Italy, Germany, France and the Netherlands have signed a contract
with Astrazeneca to supply European citizens with a vaccine against the
coronavirus, Italy’s health minister said on Saturday.
The contract is for 400 million doses of the vaccine, which was
developed with the University of Oxford and whose experimentation phase
is already advanced and expected to end in autumn, Roberto Speranza said
in a Facebook post.
He added that a first batch of doses would be made available by the end of this year.
The European Commission received a mandate from EU governments on
Friday to negotiate advance purchases of promising coronavirus vaccines,
the EU’s top health official said, but it was unclear whether there
would be enough money available.
https://www.reuters.com/article/us-health-coronavirus-vaccines/italy-germany-france-and-netherlands-sign-contract-with-astrazeneca-for-covid-vaccine-idUSKBN23K0HW?il=0
Saturday, June 13, 2020
Noninvasive Ventilation May Beat Standard Oxygen for AHRF – Study
Helmet or face mask noninvasive ventilation
(NIV) may help patients survive acute hypoxemic respiratory failure
(AHRF) or avoid endotracheal intubation, a new study shows. One expert
would like to see access to these technologies expanded to include
outpatients as well.
“There are multiple alternatives to standard oxygen which seem to be better,” lead author Bruno L. Ferreyro, MD, from the University of Toronto and Sinai Health System and University Health Network, Toronto, Canada, told Medscape Medical News.
“All of these interventions could be effective, but clinicians need to know that none of these interventions should delay timely intubation. Patients who need to be intubated need to be intubated…. [Delaying intubation] has been shown to be harmful for patients,” he continued.
Ferreyro and colleagues’ findings were published online on June 4 in JAMA.
“The current coronavirus disease 2019 (COVID-19) pandemic has further highlighted the importance of understanding the best approach to providing respiratory support for patients with respiratory failure,” the authors write.
The researchers conducted a systematic review and network meta-analysis of 25 randomized clinical trials involving 3804 participants. The primary outcome was all-cause mortality, which was measured at the longest time point during the first 90 days after randomization.
The secondary outcome was endotracheal intubation up to 30 days. Other secondary outcomes were “patient comfort, dyspnea scores, intensive care unit and hospital lengths of stay, and 6-month mortality,” the authors explain.
Treatment with helmet NIV (risk ratio [RR], 0.40; absolute risk difference, –0.19; low certainty) and face mask NIV (RR, 0.83; absolute risk difference, –0.06; moderate certainty) were linked to a lower risk for mortality compared with standard oxygen therapy (21 studies; 3370 patients).
High-flow nasal oxygen (RR, 0.87; absolute risk difference, –0.04; moderate certainty), however, was not linked to a significantly lower risk for death in comparison with standard oxygen.
Compared with high-flow nasal oxygen (RR, 0.46; absolute risk difference, –0.15; low certainty) and face mask NIV (RR, 0.48; absolute risk difference, –0.13; low certainty), helmet NIV was associated with significantly decreased mortality.
“In the case of face mask, we saw a very small marginal benefit in mortality, and that is a little bit against most recent trials, like the Frat trial,” Ferreyro said. “That association did not stand in multiple scenarios, for example, in patients with more severe respiratory states.”
The risk for endotracheal intubation was lower among those who received helmet NIV (RR, 0.26; absolute risk difference, –0.32; low certainty), face mask NIV (RR, 0.76; absolute risk difference, –0.12; moderate certainty), and high-flow nasal oxygen (RR, 0.76; absolute risk difference, –0.11; moderate certainty) (25 studies; 3804 patients) in comparison with standard oxygen.
The risk for bias resulting from lack of blinding for intubation was determined to be high.
Helmet NIV was linked to reduced risk for endotracheal intubation compared with high-flow nasal oxygen (RR, 0.35; absolute risk difference, −0.20; low certainty) and face mask NIV (RR,0.35; absolute risk difference, −0.20; low certainty).
There was no significant difference in the risk for endotracheal
intubation with face mask NIV vs high-flow nasal oxygen (RR, 1.01;
absolute risk difference, −0.00; low certainty).
Regarding concerns that these technologies could harm patients, “There is all upside and no downside” to using them, Lisa F. Wolfe, MD, associate professor of medicine (pulmonary and critical care), Northwestern University, Chicago, Illinois, told Medscape Medical News.
“There have been concerns that if we use this advanced technology, it might in some way harm patients by slowing down their access to intubation and mechanical ventilation,” but the meta-analysis shows the technology does not harm patients, she added.
“Although some have argued that the risk of spontaneous breathing should preclude any noninvasive oxygen support, the data from the analysis by Ferreyro et al indicate that it is a reasonable approach to spare a subset of patients with AHRF invasive mechanical ventilation and its inherent complications,” Patel and colleagues continue.
The included studies make it difficult to determine which individual patients might benefit the most from NIV, Wolfe said. The most common diagnoses of the included patients were pneumonia and chronic obstructive pulmonary disease, she explained. She noted that there is a need for additional research to explore these questions.
“Given this is a network meta-analysis of aggregated data, we could
not explore in detail which individual patient factors make them more
likely to respond to any of these interventions,” Ferreyro said.
“There’s still a struggle to identify which specific patients will likely benefit from each of these strategies,” he added.
Patel and colleagues caution against using a “one-size-fits-all” approach to NIV. They recommend “a precision-based approach that matches a given strategy to the observed phenotype of AHRF coupled with incorporating clinician experience and comfort with each technology.
“Although further studies are needed, the meta-analysis by Ferreyro et al has provided a useful summary of the available data to help inform clinicians as they determine locally the best way to choose wisely among several options for care of patients with AHRF, especially in the wave of patients with COVID-19 currently being encountered. Future clinical trials comparing these strategies should not focus on declaring a ‘winner’ per se but rather on identifying the patient phenotypes that stand to benefit from each noninvasive oxygenation support method. In the management of heterogeneous syndromes like AHRF, it is better to have multiple options than to focus on limiting clinical practice to a single choice,” Patel and colleagues write.
Patients with interstitial lung disease and other conditions also experience hypoxemia, Wolfe said, adding, “The ‘next evolution’ of this is going to be expanding access to these types of support devices in the outpatient arena because hypoxemia is seen in COPD in outpatients” as well as inpatients.
Study coauthor Ferguson has received personal fees from Xenios and Getinge. The other coauthors have disclosed no relevant financial relationships. Editorialist Patel has received grants from the Parker B. Francis Foundation outside the submitted work. The remaining coauthors have disclosed no relevant financial relationships. Wolfe has disclosed no relevant financial relationships.
JAMA. Published online June 4, 2020. Full text, Editorial
https://www.medscape.com/viewarticle/932267#vp_1
“There are multiple alternatives to standard oxygen which seem to be better,” lead author Bruno L. Ferreyro, MD, from the University of Toronto and Sinai Health System and University Health Network, Toronto, Canada, told Medscape Medical News.
“All of these interventions could be effective, but clinicians need to know that none of these interventions should delay timely intubation. Patients who need to be intubated need to be intubated…. [Delaying intubation] has been shown to be harmful for patients,” he continued.
Ferreyro and colleagues’ findings were published online on June 4 in JAMA.
“The current coronavirus disease 2019 (COVID-19) pandemic has further highlighted the importance of understanding the best approach to providing respiratory support for patients with respiratory failure,” the authors write.
The researchers conducted a systematic review and network meta-analysis of 25 randomized clinical trials involving 3804 participants. The primary outcome was all-cause mortality, which was measured at the longest time point during the first 90 days after randomization.
The secondary outcome was endotracheal intubation up to 30 days. Other secondary outcomes were “patient comfort, dyspnea scores, intensive care unit and hospital lengths of stay, and 6-month mortality,” the authors explain.
Treatment with helmet NIV (risk ratio [RR], 0.40; absolute risk difference, –0.19; low certainty) and face mask NIV (RR, 0.83; absolute risk difference, –0.06; moderate certainty) were linked to a lower risk for mortality compared with standard oxygen therapy (21 studies; 3370 patients).
High-flow nasal oxygen (RR, 0.87; absolute risk difference, –0.04; moderate certainty), however, was not linked to a significantly lower risk for death in comparison with standard oxygen.
Compared with high-flow nasal oxygen (RR, 0.46; absolute risk difference, –0.15; low certainty) and face mask NIV (RR, 0.48; absolute risk difference, –0.13; low certainty), helmet NIV was associated with significantly decreased mortality.
“In the case of face mask, we saw a very small marginal benefit in mortality, and that is a little bit against most recent trials, like the Frat trial,” Ferreyro said. “That association did not stand in multiple scenarios, for example, in patients with more severe respiratory states.”
The risk for endotracheal intubation was lower among those who received helmet NIV (RR, 0.26; absolute risk difference, –0.32; low certainty), face mask NIV (RR, 0.76; absolute risk difference, –0.12; moderate certainty), and high-flow nasal oxygen (RR, 0.76; absolute risk difference, –0.11; moderate certainty) (25 studies; 3804 patients) in comparison with standard oxygen.
The risk for bias resulting from lack of blinding for intubation was determined to be high.
Helmet NIV was linked to reduced risk for endotracheal intubation compared with high-flow nasal oxygen (RR, 0.35; absolute risk difference, −0.20; low certainty) and face mask NIV (RR,0.35; absolute risk difference, −0.20; low certainty).
Regarding concerns that these technologies could harm patients, “There is all upside and no downside” to using them, Lisa F. Wolfe, MD, associate professor of medicine (pulmonary and critical care), Northwestern University, Chicago, Illinois, told Medscape Medical News.
“There have been concerns that if we use this advanced technology, it might in some way harm patients by slowing down their access to intubation and mechanical ventilation,” but the meta-analysis shows the technology does not harm patients, she added.
Which Patients Benefit Remains Unclear
“Questions remain for clinicians regarding when and for which patients these various noninvasive oxygen support strategies fit into the algorithm of AHRF management and specifically for patients with COVID-19,” Bhakti K. Patel, MD, Section of Pulmonary and Critical Care Medicine, Pritzker School of Medicine, University of Chicago, Illinois, and colleagues write in an accompanying editorial.“Although some have argued that the risk of spontaneous breathing should preclude any noninvasive oxygen support, the data from the analysis by Ferreyro et al indicate that it is a reasonable approach to spare a subset of patients with AHRF invasive mechanical ventilation and its inherent complications,” Patel and colleagues continue.
The included studies make it difficult to determine which individual patients might benefit the most from NIV, Wolfe said. The most common diagnoses of the included patients were pneumonia and chronic obstructive pulmonary disease, she explained. She noted that there is a need for additional research to explore these questions.
“There’s still a struggle to identify which specific patients will likely benefit from each of these strategies,” he added.
Patel and colleagues caution against using a “one-size-fits-all” approach to NIV. They recommend “a precision-based approach that matches a given strategy to the observed phenotype of AHRF coupled with incorporating clinician experience and comfort with each technology.
“Although further studies are needed, the meta-analysis by Ferreyro et al has provided a useful summary of the available data to help inform clinicians as they determine locally the best way to choose wisely among several options for care of patients with AHRF, especially in the wave of patients with COVID-19 currently being encountered. Future clinical trials comparing these strategies should not focus on declaring a ‘winner’ per se but rather on identifying the patient phenotypes that stand to benefit from each noninvasive oxygenation support method. In the management of heterogeneous syndromes like AHRF, it is better to have multiple options than to focus on limiting clinical practice to a single choice,” Patel and colleagues write.
Patients with interstitial lung disease and other conditions also experience hypoxemia, Wolfe said, adding, “The ‘next evolution’ of this is going to be expanding access to these types of support devices in the outpatient arena because hypoxemia is seen in COPD in outpatients” as well as inpatients.
Study coauthor Ferguson has received personal fees from Xenios and Getinge. The other coauthors have disclosed no relevant financial relationships. Editorialist Patel has received grants from the Parker B. Francis Foundation outside the submitted work. The remaining coauthors have disclosed no relevant financial relationships. Wolfe has disclosed no relevant financial relationships.
JAMA. Published online June 4, 2020. Full text, Editorial
https://www.medscape.com/viewarticle/932267#vp_1
Quarantine Brings Up More Issues for Patients With Obesity
Patients with obesity not only reported more anxiety and depression,
but the majority reported less exercise, more stress eating, and
increased stockpiling of food due to COVID-19 stay-at-home orders,
researchers found.
In a small survey, around 60% of patients with obesity reported stress eating, with 56% stockpiling food and around 70% saying it has been more difficult to achieve weight loss goals during the stay-at-home orders, reported Sarah Messiah, PhD, of University of Texas Health Science Center in Dallas, and colleagues, in Clinical Obesity.
While they noted increased risks of COVID-19 infection among patients with obesity, such as its effects on pulmonary function and inflammation, the effects of the lockdown and/or mandatory stay-at-home orders on these patients have yet to be studied.
“Social crises such as the current pandemic, have the potential to influence and drive maladaptive behaviors among individuals who are vulnerable (e.g. those with chronic health conditions, unemployed, uninsured, etc.) in particular,” the authors wrote, noting the stay-at-home orders forced cancellations of metabolic and bariatric surgeries for patients who may no longer be employed or have health insurance coverage.
Researchers performed a medical chart review, where they found patients with obesity in a healthcare system-based clinic specializing in obesity and at a metabolic and bariatric surgery practice in Texas. They were asked to fill out a non-anonymous online survey about their health behaviors beginning April 15, about 2 weeks after the state’s governor issued a stay-at-home order.
Depressive symptoms were assessed using the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR).
Overall, 123 patients completed the survey, including the demographic questionnaire. Patients’ mean age was 51, about 82% were women, about half were non-Hispanic white and 29% were non-Hispanic black. Only two (2%) tested positive for SARS-CoV-2, the virus that causes COVID-19, but 15% reported COVID-19 symptoms. Over half apiece had graduated college and had an annual household income of at least $75,000, though almost 10% reported losing their job since COVID-19 started.
Patients’ mean BMI was 40, and about a third had completed metabolic and bariatric surgery. Most commonly self-reported medical conditions were high blood pressure (67%), sleep apnea (51%), and diabetes (30%).
Nearly all patients had been under a stay-at-home order, with 87% reporting they only left their house for necessities. Less than half (47%) said they went outside to walk or exercise.
About 40% of patients went grocery shopping once a week, while 32% went one to two times a week. But 61% reported healthy eating was more challenging and an equal portion reported stress eating, though 64% were cooking more often. Nearly 80% said they were not food insecure.
Around half (48%) of patients reported less time exercising, and 56% reported a decrease in intensity of exercise.
A significantly higher proportion of non-Hispanic white patients reported anxiety compared with other racial and ethnic groups, though there were no significant differences in those reporting depression. After adjustment, Hispanic patients were less likely to report anxiety than non-Hispanic whites.
They added people with obesity already have a 25% higher risk of developing mood and anxiety disorders.
This was a convenience sample, and thus prone to selection bias. It also was a largely homogenous population, and thus not generalizable to other racial or ethnic minority populations and lower socioeconomic status, Messiah and colleagues noted.
But they emphasized due to the “increase in obesogenic behavior” found here, healthcare access should not be interrupted for patients with obesity.
“In addition to asking about diet and exercise patterns, screening for indicators of mental health, loneliness, financial stressors and behaviors that may influence body weight should be implemented by healthcare teams” to prevent “exacerbating the negative health and economic consequences of excess body weight,” the group wrote.
In a small survey, around 60% of patients with obesity reported stress eating, with 56% stockpiling food and around 70% saying it has been more difficult to achieve weight loss goals during the stay-at-home orders, reported Sarah Messiah, PhD, of University of Texas Health Science Center in Dallas, and colleagues, in Clinical Obesity.
While they noted increased risks of COVID-19 infection among patients with obesity, such as its effects on pulmonary function and inflammation, the effects of the lockdown and/or mandatory stay-at-home orders on these patients have yet to be studied.
“Social crises such as the current pandemic, have the potential to influence and drive maladaptive behaviors among individuals who are vulnerable (e.g. those with chronic health conditions, unemployed, uninsured, etc.) in particular,” the authors wrote, noting the stay-at-home orders forced cancellations of metabolic and bariatric surgeries for patients who may no longer be employed or have health insurance coverage.
Researchers performed a medical chart review, where they found patients with obesity in a healthcare system-based clinic specializing in obesity and at a metabolic and bariatric surgery practice in Texas. They were asked to fill out a non-anonymous online survey about their health behaviors beginning April 15, about 2 weeks after the state’s governor issued a stay-at-home order.
Depressive symptoms were assessed using the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR).
Overall, 123 patients completed the survey, including the demographic questionnaire. Patients’ mean age was 51, about 82% were women, about half were non-Hispanic white and 29% were non-Hispanic black. Only two (2%) tested positive for SARS-CoV-2, the virus that causes COVID-19, but 15% reported COVID-19 symptoms. Over half apiece had graduated college and had an annual household income of at least $75,000, though almost 10% reported losing their job since COVID-19 started.
Patients’ mean BMI was 40, and about a third had completed metabolic and bariatric surgery. Most commonly self-reported medical conditions were high blood pressure (67%), sleep apnea (51%), and diabetes (30%).
Nearly all patients had been under a stay-at-home order, with 87% reporting they only left their house for necessities. Less than half (47%) said they went outside to walk or exercise.
About 40% of patients went grocery shopping once a week, while 32% went one to two times a week. But 61% reported healthy eating was more challenging and an equal portion reported stress eating, though 64% were cooking more often. Nearly 80% said they were not food insecure.
Around half (48%) of patients reported less time exercising, and 56% reported a decrease in intensity of exercise.
A significantly higher proportion of non-Hispanic white patients reported anxiety compared with other racial and ethnic groups, though there were no significant differences in those reporting depression. After adjustment, Hispanic patients were less likely to report anxiety than non-Hispanic whites.
They added people with obesity already have a 25% higher risk of developing mood and anxiety disorders.
This was a convenience sample, and thus prone to selection bias. It also was a largely homogenous population, and thus not generalizable to other racial or ethnic minority populations and lower socioeconomic status, Messiah and colleagues noted.
But they emphasized due to the “increase in obesogenic behavior” found here, healthcare access should not be interrupted for patients with obesity.
“In addition to asking about diet and exercise patterns, screening for indicators of mental health, loneliness, financial stressors and behaviors that may influence body weight should be implemented by healthcare teams” to prevent “exacerbating the negative health and economic consequences of excess body weight,” the group wrote.
Disclosures
Th study was supported by the NIH National Institute on Minority Health and Health Disparities.
Messiah and co-authors disclosed no relevant relationships with industry.
Messiah and co-authors disclosed no relevant relationships with industry.
Nursing Homes Shocked at ‘Insanely Wrong’ CMS Data on COVID-19
When the administrator of the Saugus Rehab and Nursing Center in Saugus, Massachusetts, heard that a new Medicare website
reported her facility had 794 confirmed cases of COVID-19 — the second
highest in the country — and 281 cases among staff, she gasped.
“Oh my God. Where are they getting those numbers from?” said Josephine Ajayi. “That doesn’t make any sense.”
Those weren’t the numbers that her facility reported to the CDC’s National Healthcare Safety Network, under new rules from the Centers for Medicare & Medicaid Services (CMS), she said.
Ajayi said her 80-bed facility actually reported 45 residents have tested positive and five residents died, although the CMS website showed no Saugus deaths. About 19 staff members tested positive for the virus, and most have returned to work, she said.
Officials at skilled nursing facilities around the country said Monday they were shocked to see their data reported inaccurately — wildly so in some cases, as at the Saugus home — on the new CMS public website launched Thursday. The numbers are scaring families, harming their reputations, and in some cases are physically impossible, given the number of beds or staff in their facilities, they said.
CMS approved an interim final rule May 1 requiring more than 15,000 nursing homes receiving Medicare or Medicaid reimbursement to report COVID data by May 31, and weekly going forward.
The data fill 56 columns detailing COVID-19 infected residents, staff, testing, and equipment, going back to at least May 1. As of Thursday, CMS said 88% of the nursing homes in the country had reported. Going forward after a grace period ended June 7, they risk fines of $1,000 and up for every week they fail to update their data.
But in many cases, nursing home officials said their data were somehow scrambled, either because nursing home personnel reported in the wrong columns, or the numbers were loaded incorrectly somewhere between the CDC and CMS.
For example, Southern Pointe Living Center in Colbert, Oklahoma, with 95 beds, was reported to have had 339 residents die of COVID-19, yet no confirmed or suspected cases.
“We have not lost anyone nor have we had a [COVID-19] case in the building,” said a woman identifying herself as an assistant at Southern Pointe but who declined to give her full name. The day after CMS released the data, on Friday, she said someone from the CDC called the facility to ask if their numbers were correct as reported, “and we told them no.”
She added, “I don’t know how that happened but that is an error on their end.” As of Tuesday morning, the posted data had not been corrected.
“Insanely wrong”
MedPage Today first learned of the inaccuracies shortly after publishing an article Friday on the new public database. In that article was a list (since removed) of “outliers” — those with the highest numbers of cases and deaths among residents and staff — that included Dellridge Health and Rehabilitation Center in Paramus, New Jersey. The CMS data indicated it had the most COVID-19 deaths of any nursing home in the country at 753.
That number is “insanely wrong,” Jonathan Mechaly, Dellridge’s marketing director, wrote in a frantic email. “We are a 90-bed center and have had less than 20 deaths!! How do you report such inaccurate numbers?”
After a download of the data, a quick sort of the columns easily reveals extreme totals in various categories. But no one called those nursing homes before the data were released to doublecheck, for example, when 100-bed Smith Village in Chicago was shown to have 1,105 confirmed COVID-19 cases among residents and 955 confirmed COVID-19 cases among staff, the most in the country.
“We apparently misread the instructions, which were not very clear,” Yahaira Ramirez, Smith Village’s director of clinical operations told MedPage Today. The facility has had only 38 positive cases among residents and 14 deaths, and among staff, 37 positive or suspected cases but no deaths, she said. But instead of showing up as a total, those numbers somehow appeared as if there were additional cases every day in May. No one caught the error.
It would have been helpful if someone from either agency had at least checked on the highest outliers before publishing, Ramirez said. “We’ve been trying to abide by a lot of the guidelines (from) CMS and CDC, but it’s been challenging. You talk to different people and you get a different answer. Unfortunately, I’m not surprised that they haven’t reached out.”
Asked why there appeared to be so many errors in the data, a CMS spokesman emailed this response:
“As with any new reporting program, there can be data submission errors in the beginning. In an effort to be transparent, CMS made the data collected by the CDC public as quickly as possible balancing transparency and speed against the potential of initial data errors.”
“CMS is advising nursing homes when their submitted data has not passed certain quality checks so they can review the CDC submission instructions and their data submission for accuracy. As CMS continues to analyze the data going forward we expect fewer errors as nursing home staff get used to these requirements and CMS has more time to quality check the data.”
Asked why CMS, at the very least, did not contact the highest outliers, for whom such large numbers of COVID-19 cases or deaths were highly unlikely because of their size, the spokesman did not respond.
It’s also true that CMS Administrator Seema Verma, in announcing the database’s launch, told reporters on a phone call that it would probably include inaccurate data.
Destroying family trust
Paula Sanders, an attorney in Harrisburg, Pennsylvania, who represents some 200 skilled nursing facilities, said many of her clients “can’t figure out where these numbers are coming from” and have been “frustrated” in trying to get them corrected since Thursday.
“This has destroyed the trust between the facilities and the families, because they’ve been reporting and telling the families, these are our numbers,” Sanders said. “Then these numbers come out and don’t make any sense at all. Unfortunately, some families are going to believe the government over the facilities.”
Sanders, who is on the legal committees of two nursing home advocacy groups, the American Health Care Association and LeadingAge, said within the two federal agencies, “there was such a rush to get these numbers out that there was no quality control. You’d think the government would say, ‘yes, we want to absolutely make sure the data we’re providing is correct, because the reputation [is in jeopardy] for the facilities if we’re wrong.'”
“But they weren’t doing that. The amount of time these facilities have spent away from patient care trying to respond to questions from reporters or family over meaningless numbers…it’s a shame. It’s just a shame.”
Adding to the confusion, Sanders said, was the CMS rulemaking process regarding reporting requirements and directions, which seemed to change even after facilities started submitting.
Sometimes the fault was admittedly that of the facilities. The CMS website showed that 92-bed Robison Jewish Health Center in Portland, Oregon, had eight staff members die of COVID-19. In fact, they had no deaths. Administrator Krista Mattox said the problem was their own data entry error, “but it caused ripples through our Oregon state licensing office.”
It would have been nice if either agency had sent an email notification showing how their data would show up, but that didn’t happen.
Karl Steinberg, MD, president-elect for the Society for Post-Acute and Long-Term Care Medicine, said it’s “highly improbable that nursing homes would make such mistakes in their data, for example, making the numbers of deaths higher than they actually were.”
He added that the whole effort to demonize COVID-19 cases in nursing homes is wrong-headed and counterproductive. “Seema Verma has pretty much said we’re going to slam these facilities, bring the hammer down hard. But to conflate quality of care in a facility with the number of cases is horrific” especially since in some parts of the country, nursing homes were required by their state governments to accept COVID-19 patients.
“I think they’re just trying to scapegoat and lay blame on the facilities,” said Steinberg, medical director of a San Diego area hospice. “Certainly some could have done better, but in a lot of cases they were like sitting ducks.”
https://www.medpagetoday.com/infectiousdisease/covid19/86967
“Oh my God. Where are they getting those numbers from?” said Josephine Ajayi. “That doesn’t make any sense.”
Those weren’t the numbers that her facility reported to the CDC’s National Healthcare Safety Network, under new rules from the Centers for Medicare & Medicaid Services (CMS), she said.
Ajayi said her 80-bed facility actually reported 45 residents have tested positive and five residents died, although the CMS website showed no Saugus deaths. About 19 staff members tested positive for the virus, and most have returned to work, she said.
Officials at skilled nursing facilities around the country said Monday they were shocked to see their data reported inaccurately — wildly so in some cases, as at the Saugus home — on the new CMS public website launched Thursday. The numbers are scaring families, harming their reputations, and in some cases are physically impossible, given the number of beds or staff in their facilities, they said.
CMS approved an interim final rule May 1 requiring more than 15,000 nursing homes receiving Medicare or Medicaid reimbursement to report COVID data by May 31, and weekly going forward.
The data fill 56 columns detailing COVID-19 infected residents, staff, testing, and equipment, going back to at least May 1. As of Thursday, CMS said 88% of the nursing homes in the country had reported. Going forward after a grace period ended June 7, they risk fines of $1,000 and up for every week they fail to update their data.
But in many cases, nursing home officials said their data were somehow scrambled, either because nursing home personnel reported in the wrong columns, or the numbers were loaded incorrectly somewhere between the CDC and CMS.
For example, Southern Pointe Living Center in Colbert, Oklahoma, with 95 beds, was reported to have had 339 residents die of COVID-19, yet no confirmed or suspected cases.
“We have not lost anyone nor have we had a [COVID-19] case in the building,” said a woman identifying herself as an assistant at Southern Pointe but who declined to give her full name. The day after CMS released the data, on Friday, she said someone from the CDC called the facility to ask if their numbers were correct as reported, “and we told them no.”
She added, “I don’t know how that happened but that is an error on their end.” As of Tuesday morning, the posted data had not been corrected.
“Insanely wrong”
MedPage Today first learned of the inaccuracies shortly after publishing an article Friday on the new public database. In that article was a list (since removed) of “outliers” — those with the highest numbers of cases and deaths among residents and staff — that included Dellridge Health and Rehabilitation Center in Paramus, New Jersey. The CMS data indicated it had the most COVID-19 deaths of any nursing home in the country at 753.
That number is “insanely wrong,” Jonathan Mechaly, Dellridge’s marketing director, wrote in a frantic email. “We are a 90-bed center and have had less than 20 deaths!! How do you report such inaccurate numbers?”
After a download of the data, a quick sort of the columns easily reveals extreme totals in various categories. But no one called those nursing homes before the data were released to doublecheck, for example, when 100-bed Smith Village in Chicago was shown to have 1,105 confirmed COVID-19 cases among residents and 955 confirmed COVID-19 cases among staff, the most in the country.
“We apparently misread the instructions, which were not very clear,” Yahaira Ramirez, Smith Village’s director of clinical operations told MedPage Today. The facility has had only 38 positive cases among residents and 14 deaths, and among staff, 37 positive or suspected cases but no deaths, she said. But instead of showing up as a total, those numbers somehow appeared as if there were additional cases every day in May. No one caught the error.
It would have been helpful if someone from either agency had at least checked on the highest outliers before publishing, Ramirez said. “We’ve been trying to abide by a lot of the guidelines (from) CMS and CDC, but it’s been challenging. You talk to different people and you get a different answer. Unfortunately, I’m not surprised that they haven’t reached out.”
Asked why there appeared to be so many errors in the data, a CMS spokesman emailed this response:
“As with any new reporting program, there can be data submission errors in the beginning. In an effort to be transparent, CMS made the data collected by the CDC public as quickly as possible balancing transparency and speed against the potential of initial data errors.”
“CMS is advising nursing homes when their submitted data has not passed certain quality checks so they can review the CDC submission instructions and their data submission for accuracy. As CMS continues to analyze the data going forward we expect fewer errors as nursing home staff get used to these requirements and CMS has more time to quality check the data.”
Asked why CMS, at the very least, did not contact the highest outliers, for whom such large numbers of COVID-19 cases or deaths were highly unlikely because of their size, the spokesman did not respond.
It’s also true that CMS Administrator Seema Verma, in announcing the database’s launch, told reporters on a phone call that it would probably include inaccurate data.
Destroying family trust
Paula Sanders, an attorney in Harrisburg, Pennsylvania, who represents some 200 skilled nursing facilities, said many of her clients “can’t figure out where these numbers are coming from” and have been “frustrated” in trying to get them corrected since Thursday.
“This has destroyed the trust between the facilities and the families, because they’ve been reporting and telling the families, these are our numbers,” Sanders said. “Then these numbers come out and don’t make any sense at all. Unfortunately, some families are going to believe the government over the facilities.”
Sanders, who is on the legal committees of two nursing home advocacy groups, the American Health Care Association and LeadingAge, said within the two federal agencies, “there was such a rush to get these numbers out that there was no quality control. You’d think the government would say, ‘yes, we want to absolutely make sure the data we’re providing is correct, because the reputation [is in jeopardy] for the facilities if we’re wrong.'”
“But they weren’t doing that. The amount of time these facilities have spent away from patient care trying to respond to questions from reporters or family over meaningless numbers…it’s a shame. It’s just a shame.”
Adding to the confusion, Sanders said, was the CMS rulemaking process regarding reporting requirements and directions, which seemed to change even after facilities started submitting.
Sometimes the fault was admittedly that of the facilities. The CMS website showed that 92-bed Robison Jewish Health Center in Portland, Oregon, had eight staff members die of COVID-19. In fact, they had no deaths. Administrator Krista Mattox said the problem was their own data entry error, “but it caused ripples through our Oregon state licensing office.”
It would have been nice if either agency had sent an email notification showing how their data would show up, but that didn’t happen.
Karl Steinberg, MD, president-elect for the Society for Post-Acute and Long-Term Care Medicine, said it’s “highly improbable that nursing homes would make such mistakes in their data, for example, making the numbers of deaths higher than they actually were.”
He added that the whole effort to demonize COVID-19 cases in nursing homes is wrong-headed and counterproductive. “Seema Verma has pretty much said we’re going to slam these facilities, bring the hammer down hard. But to conflate quality of care in a facility with the number of cases is horrific” especially since in some parts of the country, nursing homes were required by their state governments to accept COVID-19 patients.
“I think they’re just trying to scapegoat and lay blame on the facilities,” said Steinberg, medical director of a San Diego area hospice. “Certainly some could have done better, but in a lot of cases they were like sitting ducks.”
https://www.medpagetoday.com/infectiousdisease/covid19/86967
Covid-19 contact tracing tech: States that committed to, passed on Apple, Google
Since Google and Apple’s interoperable COVID-19 contact tracing tech hit the
market May 20, only three states have committed to using it while many
more are still exploring their options, according to a June 10 Business Insider report.
Google and Apple’s interoperable application programming interface is designed to measure contact tracing using Bluetooth technology in smart phones. As of June 10, Alabama, North Dakota and South Carolina are the only states that have committed to using Google and Apple’s system; and Rhode Island, South Dakota, Virginia and Washington have begun developing their own contact tracing apps, according to the report.
Business Insider contacted officials in all 50 states and Washington, D.C., to ask whether they will use the tech giants’ system. Here are the 19 states that have not yet decided:
Google and Apple’s interoperable application programming interface is designed to measure contact tracing using Bluetooth technology in smart phones. As of June 10, Alabama, North Dakota and South Carolina are the only states that have committed to using Google and Apple’s system; and Rhode Island, South Dakota, Virginia and Washington have begun developing their own contact tracing apps, according to the report.
Business Insider contacted officials in all 50 states and Washington, D.C., to ask whether they will use the tech giants’ system. Here are the 19 states that have not yet decided:
- Arkansas
- California
- Illinois
- Kansas
- Kentucky
- Maine
- Massachusetts
- Michigan
- Minnesota
- Montana
- Nevada
- New York
- Pennsylvania
- Rhode Island
- South Dakota
- Virginia
- Washington
- West Virginia
- Wisconsin
- Colorado
- Delaware
- Florida
- Georgia
- Hawaii
- Indiana
- Louisiana
- Maryland
- Missouri
- New Mexico
- North Carolina
- Ohio
- Oregon
- Tennessee
- Texas
- Vermont
COVID-19 liability waivers — part of the new normal?
As states reopen and businesses welcome workers and customers back,
Americans are finding that the “new normal” ushered in by the COVID-19
pandemic includes a new feature — COVID-19 liability waivers.
Waivers that absolve businesses of liability if a person contracts the new coronavirus on its premises may become commonplace across the country, according to CBS News. Theme parks, live events, hair salons and others are asking customers to sign these waivers.
The New York Stock Exchange and restaurant chains also are requiring the waivers, The New York Times reports. Even President Donald Trump’s reelection campaign is requiring those who attend its rallies to sign a waiver prohibiting them from suing the campaign or the venue if they contract COVID-19.
But the waivers don’t necessarily “immunize [businesses] to lawsuits,” liability attorney Richard Bell told CBS News. They are still under obligation to follow social-distancing guidelines and other rules to keep customers safe, Mr. Bell said.
Businesses and even colleges and universities are pushing Congress to provide temporary legal protection, but opponents, a majority of whom are Democrats, say that such protections may allow for reckless behavior, the Times reports.
Also, it is unlikely that there will be a “cavalcade of lawsuits” against businesses, Linda Lipsen, chief executive of the American Association for Justice, which represents trial lawyers, told the Times.
“Outside of meatpacking plants, cruises, nursing homes, veterans homes and other hot spots, there is not going to be that race to the courthouse because there are already all of these barriers to getting to court,” she said.
https://www.beckershospitalreview.com/legal-regulatory-issues/covid-19-liability-waivers-part-of-the-new-normal.html
Waivers that absolve businesses of liability if a person contracts the new coronavirus on its premises may become commonplace across the country, according to CBS News. Theme parks, live events, hair salons and others are asking customers to sign these waivers.
The New York Stock Exchange and restaurant chains also are requiring the waivers, The New York Times reports. Even President Donald Trump’s reelection campaign is requiring those who attend its rallies to sign a waiver prohibiting them from suing the campaign or the venue if they contract COVID-19.
But the waivers don’t necessarily “immunize [businesses] to lawsuits,” liability attorney Richard Bell told CBS News. They are still under obligation to follow social-distancing guidelines and other rules to keep customers safe, Mr. Bell said.
Businesses and even colleges and universities are pushing Congress to provide temporary legal protection, but opponents, a majority of whom are Democrats, say that such protections may allow for reckless behavior, the Times reports.
Also, it is unlikely that there will be a “cavalcade of lawsuits” against businesses, Linda Lipsen, chief executive of the American Association for Justice, which represents trial lawyers, told the Times.
“Outside of meatpacking plants, cruises, nursing homes, veterans homes and other hot spots, there is not going to be that race to the courthouse because there are already all of these barriers to getting to court,” she said.
https://www.beckershospitalreview.com/legal-regulatory-issues/covid-19-liability-waivers-part-of-the-new-normal.html
U.S. eases criminal record provision in coronavirus business loan program
Federal authorities administering business payroll loans as part of
U.S. coronavirus relief efforts on Friday eased rules prohibiting
lending to business owners with criminal records, allowing some with no
convictions in the past year to access funds.
The U.S. Treasury Department and the Small Business Administration said the look-back period for non-financial felony convictions has been reduced to one year from five years. The prohibition threshold for business owners with felonies involving fraud, bribery, embezzlement and similar offenses remains five years, they said.
The change goes further than what U.S. Treasury Secretary Steven Mnuchin had suggested on Wednesday. He said the period for considering felony records would be reduced to three years.
The Paycheck Protection Program, part of a historic fiscal package worth nearly $3 trillion passed by Congress and signed by President Donald Trump to deal with the economic fallout from the coronavirus pandemic, offers businesses loans that can be partially forgiven if used for employee wages.
The Treasury Department and the SBA said the decision was made in the interest of criminal justice reform.
https://www.marketscreener.com/news/U-S-eases-criminal-record-provision-in-coronavirus-business-loan-program–30765232/?countview=0
The U.S. Treasury Department and the Small Business Administration said the look-back period for non-financial felony convictions has been reduced to one year from five years. The prohibition threshold for business owners with felonies involving fraud, bribery, embezzlement and similar offenses remains five years, they said.
The change goes further than what U.S. Treasury Secretary Steven Mnuchin had suggested on Wednesday. He said the period for considering felony records would be reduced to three years.
The Paycheck Protection Program, part of a historic fiscal package worth nearly $3 trillion passed by Congress and signed by President Donald Trump to deal with the economic fallout from the coronavirus pandemic, offers businesses loans that can be partially forgiven if used for employee wages.
The Treasury Department and the SBA said the decision was made in the interest of criminal justice reform.
https://www.marketscreener.com/news/U-S-eases-criminal-record-provision-in-coronavirus-business-loan-program–30765232/?countview=0
Subscribe to:
Comments (Atom)