California, Despite Strict Mandates, Sees Surge in COVID Infections

 In October, California appeared to be reaping the benefits of strict mask and vaccine mandates after reporting the lowest COVID-19 infection rate in the nation.

The nation's most populous state, once the epicenter of the U.S.'s COVID-19 outbreak, was briefly the only one to have a "moderate" rate of transmission in October. But the state's case rate has now climbed back up to the U.S. Centers for Disease Control and Prevention's (CDC) "high" rate of transmission.

As of Sunday, California's seven-day case rate was 113.4 cases per 100,000 people, according to CDC data—much higher than the 72.7 cases per 100,000 people reported in Texas and more than double Florida's rate of 50.1. The Republican governors of both those states signed legislation restricting vaccine mandates.

California's rate is also currently much higher than that of Southern states that shunned mask and vaccine mandates and reported lower vaccination rates despite the highly contagious Delta variant fueling large outbreaks over the summer.

Experts say California is paying for its success at controlling the spread of the virus earlier with higher infection rates now.

California saw fewer coronavirus infections over the summer than states with lower vaccination rates as the Delta variant rapidly spread in unvaccinated communities.

But those who were infected now have immunity, meaning there are fewer people spreading the virus.

"California is experiencing a relatively mild uptick in cases, probably related to relatively low vaccination rates in some part of the state. It could get worse with more indoor activities, we'll have to see," Bob Wachter, chair of the medical department at the University of California-San Francisco, told Newsweek.

"The states in the South are looking pretty good right now, in part because of the absence of very cold weather and the partial protection offered by prior infection."

Ali H. Mokdad, a professor of health metrics at the University of Washington, explained that states that saw large outbreaks over the summer are doing better now because the combination of infections and vaccinations have left fewer people at risk of contracting the virus.

"What's driving this is the percentage of people who are still susceptible to the virus. In order to reduce that number of susceptible percentage in a community, you have to get more people immune, either by vaccination or by infection."

In a tweet, he said 58 percent of people in California are estimated to be immune to the Delta variant compared with an estimated 68 percent in Florida.

California worked to curb coronavirus infections with some of the strictest mandates in the country. It was the first to announce a vaccine requirement for schools and has also mandated vaccines for state employees, healthcare workers and teachers.

But while the state's vaccination rate is higher than many Southern states, it's not high enough to prevent outbreaks as 62 percent of the state's total population is fully vaccinated, compared to 60 percent in Florida and 54 percent in Texas.

Meanwhile, Mississippi, Alabama and Georgia each have less than 50 percent of their populations fully vaccinated against COVID-19, but currently have significantly lower case rates than California.

https://www.newsweek.com/california-covid-infections-surge-despite-strict-mandates-1646858

Philips in talks with FDA after new ventilator findings

 

Philips, the medical equipment maker that is recalling ventilators due to use of parts containing a potentially hazardous foam, said on Sunday it is in dicussions with U.S. regulators after a new inspection of one of the company's facilities.

Philips in September estimated it will replace up to 4 million vetilators and respiratory devices because of a polyurethane foam part that might degrade and become toxic.

The company has produced 15 million devices using the foam since 2009 but some are not in use.

On Nov. 12, the U.S. Food and Drug Administration (FDA) said that it had obtained new information during inspections of the company's Murraysville, PA facility.

The FDA asked Philips to conduct more tests on the foam used in the recalled ventilators and said the company has not sufficiently demonstrated that other devices containing the foam should not also be recalled. It also said Philips' procedures for design change may not be adequate.

"We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing," Philips CEO Frans van Houten said in a statement.

"Until we have concluded these discussions, we are not able to publicly provide further details."

It said it expected to complete its own testing of the foam in the fourth quarter.

The company has been using a replacement silicone-based foam which must now also undergo further safety testing.

The FDA statement said that while it could not be sure, on the basis of what it knows now, that the silicone-based foam being used for repaired products is safe either, it does not recommend patients stop using them, based on a risk-benefit assessment.

Philips has so far put aside 500 million euros ($572.50 million in provisions for recall costs. In October it lowered financial forecasts for the year, citing fallout from the recall and related lawsuits.

https://www.marketscreener.com/quote/stock/PHILIPS-NV-6289/news/Philips-in-talks-with-FDA-after-new-ventilator-findings-statement-37016228/

Workers claim WalMart skipped COBRA notice amid COVID-19 job loss

 Walmart Shops Inc has been accused of failing to inform staff throughout the nation who misplaced their jobs amid the COVID-19 pandemic of their proper to persevering with medical health insurance protection briefly paid for by the federal government.

Former Walmart worker Elba Vazquez and her husband filed a proposed class motion in Fort Myers, Florida, federal courtroom on Wednesday, claiming notices the retail large despatched out this 12 months omitted key info, together with that the federal authorities would subsidize insurance coverage premiums till Sept. 30 below the American Rescue Plan Act of 2021 (ARP).

A spokesman for Arkansas-based Walmart didn’t instantly reply to a request for remark Thursday.

Below the Consolidated Omnibus Finances Reconciliation Act of 1985 (COBRA), employers should present insurance coverage protection for as much as 18 months after certified workers lose their jobs however can require staff to cowl the premiums.

The ARP required corporations to offer free persevering with protection for as much as six months, with the fee offset by new tax credit.

Walmart, the biggest non-public U.S. employer with about 1.6 million workers, may face penalties of $110 per violation per day whether it is discovered to have violated the notice necessities included within the ARP.

The nationwide class proposed by Vazquez may embody “hundreds or thousands” of individuals, in accordance with the criticism.

The case is Vazquez v. Walmart Shops Inc, U.S. District Court docket for the Center District of Florida, No 2:21-cv-00848.

https://theduffeylawfirm.com/workers-claim-walmart-skipped-cobra-notice-amid-covid-19-job-loss/

Judge denies L.A. police union’s request to block COVID vaccine mandate

 A judge on Wednesday denied a request by the Los Angeles police union that he block the city’s COVID-19 vaccination mandate for police officers from taking effect.

Having rejected the Police Protective League’s petition for a temporary restraining order, California Superior Court Judge Mitchell L. Beckloff must still rule on a related request for a preliminary injunction, which would halt the mandate for officers while a lawsuit the union filed against the city over the rollout of the vaccine requirement goes forward. A court hearing on the injunction is scheduled for next month.

The judge did not explain the reasoning for his decision in court records available online Thursday.

Under the city’s mandate, all city employees including police officers are required to be fully vaccinated by Dec. 18 unless they are granted a medical or religious exemption, and agree in the run-up to the deadline to submit to regular coronavirus testing if they are unvaccinated. The union negotiated the terms of the deal with city officials, but later sued over its rollout, alleging the city negotiated in bad faith, preemptively concluded negotiations and inappropriately passed on costs for testing to officers.

https://ktla.com/news/local-news/judge-denies-l-a-police-unions-request-to-block-covid-vaccine-mandate/

One In Three Employers Require Covid Vaccination: Only The Beginning?

 At least one in three U.S. employers are requiring their workers to be vaccinated against Covid-19 and that’s only the beginning of such employer mandates, new worker and employer surveys show.

A new analysis of employer data from the global health benefits consultancy Mercer shows 36% of employers have “some type of vaccine mandate already in place.” The results come from a survey in October that had 1,000 respondents in less than a week, Mercer said.

“Workplace vaccination requirements were already gaining momentum before President Biden unveiled the Covid-19 action, driven by the need to safely return employees to their worksites and protect customers,” said Mercer’s director of health research, Beth Umland, referring to the White House effort to require vaccination for companies with 100 workers or more.

Momentum is building among even more U.S. employers to require vaccination against Covid-19 as the virus continues its spread in certain parts of the country. Meanwhile, companies are working on ways to make their employees feel comfortable returning to work and see requiring everybody to be vaccinated as key to health and safety of all workers against the Coronavirus.

The latest Kaiser Family Foundation poll shows one-quarter, or 25% of workers “say their employer has a vaccine requirement.” That is up from just 9% in June, the Kaiser analysis showed. 

The Kaiser data showed about one-fifth of workers want their employer to require vaccinations but even more, or 51%, don’t want their employer to require Covid-19 vaccinations. And this is a concern of employers pondering requirements and whether workers will flee their employment.

“The majority of employers remain concerned about the impact of the mandate on turnover,” Mercer’s Umland said. “Employers will need to focus on effective communications and may want to consider testing options as well.”

But so far vaccination mandates aren’t impacting employee turnover much.

“There was no impact on turnover for 71% of those with mandates in place; however, 25% saw a slight increase in turnover (1%-5% above normal) and 4% saw a significant increase (more than 5% above normal),” the Mercer analysis said.

https://www.forbes.com/sites/brucejapsen/2021/11/01/one-in-three-us-employers-require-covid-vaccination-and-its-only-the-beginning/

1 in 3 patients defer healthcare due to existing medical debt: TransUnion

 

• Thirty-five percent of patients with outstanding medical bills said that debt deterred them from seeking healthcare services over the past year, according to a new survey of consumers' billing experiences by TransUnion Healthcare.
• The credit bureau's healthcare data analytics unit also reported seeing a 55% rise in financial assistance transactions from September 2020 to September 2021. Those transactions, which number in the millions, are conducted by TransUnion to assess a patient's ability to pay and determine charity options.
• The rise in financial assistance transactions likely stems from the economic downturn caused by the coronavirus pandemic, the company said. The analysis was released at the Healthcare Financial Management Association annual conference underway virtually and in Minneapolis.
• The pandemic appears to again be altering the healthcare landscape as patients defer doctor visits to avoid contracting the virus. A report this month from consultants Kaufman Hall showed hospital margins declined more than 18% in September from August as patient volumes fell in key categories such as emergency room visits, operating room minutes and outpatient revenues.

Previously, almost six in 10 respondents to a TransUnion survey last September said they deferred non-COVID-related medical care in the prior six months, while nearly half said the economy had at least some impact on how they approached medical care.

TransUnion's latest data suggests financial concerns are factoring into patients' current decisions to delay seeking care as well. It echoes similar research released in June from payment technology company Patientco, which also found that one in three patients avoided seeking healthcare due to cost barriers.

"It's scary and sad to know people are forgoing their physical and mental health for fear that they'll ruin their financial health with medical treatment," said Jonathan Wiik, principal of healthcare strategy for TransUnion Healthcare.

As many as 3 million people may have lost employer-sponsored health insurance due to COVID-19 in the early months of the pandemic, according to a Kaiser Family Foundation analysis. At the same time, enrollment in Medicaid climbed as people lost their jobs and insurance, while others obtained private coverage by signing up as dependents on a family member's plan.

Amid the disruptions to coverage, many people put off getting care, Wiik said.

The upheaval wrought by the pandemic comes against the backdrop of rising healthcare expenses for workers, with average family premiums up 4% to $21,342 in 2020, according to a KFF employer health benefit survey. Workers contributed $5,588 on average to the total amount, with employers covering the remainder.

Hospitals were already running more financial assistance transactions before COVID-19 struck. The pandemic accelerated that trend, reflecting increased financial pressure on healthcare systems and patients struggling with the burden of higher costs, according to TransUnion.

Transactions rose 49% from September 2019 to September 2020 and 60% in the year before that. "We've seen that increase pretty dramatically over the last three years," Wiiks said.

While the economic downturn brought by the pandemic likely increased demand for financial assistance transactions, other factors like predatory hospital billing practices also played a role, Wiiks said.

TransUnion last year found 70% of patients said knowing the cost before having a medical procedure helped them budget for payments, while 65% said they would make at least a partial payment if an advance estimate were provided.

Hospital price transparency rules now in effect could make finding that information easier, but facilities have so far been mostly noncompliant. Last week, CMS said it was hiking up the fees for hospitals that don't post their chargemasters online to as much as $2 million a year for larger facilities.

https://www.healthcaredive.com/news/patients-defer-healthcare-existing-medical-debt-transunion/609759/

Siemens software vulnerabilities potentially put millions of medical devices at risk

 

• The U.S. Cybersecurity and Infrastructure Security Agency has issued an alert about critical vulnerabilities in Siemens software that could potentially impact millions of medical devices from multiple manufacturers.
• The cyber agency, following the lead of the researchers who identified the weaknesses, scored one of the vulnerabilities 9.8 on a 10-point risk scale, reflecting the potential for hackers to disrupt the operation of critical medical devices such as anesthesia machines and bedside monitors. To date, there are no known attacks that have specifically targeted the vulnerabilities.
• CISA's alert states that Siemens has released updates for several of the affected products and the company is advising users of unpatched devices to take countermeasures but "has not identified any additional specific workarounds or mitigations." A Siemens spokesperson in an emailed statement said the company is aware of the vulnerabilities and is investigating to identify if any of its products are affected. 

Forescout Research Labs, with support from Medigate Labs, first identified the weaknesses. The researchers discovered a set of 13 vulnerabilities that affect Siemens' software, which is often used in computers embedded in larger systems such as medical devices. The vulnerabilities, which range from a moderate 5.3 to a critical 9.8 on the risk scale, could cause denial of service, information leaks or the execution of remote code.

Anesthesia machines, ventilators and patient monitors are among the medical devices possibly impacted. Forescout researchers used various techniques to estimate the number of devices affected by the vulnerabilities, known collectively as Nucleus:13, and discovered evidence of the use of the software in Zoll defibrillators, Zonare ultrasound devices, a GE Healthcare anesthesia machine and a Nihon Kohden bedside monitor.

GE has already evaluated the impact of Nucleus:13 on its devices, completing assessments of the "limited number" of subcomponents that use the software. "The product teams have evaluated the security design and mitigating controls. Given these design controls and mitigations in place GE Healthcare has determined these products are not impacted by these vulnerabilities," GE wrote.

A Siemens Healthineers spokesperson said the company continues to "monitor the issue as it develops and might notify customers, if it is necessary, through Siemens Healthineers teamplay Fleet customer online portal."

FDA wants all manufacturers to assess their exposure to these vulnerabilities in the Siemens software that was originally released in 1993.

"It is important for medical device manufacturers to have a mechanism to quickly ascertain if their devices are affected," Kevin Fu, acting director of medical device cybersecurity at the FDA's Center for Devices and Radiological Health, told CNN, the first outlet to report the news.

An assessment performed by Forescout identified more than 2,200 healthcare devices vulnerable to the cybersecurity weaknesses. The number of affected devices is more than twice that in any other industry. Across all industries, the researchers identified "close to 5,500 devices from 16 vendors in 127 customers."

CISA is advising users to take defensive measures to cut the risk of the vulnerabilities being exploited and to update vulnerable devices once updates are available.

Nick Yuran, CEO of security consultancy Harbor Labs, said none of his clients use the affected version of the Nucleus stack but sees it as yet "another wake-up call" for the medtech industry about the hidden risks in older legacy medical devices.

"We often find these same classes of vulnerability being repeated across different software platforms of the same era. Based on the age of Nucleus, some of the affected devices could have been in clinical use with these vulnerabilities for more than 20 years," Yuran said.

The three most severe vulnerabilities described in Nucleus:13 all allow the attacker to launch a denial-of-service attack or perform remote code execution, Yuran warned, which are all "potential security outcomes that have historically led regulators to intervene with a strong hand."

The good news is that most of the classes of medical devices affected by the vulnerabilities are "commonly either not networked, or are shielded and isolated on their own network segments," Yuran added.

https://www.healthcaredive.com/news/siemens-software-vulnerabilities-puts-devices-at-risk-cybersecurity/609912/