Cardiology News

Being aged older than 65 years was associated with the highest risk of people with rheumatic and musculoskeletal diseases (RMDs) needing hospital treatment for COVID-19, according to the first results to be reported from ReCoVery, the German national COVID-19 registry.

Older patients with RMDs were five times more likely than younger patients to be hospitalized if they tested positive for SARS‑CoV‑2 and developed COVID-19 (odds ratio, 5.1; 95% confidence interval, 2.3-11.4).

The likelihood of hospitalization was also significantly increased by the current or prior use of glucocorticoids (OR, 2.59; 95% CI, 1.2-5.4) and by the presence of cardiovascular disease (OR, 2.27; 95% CI, 1.2-5.4).

“The register is a joint initiative of the German Society for Rheumatology and the Justus Liebig University in Giessen,” explained Anne Regierer, MD, during a live session of the annual European Congress of Rheumatology, held online this year due to COVID-19.

“The current pandemic has changed all of our lives. For patients it brought a lot of uncertainty and fears,” said Dr. Regierer, of the German Rheumatism Research Center Berlin.

“The risk of SARS-CoV-2 infection in patients with inflammatory rheumatic diseases [IRD] is still largely unknown. We still don’t know whether they have a high risk of getting the infection or whether they have a higher risk of a severer case ... therefore there’s an urgent need to have data to generate evidence for the management of our patients.”

Launched at the end of March 2020, the German registry now includes data on 251 patients – 194 of whom have recovered – provided by more than 200 registered rheumatologists. The registry data have now been integrated into the EULAR COVID-19 Database, which is itself part of a global effort to better understand and optimally manage RMD patients during the pandemic.

“The data presented by Dr. Regierer looked at similar outcomes and found quite similar results, which is reassuring,” Kimme Hyrich, MD, PhD, professor of epidemiology at the University of Manchester (England) and a consultant rheumatologist in the Kellgren Centre for Rheumatology at Manchester University Hospitals NHS Foundation Trust, said in an interview.

“We are very grateful for this collaboration [with the German society and others]. Our first publication has looked at hospitalization, but with more data we may have the opportunity to look at less-common outcomes [e.g. death, other COVID complications] or within individual diseases or treatments. So far I don’t think we will come to a different conclusion,” observed Dr. Hyrich, who is on the steering committee for the EULAR COVID-19 Database.

“These initial data are reassuring in that the majority of cases of COVID reported to our database have recovered, including those who were hospitalized,” she said.

Current EULAR advice is to continue treatment with glucocorticoids in patients who are being chronically treated, but to use them at the lowest possible dose.

The objectives of this first analysis of the German registry was to provide a description of the patients who did and did not require hospitalization and those who needed ventilation, as well as look at possible risk factors for hospitalization.

Dr. Regierer reported that, of 192 patients they included – all with a positive lab test for SARS-CoV-2 – 128 (67%) did not require hospital admission. Of those that did (n = 64), 43 (22%) did not need ventilation and 21 (11%) did. Fifteen patients died, all of whom had been hospitalized, and all but one of them had needed ventilation.

Concerning the characteristics of the patients, those who needed hospital treatment with and without ventilation were older than those who were not admitted (70 vs. 65 vs. 54 years, respectively).

“Looking at the sexes, the gender distribution is also interesting. We see 69% females in the nonhospitalized patients, 65% of the inpatients without ventilation, but only 43% females in the ventilated patients. So in this group, the male patients are the majority,” Dr. Regierer observed.

Just over half of all patients in the nonhospitalized and the hospitalized without ventilation groups had IRD in remission, but those in the hospitalized with ventilation group less than one-fifth had their IRD under control.

“Of course we have to keep in mind the small sample sizes,” Dr. Regierer said, but the distribution of patients by disease type was “what you’d expect in clinical care.” The majority of patients in each of the three groups had RA (47%, 56%, and 57%), followed by psoriatic arthritis (19%, 7%, and 14%), axial spondyloarthritis (11%, 5%, and 0%), systemic lupus erythematosus (6%, 2%, and 0%), and vasculitis (1%, 5%, and 5%).

Patients who were hospitalized with and without ventilation were more likely to have more than one comorbidity than those who were not hospitalized with COVID-19.

“The most frequent comorbidity was cardiovascular disease with 58% and 76% in the inpatient groups,” Dr. Regierer reported. One-third of the nonhospitalized patients had a cardiovascular comorbidity.

“If we look at pulmonary disease, we see that 38% of the ventilator patients had an underlying pulmonary disease,” she added. This was in comparison with 19% of the hospitalized without ventilation and 13% of the nonhospitalized patients. Diabetes was another common comorbidity in hospitalized patients with (16%) and without (19%) ventilation versus just 2% of nonhospitalized patients. While these and other comorbidities such as chronic renal insufficiency were associated with higher odds ratios in the multivariate risk factor analysis, they did not reach statistical significance.

With regard to RMD treatments, more than 60% of patients in the hospitalized group had received treatment with glucocorticoids versus 37% of those who did not get admitted. No differences were seen for the other treatments.

Interestingly, “female sex, remission, and use of NSAIDs have an odds ratio smaller than 1. So there might be a lower risk of hospitalization associated with these factors,” Dr. Regierer said.

Dr. Regierer has received grant support and is part of speaker’s bureaus for a variety of pharmaceutical companies. Dr. Hyrich disclosed grant income from Bristol-Myers Squibb, UCB, and Pfizer, and receiving speaker fees from AbbVie.

Being aged older than 65 years was associated with the highest risk of people with rheumatic and musculoskeletal diseases (RMDs) needing hospital treatment for COVID-19, according to the first results to be reported from ReCoVery, the German national COVID-19 registry.

Older patients with RMDs were five times more likely than younger patients to be hospitalized if they tested positive for SARS‑CoV‑2 and developed COVID-19 (odds ratio, 5.1; 95% confidence interval, 2.3-11.4).

The likelihood of hospitalization was also significantly increased by the current or prior use of glucocorticoids (OR, 2.59; 95% CI, 1.2-5.4) and by the presence of cardiovascular disease (OR, 2.27; 95% CI, 1.2-5.4).

“The register is a joint initiative of the German Society for Rheumatology and the Justus Liebig University in Giessen,” explained Anne Regierer, MD, during a live session of the annual European Congress of Rheumatology, held online this year due to COVID-19.

“The current pandemic has changed all of our lives. For patients it brought a lot of uncertainty and fears,” said Dr. Regierer, of the German Rheumatism Research Center Berlin.

“The risk of SARS-CoV-2 infection in patients with inflammatory rheumatic diseases [IRD] is still largely unknown. We still don’t know whether they have a high risk of getting the infection or whether they have a higher risk of a severer case ... therefore there’s an urgent need to have data to generate evidence for the management of our patients.”

Launched at the end of March 2020, the German registry now includes data on 251 patients – 194 of whom have recovered – provided by more than 200 registered rheumatologists. The registry data have now been integrated into the EULAR COVID-19 Database, which is itself part of a global effort to better understand and optimally manage RMD patients during the pandemic.

“The data presented by Dr. Regierer looked at similar outcomes and found quite similar results, which is reassuring,” Kimme Hyrich, MD, PhD, professor of epidemiology at the University of Manchester (England) and a consultant rheumatologist in the Kellgren Centre for Rheumatology at Manchester University Hospitals NHS Foundation Trust, said in an interview.

“We are very grateful for this collaboration [with the German society and others]. Our first publication has looked at hospitalization, but with more data we may have the opportunity to look at less-common outcomes [e.g. death, other COVID complications] or within individual diseases or treatments. So far I don’t think we will come to a different conclusion,” observed Dr. Hyrich, who is on the steering committee for the EULAR COVID-19 Database.

“These initial data are reassuring in that the majority of cases of COVID reported to our database have recovered, including those who were hospitalized,” she said.

Current EULAR advice is to continue treatment with glucocorticoids in patients who are being chronically treated, but to use them at the lowest possible dose.

The objectives of this first analysis of the German registry was to provide a description of the patients who did and did not require hospitalization and those who needed ventilation, as well as look at possible risk factors for hospitalization.

Dr. Regierer reported that, of 192 patients they included – all with a positive lab test for SARS-CoV-2 – 128 (67%) did not require hospital admission. Of those that did (n = 64), 43 (22%) did not need ventilation and 21 (11%) did. Fifteen patients died, all of whom had been hospitalized, and all but one of them had needed ventilation.

Concerning the characteristics of the patients, those who needed hospital treatment with and without ventilation were older than those who were not admitted (70 vs. 65 vs. 54 years, respectively).

“Looking at the sexes, the gender distribution is also interesting. We see 69% females in the nonhospitalized patients, 65% of the inpatients without ventilation, but only 43% females in the ventilated patients. So in this group, the male patients are the majority,” Dr. Regierer observed.

Just over half of all patients in the nonhospitalized and the hospitalized without ventilation groups had IRD in remission, but those in the hospitalized with ventilation group less than one-fifth had their IRD under control.

“Of course we have to keep in mind the small sample sizes,” Dr. Regierer said, but the distribution of patients by disease type was “what you’d expect in clinical care.” The majority of patients in each of the three groups had RA (47%, 56%, and 57%), followed by psoriatic arthritis (19%, 7%, and 14%), axial spondyloarthritis (11%, 5%, and 0%), systemic lupus erythematosus (6%, 2%, and 0%), and vasculitis (1%, 5%, and 5%).

Patients who were hospitalized with and without ventilation were more likely to have more than one comorbidity than those who were not hospitalized with COVID-19.

“The most frequent comorbidity was cardiovascular disease with 58% and 76% in the inpatient groups,” Dr. Regierer reported. One-third of the nonhospitalized patients had a cardiovascular comorbidity.

“If we look at pulmonary disease, we see that 38% of the ventilator patients had an underlying pulmonary disease,” she added. This was in comparison with 19% of the hospitalized without ventilation and 13% of the nonhospitalized patients. Diabetes was another common comorbidity in hospitalized patients with (16%) and without (19%) ventilation versus just 2% of nonhospitalized patients. While these and other comorbidities such as chronic renal insufficiency were associated with higher odds ratios in the multivariate risk factor analysis, they did not reach statistical significance.

With regard to RMD treatments, more than 60% of patients in the hospitalized group had received treatment with glucocorticoids versus 37% of those who did not get admitted. No differences were seen for the other treatments.

Interestingly, “female sex, remission, and use of NSAIDs have an odds ratio smaller than 1. So there might be a lower risk of hospitalization associated with these factors,” Dr. Regierer said.

Dr. Regierer has received grant support and is part of speaker’s bureaus for a variety of pharmaceutical companies. Dr. Hyrich disclosed grant income from Bristol-Myers Squibb, UCB, and Pfizer, and receiving speaker fees from AbbVie.

Being aged older than 65 years was associated with the highest risk of people with rheumatic and musculoskeletal diseases (RMDs) needing hospital treatment for COVID-19, according to the first results to be reported from ReCoVery, the German national COVID-19 registry.

Older patients with RMDs were five times more likely than younger patients to be hospitalized if they tested positive for SARS‑CoV‑2 and developed COVID-19 (odds ratio, 5.1; 95% confidence interval, 2.3-11.4).

The likelihood of hospitalization was also significantly increased by the current or prior use of glucocorticoids (OR, 2.59; 95% CI, 1.2-5.4) and by the presence of cardiovascular disease (OR, 2.27; 95% CI, 1.2-5.4).

“The register is a joint initiative of the German Society for Rheumatology and the Justus Liebig University in Giessen,” explained Anne Regierer, MD, during a live session of the annual European Congress of Rheumatology, held online this year due to COVID-19.

“The current pandemic has changed all of our lives. For patients it brought a lot of uncertainty and fears,” said Dr. Regierer, of the German Rheumatism Research Center Berlin.

“The risk of SARS-CoV-2 infection in patients with inflammatory rheumatic diseases [IRD] is still largely unknown. We still don’t know whether they have a high risk of getting the infection or whether they have a higher risk of a severer case ... therefore there’s an urgent need to have data to generate evidence for the management of our patients.”

Launched at the end of March 2020, the German registry now includes data on 251 patients – 194 of whom have recovered – provided by more than 200 registered rheumatologists. The registry data have now been integrated into the EULAR COVID-19 Database, which is itself part of a global effort to better understand and optimally manage RMD patients during the pandemic.

“The data presented by Dr. Regierer looked at similar outcomes and found quite similar results, which is reassuring,” Kimme Hyrich, MD, PhD, professor of epidemiology at the University of Manchester (England) and a consultant rheumatologist in the Kellgren Centre for Rheumatology at Manchester University Hospitals NHS Foundation Trust, said in an interview.

“We are very grateful for this collaboration [with the German society and others]. Our first publication has looked at hospitalization, but with more data we may have the opportunity to look at less-common outcomes [e.g. death, other COVID complications] or within individual diseases or treatments. So far I don’t think we will come to a different conclusion,” observed Dr. Hyrich, who is on the steering committee for the EULAR COVID-19 Database.

“These initial data are reassuring in that the majority of cases of COVID reported to our database have recovered, including those who were hospitalized,” she said.

Current EULAR advice is to continue treatment with glucocorticoids in patients who are being chronically treated, but to use them at the lowest possible dose.

The objectives of this first analysis of the German registry was to provide a description of the patients who did and did not require hospitalization and those who needed ventilation, as well as look at possible risk factors for hospitalization.

Dr. Regierer reported that, of 192 patients they included – all with a positive lab test for SARS-CoV-2 – 128 (67%) did not require hospital admission. Of those that did (n = 64), 43 (22%) did not need ventilation and 21 (11%) did. Fifteen patients died, all of whom had been hospitalized, and all but one of them had needed ventilation.

Concerning the characteristics of the patients, those who needed hospital treatment with and without ventilation were older than those who were not admitted (70 vs. 65 vs. 54 years, respectively).

“Looking at the sexes, the gender distribution is also interesting. We see 69% females in the nonhospitalized patients, 65% of the inpatients without ventilation, but only 43% females in the ventilated patients. So in this group, the male patients are the majority,” Dr. Regierer observed.

Just over half of all patients in the nonhospitalized and the hospitalized without ventilation groups had IRD in remission, but those in the hospitalized with ventilation group less than one-fifth had their IRD under control.

“Of course we have to keep in mind the small sample sizes,” Dr. Regierer said, but the distribution of patients by disease type was “what you’d expect in clinical care.” The majority of patients in each of the three groups had RA (47%, 56%, and 57%), followed by psoriatic arthritis (19%, 7%, and 14%), axial spondyloarthritis (11%, 5%, and 0%), systemic lupus erythematosus (6%, 2%, and 0%), and vasculitis (1%, 5%, and 5%).

Patients who were hospitalized with and without ventilation were more likely to have more than one comorbidity than those who were not hospitalized with COVID-19.

“The most frequent comorbidity was cardiovascular disease with 58% and 76% in the inpatient groups,” Dr. Regierer reported. One-third of the nonhospitalized patients had a cardiovascular comorbidity.

“If we look at pulmonary disease, we see that 38% of the ventilator patients had an underlying pulmonary disease,” she added. This was in comparison with 19% of the hospitalized without ventilation and 13% of the nonhospitalized patients. Diabetes was another common comorbidity in hospitalized patients with (16%) and without (19%) ventilation versus just 2% of nonhospitalized patients. While these and other comorbidities such as chronic renal insufficiency were associated with higher odds ratios in the multivariate risk factor analysis, they did not reach statistical significance.

With regard to RMD treatments, more than 60% of patients in the hospitalized group had received treatment with glucocorticoids versus 37% of those who did not get admitted. No differences were seen for the other treatments.

Interestingly, “female sex, remission, and use of NSAIDs have an odds ratio smaller than 1. So there might be a lower risk of hospitalization associated with these factors,” Dr. Regierer said.

Dr. Regierer has received grant support and is part of speaker’s bureaus for a variety of pharmaceutical companies. Dr. Hyrich disclosed grant income from Bristol-Myers Squibb, UCB, and Pfizer, and receiving speaker fees from AbbVie.

The toll that COVID-19 has taken on nursing homes and their postacute and long-term care residents has a multilayered backstory involving underresourced organizational structures, inherent susceptibilities, minimally trained infection prevention staff, variable abilities to isolate and quarantine large numbers of patients and residents, and a lack of governmental support.

“Nursing homes have been trying their best to combat this pandemic using the best infection control procedures they have, but blindfolded and with their hands tied behind their backs,” said Joseph G. Ouslander, MD, professor of geriatric medicine at Florida Atlantic University, Boca Raton, which has teaching affiliations with three senior communities.

Nursing home leaders are debating how to best use testing to guide transmission-based precautions and isolation strategies and how to keep residents safe while allowing some socialization after months of conflicting guidance from public health officials (on testing and on sites of care for patients discharged from the hospital, for instance), with a lack of adequate personal protective equipment (PPE) and testing supplies, and with nursing home resident deaths estimated to account for at least one-quarter of the total COVID-19–related mortality in the United States.

“COVID is not going away [over the next couple of years],” said Michael Wasserman, MD, medical director of the Eisenberg Village at the Los Angeles Jewish Home and president of the California Association of Long-Term Care Medicine.

Dr. Wasserman and other experts in both long-term care and infectious disease said in interviews that, through the rest of the pandemic and beyond, nursing homes need the following:

• Full-time, well-trained “infection preventionists” – infection prevention managers, in essence – who can lead improvements in emergency preparedness and infection prevention and control (IPC)
• Medical directors who are well qualified and engaged
• A survey/inspection process that is educational and not solely punitive
• More resources and attention to structural reform

“If this pandemic doesn’t create significant change in the nursing home industry, nothing ever will,” Dr. Wasserman said.
 

Prepandemic experience

When Ghinwa Dumyati, MD, began working with nursing homes in early March to prevent and contain COVID-19 outbreaks, her focus was on PPE.

Nursing home staff were intimately familiar with standard precautions, and many had used contact precautions to prevent transmission of infections like Clostridioides difficile and Candida auris, as well as droplet precautions for influenza. With the threat of COVID-19, nursing homes “had a brand-new requirement to do both contact and droplet precautions – with a new need for eye protection – and in some situations, respiratory precautions with N95 masks,” said Dr. Dumyati, professor of medicine and director of communicable disease surveillance and prevention at the University of Rochester (N.Y.) Medical Center. “And on top of that, [staff] had to learn to conserve and reuse PPE.”

Staff had not been fit-tested for use of N95 respirators, she noted. “The only time an N95 was used in the nursing home prior to COVID-19,” she said, “was for a suspected tuberculosis patient [before hospital admission].”

Similarly, nursing homes had experience in quarantining units to prevent transmission of illnesses like influenza or norovirus – keeping residents in their rooms with no visitations or social activity, for instance – but never did they have to arrange “massive movements of residents to completely new units or parts of a unit,” said Dr. Dumyati, who also has led hospital and nursing home collaborative programs in Rochester to beat back C. difficile, and is now helping to formulate COVID-19 recommendations and guidance for members of AMDA – The Society for Post-Acute and Long-Term Care.

As the SARS-CoV-2 virus began its spread through the United States, efforts to strengthen IPC programs in nursing homes in Rochester and elsewhere had been focused largely on multidrug resistant organisms (MDROs) and antibiotic stewardship – not on pandemic preparedness.

Reducing antibiotic use had become a national priority, and a 2016 rule by the Centers for Medicare & Medicaid Services required nursing homes to develop, over a 3-year period, an IPC program that included an antibiotic stewardship component and employment of a trained infection preventionist on at least a half-time basis. Emergency preparedness (e.g., having alternate energy sources for a facility) was also included in the rule, but it was only in 2019 when CMS updated its “Requirements for Participation” rule to stipulate that emergency preparedness include planning for “emerging infectious diseases.”

Courtesy Dr. Patricia Stone

“The 2016 regulations came about because infections were so problematic in nursing homes,” especially urinary tract infections, C. difficile, and drug-resistant infections, said Patricia Stone, PhD, RN, of the Center for Health Policy at the Columbia University School of Nursing, New York, who has published widely on infection prevention and control in nursing homes.

An analysis of IPC practices in 2014 and in 2018 suggests that the IPC-focused rules were helping, mainly with antibiotic stewardship programs but also with respect to some of the practices aimed at outbreak control, such as having policies in place for grouping infected residents together, instructing infected staff to stay home, and quarantining units on which outbreaks occur, Dr. Stone said. Policies for confining residents to rooms were reported by approximately 74% of nursing homes in 2014, and by approximately 87% in 2018, for instance. Overall, nursing homes were “getting better policies in place,” she said. The analysis compared data from two cross-sectional surveys of nursing homes conducted in 2014 and 2018 (945 and 888 facilities, respectively).

Nursing homes “have a long way to go,” however, with respect to the training of infection preventionists, Dr. Stone said. In 2014, her analysis shows, almost 65% of infection preventionists had no specific infection-control training and less than 3% were Certified in Infection Control (CIC) – a credential awarded by the Certification Board of Infection Control & Epidemiology. Of the 35% who had some form of official training, most completed state or local training courses.

The numbers improved slightly in 2018, with 7% of nursing homes reporting their infection preventionists had the highest-level certification, and 44% reporting that their infection preventionists had no specific infection-control training. Research has shown that infection-control training of any kind has a “strong effect” on IPC-related outcomes. While not demonstrated in research thus far, it seems plausible that “facilities with certified [infection preventionists] will have better processes in place,” said Dr. Stone, whose research has documented the need for more monitoring of staff compliance with hand-washing and other IPC procedures.

Infection preventionists in nursing homes typically have been directors of nursing or assistant directors of nursing who fold IPC responsibilities into a multitude of other responsibilities. Before the 2016 rules, some smaller facilities hired off-site consultants to do the job.

CMS upped the ante after several months of COVID-19, recommending in mid-May that nursing homes assign at least one individual with training in infection control “to provide on-site management of the IPC program.” The infection preventionists should be a “full-time role” in facilities that have more than 100 residents, the CMS guidance said. (Prior to the pandemic, CMS issued proposed regulations in 2019 that would modify the time an infection preventionist must devote to a facility from “part time” to “sufficient time.”)

However, neither the 2016 rule nor the most recent guidance on infection preventionists define the length or content of training.

Swati Gaur, MD, chair of the Infection Advisory Committee of AMDA and a certified medical director of two skilled nursing facilities in Gainesville, Ga., said that the pandemic “has really started to crystallize some of the limitations of having a very vague role, not just in terms of what an [infection preventionists] does [in the nursing home] but also the training,”

Fortunately, Dr. Gaur said, when SARS-CoV-2 struck, she had just transitioned her facilities’ designated infection preventionist to work full-time on the role. She had worked closely with her infection preventionist on IPC issues but wishes she had arranged for more rigorous independent training. “The role of the [infection preventionist] is huge and complicated,” now involving employee health, contract tracing, cohorting, isolation, and compliance with precautions and use of PPE, in addition to surveillance, data reporting, and communication with public health officials, she said.

“Facilities are finding out now that [the infection preventionist] cannot be an afterthought. And it won’t end with COVID. We have other respiratory illnesses like flu and other viruses that we struggle with all the time,” said Dr. Gaur, who is working alongside Dr. Dumyati and two other long-term care experts on AMDA’s COVID-19 guidance. The nursing homes that Dr. Gaur directs are part of the Northeast Georgia Health Care System and together include 271 beds.
 

Moving forward

IPC practices often collide with facilities’ role as a home, especially to those receiving long-term care. “We always have to measure what we do [to prevent and control infections] against patient autonomy and residents’ rights,” said Dr. Gaur. “We have struggled with these issues, prior to the pandemic. If patients are positive for multidrug resistant organisms [for instance], how long can they be isolated in their own rooms? You can’t for days and months put someone in a single room and create isolation. That’s where the science of infection prevention can collide with residents’ rights.”

Over the years, the Centers for Disease Control and Prevention has acknowledged this discordance, leaving it to facilities to decide, for instance, whether to actively screen for colonization with MDROs. In 2019, to help nursing homes prevent the transmission of MDROs from residents who are colonized but not actively infected, the CDC introduced new “enhanced barrier precautions” that require the use of gowns and gloves for specific resident activities identified as having a high risk of MDRO transmission. The new category of precautions is less restrictive than traditional contact precautions, which keep residents in their rooms.

Infection control in nursing homes “isn’t where it needs to be ... but we’re always going to have in nursing homes a situation where there’s a high potential for rapid transmission of infectious disease,” said Christopher Crnich, MD, PhD, an infectious disease specialist at the University of Wisconsin–Madison who chairs the long-term care special interest group of the Society of Healthcare Epidemiology of America and has offered COVID-19 advice to his state’s department of public health.

“Anytime you have a congregative community, particularly one that involves susceptible hosts, there will be an intrinsically susceptible environment ... I’m a bit disturbed by the emphasis on saying, ‘This nursing home had a COVID-19 outbreak, therefore this nursing home did something wrong,’ ” Dr. Crnich said.

“How we mitigate the size of the outbreaks is where we need to focus our attention,” he said. The goal with SARS-CoV-2, he said, is to recognize its introduction “as rapidly as possible” and stop its spread through empiric symptom- and exposure-based isolation, multiple waves of targeted testing, widespread use of contact and droplet precautions, and isolating staff as necessary.

As awareness grew this year among long-term care leaders that relying too heavily on symptom-based strategies may not be effective to prevent introduction and transmission of SARS-CoV-2, a study published in April in the New England Journal of Medicine cemented the need for a testing strategy not limited to symptomatic individuals.

The study documented that more than half of residents in a nursing home who had positive polymerase chain reaction (PCR) test results were asymptomatic at the time of testing, and that most went on to develop symptoms. The study was conducted after one case of COVID-19 had been identified.

Some states issued calls this spring for “universal testing” of all nursing home patients and staff, and the CMS recommendations issued to state and local officials in mid-May for phased nursing home “reopening” call for baseline testing of all residents and staff, followed by retesting all residents weekly until all residents test negative and by retesting all staff continuing every week.

However, the experts contacted for this story said that, without a highly accurate and accessible point-of-care test (and even with one, considering the virus’ incubation period), a universal approach that includes all nursing home residents may have more limited value than is being touted. In many scenarios, they said, it is most meaningful to focus still-limited testing supplies on the staff, many of whom work at more than one facility and are believed to be primary vectors of SARS-CoV-2.

Dr. Ouslander, Dr. Wasserman and other long-term care leaders have been discussing testing at length, trying to reach consensus on best policies. “I don’t think there’s any uniform approach or uniform agreement,” said Dr. Ouslander. “For me, under ideal circumstances what needs to be done to protect older people in nursing homes is to get access to as many accurate viral tests as possible and test staff at least once a week or every 10 days.”

In some facilities, there may be an unspoken barrier to the frequent testing of staff: Fear that staff who test positive will need to be quarantined, with no one to take their place on the front line. Dr. Ouslander said he knows of one county health department that has discouraged nursing homes from testing asymptomatic staff. “It’s insane and truly shocking,” he said.

At the University of Rochester Medical Center, Dr. Dumyati said, staffing agencies are running short of nurse aide substitutes, and staffing issues have become the “biggest challenge” facing a regional multidisciplinary group of medical directors, hospital leaders, and health department officials who are working to troubleshoot COVID-19 issues. “Some of our nursing homes have ended up sending some of their residents to other nursing homes or to the hospital [because of the loss of staff],” she said.

Currently in the state of New York, she noted, COVID-19 patients may not be discharged to nursing homes until they test negative for the virus through PCR testing. “And some people don’t clear by PCR for 4-6 weeks.”


 

The barriers

Staffing shortages – real in some locales, and anticipated in others as economic reopening grows – are reflective of underlying structural and financial factors that work against optimal IPC, experts said. It’s not uncommon for certified nurse assistants (CNAs) to be assigned to 10-15 residents. And according to AMDA, 30%-46% of CNAs are reported to receive some form of public assistance. Low wages force many CNAs to work other jobs, including shifts at other nursing homes.

Turnover of nursing home leadership also creates problems. Dr. Crnich calls it “one of the biggest barriers” to effective IPC in nursing homes. “Facilities can tolerate some turnover in their front line staff,” he said, “as long as their leadership structure remains relatively stable.” Dr. Stone and her coinvestigators have documented at least yearly turnover in top positions: They found that, in 2018, approximately one-quarter of facilities reported employing three or more infection preventionists, three or more administrators, and three or more directors of nursing during the prior 3 years.

Medical directors, moreover, are not uniformly qualified, engaged with their facilities, or supported by nursing home administrators. “It’s an open secret, I think, that a lot of facilities want a medical director who is a good referral source,” said Dr. Gaur. “A medical director needs to be completely engaged in [quality improvement and] infection control practices.”

Some nursing home chains, she noted, “have realized the value of the medical director, and have changed the way they’re paying them. They’re actually holding them accountable [for quality and outcomes].”

Medical directors such as Dr. Wasserman, who previously oversaw a 74-facility nursing home chain in California as chief medical officer and then chief executive officer and has worked on nursing home quality improvement processes for his state, said there is much that can be done clinically to prevent the spread of infections, such as more frequent use of telemedicine, more attention to “deprescribing” unnecessary medications (which reduces the number of medication passes and, thus, the number of “transmission opportunities”), and the use of continuous remote monitoring. He has been trying to secure Bluetooth-enabled pulse oximetry and temperature monitoring for the Los Angeles Jewish Home and other facilities.

Dr. Wasserman and other long-term care leaders believe that a more educational inspection process would also lead to improvements in IPC. “The punitive nature of the survey process is morally deflating to frontline staff [and] penalties take money away from operations,” Dr. Wasserman said. “It’s not a productive approach to quality improvement.”

Dr. Stone agreed. Infection control is now the primary focus of CMS’s inspection process, and she said that increased regulatory scrutiny of IPC beyond COVID-19 is a “good thing.” Her research has shown that most deficiencies identified by inspectors are infection control deficiencies, and that in 2014 and 2018, approximately one-third of nursing homes had infection control citations. (CMS recently increased penalties and fines for identified deficiencies.)

“But my hope would be that the survey process would be more educational [as it is for hospitals],” she said. “We need to be supporting nursing homes to do a better job.”

A silver lining of the COVID-19 pandemic, as Dr. Stone sees it, is that nursing homes may be more engaged with data reporting and infection surveillance going forward. Nursing homes are now required to report their COVID-19 cases to the CDC through its hospital-dominant National Healthcare Safety Network, and the CDC has made technical changes that now make it “easier [than it was in the past] for nursing homes to join and participate,” she said. “Now that all nursing homes are engaged, will they be engaged post-COVID, too? I hope so. Surveillance [of infections] is a first step toward better outcomes.”

For now, said Dr. Crnich, the intensive prevention and mitigation efforts that are being required of nursing homes to minimize COVID-19’s impact is “a big deal and will tax the resources of most nursing homes and exceed the resources of many” without outside support, Dr. Crnich said. “This has been the most illuminating part of all this, and will probably require us to reconsider how we’re resourcing our nursing homes moving forward into the future.”

The toll that COVID-19 has taken on nursing homes and their postacute and long-term care residents has a multilayered backstory involving underresourced organizational structures, inherent susceptibilities, minimally trained infection prevention staff, variable abilities to isolate and quarantine large numbers of patients and residents, and a lack of governmental support.

“Nursing homes have been trying their best to combat this pandemic using the best infection control procedures they have, but blindfolded and with their hands tied behind their backs,” said Joseph G. Ouslander, MD, professor of geriatric medicine at Florida Atlantic University, Boca Raton, which has teaching affiliations with three senior communities.

Nursing home leaders are debating how to best use testing to guide transmission-based precautions and isolation strategies and how to keep residents safe while allowing some socialization after months of conflicting guidance from public health officials (on testing and on sites of care for patients discharged from the hospital, for instance), with a lack of adequate personal protective equipment (PPE) and testing supplies, and with nursing home resident deaths estimated to account for at least one-quarter of the total COVID-19–related mortality in the United States.

“COVID is not going away [over the next couple of years],” said Michael Wasserman, MD, medical director of the Eisenberg Village at the Los Angeles Jewish Home and president of the California Association of Long-Term Care Medicine.

Dr. Wasserman and other experts in both long-term care and infectious disease said in interviews that, through the rest of the pandemic and beyond, nursing homes need the following:

• Full-time, well-trained “infection preventionists” – infection prevention managers, in essence – who can lead improvements in emergency preparedness and infection prevention and control (IPC)
• Medical directors who are well qualified and engaged
• A survey/inspection process that is educational and not solely punitive
• More resources and attention to structural reform

“If this pandemic doesn’t create significant change in the nursing home industry, nothing ever will,” Dr. Wasserman said.
 

Prepandemic experience

When Ghinwa Dumyati, MD, began working with nursing homes in early March to prevent and contain COVID-19 outbreaks, her focus was on PPE.

Nursing home staff were intimately familiar with standard precautions, and many had used contact precautions to prevent transmission of infections like Clostridioides difficile and Candida auris, as well as droplet precautions for influenza. With the threat of COVID-19, nursing homes “had a brand-new requirement to do both contact and droplet precautions – with a new need for eye protection – and in some situations, respiratory precautions with N95 masks,” said Dr. Dumyati, professor of medicine and director of communicable disease surveillance and prevention at the University of Rochester (N.Y.) Medical Center. “And on top of that, [staff] had to learn to conserve and reuse PPE.”

Staff had not been fit-tested for use of N95 respirators, she noted. “The only time an N95 was used in the nursing home prior to COVID-19,” she said, “was for a suspected tuberculosis patient [before hospital admission].”

Similarly, nursing homes had experience in quarantining units to prevent transmission of illnesses like influenza or norovirus – keeping residents in their rooms with no visitations or social activity, for instance – but never did they have to arrange “massive movements of residents to completely new units or parts of a unit,” said Dr. Dumyati, who also has led hospital and nursing home collaborative programs in Rochester to beat back C. difficile, and is now helping to formulate COVID-19 recommendations and guidance for members of AMDA – The Society for Post-Acute and Long-Term Care.

As the SARS-CoV-2 virus began its spread through the United States, efforts to strengthen IPC programs in nursing homes in Rochester and elsewhere had been focused largely on multidrug resistant organisms (MDROs) and antibiotic stewardship – not on pandemic preparedness.

Reducing antibiotic use had become a national priority, and a 2016 rule by the Centers for Medicare & Medicaid Services required nursing homes to develop, over a 3-year period, an IPC program that included an antibiotic stewardship component and employment of a trained infection preventionist on at least a half-time basis. Emergency preparedness (e.g., having alternate energy sources for a facility) was also included in the rule, but it was only in 2019 when CMS updated its “Requirements for Participation” rule to stipulate that emergency preparedness include planning for “emerging infectious diseases.”

Courtesy Dr. Patricia Stone

“The 2016 regulations came about because infections were so problematic in nursing homes,” especially urinary tract infections, C. difficile, and drug-resistant infections, said Patricia Stone, PhD, RN, of the Center for Health Policy at the Columbia University School of Nursing, New York, who has published widely on infection prevention and control in nursing homes.

An analysis of IPC practices in 2014 and in 2018 suggests that the IPC-focused rules were helping, mainly with antibiotic stewardship programs but also with respect to some of the practices aimed at outbreak control, such as having policies in place for grouping infected residents together, instructing infected staff to stay home, and quarantining units on which outbreaks occur, Dr. Stone said. Policies for confining residents to rooms were reported by approximately 74% of nursing homes in 2014, and by approximately 87% in 2018, for instance. Overall, nursing homes were “getting better policies in place,” she said. The analysis compared data from two cross-sectional surveys of nursing homes conducted in 2014 and 2018 (945 and 888 facilities, respectively).

Nursing homes “have a long way to go,” however, with respect to the training of infection preventionists, Dr. Stone said. In 2014, her analysis shows, almost 65% of infection preventionists had no specific infection-control training and less than 3% were Certified in Infection Control (CIC) – a credential awarded by the Certification Board of Infection Control & Epidemiology. Of the 35% who had some form of official training, most completed state or local training courses.

The numbers improved slightly in 2018, with 7% of nursing homes reporting their infection preventionists had the highest-level certification, and 44% reporting that their infection preventionists had no specific infection-control training. Research has shown that infection-control training of any kind has a “strong effect” on IPC-related outcomes. While not demonstrated in research thus far, it seems plausible that “facilities with certified [infection preventionists] will have better processes in place,” said Dr. Stone, whose research has documented the need for more monitoring of staff compliance with hand-washing and other IPC procedures.

Infection preventionists in nursing homes typically have been directors of nursing or assistant directors of nursing who fold IPC responsibilities into a multitude of other responsibilities. Before the 2016 rules, some smaller facilities hired off-site consultants to do the job.

CMS upped the ante after several months of COVID-19, recommending in mid-May that nursing homes assign at least one individual with training in infection control “to provide on-site management of the IPC program.” The infection preventionists should be a “full-time role” in facilities that have more than 100 residents, the CMS guidance said. (Prior to the pandemic, CMS issued proposed regulations in 2019 that would modify the time an infection preventionist must devote to a facility from “part time” to “sufficient time.”)

However, neither the 2016 rule nor the most recent guidance on infection preventionists define the length or content of training.

Swati Gaur, MD, chair of the Infection Advisory Committee of AMDA and a certified medical director of two skilled nursing facilities in Gainesville, Ga., said that the pandemic “has really started to crystallize some of the limitations of having a very vague role, not just in terms of what an [infection preventionists] does [in the nursing home] but also the training,”

Fortunately, Dr. Gaur said, when SARS-CoV-2 struck, she had just transitioned her facilities’ designated infection preventionist to work full-time on the role. She had worked closely with her infection preventionist on IPC issues but wishes she had arranged for more rigorous independent training. “The role of the [infection preventionist] is huge and complicated,” now involving employee health, contract tracing, cohorting, isolation, and compliance with precautions and use of PPE, in addition to surveillance, data reporting, and communication with public health officials, she said.

“Facilities are finding out now that [the infection preventionist] cannot be an afterthought. And it won’t end with COVID. We have other respiratory illnesses like flu and other viruses that we struggle with all the time,” said Dr. Gaur, who is working alongside Dr. Dumyati and two other long-term care experts on AMDA’s COVID-19 guidance. The nursing homes that Dr. Gaur directs are part of the Northeast Georgia Health Care System and together include 271 beds.
 

Moving forward

IPC practices often collide with facilities’ role as a home, especially to those receiving long-term care. “We always have to measure what we do [to prevent and control infections] against patient autonomy and residents’ rights,” said Dr. Gaur. “We have struggled with these issues, prior to the pandemic. If patients are positive for multidrug resistant organisms [for instance], how long can they be isolated in their own rooms? You can’t for days and months put someone in a single room and create isolation. That’s where the science of infection prevention can collide with residents’ rights.”

Over the years, the Centers for Disease Control and Prevention has acknowledged this discordance, leaving it to facilities to decide, for instance, whether to actively screen for colonization with MDROs. In 2019, to help nursing homes prevent the transmission of MDROs from residents who are colonized but not actively infected, the CDC introduced new “enhanced barrier precautions” that require the use of gowns and gloves for specific resident activities identified as having a high risk of MDRO transmission. The new category of precautions is less restrictive than traditional contact precautions, which keep residents in their rooms.

Infection control in nursing homes “isn’t where it needs to be ... but we’re always going to have in nursing homes a situation where there’s a high potential for rapid transmission of infectious disease,” said Christopher Crnich, MD, PhD, an infectious disease specialist at the University of Wisconsin–Madison who chairs the long-term care special interest group of the Society of Healthcare Epidemiology of America and has offered COVID-19 advice to his state’s department of public health.

“Anytime you have a congregative community, particularly one that involves susceptible hosts, there will be an intrinsically susceptible environment ... I’m a bit disturbed by the emphasis on saying, ‘This nursing home had a COVID-19 outbreak, therefore this nursing home did something wrong,’ ” Dr. Crnich said.

“How we mitigate the size of the outbreaks is where we need to focus our attention,” he said. The goal with SARS-CoV-2, he said, is to recognize its introduction “as rapidly as possible” and stop its spread through empiric symptom- and exposure-based isolation, multiple waves of targeted testing, widespread use of contact and droplet precautions, and isolating staff as necessary.

As awareness grew this year among long-term care leaders that relying too heavily on symptom-based strategies may not be effective to prevent introduction and transmission of SARS-CoV-2, a study published in April in the New England Journal of Medicine cemented the need for a testing strategy not limited to symptomatic individuals.

The study documented that more than half of residents in a nursing home who had positive polymerase chain reaction (PCR) test results were asymptomatic at the time of testing, and that most went on to develop symptoms. The study was conducted after one case of COVID-19 had been identified.

Some states issued calls this spring for “universal testing” of all nursing home patients and staff, and the CMS recommendations issued to state and local officials in mid-May for phased nursing home “reopening” call for baseline testing of all residents and staff, followed by retesting all residents weekly until all residents test negative and by retesting all staff continuing every week.

However, the experts contacted for this story said that, without a highly accurate and accessible point-of-care test (and even with one, considering the virus’ incubation period), a universal approach that includes all nursing home residents may have more limited value than is being touted. In many scenarios, they said, it is most meaningful to focus still-limited testing supplies on the staff, many of whom work at more than one facility and are believed to be primary vectors of SARS-CoV-2.

Dr. Ouslander, Dr. Wasserman and other long-term care leaders have been discussing testing at length, trying to reach consensus on best policies. “I don’t think there’s any uniform approach or uniform agreement,” said Dr. Ouslander. “For me, under ideal circumstances what needs to be done to protect older people in nursing homes is to get access to as many accurate viral tests as possible and test staff at least once a week or every 10 days.”

In some facilities, there may be an unspoken barrier to the frequent testing of staff: Fear that staff who test positive will need to be quarantined, with no one to take their place on the front line. Dr. Ouslander said he knows of one county health department that has discouraged nursing homes from testing asymptomatic staff. “It’s insane and truly shocking,” he said.

At the University of Rochester Medical Center, Dr. Dumyati said, staffing agencies are running short of nurse aide substitutes, and staffing issues have become the “biggest challenge” facing a regional multidisciplinary group of medical directors, hospital leaders, and health department officials who are working to troubleshoot COVID-19 issues. “Some of our nursing homes have ended up sending some of their residents to other nursing homes or to the hospital [because of the loss of staff],” she said.

Currently in the state of New York, she noted, COVID-19 patients may not be discharged to nursing homes until they test negative for the virus through PCR testing. “And some people don’t clear by PCR for 4-6 weeks.”


 

The barriers

Staffing shortages – real in some locales, and anticipated in others as economic reopening grows – are reflective of underlying structural and financial factors that work against optimal IPC, experts said. It’s not uncommon for certified nurse assistants (CNAs) to be assigned to 10-15 residents. And according to AMDA, 30%-46% of CNAs are reported to receive some form of public assistance. Low wages force many CNAs to work other jobs, including shifts at other nursing homes.

Turnover of nursing home leadership also creates problems. Dr. Crnich calls it “one of the biggest barriers” to effective IPC in nursing homes. “Facilities can tolerate some turnover in their front line staff,” he said, “as long as their leadership structure remains relatively stable.” Dr. Stone and her coinvestigators have documented at least yearly turnover in top positions: They found that, in 2018, approximately one-quarter of facilities reported employing three or more infection preventionists, three or more administrators, and three or more directors of nursing during the prior 3 years.

Medical directors, moreover, are not uniformly qualified, engaged with their facilities, or supported by nursing home administrators. “It’s an open secret, I think, that a lot of facilities want a medical director who is a good referral source,” said Dr. Gaur. “A medical director needs to be completely engaged in [quality improvement and] infection control practices.”

Some nursing home chains, she noted, “have realized the value of the medical director, and have changed the way they’re paying them. They’re actually holding them accountable [for quality and outcomes].”

Medical directors such as Dr. Wasserman, who previously oversaw a 74-facility nursing home chain in California as chief medical officer and then chief executive officer and has worked on nursing home quality improvement processes for his state, said there is much that can be done clinically to prevent the spread of infections, such as more frequent use of telemedicine, more attention to “deprescribing” unnecessary medications (which reduces the number of medication passes and, thus, the number of “transmission opportunities”), and the use of continuous remote monitoring. He has been trying to secure Bluetooth-enabled pulse oximetry and temperature monitoring for the Los Angeles Jewish Home and other facilities.

Dr. Wasserman and other long-term care leaders believe that a more educational inspection process would also lead to improvements in IPC. “The punitive nature of the survey process is morally deflating to frontline staff [and] penalties take money away from operations,” Dr. Wasserman said. “It’s not a productive approach to quality improvement.”

Dr. Stone agreed. Infection control is now the primary focus of CMS’s inspection process, and she said that increased regulatory scrutiny of IPC beyond COVID-19 is a “good thing.” Her research has shown that most deficiencies identified by inspectors are infection control deficiencies, and that in 2014 and 2018, approximately one-third of nursing homes had infection control citations. (CMS recently increased penalties and fines for identified deficiencies.)

“But my hope would be that the survey process would be more educational [as it is for hospitals],” she said. “We need to be supporting nursing homes to do a better job.”

A silver lining of the COVID-19 pandemic, as Dr. Stone sees it, is that nursing homes may be more engaged with data reporting and infection surveillance going forward. Nursing homes are now required to report their COVID-19 cases to the CDC through its hospital-dominant National Healthcare Safety Network, and the CDC has made technical changes that now make it “easier [than it was in the past] for nursing homes to join and participate,” she said. “Now that all nursing homes are engaged, will they be engaged post-COVID, too? I hope so. Surveillance [of infections] is a first step toward better outcomes.”

For now, said Dr. Crnich, the intensive prevention and mitigation efforts that are being required of nursing homes to minimize COVID-19’s impact is “a big deal and will tax the resources of most nursing homes and exceed the resources of many” without outside support, Dr. Crnich said. “This has been the most illuminating part of all this, and will probably require us to reconsider how we’re resourcing our nursing homes moving forward into the future.”

The toll that COVID-19 has taken on nursing homes and their postacute and long-term care residents has a multilayered backstory involving underresourced organizational structures, inherent susceptibilities, minimally trained infection prevention staff, variable abilities to isolate and quarantine large numbers of patients and residents, and a lack of governmental support.

“Nursing homes have been trying their best to combat this pandemic using the best infection control procedures they have, but blindfolded and with their hands tied behind their backs,” said Joseph G. Ouslander, MD, professor of geriatric medicine at Florida Atlantic University, Boca Raton, which has teaching affiliations with three senior communities.

Nursing home leaders are debating how to best use testing to guide transmission-based precautions and isolation strategies and how to keep residents safe while allowing some socialization after months of conflicting guidance from public health officials (on testing and on sites of care for patients discharged from the hospital, for instance), with a lack of adequate personal protective equipment (PPE) and testing supplies, and with nursing home resident deaths estimated to account for at least one-quarter of the total COVID-19–related mortality in the United States.

“COVID is not going away [over the next couple of years],” said Michael Wasserman, MD, medical director of the Eisenberg Village at the Los Angeles Jewish Home and president of the California Association of Long-Term Care Medicine.

Dr. Wasserman and other experts in both long-term care and infectious disease said in interviews that, through the rest of the pandemic and beyond, nursing homes need the following:

• Full-time, well-trained “infection preventionists” – infection prevention managers, in essence – who can lead improvements in emergency preparedness and infection prevention and control (IPC)
• Medical directors who are well qualified and engaged
• A survey/inspection process that is educational and not solely punitive
• More resources and attention to structural reform

“If this pandemic doesn’t create significant change in the nursing home industry, nothing ever will,” Dr. Wasserman said.
 

Prepandemic experience

When Ghinwa Dumyati, MD, began working with nursing homes in early March to prevent and contain COVID-19 outbreaks, her focus was on PPE.

Nursing home staff were intimately familiar with standard precautions, and many had used contact precautions to prevent transmission of infections like Clostridioides difficile and Candida auris, as well as droplet precautions for influenza. With the threat of COVID-19, nursing homes “had a brand-new requirement to do both contact and droplet precautions – with a new need for eye protection – and in some situations, respiratory precautions with N95 masks,” said Dr. Dumyati, professor of medicine and director of communicable disease surveillance and prevention at the University of Rochester (N.Y.) Medical Center. “And on top of that, [staff] had to learn to conserve and reuse PPE.”

Staff had not been fit-tested for use of N95 respirators, she noted. “The only time an N95 was used in the nursing home prior to COVID-19,” she said, “was for a suspected tuberculosis patient [before hospital admission].”

Similarly, nursing homes had experience in quarantining units to prevent transmission of illnesses like influenza or norovirus – keeping residents in their rooms with no visitations or social activity, for instance – but never did they have to arrange “massive movements of residents to completely new units or parts of a unit,” said Dr. Dumyati, who also has led hospital and nursing home collaborative programs in Rochester to beat back C. difficile, and is now helping to formulate COVID-19 recommendations and guidance for members of AMDA – The Society for Post-Acute and Long-Term Care.

As the SARS-CoV-2 virus began its spread through the United States, efforts to strengthen IPC programs in nursing homes in Rochester and elsewhere had been focused largely on multidrug resistant organisms (MDROs) and antibiotic stewardship – not on pandemic preparedness.

Reducing antibiotic use had become a national priority, and a 2016 rule by the Centers for Medicare & Medicaid Services required nursing homes to develop, over a 3-year period, an IPC program that included an antibiotic stewardship component and employment of a trained infection preventionist on at least a half-time basis. Emergency preparedness (e.g., having alternate energy sources for a facility) was also included in the rule, but it was only in 2019 when CMS updated its “Requirements for Participation” rule to stipulate that emergency preparedness include planning for “emerging infectious diseases.”

Courtesy Dr. Patricia Stone

“The 2016 regulations came about because infections were so problematic in nursing homes,” especially urinary tract infections, C. difficile, and drug-resistant infections, said Patricia Stone, PhD, RN, of the Center for Health Policy at the Columbia University School of Nursing, New York, who has published widely on infection prevention and control in nursing homes.

An analysis of IPC practices in 2014 and in 2018 suggests that the IPC-focused rules were helping, mainly with antibiotic stewardship programs but also with respect to some of the practices aimed at outbreak control, such as having policies in place for grouping infected residents together, instructing infected staff to stay home, and quarantining units on which outbreaks occur, Dr. Stone said. Policies for confining residents to rooms were reported by approximately 74% of nursing homes in 2014, and by approximately 87% in 2018, for instance. Overall, nursing homes were “getting better policies in place,” she said. The analysis compared data from two cross-sectional surveys of nursing homes conducted in 2014 and 2018 (945 and 888 facilities, respectively).

Nursing homes “have a long way to go,” however, with respect to the training of infection preventionists, Dr. Stone said. In 2014, her analysis shows, almost 65% of infection preventionists had no specific infection-control training and less than 3% were Certified in Infection Control (CIC) – a credential awarded by the Certification Board of Infection Control & Epidemiology. Of the 35% who had some form of official training, most completed state or local training courses.

The numbers improved slightly in 2018, with 7% of nursing homes reporting their infection preventionists had the highest-level certification, and 44% reporting that their infection preventionists had no specific infection-control training. Research has shown that infection-control training of any kind has a “strong effect” on IPC-related outcomes. While not demonstrated in research thus far, it seems plausible that “facilities with certified [infection preventionists] will have better processes in place,” said Dr. Stone, whose research has documented the need for more monitoring of staff compliance with hand-washing and other IPC procedures.

Infection preventionists in nursing homes typically have been directors of nursing or assistant directors of nursing who fold IPC responsibilities into a multitude of other responsibilities. Before the 2016 rules, some smaller facilities hired off-site consultants to do the job.

CMS upped the ante after several months of COVID-19, recommending in mid-May that nursing homes assign at least one individual with training in infection control “to provide on-site management of the IPC program.” The infection preventionists should be a “full-time role” in facilities that have more than 100 residents, the CMS guidance said. (Prior to the pandemic, CMS issued proposed regulations in 2019 that would modify the time an infection preventionist must devote to a facility from “part time” to “sufficient time.”)

However, neither the 2016 rule nor the most recent guidance on infection preventionists define the length or content of training.

Swati Gaur, MD, chair of the Infection Advisory Committee of AMDA and a certified medical director of two skilled nursing facilities in Gainesville, Ga., said that the pandemic “has really started to crystallize some of the limitations of having a very vague role, not just in terms of what an [infection preventionists] does [in the nursing home] but also the training,”

Fortunately, Dr. Gaur said, when SARS-CoV-2 struck, she had just transitioned her facilities’ designated infection preventionist to work full-time on the role. She had worked closely with her infection preventionist on IPC issues but wishes she had arranged for more rigorous independent training. “The role of the [infection preventionist] is huge and complicated,” now involving employee health, contract tracing, cohorting, isolation, and compliance with precautions and use of PPE, in addition to surveillance, data reporting, and communication with public health officials, she said.

“Facilities are finding out now that [the infection preventionist] cannot be an afterthought. And it won’t end with COVID. We have other respiratory illnesses like flu and other viruses that we struggle with all the time,” said Dr. Gaur, who is working alongside Dr. Dumyati and two other long-term care experts on AMDA’s COVID-19 guidance. The nursing homes that Dr. Gaur directs are part of the Northeast Georgia Health Care System and together include 271 beds.
 

Moving forward

IPC practices often collide with facilities’ role as a home, especially to those receiving long-term care. “We always have to measure what we do [to prevent and control infections] against patient autonomy and residents’ rights,” said Dr. Gaur. “We have struggled with these issues, prior to the pandemic. If patients are positive for multidrug resistant organisms [for instance], how long can they be isolated in their own rooms? You can’t for days and months put someone in a single room and create isolation. That’s where the science of infection prevention can collide with residents’ rights.”

Over the years, the Centers for Disease Control and Prevention has acknowledged this discordance, leaving it to facilities to decide, for instance, whether to actively screen for colonization with MDROs. In 2019, to help nursing homes prevent the transmission of MDROs from residents who are colonized but not actively infected, the CDC introduced new “enhanced barrier precautions” that require the use of gowns and gloves for specific resident activities identified as having a high risk of MDRO transmission. The new category of precautions is less restrictive than traditional contact precautions, which keep residents in their rooms.

Infection control in nursing homes “isn’t where it needs to be ... but we’re always going to have in nursing homes a situation where there’s a high potential for rapid transmission of infectious disease,” said Christopher Crnich, MD, PhD, an infectious disease specialist at the University of Wisconsin–Madison who chairs the long-term care special interest group of the Society of Healthcare Epidemiology of America and has offered COVID-19 advice to his state’s department of public health.

“Anytime you have a congregative community, particularly one that involves susceptible hosts, there will be an intrinsically susceptible environment ... I’m a bit disturbed by the emphasis on saying, ‘This nursing home had a COVID-19 outbreak, therefore this nursing home did something wrong,’ ” Dr. Crnich said.

“How we mitigate the size of the outbreaks is where we need to focus our attention,” he said. The goal with SARS-CoV-2, he said, is to recognize its introduction “as rapidly as possible” and stop its spread through empiric symptom- and exposure-based isolation, multiple waves of targeted testing, widespread use of contact and droplet precautions, and isolating staff as necessary.

As awareness grew this year among long-term care leaders that relying too heavily on symptom-based strategies may not be effective to prevent introduction and transmission of SARS-CoV-2, a study published in April in the New England Journal of Medicine cemented the need for a testing strategy not limited to symptomatic individuals.

The study documented that more than half of residents in a nursing home who had positive polymerase chain reaction (PCR) test results were asymptomatic at the time of testing, and that most went on to develop symptoms. The study was conducted after one case of COVID-19 had been identified.

Some states issued calls this spring for “universal testing” of all nursing home patients and staff, and the CMS recommendations issued to state and local officials in mid-May for phased nursing home “reopening” call for baseline testing of all residents and staff, followed by retesting all residents weekly until all residents test negative and by retesting all staff continuing every week.

However, the experts contacted for this story said that, without a highly accurate and accessible point-of-care test (and even with one, considering the virus’ incubation period), a universal approach that includes all nursing home residents may have more limited value than is being touted. In many scenarios, they said, it is most meaningful to focus still-limited testing supplies on the staff, many of whom work at more than one facility and are believed to be primary vectors of SARS-CoV-2.

Dr. Ouslander, Dr. Wasserman and other long-term care leaders have been discussing testing at length, trying to reach consensus on best policies. “I don’t think there’s any uniform approach or uniform agreement,” said Dr. Ouslander. “For me, under ideal circumstances what needs to be done to protect older people in nursing homes is to get access to as many accurate viral tests as possible and test staff at least once a week or every 10 days.”

In some facilities, there may be an unspoken barrier to the frequent testing of staff: Fear that staff who test positive will need to be quarantined, with no one to take their place on the front line. Dr. Ouslander said he knows of one county health department that has discouraged nursing homes from testing asymptomatic staff. “It’s insane and truly shocking,” he said.

At the University of Rochester Medical Center, Dr. Dumyati said, staffing agencies are running short of nurse aide substitutes, and staffing issues have become the “biggest challenge” facing a regional multidisciplinary group of medical directors, hospital leaders, and health department officials who are working to troubleshoot COVID-19 issues. “Some of our nursing homes have ended up sending some of their residents to other nursing homes or to the hospital [because of the loss of staff],” she said.

Currently in the state of New York, she noted, COVID-19 patients may not be discharged to nursing homes until they test negative for the virus through PCR testing. “And some people don’t clear by PCR for 4-6 weeks.”


 

The barriers

Staffing shortages – real in some locales, and anticipated in others as economic reopening grows – are reflective of underlying structural and financial factors that work against optimal IPC, experts said. It’s not uncommon for certified nurse assistants (CNAs) to be assigned to 10-15 residents. And according to AMDA, 30%-46% of CNAs are reported to receive some form of public assistance. Low wages force many CNAs to work other jobs, including shifts at other nursing homes.

Turnover of nursing home leadership also creates problems. Dr. Crnich calls it “one of the biggest barriers” to effective IPC in nursing homes. “Facilities can tolerate some turnover in their front line staff,” he said, “as long as their leadership structure remains relatively stable.” Dr. Stone and her coinvestigators have documented at least yearly turnover in top positions: They found that, in 2018, approximately one-quarter of facilities reported employing three or more infection preventionists, three or more administrators, and three or more directors of nursing during the prior 3 years.

Medical directors, moreover, are not uniformly qualified, engaged with their facilities, or supported by nursing home administrators. “It’s an open secret, I think, that a lot of facilities want a medical director who is a good referral source,” said Dr. Gaur. “A medical director needs to be completely engaged in [quality improvement and] infection control practices.”

Some nursing home chains, she noted, “have realized the value of the medical director, and have changed the way they’re paying them. They’re actually holding them accountable [for quality and outcomes].”

Medical directors such as Dr. Wasserman, who previously oversaw a 74-facility nursing home chain in California as chief medical officer and then chief executive officer and has worked on nursing home quality improvement processes for his state, said there is much that can be done clinically to prevent the spread of infections, such as more frequent use of telemedicine, more attention to “deprescribing” unnecessary medications (which reduces the number of medication passes and, thus, the number of “transmission opportunities”), and the use of continuous remote monitoring. He has been trying to secure Bluetooth-enabled pulse oximetry and temperature monitoring for the Los Angeles Jewish Home and other facilities.

Dr. Wasserman and other long-term care leaders believe that a more educational inspection process would also lead to improvements in IPC. “The punitive nature of the survey process is morally deflating to frontline staff [and] penalties take money away from operations,” Dr. Wasserman said. “It’s not a productive approach to quality improvement.”

Dr. Stone agreed. Infection control is now the primary focus of CMS’s inspection process, and she said that increased regulatory scrutiny of IPC beyond COVID-19 is a “good thing.” Her research has shown that most deficiencies identified by inspectors are infection control deficiencies, and that in 2014 and 2018, approximately one-third of nursing homes had infection control citations. (CMS recently increased penalties and fines for identified deficiencies.)

“But my hope would be that the survey process would be more educational [as it is for hospitals],” she said. “We need to be supporting nursing homes to do a better job.”

A silver lining of the COVID-19 pandemic, as Dr. Stone sees it, is that nursing homes may be more engaged with data reporting and infection surveillance going forward. Nursing homes are now required to report their COVID-19 cases to the CDC through its hospital-dominant National Healthcare Safety Network, and the CDC has made technical changes that now make it “easier [than it was in the past] for nursing homes to join and participate,” she said. “Now that all nursing homes are engaged, will they be engaged post-COVID, too? I hope so. Surveillance [of infections] is a first step toward better outcomes.”

For now, said Dr. Crnich, the intensive prevention and mitigation efforts that are being required of nursing homes to minimize COVID-19’s impact is “a big deal and will tax the resources of most nursing homes and exceed the resources of many” without outside support, Dr. Crnich said. “This has been the most illuminating part of all this, and will probably require us to reconsider how we’re resourcing our nursing homes moving forward into the future.”

Here are the stories our MDedge editors across specialties think you need to know about today:

ACS Update: ‘It is best not to drink alcohol’

The American Cancer Society (ACS) is taking its strongest stance yet against drinking. In its updated cancer prevention guidelines, the ACS now recommends that “it is best not to drink alcohol.” Previously, the organizations had suggested that, for those who consume alcoholic beverages, intake should be no more than one drink per day for women or two per day for men. That recommendation is still in place, but is now accompanied by this new, stronger directive. The guidelines also place more emphasis on reducing the consumption of processed and red meat and highly processed foods, and on increasing physical activity. “Individual choice is an important part of a healthy lifestyle, but having the right policies and environmental factors to break down these barriers is also important, and that is something that clinicians can support,” said Laura Makaroff, DO, American Cancer Society senior vice president. The guidelines were published in CA: A Cancer Journal for Clinicians. Read more.

COVID health system changes may be here to stay

The COVID-19 pandemic has forced sudden major changes to the nation’s health care system that are unlikely to be reversed. While there’s some good news, there are also some alarming trends. Experts said there are three trends that are likely to stick around: telehealth for all, an exodus of primary care physicians, and less emphasis on hospital care. “I’ve been trying to raise the alarm about the kind of perilous future of primary care,” said Farzad Mostashari, MD, a top Department of Health & Human Services official in the Obama administration. Dr. Mostashari runs Aledade, a company that helps primary care doctors make the transition from fee-for-service medicine to new payment models. The American Academy of Family Physicians reports that 70% of primary care physicians are reporting declines in patient volume of 50% or more since March, and 40% have laid off or furloughed staff. The AAFP has joined other primary care and insurance groups in asking HHS for an infusion of cash. “This is absolutely essential to effectively treat patients today and to maintain their ongoing operations until we overcome this public health emergency,” the groups wrote. Read more.

Asthma-COPD overlap deaths

Death rates for combined asthma and chronic obstructive pulmonary disease declined during 1999-2016, but the risk remains higher among women, compared with men, and in certain occupations, according to a recent report from the Centers for Disease Control and Prevention. There is also an association between mortality and nonworking status among adults aged 25-64 years, which “suggests that asthma-COPD overlap might be associated with substantial morbidity,” Katelynn E. Dodd, MPH, and associates at the CDC’s National Institute for Occupational Safety and Health said in the Morbidity and Mortality Weekly Report. “These patients have been reported to have worse health outcomes than do those with asthma or COPD alone.” Read more.

Cancer triage in a pandemic: There’s an app for that

Deciding which cancer patients need immediate treatment and who can safely wait is an uncomfortable assessment for cancer clinicians during the COVID-19 pandemic. Now, a new tool, which appears to be the first of its kind, quantifies that risk-benefit analysis. But its presence immediately raises the question: can it help? OncCOVID is a free tool that was launched in May by the University of Michigan. It allows physicians to individualize risk estimates for delaying treatment of up to 25 early- to late-stage cancers. It includes more than 45 patient characteristics, such as age, location, cancer type, cancer stage, treatment plan, underlying medical conditions, and proposed length of delay in care. “We thought, isn’t it better to at least provide some evidence-based quantification, rather than a back-of-the-envelope three-tier system that is just sort of ‘made up’?“ explained one of the developers, Daniel Spratt, MD, associate professor of radiation oncology at Michigan Medicine. Read more.
 

For more on COVID-19, visit our Resource Center . All of our latest news is available on MDedge.com .

Here are the stories our MDedge editors across specialties think you need to know about today:

ACS Update: ‘It is best not to drink alcohol’

The American Cancer Society (ACS) is taking its strongest stance yet against drinking. In its updated cancer prevention guidelines, the ACS now recommends that “it is best not to drink alcohol.” Previously, the organizations had suggested that, for those who consume alcoholic beverages, intake should be no more than one drink per day for women or two per day for men. That recommendation is still in place, but is now accompanied by this new, stronger directive. The guidelines also place more emphasis on reducing the consumption of processed and red meat and highly processed foods, and on increasing physical activity. “Individual choice is an important part of a healthy lifestyle, but having the right policies and environmental factors to break down these barriers is also important, and that is something that clinicians can support,” said Laura Makaroff, DO, American Cancer Society senior vice president. The guidelines were published in CA: A Cancer Journal for Clinicians. Read more.

COVID health system changes may be here to stay

The COVID-19 pandemic has forced sudden major changes to the nation’s health care system that are unlikely to be reversed. While there’s some good news, there are also some alarming trends. Experts said there are three trends that are likely to stick around: telehealth for all, an exodus of primary care physicians, and less emphasis on hospital care. “I’ve been trying to raise the alarm about the kind of perilous future of primary care,” said Farzad Mostashari, MD, a top Department of Health & Human Services official in the Obama administration. Dr. Mostashari runs Aledade, a company that helps primary care doctors make the transition from fee-for-service medicine to new payment models. The American Academy of Family Physicians reports that 70% of primary care physicians are reporting declines in patient volume of 50% or more since March, and 40% have laid off or furloughed staff. The AAFP has joined other primary care and insurance groups in asking HHS for an infusion of cash. “This is absolutely essential to effectively treat patients today and to maintain their ongoing operations until we overcome this public health emergency,” the groups wrote. Read more.

Asthma-COPD overlap deaths

Death rates for combined asthma and chronic obstructive pulmonary disease declined during 1999-2016, but the risk remains higher among women, compared with men, and in certain occupations, according to a recent report from the Centers for Disease Control and Prevention. There is also an association between mortality and nonworking status among adults aged 25-64 years, which “suggests that asthma-COPD overlap might be associated with substantial morbidity,” Katelynn E. Dodd, MPH, and associates at the CDC’s National Institute for Occupational Safety and Health said in the Morbidity and Mortality Weekly Report. “These patients have been reported to have worse health outcomes than do those with asthma or COPD alone.” Read more.

Cancer triage in a pandemic: There’s an app for that

Deciding which cancer patients need immediate treatment and who can safely wait is an uncomfortable assessment for cancer clinicians during the COVID-19 pandemic. Now, a new tool, which appears to be the first of its kind, quantifies that risk-benefit analysis. But its presence immediately raises the question: can it help? OncCOVID is a free tool that was launched in May by the University of Michigan. It allows physicians to individualize risk estimates for delaying treatment of up to 25 early- to late-stage cancers. It includes more than 45 patient characteristics, such as age, location, cancer type, cancer stage, treatment plan, underlying medical conditions, and proposed length of delay in care. “We thought, isn’t it better to at least provide some evidence-based quantification, rather than a back-of-the-envelope three-tier system that is just sort of ‘made up’?“ explained one of the developers, Daniel Spratt, MD, associate professor of radiation oncology at Michigan Medicine. Read more.
 

For more on COVID-19, visit our Resource Center . All of our latest news is available on MDedge.com .

Here are the stories our MDedge editors across specialties think you need to know about today:

ACS Update: ‘It is best not to drink alcohol’

The American Cancer Society (ACS) is taking its strongest stance yet against drinking. In its updated cancer prevention guidelines, the ACS now recommends that “it is best not to drink alcohol.” Previously, the organizations had suggested that, for those who consume alcoholic beverages, intake should be no more than one drink per day for women or two per day for men. That recommendation is still in place, but is now accompanied by this new, stronger directive. The guidelines also place more emphasis on reducing the consumption of processed and red meat and highly processed foods, and on increasing physical activity. “Individual choice is an important part of a healthy lifestyle, but having the right policies and environmental factors to break down these barriers is also important, and that is something that clinicians can support,” said Laura Makaroff, DO, American Cancer Society senior vice president. The guidelines were published in CA: A Cancer Journal for Clinicians. Read more.

COVID health system changes may be here to stay

The COVID-19 pandemic has forced sudden major changes to the nation’s health care system that are unlikely to be reversed. While there’s some good news, there are also some alarming trends. Experts said there are three trends that are likely to stick around: telehealth for all, an exodus of primary care physicians, and less emphasis on hospital care. “I’ve been trying to raise the alarm about the kind of perilous future of primary care,” said Farzad Mostashari, MD, a top Department of Health & Human Services official in the Obama administration. Dr. Mostashari runs Aledade, a company that helps primary care doctors make the transition from fee-for-service medicine to new payment models. The American Academy of Family Physicians reports that 70% of primary care physicians are reporting declines in patient volume of 50% or more since March, and 40% have laid off or furloughed staff. The AAFP has joined other primary care and insurance groups in asking HHS for an infusion of cash. “This is absolutely essential to effectively treat patients today and to maintain their ongoing operations until we overcome this public health emergency,” the groups wrote. Read more.

Asthma-COPD overlap deaths

Death rates for combined asthma and chronic obstructive pulmonary disease declined during 1999-2016, but the risk remains higher among women, compared with men, and in certain occupations, according to a recent report from the Centers for Disease Control and Prevention. There is also an association between mortality and nonworking status among adults aged 25-64 years, which “suggests that asthma-COPD overlap might be associated with substantial morbidity,” Katelynn E. Dodd, MPH, and associates at the CDC’s National Institute for Occupational Safety and Health said in the Morbidity and Mortality Weekly Report. “These patients have been reported to have worse health outcomes than do those with asthma or COPD alone.” Read more.

Cancer triage in a pandemic: There’s an app for that

Deciding which cancer patients need immediate treatment and who can safely wait is an uncomfortable assessment for cancer clinicians during the COVID-19 pandemic. Now, a new tool, which appears to be the first of its kind, quantifies that risk-benefit analysis. But its presence immediately raises the question: can it help? OncCOVID is a free tool that was launched in May by the University of Michigan. It allows physicians to individualize risk estimates for delaying treatment of up to 25 early- to late-stage cancers. It includes more than 45 patient characteristics, such as age, location, cancer type, cancer stage, treatment plan, underlying medical conditions, and proposed length of delay in care. “We thought, isn’t it better to at least provide some evidence-based quantification, rather than a back-of-the-envelope three-tier system that is just sort of ‘made up’?“ explained one of the developers, Daniel Spratt, MD, associate professor of radiation oncology at Michigan Medicine. Read more.
 

For more on COVID-19, visit our Resource Center . All of our latest news is available on MDedge.com .

I am writing this commentary to bring to readers’ attention a medical and ethical complexity related to human sitters for presumably suicidal, COVID-19–positive hospitalized patients.

To shape and bundle the ethics issues addressed here into a single question, I offer the following: Should policies and practices requiring that patients in presumed need of a sitter because of assessed suicidality change when the patient is COVID-19–positive? Although the analysis might be similar when a sitter is monitoring a Patient Under Investigation (PUI), here I focus only on COVID-19–positive patients. Similarly, there are other reasons for sitters, of course, such as to prevent elopement, or, if a patient is in restraints, to prevent the patient from pulling out lines or tubes. Again, discussion of some of these ethical complications is beyond the scope of this piece. Just considering the matter of potential suicidality and sitters is complex enough. And so, to start, I sought out existing sources for guidance.

In looking for such sources, I first turned to the Centers for Medicare and Medicaid Services before COVID-19. CMS has required that there be a sitter for a patient who is suicidal and that the sitter remain in the room so that the sitter can intervene expeditiously if the patient tries to hurt himself or herself. There has been no change in this guidance since the COVID-19 pandemic in the United States. To the best of my knowledge, there is no substantive guidance for protecting sitters from contagion other than PPE. Given this, it begs the question: Shouldn’t the CMS guidance be changed to allow for hospitals to study different approaches to contagion reduction for sitters?

In my hospital, I already have begun discussing the potential risks of harm and potential benefits to our suicidal patients of having a sitter directly outside the patient’s room. I also have considered whether to have one sitter watching several room cameras at once, commonly referred to as “telehealth strategies.”

To be sure, sitting for hours in the room of a COVID-19–positive patient is onerous. The sitter is required to be in full PPE (N-95 mask, gown, and gloves), which is hot and uncomfortable. Current practice is resource intensive in other ways. It requires changing out the sitter every 2 hours, which uses substantial amounts of PPE and multiple sitters.

Regardless, however, there are really no data upon which to base any sound ethics judgment about what should or should not be tried. We just have no information on how to attempt to balance potential risks and prospects for the benefit of whom and when. And, given that good clinical ethics always begin with the facts, I write this piece to see whether readers have thought about these issues before – and whether any of clinicians have started collecting the valuable data needed to begin making sound ethical judgments about how to care for our presumably suicidal COVID-19–positive patients and the sitters who watch over them.
 

Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].

This column is an outcome of a discussion that occurred during Psych/Ethics rounds on June 5, and does not represent any official statements of Medstar Washington Hospital Center or any entity of the MedStar Corp. Dr. Ritchie would like to thank Evan G. DeRenzo, PhD, of the John J. Lynch Center for Ethics, for her thoughtful review of a previous draft of this commentary.

I am writing this commentary to bring to readers’ attention a medical and ethical complexity related to human sitters for presumably suicidal, COVID-19–positive hospitalized patients.

To shape and bundle the ethics issues addressed here into a single question, I offer the following: Should policies and practices requiring that patients in presumed need of a sitter because of assessed suicidality change when the patient is COVID-19–positive? Although the analysis might be similar when a sitter is monitoring a Patient Under Investigation (PUI), here I focus only on COVID-19–positive patients. Similarly, there are other reasons for sitters, of course, such as to prevent elopement, or, if a patient is in restraints, to prevent the patient from pulling out lines or tubes. Again, discussion of some of these ethical complications is beyond the scope of this piece. Just considering the matter of potential suicidality and sitters is complex enough. And so, to start, I sought out existing sources for guidance.

In looking for such sources, I first turned to the Centers for Medicare and Medicaid Services before COVID-19. CMS has required that there be a sitter for a patient who is suicidal and that the sitter remain in the room so that the sitter can intervene expeditiously if the patient tries to hurt himself or herself. There has been no change in this guidance since the COVID-19 pandemic in the United States. To the best of my knowledge, there is no substantive guidance for protecting sitters from contagion other than PPE. Given this, it begs the question: Shouldn’t the CMS guidance be changed to allow for hospitals to study different approaches to contagion reduction for sitters?

In my hospital, I already have begun discussing the potential risks of harm and potential benefits to our suicidal patients of having a sitter directly outside the patient’s room. I also have considered whether to have one sitter watching several room cameras at once, commonly referred to as “telehealth strategies.”

To be sure, sitting for hours in the room of a COVID-19–positive patient is onerous. The sitter is required to be in full PPE (N-95 mask, gown, and gloves), which is hot and uncomfortable. Current practice is resource intensive in other ways. It requires changing out the sitter every 2 hours, which uses substantial amounts of PPE and multiple sitters.

Regardless, however, there are really no data upon which to base any sound ethics judgment about what should or should not be tried. We just have no information on how to attempt to balance potential risks and prospects for the benefit of whom and when. And, given that good clinical ethics always begin with the facts, I write this piece to see whether readers have thought about these issues before – and whether any of clinicians have started collecting the valuable data needed to begin making sound ethical judgments about how to care for our presumably suicidal COVID-19–positive patients and the sitters who watch over them.
 

Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].

This column is an outcome of a discussion that occurred during Psych/Ethics rounds on June 5, and does not represent any official statements of Medstar Washington Hospital Center or any entity of the MedStar Corp. Dr. Ritchie would like to thank Evan G. DeRenzo, PhD, of the John J. Lynch Center for Ethics, for her thoughtful review of a previous draft of this commentary.

I am writing this commentary to bring to readers’ attention a medical and ethical complexity related to human sitters for presumably suicidal, COVID-19–positive hospitalized patients.

To shape and bundle the ethics issues addressed here into a single question, I offer the following: Should policies and practices requiring that patients in presumed need of a sitter because of assessed suicidality change when the patient is COVID-19–positive? Although the analysis might be similar when a sitter is monitoring a Patient Under Investigation (PUI), here I focus only on COVID-19–positive patients. Similarly, there are other reasons for sitters, of course, such as to prevent elopement, or, if a patient is in restraints, to prevent the patient from pulling out lines or tubes. Again, discussion of some of these ethical complications is beyond the scope of this piece. Just considering the matter of potential suicidality and sitters is complex enough. And so, to start, I sought out existing sources for guidance.

In looking for such sources, I first turned to the Centers for Medicare and Medicaid Services before COVID-19. CMS has required that there be a sitter for a patient who is suicidal and that the sitter remain in the room so that the sitter can intervene expeditiously if the patient tries to hurt himself or herself. There has been no change in this guidance since the COVID-19 pandemic in the United States. To the best of my knowledge, there is no substantive guidance for protecting sitters from contagion other than PPE. Given this, it begs the question: Shouldn’t the CMS guidance be changed to allow for hospitals to study different approaches to contagion reduction for sitters?

In my hospital, I already have begun discussing the potential risks of harm and potential benefits to our suicidal patients of having a sitter directly outside the patient’s room. I also have considered whether to have one sitter watching several room cameras at once, commonly referred to as “telehealth strategies.”

To be sure, sitting for hours in the room of a COVID-19–positive patient is onerous. The sitter is required to be in full PPE (N-95 mask, gown, and gloves), which is hot and uncomfortable. Current practice is resource intensive in other ways. It requires changing out the sitter every 2 hours, which uses substantial amounts of PPE and multiple sitters.

Regardless, however, there are really no data upon which to base any sound ethics judgment about what should or should not be tried. We just have no information on how to attempt to balance potential risks and prospects for the benefit of whom and when. And, given that good clinical ethics always begin with the facts, I write this piece to see whether readers have thought about these issues before – and whether any of clinicians have started collecting the valuable data needed to begin making sound ethical judgments about how to care for our presumably suicidal COVID-19–positive patients and the sitters who watch over them.
 

Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].

This column is an outcome of a discussion that occurred during Psych/Ethics rounds on June 5, and does not represent any official statements of Medstar Washington Hospital Center or any entity of the MedStar Corp. Dr. Ritchie would like to thank Evan G. DeRenzo, PhD, of the John J. Lynch Center for Ethics, for her thoughtful review of a previous draft of this commentary.

Pediatric patients hospitalized with more severe COVID-19 disease had higher levels of several inflammatory markers than did those with less severe disease, according to data from 50 patients at a single tertiary care center.

Courtesy NIAID-RML

“Risk factors for severe disease in pediatric populations have not been clearly identified and the high prevalence of SARS-CoV-2 in NYC offers an opportunity to describe severe pediatric disease in more detail,” wrote Philip Zachariah, MD, of New York–Presbyterian Hospital, New York, and colleagues.

In a retrospective case series published in JAMA Pediatrics, the researchers reviewed data from 50 patients: 41 classified as severe and 9 classified as nonsevere. Among the patients, 27 were male and 25 were Hispanic. The patient population had a median of 2 days from symptom onset to hospital admission. The most common symptoms were fever (80%) and respiratory symptoms (64%). Seventy-six percent of patients had a median length of stay of 3 days (range 1-30 days).

At hospital admission, children with severe disease had significantly higher levels of several inflammatory markers compared with those without severe disease, notably C-reactive protein (median 8.978 mg/dL vs. 0.64 mg/dL) and procalcitonin (median 0.31 ng/mL vs. 0.17 ng/mL, (P < .001 for both). High mean peak levels of C-reactive protein, procalcitonin, interleukin 6, ferritin, and D-dimer were seen among the nine children (16%) who required mechanical ventilation, Dr. Zachariah and associates said.

None of the 14 infants and 1 of the 8 immunocompromised children in the study had severe disease, the researchers wrote.

Bacterial coinfections detected while patients were hospitalized were bacteremia in 6%, suspected bacterial pneumonia in 18%, urinary tract infections in 10%, skin and soft tissue infections in 6%, and streptococcus pharyngitis in 2%, Dr. Zachariah and associates reported.

Overall, 61% of the children had comorbidities identified in previous COVID-19 studies, of which obesity was the most common (22%); other comorbidities included asthma, sickle cell disease, cardiac disease, and diabetes. Obesity also was significantly associated with the need for mechanical ventilation in children aged 2 years and older (67%). A total of 16 patients required respiratory support, 9 of these were placed on mechanical ventilation; 6 of these 9 children were obese.

Fifteen patients (30%) who met criteria for increased oxygen requirements and respiratory distress received hydroxychloroquine, but the small sample size did not allow for assessment of treatment efficacy, the researchers said.

“Expanding our knowledge of COVID-19 [disease] in children will potentially permit early recognition of SARS-CoV-2 infection, understanding of the natural history of disease, and potential complications, said Stephen I. Pelton, MD, professor of pediatrics and epidemiology at Boston University and senior attending physician at Boston Medical Center. This review of 50 SARS-CoV-2 infected children (less than 21 years of age) “provides insight into the short period of symptoms prior to hospitalization, challenges the concept that infants less than 1 year are at greatest risk of severe disease (as from the experience in China), and suggests rapid recovery in many children, as median length of stay was 3 days.

“The review revealed two findings that were surprising to me. First, the median length of stay of 3 days. As nearly 20% of the children required mechanical ventilation, it suggests many of the children were discharged quickly after evaluation, suggesting that we need to identify markers of severity to predict those children likely to have progressive disease and require respiratory support,” Dr. Pelton noted.

“The second observation suggests high rates of bacterial infection (bacteremia, pneumonia, UTI, and skin and soft tissue infection). I do not think this has been widely reported in adults, and may represent a difference between child and adult disease. More studies such as this will be required to identify how common coinfection with bacteria is,” he said.

“The take-home message is that although most children with COVID-19 have a mild or even asymptomatic course, some become severely ill requiring ventilator support and potentially ECMO [extracorporeal membrane oxygenation]. Potential predictors of severity include high C-reactive protein, obesity, and older age [adolescence], said Dr. Pelton, who was not involved in the study.

What additional research is needed? Dr. Pelton said that better markers of severe disease are needed, as well as an understanding of why obesity is a risk factor for severe disease in both children and adults. Are these prediabetic patients? he asked.

The study findings were limited by the small sample size and high proportion of Hispanic patients, which may limit generalizability, and some symptoms and comorbidities may have been missed because of the retrospective nature of the study, the researchers noted. However, the results support the need for hospitals to remain vigilant to the variable presentations of COVID-19 infections in children.

“Therapeutic considerations need to [include] the risk of toxicity, control of antiviral replication, and early recognition and management of immune dysregulation,” they concluded.

The study received no outside funding. Dr. Zachariah had no financial conflicts to disclose. Two coauthors reported ties with various pharmaceutical companies and organizations. Dr. Pelton said he had no relevant financial disclosures.

[email protected]

SOURCE: Zachariah P et al. JAMA Pediatr. 2020 June 3. doi:10.1001/jamapediatrics.2020.2430.

Pediatric patients hospitalized with more severe COVID-19 disease had higher levels of several inflammatory markers than did those with less severe disease, according to data from 50 patients at a single tertiary care center.

Courtesy NIAID-RML

“Risk factors for severe disease in pediatric populations have not been clearly identified and the high prevalence of SARS-CoV-2 in NYC offers an opportunity to describe severe pediatric disease in more detail,” wrote Philip Zachariah, MD, of New York–Presbyterian Hospital, New York, and colleagues.

In a retrospective case series published in JAMA Pediatrics, the researchers reviewed data from 50 patients: 41 classified as severe and 9 classified as nonsevere. Among the patients, 27 were male and 25 were Hispanic. The patient population had a median of 2 days from symptom onset to hospital admission. The most common symptoms were fever (80%) and respiratory symptoms (64%). Seventy-six percent of patients had a median length of stay of 3 days (range 1-30 days).

At hospital admission, children with severe disease had significantly higher levels of several inflammatory markers compared with those without severe disease, notably C-reactive protein (median 8.978 mg/dL vs. 0.64 mg/dL) and procalcitonin (median 0.31 ng/mL vs. 0.17 ng/mL, (P < .001 for both). High mean peak levels of C-reactive protein, procalcitonin, interleukin 6, ferritin, and D-dimer were seen among the nine children (16%) who required mechanical ventilation, Dr. Zachariah and associates said.

None of the 14 infants and 1 of the 8 immunocompromised children in the study had severe disease, the researchers wrote.

Bacterial coinfections detected while patients were hospitalized were bacteremia in 6%, suspected bacterial pneumonia in 18%, urinary tract infections in 10%, skin and soft tissue infections in 6%, and streptococcus pharyngitis in 2%, Dr. Zachariah and associates reported.

Overall, 61% of the children had comorbidities identified in previous COVID-19 studies, of which obesity was the most common (22%); other comorbidities included asthma, sickle cell disease, cardiac disease, and diabetes. Obesity also was significantly associated with the need for mechanical ventilation in children aged 2 years and older (67%). A total of 16 patients required respiratory support, 9 of these were placed on mechanical ventilation; 6 of these 9 children were obese.

Fifteen patients (30%) who met criteria for increased oxygen requirements and respiratory distress received hydroxychloroquine, but the small sample size did not allow for assessment of treatment efficacy, the researchers said.

“Expanding our knowledge of COVID-19 [disease] in children will potentially permit early recognition of SARS-CoV-2 infection, understanding of the natural history of disease, and potential complications, said Stephen I. Pelton, MD, professor of pediatrics and epidemiology at Boston University and senior attending physician at Boston Medical Center. This review of 50 SARS-CoV-2 infected children (less than 21 years of age) “provides insight into the short period of symptoms prior to hospitalization, challenges the concept that infants less than 1 year are at greatest risk of severe disease (as from the experience in China), and suggests rapid recovery in many children, as median length of stay was 3 days.

“The review revealed two findings that were surprising to me. First, the median length of stay of 3 days. As nearly 20% of the children required mechanical ventilation, it suggests many of the children were discharged quickly after evaluation, suggesting that we need to identify markers of severity to predict those children likely to have progressive disease and require respiratory support,” Dr. Pelton noted.

“The second observation suggests high rates of bacterial infection (bacteremia, pneumonia, UTI, and skin and soft tissue infection). I do not think this has been widely reported in adults, and may represent a difference between child and adult disease. More studies such as this will be required to identify how common coinfection with bacteria is,” he said.

“The take-home message is that although most children with COVID-19 have a mild or even asymptomatic course, some become severely ill requiring ventilator support and potentially ECMO [extracorporeal membrane oxygenation]. Potential predictors of severity include high C-reactive protein, obesity, and older age [adolescence], said Dr. Pelton, who was not involved in the study.

What additional research is needed? Dr. Pelton said that better markers of severe disease are needed, as well as an understanding of why obesity is a risk factor for severe disease in both children and adults. Are these prediabetic patients? he asked.

The study findings were limited by the small sample size and high proportion of Hispanic patients, which may limit generalizability, and some symptoms and comorbidities may have been missed because of the retrospective nature of the study, the researchers noted. However, the results support the need for hospitals to remain vigilant to the variable presentations of COVID-19 infections in children.

“Therapeutic considerations need to [include] the risk of toxicity, control of antiviral replication, and early recognition and management of immune dysregulation,” they concluded.

The study received no outside funding. Dr. Zachariah had no financial conflicts to disclose. Two coauthors reported ties with various pharmaceutical companies and organizations. Dr. Pelton said he had no relevant financial disclosures.

[email protected]

SOURCE: Zachariah P et al. JAMA Pediatr. 2020 June 3. doi:10.1001/jamapediatrics.2020.2430.

Pediatric patients hospitalized with more severe COVID-19 disease had higher levels of several inflammatory markers than did those with less severe disease, according to data from 50 patients at a single tertiary care center.

Courtesy NIAID-RML

“Risk factors for severe disease in pediatric populations have not been clearly identified and the high prevalence of SARS-CoV-2 in NYC offers an opportunity to describe severe pediatric disease in more detail,” wrote Philip Zachariah, MD, of New York–Presbyterian Hospital, New York, and colleagues.

In a retrospective case series published in JAMA Pediatrics, the researchers reviewed data from 50 patients: 41 classified as severe and 9 classified as nonsevere. Among the patients, 27 were male and 25 were Hispanic. The patient population had a median of 2 days from symptom onset to hospital admission. The most common symptoms were fever (80%) and respiratory symptoms (64%). Seventy-six percent of patients had a median length of stay of 3 days (range 1-30 days).

At hospital admission, children with severe disease had significantly higher levels of several inflammatory markers compared with those without severe disease, notably C-reactive protein (median 8.978 mg/dL vs. 0.64 mg/dL) and procalcitonin (median 0.31 ng/mL vs. 0.17 ng/mL, (P < .001 for both). High mean peak levels of C-reactive protein, procalcitonin, interleukin 6, ferritin, and D-dimer were seen among the nine children (16%) who required mechanical ventilation, Dr. Zachariah and associates said.

None of the 14 infants and 1 of the 8 immunocompromised children in the study had severe disease, the researchers wrote.

Bacterial coinfections detected while patients were hospitalized were bacteremia in 6%, suspected bacterial pneumonia in 18%, urinary tract infections in 10%, skin and soft tissue infections in 6%, and streptococcus pharyngitis in 2%, Dr. Zachariah and associates reported.

Overall, 61% of the children had comorbidities identified in previous COVID-19 studies, of which obesity was the most common (22%); other comorbidities included asthma, sickle cell disease, cardiac disease, and diabetes. Obesity also was significantly associated with the need for mechanical ventilation in children aged 2 years and older (67%). A total of 16 patients required respiratory support, 9 of these were placed on mechanical ventilation; 6 of these 9 children were obese.

Fifteen patients (30%) who met criteria for increased oxygen requirements and respiratory distress received hydroxychloroquine, but the small sample size did not allow for assessment of treatment efficacy, the researchers said.

“Expanding our knowledge of COVID-19 [disease] in children will potentially permit early recognition of SARS-CoV-2 infection, understanding of the natural history of disease, and potential complications, said Stephen I. Pelton, MD, professor of pediatrics and epidemiology at Boston University and senior attending physician at Boston Medical Center. This review of 50 SARS-CoV-2 infected children (less than 21 years of age) “provides insight into the short period of symptoms prior to hospitalization, challenges the concept that infants less than 1 year are at greatest risk of severe disease (as from the experience in China), and suggests rapid recovery in many children, as median length of stay was 3 days.

“The review revealed two findings that were surprising to me. First, the median length of stay of 3 days. As nearly 20% of the children required mechanical ventilation, it suggests many of the children were discharged quickly after evaluation, suggesting that we need to identify markers of severity to predict those children likely to have progressive disease and require respiratory support,” Dr. Pelton noted.

“The second observation suggests high rates of bacterial infection (bacteremia, pneumonia, UTI, and skin and soft tissue infection). I do not think this has been widely reported in adults, and may represent a difference between child and adult disease. More studies such as this will be required to identify how common coinfection with bacteria is,” he said.

“The take-home message is that although most children with COVID-19 have a mild or even asymptomatic course, some become severely ill requiring ventilator support and potentially ECMO [extracorporeal membrane oxygenation]. Potential predictors of severity include high C-reactive protein, obesity, and older age [adolescence], said Dr. Pelton, who was not involved in the study.

What additional research is needed? Dr. Pelton said that better markers of severe disease are needed, as well as an understanding of why obesity is a risk factor for severe disease in both children and adults. Are these prediabetic patients? he asked.

The study findings were limited by the small sample size and high proportion of Hispanic patients, which may limit generalizability, and some symptoms and comorbidities may have been missed because of the retrospective nature of the study, the researchers noted. However, the results support the need for hospitals to remain vigilant to the variable presentations of COVID-19 infections in children.

“Therapeutic considerations need to [include] the risk of toxicity, control of antiviral replication, and early recognition and management of immune dysregulation,” they concluded.

The study received no outside funding. Dr. Zachariah had no financial conflicts to disclose. Two coauthors reported ties with various pharmaceutical companies and organizations. Dr. Pelton said he had no relevant financial disclosures.

[email protected]

SOURCE: Zachariah P et al. JAMA Pediatr. 2020 June 3. doi:10.1001/jamapediatrics.2020.2430.

The U.S. health care system is famously resistant to government-imposed change. It took decades to create Medicare and Medicaid, mostly because of opposition from the medical-industrial complex. Then it was nearly another half-century before the passage of the Affordable Care Act.

But the COVID-19 pandemic has done what no president or social movement or venture capitalist could have dreamed of: It forced sudden major changes to the nation’s health care system that are unlikely to be reversed.

“Health care is never going back to the way it was before,” said Gail Wilensky, a health economist who ran the Medicare and Medicaid programs for President George H.W. Bush in the early 1990s.

Ms. Wilensky is far from the only longtime observer of the American health care system to marvel at the speed of some long-sought changes. But experts warn that the breakthroughs may not all make the health system work better or make it less expensive.

That said, here are three trends that seem likely to continue.
 

Telehealth for all

Telehealth is not new; medical professionals have used it to reach patients in rural or remote settings since the late 1980s.

But even while technology has made video visits easier, it has failed to reach critical mass, largely because of political fights. Licensing has been one main obstacle – determining how a doctor in one state can legally treat a patient in a state where the doctor is not licensed.

The other obstacle, not surprisingly, is payment. Should a video visit be reimbursed at the same rate as an in-person visit? Will making it easier for doctors and other medical professionals to use telehealth encourage unnecessary care, thus driving up the nation’s $3.6 trillion health tab even more? Or could it replace care once provided free by phone?

Still, the pandemic has pushed aside those sticking points. Almost overnight, by necessity, every health care provider who can is delivering telemedicine. A new survey from Gallup found the number of patients reporting “virtual” medical visits more than doubled, from 12% to 27%, from late March to mid-May. That is attributable, at least in part, to Medicare having made it easier for doctors to bill for virtual visits.

It’s easy to see why many patients like video visits – there’s no parking to find and pay for, and it takes far less time out of a workday than going to an office.

Doctors and other practitioners seem more ambivalent. On one hand, it can be harder to examine a patient over video and some services just can’t be done via a digital connection. On the other hand, they can see more patients in the same amount of time and may need less support staff and possibly smaller offices if more visits are conducted virtually.

Of course, telemedicine doesn’t work for everyone. Many areas and patients don’t have reliable or robust broadband connections that make video visits work. And some patients, particularly the oldest seniors, lack the technological skills needed to connect.
 

Primary care doctors in peril

Another trend that has suddenly accelerated is worry over the nation’s dwindling supply of primary care doctors. The exodus of practitioners performing primary care has been a concern over the past several years, as baby boomer doctors retire and others have grown weary of more and more bureaucracy from government and private payers. Having faced a difficult financial crisis during the pandemic, more family physicians may move into retirement or seek other professional options.

At the same time, fewer current medical students are choosing specialties in primary care.

“I’ve been trying to raise the alarm about the kind of perilous future of primary care,” said Farzad Mostashari, MD, a top Department of Health & Human Services official in the Obama administration. Dr. Mostashari runs Aledade, a company that helps primary care doctors make the transition from fee-for-service medicine to new payment models.

The American Academy of Family Physicians reports that 70% of primary care physicians are reporting declines in patient volume of 50% or more since March, and 40% have laid off or furloughed staff. The AAFP has joined other primary care and insurance groups in asking HHS for an infusion of cash.

“This is absolutely essential to effectively treat patients today and to maintain their ongoing operations until we overcome this public health emergency,” the groups wrote.

One easy way to help keep primary care doctors afloat would be to pay them not according to what they do, but in a lump sum to keep patients healthy. This move from fee-for-service to what’s known as capitation or value-based care has unfolded gradually and was championed in the Affordable Care Act.

But some experts argue it needs to happen more quickly and they predict that the coronavirus pandemic could finally mark the beginning of the end for doctors who still charge for each service individually. Dr. Mostashari, who spends his time helping doctors make the transition, said in times like these, it would make more sense for primary care doctors to have “a steady monthly revenue stream, and [the doctor] can decide the best way to deliver that care: unlimited texts, phone calls, video calls. The goal is to give you satisfactory outcomes and a great patient experience.”

Still, many physicians, particularly those in solo or small practices, worry about the potential financial risk – especially the possibility of getting paid less if they don’t meet certain benchmarks that the doctors may not be able to directly control.

But with many practices now ground to a halt, or just starting to reopen, those physicians who get paid per patient rather than per service are in a much better position to stay afloat. That model may gain traction as doctors ponder the next pandemic, or the next wave of this one.
 

Hospitals on the decline?

The pandemic also might lead to less emphasis on hospital-based care. While hospitals in many parts of the country have obviously been full of very sick COVID patients, they have closed down other nonemergency services to preserve supplies and resources to fight the pandemic. People with other ailments have stayed away in droves even when services were available, for fear of catching something worse than what they already have.

Many experts predict that care won’t just snap back when the current emergency wanes. Mark Smith, MD, former president of the California Health Care Foundation, said among consumers, a switch has been flipped. “Overnight it seems we’ve gone from high-touch to no-touch.”

Which is not great for hospitals that have spent millions trying to attract patients to their labor-and-delivery units, orthopedic centers, and other parts of the facility that once generated lots of income.

Even more concerning is that hospitals’ ability to weather the current financial shock varies widely. Those most in danger of closing are in rural and underserved areas, where patients could wind up with even less access to care that is scarce already.

All of which underscores the point that not all these changes will necessarily be good for the health system or society. Financial pressures could end up driving more consolidation, which could push up prices as large groups of hospitals and doctors gain more bargaining clout.

But the changes are definitely happening at a pace few have ever seen, said Ms. Wilensky, “When you’re forced to find different ways of doing things, and you find out they are easier and more efficient, it’s going to be hard to go back to the old way.”
 

A version of this article originally appeared on Kaiser Health News, which is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The U.S. health care system is famously resistant to government-imposed change. It took decades to create Medicare and Medicaid, mostly because of opposition from the medical-industrial complex. Then it was nearly another half-century before the passage of the Affordable Care Act.

But the COVID-19 pandemic has done what no president or social movement or venture capitalist could have dreamed of: It forced sudden major changes to the nation’s health care system that are unlikely to be reversed.

“Health care is never going back to the way it was before,” said Gail Wilensky, a health economist who ran the Medicare and Medicaid programs for President George H.W. Bush in the early 1990s.

Ms. Wilensky is far from the only longtime observer of the American health care system to marvel at the speed of some long-sought changes. But experts warn that the breakthroughs may not all make the health system work better or make it less expensive.

That said, here are three trends that seem likely to continue.
 

Telehealth for all

Telehealth is not new; medical professionals have used it to reach patients in rural or remote settings since the late 1980s.

But even while technology has made video visits easier, it has failed to reach critical mass, largely because of political fights. Licensing has been one main obstacle – determining how a doctor in one state can legally treat a patient in a state where the doctor is not licensed.

The other obstacle, not surprisingly, is payment. Should a video visit be reimbursed at the same rate as an in-person visit? Will making it easier for doctors and other medical professionals to use telehealth encourage unnecessary care, thus driving up the nation’s $3.6 trillion health tab even more? Or could it replace care once provided free by phone?

Still, the pandemic has pushed aside those sticking points. Almost overnight, by necessity, every health care provider who can is delivering telemedicine. A new survey from Gallup found the number of patients reporting “virtual” medical visits more than doubled, from 12% to 27%, from late March to mid-May. That is attributable, at least in part, to Medicare having made it easier for doctors to bill for virtual visits.

It’s easy to see why many patients like video visits – there’s no parking to find and pay for, and it takes far less time out of a workday than going to an office.

Doctors and other practitioners seem more ambivalent. On one hand, it can be harder to examine a patient over video and some services just can’t be done via a digital connection. On the other hand, they can see more patients in the same amount of time and may need less support staff and possibly smaller offices if more visits are conducted virtually.

Of course, telemedicine doesn’t work for everyone. Many areas and patients don’t have reliable or robust broadband connections that make video visits work. And some patients, particularly the oldest seniors, lack the technological skills needed to connect.
 

Primary care doctors in peril

Another trend that has suddenly accelerated is worry over the nation’s dwindling supply of primary care doctors. The exodus of practitioners performing primary care has been a concern over the past several years, as baby boomer doctors retire and others have grown weary of more and more bureaucracy from government and private payers. Having faced a difficult financial crisis during the pandemic, more family physicians may move into retirement or seek other professional options.

At the same time, fewer current medical students are choosing specialties in primary care.

“I’ve been trying to raise the alarm about the kind of perilous future of primary care,” said Farzad Mostashari, MD, a top Department of Health & Human Services official in the Obama administration. Dr. Mostashari runs Aledade, a company that helps primary care doctors make the transition from fee-for-service medicine to new payment models.

The American Academy of Family Physicians reports that 70% of primary care physicians are reporting declines in patient volume of 50% or more since March, and 40% have laid off or furloughed staff. The AAFP has joined other primary care and insurance groups in asking HHS for an infusion of cash.

“This is absolutely essential to effectively treat patients today and to maintain their ongoing operations until we overcome this public health emergency,” the groups wrote.

One easy way to help keep primary care doctors afloat would be to pay them not according to what they do, but in a lump sum to keep patients healthy. This move from fee-for-service to what’s known as capitation or value-based care has unfolded gradually and was championed in the Affordable Care Act.

But some experts argue it needs to happen more quickly and they predict that the coronavirus pandemic could finally mark the beginning of the end for doctors who still charge for each service individually. Dr. Mostashari, who spends his time helping doctors make the transition, said in times like these, it would make more sense for primary care doctors to have “a steady monthly revenue stream, and [the doctor] can decide the best way to deliver that care: unlimited texts, phone calls, video calls. The goal is to give you satisfactory outcomes and a great patient experience.”

Still, many physicians, particularly those in solo or small practices, worry about the potential financial risk – especially the possibility of getting paid less if they don’t meet certain benchmarks that the doctors may not be able to directly control.

But with many practices now ground to a halt, or just starting to reopen, those physicians who get paid per patient rather than per service are in a much better position to stay afloat. That model may gain traction as doctors ponder the next pandemic, or the next wave of this one.
 

Hospitals on the decline?

The pandemic also might lead to less emphasis on hospital-based care. While hospitals in many parts of the country have obviously been full of very sick COVID patients, they have closed down other nonemergency services to preserve supplies and resources to fight the pandemic. People with other ailments have stayed away in droves even when services were available, for fear of catching something worse than what they already have.

Many experts predict that care won’t just snap back when the current emergency wanes. Mark Smith, MD, former president of the California Health Care Foundation, said among consumers, a switch has been flipped. “Overnight it seems we’ve gone from high-touch to no-touch.”

Which is not great for hospitals that have spent millions trying to attract patients to their labor-and-delivery units, orthopedic centers, and other parts of the facility that once generated lots of income.

Even more concerning is that hospitals’ ability to weather the current financial shock varies widely. Those most in danger of closing are in rural and underserved areas, where patients could wind up with even less access to care that is scarce already.

All of which underscores the point that not all these changes will necessarily be good for the health system or society. Financial pressures could end up driving more consolidation, which could push up prices as large groups of hospitals and doctors gain more bargaining clout.

But the changes are definitely happening at a pace few have ever seen, said Ms. Wilensky, “When you’re forced to find different ways of doing things, and you find out they are easier and more efficient, it’s going to be hard to go back to the old way.”
 

A version of this article originally appeared on Kaiser Health News, which is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The U.S. health care system is famously resistant to government-imposed change. It took decades to create Medicare and Medicaid, mostly because of opposition from the medical-industrial complex. Then it was nearly another half-century before the passage of the Affordable Care Act.

But the COVID-19 pandemic has done what no president or social movement or venture capitalist could have dreamed of: It forced sudden major changes to the nation’s health care system that are unlikely to be reversed.

“Health care is never going back to the way it was before,” said Gail Wilensky, a health economist who ran the Medicare and Medicaid programs for President George H.W. Bush in the early 1990s.

Ms. Wilensky is far from the only longtime observer of the American health care system to marvel at the speed of some long-sought changes. But experts warn that the breakthroughs may not all make the health system work better or make it less expensive.

That said, here are three trends that seem likely to continue.
 

Telehealth for all

Telehealth is not new; medical professionals have used it to reach patients in rural or remote settings since the late 1980s.

But even while technology has made video visits easier, it has failed to reach critical mass, largely because of political fights. Licensing has been one main obstacle – determining how a doctor in one state can legally treat a patient in a state where the doctor is not licensed.

The other obstacle, not surprisingly, is payment. Should a video visit be reimbursed at the same rate as an in-person visit? Will making it easier for doctors and other medical professionals to use telehealth encourage unnecessary care, thus driving up the nation’s $3.6 trillion health tab even more? Or could it replace care once provided free by phone?

Still, the pandemic has pushed aside those sticking points. Almost overnight, by necessity, every health care provider who can is delivering telemedicine. A new survey from Gallup found the number of patients reporting “virtual” medical visits more than doubled, from 12% to 27%, from late March to mid-May. That is attributable, at least in part, to Medicare having made it easier for doctors to bill for virtual visits.

It’s easy to see why many patients like video visits – there’s no parking to find and pay for, and it takes far less time out of a workday than going to an office.

Doctors and other practitioners seem more ambivalent. On one hand, it can be harder to examine a patient over video and some services just can’t be done via a digital connection. On the other hand, they can see more patients in the same amount of time and may need less support staff and possibly smaller offices if more visits are conducted virtually.

Of course, telemedicine doesn’t work for everyone. Many areas and patients don’t have reliable or robust broadband connections that make video visits work. And some patients, particularly the oldest seniors, lack the technological skills needed to connect.
 

Primary care doctors in peril

Another trend that has suddenly accelerated is worry over the nation’s dwindling supply of primary care doctors. The exodus of practitioners performing primary care has been a concern over the past several years, as baby boomer doctors retire and others have grown weary of more and more bureaucracy from government and private payers. Having faced a difficult financial crisis during the pandemic, more family physicians may move into retirement or seek other professional options.

At the same time, fewer current medical students are choosing specialties in primary care.

“I’ve been trying to raise the alarm about the kind of perilous future of primary care,” said Farzad Mostashari, MD, a top Department of Health & Human Services official in the Obama administration. Dr. Mostashari runs Aledade, a company that helps primary care doctors make the transition from fee-for-service medicine to new payment models.

The American Academy of Family Physicians reports that 70% of primary care physicians are reporting declines in patient volume of 50% or more since March, and 40% have laid off or furloughed staff. The AAFP has joined other primary care and insurance groups in asking HHS for an infusion of cash.

“This is absolutely essential to effectively treat patients today and to maintain their ongoing operations until we overcome this public health emergency,” the groups wrote.

One easy way to help keep primary care doctors afloat would be to pay them not according to what they do, but in a lump sum to keep patients healthy. This move from fee-for-service to what’s known as capitation or value-based care has unfolded gradually and was championed in the Affordable Care Act.

But some experts argue it needs to happen more quickly and they predict that the coronavirus pandemic could finally mark the beginning of the end for doctors who still charge for each service individually. Dr. Mostashari, who spends his time helping doctors make the transition, said in times like these, it would make more sense for primary care doctors to have “a steady monthly revenue stream, and [the doctor] can decide the best way to deliver that care: unlimited texts, phone calls, video calls. The goal is to give you satisfactory outcomes and a great patient experience.”

Still, many physicians, particularly those in solo or small practices, worry about the potential financial risk – especially the possibility of getting paid less if they don’t meet certain benchmarks that the doctors may not be able to directly control.

But with many practices now ground to a halt, or just starting to reopen, those physicians who get paid per patient rather than per service are in a much better position to stay afloat. That model may gain traction as doctors ponder the next pandemic, or the next wave of this one.
 

Hospitals on the decline?

The pandemic also might lead to less emphasis on hospital-based care. While hospitals in many parts of the country have obviously been full of very sick COVID patients, they have closed down other nonemergency services to preserve supplies and resources to fight the pandemic. People with other ailments have stayed away in droves even when services were available, for fear of catching something worse than what they already have.

Many experts predict that care won’t just snap back when the current emergency wanes. Mark Smith, MD, former president of the California Health Care Foundation, said among consumers, a switch has been flipped. “Overnight it seems we’ve gone from high-touch to no-touch.”

Which is not great for hospitals that have spent millions trying to attract patients to their labor-and-delivery units, orthopedic centers, and other parts of the facility that once generated lots of income.

Even more concerning is that hospitals’ ability to weather the current financial shock varies widely. Those most in danger of closing are in rural and underserved areas, where patients could wind up with even less access to care that is scarce already.

All of which underscores the point that not all these changes will necessarily be good for the health system or society. Financial pressures could end up driving more consolidation, which could push up prices as large groups of hospitals and doctors gain more bargaining clout.

But the changes are definitely happening at a pace few have ever seen, said Ms. Wilensky, “When you’re forced to find different ways of doing things, and you find out they are easier and more efficient, it’s going to be hard to go back to the old way.”
 

A version of this article originally appeared on Kaiser Health News, which is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The presence of pulmonary arterial hypertension, whether preexisting or occurring in conjunction with a COVID-19 infection, will likely increase the risk for morbidity and mortality in these patients, according to a research article published in Pulmonary Circulation.

“The impetus for this manuscript was a recent discussion within the Pulmonary Hypertension Association (PHA) and [its] Scientific Leadership Council who expressed a need for guidelines from experts in the field,” wrote John J. Ryan, MD, of the University of Utah, Salt Lake City, and colleagues.

The authors highlight some of the unique challenges in caring for patients with pulmonary hypertension (PH), particularly pulmonary arterial hypertension (PAH), in the context of the COVID-19 pandemic.

Telemedicine and temporary visit schedules for new and returning PAH patients can help reduce risk of virus transmission, if patient accessibility to telemedicine is feasible. Protocols to reduce the risk of virus exposure or transmission in the office setting included less frequent echocardiography and 6-Minute Walk Tests (6MWTs) for patients in stable condition. In stable patients, “avoid pulmonary function of V/Q tests when possible,” the authors wrote.

New patients who have been referred for PAH present a challenge in conducting a thorough evaluation that would normally include measurement of invasive hemodynamics in keeping with current diagnostic guidelines. Clinicians will need to balance the potential risks of COVID-19 exposure during elective procedures against the benefits of full evaluations to plan PAH treatment, the authors noted.

For established patients who are clinically stable, remote visits may be an option, with a risk/benefit assessment of the need for in-person diagnostic tests at the current time, they said. However, telemedicine’s limitations include not only patient accessibility and understanding of audio and video technology, but also inability to accurately measure vital signs, they said.

As for routine testing such as echocardiograms, 6MWTs, and other laboratory testing, “it is important to consider the additive value of these sometimes comprehensive tests in the context of the risks associated with visiting the hospital or clinic to obtain them,” the authors said.

Patients who are unstable and experience worsening right heart failure (RHF) at home may have contracted a COVID-19 infection, but the differential diagnosis includes sepsis, ischemia, and PAH disease progression. “During the current pandemic, fever at home in a PAH patient should be assumed to represent a COVID-19 infection,” and patients with worsening respiratory symptoms that require hospitalization should be tested for COVID-19, the authors emphasized.

Use of ECMO or other intensive interventions should be considered in the context of risk assessment, the authors said. “As a general recommendation, practitioners should consider utilizing an established PAH-specific risk assessment tool to help identify patients who are more likely to survive heroic interventions during the COVID-19 outbreak,” they wrote.

Training and education of PH providers will continue to be limited by the pandemic, and many clinical trials and research programs have been suspended and will need to be restructured to minimize risk of transmission of the COVID-19 virus, the authors said. However, health care providers must continue to provide PAH patients and families with advice and updates in best practices, while “acknowledging that the situation changes rapidly,” they concluded.

Dr. Ryan disclosed participating on the speakers bureau, and provides consulting services for, Actelion and Bayer, as well as research support from the Reagan Corporation, the Gordon Family, and the Cushman Family.

SOURCE: Ryan JJ et al. Pulm Circ. 2020 Apr 29. doi: 10.1177/2045894020920153.

The presence of pulmonary arterial hypertension, whether preexisting or occurring in conjunction with a COVID-19 infection, will likely increase the risk for morbidity and mortality in these patients, according to a research article published in Pulmonary Circulation.

“The impetus for this manuscript was a recent discussion within the Pulmonary Hypertension Association (PHA) and [its] Scientific Leadership Council who expressed a need for guidelines from experts in the field,” wrote John J. Ryan, MD, of the University of Utah, Salt Lake City, and colleagues.

The authors highlight some of the unique challenges in caring for patients with pulmonary hypertension (PH), particularly pulmonary arterial hypertension (PAH), in the context of the COVID-19 pandemic.

Telemedicine and temporary visit schedules for new and returning PAH patients can help reduce risk of virus transmission, if patient accessibility to telemedicine is feasible. Protocols to reduce the risk of virus exposure or transmission in the office setting included less frequent echocardiography and 6-Minute Walk Tests (6MWTs) for patients in stable condition. In stable patients, “avoid pulmonary function of V/Q tests when possible,” the authors wrote.

New patients who have been referred for PAH present a challenge in conducting a thorough evaluation that would normally include measurement of invasive hemodynamics in keeping with current diagnostic guidelines. Clinicians will need to balance the potential risks of COVID-19 exposure during elective procedures against the benefits of full evaluations to plan PAH treatment, the authors noted.

For established patients who are clinically stable, remote visits may be an option, with a risk/benefit assessment of the need for in-person diagnostic tests at the current time, they said. However, telemedicine’s limitations include not only patient accessibility and understanding of audio and video technology, but also inability to accurately measure vital signs, they said.

As for routine testing such as echocardiograms, 6MWTs, and other laboratory testing, “it is important to consider the additive value of these sometimes comprehensive tests in the context of the risks associated with visiting the hospital or clinic to obtain them,” the authors said.

Patients who are unstable and experience worsening right heart failure (RHF) at home may have contracted a COVID-19 infection, but the differential diagnosis includes sepsis, ischemia, and PAH disease progression. “During the current pandemic, fever at home in a PAH patient should be assumed to represent a COVID-19 infection,” and patients with worsening respiratory symptoms that require hospitalization should be tested for COVID-19, the authors emphasized.

Use of ECMO or other intensive interventions should be considered in the context of risk assessment, the authors said. “As a general recommendation, practitioners should consider utilizing an established PAH-specific risk assessment tool to help identify patients who are more likely to survive heroic interventions during the COVID-19 outbreak,” they wrote.

Training and education of PH providers will continue to be limited by the pandemic, and many clinical trials and research programs have been suspended and will need to be restructured to minimize risk of transmission of the COVID-19 virus, the authors said. However, health care providers must continue to provide PAH patients and families with advice and updates in best practices, while “acknowledging that the situation changes rapidly,” they concluded.

Dr. Ryan disclosed participating on the speakers bureau, and provides consulting services for, Actelion and Bayer, as well as research support from the Reagan Corporation, the Gordon Family, and the Cushman Family.

SOURCE: Ryan JJ et al. Pulm Circ. 2020 Apr 29. doi: 10.1177/2045894020920153.

The presence of pulmonary arterial hypertension, whether preexisting or occurring in conjunction with a COVID-19 infection, will likely increase the risk for morbidity and mortality in these patients, according to a research article published in Pulmonary Circulation.

“The impetus for this manuscript was a recent discussion within the Pulmonary Hypertension Association (PHA) and [its] Scientific Leadership Council who expressed a need for guidelines from experts in the field,” wrote John J. Ryan, MD, of the University of Utah, Salt Lake City, and colleagues.

The authors highlight some of the unique challenges in caring for patients with pulmonary hypertension (PH), particularly pulmonary arterial hypertension (PAH), in the context of the COVID-19 pandemic.

Telemedicine and temporary visit schedules for new and returning PAH patients can help reduce risk of virus transmission, if patient accessibility to telemedicine is feasible. Protocols to reduce the risk of virus exposure or transmission in the office setting included less frequent echocardiography and 6-Minute Walk Tests (6MWTs) for patients in stable condition. In stable patients, “avoid pulmonary function of V/Q tests when possible,” the authors wrote.

New patients who have been referred for PAH present a challenge in conducting a thorough evaluation that would normally include measurement of invasive hemodynamics in keeping with current diagnostic guidelines. Clinicians will need to balance the potential risks of COVID-19 exposure during elective procedures against the benefits of full evaluations to plan PAH treatment, the authors noted.

For established patients who are clinically stable, remote visits may be an option, with a risk/benefit assessment of the need for in-person diagnostic tests at the current time, they said. However, telemedicine’s limitations include not only patient accessibility and understanding of audio and video technology, but also inability to accurately measure vital signs, they said.

As for routine testing such as echocardiograms, 6MWTs, and other laboratory testing, “it is important to consider the additive value of these sometimes comprehensive tests in the context of the risks associated with visiting the hospital or clinic to obtain them,” the authors said.

Patients who are unstable and experience worsening right heart failure (RHF) at home may have contracted a COVID-19 infection, but the differential diagnosis includes sepsis, ischemia, and PAH disease progression. “During the current pandemic, fever at home in a PAH patient should be assumed to represent a COVID-19 infection,” and patients with worsening respiratory symptoms that require hospitalization should be tested for COVID-19, the authors emphasized.

Use of ECMO or other intensive interventions should be considered in the context of risk assessment, the authors said. “As a general recommendation, practitioners should consider utilizing an established PAH-specific risk assessment tool to help identify patients who are more likely to survive heroic interventions during the COVID-19 outbreak,” they wrote.

Training and education of PH providers will continue to be limited by the pandemic, and many clinical trials and research programs have been suspended and will need to be restructured to minimize risk of transmission of the COVID-19 virus, the authors said. However, health care providers must continue to provide PAH patients and families with advice and updates in best practices, while “acknowledging that the situation changes rapidly,” they concluded.

Dr. Ryan disclosed participating on the speakers bureau, and provides consulting services for, Actelion and Bayer, as well as research support from the Reagan Corporation, the Gordon Family, and the Cushman Family.

SOURCE: Ryan JJ et al. Pulm Circ. 2020 Apr 29. doi: 10.1177/2045894020920153.

High-dose oral famotidine might improve cardinal symptoms of COVID-19 infection, according to the findings of a small outpatient case series and a subsequent retrospective study.

After developing COVID-19 symptoms, the 10 patients in the case series began self-medicating with 60-240 mg famotidine daily over a median of 11 days. “All patients reported marked improvements of disease-related symptoms after starting famotidine,” first author Tobias Janowitz, MD, PhD, of Cold Spring Harbor Laboratory, N.Y., and associates wrote in Gut.

Improvements began within 24-48 hours of starting on the histamine-2 receptor antagonist. By 14 days after treatment initiation, all patients reported near-normalization of both respiratory and systemic symptoms, the researchers reported.

The patients were 23-71 years old. Seven tested positive for COVID-19, two had antibodies to COVID-19, and one had a clinical diagnosis of COVID-19 without laboratory confirmation. Over a median of 11 days (range, 5-21 days), six patients self-administered 80 mg famotidine three times daily and four self-administered lower amounts – from 60 to 150 mg of famotidine daily, divided into two or three doses. Patients started on famotidine between 2 and 26 days after symptom onset.

Through phone interviews and questionnaires, the researchers ascertained changes in cough, dyspnea, fatigue, headache, anosmia, and general unwellness by using a modified four-point Eastern Cooperative Oncology Group (ECOG) performance status scale. Improvements were seen across all symptom categories, and respiratory symptoms improved faster than systemic symptoms. Apart from two cases of persistent anosmia, symptoms resolved completely within 14 days of starting famotidine.

Seven patients reported no side effects of famotidine; one reported grade 1 dizziness and infrequent perceptions of tachycardia; one reported grade 1 dizziness, dry skin, and insomnia; and one reported grade 1 gastrointestinal symptoms and temporary forgetfulness. “Other than forgetfulness, all of these side effects are listed in the prescription information for famotidine, and all side effects resolved on discontinuation of famotidine,” the investigators wrote.

While the findings are intriguing, Dr. Janowitz and associates cautioned against overinterpretation of them. Another expert agreed: “This is a preliminary study based on a hypothesized antiviral effect. It’s important to know that it doesn’t really prove it works,” said Amesh Adalja, MD, senior scholar at the Johns Hopkins University Center for Health Security, Baltimore, and a spokesperson for the Infectious Diseases Society of America, during an interview with MDedge.

These patients might have improved anyway, without self-administering famotidine, said Dr. Adalja, who was not involved in the study.

Furthermore, the mechanism by which famotidine might act on COVID-19 remains unclear. The drug “could have a viral target, for example, one of the viral proteases, or a host target, resulting, for example, in modulation of the immunological response to the virus,” Dr. Janowitz and associates wrote.

Dr. Adalja noted that many compounds show effects against COVID-19 that are not well understood. He called for randomized trials to evaluate the biological plausibility of famotidine use, and its potential efficacy.

“This is a cheap, over-the-counter drug, but no drug is without side effects,” he added. “We need to know whether it works.”

Based on the case series findings, researchers conducted another retrospective study of patients hospitalized with COVID-19 infection. Those who were incidentally taking famotidine before or at hospitalization had a significantly reduced risk of intubation or death, with a hazard ratio of 0.43 (Gastroenterology. 2020 May 22. doi: 10.1053/j.gastro.2020.05.053)

The National Institutes of Health provided partial support. The investigators reported having no conflicts of interest.

SOURCE: Janowitz T et al. Gut. 2020 Jun 4. doi: 10.1136/gutjnl-2020-321852.

High-dose oral famotidine might improve cardinal symptoms of COVID-19 infection, according to the findings of a small outpatient case series and a subsequent retrospective study.

After developing COVID-19 symptoms, the 10 patients in the case series began self-medicating with 60-240 mg famotidine daily over a median of 11 days. “All patients reported marked improvements of disease-related symptoms after starting famotidine,” first author Tobias Janowitz, MD, PhD, of Cold Spring Harbor Laboratory, N.Y., and associates wrote in Gut.

Improvements began within 24-48 hours of starting on the histamine-2 receptor antagonist. By 14 days after treatment initiation, all patients reported near-normalization of both respiratory and systemic symptoms, the researchers reported.

The patients were 23-71 years old. Seven tested positive for COVID-19, two had antibodies to COVID-19, and one had a clinical diagnosis of COVID-19 without laboratory confirmation. Over a median of 11 days (range, 5-21 days), six patients self-administered 80 mg famotidine three times daily and four self-administered lower amounts – from 60 to 150 mg of famotidine daily, divided into two or three doses. Patients started on famotidine between 2 and 26 days after symptom onset.

Through phone interviews and questionnaires, the researchers ascertained changes in cough, dyspnea, fatigue, headache, anosmia, and general unwellness by using a modified four-point Eastern Cooperative Oncology Group (ECOG) performance status scale. Improvements were seen across all symptom categories, and respiratory symptoms improved faster than systemic symptoms. Apart from two cases of persistent anosmia, symptoms resolved completely within 14 days of starting famotidine.

Seven patients reported no side effects of famotidine; one reported grade 1 dizziness and infrequent perceptions of tachycardia; one reported grade 1 dizziness, dry skin, and insomnia; and one reported grade 1 gastrointestinal symptoms and temporary forgetfulness. “Other than forgetfulness, all of these side effects are listed in the prescription information for famotidine, and all side effects resolved on discontinuation of famotidine,” the investigators wrote.

While the findings are intriguing, Dr. Janowitz and associates cautioned against overinterpretation of them. Another expert agreed: “This is a preliminary study based on a hypothesized antiviral effect. It’s important to know that it doesn’t really prove it works,” said Amesh Adalja, MD, senior scholar at the Johns Hopkins University Center for Health Security, Baltimore, and a spokesperson for the Infectious Diseases Society of America, during an interview with MDedge.

These patients might have improved anyway, without self-administering famotidine, said Dr. Adalja, who was not involved in the study.

Furthermore, the mechanism by which famotidine might act on COVID-19 remains unclear. The drug “could have a viral target, for example, one of the viral proteases, or a host target, resulting, for example, in modulation of the immunological response to the virus,” Dr. Janowitz and associates wrote.

Dr. Adalja noted that many compounds show effects against COVID-19 that are not well understood. He called for randomized trials to evaluate the biological plausibility of famotidine use, and its potential efficacy.

“This is a cheap, over-the-counter drug, but no drug is without side effects,” he added. “We need to know whether it works.”

Based on the case series findings, researchers conducted another retrospective study of patients hospitalized with COVID-19 infection. Those who were incidentally taking famotidine before or at hospitalization had a significantly reduced risk of intubation or death, with a hazard ratio of 0.43 (Gastroenterology. 2020 May 22. doi: 10.1053/j.gastro.2020.05.053)

The National Institutes of Health provided partial support. The investigators reported having no conflicts of interest.

SOURCE: Janowitz T et al. Gut. 2020 Jun 4. doi: 10.1136/gutjnl-2020-321852.

High-dose oral famotidine might improve cardinal symptoms of COVID-19 infection, according to the findings of a small outpatient case series and a subsequent retrospective study.

After developing COVID-19 symptoms, the 10 patients in the case series began self-medicating with 60-240 mg famotidine daily over a median of 11 days. “All patients reported marked improvements of disease-related symptoms after starting famotidine,” first author Tobias Janowitz, MD, PhD, of Cold Spring Harbor Laboratory, N.Y., and associates wrote in Gut.

Improvements began within 24-48 hours of starting on the histamine-2 receptor antagonist. By 14 days after treatment initiation, all patients reported near-normalization of both respiratory and systemic symptoms, the researchers reported.

The patients were 23-71 years old. Seven tested positive for COVID-19, two had antibodies to COVID-19, and one had a clinical diagnosis of COVID-19 without laboratory confirmation. Over a median of 11 days (range, 5-21 days), six patients self-administered 80 mg famotidine three times daily and four self-administered lower amounts – from 60 to 150 mg of famotidine daily, divided into two or three doses. Patients started on famotidine between 2 and 26 days after symptom onset.

Through phone interviews and questionnaires, the researchers ascertained changes in cough, dyspnea, fatigue, headache, anosmia, and general unwellness by using a modified four-point Eastern Cooperative Oncology Group (ECOG) performance status scale. Improvements were seen across all symptom categories, and respiratory symptoms improved faster than systemic symptoms. Apart from two cases of persistent anosmia, symptoms resolved completely within 14 days of starting famotidine.

Seven patients reported no side effects of famotidine; one reported grade 1 dizziness and infrequent perceptions of tachycardia; one reported grade 1 dizziness, dry skin, and insomnia; and one reported grade 1 gastrointestinal symptoms and temporary forgetfulness. “Other than forgetfulness, all of these side effects are listed in the prescription information for famotidine, and all side effects resolved on discontinuation of famotidine,” the investigators wrote.

While the findings are intriguing, Dr. Janowitz and associates cautioned against overinterpretation of them. Another expert agreed: “This is a preliminary study based on a hypothesized antiviral effect. It’s important to know that it doesn’t really prove it works,” said Amesh Adalja, MD, senior scholar at the Johns Hopkins University Center for Health Security, Baltimore, and a spokesperson for the Infectious Diseases Society of America, during an interview with MDedge.

These patients might have improved anyway, without self-administering famotidine, said Dr. Adalja, who was not involved in the study.

Furthermore, the mechanism by which famotidine might act on COVID-19 remains unclear. The drug “could have a viral target, for example, one of the viral proteases, or a host target, resulting, for example, in modulation of the immunological response to the virus,” Dr. Janowitz and associates wrote.

Dr. Adalja noted that many compounds show effects against COVID-19 that are not well understood. He called for randomized trials to evaluate the biological plausibility of famotidine use, and its potential efficacy.

“This is a cheap, over-the-counter drug, but no drug is without side effects,” he added. “We need to know whether it works.”

Based on the case series findings, researchers conducted another retrospective study of patients hospitalized with COVID-19 infection. Those who were incidentally taking famotidine before or at hospitalization had a significantly reduced risk of intubation or death, with a hazard ratio of 0.43 (Gastroenterology. 2020 May 22. doi: 10.1053/j.gastro.2020.05.053)

The National Institutes of Health provided partial support. The investigators reported having no conflicts of interest.

SOURCE: Janowitz T et al. Gut. 2020 Jun 4. doi: 10.1136/gutjnl-2020-321852.

The American Diabetes Association’s 80th Scientific Sessions will forge ahead virtually this year in the face of the COVID-19 pandemic, with nearly all of its originally scheduled content to be presented online.

The meeting will take place online June 12-16, the same days it was slated to occur in Chicago and at the same times. All presentations were recorded in advance, but participants will be able to ask real-time questions during some sessions. Registered attendees – who paid a reduced fee – will have access to the online content for 90 days afterward.

ADA announced the shift in plans on April 3, after Chicago’s McCormick Place convention center became unavailable due to the COVID-19 pandemic. While some major medical meetings had to be canceled entirely or trimmed down online, “This is one of the international meetings that has had more time to really get ready to plan such a virtual session,” association co-president Robert H. Eckel, MD, told Medscape Medical News.

This year’s program features fewer blockbuster randomized clinical trials than in years past.

But it does offer a huge amount of clinical research focused on both type 1 and type 2 diabetes, children with diabetes, gestational diabetes, and much more. Also included are deep dives into optimal clinical translation of findings from previous cardiovascular outcomes trials (CVOTs).

Noteworthy sessions include four new automated insulin delivery system trials on Friday, new diabetes-specific data from the DAPA-HF trial on Saturday, and a debate on Sunday about the future of metformin as first-line therapy for people with established heart disease or at high risk.

And on Tuesday morning, full results from the CVOT VERTIS-CV, with the sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin (Steglatro, Merck), will be reported.

Also presented on Tuesday will be the first cardiovascular and cancer outcomes from the Diabetes Prevention Program Outcomes Study (DPPOS).

The online content will cover roughly 90% of what was originally scheduled, meeting planning committee chair Jose C. Florez, MD, PhD, told Medscape Medical News.

There is no session officially addressing COVID-19, he said, because the topics were already finalized by February, but “I’m sure it will be discussed in informal exchanges ... the data are just coming out,” he said.

Florez also called attention to two symposia addressing the other major topic dominating today’s news: racial disparities. One on Friday will address that topic with regard to maternal/fetal health, and another on Monday will cover disparities in diabetes care generally.

“Both because of COVID-19 and how it has affected people with diabetes, and within that, disadvantaged people, more aggressively, and in the current context of how racism is coming to the surface, these two sessions will become very, very pertinent,” he said.
 

Putting the Treatment Pieces Together in Type 2 Diabetes

The Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes Trial (VERTIS-CV) session will include the major cardiovascular, metabolic, renal, and safety outcomes for that drug, along with a meta-analysis of outcomes from trials of several different SGLT2 inhibitors.

All eyes will be on the VERTIS-CV presentation because ertugliflozin broke ranks with the other drugs in this class and failed to produce statistically significant drops in the relevant endpoints, as detailed in top-line data issued by the company in April.

And the provocatively titled session, “DAPA-HF Update: Have We Lost SGLT2 inhibitors to Cardiologists?!” will include a review of the trial’s main findings presented at the European Society of Cardiology meeting in September 2019, and published a few weeks later in the New England Journal of Medicine, along with new data on patient-centered and metabolic outcomes, and diabetes prevention. An independent commentator will presumably address the session title’s question.

Eckel, who has been working to establish a new cardiometabolic medicine subspecialty, commented: “I think we have not lost it, but I think SGLT2 inhibitors are a perfect example of why we need physicians trained in this overlap of diabetes medicine and cardiology.”

And, he said, we may be coming to the end of the CVOTs trial phenomenon.

“I think unless there’s a whole new class of drugs developed, we may be done with CVOTs for dipeptidyl peptidase-4 (DPP-4) inhibitors, SGLT2 inhibitors, and glucagon-like peptide 1 (GLP-1) receptor agonists. We’ve learned a lot, and I’m not sure we need more other than mechanistic studies ... I don’t think we really know yet how SGLT2 inhibitors or GLP-1 agonists work,” Eckel said.

Metformin, on the other hand, has not been subject to a CVOT because it has been available as a generic since long before the US Food and Drug Administration mandated the CVOTs for new drugs for type 2 diabetes in 2008.

Such a trial is unlikely to be conducted at this point, but the new DPPOS data might actually come close, Florez noted.

The DPPOS is the observational follow-up of the landmark randomized DPP trial, which found that intensive lifestyle intervention and metformin reduced progression from prediabetes to type 2 diabetes.

Numerous additional outcomes have been reported over the years, but this will be the first-ever reporting of DPPOS data on both hard cardiovascular events and cancer incidence in people who have been continuously taking metformin for more than 20 years.

“There’s a lot of interest in whether metformin has an effect on cardiovascular events and cancer ... I think that’s going to be a very interesting session,” Florez said, noting that “short of a randomized clinical trial, which it’s hard to imagine would come to be, this is really, really good.”

Also examining metformin will be a debate on Sunday, “Should Metformin Be Considered First-Line Therapy for Individuals with Type 2 Diabetes With Established Arteriosclerotic Cardiovascular Disease (ASCVD) or at High Risk for ASCVD?”

And on Saturday, a debate will address another old-guard diabetes drug class, asking: “Is There a Current Place for Sulfonylureas in the Treatment of Type 2 Diabetes?”

Overall, Florez said, meeting attendees will come away with “a more clear understanding of the placement of SGLT2 inhibitors and GLP-1 agonists in the type 2 diabetes treatment algorithm.”

“What are the settings in which these [newer] drugs ought to be used, compared to the old-timers like metformin and sulfonylureas? One thing is having the trials, but the other is figuring out how you interpret these in deciding what happens at the point of care.”

Two more future-looking type 2 diabetes symposia of potential interest to clinicians are “Unraveling the Heterogeneity in Type 2 Diabetes” on Sunday and “Perspectives on the Future of Precision Diabetes Medicine — A Joint ADA/EASD Symposium” on Monday.
 

Type 1 Diabetes, Technology, and Kids

A symposium on Friday will feature four new clinical trials of automated insulin delivery systems for people with type 1 diabetes, the “US Advanced Hybrid Closed-Loop (AHCL) Pivotal Safety Study, FLAIR — An NIDDK-Sponsored International, Multi-site Randomized Crossover Trial of AHCL vs 670G,” the New Zealand AHCL randomized crossover trial, and the Horizon Automated Glucose Control System pre-pivotal trial data.

“Closed-loop devices are getting a lot of traction ... These trials will continue to advance the notion that these devices will narrow the glycemic range, prevent hypoglycemia, and improve quality of life because people don’t have to pay as much attention mentally to the management of the diabetes,” Florez said.

He added that although these trials “have been in the works for a while and they’re not big surprises, they continue to build a body of evidence suggesting that these devices will be part of our armamentarium in the very near future.”

And on Saturday, a debate will address the somewhat controversial question of whether continuous glucose monitoring in type 2 diabetes is worth the cost.

There will also be plenty of pediatric diabetes material presented this year, too.

On Sunday, there will be new insights from the Restoring Insulin Secretion (RISE) study, which examines prediabetes and type 2 diabetes in youth, and on Monday, 20-year data from the SEARCH for Diabetes in Youth Study will be reported.

And on Monday, the most recent findings from The Environmental Determinants of Diabetes in the Young (TEDDY) study of environmental triggers of type 1 diabetes will be presented.
 

All-Virtual Meeting: Pros and Cons

The all-virtual meeting format will have pluses and minuses, Eckel predicts.

Advantages include the fact that attendees don’t have to physically run from room to room or make difficult decisions about conflicting sessions.

“The fact that this meeting will be taking place in reality in terms of the timing of sessions, one can transition from one room to another in a matter of seconds if you want to,” he noted.

However, he observed, “a lot of interesting things happen in the hallways at meetings. Colleagues from around the world get together and knock heads about their ongoing research and potential collaborations can be formulated.

“Opportunities to engage with one another beyond the formality of the meeting is going to be lost to some extent.”

What’s more, the sessions will all be in Central US (Chicago) time, “So if you live in Thailand, the session may be occurring at a time when you’re in bed. If you want to see it live, then you’ve got to get up. Then you can ask a question.”

On the other hand, since all the content will be available online for 90 days, “if you want to stay in bed and you live in Thailand, you can get up a week from now during the day and log into a session you may have missed.”

Indeed, Florez said, “One silver lining of this virtual conference is that we’ve lowered the barriers for people to attend. It’s much more global. We’ve had an amazing influx of new registrants who were not planning on coming and were not registered for the original meeting and have registered since [more than 10,000 at the time of writing], and they continue to pile in.”

“We plan to reach people we haven’t reached before. The big question for ADA moving forward will be how much this can become a permanent feature, where even if we do it in person in the future, maybe we offer at least some virtual options so that our reach can go farther.”

Eckel has reported sitting on the scientific advisory board for a Kowa Company trial of pemafibrate and on an advisory board for Novo Nordisk. Florez has reported being a speaker for Novo Nordisk and receiving an honorarium from ADA for chairing the conference planning committee.
 

This article originally appeared on Medscape.com.

The American Diabetes Association’s 80th Scientific Sessions will forge ahead virtually this year in the face of the COVID-19 pandemic, with nearly all of its originally scheduled content to be presented online.

The meeting will take place online June 12-16, the same days it was slated to occur in Chicago and at the same times. All presentations were recorded in advance, but participants will be able to ask real-time questions during some sessions. Registered attendees – who paid a reduced fee – will have access to the online content for 90 days afterward.

ADA announced the shift in plans on April 3, after Chicago’s McCormick Place convention center became unavailable due to the COVID-19 pandemic. While some major medical meetings had to be canceled entirely or trimmed down online, “This is one of the international meetings that has had more time to really get ready to plan such a virtual session,” association co-president Robert H. Eckel, MD, told Medscape Medical News.

This year’s program features fewer blockbuster randomized clinical trials than in years past.

But it does offer a huge amount of clinical research focused on both type 1 and type 2 diabetes, children with diabetes, gestational diabetes, and much more. Also included are deep dives into optimal clinical translation of findings from previous cardiovascular outcomes trials (CVOTs).

Noteworthy sessions include four new automated insulin delivery system trials on Friday, new diabetes-specific data from the DAPA-HF trial on Saturday, and a debate on Sunday about the future of metformin as first-line therapy for people with established heart disease or at high risk.

And on Tuesday morning, full results from the CVOT VERTIS-CV, with the sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin (Steglatro, Merck), will be reported.

Also presented on Tuesday will be the first cardiovascular and cancer outcomes from the Diabetes Prevention Program Outcomes Study (DPPOS).

The online content will cover roughly 90% of what was originally scheduled, meeting planning committee chair Jose C. Florez, MD, PhD, told Medscape Medical News.

There is no session officially addressing COVID-19, he said, because the topics were already finalized by February, but “I’m sure it will be discussed in informal exchanges ... the data are just coming out,” he said.

Florez also called attention to two symposia addressing the other major topic dominating today’s news: racial disparities. One on Friday will address that topic with regard to maternal/fetal health, and another on Monday will cover disparities in diabetes care generally.

“Both because of COVID-19 and how it has affected people with diabetes, and within that, disadvantaged people, more aggressively, and in the current context of how racism is coming to the surface, these two sessions will become very, very pertinent,” he said.
 

Putting the Treatment Pieces Together in Type 2 Diabetes

The Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes Trial (VERTIS-CV) session will include the major cardiovascular, metabolic, renal, and safety outcomes for that drug, along with a meta-analysis of outcomes from trials of several different SGLT2 inhibitors.

All eyes will be on the VERTIS-CV presentation because ertugliflozin broke ranks with the other drugs in this class and failed to produce statistically significant drops in the relevant endpoints, as detailed in top-line data issued by the company in April.

And the provocatively titled session, “DAPA-HF Update: Have We Lost SGLT2 inhibitors to Cardiologists?!” will include a review of the trial’s main findings presented at the European Society of Cardiology meeting in September 2019, and published a few weeks later in the New England Journal of Medicine, along with new data on patient-centered and metabolic outcomes, and diabetes prevention. An independent commentator will presumably address the session title’s question.

Eckel, who has been working to establish a new cardiometabolic medicine subspecialty, commented: “I think we have not lost it, but I think SGLT2 inhibitors are a perfect example of why we need physicians trained in this overlap of diabetes medicine and cardiology.”

And, he said, we may be coming to the end of the CVOTs trial phenomenon.

“I think unless there’s a whole new class of drugs developed, we may be done with CVOTs for dipeptidyl peptidase-4 (DPP-4) inhibitors, SGLT2 inhibitors, and glucagon-like peptide 1 (GLP-1) receptor agonists. We’ve learned a lot, and I’m not sure we need more other than mechanistic studies ... I don’t think we really know yet how SGLT2 inhibitors or GLP-1 agonists work,” Eckel said.

Metformin, on the other hand, has not been subject to a CVOT because it has been available as a generic since long before the US Food and Drug Administration mandated the CVOTs for new drugs for type 2 diabetes in 2008.

Such a trial is unlikely to be conducted at this point, but the new DPPOS data might actually come close, Florez noted.

The DPPOS is the observational follow-up of the landmark randomized DPP trial, which found that intensive lifestyle intervention and metformin reduced progression from prediabetes to type 2 diabetes.

Numerous additional outcomes have been reported over the years, but this will be the first-ever reporting of DPPOS data on both hard cardiovascular events and cancer incidence in people who have been continuously taking metformin for more than 20 years.

“There’s a lot of interest in whether metformin has an effect on cardiovascular events and cancer ... I think that’s going to be a very interesting session,” Florez said, noting that “short of a randomized clinical trial, which it’s hard to imagine would come to be, this is really, really good.”

Also examining metformin will be a debate on Sunday, “Should Metformin Be Considered First-Line Therapy for Individuals with Type 2 Diabetes With Established Arteriosclerotic Cardiovascular Disease (ASCVD) or at High Risk for ASCVD?”

And on Saturday, a debate will address another old-guard diabetes drug class, asking: “Is There a Current Place for Sulfonylureas in the Treatment of Type 2 Diabetes?”

Overall, Florez said, meeting attendees will come away with “a more clear understanding of the placement of SGLT2 inhibitors and GLP-1 agonists in the type 2 diabetes treatment algorithm.”

“What are the settings in which these [newer] drugs ought to be used, compared to the old-timers like metformin and sulfonylureas? One thing is having the trials, but the other is figuring out how you interpret these in deciding what happens at the point of care.”

Two more future-looking type 2 diabetes symposia of potential interest to clinicians are “Unraveling the Heterogeneity in Type 2 Diabetes” on Sunday and “Perspectives on the Future of Precision Diabetes Medicine — A Joint ADA/EASD Symposium” on Monday.
 

Type 1 Diabetes, Technology, and Kids

A symposium on Friday will feature four new clinical trials of automated insulin delivery systems for people with type 1 diabetes, the “US Advanced Hybrid Closed-Loop (AHCL) Pivotal Safety Study, FLAIR — An NIDDK-Sponsored International, Multi-site Randomized Crossover Trial of AHCL vs 670G,” the New Zealand AHCL randomized crossover trial, and the Horizon Automated Glucose Control System pre-pivotal trial data.

“Closed-loop devices are getting a lot of traction ... These trials will continue to advance the notion that these devices will narrow the glycemic range, prevent hypoglycemia, and improve quality of life because people don’t have to pay as much attention mentally to the management of the diabetes,” Florez said.

He added that although these trials “have been in the works for a while and they’re not big surprises, they continue to build a body of evidence suggesting that these devices will be part of our armamentarium in the very near future.”

And on Saturday, a debate will address the somewhat controversial question of whether continuous glucose monitoring in type 2 diabetes is worth the cost.

There will also be plenty of pediatric diabetes material presented this year, too.

On Sunday, there will be new insights from the Restoring Insulin Secretion (RISE) study, which examines prediabetes and type 2 diabetes in youth, and on Monday, 20-year data from the SEARCH for Diabetes in Youth Study will be reported.

And on Monday, the most recent findings from The Environmental Determinants of Diabetes in the Young (TEDDY) study of environmental triggers of type 1 diabetes will be presented.
 

All-Virtual Meeting: Pros and Cons

The all-virtual meeting format will have pluses and minuses, Eckel predicts.

Advantages include the fact that attendees don’t have to physically run from room to room or make difficult decisions about conflicting sessions.

“The fact that this meeting will be taking place in reality in terms of the timing of sessions, one can transition from one room to another in a matter of seconds if you want to,” he noted.

However, he observed, “a lot of interesting things happen in the hallways at meetings. Colleagues from around the world get together and knock heads about their ongoing research and potential collaborations can be formulated.

“Opportunities to engage with one another beyond the formality of the meeting is going to be lost to some extent.”

What’s more, the sessions will all be in Central US (Chicago) time, “So if you live in Thailand, the session may be occurring at a time when you’re in bed. If you want to see it live, then you’ve got to get up. Then you can ask a question.”

On the other hand, since all the content will be available online for 90 days, “if you want to stay in bed and you live in Thailand, you can get up a week from now during the day and log into a session you may have missed.”

Indeed, Florez said, “One silver lining of this virtual conference is that we’ve lowered the barriers for people to attend. It’s much more global. We’ve had an amazing influx of new registrants who were not planning on coming and were not registered for the original meeting and have registered since [more than 10,000 at the time of writing], and they continue to pile in.”

“We plan to reach people we haven’t reached before. The big question for ADA moving forward will be how much this can become a permanent feature, where even if we do it in person in the future, maybe we offer at least some virtual options so that our reach can go farther.”

Eckel has reported sitting on the scientific advisory board for a Kowa Company trial of pemafibrate and on an advisory board for Novo Nordisk. Florez has reported being a speaker for Novo Nordisk and receiving an honorarium from ADA for chairing the conference planning committee.
 

This article originally appeared on Medscape.com.

The American Diabetes Association’s 80th Scientific Sessions will forge ahead virtually this year in the face of the COVID-19 pandemic, with nearly all of its originally scheduled content to be presented online.

The meeting will take place online June 12-16, the same days it was slated to occur in Chicago and at the same times. All presentations were recorded in advance, but participants will be able to ask real-time questions during some sessions. Registered attendees – who paid a reduced fee – will have access to the online content for 90 days afterward.

ADA announced the shift in plans on April 3, after Chicago’s McCormick Place convention center became unavailable due to the COVID-19 pandemic. While some major medical meetings had to be canceled entirely or trimmed down online, “This is one of the international meetings that has had more time to really get ready to plan such a virtual session,” association co-president Robert H. Eckel, MD, told Medscape Medical News.

This year’s program features fewer blockbuster randomized clinical trials than in years past.

But it does offer a huge amount of clinical research focused on both type 1 and type 2 diabetes, children with diabetes, gestational diabetes, and much more. Also included are deep dives into optimal clinical translation of findings from previous cardiovascular outcomes trials (CVOTs).

Noteworthy sessions include four new automated insulin delivery system trials on Friday, new diabetes-specific data from the DAPA-HF trial on Saturday, and a debate on Sunday about the future of metformin as first-line therapy for people with established heart disease or at high risk.

And on Tuesday morning, full results from the CVOT VERTIS-CV, with the sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin (Steglatro, Merck), will be reported.

Also presented on Tuesday will be the first cardiovascular and cancer outcomes from the Diabetes Prevention Program Outcomes Study (DPPOS).

The online content will cover roughly 90% of what was originally scheduled, meeting planning committee chair Jose C. Florez, MD, PhD, told Medscape Medical News.

There is no session officially addressing COVID-19, he said, because the topics were already finalized by February, but “I’m sure it will be discussed in informal exchanges ... the data are just coming out,” he said.

Florez also called attention to two symposia addressing the other major topic dominating today’s news: racial disparities. One on Friday will address that topic with regard to maternal/fetal health, and another on Monday will cover disparities in diabetes care generally.

“Both because of COVID-19 and how it has affected people with diabetes, and within that, disadvantaged people, more aggressively, and in the current context of how racism is coming to the surface, these two sessions will become very, very pertinent,” he said.
 

Putting the Treatment Pieces Together in Type 2 Diabetes

The Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes Trial (VERTIS-CV) session will include the major cardiovascular, metabolic, renal, and safety outcomes for that drug, along with a meta-analysis of outcomes from trials of several different SGLT2 inhibitors.

All eyes will be on the VERTIS-CV presentation because ertugliflozin broke ranks with the other drugs in this class and failed to produce statistically significant drops in the relevant endpoints, as detailed in top-line data issued by the company in April.

And the provocatively titled session, “DAPA-HF Update: Have We Lost SGLT2 inhibitors to Cardiologists?!” will include a review of the trial’s main findings presented at the European Society of Cardiology meeting in September 2019, and published a few weeks later in the New England Journal of Medicine, along with new data on patient-centered and metabolic outcomes, and diabetes prevention. An independent commentator will presumably address the session title’s question.

Eckel, who has been working to establish a new cardiometabolic medicine subspecialty, commented: “I think we have not lost it, but I think SGLT2 inhibitors are a perfect example of why we need physicians trained in this overlap of diabetes medicine and cardiology.”

And, he said, we may be coming to the end of the CVOTs trial phenomenon.

“I think unless there’s a whole new class of drugs developed, we may be done with CVOTs for dipeptidyl peptidase-4 (DPP-4) inhibitors, SGLT2 inhibitors, and glucagon-like peptide 1 (GLP-1) receptor agonists. We’ve learned a lot, and I’m not sure we need more other than mechanistic studies ... I don’t think we really know yet how SGLT2 inhibitors or GLP-1 agonists work,” Eckel said.

Metformin, on the other hand, has not been subject to a CVOT because it has been available as a generic since long before the US Food and Drug Administration mandated the CVOTs for new drugs for type 2 diabetes in 2008.

Such a trial is unlikely to be conducted at this point, but the new DPPOS data might actually come close, Florez noted.

The DPPOS is the observational follow-up of the landmark randomized DPP trial, which found that intensive lifestyle intervention and metformin reduced progression from prediabetes to type 2 diabetes.

Numerous additional outcomes have been reported over the years, but this will be the first-ever reporting of DPPOS data on both hard cardiovascular events and cancer incidence in people who have been continuously taking metformin for more than 20 years.

“There’s a lot of interest in whether metformin has an effect on cardiovascular events and cancer ... I think that’s going to be a very interesting session,” Florez said, noting that “short of a randomized clinical trial, which it’s hard to imagine would come to be, this is really, really good.”

Also examining metformin will be a debate on Sunday, “Should Metformin Be Considered First-Line Therapy for Individuals with Type 2 Diabetes With Established Arteriosclerotic Cardiovascular Disease (ASCVD) or at High Risk for ASCVD?”

And on Saturday, a debate will address another old-guard diabetes drug class, asking: “Is There a Current Place for Sulfonylureas in the Treatment of Type 2 Diabetes?”

Overall, Florez said, meeting attendees will come away with “a more clear understanding of the placement of SGLT2 inhibitors and GLP-1 agonists in the type 2 diabetes treatment algorithm.”

“What are the settings in which these [newer] drugs ought to be used, compared to the old-timers like metformin and sulfonylureas? One thing is having the trials, but the other is figuring out how you interpret these in deciding what happens at the point of care.”

Two more future-looking type 2 diabetes symposia of potential interest to clinicians are “Unraveling the Heterogeneity in Type 2 Diabetes” on Sunday and “Perspectives on the Future of Precision Diabetes Medicine — A Joint ADA/EASD Symposium” on Monday.
 

Type 1 Diabetes, Technology, and Kids

A symposium on Friday will feature four new clinical trials of automated insulin delivery systems for people with type 1 diabetes, the “US Advanced Hybrid Closed-Loop (AHCL) Pivotal Safety Study, FLAIR — An NIDDK-Sponsored International, Multi-site Randomized Crossover Trial of AHCL vs 670G,” the New Zealand AHCL randomized crossover trial, and the Horizon Automated Glucose Control System pre-pivotal trial data.

“Closed-loop devices are getting a lot of traction ... These trials will continue to advance the notion that these devices will narrow the glycemic range, prevent hypoglycemia, and improve quality of life because people don’t have to pay as much attention mentally to the management of the diabetes,” Florez said.

He added that although these trials “have been in the works for a while and they’re not big surprises, they continue to build a body of evidence suggesting that these devices will be part of our armamentarium in the very near future.”

And on Saturday, a debate will address the somewhat controversial question of whether continuous glucose monitoring in type 2 diabetes is worth the cost.

There will also be plenty of pediatric diabetes material presented this year, too.

On Sunday, there will be new insights from the Restoring Insulin Secretion (RISE) study, which examines prediabetes and type 2 diabetes in youth, and on Monday, 20-year data from the SEARCH for Diabetes in Youth Study will be reported.

And on Monday, the most recent findings from The Environmental Determinants of Diabetes in the Young (TEDDY) study of environmental triggers of type 1 diabetes will be presented.
 

All-Virtual Meeting: Pros and Cons

The all-virtual meeting format will have pluses and minuses, Eckel predicts.

Advantages include the fact that attendees don’t have to physically run from room to room or make difficult decisions about conflicting sessions.

“The fact that this meeting will be taking place in reality in terms of the timing of sessions, one can transition from one room to another in a matter of seconds if you want to,” he noted.

However, he observed, “a lot of interesting things happen in the hallways at meetings. Colleagues from around the world get together and knock heads about their ongoing research and potential collaborations can be formulated.

“Opportunities to engage with one another beyond the formality of the meeting is going to be lost to some extent.”

What’s more, the sessions will all be in Central US (Chicago) time, “So if you live in Thailand, the session may be occurring at a time when you’re in bed. If you want to see it live, then you’ve got to get up. Then you can ask a question.”

On the other hand, since all the content will be available online for 90 days, “if you want to stay in bed and you live in Thailand, you can get up a week from now during the day and log into a session you may have missed.”

Indeed, Florez said, “One silver lining of this virtual conference is that we’ve lowered the barriers for people to attend. It’s much more global. We’ve had an amazing influx of new registrants who were not planning on coming and were not registered for the original meeting and have registered since [more than 10,000 at the time of writing], and they continue to pile in.”

“We plan to reach people we haven’t reached before. The big question for ADA moving forward will be how much this can become a permanent feature, where even if we do it in person in the future, maybe we offer at least some virtual options so that our reach can go farther.”

Eckel has reported sitting on the scientific advisory board for a Kowa Company trial of pemafibrate and on an advisory board for Novo Nordisk. Florez has reported being a speaker for Novo Nordisk and receiving an honorarium from ADA for chairing the conference planning committee.
 

This article originally appeared on Medscape.com.

The coding expert answers your questions

Betsy Nicoletti, MS, a nationally recognized coding expert, will take your coding questions via email and provide guidance on how to code properly to maximize reimbursement. Have a question about coding? Send it here.

In this column, Nicoletti addresses several readers’ questions on using telehealth and provides guidance on delivering mental health services remotely.
 

Telehealth: Frequently asked questions

Since the Centers for Medicare & Medicaid Services (CMS) expanded use of telehealth during the COVID-19 emergency, I’ve seen various follow-up questions coming from physicians. Here are the most common ones received and some guidance.

Q: How long can we continue using telehealth?

A: Private payers will set their own rules for the end date. For Medicare, telehealth is allowed until the end of the public health emergency. Department of Health & Human Services Secretary Alex M. Azar II renewed the status of the public health emergency, effective April 26, 2020, for an additional 90 days.

Q: Can I bill Medicare annual wellness visits via telehealth?

A: Yes, you can bill the initial and subsequent Medicare wellness visits (G0438, G0439) via telehealth, but the Welcome to Medicare visit (G0402) is not on the list of telehealth services.

In fact, the wellness visits mentioned above may be billed with audio-only communications because of the expansion of telehealth services, although these visits require height, weight, BMI calculation, and blood pressure, and CMS has not issued guidance about whether the patient’s self-reported measurements are sufficient or whether they can be deferred.

Q: Can I bill an office visit via telehealth?

A: Yes, you may bill new and established patient visits 99201-99215 via telehealth, but for Medicare, these still require the use of real-time, audio-visual communications equipment.

Q: Can I bill an office visit conducted via telephone only?

A: For Medicare patients, you may not bill office visit codes for audio only communication. If there is audio only, use phone call codes 99441-99443. In order to bill an office visit, with codes 99201-99215 to a Medicare patient, audio and visual, real time communication is required. Some state Medicaid programs and private insurers allow office visits to be billed with audio equipment only, so check your state requirements.

Q: How do I select a level of office visit?

A: CMS’s announcement on March 31 relaxed the rules for practitioners to select a level of service for office and other patient services (99201-99215). CMS stated that clinicians could use either total time or medical decision-making to select a code.

If using time, count the practitioner’s total time for the visit, both face to face and non–face to face. It does not need to be greater than 50% in counseling. If using medical decision-making, history and exam are not needed to select the level of service. Medical decision-making alone can be used to select the code.

Q: Can I count the time it takes my medical assistant to set up the audio-visual communication with a patient?

A: No, you cannot count staff time in coding and billing a patient visit in this manner.

Q: Is there a code for a registered nurse to use for making phone calls with patients?

A: No, unfortunately.

Q: How do I know if a service can be billed with phone only?

A: These are indicated as “yes” on CMS’s list of covered telehealth services as allowed via audio only.
 

Providing mental health services during COVID-19

Q: I am a mental health provider who finds himself trying to provide the best care for my patients during this pandemic. How do I bill for behavioral health services if I am not able to conduct in-person visits?

A: Psychiatrists and behavioral health professionals can perform psychiatric diagnostic evaluations and psychotherapy over the phone during the public health emergency.

The use of real-time, audio-visual communication equipment is not required. This is one of the many changes CMS made in its interim final rule regarding COVID-19, released April 30.

Not only did CMS update the list of Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes that could be reported via real-time, audio-visual communication, but it also added a column to guidance on covered telehealth services: “Can Audio-only Interaction Meet the Requirements?” The codes for psychiatric diagnostic evaluations and psychotherapy are indicated as “yes.”

In addition to psychiatric diagnostic evaluations and time-based psychotherapy codes, psychotherapy for crisis, family, and group psychotherapy can be done with audio-only technology.

CMS has issued multiple waivers and two major rules that greatly expand the ability of medical practices to treat patients without requiring an in-person visit. This latest change, allowing some services to be performed with audio equipment only, is remarkable.

For Medicare patients, report the place of service that would have been used if the patient was seen in person. This could be office (POS 11), outpatient department (POS 19, 21), or community mental health center (POS 53).

Some private payers require the place of service for telehealth (02). The lack of consistency between payers is difficult for practices. Append modifier 95 to the CPT code for all payers. The definition of modifier 95 is “synchronous telemedicine service using audio and visual communication.” However, as CMS added these services to the telehealth list, use modifier 95.

Have a coding question? Send it in and it may be answered in a future column. (Please be sure to note your specialty in the text of the question.)

Betsy Nicoletti, MS, is a consultant, author, and speaker, as well as the founder of CodingIntel.com, a library of medical practice coding resources.

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

The coding expert answers your questions

Betsy Nicoletti, MS, a nationally recognized coding expert, will take your coding questions via email and provide guidance on how to code properly to maximize reimbursement. Have a question about coding? Send it here.

In this column, Nicoletti addresses several readers’ questions on using telehealth and provides guidance on delivering mental health services remotely.
 

Telehealth: Frequently asked questions

Since the Centers for Medicare & Medicaid Services (CMS) expanded use of telehealth during the COVID-19 emergency, I’ve seen various follow-up questions coming from physicians. Here are the most common ones received and some guidance.

Q: How long can we continue using telehealth?

A: Private payers will set their own rules for the end date. For Medicare, telehealth is allowed until the end of the public health emergency. Department of Health & Human Services Secretary Alex M. Azar II renewed the status of the public health emergency, effective April 26, 2020, for an additional 90 days.

Q: Can I bill Medicare annual wellness visits via telehealth?

A: Yes, you can bill the initial and subsequent Medicare wellness visits (G0438, G0439) via telehealth, but the Welcome to Medicare visit (G0402) is not on the list of telehealth services.

In fact, the wellness visits mentioned above may be billed with audio-only communications because of the expansion of telehealth services, although these visits require height, weight, BMI calculation, and blood pressure, and CMS has not issued guidance about whether the patient’s self-reported measurements are sufficient or whether they can be deferred.

Q: Can I bill an office visit via telehealth?

A: Yes, you may bill new and established patient visits 99201-99215 via telehealth, but for Medicare, these still require the use of real-time, audio-visual communications equipment.

Q: Can I bill an office visit conducted via telephone only?

A: For Medicare patients, you may not bill office visit codes for audio only communication. If there is audio only, use phone call codes 99441-99443. In order to bill an office visit, with codes 99201-99215 to a Medicare patient, audio and visual, real time communication is required. Some state Medicaid programs and private insurers allow office visits to be billed with audio equipment only, so check your state requirements.

Q: How do I select a level of office visit?

A: CMS’s announcement on March 31 relaxed the rules for practitioners to select a level of service for office and other patient services (99201-99215). CMS stated that clinicians could use either total time or medical decision-making to select a code.

If using time, count the practitioner’s total time for the visit, both face to face and non–face to face. It does not need to be greater than 50% in counseling. If using medical decision-making, history and exam are not needed to select the level of service. Medical decision-making alone can be used to select the code.

Q: Can I count the time it takes my medical assistant to set up the audio-visual communication with a patient?

A: No, you cannot count staff time in coding and billing a patient visit in this manner.

Q: Is there a code for a registered nurse to use for making phone calls with patients?

A: No, unfortunately.

Q: How do I know if a service can be billed with phone only?

A: These are indicated as “yes” on CMS’s list of covered telehealth services as allowed via audio only.
 

Providing mental health services during COVID-19

Q: I am a mental health provider who finds himself trying to provide the best care for my patients during this pandemic. How do I bill for behavioral health services if I am not able to conduct in-person visits?

A: Psychiatrists and behavioral health professionals can perform psychiatric diagnostic evaluations and psychotherapy over the phone during the public health emergency.

The use of real-time, audio-visual communication equipment is not required. This is one of the many changes CMS made in its interim final rule regarding COVID-19, released April 30.

Not only did CMS update the list of Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes that could be reported via real-time, audio-visual communication, but it also added a column to guidance on covered telehealth services: “Can Audio-only Interaction Meet the Requirements?” The codes for psychiatric diagnostic evaluations and psychotherapy are indicated as “yes.”

In addition to psychiatric diagnostic evaluations and time-based psychotherapy codes, psychotherapy for crisis, family, and group psychotherapy can be done with audio-only technology.

CMS has issued multiple waivers and two major rules that greatly expand the ability of medical practices to treat patients without requiring an in-person visit. This latest change, allowing some services to be performed with audio equipment only, is remarkable.

For Medicare patients, report the place of service that would have been used if the patient was seen in person. This could be office (POS 11), outpatient department (POS 19, 21), or community mental health center (POS 53).

Some private payers require the place of service for telehealth (02). The lack of consistency between payers is difficult for practices. Append modifier 95 to the CPT code for all payers. The definition of modifier 95 is “synchronous telemedicine service using audio and visual communication.” However, as CMS added these services to the telehealth list, use modifier 95.

Have a coding question? Send it in and it may be answered in a future column. (Please be sure to note your specialty in the text of the question.)

Betsy Nicoletti, MS, is a consultant, author, and speaker, as well as the founder of CodingIntel.com, a library of medical practice coding resources.

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

The coding expert answers your questions

Betsy Nicoletti, MS, a nationally recognized coding expert, will take your coding questions via email and provide guidance on how to code properly to maximize reimbursement. Have a question about coding? Send it here.

In this column, Nicoletti addresses several readers’ questions on using telehealth and provides guidance on delivering mental health services remotely.
 

Telehealth: Frequently asked questions

Since the Centers for Medicare & Medicaid Services (CMS) expanded use of telehealth during the COVID-19 emergency, I’ve seen various follow-up questions coming from physicians. Here are the most common ones received and some guidance.

Q: How long can we continue using telehealth?

A: Private payers will set their own rules for the end date. For Medicare, telehealth is allowed until the end of the public health emergency. Department of Health & Human Services Secretary Alex M. Azar II renewed the status of the public health emergency, effective April 26, 2020, for an additional 90 days.

Q: Can I bill Medicare annual wellness visits via telehealth?

A: Yes, you can bill the initial and subsequent Medicare wellness visits (G0438, G0439) via telehealth, but the Welcome to Medicare visit (G0402) is not on the list of telehealth services.

In fact, the wellness visits mentioned above may be billed with audio-only communications because of the expansion of telehealth services, although these visits require height, weight, BMI calculation, and blood pressure, and CMS has not issued guidance about whether the patient’s self-reported measurements are sufficient or whether they can be deferred.

Q: Can I bill an office visit via telehealth?

A: Yes, you may bill new and established patient visits 99201-99215 via telehealth, but for Medicare, these still require the use of real-time, audio-visual communications equipment.

Q: Can I bill an office visit conducted via telephone only?

A: For Medicare patients, you may not bill office visit codes for audio only communication. If there is audio only, use phone call codes 99441-99443. In order to bill an office visit, with codes 99201-99215 to a Medicare patient, audio and visual, real time communication is required. Some state Medicaid programs and private insurers allow office visits to be billed with audio equipment only, so check your state requirements.

Q: How do I select a level of office visit?

A: CMS’s announcement on March 31 relaxed the rules for practitioners to select a level of service for office and other patient services (99201-99215). CMS stated that clinicians could use either total time or medical decision-making to select a code.

If using time, count the practitioner’s total time for the visit, both face to face and non–face to face. It does not need to be greater than 50% in counseling. If using medical decision-making, history and exam are not needed to select the level of service. Medical decision-making alone can be used to select the code.

Q: Can I count the time it takes my medical assistant to set up the audio-visual communication with a patient?

A: No, you cannot count staff time in coding and billing a patient visit in this manner.

Q: Is there a code for a registered nurse to use for making phone calls with patients?

A: No, unfortunately.

Q: How do I know if a service can be billed with phone only?

A: These are indicated as “yes” on CMS’s list of covered telehealth services as allowed via audio only.
 

Providing mental health services during COVID-19

Q: I am a mental health provider who finds himself trying to provide the best care for my patients during this pandemic. How do I bill for behavioral health services if I am not able to conduct in-person visits?

A: Psychiatrists and behavioral health professionals can perform psychiatric diagnostic evaluations and psychotherapy over the phone during the public health emergency.

The use of real-time, audio-visual communication equipment is not required. This is one of the many changes CMS made in its interim final rule regarding COVID-19, released April 30.

Not only did CMS update the list of Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes that could be reported via real-time, audio-visual communication, but it also added a column to guidance on covered telehealth services: “Can Audio-only Interaction Meet the Requirements?” The codes for psychiatric diagnostic evaluations and psychotherapy are indicated as “yes.”

In addition to psychiatric diagnostic evaluations and time-based psychotherapy codes, psychotherapy for crisis, family, and group psychotherapy can be done with audio-only technology.

CMS has issued multiple waivers and two major rules that greatly expand the ability of medical practices to treat patients without requiring an in-person visit. This latest change, allowing some services to be performed with audio equipment only, is remarkable.

For Medicare patients, report the place of service that would have been used if the patient was seen in person. This could be office (POS 11), outpatient department (POS 19, 21), or community mental health center (POS 53).

Some private payers require the place of service for telehealth (02). The lack of consistency between payers is difficult for practices. Append modifier 95 to the CPT code for all payers. The definition of modifier 95 is “synchronous telemedicine service using audio and visual communication.” However, as CMS added these services to the telehealth list, use modifier 95.

Have a coding question? Send it in and it may be answered in a future column. (Please be sure to note your specialty in the text of the question.)

Betsy Nicoletti, MS, is a consultant, author, and speaker, as well as the founder of CodingIntel.com, a library of medical practice coding resources.

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