately compensate providers,” according to the Biden plan.

“But the brutal truth is it will take months before we can get the majority of Americans vaccinated,” said Mr. Biden.

As part of the goal of ensuring an equitable pandemic response, the president will sign an order that establishes a COVID-19 Health Equity Task Force. The task force is charged with providing recommendations for allocating resources and funding in communities with inequities in COVID-19 outcomes by race, ethnicity, geography, disability, and other considerations.

Finally, the administration has committed to being more transparent and sharing more information. The national plan calls for the federal government to conduct regular, expert-led, science-based public briefings and to release regular reports on the pandemic. The administration said it will launch massive science-based public information campaigns – in multiple languages – to educate Americans on masks, testing, and vaccines, and also work to counter misinformation and disinformation.

The American Academy of Family Physicians (AAFP) applauded Mr. Biden’s initiative. “If enacted, this bold legislative agenda will provide much-needed support to American families struggling during the pandemic – especially communities of color and those hardest hit by the virus,” Ada D. Stewart, MD, AAFP president, said in a statement.

Dr. Stewart also noted that family physicians “are uniquely positioned in their communities to educate patients, prioritize access, and coordinate administration of the COVID-19 vaccines,” and urged the administration to ensure that family physicians and staff be vaccinated as soon as possible, to help them “more safely provide care to their communities.”

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

President Joe Biden signed 10 new executive orders on his second day in office that are designed to help roll out his broader plan to fight COVID-19.

Whitehouse.gov

“For the past year, we couldn’t rely on the federal government to act with the urgency and focus and coordination we needed, and we have seen the tragic cost of that failure,” Mr. Biden said in remarks from the White House, unveiling his 198-page National Strategy for the COVID-19 Response and Pandemic Preparedness.

He said as many as 500,000 Americans will have died by February. “It’s going to take months for us to turn things around,” he said.

“Our national strategy is comprehensive – it’s based on science, not politics; it’s based on truth, not denial,” Mr. Biden said. He also promised to restore public trust, in part by having scientists and public health experts speak to the public. “That’s why you’ll be hearing a lot more from Dr. Fauci again, not from the president,” he said, adding that the experts will be “free from political interference.”

While the president’s executive orders can help accomplish some of the plan’s proposals, the majority will require new funding from Congress and will be included in the $1.9 trillion American Rescue package that Mr. Biden hopes legislators will approve.
 

Ten new orders

The 10 new pandemic-related orders Biden signed on Jan. 21 follow two he signed on his first day in office.

One establishes a COVID-19 Response Office responsible for coordinating the pandemic response across all federal departments and agencies and also reestablishes the White House Directorate on Global Health Security and Biodefense, which was disabled by the Trump administration.

The other order requires masks and physical distancing in all federal buildings, on all federal lands, and by federal employees and contractors.

Among the new orders will be directives that:

• Require individuals to also wear masks in airports and planes, and when using other modes of public transportation including trains, boats, and intercity buses, and also require international travelers to produce proof of a recent negative COVID-19 test prior to entry and to quarantine after entry.
• Federal agencies use all powers, including the Defense Production Act, to accelerate manufacturing and delivery of supplies such as N95 masks, gowns, gloves, swabs, reagents, pipette tips, rapid test kits, and nitrocellulose material for rapid antigen tests, and all equipment and material needed to accelerate manufacture, delivery, and administration of COVID-19 vaccine.
• Create a Pandemic Testing Board to expand supply and access, to promote more surge capacity, and to ensure equitable access to tests.
• Facilitate discovery, development, and trials of potential COVID-19 treatments, as well as expand access to programs that can meet the long-term health needs of those recovering from the disease.
• Facilitate more and better data sharing that will allow businesses, schools, hospitals, and individuals to make real-time decisions based on spread in their community.
• Direct the Education and Health & Human Services departments to provide schools and child-care operations guidance on how to reopen and operate safely.
• Direct the Occupational Safety and Health Administration (OSHA) to immediately release clear guidance for employers to help keep workers safe and to enforce health and safety requirements.

The plan also sets goals for vaccination – including 100 million shots in the administration’s first 100 days. President Biden had already previewed his goals for vaccination, including setting up mass vaccination sites and mobile vaccination sites. During his remarks, Mr. Biden said that he had already directed the Federal Emergency Management Agency (FEMA) to begin setting up the vaccination centers.

The administration is also going to look into improving reimbursement for giving vaccines. As a start, the HHS will ask the Centers for Medicare & Medicaid Services to consider if a higher rate “may more accurately compensate providers,” according to the Biden plan.

“But the brutal truth is it will take months before we can get the majority of Americans vaccinated,” said Mr. Biden.

As part of the goal of ensuring an equitable pandemic response, the president will sign an order that establishes a COVID-19 Health Equity Task Force. The task force is charged with providing recommendations for allocating resources and funding in communities with inequities in COVID-19 outcomes by race, ethnicity, geography, disability, and other considerations.

Finally, the administration has committed to being more transparent and sharing more information. The national plan calls for the federal government to conduct regular, expert-led, science-based public briefings and to release regular reports on the pandemic. The administration said it will launch massive science-based public information campaigns – in multiple languages – to educate Americans on masks, testing, and vaccines, and also work to counter misinformation and disinformation.

The American Academy of Family Physicians (AAFP) applauded Mr. Biden’s initiative. “If enacted, this bold legislative agenda will provide much-needed support to American families struggling during the pandemic – especially communities of color and those hardest hit by the virus,” Ada D. Stewart, MD, AAFP president, said in a statement.

Dr. Stewart also noted that family physicians “are uniquely positioned in their communities to educate patients, prioritize access, and coordinate administration of the COVID-19 vaccines,” and urged the administration to ensure that family physicians and staff be vaccinated as soon as possible, to help them “more safely provide care to their communities.”

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

President Joe Biden signed 10 new executive orders on his second day in office that are designed to help roll out his broader plan to fight COVID-19.

Whitehouse.gov

“For the past year, we couldn’t rely on the federal government to act with the urgency and focus and coordination we needed, and we have seen the tragic cost of that failure,” Mr. Biden said in remarks from the White House, unveiling his 198-page National Strategy for the COVID-19 Response and Pandemic Preparedness.

He said as many as 500,000 Americans will have died by February. “It’s going to take months for us to turn things around,” he said.

“Our national strategy is comprehensive – it’s based on science, not politics; it’s based on truth, not denial,” Mr. Biden said. He also promised to restore public trust, in part by having scientists and public health experts speak to the public. “That’s why you’ll be hearing a lot more from Dr. Fauci again, not from the president,” he said, adding that the experts will be “free from political interference.”

While the president’s executive orders can help accomplish some of the plan’s proposals, the majority will require new funding from Congress and will be included in the $1.9 trillion American Rescue package that Mr. Biden hopes legislators will approve.
 

Ten new orders

The 10 new pandemic-related orders Biden signed on Jan. 21 follow two he signed on his first day in office.

One establishes a COVID-19 Response Office responsible for coordinating the pandemic response across all federal departments and agencies and also reestablishes the White House Directorate on Global Health Security and Biodefense, which was disabled by the Trump administration.

The other order requires masks and physical distancing in all federal buildings, on all federal lands, and by federal employees and contractors.

Among the new orders will be directives that:

• Require individuals to also wear masks in airports and planes, and when using other modes of public transportation including trains, boats, and intercity buses, and also require international travelers to produce proof of a recent negative COVID-19 test prior to entry and to quarantine after entry.
• Federal agencies use all powers, including the Defense Production Act, to accelerate manufacturing and delivery of supplies such as N95 masks, gowns, gloves, swabs, reagents, pipette tips, rapid test kits, and nitrocellulose material for rapid antigen tests, and all equipment and material needed to accelerate manufacture, delivery, and administration of COVID-19 vaccine.
• Create a Pandemic Testing Board to expand supply and access, to promote more surge capacity, and to ensure equitable access to tests.
• Facilitate discovery, development, and trials of potential COVID-19 treatments, as well as expand access to programs that can meet the long-term health needs of those recovering from the disease.
• Facilitate more and better data sharing that will allow businesses, schools, hospitals, and individuals to make real-time decisions based on spread in their community.
• Direct the Education and Health & Human Services departments to provide schools and child-care operations guidance on how to reopen and operate safely.
• Direct the Occupational Safety and Health Administration (OSHA) to immediately release clear guidance for employers to help keep workers safe and to enforce health and safety requirements.

The plan also sets goals for vaccination – including 100 million shots in the administration’s first 100 days. President Biden had already previewed his goals for vaccination, including setting up mass vaccination sites and mobile vaccination sites. During his remarks, Mr. Biden said that he had already directed the Federal Emergency Management Agency (FEMA) to begin setting up the vaccination centers.

The administration is also going to look into improving reimbursement for giving vaccines. As a start, the HHS will ask the Centers for Medicare & Medicaid Services to consider if a higher rate “may more accurately compensate providers,” according to the Biden plan.

“But the brutal truth is it will take months before we can get the majority of Americans vaccinated,” said Mr. Biden.

As part of the goal of ensuring an equitable pandemic response, the president will sign an order that establishes a COVID-19 Health Equity Task Force. The task force is charged with providing recommendations for allocating resources and funding in communities with inequities in COVID-19 outcomes by race, ethnicity, geography, disability, and other considerations.

Finally, the administration has committed to being more transparent and sharing more information. The national plan calls for the federal government to conduct regular, expert-led, science-based public briefings and to release regular reports on the pandemic. The administration said it will launch massive science-based public information campaigns – in multiple languages – to educate Americans on masks, testing, and vaccines, and also work to counter misinformation and disinformation.

The American Academy of Family Physicians (AAFP) applauded Mr. Biden’s initiative. “If enacted, this bold legislative agenda will provide much-needed support to American families struggling during the pandemic – especially communities of color and those hardest hit by the virus,” Ada D. Stewart, MD, AAFP president, said in a statement.

Dr. Stewart also noted that family physicians “are uniquely positioned in their communities to educate patients, prioritize access, and coordinate administration of the COVID-19 vaccines,” and urged the administration to ensure that family physicians and staff be vaccinated as soon as possible, to help them “more safely provide care to their communities.”

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

Primary care physicians (PCPs) generate only a small part of the $75 billion to $100 billion wasted every year on low-value care, according to a brief report published online Jan. 18 in Annals of Internal Medicine.

However, one expert said there are better ways to curb low-value care than focusing on which specialties are guilty of the practice.

Analyzing a 20% random sample of Medicare Part B claims, Aaron Baum, PhD, with the Icahn School of Medicine at Mount Sinai, New York, and colleagues found that the services primary care physicians performed or ordered made up on average 8.3% of the low-value care their patients received (interquartile range, 3.9%-15.1%; 95th percentile, 35.6%) and their referrals made up 15.4% (IQR, 6.3%-26.4%; 95th percentile, 44.6%).

By specialty, cardiology had the worst record with 27% of all spending on low-value services ($1.8 billion) attributed to that specialty. Yet, of the 25 highest-spending specialties in the report, 12 of them were associated with 1% or less than 1% each of all low-value spending, indicating the waste was widely distributed.

Dr. Baum said in an interview that though there are some PCPs guilty of high spending on low-value services, overall, most primary care physicians’ low-value services add up to only 0.3% of Part B spending. He noted that Part B spending is about one-third of all Medicare spending.

Primary care is often thought to be at the core of care management and spending and PCPs are often seen as the gatekeepers, but this analysis suggests that efforts to make big differences in curtailing low-value spending might be more effective elsewhere.

“There’s only so much spending you can reduce by changing primary care physicians’ services that they directly perform,” Dr. Baum said.
 

Low-value care is costly, can be harmful

Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, said in an interview that the report adds confirmation to previous research that has consistently shown low-value care is “extremely common, very costly, and provided by primary care providers and specialists alike.” He noted that it can also be harmful.

“The math is simple,” he said. “If we want to improve coverage and lower patient costs for essential services like visits, diagnostic tests, and drugs, we have to reduce spending on those services that do not make Americans any healthier.”

The study ranked 31 clinical services judged to be low value by physician societies, Medicare and clinical guidelines, and their use among beneficiaries enrolled between 2007 and 2014. Here’s how the top six low-value services compare.

Dr. Fendrick said a weakness of the paper is the years of the data (2007-2014). Some of the criteria around low-value care have changed since then. The age that a prostate-specific antigen test becomes low-value is now 70 years, for instance, instead of 75. He added that some of the figures attributed to non-PCP providers appear out of date.

Dr. Fendrick said, “I understand that there are Medicare patients who end up at a gastroenterologist or surgeon’s office to get colorectal cancer screening, but it would be very hard for me to believe that half of stress tests and over half of colon cancer screening over [age] 85 [years] and half of PSA for people over 75 did not have some type of referring clinicians involved. I certainly don’t think that would be the case in 2020-2021.”

Dr. Baum said those years were the latest years available for the data points needed for this analysis, but he and his colleagues were working to update the data for future publication.

Dr. Fendrick said not much has changed in recent years in terms of waste on low-value care, even with campaigns such as Choosing Wisely dedicated to identifying low-value services or procedures in each specialty.

“I believe there’s not a particular group of clinicians one way or the other who are actually doing any better now than they were 7 years ago,” he said. He would rather focus less on which specialties are associated with the most low-value care and more on the underlying policies that encourage low-value care.

“If you’re going to get paid for doing a stress test and get paid nothing or significantly less if you don’t, the incentives are in the wrong direction,” he said.

Dr. Fendrick said the pandemic era provides an opportunity to eliminate low-value care because use of those services has dropped drastically as resources have been diverted to COVID-19 patients and many services have been delayed or canceled.

He said he has been pushing an approach that providers should be paid more after the pandemic “to do the things we want them to do.”

As an example, he said, instead of paying $886 million on colonoscopies for people over the age of 85, “why don’t we put a policy in place that would make it better for patients by lowering cost sharing and better for providers by paying them more to do the service on the people who need it as opposed to the people who don’t?”

The research was funded by the American Board of Family Medicine Foundation. Dr. Baum and a coauthor reported receiving personal fees from American Board of Family Medicine Foundation during the conduct of the study. Another coauthor reported receiving personal fees from Collective Health, HealthRight 360, PLOS Medicine, and the New England Journal of Medicine, outside the submitted work. Dr. Fendrick disclosed no relevant financial relationships.

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

Primary care physicians (PCPs) generate only a small part of the $75 billion to $100 billion wasted every year on low-value care, according to a brief report published online Jan. 18 in Annals of Internal Medicine.

However, one expert said there are better ways to curb low-value care than focusing on which specialties are guilty of the practice.

Analyzing a 20% random sample of Medicare Part B claims, Aaron Baum, PhD, with the Icahn School of Medicine at Mount Sinai, New York, and colleagues found that the services primary care physicians performed or ordered made up on average 8.3% of the low-value care their patients received (interquartile range, 3.9%-15.1%; 95th percentile, 35.6%) and their referrals made up 15.4% (IQR, 6.3%-26.4%; 95th percentile, 44.6%).

By specialty, cardiology had the worst record with 27% of all spending on low-value services ($1.8 billion) attributed to that specialty. Yet, of the 25 highest-spending specialties in the report, 12 of them were associated with 1% or less than 1% each of all low-value spending, indicating the waste was widely distributed.

Dr. Baum said in an interview that though there are some PCPs guilty of high spending on low-value services, overall, most primary care physicians’ low-value services add up to only 0.3% of Part B spending. He noted that Part B spending is about one-third of all Medicare spending.

Primary care is often thought to be at the core of care management and spending and PCPs are often seen as the gatekeepers, but this analysis suggests that efforts to make big differences in curtailing low-value spending might be more effective elsewhere.

“There’s only so much spending you can reduce by changing primary care physicians’ services that they directly perform,” Dr. Baum said.
 

Low-value care is costly, can be harmful

Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, said in an interview that the report adds confirmation to previous research that has consistently shown low-value care is “extremely common, very costly, and provided by primary care providers and specialists alike.” He noted that it can also be harmful.

“The math is simple,” he said. “If we want to improve coverage and lower patient costs for essential services like visits, diagnostic tests, and drugs, we have to reduce spending on those services that do not make Americans any healthier.”

The study ranked 31 clinical services judged to be low value by physician societies, Medicare and clinical guidelines, and their use among beneficiaries enrolled between 2007 and 2014. Here’s how the top six low-value services compare.

Dr. Fendrick said a weakness of the paper is the years of the data (2007-2014). Some of the criteria around low-value care have changed since then. The age that a prostate-specific antigen test becomes low-value is now 70 years, for instance, instead of 75. He added that some of the figures attributed to non-PCP providers appear out of date.

Dr. Fendrick said, “I understand that there are Medicare patients who end up at a gastroenterologist or surgeon’s office to get colorectal cancer screening, but it would be very hard for me to believe that half of stress tests and over half of colon cancer screening over [age] 85 [years] and half of PSA for people over 75 did not have some type of referring clinicians involved. I certainly don’t think that would be the case in 2020-2021.”

Dr. Baum said those years were the latest years available for the data points needed for this analysis, but he and his colleagues were working to update the data for future publication.

Dr. Fendrick said not much has changed in recent years in terms of waste on low-value care, even with campaigns such as Choosing Wisely dedicated to identifying low-value services or procedures in each specialty.

“I believe there’s not a particular group of clinicians one way or the other who are actually doing any better now than they were 7 years ago,” he said. He would rather focus less on which specialties are associated with the most low-value care and more on the underlying policies that encourage low-value care.

“If you’re going to get paid for doing a stress test and get paid nothing or significantly less if you don’t, the incentives are in the wrong direction,” he said.

Dr. Fendrick said the pandemic era provides an opportunity to eliminate low-value care because use of those services has dropped drastically as resources have been diverted to COVID-19 patients and many services have been delayed or canceled.

He said he has been pushing an approach that providers should be paid more after the pandemic “to do the things we want them to do.”

As an example, he said, instead of paying $886 million on colonoscopies for people over the age of 85, “why don’t we put a policy in place that would make it better for patients by lowering cost sharing and better for providers by paying them more to do the service on the people who need it as opposed to the people who don’t?”

The research was funded by the American Board of Family Medicine Foundation. Dr. Baum and a coauthor reported receiving personal fees from American Board of Family Medicine Foundation during the conduct of the study. Another coauthor reported receiving personal fees from Collective Health, HealthRight 360, PLOS Medicine, and the New England Journal of Medicine, outside the submitted work. Dr. Fendrick disclosed no relevant financial relationships.

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

Primary care physicians (PCPs) generate only a small part of the $75 billion to $100 billion wasted every year on low-value care, according to a brief report published online Jan. 18 in Annals of Internal Medicine.

However, one expert said there are better ways to curb low-value care than focusing on which specialties are guilty of the practice.

Analyzing a 20% random sample of Medicare Part B claims, Aaron Baum, PhD, with the Icahn School of Medicine at Mount Sinai, New York, and colleagues found that the services primary care physicians performed or ordered made up on average 8.3% of the low-value care their patients received (interquartile range, 3.9%-15.1%; 95th percentile, 35.6%) and their referrals made up 15.4% (IQR, 6.3%-26.4%; 95th percentile, 44.6%).

By specialty, cardiology had the worst record with 27% of all spending on low-value services ($1.8 billion) attributed to that specialty. Yet, of the 25 highest-spending specialties in the report, 12 of them were associated with 1% or less than 1% each of all low-value spending, indicating the waste was widely distributed.

Dr. Baum said in an interview that though there are some PCPs guilty of high spending on low-value services, overall, most primary care physicians’ low-value services add up to only 0.3% of Part B spending. He noted that Part B spending is about one-third of all Medicare spending.

Primary care is often thought to be at the core of care management and spending and PCPs are often seen as the gatekeepers, but this analysis suggests that efforts to make big differences in curtailing low-value spending might be more effective elsewhere.

“There’s only so much spending you can reduce by changing primary care physicians’ services that they directly perform,” Dr. Baum said.
 

Low-value care is costly, can be harmful

Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, said in an interview that the report adds confirmation to previous research that has consistently shown low-value care is “extremely common, very costly, and provided by primary care providers and specialists alike.” He noted that it can also be harmful.

“The math is simple,” he said. “If we want to improve coverage and lower patient costs for essential services like visits, diagnostic tests, and drugs, we have to reduce spending on those services that do not make Americans any healthier.”

The study ranked 31 clinical services judged to be low value by physician societies, Medicare and clinical guidelines, and their use among beneficiaries enrolled between 2007 and 2014. Here’s how the top six low-value services compare.

Dr. Fendrick said a weakness of the paper is the years of the data (2007-2014). Some of the criteria around low-value care have changed since then. The age that a prostate-specific antigen test becomes low-value is now 70 years, for instance, instead of 75. He added that some of the figures attributed to non-PCP providers appear out of date.

Dr. Fendrick said, “I understand that there are Medicare patients who end up at a gastroenterologist or surgeon’s office to get colorectal cancer screening, but it would be very hard for me to believe that half of stress tests and over half of colon cancer screening over [age] 85 [years] and half of PSA for people over 75 did not have some type of referring clinicians involved. I certainly don’t think that would be the case in 2020-2021.”

Dr. Baum said those years were the latest years available for the data points needed for this analysis, but he and his colleagues were working to update the data for future publication.

Dr. Fendrick said not much has changed in recent years in terms of waste on low-value care, even with campaigns such as Choosing Wisely dedicated to identifying low-value services or procedures in each specialty.

“I believe there’s not a particular group of clinicians one way or the other who are actually doing any better now than they were 7 years ago,” he said. He would rather focus less on which specialties are associated with the most low-value care and more on the underlying policies that encourage low-value care.

“If you’re going to get paid for doing a stress test and get paid nothing or significantly less if you don’t, the incentives are in the wrong direction,” he said.

Dr. Fendrick said the pandemic era provides an opportunity to eliminate low-value care because use of those services has dropped drastically as resources have been diverted to COVID-19 patients and many services have been delayed or canceled.

He said he has been pushing an approach that providers should be paid more after the pandemic “to do the things we want them to do.”

As an example, he said, instead of paying $886 million on colonoscopies for people over the age of 85, “why don’t we put a policy in place that would make it better for patients by lowering cost sharing and better for providers by paying them more to do the service on the people who need it as opposed to the people who don’t?”

The research was funded by the American Board of Family Medicine Foundation. Dr. Baum and a coauthor reported receiving personal fees from American Board of Family Medicine Foundation during the conduct of the study. Another coauthor reported receiving personal fees from Collective Health, HealthRight 360, PLOS Medicine, and the New England Journal of Medicine, outside the submitted work. Dr. Fendrick disclosed no relevant financial relationships.

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

President Joe Biden kicked off his new administration Jan. 20 with an immediate focus on attempts to stop the spread of COVID-19, including closer coordination with other nations.

Mr. Biden signed 17 executive orders, memoranda, and directives addressing not only the pandemic but also economic concerns, climate change, and racial inequity.

At the top of the list of actions was what his transition team called a “100 Days Masking Challenge.” Mr. Biden issued an executive order requiring masks and physical distancing in all federal buildings, on all federal lands, and by federal employees and contractors.

The president also halted the Trump administration’s process of withdrawing from the World Health Organization. Instead, Mr. Biden named Anthony Fauci, MD, the director of the National Institute for Allergy and Infectious Diseases, as the head of a delegation to participate in the WHO executive board meeting that is being held this week.

Mr. Biden also signed an executive order creating the position of COVID-19 response coordinator, which will report directly to the president and be responsible for coordinating all elements of the COVID-19 response across government, including the production and distribution of vaccines and medical supplies.

The newly inaugurated president also intends to restore the National Security Council’s Directorate for Global Health Security and Biodefense, which will aid in the response to the pandemic, his transition team said.

The American Medical Association was among the first to commend the first-day actions.

“Defeating COVID-19 requires bold, coordinated federal leadership and strong adherence to the public health steps we know stop the spread of this virus – wearing masks, practicing physical distancing, and washing hands,” said AMA President Susan R. Bailey, MD in a news release. “We are pleased by the Biden administration’s steps today, including universal mask wearing within federal jurisdictions, providing federal leadership for COVID-19 response, and reengaging with the World Health Organization. Taking these actions on day 1 of the administration sends the right message – that our nation is laser focused on stopping the ravages of COVID-19.”

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

President Joe Biden kicked off his new administration Jan. 20 with an immediate focus on attempts to stop the spread of COVID-19, including closer coordination with other nations.

Mr. Biden signed 17 executive orders, memoranda, and directives addressing not only the pandemic but also economic concerns, climate change, and racial inequity.

At the top of the list of actions was what his transition team called a “100 Days Masking Challenge.” Mr. Biden issued an executive order requiring masks and physical distancing in all federal buildings, on all federal lands, and by federal employees and contractors.

The president also halted the Trump administration’s process of withdrawing from the World Health Organization. Instead, Mr. Biden named Anthony Fauci, MD, the director of the National Institute for Allergy and Infectious Diseases, as the head of a delegation to participate in the WHO executive board meeting that is being held this week.

Mr. Biden also signed an executive order creating the position of COVID-19 response coordinator, which will report directly to the president and be responsible for coordinating all elements of the COVID-19 response across government, including the production and distribution of vaccines and medical supplies.

The newly inaugurated president also intends to restore the National Security Council’s Directorate for Global Health Security and Biodefense, which will aid in the response to the pandemic, his transition team said.

The American Medical Association was among the first to commend the first-day actions.

“Defeating COVID-19 requires bold, coordinated federal leadership and strong adherence to the public health steps we know stop the spread of this virus – wearing masks, practicing physical distancing, and washing hands,” said AMA President Susan R. Bailey, MD in a news release. “We are pleased by the Biden administration’s steps today, including universal mask wearing within federal jurisdictions, providing federal leadership for COVID-19 response, and reengaging with the World Health Organization. Taking these actions on day 1 of the administration sends the right message – that our nation is laser focused on stopping the ravages of COVID-19.”

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

President Joe Biden kicked off his new administration Jan. 20 with an immediate focus on attempts to stop the spread of COVID-19, including closer coordination with other nations.

Mr. Biden signed 17 executive orders, memoranda, and directives addressing not only the pandemic but also economic concerns, climate change, and racial inequity.

At the top of the list of actions was what his transition team called a “100 Days Masking Challenge.” Mr. Biden issued an executive order requiring masks and physical distancing in all federal buildings, on all federal lands, and by federal employees and contractors.

The president also halted the Trump administration’s process of withdrawing from the World Health Organization. Instead, Mr. Biden named Anthony Fauci, MD, the director of the National Institute for Allergy and Infectious Diseases, as the head of a delegation to participate in the WHO executive board meeting that is being held this week.

Mr. Biden also signed an executive order creating the position of COVID-19 response coordinator, which will report directly to the president and be responsible for coordinating all elements of the COVID-19 response across government, including the production and distribution of vaccines and medical supplies.

The newly inaugurated president also intends to restore the National Security Council’s Directorate for Global Health Security and Biodefense, which will aid in the response to the pandemic, his transition team said.

The American Medical Association was among the first to commend the first-day actions.

“Defeating COVID-19 requires bold, coordinated federal leadership and strong adherence to the public health steps we know stop the spread of this virus – wearing masks, practicing physical distancing, and washing hands,” said AMA President Susan R. Bailey, MD in a news release. “We are pleased by the Biden administration’s steps today, including universal mask wearing within federal jurisdictions, providing federal leadership for COVID-19 response, and reengaging with the World Health Organization. Taking these actions on day 1 of the administration sends the right message – that our nation is laser focused on stopping the ravages of COVID-19.”

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

Many emergency medicine (EM) physicians who responded to a Medscape survey said they have treated COVID-19 patients without appropriate personal protective equipment (PPE).

In the Medscape Emergency Medicine Physicians’ COVID-19 Experience Report, 21% of respondents said that that was sometimes the case; 7% said that it was often the case; and 1% said they always treat patients without appropriate PPE.

EM physicians were the physicians most likely to treat COVID-19 patients in person.

Steep income drops

Survey authors wrote that two-thirds of EM physicians have experienced income loss during the pandemic. Most (71%) saw their income drop by between 11% and 50%; 11% saw a decrease of more than 50%. Among other specialties, the percentages of those who have experienced a drop of more than 50% are far higher. Among ophthalmologists, 51% said they had experienced such a drop; among allergists, 46%; plastic surgeons, 46%; and otolaryngologists, 45%.

Asked whether their burnout levels have increased in the wake of COVID-19, 74% of EM physicians said burnout had intensified; 23% reported no change; and 3% said burnout had lessened.

Reports of loneliness have been widespread during the pandemic, owing to stay-at-home orders and social distancing. More EM physicians than physicians in general said feelings of loneliness had increased for them in the past year.

More than half of EM doctors (55%) said they are experiencing more loneliness in the pandemic, compared with 46% of all physicians who felt that way; 42% said those feelings have not changed; and 3% said they have been less lonely.
 

Grief and stress relief

Fewer than half (42%) of the respondents reported that their workplace offers clinician activities to help with grief and stress; 39% said their workplace didn’t offer such help; and 19% said they were unsure.

The percentages were nearly identical to the percentages of physicians overall who answered whether their workplace offered help for grief and stress.

Along with insecurity regarding physical and mental health, COVID-19 has introduced more questions about financial health. Here’s a look at how emergency physicians said they would change the way they save and spend.

Challenges to daily practice

By the time this survey was taken, a large percentage of patients had delayed or avoided urgent or routine medical care for reasons related to COVID-19, so survey authors asked whether EM physicians’ patient population had changed.

Survey authors wrote that “most EM physicians (82%) are seeing patients with non-COVID diseases, such as cardiovascular problems or diabetes, who otherwise probably would have sought treatment earlier.”

COVID-19 has also thrown a major obstacle into most EM physicians’ careers by preventing them from doing the job to the best of their ability. That loss is one of the three primary components of burnout.

More than two-thirds (67%) said COVID-19 has hampered their ability to be as good a doctor as they would like.

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

Many emergency medicine (EM) physicians who responded to a Medscape survey said they have treated COVID-19 patients without appropriate personal protective equipment (PPE).

In the Medscape Emergency Medicine Physicians’ COVID-19 Experience Report, 21% of respondents said that that was sometimes the case; 7% said that it was often the case; and 1% said they always treat patients without appropriate PPE.

EM physicians were the physicians most likely to treat COVID-19 patients in person.

Steep income drops

Survey authors wrote that two-thirds of EM physicians have experienced income loss during the pandemic. Most (71%) saw their income drop by between 11% and 50%; 11% saw a decrease of more than 50%. Among other specialties, the percentages of those who have experienced a drop of more than 50% are far higher. Among ophthalmologists, 51% said they had experienced such a drop; among allergists, 46%; plastic surgeons, 46%; and otolaryngologists, 45%.

Asked whether their burnout levels have increased in the wake of COVID-19, 74% of EM physicians said burnout had intensified; 23% reported no change; and 3% said burnout had lessened.

Reports of loneliness have been widespread during the pandemic, owing to stay-at-home orders and social distancing. More EM physicians than physicians in general said feelings of loneliness had increased for them in the past year.

More than half of EM doctors (55%) said they are experiencing more loneliness in the pandemic, compared with 46% of all physicians who felt that way; 42% said those feelings have not changed; and 3% said they have been less lonely.
 

Grief and stress relief

Fewer than half (42%) of the respondents reported that their workplace offers clinician activities to help with grief and stress; 39% said their workplace didn’t offer such help; and 19% said they were unsure.

The percentages were nearly identical to the percentages of physicians overall who answered whether their workplace offered help for grief and stress.

Along with insecurity regarding physical and mental health, COVID-19 has introduced more questions about financial health. Here’s a look at how emergency physicians said they would change the way they save and spend.

Challenges to daily practice

By the time this survey was taken, a large percentage of patients had delayed or avoided urgent or routine medical care for reasons related to COVID-19, so survey authors asked whether EM physicians’ patient population had changed.

Survey authors wrote that “most EM physicians (82%) are seeing patients with non-COVID diseases, such as cardiovascular problems or diabetes, who otherwise probably would have sought treatment earlier.”

COVID-19 has also thrown a major obstacle into most EM physicians’ careers by preventing them from doing the job to the best of their ability. That loss is one of the three primary components of burnout.

More than two-thirds (67%) said COVID-19 has hampered their ability to be as good a doctor as they would like.

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

Many emergency medicine (EM) physicians who responded to a Medscape survey said they have treated COVID-19 patients without appropriate personal protective equipment (PPE).

In the Medscape Emergency Medicine Physicians’ COVID-19 Experience Report, 21% of respondents said that that was sometimes the case; 7% said that it was often the case; and 1% said they always treat patients without appropriate PPE.

EM physicians were the physicians most likely to treat COVID-19 patients in person.

Steep income drops

Survey authors wrote that two-thirds of EM physicians have experienced income loss during the pandemic. Most (71%) saw their income drop by between 11% and 50%; 11% saw a decrease of more than 50%. Among other specialties, the percentages of those who have experienced a drop of more than 50% are far higher. Among ophthalmologists, 51% said they had experienced such a drop; among allergists, 46%; plastic surgeons, 46%; and otolaryngologists, 45%.

Asked whether their burnout levels have increased in the wake of COVID-19, 74% of EM physicians said burnout had intensified; 23% reported no change; and 3% said burnout had lessened.

Reports of loneliness have been widespread during the pandemic, owing to stay-at-home orders and social distancing. More EM physicians than physicians in general said feelings of loneliness had increased for them in the past year.

More than half of EM doctors (55%) said they are experiencing more loneliness in the pandemic, compared with 46% of all physicians who felt that way; 42% said those feelings have not changed; and 3% said they have been less lonely.
 

Grief and stress relief

Fewer than half (42%) of the respondents reported that their workplace offers clinician activities to help with grief and stress; 39% said their workplace didn’t offer such help; and 19% said they were unsure.

The percentages were nearly identical to the percentages of physicians overall who answered whether their workplace offered help for grief and stress.

Along with insecurity regarding physical and mental health, COVID-19 has introduced more questions about financial health. Here’s a look at how emergency physicians said they would change the way they save and spend.

Challenges to daily practice

By the time this survey was taken, a large percentage of patients had delayed or avoided urgent or routine medical care for reasons related to COVID-19, so survey authors asked whether EM physicians’ patient population had changed.

Survey authors wrote that “most EM physicians (82%) are seeing patients with non-COVID diseases, such as cardiovascular problems or diabetes, who otherwise probably would have sought treatment earlier.”

COVID-19 has also thrown a major obstacle into most EM physicians’ careers by preventing them from doing the job to the best of their ability. That loss is one of the three primary components of burnout.

More than two-thirds (67%) said COVID-19 has hampered their ability to be as good a doctor as they would like.

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

Use of sodium-glucose cotransporter 2 (SGLT2) inhibitors during acute COVID-19 illness raises the risk for euglycemic diabetic ketoacidosis (euDKA), a new case series suggests.

Five patients with type 2 diabetes who were taking SGLT2 inhibitors presented in DKA despite having glucose levels below 300 mg/dL. The report was published online last month in AACE Clinical Case Reports by Rebecca J. Vitale, MD, and colleagues at Brigham and Women’s Hospital, Boston.

“A cluster of euglycemic DKA cases at our hospital during the first wave of the pandemic suggests that patients with diabetes taking SGLT2 inhibitors may be at enhanced risk for euDKA when they contract COVID-19,” senior author Naomi D.L. Fisher, MD, said in an interview.

Dr. Fisher, an endocrinologist, added: “This complication is preventable with the simple measure of holding the drug. We are hopeful that widespread patient and physician education will prevent future cases of euDKA as COVID-19 infections continue to surge.”

These cases underscore recommendations published early in the COVID-19 pandemic by an international panel, she noted.

“Patients who are acutely ill with nausea, vomiting, abdominal pain, or diarrhea, or who are experiencing loss of appetite with reduced food and fluid intake, should be advised to hold their SGLT2 inhibitor. This medication should not be resumed until patients are feeling better and eating and drinking normally.”  

On the other hand, “If patients with asymptomatic or mild COVID-19 infection are otherwise well, and are eating and drinking normally, there is no evidence that SGLT2 inhibitors need to be stopped. These patients should monitor [themselves] closely for worsening symptoms, especially resulting in poor hydration and nutrition, which would be reason to discontinue their medication.” 
 

Pay special attention to the elderly, those with complications

However, special consideration should be given to elderly patients and those with medical conditions known to increase the likelihood of severe infection, like heart failure and chronic obstructive pulmonary disease, Dr. Fisher added.

The SGLT2 inhibitor class of drugs causes significant urinary glucose excretion, and they are also diuretics. A decrease in available glucose and volume depletion are probably both important contributors to euDKA, she explained.

With COVID-19 infection the euDKA risk is compounded by several mechanisms. Most cases of euDKA are associated with an underlying state of starvation that can be triggered by vomiting, diarrhea, loss of appetite, and poor oral intake.

In addition – although not yet known for certain – SARS-CoV-2 may also be toxic to pancreatic beta cells and thus reduce insulin secretion. The maladaptive inflammatory response seen with COVID-19 may also contribute, she said.  

The patients in the current case series were three men and two women seen between March and May 2020. They ranged in age from 52 to 79 years.

None had a prior history of DKA or any known diabetes complications. In all of them, antihyperglycemic medications, including SGLT2 inhibitors, were stopped on hospital admission. The patients were initially treated with intravenous insulin, and then subcutaneous insulin after the DKA diagnosis.

Three of the patients were discharged to rehabilitation facilities on hospital days 28-47 and one (age 53 years) was discharged home on day 11. The other patient also had hypertension and nonalcoholic steatohepatitis.

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

Use of sodium-glucose cotransporter 2 (SGLT2) inhibitors during acute COVID-19 illness raises the risk for euglycemic diabetic ketoacidosis (euDKA), a new case series suggests.

Five patients with type 2 diabetes who were taking SGLT2 inhibitors presented in DKA despite having glucose levels below 300 mg/dL. The report was published online last month in AACE Clinical Case Reports by Rebecca J. Vitale, MD, and colleagues at Brigham and Women’s Hospital, Boston.

“A cluster of euglycemic DKA cases at our hospital during the first wave of the pandemic suggests that patients with diabetes taking SGLT2 inhibitors may be at enhanced risk for euDKA when they contract COVID-19,” senior author Naomi D.L. Fisher, MD, said in an interview.

Dr. Fisher, an endocrinologist, added: “This complication is preventable with the simple measure of holding the drug. We are hopeful that widespread patient and physician education will prevent future cases of euDKA as COVID-19 infections continue to surge.”

These cases underscore recommendations published early in the COVID-19 pandemic by an international panel, she noted.

“Patients who are acutely ill with nausea, vomiting, abdominal pain, or diarrhea, or who are experiencing loss of appetite with reduced food and fluid intake, should be advised to hold their SGLT2 inhibitor. This medication should not be resumed until patients are feeling better and eating and drinking normally.”  

On the other hand, “If patients with asymptomatic or mild COVID-19 infection are otherwise well, and are eating and drinking normally, there is no evidence that SGLT2 inhibitors need to be stopped. These patients should monitor [themselves] closely for worsening symptoms, especially resulting in poor hydration and nutrition, which would be reason to discontinue their medication.” 
 

Pay special attention to the elderly, those with complications

However, special consideration should be given to elderly patients and those with medical conditions known to increase the likelihood of severe infection, like heart failure and chronic obstructive pulmonary disease, Dr. Fisher added.

The SGLT2 inhibitor class of drugs causes significant urinary glucose excretion, and they are also diuretics. A decrease in available glucose and volume depletion are probably both important contributors to euDKA, she explained.

With COVID-19 infection the euDKA risk is compounded by several mechanisms. Most cases of euDKA are associated with an underlying state of starvation that can be triggered by vomiting, diarrhea, loss of appetite, and poor oral intake.

In addition – although not yet known for certain – SARS-CoV-2 may also be toxic to pancreatic beta cells and thus reduce insulin secretion. The maladaptive inflammatory response seen with COVID-19 may also contribute, she said.  

The patients in the current case series were three men and two women seen between March and May 2020. They ranged in age from 52 to 79 years.

None had a prior history of DKA or any known diabetes complications. In all of them, antihyperglycemic medications, including SGLT2 inhibitors, were stopped on hospital admission. The patients were initially treated with intravenous insulin, and then subcutaneous insulin after the DKA diagnosis.

Three of the patients were discharged to rehabilitation facilities on hospital days 28-47 and one (age 53 years) was discharged home on day 11. The other patient also had hypertension and nonalcoholic steatohepatitis.

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

Use of sodium-glucose cotransporter 2 (SGLT2) inhibitors during acute COVID-19 illness raises the risk for euglycemic diabetic ketoacidosis (euDKA), a new case series suggests.

Five patients with type 2 diabetes who were taking SGLT2 inhibitors presented in DKA despite having glucose levels below 300 mg/dL. The report was published online last month in AACE Clinical Case Reports by Rebecca J. Vitale, MD, and colleagues at Brigham and Women’s Hospital, Boston.

“A cluster of euglycemic DKA cases at our hospital during the first wave of the pandemic suggests that patients with diabetes taking SGLT2 inhibitors may be at enhanced risk for euDKA when they contract COVID-19,” senior author Naomi D.L. Fisher, MD, said in an interview.

Dr. Fisher, an endocrinologist, added: “This complication is preventable with the simple measure of holding the drug. We are hopeful that widespread patient and physician education will prevent future cases of euDKA as COVID-19 infections continue to surge.”

These cases underscore recommendations published early in the COVID-19 pandemic by an international panel, she noted.

“Patients who are acutely ill with nausea, vomiting, abdominal pain, or diarrhea, or who are experiencing loss of appetite with reduced food and fluid intake, should be advised to hold their SGLT2 inhibitor. This medication should not be resumed until patients are feeling better and eating and drinking normally.”  

On the other hand, “If patients with asymptomatic or mild COVID-19 infection are otherwise well, and are eating and drinking normally, there is no evidence that SGLT2 inhibitors need to be stopped. These patients should monitor [themselves] closely for worsening symptoms, especially resulting in poor hydration and nutrition, which would be reason to discontinue their medication.” 
 

Pay special attention to the elderly, those with complications

However, special consideration should be given to elderly patients and those with medical conditions known to increase the likelihood of severe infection, like heart failure and chronic obstructive pulmonary disease, Dr. Fisher added.

The SGLT2 inhibitor class of drugs causes significant urinary glucose excretion, and they are also diuretics. A decrease in available glucose and volume depletion are probably both important contributors to euDKA, she explained.

With COVID-19 infection the euDKA risk is compounded by several mechanisms. Most cases of euDKA are associated with an underlying state of starvation that can be triggered by vomiting, diarrhea, loss of appetite, and poor oral intake.

In addition – although not yet known for certain – SARS-CoV-2 may also be toxic to pancreatic beta cells and thus reduce insulin secretion. The maladaptive inflammatory response seen with COVID-19 may also contribute, she said.  

The patients in the current case series were three men and two women seen between March and May 2020. They ranged in age from 52 to 79 years.

None had a prior history of DKA or any known diabetes complications. In all of them, antihyperglycemic medications, including SGLT2 inhibitors, were stopped on hospital admission. The patients were initially treated with intravenous insulin, and then subcutaneous insulin after the DKA diagnosis.

Three of the patients were discharged to rehabilitation facilities on hospital days 28-47 and one (age 53 years) was discharged home on day 11. The other patient also had hypertension and nonalcoholic steatohepatitis.

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

The United States set a new weekly high for COVID-19 cases in children, surpassing 200,000 for the first time since the pandemic began, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

There were 211,466 new cases reported in children during the week of Jan. 8-14, topping the previous high (Dec. 11-17) by almost 30,000. Those new cases bring the total for the pandemic to over 2.5 million children infected with the coronavirus, which represents 12.6% of all reported cases, the AAP and the CHA said Jan. 19 in their weekly COVID-19 report.

The rise in cases also brought an increase in the proportion reported among children. The week before (Jan. 1-7), cases in children were 12.9% of all cases reported, but the most recent week saw that number rise to 14.5% of all cases, the highest it’s been since early October, based on data collected from the health department websites of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rio, and Guam.

The corresponding figures for severe illness continue to be low: Children represent 1.8% of all hospitalizations from COVID-19 in 24 states and New York City and 0.06% of all deaths in 43 states and New York City. Three deaths were reported for the week of Jan. 8-14, making for a total of 191 since the pandemic started, the AAP and CHA said in their report.

Among the states, California has the most overall cases at just over 350,000, Wyoming has the highest proportion of cases in children (20.3%), and North Dakota has the highest rate of infection (over 8,100 per 100,000 children). The infection rate for the nation is now above 3,300 per 100,000 children, and 11 states reported rates over 5,000, according to the AAP and the CHA.

[email protected]

The United States set a new weekly high for COVID-19 cases in children, surpassing 200,000 for the first time since the pandemic began, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

There were 211,466 new cases reported in children during the week of Jan. 8-14, topping the previous high (Dec. 11-17) by almost 30,000. Those new cases bring the total for the pandemic to over 2.5 million children infected with the coronavirus, which represents 12.6% of all reported cases, the AAP and the CHA said Jan. 19 in their weekly COVID-19 report.

The rise in cases also brought an increase in the proportion reported among children. The week before (Jan. 1-7), cases in children were 12.9% of all cases reported, but the most recent week saw that number rise to 14.5% of all cases, the highest it’s been since early October, based on data collected from the health department websites of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rio, and Guam.

The corresponding figures for severe illness continue to be low: Children represent 1.8% of all hospitalizations from COVID-19 in 24 states and New York City and 0.06% of all deaths in 43 states and New York City. Three deaths were reported for the week of Jan. 8-14, making for a total of 191 since the pandemic started, the AAP and CHA said in their report.

Among the states, California has the most overall cases at just over 350,000, Wyoming has the highest proportion of cases in children (20.3%), and North Dakota has the highest rate of infection (over 8,100 per 100,000 children). The infection rate for the nation is now above 3,300 per 100,000 children, and 11 states reported rates over 5,000, according to the AAP and the CHA.

[email protected]

The United States set a new weekly high for COVID-19 cases in children, surpassing 200,000 for the first time since the pandemic began, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

There were 211,466 new cases reported in children during the week of Jan. 8-14, topping the previous high (Dec. 11-17) by almost 30,000. Those new cases bring the total for the pandemic to over 2.5 million children infected with the coronavirus, which represents 12.6% of all reported cases, the AAP and the CHA said Jan. 19 in their weekly COVID-19 report.

The rise in cases also brought an increase in the proportion reported among children. The week before (Jan. 1-7), cases in children were 12.9% of all cases reported, but the most recent week saw that number rise to 14.5% of all cases, the highest it’s been since early October, based on data collected from the health department websites of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rio, and Guam.

The corresponding figures for severe illness continue to be low: Children represent 1.8% of all hospitalizations from COVID-19 in 24 states and New York City and 0.06% of all deaths in 43 states and New York City. Three deaths were reported for the week of Jan. 8-14, making for a total of 191 since the pandemic started, the AAP and CHA said in their report.

Among the states, California has the most overall cases at just over 350,000, Wyoming has the highest proportion of cases in children (20.3%), and North Dakota has the highest rate of infection (over 8,100 per 100,000 children). The infection rate for the nation is now above 3,300 per 100,000 children, and 11 states reported rates over 5,000, according to the AAP and the CHA.

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A scoring system that predicts risk for new heart failure over 5 years that is based solely on a few familiar, readily available biomarkers could potentially help steer patients with diabetes or even prediabetes toward HF-preventive therapies, researchers proposed based on a new study.

They foresee the risk-stratification tool, based on data pooled from three major community-based cohort studies but not independently validated, as a way to select patients with diabetes and prediabetes for treatment with SGLT2 inhibitors.

Several members of that drug class, conceived as antidiabetic agents, have been shown to help in prevention or treatment of HF in patients with diabetes and those without diabetes but at increased cardiovascular (CV) risk. Yet their uptake in practice has been lagging, the group noted.

Most HF benefits in the SGLT2 inhibitor trials “were seen in patients who have established cardiovascular disease – basically a history of heart attack or stroke,” Ambarish Pandey, MD, MSCS, University of Texas Southwestern Medical Center, Dallas, said in an interview.

“So we wanted to see how we can identify high-risk patients without a history of cardiovascular disease using these biomarkers, as an approach to targeting SGLT2 inhibitors, which are fairly expensive therapies,” he said. Without such risk stratification, “you end up treating so many more patients to get very modest returns.”

The group developed a scoring system based on four biomarkers that are “easily measured with inexpensive tests,” Dr. Pandey said: high-sensitivity-assay cardiac troponin T (hs-cTnT) and C-reactive protein (hs-CRP) levels, N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) levels, and electrocardiography for evidence of left-ventricular hypertrophy (ECG-LVH).

The derivation cohort consisted of participants in the Atherosclerosis Risk in Communities RIC, Dallas Heart Study, and Multi-Ethnic Study of Atherosclerosis Multi-Ethnic Study of Atherosclerosis epidemiologic studies who were free of coronary heart disease, stroke, or HF for whom there were sufficient data on CV risk factors and the four biomarkers. None were taking SGLT2 inhibitors at enrollment in their respective studies, the researchers noted.

Members of the pooled cohorts who had diabetes or prediabetes were assigned 1 point for each abnormal biomarker. The 5-year risk for incident HF went up continuously along with the score in people with diabetes and in those with prediabetes, the latter defined as a fasting plasma glucose level from 100 mg/dL to less than 126 mg/dL.

For those with a score of 1, compared with 0, for example, the risk for HF went up 82% with diabetes and 40% with prediabetes. But for those with a score of 3 or 4, the risk went up more than four and a half times with diabetes and more than three and a half times for those with prediabetes. Risk increases were independent of other likely HF risk factors and consistently significant.

The analysis was published Jan. 6 in JACC: Heart Failure.

The biomarker score should be especially useful in patients considered at low to intermediate risk, based on clinical characteristics, as a means to identify residual HF risk and, potentially, select candidates for SGLT2-inhibitor therapy, Dr. Pandey said.

“The other purpose of the study was to broaden the scope of heart failure prevention in dysglycemia by looking also at prediabetes, not just diabetes,” he said. There isn’t much high-quality evidence supporting SGLT2-inhibitor therapy in prediabetes, but it follows that the drugs may be helpful in prediabetes because they are protective in patients with and without diabetes.

“Our work suggests that prediabetes patients who have elevated biomarkers are at a higher risk of heart failure,” Dr. Pandey said, suggesting that the HF risk score could potentially help select their drug therapy as well.

The current study seems “to provide a proof of concept that one can use circulating biomarkers to more precisely identify patients in whom therapies might be expected to exert greatest benefit,” which is especially important for potentially expensive agents like the SGLT2 inhibitors, James L. Januzzi, MD, Massachusetts General Hospital, Boston, said in an interview.

Importantly in the analysis, a greater number of biomarker abnormalities not only corresponded to rising levels of risk, the risk increases were “dramatic,” and therefore so was the supposed potential benefit of SGLT2-inhibitor therapy, said Dr. Januzzi, who isn’t a coauthor but was an editor for its publication in JACC: Heart Failure.

The uptake of SGLT2 inhibitors for heart failure in practice has been less rapid than hoped, he observed, so if “this hypothetical construct holds up” for the drug class, “it might actually help kick-start focusing on who might optimally receive the drugs.”

Elevated levels of hs-cTnT, hs-CRP, and NT-proBNP, as well as presence of ECG-LVH, were each independently associated with a significantly increased 5-year risk for HF in unadjusted and adjusted analyses of the 6,799 people in the pooled cohort, 33.2% of whom had diabetes and 66.8% of whom had prediabetes, the group writes.

The scoring system would require validation in other cohorts before it could be used, Dr. Pandey observed; once there is “robust validation,” it might be applied first to patients with dysglycemia at intermediate CV risk by standard clinical measures.

Certainly the HF risk-stratification scoring system requires validation in other studies, Dr. Januzzi agreed. But it is intuitively appealing, and the study’s results are consistent with “data that we’re submitting for publication imminently” based on the CANVAS CV-outcomes trial of the SGLT2 inhibitor canagliflozin (Invokana) in patients with diabetes.

Dr. Pandey disclosed receiving support from the Gilead Sciences Research Scholar Program and serving on an advisory board of Roche Diagnostics. Dr. Januzzi disclosed receiving grant support from Novartis, Applied Therapeutics, and Innolife; consulting for Abbott Diagnostics, Janssen, Novartis, Quidel, and Roche Diagnostics; and serving on end-point committees or data safety monitoring boards for trials supported by Abbott, AbbVie, Amgen, CVRx, Janssen, MyoKardia, and Takeda.

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

A scoring system that predicts risk for new heart failure over 5 years that is based solely on a few familiar, readily available biomarkers could potentially help steer patients with diabetes or even prediabetes toward HF-preventive therapies, researchers proposed based on a new study.

They foresee the risk-stratification tool, based on data pooled from three major community-based cohort studies but not independently validated, as a way to select patients with diabetes and prediabetes for treatment with SGLT2 inhibitors.

Several members of that drug class, conceived as antidiabetic agents, have been shown to help in prevention or treatment of HF in patients with diabetes and those without diabetes but at increased cardiovascular (CV) risk. Yet their uptake in practice has been lagging, the group noted.

Most HF benefits in the SGLT2 inhibitor trials “were seen in patients who have established cardiovascular disease – basically a history of heart attack or stroke,” Ambarish Pandey, MD, MSCS, University of Texas Southwestern Medical Center, Dallas, said in an interview.

“So we wanted to see how we can identify high-risk patients without a history of cardiovascular disease using these biomarkers, as an approach to targeting SGLT2 inhibitors, which are fairly expensive therapies,” he said. Without such risk stratification, “you end up treating so many more patients to get very modest returns.”

The group developed a scoring system based on four biomarkers that are “easily measured with inexpensive tests,” Dr. Pandey said: high-sensitivity-assay cardiac troponin T (hs-cTnT) and C-reactive protein (hs-CRP) levels, N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) levels, and electrocardiography for evidence of left-ventricular hypertrophy (ECG-LVH).

The derivation cohort consisted of participants in the Atherosclerosis Risk in Communities RIC, Dallas Heart Study, and Multi-Ethnic Study of Atherosclerosis Multi-Ethnic Study of Atherosclerosis epidemiologic studies who were free of coronary heart disease, stroke, or HF for whom there were sufficient data on CV risk factors and the four biomarkers. None were taking SGLT2 inhibitors at enrollment in their respective studies, the researchers noted.

Members of the pooled cohorts who had diabetes or prediabetes were assigned 1 point for each abnormal biomarker. The 5-year risk for incident HF went up continuously along with the score in people with diabetes and in those with prediabetes, the latter defined as a fasting plasma glucose level from 100 mg/dL to less than 126 mg/dL.

For those with a score of 1, compared with 0, for example, the risk for HF went up 82% with diabetes and 40% with prediabetes. But for those with a score of 3 or 4, the risk went up more than four and a half times with diabetes and more than three and a half times for those with prediabetes. Risk increases were independent of other likely HF risk factors and consistently significant.

The analysis was published Jan. 6 in JACC: Heart Failure.

The biomarker score should be especially useful in patients considered at low to intermediate risk, based on clinical characteristics, as a means to identify residual HF risk and, potentially, select candidates for SGLT2-inhibitor therapy, Dr. Pandey said.

“The other purpose of the study was to broaden the scope of heart failure prevention in dysglycemia by looking also at prediabetes, not just diabetes,” he said. There isn’t much high-quality evidence supporting SGLT2-inhibitor therapy in prediabetes, but it follows that the drugs may be helpful in prediabetes because they are protective in patients with and without diabetes.

“Our work suggests that prediabetes patients who have elevated biomarkers are at a higher risk of heart failure,” Dr. Pandey said, suggesting that the HF risk score could potentially help select their drug therapy as well.

The current study seems “to provide a proof of concept that one can use circulating biomarkers to more precisely identify patients in whom therapies might be expected to exert greatest benefit,” which is especially important for potentially expensive agents like the SGLT2 inhibitors, James L. Januzzi, MD, Massachusetts General Hospital, Boston, said in an interview.

Importantly in the analysis, a greater number of biomarker abnormalities not only corresponded to rising levels of risk, the risk increases were “dramatic,” and therefore so was the supposed potential benefit of SGLT2-inhibitor therapy, said Dr. Januzzi, who isn’t a coauthor but was an editor for its publication in JACC: Heart Failure.

The uptake of SGLT2 inhibitors for heart failure in practice has been less rapid than hoped, he observed, so if “this hypothetical construct holds up” for the drug class, “it might actually help kick-start focusing on who might optimally receive the drugs.”

Elevated levels of hs-cTnT, hs-CRP, and NT-proBNP, as well as presence of ECG-LVH, were each independently associated with a significantly increased 5-year risk for HF in unadjusted and adjusted analyses of the 6,799 people in the pooled cohort, 33.2% of whom had diabetes and 66.8% of whom had prediabetes, the group writes.

The scoring system would require validation in other cohorts before it could be used, Dr. Pandey observed; once there is “robust validation,” it might be applied first to patients with dysglycemia at intermediate CV risk by standard clinical measures.

Certainly the HF risk-stratification scoring system requires validation in other studies, Dr. Januzzi agreed. But it is intuitively appealing, and the study’s results are consistent with “data that we’re submitting for publication imminently” based on the CANVAS CV-outcomes trial of the SGLT2 inhibitor canagliflozin (Invokana) in patients with diabetes.

Dr. Pandey disclosed receiving support from the Gilead Sciences Research Scholar Program and serving on an advisory board of Roche Diagnostics. Dr. Januzzi disclosed receiving grant support from Novartis, Applied Therapeutics, and Innolife; consulting for Abbott Diagnostics, Janssen, Novartis, Quidel, and Roche Diagnostics; and serving on end-point committees or data safety monitoring boards for trials supported by Abbott, AbbVie, Amgen, CVRx, Janssen, MyoKardia, and Takeda.

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

A scoring system that predicts risk for new heart failure over 5 years that is based solely on a few familiar, readily available biomarkers could potentially help steer patients with diabetes or even prediabetes toward HF-preventive therapies, researchers proposed based on a new study.

They foresee the risk-stratification tool, based on data pooled from three major community-based cohort studies but not independently validated, as a way to select patients with diabetes and prediabetes for treatment with SGLT2 inhibitors.

Several members of that drug class, conceived as antidiabetic agents, have been shown to help in prevention or treatment of HF in patients with diabetes and those without diabetes but at increased cardiovascular (CV) risk. Yet their uptake in practice has been lagging, the group noted.

Most HF benefits in the SGLT2 inhibitor trials “were seen in patients who have established cardiovascular disease – basically a history of heart attack or stroke,” Ambarish Pandey, MD, MSCS, University of Texas Southwestern Medical Center, Dallas, said in an interview.

“So we wanted to see how we can identify high-risk patients without a history of cardiovascular disease using these biomarkers, as an approach to targeting SGLT2 inhibitors, which are fairly expensive therapies,” he said. Without such risk stratification, “you end up treating so many more patients to get very modest returns.”

The group developed a scoring system based on four biomarkers that are “easily measured with inexpensive tests,” Dr. Pandey said: high-sensitivity-assay cardiac troponin T (hs-cTnT) and C-reactive protein (hs-CRP) levels, N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) levels, and electrocardiography for evidence of left-ventricular hypertrophy (ECG-LVH).

The derivation cohort consisted of participants in the Atherosclerosis Risk in Communities RIC, Dallas Heart Study, and Multi-Ethnic Study of Atherosclerosis Multi-Ethnic Study of Atherosclerosis epidemiologic studies who were free of coronary heart disease, stroke, or HF for whom there were sufficient data on CV risk factors and the four biomarkers. None were taking SGLT2 inhibitors at enrollment in their respective studies, the researchers noted.

Members of the pooled cohorts who had diabetes or prediabetes were assigned 1 point for each abnormal biomarker. The 5-year risk for incident HF went up continuously along with the score in people with diabetes and in those with prediabetes, the latter defined as a fasting plasma glucose level from 100 mg/dL to less than 126 mg/dL.

For those with a score of 1, compared with 0, for example, the risk for HF went up 82% with diabetes and 40% with prediabetes. But for those with a score of 3 or 4, the risk went up more than four and a half times with diabetes and more than three and a half times for those with prediabetes. Risk increases were independent of other likely HF risk factors and consistently significant.

The analysis was published Jan. 6 in JACC: Heart Failure.

The biomarker score should be especially useful in patients considered at low to intermediate risk, based on clinical characteristics, as a means to identify residual HF risk and, potentially, select candidates for SGLT2-inhibitor therapy, Dr. Pandey said.

“The other purpose of the study was to broaden the scope of heart failure prevention in dysglycemia by looking also at prediabetes, not just diabetes,” he said. There isn’t much high-quality evidence supporting SGLT2-inhibitor therapy in prediabetes, but it follows that the drugs may be helpful in prediabetes because they are protective in patients with and without diabetes.

“Our work suggests that prediabetes patients who have elevated biomarkers are at a higher risk of heart failure,” Dr. Pandey said, suggesting that the HF risk score could potentially help select their drug therapy as well.

The current study seems “to provide a proof of concept that one can use circulating biomarkers to more precisely identify patients in whom therapies might be expected to exert greatest benefit,” which is especially important for potentially expensive agents like the SGLT2 inhibitors, James L. Januzzi, MD, Massachusetts General Hospital, Boston, said in an interview.

Importantly in the analysis, a greater number of biomarker abnormalities not only corresponded to rising levels of risk, the risk increases were “dramatic,” and therefore so was the supposed potential benefit of SGLT2-inhibitor therapy, said Dr. Januzzi, who isn’t a coauthor but was an editor for its publication in JACC: Heart Failure.

The uptake of SGLT2 inhibitors for heart failure in practice has been less rapid than hoped, he observed, so if “this hypothetical construct holds up” for the drug class, “it might actually help kick-start focusing on who might optimally receive the drugs.”

Elevated levels of hs-cTnT, hs-CRP, and NT-proBNP, as well as presence of ECG-LVH, were each independently associated with a significantly increased 5-year risk for HF in unadjusted and adjusted analyses of the 6,799 people in the pooled cohort, 33.2% of whom had diabetes and 66.8% of whom had prediabetes, the group writes.

The scoring system would require validation in other cohorts before it could be used, Dr. Pandey observed; once there is “robust validation,” it might be applied first to patients with dysglycemia at intermediate CV risk by standard clinical measures.

Certainly the HF risk-stratification scoring system requires validation in other studies, Dr. Januzzi agreed. But it is intuitively appealing, and the study’s results are consistent with “data that we’re submitting for publication imminently” based on the CANVAS CV-outcomes trial of the SGLT2 inhibitor canagliflozin (Invokana) in patients with diabetes.

Dr. Pandey disclosed receiving support from the Gilead Sciences Research Scholar Program and serving on an advisory board of Roche Diagnostics. Dr. Januzzi disclosed receiving grant support from Novartis, Applied Therapeutics, and Innolife; consulting for Abbott Diagnostics, Janssen, Novartis, Quidel, and Roche Diagnostics; and serving on end-point committees or data safety monitoring boards for trials supported by Abbott, AbbVie, Amgen, CVRx, Janssen, MyoKardia, and Takeda.

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

Nearly a quarter of ED visits were deemed preventable in a single-center study of patients with non–small cell lung cancer.

The leading cause of ED visits in the study was the cancer itself, although many visits were unrelated to non–small cell lung cancer (NSCLC) or cancer therapy.

Less than 10% of ED visits were related to cancer therapy, but visits were much more common among patients receiving chemotherapy than among those receiving immunotherapy or tyrosine kinase inhibitors (TKIs).

Manan P. Shah, MD, and Joel W. Neal, MD, PhD, both of Stanford (Calif. ) University, reported these results in JCO Oncology Practice.

The authors noted that, in the United States, care of patients with cancer, among all diseases, leads to the highest per-person cost. Unplanned hospital visits are among the largest drivers of increased spending in advanced cancer care, accounting for 48% of spending. However, that spending may not be indicative of better quality care, but rather of inefficiency, according to the authors.

One registry spanning 2009-2012 and including more than 400,000 newly diagnosed cancer patients found lung cancer to have the third-highest rate of unplanned hospitalizations (after hepatobiliary and pancreatic cancer). Those findings were published in JCO Oncology Practice in 2018.

While the reason for presentation to the ED is often the cancer or its therapy in this population, there is a paucity of research on the relative contribution of factors leading to unplanned hospital visits.

Common precipitants of medical emergencies in advanced stages of lung cancer include pulmonary embolism, obstructive pneumonia, spinal cord compression caused by metastasis, and tumor progression or pleural effusion leading to respiratory failure.

Lung cancer therapies, such as TKIs, immunotherapy, and cytotoxic chemotherapy, can also cause various medical emergencies arising out of skin reactions, gastrointestinal dysfunction, organ inflammatory processes, and bone marrow suppression.
 

Identifying drivers of unplanned ED visits

The primary goals of Dr. Shah and Dr. Neal’s study were to understand the drivers of unplanned ED visits and identify potential strategies to prevent them.

Drawing from the Stanford Medicine Research Data Repository, the authors identified 97 NSCLC patients with 173 ED visits at Stanford.

Patients were sorted according to which of the three therapies they had been receiving in the 3 months prior to the unplanned visit – TKIs (n = 47), immunotherapy (n = 24), or chemotherapy (n = 26). Patients receiving a combination of chemotherapy and immunotherapy were classified under the immunotherapy category.

ED visits were divided into four categories: cancer related, therapy related, unrelated to cancer or therapy, and rule-out (when an outpatient provider sent the patient to rule out medico-oncologic emergencies such as pulmonary embolism or cord compression).

If the patient’s main complaint(s) began 2 or more days before presentation, the diagnostics or therapeutics could have been provided in an outpatient setting (e.g., in clinic or urgent care), and the patient was discharged directly from the ED, the encounter was classified as potentially preventable. Among these preventable encounters, those made during business hours were also labeled unnecessary because they could have been managed through the Stanford sick call system for same-day urgent visits.
 

Leading cause is cancer

Overall, the leading cause of ED visits was NSCLC itself (54%). The patient’s cancer contributed to 61% of ED visits in the TKI group, 49% in the immunotherapy group, and 42% in the chemotherapy group.

Many ED visits were deemed unrelated to cancer or its therapies – 30% in the TKI group, 26% in the immunotherapy group, and 32% in the chemotherapy group.

Rule-out cases contributed to 7% of ED visits in the TKI group, 14% in the immunotherapy group, and 5% in the chemotherapy group.

Overall, 9% of ED visits were therapy related. The smallest proportion of these was observed in the TKI group (2%), which was significantly smaller than in the immunotherapy group (12%), a rate also significantly smaller than in the chemotherapy group (21%, P < .001).

Most unplanned ED visits did not lead to admissions (55%), were for complaints that began 2 or more days prior to presentation (53%), led to diagnostics or therapeutics that could have been administered in an outpatient setting (48%), and were during business hours (52%).

As a result, 24% of visits were classified as preventable, and 10% were deemed unnecessary.
 

Preventive strategies

“Our study suggests that TKIs lead to fewer emergency room visits than immunotherapy and chemotherapy,” Dr. Shah said in an interview.

“Overall, this may not necessarily change which therapy we prescribe,” he added, “as TKI therapy is often first line for patients with targeted mutations. However, recognizing that those on chemotherapy or immunotherapy are at higher risk for emergency room visits, we may target preventative strategies, for example, nursing phone calls, telemonitoring of symptoms, and frequent video visits toward this high-risk population.”

Dr. Shah and Dr. Neal said it’s “reassuring” that TKIs and immunotherapy are small drivers of unplanned hospital care. However, they also said efforts aimed at reducing chemotherapy-related ED visits are warranted.

The authors speculated that early intervention, extension of ambulatory care, and patient education about outpatient avenues of care could eliminate a significant proportion (at least 20%) of unplanned ED visits by NSCLC patients.

There was no specific funding for this study. Dr. Shah disclosed no conflicts of interest. Dr. Neal disclosed relationships with many companies, including this news organization.

Nearly a quarter of ED visits were deemed preventable in a single-center study of patients with non–small cell lung cancer.

The leading cause of ED visits in the study was the cancer itself, although many visits were unrelated to non–small cell lung cancer (NSCLC) or cancer therapy.

Less than 10% of ED visits were related to cancer therapy, but visits were much more common among patients receiving chemotherapy than among those receiving immunotherapy or tyrosine kinase inhibitors (TKIs).

Manan P. Shah, MD, and Joel W. Neal, MD, PhD, both of Stanford (Calif. ) University, reported these results in JCO Oncology Practice.

The authors noted that, in the United States, care of patients with cancer, among all diseases, leads to the highest per-person cost. Unplanned hospital visits are among the largest drivers of increased spending in advanced cancer care, accounting for 48% of spending. However, that spending may not be indicative of better quality care, but rather of inefficiency, according to the authors.

One registry spanning 2009-2012 and including more than 400,000 newly diagnosed cancer patients found lung cancer to have the third-highest rate of unplanned hospitalizations (after hepatobiliary and pancreatic cancer). Those findings were published in JCO Oncology Practice in 2018.

While the reason for presentation to the ED is often the cancer or its therapy in this population, there is a paucity of research on the relative contribution of factors leading to unplanned hospital visits.

Common precipitants of medical emergencies in advanced stages of lung cancer include pulmonary embolism, obstructive pneumonia, spinal cord compression caused by metastasis, and tumor progression or pleural effusion leading to respiratory failure.

Lung cancer therapies, such as TKIs, immunotherapy, and cytotoxic chemotherapy, can also cause various medical emergencies arising out of skin reactions, gastrointestinal dysfunction, organ inflammatory processes, and bone marrow suppression.
 

Identifying drivers of unplanned ED visits

The primary goals of Dr. Shah and Dr. Neal’s study were to understand the drivers of unplanned ED visits and identify potential strategies to prevent them.

Drawing from the Stanford Medicine Research Data Repository, the authors identified 97 NSCLC patients with 173 ED visits at Stanford.

Patients were sorted according to which of the three therapies they had been receiving in the 3 months prior to the unplanned visit – TKIs (n = 47), immunotherapy (n = 24), or chemotherapy (n = 26). Patients receiving a combination of chemotherapy and immunotherapy were classified under the immunotherapy category.

ED visits were divided into four categories: cancer related, therapy related, unrelated to cancer or therapy, and rule-out (when an outpatient provider sent the patient to rule out medico-oncologic emergencies such as pulmonary embolism or cord compression).

If the patient’s main complaint(s) began 2 or more days before presentation, the diagnostics or therapeutics could have been provided in an outpatient setting (e.g., in clinic or urgent care), and the patient was discharged directly from the ED, the encounter was classified as potentially preventable. Among these preventable encounters, those made during business hours were also labeled unnecessary because they could have been managed through the Stanford sick call system for same-day urgent visits.
 

Leading cause is cancer

Overall, the leading cause of ED visits was NSCLC itself (54%). The patient’s cancer contributed to 61% of ED visits in the TKI group, 49% in the immunotherapy group, and 42% in the chemotherapy group.

Many ED visits were deemed unrelated to cancer or its therapies – 30% in the TKI group, 26% in the immunotherapy group, and 32% in the chemotherapy group.

Rule-out cases contributed to 7% of ED visits in the TKI group, 14% in the immunotherapy group, and 5% in the chemotherapy group.

Overall, 9% of ED visits were therapy related. The smallest proportion of these was observed in the TKI group (2%), which was significantly smaller than in the immunotherapy group (12%), a rate also significantly smaller than in the chemotherapy group (21%, P < .001).

Most unplanned ED visits did not lead to admissions (55%), were for complaints that began 2 or more days prior to presentation (53%), led to diagnostics or therapeutics that could have been administered in an outpatient setting (48%), and were during business hours (52%).

As a result, 24% of visits were classified as preventable, and 10% were deemed unnecessary.
 

Preventive strategies

“Our study suggests that TKIs lead to fewer emergency room visits than immunotherapy and chemotherapy,” Dr. Shah said in an interview.

“Overall, this may not necessarily change which therapy we prescribe,” he added, “as TKI therapy is often first line for patients with targeted mutations. However, recognizing that those on chemotherapy or immunotherapy are at higher risk for emergency room visits, we may target preventative strategies, for example, nursing phone calls, telemonitoring of symptoms, and frequent video visits toward this high-risk population.”

Dr. Shah and Dr. Neal said it’s “reassuring” that TKIs and immunotherapy are small drivers of unplanned hospital care. However, they also said efforts aimed at reducing chemotherapy-related ED visits are warranted.

The authors speculated that early intervention, extension of ambulatory care, and patient education about outpatient avenues of care could eliminate a significant proportion (at least 20%) of unplanned ED visits by NSCLC patients.

There was no specific funding for this study. Dr. Shah disclosed no conflicts of interest. Dr. Neal disclosed relationships with many companies, including this news organization.

Nearly a quarter of ED visits were deemed preventable in a single-center study of patients with non–small cell lung cancer.

The leading cause of ED visits in the study was the cancer itself, although many visits were unrelated to non–small cell lung cancer (NSCLC) or cancer therapy.

Less than 10% of ED visits were related to cancer therapy, but visits were much more common among patients receiving chemotherapy than among those receiving immunotherapy or tyrosine kinase inhibitors (TKIs).

Manan P. Shah, MD, and Joel W. Neal, MD, PhD, both of Stanford (Calif. ) University, reported these results in JCO Oncology Practice.

The authors noted that, in the United States, care of patients with cancer, among all diseases, leads to the highest per-person cost. Unplanned hospital visits are among the largest drivers of increased spending in advanced cancer care, accounting for 48% of spending. However, that spending may not be indicative of better quality care, but rather of inefficiency, according to the authors.

One registry spanning 2009-2012 and including more than 400,000 newly diagnosed cancer patients found lung cancer to have the third-highest rate of unplanned hospitalizations (after hepatobiliary and pancreatic cancer). Those findings were published in JCO Oncology Practice in 2018.

While the reason for presentation to the ED is often the cancer or its therapy in this population, there is a paucity of research on the relative contribution of factors leading to unplanned hospital visits.

Common precipitants of medical emergencies in advanced stages of lung cancer include pulmonary embolism, obstructive pneumonia, spinal cord compression caused by metastasis, and tumor progression or pleural effusion leading to respiratory failure.

Lung cancer therapies, such as TKIs, immunotherapy, and cytotoxic chemotherapy, can also cause various medical emergencies arising out of skin reactions, gastrointestinal dysfunction, organ inflammatory processes, and bone marrow suppression.
 

Identifying drivers of unplanned ED visits

The primary goals of Dr. Shah and Dr. Neal’s study were to understand the drivers of unplanned ED visits and identify potential strategies to prevent them.

Drawing from the Stanford Medicine Research Data Repository, the authors identified 97 NSCLC patients with 173 ED visits at Stanford.

Patients were sorted according to which of the three therapies they had been receiving in the 3 months prior to the unplanned visit – TKIs (n = 47), immunotherapy (n = 24), or chemotherapy (n = 26). Patients receiving a combination of chemotherapy and immunotherapy were classified under the immunotherapy category.

ED visits were divided into four categories: cancer related, therapy related, unrelated to cancer or therapy, and rule-out (when an outpatient provider sent the patient to rule out medico-oncologic emergencies such as pulmonary embolism or cord compression).

If the patient’s main complaint(s) began 2 or more days before presentation, the diagnostics or therapeutics could have been provided in an outpatient setting (e.g., in clinic or urgent care), and the patient was discharged directly from the ED, the encounter was classified as potentially preventable. Among these preventable encounters, those made during business hours were also labeled unnecessary because they could have been managed through the Stanford sick call system for same-day urgent visits.
 

Leading cause is cancer

Overall, the leading cause of ED visits was NSCLC itself (54%). The patient’s cancer contributed to 61% of ED visits in the TKI group, 49% in the immunotherapy group, and 42% in the chemotherapy group.

Many ED visits were deemed unrelated to cancer or its therapies – 30% in the TKI group, 26% in the immunotherapy group, and 32% in the chemotherapy group.

Rule-out cases contributed to 7% of ED visits in the TKI group, 14% in the immunotherapy group, and 5% in the chemotherapy group.

Overall, 9% of ED visits were therapy related. The smallest proportion of these was observed in the TKI group (2%), which was significantly smaller than in the immunotherapy group (12%), a rate also significantly smaller than in the chemotherapy group (21%, P < .001).

Most unplanned ED visits did not lead to admissions (55%), were for complaints that began 2 or more days prior to presentation (53%), led to diagnostics or therapeutics that could have been administered in an outpatient setting (48%), and were during business hours (52%).

As a result, 24% of visits were classified as preventable, and 10% were deemed unnecessary.
 

Preventive strategies

“Our study suggests that TKIs lead to fewer emergency room visits than immunotherapy and chemotherapy,” Dr. Shah said in an interview.

“Overall, this may not necessarily change which therapy we prescribe,” he added, “as TKI therapy is often first line for patients with targeted mutations. However, recognizing that those on chemotherapy or immunotherapy are at higher risk for emergency room visits, we may target preventative strategies, for example, nursing phone calls, telemonitoring of symptoms, and frequent video visits toward this high-risk population.”

Dr. Shah and Dr. Neal said it’s “reassuring” that TKIs and immunotherapy are small drivers of unplanned hospital care. However, they also said efforts aimed at reducing chemotherapy-related ED visits are warranted.

The authors speculated that early intervention, extension of ambulatory care, and patient education about outpatient avenues of care could eliminate a significant proportion (at least 20%) of unplanned ED visits by NSCLC patients.

There was no specific funding for this study. Dr. Shah disclosed no conflicts of interest. Dr. Neal disclosed relationships with many companies, including this news organization.