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Tuesday, April 4, 2023

InflaRx Gets Emergency Use Authorization for Treatment of Critically Ill COVID-19 Patients

 

  • Vilobelimab is the first authorized drug to control complement factor C5a, a protein that plays an important and often harmful role in the body's immune response

  • FDA granted EUA based on Phase III clinical trial results showing a significant relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in critically ill invasively mechanically ventilated COVID-19 patients

  • InflaRx continues the dialogue with FDA to discuss next steps towards a Biologics License Application submission for full approval

  • Encouraging pre-submission meetings held with EMA in Europe; InflaRx plans to apply for full approval to treat critically ill COVID-19 patients

  • Company to host a conference call tomorrow, April 5th at 8:30 am EDT/2:30 pm CEST

InflaRx will host a conference call to discuss today’s news on April 5th at 8:30 am EDT (2:30 pm CEST). To participate in the conference call, participants may pre-register here and will receive a dedicated link and dial-in details to easily and quickly access the call. A replay will be available on the InflaRx website in the Investors - Events & Presentations section.

States Step In as Telehealth and Clinic Patients Get Blindsided by Hospital Fees

 When Brittany Tesso's then-3-year-old son, Roman, needed an evaluation for speech therapy in 2021, his pediatrician referred him to Children's Hospital Colorado in Aurora. With in-person visits on hold due to the covid-19 pandemic, the Tessos met with a panel of specialists via video chat.

The specialists, some of whom appeared to be calling from their homes, observed Roman speaking, playing with toys, and eating chicken nuggets. They asked about his diet.

Tesso thought the $676.86 bill she received for the one-hour session was pretty steep. When she got a second bill for $847.35, she assumed it was a mistake. Then she learned the second bill was for the costs of being seen in a hospital — the equipment, the medical records, and the support staff.

"I didn't come to your facility," she argued when disputing the charges with a hospital billing representative. "They didn't use any equipment."

This is the facility fee, the hospital employee told her, and every patient gets charged this.

"Even for a telehealth consultation?" Tesso laughed in disbelief, which soon turned into anger.

Millions of Americans are similarly blindsided by hospital bills for doctor appointments that didn't require setting foot inside a hospital. Hospitals argue that facility fees are needed to pay for staff and overhead expenses, particularly when hospitals don't employ their own physicians. But consumer advocates say there's no reason hospitals should charge more than independent clinics for the same services.

"If there is no change in patient care, then the fees seem artificial at best," said Aditi Sen, a Johns Hopkins University health economist.

At least eight states agree such charges are questionable. They have implemented limits on facility fees or are moving to clamp down on the charges. Among them are Connecticut, which already limits facility fees, and Colorado, where lawmakers are considering a similar measure. Together, the initiatives could signal a wave of restrictions similar to the movement that led to a federal law to ban surprise bills, which took effect last year.

"Facility fees are simply another way that hospital CEOs are lining their pockets at the expense of patients," said Rep. Emily Sirota, the Denver Democrat who sponsored the Colorado bill.

Generally, patients at independent physician clinics receive a single bill that covers the physician's fee as well as overhead costs. But when the clinic is owned by a hospital, the patient generally receives separate bills for the physician's fee and the facility fee. In some cases, the hospital sends a single bill covering both fees. Medicare reduces the physician's payment when a facility fee is charged. But private health plans and hospitals don't disclose how physician and facility fees are set.

Children's Hospital Colorado officials declined to comment on the specifics of Tesso's experience but said that facility fees cover other costs of running the hospital.

"Those payments for outpatient care are how we pay our nurses, our child life specialists, or social workers," Zach Zaslow, senior director of government affairs for Children's Hospital said in a February call with reporters. "It's how we buy and maintain our imaging equipment, our labs, our diagnostic tests, really all of the care that you expect when you come to a hospital for kids."

Research suggests that when hospitals acquire physician practices and hire those doctors, the physicians' professional fees go up and, with the addition of facility fees, the total cost of care to the patient increases, as well. Other factors are in play, too. For instance, health plans pay the rates negotiated with the hospital, and hospitals have more market power than independent clinics to demand higher rates.

Those economic forces have driven consolidation, as hospital systems gobble up physician clinics. According to the Physicians Advocacy Institute, 3 in 4 physicians are now employed by hospitals, health systems, or other corporate entities. And less competition usually leads to higher prices.

One study found that prices for the services provided by physicians increase by an average of 14% after a hospital acquisition. Another found that billing for laboratory tests and imaging, such as MRIs or CT scans, rise sharply after a practice is acquired.

Patients who get their labs drawn in a hospital outpatient department are charged up to three times what they would pay in an office, Sen said. "It's very hard to argue that the hospital outpatient department is doing that differently with better outcomes," she said.

Hospital officials say they acquire physician practices to maintain care options for patients. "Many of those physician practices are not viable and they were having trouble making ends meet, which is why they wanted to be bought," said Julie Lonborg, a senior vice president for the Colorado Hospital Association.

Along with Colorado and Connecticut, other states that have implemented or are considering limits on facility fees are IndianaMinnesota, New Hampshire, Ohio, Texas, and Washington. Those measures include collecting data on what facility fees hospitals charge, prohibiting add-on fees for telehealth, and requiring site-neutral payments for certain Medicaid services. A federal bill introduced in 2022 would require off-campus hospital outpatient departments to bill as physician providers, eliminating the possibility of charging facility fees.

Connecticut has gone the furthest, banning facility fees for basic doctor visits off-campus, and for telehealth appointments through June 2024. But the law's application still has limitations, and with rising health care costs, the amount of facility fees in Connecticut continues to increase.

"It hasn't changed much, partly because there's so much money involved," said Ted Doolittle, who heads the state's Office of the Healthcare Advocate. "They can't just painlessly take that needle out of their arm. They're addicted to it."

The Colorado bill would prohibit facility fees for primary care visits, preventive care services that are exempted from cost sharing, and telehealth appointments. Hospitals would also be required to notify patients if a facility fee would apply. The ban would not apply to rural hospitals. The bill was scaled back from a much broader proposal after criticism from hospitals about its potential consequences.

Rural hospital executives, like Kevin Stansbury, CEO of Lincoln Health, a small community hospital in the eastern Colorado town of Hugo, had been particularly worried about the impact of a fee ban. The state hospital association estimated his hospital would lose as much as $13 million a year if facility fees were banned. The 37-bed hospital's netted $22 million in patient revenue last year, resulting in a loss. It stays open only through local taxes, Stansbury said.

"This will still harm access to care — and especially essential primary and preventive care that is helping Coloradans stay healthier and out of the hospital," Lonborg said of the revised approach. "It will also have a detrimental impact on access to specialty care through telehealth, which many Coloradans, especially in rural parts of the state, have come to depend on."

The Colorado bill presents particular challenges for health systems such as UC Health and Children's Hospital, which rely on the University of Colorado School of Medicine for staffing. For outpatient appointments, the medical school bills for the doctor's fee, while the hospital bills a facility fee.

"The professional fee goes solely to the provider, and, very frequently, they're not employed by us," said Dan Weaver, vice president of communications for UC Health. "None of that supports the clinic or the staff members."

Without a facility fee, the hospital would not receive any payment for outpatient services covered by the ban. Weaver said the combination of the clinicians' and facility fees is often higher than fees charged in independent clinics because hospitals provide extra services that independent physician clinics cannot afford.

"Prohibiting facility fees for primary care services and for telehealth would still cause significant problems for patients throughout our state, forcing some clinics to close, and causing patients to lose access to the care they need," he said.

Backers of the Colorado bill disagree.

"The data on their costs and their revenue paints a little different picture of their financial health," said Isabel Cruz, policy manager for the Colorado Consumer Health Initiative, which backs the bill.

From 2019 through 2022, UC Health had a net income of $2.8 billion, including investment gains and losses.

The Colorado market is dominated by large health systems that can dictate higher rates to health plans. Plans pass on those costs through higher premiums or out-of-pocket costs.

"Unless the employers and patients that are incurring the prices are raising the alarm, there really isn't a strong incentive for health plans to push against this," said Christopher Whaley, a health care economist with the nonprofit think tank Rand Corp.

Consumer complaints helped pave the way for the federal No Surprises Act, which protects against unanticipated out-of-network bills. But far more people get hit with facility fees — about half of patients compared with 1 in 4 hospital patients who receive surprise bills, Whaley said.

Dr. Mark Fendrick, a University of Michigan health policy professor, said facility fees are also generally surprises but don't fall under the definition of the No Surprises Act. And with the rise of high-deductible plans, patients are more likely to have to pay those fees out-of-pocket.

"It falls on the patient," Fendrick said. "It's a tax on the sick."

Tesso held off paying the facility fee for her son's visit as long as possible. And when her pediatrician again referred them to Children's Hospital, she called to inquire what the facility fee would be. The hospital quoted a price of $994, on top of the doctor's fee. She took her son to an independent doctor instead and paid a $50 copay.

https://www.medscape.com/viewarticle/990387

Docs and Patients Don't Prefer Telehealth Despite Pandemic Popularity

 Despite telemedicine's rapid rise in popularity, fueled by pandemic payment incentives and temporary rule waivers, physicians and patients still prefer in-person care, according to a new study published online today in Health Affairs.

Researchers from the Harvard T. H. Chan School of Public Health conducted dual surveys: one from February to May 2021 among primary care physicians who participated in pandemic video visits and the other from April to May 2021 among patients who had a video visit with a primary care physician during the pandemic.

Of 337 primary care physicians, 90% said their pandemic video visits went well. Patients agreed, with 90% of the 1417 surveyed ranking their most recent video visit similarly, and half reporting they would have delayed care or not seen a doctor if video visits were not an option.

Still, 80% of physicians said they would prefer to provide most care in person after the pandemic, and those who experienced significant technological challenges were more likely to express this sentiment.

In contrast, 64% of patients preferred a return to in-person visits. Older patients (85%), those with less education (81%), and those who were Asian (88%) were more likely to prefer in-person visits — a nod to the "digital divide," which typically favors younger, wealthier and White patients, study authors noted.

Although older patients have more complex medical problems that are often better addressed in person, it's possible a lack of access or distrust in virtual platforms keeps some populations from engaging with the technology, Marty S. Player, MD, MSCR, associate professor and director of primary care telemedicine at the Medical University of South Carolina in Charleston, told Medscape Medical News.

"For younger people who have grown up in a much more digital world, a virtual visit isn't out of step with how they interact with many other institutions," said Player, senior author of a study on virtual urgent care that showed a similar demographic split in technological uptake.

However, Player said physicians should consider the therapeutic power that touch and physical exams produce for some patients and how that may contribute to the demand for face-to-face encounters.

Technical Woes and Worse Quality of Care

Among all participants, virtual quality of care concerns centered on the challenges of conducting a physical exam, including obtaining accurate vital signs. In addition, technical issues, such as poor internet connectivity and audio or video quality, were common, affecting at least 52% of physicians and 23% of patients.

Patients viewed virtual visits more favorably, with more than half (51%) reporting an experience equivalent to in-person appointments. Just 29% of physicians felt similarly, whereas 60% said the video visit quality of care was worse.

Perceptions of quality varied by type of care. For example, most physicians (75%) and patients (88%) reported that video visits for mental health or triage of COVID-19 symptoms were equivalent to or better than office-based appointments. But other types of care didn't fare as well. About half (46%) of physicians said video visits were inferior for managing chronic conditions, and more than 60% felt virtual care wasn't ideal for preventive care or acute issues like back pain.

Although telemedicine can offer greater access to care, worries over quality and technical problems may keep video visits from becoming a large portion of primary care, said the study's authors.

And with the COVID-19 public health emergency set to end May 11, many policies supporting virtual care will also sunset. As a result, telehealth may remain underutilized without further investments in virtual physical exam technology, integrated clinical workflows, and patient education and infrastructure for underserved communities.

"Policy changes that expand reimbursement for telehealth visits and align them with reimbursement rates for in-person care could incentivize providers and increase patient access," said Player, adding that the FY 2023 Omnibus Appropriations bill extended some telemedicine capabilities for rural health systems and Medicare beneficiaries.

"That shows policymakers understand the importance telemedicine has come to play in the American medical system," he said.

https://www.medscape.com/viewarticle/990399

Biden meets with advisers on 'risks and opportunities' in AI technologies

 President Joe Biden is slated to hold a meeting at 2:45 p.m. Eastern Tuesday about "the risks and opportunities that artificial intelligence (AI) technologies pose for individuals, society and national security," the White House said in a statement. Biden "will discuss the importance of protecting rights and safety to ensure responsible innovation and appropriate safeguards, and he "will call on Congress to pass bipartisan privacy legislation to protect kids and limit personal data tech companies collect on all of us," the White House added. He is slated to meet with a group called the President's Council of Advisors on Science and Technology (PCAST).

https://www.morningstar.com/news/marketwatch/20230404260/biden-meets-with-advisers-on-risks-and-opportunities-in-ai-technologies

'We are going to see parts of the economy break': Recession fears move back to the forefront of markets

 Investors appear to be reconsidering the risk that the U.S. economy could be about to tip into a recession, following Tuesday's data which revealed the red-hot labor market is finally loosening up. That data showed job openings fell to a 21-month low of 9.9 million in February, down from a revised 10.6 million for the prior month. 

Soon after those figures came out, alongside a report revealing factory orders declined a third time in the past four months, investors flocked to the safety of Treasurys -- particularly 6-month and 1-year T-bills , plus the 2-year note -- and sent gold prices toward record highs. Tuesday's data dented the appeal of stocks, with all three major indexes lower in afternoon trading. The ICE U.S. Dollar Index was off 0.5%. And traders now see a 98% chance that the Federal Reserve's main interest rate target will fall by year-end from where it is now -- between 4.75% and 5%; they also see a decent chance that policy makers will pause next month and in June before possibly cutting rates in July.

The tone in financial markets has shifted since March, when stocks managed to shake off concerns about the global banking sector and posted their biggest monthly gains since January. That occurred as the 2-year Treasury yield posted its biggest-monthly plunge since January 2008, and the 10-year had its largest monthly drop since March 2020. On Tuesday, though, stocks fell in tandem with yields as traders priced in a scenario in which the Fed is essentially done with interest rate rate hikes after May. Fed funds futures traders have clung to prospects of rate cuts by year-end since March, when troubles at Swiss banking giant Credit Suisse (CSGN.EB) prompted them to factor in a full percentage point of easing from the Fed through December

"Because we've really seen job openings remain elevated for quite some time, today's data was significant," said Edward Moya, a senior market analyst for the Americas at OANDA Corp. in New York. "It looks pretty clear that we are going to see parts of the economy break and we are heading for a recession. We forget that there's also a banking crisis going on, so there's going to be some pain that's really going to cripple small and medium businesses. We are going to see some tough times and are probably going to see this play out in markets." 

Talk of a possible U.S. recession has gone on for about a year, without coming to fruition -- helping stock investors focus on the brighter side of things and all three major indexes score year-to-date gains.Just a day ago, a surprise oil-production cut announcement led by Saudi Arabia over the weekend put the prospects of $100-per-barrel oil prices back on the radar, and initially seemed bad for the Fed's ongoing fight against inflation. As Monday's trading wore on, investors regarded higher oil prices as beneficial for some U.S. companies, and used the OPEC+ announcement as an opportunity to drive Dow Industrials and the S&P 500 to a higher finish

.While Tuesday's job-openings data generally supports the idea that a softer labor market could help ease wage pressures, investors appeared to be more focused for now on the signs it is sending about the prospects for economic growth, according to Moya.

 "We now seem comfortable living with $100-a-barrel oil and, right now, it's pretty clear we are recession-bound. There were a lot of people thinking an oil spike would keep inflation jitters in place, but it seems like there's too much weakness in the economy to do that."

At bond giant PIMCO, economist Tiffany Wilding and Andrew Balls, chief investment officer of global fixed income, released a 6- to 12-month economic outlook for global markets and economies. In it, they said that recent volatility in the banking sector has raised the prospect of a significant tightening in credit conditions and, therefore, the risk of a "sooner and deeper recession." 

Meanwhile, Mark Haefele, CIO of UBS Global Wealth Management, said his firm is maintaining a cautious stance on growth stocks and that a "new bull market is unlikely on the horizon." 

And at BMO Capital Markets, rates strategists Ian Lyngen and Ben Jeffery said "there is mounting evidence that the notion the U.S. economy is on strong enough footing to withstand materially higher interest rates may have been misplaced."

"The JOLTS [Job Openings and Labor Turnover Survey] data showed job openings decelerating a lot more rapidly than initially anticipated, suggesting the number of openings per person has fallen quite sharply," said Gennadiy Goldberg, a senior U.S. rates strategist at TD Securities in New York."It's the first indication that firms are stopping their hiring sprees," Goldberg said via phone. 

"The question for markets is, 'Will this translate into weaker payroll growth in the coming months?"

TD doesn't see a growing risk of a recession since "the labor market is quite strong," Goldberg said. The firm expects Friday's nonfarm payroll report to show a gain of 270,000 jobs in March, above the 238,000 median forecast of economists polled by The Wall Street Journal. "We are starting to see the first signs that the labor market is starting to react to tighter financial conditions," Goldberg said. "But we can't take away much from this about the next few payrolls or the depth of the next recession."

https://www.morningstar.com/news/marketwatch/20230404261/we-are-going-to-see-parts-of-the-economy-break-recession-fears-move-back-to-the-forefront-of-markets

Nashville shooter fired 152 shots inside school, documented plans to commit mass murder

 The shooter who took the lives of six people at The Covenant School last week fired a total of 152 rounds before being shot by officers, Nashville police said in an update on their investigation Monday.

According to police, Audrey Hale fired 126 rifle rounds and 26 nine-millimeter rounds while at the school. Based on the currently available information, investigators believe Hale worked alone.

Police also said collective writings written by Hale (found in the shooter’s bedroom and vehicle) show Hale was planning over a period of months to commit mass murder at The Covenant School. Hale also considered “the actions of other mass murderers,” the documents show.

Police said the writings remain under careful review by the Metro Nashville Police Department and the FBI’s Behavioral Analysis Unit in Virginia.

Two Metro police officers shot and killed Hale. Officer Rex Englebert shot a total of four rounds from his rifle, while officer Michael Collazo fired four rounds from his nine-millimeter pistol, police said.

Newly obtained search warrants released Monday revealed what investigators seized from the home of Hale.

Officers reported finding two shotguns, one in a bedroom closet and another next to a desk in a bedroom. Investigators also took 30 journals, some with references to school shootings and firearms courses.

A suicide note was also found, as well as five Covenant School yearbooks.

Investigators still have not determined a motive for the shooting. That part of the investigation remains ongoing by the homicide unit in consultation with the FBI’s Behavioral Analysis Unit.

As the investigation continues, the community mourns the six people killed in last week’s school shooting in Nashville with funerals and memorial services.

The children killed were Evelyn Dieckhaus, Hallie Scruggs and William Kinney. Also killed were Katherine Koonce, 60, the head of the school; Mike Hill, 61, a custodian, and Cynthia Peak, 61, a substitute teacher.

https://thehill.com/homenews/state-watch/3931736-nashville-shooter-fired-152-shots-inside-school-documented-plans-to-commit-mass-murder-police-say/

House GOP launches probe into use of COVID-19 education funds

 House Republicans announced Tuesday they are investigating potential misuse of coronavirus pandemic education funds and are requesting documents from the Department of Education regarding its guidance and use of the money. 

The investigation will be led by House Committee on Oversight and Accountability Chairman James Comer (R-Ky.), Committee on Education and the Workforce Chairwoman Virginia Foxx (R-N.C.) and Select Subcommittee on the Coronavirus Crisis Chairman Brad Wenstrup (R-Ohio).

The three Republicans believe some of the billions of dollars in emergency COVID-19 education funding was used to support “left-wing agendas” and not address COVID-related issues such as the learning loss during the pandemic. 

The lawmakers sent a letter to Education Secretary Miguel Cardona on Monday “calling for all documents, communications, and policies guiding the Department’s administration [of] COVID-19 education funds” to aid in their investigation. 

“It is important for the American people and their elected lawmakers to understand how the Department administers funds intended to assist students during the pandemic and the extent to which any funds may have been misused by State Educational Agencies or Local Educational Agencies for unrelated purposes,” they said. 

In their letter to Cardona, the GOP chairs gave potential examples of misuse including schools that used the funds for training teachers in topics such as “implicit bias,” “anti-bias strategies, environmental literacy…ethnic studies, and LGBTQ+ cultural competency.”

“These activities appear to have nothing to do with COVID-19 mitigation or learning loss and are a waste and misuse of taxpayer-funded COVID-19 relief programs,” they said. 

The Hill has reached out to the Education Department for comment.

The letter states Cardona has until April 17 to produce the documents. 

The request happened after the Select Subcommittee on the Coronavirus Pandemic had a hearing titled “The Consequences of School Closures: Intended and Unintended,” where lawmakers debated who was to blame for the prolonged school closures.

This isn’t the first time Republicans have asserted pandemic education funds were mishandled. Comer and Foxx sent a letter to Cardona in October, when Republicans were in the minority in the House, requesting documents related to the funding. 

https://thehill.com/homenews/house/3933306-house-gop-launches-probe-into-use-of-covid-19-education-funds/