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Thursday, May 9, 2024

Pre-Approval Plan Proposed for Medicare Advantage Insurers

 Medicare Advantage (MA) insurers that impose prior authorization requirements on doctors in accountable care organizations (ACOs) should have to get them pre-approved by CMS, Sen. Sheldon Whitehouse (D-R.I.) said Wednesday.

"There is no logic to prior authorization," Whitehouse, chairman of the Senate Budget Committee, said at a committee hearing on alleviating administrative burdens in healthcareopens in a new tab or window. "So I propose the companies in Medicare get prior authorization from CMS before they're allowed to impose prior authorization on doctors who are practicing in successful accountable care organizations" that have a proven track record of providing efficient patient care. "No prior authorization without prior authorization."

"Billing and insurance-related costs still total nearly $200 billion a year," he said. "The lack of standardization has been one major pain point. Different insurers apply different processes and rules to different providers, creating a web of confusion, driving up costs, and making doctors sometimes spend more time on administration than on providing actual care."

Whitehouse referred to a 2022 report on health worker burnoutopens in a new tab or window from the HHS Surgeon General, which "specifically called on insurers to -- and I'm quoting him here -- reduce requirements for prior authorizations, streamline paperwork requirements, and develop simplified common billing forms. And when the Surgeon General is focusing on administration, you know it's long past time," he said.

He noted he is developing legislation that would -- in addition to lifting prior authorization requirements from ACOs -- require CMS to identify the worst prior authorization practices and set standards for prior authorization that would apply to all MA plans.

Hearing witness David Cutler, PhD, professor of applied economics at Harvard University in Boston, agreed, urging the use of more nationwide standards for prior authorization and other healthcare transactions, similar to the way grocery stores implemented standardized UPC codes for all items, and banks standardized requirements for electronic transactions.

"In retail, with the UPC codes, the standardization was done by supermarkets," he said. "In banking, where we transfer upwards of $50 trillion a year at very low expense, the standardization was done by the Federal Reserve. [But] nobody has done it yet in healthcare ... The federal government is the only organization that will be able to do this."

The federal government should also step in to guide the use of artificial intelligence (AI) to simplify healthcare administration, he suggested. Although health insurers are already thinking about how to use AI, they're thinking about using it only internally.

"They're not thinking about the ecosystem and the providers and the payers," Cutler said. "Providers would like to use AI technology, but they don't know how. Providing guidance and leadership now could help the federal government save tremendous amounts of funds and improve the quality of healthcare at the same time."

But not everyone agreed with that approach. "EMR [electronic medical records] may allow clinicians to access their medical records remotely, but that has transformed into an environment where it's expected that physicians be constantly attached to their computer," said hearing witness Anthony DiGiorgio, DO, an assistant professor of neurological surgery at the University of California San Francisco. "This is due to CMS ... regulations like the 'appropriate use' criteria, which just add meaningless clicks to our workflow. All of this relegates the physician to an order entry clerk completing cumbersome tasks in the EMR [that] can be performed by a medical assistant."

"The answer to these burdens is not more top-down regulation," DiGiorgio said. "Ultimately, it's time to give the market a chance to drive meaningful change in healthcare delivery, allowing frontline physicians to focus on what matters most: providing quality care to patients without the suffocating weight of unnecessary administrative burdens."

Committee member Sen. Ron Johnson (R-Wisc.) concurred. "We've taken free-market competition out of healthcare," he said. "Why aren't we talking about high-deductible insurance plans that cover the catastrophic events, and then bring consumers back into the process? Isn't that the real solution?"

He said that some doctors in Wisconsin "are just dropping out of the system, not taking Medicare and Medicaid patients, and just literally charging cash ... It's $55 for a half-hour visit, and the doctors love it."

Noah Benedict, president and CEO of Rhode Island Primary Care Physicians in Cranston, discussed the results of a provider survey at his 168-physician practice. In all, "73% reported an average wait time before a prior authorization to be at least 2 days, and of the 73%, 38% of providers reported an average wait time for a prior authorization to be at least 3 to 5 days," he said.

In addition, "31% of providers report that for patients whose treatment requires prior authorization, the process often leads to patients abandoning their recommended course of treatment," he noted, while "62% of providers report that prior authorizations have a significant negative impact on those patients [requiring one], potentially leading to compromised health outcomes, and 97% of our providers describe the burden associated with prior authorizations as 'high' or 'extremely high.'"

In terms of the cost to the practice, "each provider requires 0.2 FTE [full-time equivalent] support daily, or 8 hours a week, to manage prior authorizations," he added. "That equates to over $12,000 per year per provider, and roughly $2.1 million to support the administrative lift."

He concluded that "while there isn't a single solution to address this intricate problem, one approach is to consider a greater proliferation of value-based payment models," because "value-based care correlates the amount healthcare providers earn for their services to the outcomes they deliver for their patients, as compared to fee-for-service, which rewards volume."

https://www.medpagetoday.com/practicemanagement/reimbursement/110038

Adult RSV Shots Given to More Than 30 Babies by Mistake

Nearly three dozen babies and young children have received respiratory syncytial virus (RSV) vaccines, which are only approved for adults, according to a brief CDC report.

Data from the Vaccine Adverse Event Reporting System (VAERS) revealed 27 reports of the Pfizer RSV vaccine (Abrysvo) and seven reports of the GSK RSV vaccine (Arexvy) being mistakenly administered to children under the age of 2 between Aug. 21, 2023 and March 18, 2024, Pedro Moro, MD, MPH, of the CDC in Atlanta, and colleagues detailed in Pediatricsopens in a new tab or window.

"While rare, vaccine administration errors are known to occur and may increase after a new vaccine or product is introduced," Moro told MedPage Today in an email.

Thirty-one of the children who received the vaccines were infants under 8 months of age. In 21 of the cases, the vaccines were given in family medicine practices.

"Healthcare facilities that provide preventive care for children and adults might store and administer Pfizer and GSK RSV vaccines, other routine vaccines, and nirsevimab [Beyfortus]," Moro and colleagues wrote in the report. "Thus, the potential exists for Pfizer or GSK RSV vaccines to be administered in error to infants and young children."

Eric Simões, MD, a pediatric infectious diseases expert at Children's Hospital Colorado in Aurora, told MedPage Today that he was "not surprised" by the vaccine errors. "Mistakes will happen, especially with COVID vaccines being given to [both] adults and children, with pneumococcal vaccines being first given to children and now to adults, etc."

Simões said that he did not personally know of any cases where the RSV vaccines had been administered to children, but emphasized that "adult RSV vaccines should absolutely not be given to children."

The Pfizer vaccine is approved for use in pregnant individualsopens in a new tab or window at 32 through 36 weeks gestational age, to prevent serious RSV cases in infants, and both the Pfizer vaccineopens in a new tab or window and GSK vaccineopens in a new tab or window are approved and recommended for adults 60 years of age and older.

Twenty-seven of the reports noted no adverse health events associated with the erroneous vaccines, but the remaining seven described at least one adverse event. One of those events occurred in an infant with a history of congenital heart disease who received the GSK RSV vaccine in combination with routine childhood vaccinations. That child required hospitalization for cardiorespiratory arrest within 24 hours after vaccine receipt. The remaining six reports described injection site reactions or systemic reactions, such as irritability, after receiving the RSV vaccines.

"Administration errors are preventable with proper education and training," the authors of the report emphasized. They suggested several strategies to prevent vaccine administration errors, including only ordering products that are approved for the patient population a facility serves, electronic health record alerts or warnings, close attention to labeling, and best practices for vaccine storage.

"To prevent mix-ups, CDC reached out to clinicians to educate them about the proper administration of the RSV vaccines," Moro said. "Education and additional vigilance will reduce the likelihood of errors."

The CDC and FDA will continue to monitor VAERS for vaccine administration errors, and clinicians are encouraged to report errors to VAERS.

The report was published several months after a noticeopens in a new tab or window was sent to healthcare providers that the CDC and FDA had received reports of 25 cases of the RSV vaccines being administered in error to young children in outpatient settings. At that time, there were also 128 reports of the GSK RSV vaccine being administered in error to pregnant people in outpatient settings and pharmacies. However, the CDC noted that, overall, these were a small number of cases relative to an estimated 1 million infants protected from RSV either through vaccination of pregnant individuals or infant receipt of nirsevimab -- a monoclonal antibody recommended for all infantsopens in a new tab or window under 8 months of age entering their first RSV season or born during it.

In instances when an RSV vaccine is given in error to children, no special monitoring is needed, according to the CDCopens in a new tab or window. However, because the efficacy of the adult RSV vaccines in infants and young children has not been evaluated, children who receive an RSV vaccine in error should receive nirsevimab to prevent severe RSV disease, if otherwise eligible.

Disclosures

Moro and other study co-authors reported no potential conflicts of interest.

Simões reported consulting for GSK and has received grants for research and consulting from Pfizer.

Primary Source

Pediatrics

Source Reference: opens in a new tab or windowMoro PL, et al "Incorrect administration of adult RSV vaccines to young children" Pediatrics 2024: DOI: 0.1542/peds.2024-066174.


https://www.medpagetoday.com/pediatrics/vaccines/110034

First Shipment Of Gaza Aid For US-Built Pier Departs Cyprus, UN Claims "Full-Blown Famine"

 The US military has reportedly completed building the off-shore pier for Gaza humanitarian aid deliveries, but it has yet to be anchored to Gaza's shore that this crucial part of the process has been held up due to inclement weather in the eastern Mediterranean. 

"As of today, the U.S. military has completed the off-shore construction of the Trident pier section, or the causeway, which is the component that will eventually be anchored to the Gaza shore," Pentagon deputy press secretary Sabrina Singh told reporters Thursday.

"Today there are still forecasted high winds and high sea swells, which are causing unsafe conditions for the JLOTS components to be moved, so the pier sections and military vessels involved in its construction are still positioned at the Port of Ashdod," she added.

Cyprus’ foreign ministry on the same day announced that the first vessel carrying humanitarian aid to be offloaded on the newly US-constructed pier is en route. 

It comes two full months after President Biden first unveiled the plan for the US Army to construct a pier. "The US vessel, loaded with much needed humanitarian assistance, departed from the Larnaca port with the aim of transferring as much aid to Gaza as possible through the maritime corridor," said Foreign Minister Constantinos Kombos.

The Pentagon indicated further that it hopes to have the final causeway section of the pier in place and functional by "later this week."

"The Sagamore is a cargo vessel that will use the JLOTS system [Joint Logistics Over-the-Shore system], and will make trips between Cyprus and the offshore floating pier as USAID and other partners collect aid from around the world,” Singh explained in the briefing.

Time is of the essence given the United Nations is now warning that northern Gaza is already in a state of "full-blown famine." Additionally hundreds of thousands of civilians are now fleeing the southern city of Rafah as the city faces an imminent IDF ground invasion.

At the UN Security Council (UNCS), China in particular has been stepping up its criticisms of Washington policy on Israel of late. Beijing has also been highlighting US 'hypocrisy' in daily press briefings. For example, the Chinese foreign ministry this week issued a statement saying "China... strongly calls on Israel to heed the overwhelming demands of the international community, stop attacking Rafah, and do everything it can to avoid a more serious humanitarian disaster in the Gaza Strip."

Hamas has continued to threaten the project, especially if US troops are found to be at the pier site:

Bloomberg has further featured the following Chinese Embassy statement

Liu Pengyu, a spokesperson for the Chinese Embassy in Washington, criticized the US for talking about "a ceasefire while pouring weapons" into the "biggest humanitarian tragedy in the 21st century," in an emailed statement.

China has lately launched its own efforts at mediating the conflict, given it hosted Hamas and Fatah officials in Beijing last week for rare talks aimed at achieving Palestinian political unity.

https://www.zerohedge.com/geopolitical/first-ship-us-built-floating-aid-pier-departs-cyprus-un-says-full-blown-famine

'Google DeepMind unveils next generation of drug discovery AI model'

 Google Deepmind has unveiled the third major version of its "AlphaFold" artificial intelligence model, designed to help scientists design drugs and target disease more effectively.

In 2020, the company made a significant advance in molecular biology by using AI to successfully predict the behaviour of microscopic proteins.

With the latest incarnation of AlphaFold, researchers at DeepMind and sister company Isomorphic Labs – both overseen by cofounder Demis Hassabis – have mapped the behaviour for all of life's molecules, including human DNA.

The interactions of proteins - from enzymes crucial to the human metabolism, to the antibodies that fight infectious diseases - with other molecules is key to drug discovery and development.

DeepMind said the findings, published in research journal Nature on Wednesday, would reduce the time and money needed to develop potentially life-changing treatments.

“With these new capabilities, we can design a molecule that will bind to a specific place on a protein, and we can predict how strongly it will bind,” Hassabis said in a press briefing on Tuesday.

“It's a critical step if you want to design drugs and compounds that will help with disease.”

The company also announced the release of the “AlphaFold server”, a free online tool that scientists can use to test their hypotheses before running real-world tests.

Since 2021, AlphaFold’s predictions have been freely accessible to non-commercial researchers, as part of a database containing more than 200 million protein structures, and has been cited thousands of times in others’ work.

DeepMind said the new server required less computing knowledge, allowing researchers to run tests with just a few clicks of a button.

John Jumper, a senior research scientist at DeepMind, said: “It’s going to be really important how much easier the AlphaFold server makes it for biologists – who are experts in biology, not computer science – to test larger, more complex cases."

Dr Nicole Wheeler, an expert in microbiology at the University of Birmingham, said AlphaFold 3 could significantly speed up the drug discovery pipeline, as "physically producing and testing biological designs is a big bottleneck in biotechnology at the moment".

https://finance.yahoo.com/news/google-deepmind-unveils-next-generation-150340750.html

'US to post influenza A wastewater data online to help with bird flu probe, official says'

 The U.S. Centers for Disease Control and Prevention (CDC) is planning to post data on influenza A found in wastewater in a public dashboard possibly as soon as Friday that could offer new clues into the outbreak of H5N1 bird flu in cattle herds.

CDC wastewater team lead Amy Kirby told Reuters that the agency has identified spikes of influenza A, of which H5N1 is a subtype, in a handful of sites and is investigating the source. She said there is no indication of human infection with H5N1.

Kirby said the CDC has been collecting influenza data in wastewater in about 600 sites since at least last fall to better track respiratory infections. That data can now be helpful in tracking the outbreak of H5N1 bird flu that has infected 42 dairy herds in nine U.S. states, and one dairy farm worker.

The tests are capable of detecting many types of influenza A, including the H5N1 subtype, but the findings do not indicate the source of the virus or whether it came from a bird, cow, milk or from farm runoff or humans.

https://www.yahoo.com/news/us-post-influenza-wastewater-data-212112108.html

US FDA advises healthcare facilities to switch from Getinge's heart devices

 The U.S Food and Drug Administration (FDA) on Wednesday advised healthcare facilities to move away from using Getinge's heart devices in patients as they faced safety and quality concerns despite a string of recalls.

The recommendation is based on concerns that the company has not sufficiently addressed the problems and risks with the recalled devices, it added.

Getinge did not immediately respond to a Reuters request for comment.

The FDA suggests providers to move away from the use of Getinge's Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and its Cardiohelp system and HLS Sets.

The health regulator recommends providers to transition away from these Getinge cardiovascular devices and use alternative devices if possible.

The Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump IABP are electromechanical systems that inflate and deflate balloons in the aorta to provide temporary support to the left ventricle.

Getinge initiated 12 voluntary recalls in the U.S. for the devices between Jan. 1, 2023 and April 11, 2024. Of these recalls, eight were classified as the most serious.

In the last 12 months, the health regulator has received 2,964 medical device reports related to Cardiosave Intra-Aortic Balloon Pumps, of which 15 were reported as resulting in patient death or serious injury.

The company's Cardiohelp system pumps blood out of the patient to oxygenate the blood during cardiopulmonary bypass surgeries. The HLS Set is an oxygenator and blood pump, which is a disposable component of the Cardiohelp system.

From January 1, 2023, through April 11, 2024, Getinge initiated eight voluntary recalls for the Cardiohelp system, including the HLS Set.

The FDA received 246 reports related to the device, in the last 12 months, of which 33 were reported as resulting in patient serious injury or death.

The FDA said it recognizes that alternative treatment options are limited. It added it is working with other manufacturers to assess their ability to manufacture and distribute alternative devices.

https://www.yahoo.com/news/us-fda-recommends-healthcare-providers-173847190.html

'Biden concerned over Boeing firefighters' lockout'

 U.S. President Joe Biden said on Thursday he is concerned that Boeing has locked out its unionized firefighters, raising pressure on the U.S. planemaker to resolve the contract dispute.

Earlier this month, Boeing locked out nearly 130 members of the International Association of Fire Fighters Local I-66 who have rejected two contract offers.

"I’m concerned by reports that Boeing locked out IAFF I-66 members," Biden wrote on the social media site X. "I encourage folks to return to the table to secure a deal that benefits Boeing and gets these firefighters the pay and benefits they deserve."

Biden's message in support of the firefighters raises the possibility of White House involvement in separate talks between Boeing and its unionized factory workers in Washington state, two sources familiar with the matter said. Those workers produce the planemaker's best-selling jet.

The International Association of Machinists and Aerospace Workers (IAM) is negotiating a new contract on behalf of over 30,000 workers who build Boeing's 737 MAX jets, at a time when the planemaker needs to ramp up production.

Boeing 737 MAX jetliner production has fallen sharply as U.S. regulators step up factory checks following a blowout on a nearly new 737 MAX 9 in January, blamed on an assembly error.

The head of the IAM local bargaining with Boeing was not immediately available for comment.

Biden, who has racked up union endorsements as he runs for re-election in November against former President Donald Trump, has visited picket lines for the United Auto Workers (UAW). He considers support for labor to be a cornerstone of his economic policies.

The votes of union members could be crucial to deciding the 2024 election in key swing states like Michigan, Pennsylvania, Nevada and Wisconsin.

"Imagine if he'd throw his hat in for the IAM," said one investor who spoke on condition of anonymity.

Boeing has said its latest offer, which would increase firefighters' take-home pay from $91,000 on average to $112,000 on average in the first year of the contract, remains on the table.

“We remain committed to securing an agreement. Our offer provides significant pay increases and increased benefits," Boeing said in a statement. "The union should allow our employees to vote (on) our offer, which was presented before the lockout.”

IAFF General President Edward Kelly said the firefighters are "are grateful that the President stands up for collective bargaining" and continues to have their backs.

https://finance.yahoo.com/news/biden-concerned-over-boeing-firefighters-210008680.html