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Wednesday, April 26, 2023

First Republic faces potential curb on borrowing from Fed

 U.S. bank regulators are weighing the prospect of downgrading their private assessments of First Republic Bank, which could lead it to face potential curbs on borrowing from the Federal Reserve, Bloomberg News reported on Wednesday.

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

Senior officials are increasingly weighing whether to downgrade their scoring of the firm's condition, including its so-called Camels rating, the report said citing people, adding that would likely limit the bank's use of the Fed's discount window and an emergency facility launched last month.

First Republic's market value plunged below $1 billion for the first time ever on Wednesday after a report said the U.S. government was unwilling to intervene in the rescue process, hammering the lender's stock.

The banking sector has come under renewed pressure following First Republic's results on Monday after it reported outflows of more than $100 billion in deposits in the first quarter.

https://finance.yahoo.com/news/1-first-republic-faces-potential-185721758.html

4 dead in ongoing bacterial outbreak at Seattle hospital

 Over the last six months, 31 patients at Seattle-based Virginia Mason Medical Center have been infected with Klebsiella pneumoniae and four have since died, NPR affiliate KUOW reported April 25.

Klebsiella pneumoniae is a bacteria commonly found in healthcare settings that is antibiotic resistant. It can cause pneumonia, meningitis and wound or bloodstream infections.

Public health officials said the outbreak is ongoing but that the number of new cases is decreasing. Infected patients were hospitalized in various departments and the hospital has not discovered the source of the bacteria, according to the report. 

The ongoing risk to Virginia Mason patients is unknown because it can take months for an infection to show up as an illness, public health officials told KUOW. The patients who died came to the hospital with complex diagnoses, so it is unknown whether  the bacteria caused their deaths.

Virginia Mason is implementing increased safety measures and treating infected patients. It has also sent letters to patients who may have been exposed.
"Beginning in October 2022, Virginia Mason Medical Center detected an increase in cases of Klebsiella pneumoniae bacteria at our downtown campus," Sydney Bersante, interim president at Virginia Mason Medical Center, said in a statement. "We immediately implemented increased safety measures, notified patients who had tested positive for the bacteria, and promptly provided treatment where necessary. While the risk of transmission is extremely low for patients, we continue to take proactive steps to avoid additional transmission. We are continuing to investigate the source of this outbreak jointly with local and state public health partners."

https://www.beckershospitalreview.com/infection-control/4-dead-in-ongoing-bacterial-outbreak-at-seattle-hospital.html

Granholm ‘important admission’ over US money flow to China after pressed by GOP senator

 After pressing Biden’s energy secretary over economic connections with China and pushing her to admit it's a country "of concern" during a Senate hearing Wednesday, Sen. Eric Schmitt, R-Mo., said Republicans plan to "hold her feet to the fire" over cutting ties with the communist nation. 

"You look at all of the money that's going to be flowing from Washington, D.C. on this sort of semi-Green New Deal that they passed last year, we have to have that kind of oversight, make sure we're not aiding and abetting our adversary like China," Sen. Schmitt told Fox News Digital after the hearing. "And so I think that was an important admission from today."

U.S. Energy Secretary Jennifer Granholm was left stumbling over Schmitt’s questioning on the Biden administration selling oil from the Strategic Petroleum Reserve to China, her past praise of the Chinese Communist Party (CCP) and the green energy push potentially funding Chinese operations.

"I want to ask you about Microvast, which is a lithium battery company that operates primarily out of the People's Republic of China. Your agency granted $200 million worth of a grant to this company. You're aware of this, correct?" Schmitt said in the Senate Committee on Armed Services hearing.

"There were awards, there were selections that were named. And all of those companies were going through a vetting process to ensure that there's no money flowing to countries of concern," Granholm responded. "And so those vetting processes are going on. Not a dollar has gone out the door yet."

Eric Schmitt questions Jennifer Granholm

Sen. Eric Schmitt, R-Mo., pressed Energy Secretary Jennifer Granholm on Capitol Hill Wednesday over policies potentially fueling the Communist Chinese Party. (Getty Images)

Schmitt then asked Granholm to clarify whether she’s actually willing to make the commitment that "no dollars will go to any company, any energy company taking advantage of either tax credits or grants that are owned by China, by a Chinese company."

"No state-owned enterprise will get funding from the bipartisan effort," the secretary confirmed.

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The grant Schmitt referenced in Wednesday’s hearing is "just one piece" to the China puzzle, he explained while warning that Granholm’s "obsession with climate alarmism" creates a national security risk.

"We're going to be begging countries like Venezuela and Saudi Arabia for oil, shipping strategic petroleum reserves to China is a national security issue. And it also makes them way more expensive for families across the country," the senator said.

Expanding on the China threat, he added that "they're building a nuclear arsenal. They've weaponized islands in the South China Sea. It's a real lack of priorities from this administration, specifically the Department of Energy."

Republicans intend to follow up with Granholm to learn more about the so-called "vetting process" companies go through before receiving government funding, according to Schmitt.

"What are they looking at? What should they be looking at? This is serious business, right? Obviously, the department that she controls or is the head of deals with really sensitive information, and funding companies that have ties to communist China in the environment we're in right now is just a nonstarter," the senator explained.

Granholm also stated in her testimony that the Biden White House wants energy to be made in America. But Schmitt stressed that's not consistent with their policy.

"They're essentially shipping jobs overseas, they're transitioning to technologies that are found in China, rare earth materials that they blocked here, they go get out in China, we have all the oil and natural gas that we'll ever need right under our feet in the United States of America," Schmitt explained. 

"Bringing those jobs home, bringing those supply chains home, making sure we're tapping American energy, having robust exploration is really important," he continued. "We should not be shifting this focus to China."

https://www.foxbusiness.com/politics/bidens-energy-secretary-no-dollar-china-pressed-gop-senator

No Pills, No Surgery, No Electrodes for Parkinson's Disease?

 Several technologies for delivering levodopa-carbidopa in a more physiologically natural fashion than is possible with ordinary oral versions for Parkinson's disease took center stage here at neurology's leading scientific conference.

In plenary sessions and late-breaking abstract presentations at the American Academy of Neurology (AAN) annual meetingopens in a new tab or window, researchers provided updates on two subcutaneous delivery systems -- one of which could gain FDA approval almost any time -- and another with a unique oral drip system.

Many neurologists see this type of treatment as a potential bridge for patients no longer controlled adequately with oral medications but whose disease is not so far advanced that surgical procedures such as thalamotomy, or implantation of deep brain stimulation systems, appear necessary. If dopaminergic stimulus could be provided continuously, instead of intermittently as is the case for oral drugs, it's believed that so-called "on" time could be prolonged and "off" time reduced, helping patients get through the day comfortably without undergoing risky surgeries.

AbbVie is the leader in the race to bring such systems to market. In fact, it already sells a continuous-delivery system for levodopa-carbidopa. Called Duopaopens in a new tab or window, it pumps a levodopa-carbidopa gel directly into the intestinal tract for 16 hours per day. But it is far from non-invasive -- it requires a surgeon to create an abdominal stoma for quasi-permanent port placement.

The drawbacks being obvious, AbbVie has been pursuing an alternative: a subcutaneous delivery system temporarily named ABBV-951 that uses prodrugs for levodopa and carbidopa in liquid form. Primary results from a phase III trialopens in a new tab or window were published several months ago, showing that the foslevodopa-foscarbidopa system extended "on" time without troublesome dyskinesia (a standard endpoint for Parkinson's disease drugs) by some 2 hours relative to immediate-release oral levodopa-carbidopa.

FDA approval is expected, but in late March, the agency told AbbVie

opens in a new tab or window that it had questions about the system's mechanical pump (though not about the system's efficacy or safety). No new clinical studies were requested and AbbVie promised to resubmit its application "as soon as possible."

The company presented several follow-up studies at the AAN meeting, including one comparing ABBV-951 with Duopa for pharmacokinetic parameters. Mean levodopa blood levels were virtually identical over 24-hour evaluations. Ratios of areas under the receiver operating characteristic curve indicated that levodopa availability was about 8% higher with the new system versus Duopa, and differences between maximum and minimum concentrations were somewhat lower.

The regulatory delay may give an alternative subcutaneous system a chance to catch up. Called ND0612opens in a new tab or window, the product is under development by California-based NeuroDerm, now a unit of Mitsubishi Tanabe Pharma, and is designed to release regular liquid levodopa-carbidopa around the clock. The infusion device is placed primarily on sides of the abdomen and on the lower back.

At the AAN meeting, Alberto Espay, MD, of the University of Cincinnati, presented results from the product's pivotal phase III trial, called BouNDless

opens in a new tab or window. It randomized 259 Parkinson's disease patients to use ND0612 or ordinary oral levodopa-carbidopa medications for 12 weeks.

BouNDless began with two sequential run-in periods of 4-6 weeks each, beginning with standard oral therapy followed by ND0612, during which dosing regimens for the two types of treatment were optimized for each participant individually. When ND0612 was in use, patients could also receive immediate-release levodopa-carbidopa to maximize symptom control.

Of 381 patients initially enrolled, 259 completed the run-in phase -- no specific reason was given for most of the dropouts, although 6% of patients using the subcutaneous system during the run-in quit because of infusion-site reactions.

The remaining 259 were then randomized to ND0612 (plus supplementary oral medications as needed) or to standard oral levodopa-carbidopa for 12 weeks in a double-blind, double-dummy format. ND0612 provided up to 720 mg of levodopa and 90 mg of carbidopa per 24-hour period.

Mean patient age was about 64, and just under two-thirds were men. Time since initial diagnosis was 10 years, with motor fluctuations first appearing a mean 5 years previously.

Prior to the run-in, "on" time without troublesome dyskinesia averaged about 9.4 hours/day, rising to about 12 hours with ND0612 during the run-in phase. "Off" time at that point averaged 3.5 hours. After randomization, "on" time remained near that level through the 12-week treatment period among patients assigned to the subcutaneous system. The oral-therapy control group, on the other hand, saw "on" time slip back to near baseline. At week 12, the net difference in "on" time favoring ND0612 was 1.72 hours (95% CI 1.08-2.36).

"Off" time showed the reverse pattern: at week 12, it stood at 1.90 hours with oral therapy, versus 0.50 hours with ND0612 (P<0.0001). Other outcome measures, including Unified Parkinson's Disease Rating Scale part II scores and patients' and clinicians' global impressions, also significantly favored ND0612.

Infusion-site reactions remained a problem, Espay acknowledged. Some 13% of patients using the system complained of moderate irritation and one patient considered it severe. Seven patients assigned to the system dropped out because of treatment-emergent adverse effects, compared with four in the oral-therapy group. Skin irritation, he said, "is the Achilles heel of all SQ [subcutaneous] based therapies." He said rotating the application site to different parts of the body appears so far to be the best way to minimize the problem.

Preliminary results with a third approach were also reported at the AAN meeting. This involved a plastic oral appliance similar to the retainers that orthodontics patients often wear for maintenance, but with a small pump attachedopens in a new tab or window that drips a levodopa-carbidopa paste onto the back of the tongue, where it is then swallowed with saliva. Called DopaFuse, the system was developed by a company called SynAgile, based in Wyoming. Its chief medical officer, C. Warren Olanow, MD, formerly of the Icahn School of Medicine at Mount Sinai in New York City, presented findings from a small, 2-week phase II trialopens in a new tab or window.

Like BouNDless, the trial had a somewhat complicated design. On study day 1, patients came into the clinic and received standard oral levodopa-carbidopa that day, with frequent blood sampling and clinical tests that day. On day 2, still in clinic, patients then used the DopaFuse system and underwent the same testing. On day 3, patients (also still in clinic) took one dose of regular oral medication and then used DopaFuse for the rest of the day. From day 4 to 14, patients repeated the day 3 procedure at home, and on day 15, they returned to the clinic for further testing.

Sixteen patients participated. Some patients found the device uncomfortable: a total of eight instances of abrasion or laceration inside the adjacent cheek were reported. All but one was considered mild, however, and all resolved after one day. No adverse events were considered serious and none of the patients discontinued on account of them.

Pharmacokinetic parameters indicated that the device was working as intended. Motor fluctuations while using DopaFuse on day 3 were smaller by about half relative to day 1 when patients received regular oral therapy. "On" time without severe dyskinesia was extended by about 1.5 hours relative to regular oral treatment, as was "on" time without any dyskinesia. "Off" time was reduced with DopaFuse to a corresponding degree.

The key clinical issue with all of these systems is, once approved, where they would fit in the treatment landscape. This came up after Espay's presentation when a session moderator posed the question directly. Espay responded, "The way in which we at the moment conceive this therapy is in adapting it into the early phase of advanced treatment, for individuals who are experiencing more fluctuations, for whom [conventional] dose optimization is not quite effective."

It would be an option, he added, "for individuals currently being considered for deep brain stimulation, for instance." Asked later whether one might introduce a continuous-infusion therapy earlier in the disease process, Espay agreed that it might indeed be warranted, but for now it remains only a "theoretical" possibility that needs more research. "We have not the data yet to demonstrate that it would in fact pan out," he said.

Disclosures

The ND0612 study was funded by NeuroDerm.

The DopaFuse study was sponsored by SynAgile.

The study of foscarbidopa-foslevodopa continuous infusion was supported by AbbVie.

Espay reported relationships with NeuroDerm and numerous other commercial entities. Olanow is SynAgile's chief medical officer. Both authors of the foscarbidopa-foslevodopa study were AbbVie employees.

Primary Source

American Academy of Neurology

Source Reference: opens in a new tab or windowEspay A, et al "Efficacy and safety of continuous subcutaneous ND0612 infusion compared with oral immediate-release levodopa-carbidopa in patients with Parkinson's disease and motor fluctuations" AAN 2023.

Secondary Source

American Academy of Neurology

Source Reference: opens in a new tab or windowOlanow CW, et al "Continuous delivery of levodopa/carbidopa using the intra-oral DopaFuse system: a safety, tolerability, PK, and efficacy trial" AAN 2023.

Additional Source

American Academy of Neurology

Source Reference: opens in a new tab or windowRosebraugh M, et al "Foslevodopa-foscarbidopa subcutaneous infusion maintains similar levodopa exposure to levodopa-carbidopa intestinal gel delivered to the jejunum when infused for 24 hours" AAN 2023.


https://www.medpagetoday.com/meetingcoverage/aan/104206

Return of Medicare 3-Day Rule Will Stress Crowded Hospitals Further

 Emergency physicians are concerned about the return of Medicare's 3-day rule

opens in a new tab or window when a waiver that suspended it expires with the COVID Public Health Emergency (PHE) on May 11, warning it will make hospital overcrowding much worse.

The waiver has allowed hospitals to bypass a requirement that traditional Medicare beneficiaries must have 3 full days of an acute stay in order for Medicare to cover their skilled nursing facility (SNF) care when they are discharged.

At the moment, these patients can be discharged directly to a nursing home -- even from the emergency department if appropriate and they have been stabilized -- and still get Medicare coverage for their SNF stay.

When the original policy goes back into effect, patients not hospitalized for that duration will have to pay out-of-pocket for SNF care. Additionally, many skilled nursing facilities won't accept beneficiaries who didn't fulfill the requirement.

That means hospitalists will be under more pressure to keep these patients in acute care beds for the required 3 days, even if they don't really need to be there, emergency physicians said.

"Patients need to meet criteria in order to be admitted in the first place," Jeffrey Davis, director of regulatory and external affairs for the American College of Emergency Physicians (ACEP), told MedPage Today. "But sometimes when a patient needs only 1 or 2 days, they're going to try to keep them there for 3 days so they qualify if they need SNF coverage."

He gave an example of a patient who has a knee operation and there's a surgical complication that takes him to the emergency department. "If he needed rehab treatment, he could probably go safely and directly to a skilled nursing facility. But instead, you have to be an inpatient for 3 days. It doesn't make any sense."

The domino effect means inpatient units will fill up faster, beds will be occupied for longer periods, and more patients will be boarded in the emergency department, taxing emergency department staff even more, Davis said.

The ACEP website has a sectionopens in a new tab or window devoted to what Davis called "horrific" stories of boarding in hospital emergency rooms, where patients are receiving what he called "hallway medicine."

"Our worry is if they reinstate this, it will make matters even worse, because when the inpatient beds are full, this backs up and locks up whole lines of patients," he said.

Davis noted that most Medicare Advantage enrollees and beneficiaries cared for under certain experimental models such as acute care organizations (ACOs) are not bound by the rule.

Hospital Overcrowding 'Already the Worst in My Career'

A combination of factors in the current "peri-pandemic" period are contributing to hospital overcrowding, said Abhi Mehrotra, MD, an emergency physician and vice chair of emergency medicine at the University of North Carolina Hospitals.

Right now, for example, 60% to 70% of his hospitals' emergency room beds last week were occupied by patients "waiting to go someplace else, either into the hospital for a medical reason, or into a state psychiatric facility, or other kind of hospitalization for behavioral health purposes," said Mehrotra, who is also the past president of ACEP's North Carolina chapter.

"We are definitely over capacity and crowded on the inpatient side, and that has led to emergency department boarding and ED overcrowding," he said.

Workforce issues play a role as well. Mehrotra said his hospital has "had times when beds within the hospital had to be shut down because we didn't have nurse staffing for those beds. I've heard of facilities that have shut down operating rooms because they don't have the staff to run them."

Some of the beds are filled with patients receiving long-delayed but necessary elective care. But much more glaring and difficult, he said, is that "the patients have changed."

"We didn't use to have patients brought into the emergency room because their families weren't able to care for them," he said. Patients have behavioral or cognitive issues, and "they need other resources and placement but there's no medical diagnosis to admit them."

Sometimes the nursing homes themselves can't take care of a patient whose status has changed, and send them to the hospital as well.

Scripps Health in San Diego has been keeping track of "avoidable bed days," or ABDs -- days in which patients were medically stable enough to be discharged but remained in acute care because there was no safe, appropriate setting for them to move to.

From Oct. 16, 2022 to April 15, 2023, its five hospitals and behavioral health unit counted 18,301 avoidable bed days affecting 1,958 unique patients, or an average of 101 ABDs per day.

Scripps Health president and CEO Chris Van Gorder said most of his system and that of others in his region are at capacity.

"Because of low state and federal reimbursement for their patients, SNFs, long-term care, and behavioral health facilities are not taking these low-pay and sometimes, complex patients and we are ending up with beds that are tied up for months and longer," he said.

"To be honest," Van Gorder said, "while the end of the PHE will make things a bit worse, they are already the worst I've seen in my healthcare career."

'Antiquated' Rule

Vincent Mor, PhD, of the Brown University School of Public Health in Rhode Island, and author of an invited commentaryopens in a new tab or window on the 3-day rule's history in JAMA Internal Medicine, agreed that the waiver's demise could lead to additional patients taking up hospital beds.

Depending on the size of the hospital, he said, on any day "you could have as many as 10 or 15 extra bed days waiting for that third day to finish."

"If the emergency doctors are concerned about it, it's because they're admitting people who they may not need to admit," he said.

Many others interviewed said it's time for the 3-day rule -- which is as old as Medicare itself, going back to 1965 -- to be abolished.

Leading Age, an advocacy organization for long-term and other senior care providers, has petitionedopens in a new tab or window HHS Secretary Xavier Becerra to permanently extend the waiver.

Although the rule's original intention of preventing hospitals from inappropriately discharging certain patients was noble, recent Medicare audits showed the waiver had no negative impact on patient outcomes, according to Leading Age.

In a statement, the group called the 3-day rule "antiquated" and said it's "onerous for patients and providers and reimplementing it will create hardships for older adults and families who need access to care."

https://www.medpagetoday.com/special-reports/features/104199

Vertex: FDA OKs TRIKAFTA in Children With Cystic Fibrosis

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved the expanded use of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 2 through 5 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to TRIKAFTA® based on in vitro data. TRIKAFTA® was previously approved by the FDA for use in people with CF 6 years and older with at least one F508del mutation or a mutation in the CFTR gene that is responsive to TRIKAFTA® based on in vitro data.

https://finance.yahoo.com/news/vertex-announces-u-fda-approval-173700063.html

Kaiser Permanente to acquire Geisinger Health

 Kaiser Permanente is acquiring 10-hospital Geisinger Health in a deal described as the first step toward a new multi-system value-based care organization, according to a Wednesday announcement.

That new entity, called Risant Health, will be a nonprofit organization that operates “separately and distinctly from Kaiser Permanente’s core integrated care and coverage model,” the organizations said.

"Upon regulatory approval, Geisinger becomes part of the new organization through acquisition," the organizations wrote in the announcement.

Of note, Kaiser said it intends to bolster Risant beyond Geisinger by acquiring additional “like-minded, nonprofit, value-oriented community-based health systems.”

These systems, like Geisinger, would continue to operate as regional or community-based providers with the benefit of additional “expertise, resources and support” from the larger organization, Kaiser said.

“We know fully replicating [Kaiser Permanente’s] closed integrated care and coverage model is not viable in all communities,” Greg Adams, chair and CEO of Kaiser Permanente, said in the announcement. “By helping other health systems achieve our value-based quality outcomes and savings in multi-payer, multi-provider environments, we believe Risant Health can deliver a transformative new solution to America’s systemic health care problems. And, given its history in this space, we can think of no better organization than Geisinger to be the inaugural health system to join Risant Health.”

Financial terms and a timeline for the deal, which is subject to regulatory approval, were not disclosed. The deal would see Geisinger maintain its branding and continue working with other health plans, employed physicians and independent providers, according to the announcement.

In an interview with the New York Times, Kaiser leadership said it’s aiming to invest $5 billion into Risant over the next half decade and expects to add “five or six” additional systems to the new entity.

Oakland, California-based Kaiser Permanente is among the country’s largest nonprofit systems with 39 hospitals. Its operations span eight states coast to coast with roughly 13 million members who receive care through its integrated model. The organization reported $95.4 billion in operating revenue across 2022 as well as a $1.3 billion operating loss and a nearly $4.5 billion net loss.

Geisinger is a fellow nonprofit system based in Danville, Pennsylvania with 10 hospital campuses and a health plan covering about 600,000 members. It reported $6.9 billion in operating revenue during 2022 as well as $239 million in operating losses and $842 million in net losses.

The organizations describe the deal as a chance for Geisinger to strengthen its care services and, due it its participation in a broader value-based platform, benefit from enhanced model design, pharmacy, consumer digital engagement, health plan product development and purchasing. Its position at the front of the line also allows Geisinger to mold nascent Risant’s strategy and operational model.

“Geisinger is excited for what joining Risant Health will mean both for our system and for the communities we serve in Pennsylvania,” Jaewon Ryu, M.D., president and CEO of Geisinger Health, said in a statement. “Geisinger will be able to accelerate our vision and continue to invest in new and existing capabilities and facilities, while charting a path for the future of American health care, through Risant Health.

Ryu is slated to transition from his role at Geisinger to a new position as CEO of Risant should the deal go through, according to the announcement.

That said, healthcare consolidation has become a major concern for the administration and lawmakers.

Federal regulators have had no qualms about stepping in to block hospital acquisition deals—though these usually tend to involve acquisitions in which systems in similar geographies are increasing their market power as opposed to so-called cross-market mergers.

Kaiser and Geisinger’s announcement also landed as representatives on Capitol Hill were holding a hearing on, among other healthcare issues, whether provider consolidation and healthcare payers’ vertical integration purchases warranted new legislation or other strengthened enforcement.

https://www.fiercehealthcare.com/providers/kaiser-permanente-acquire-geisinger-health-bid-launch-multi-system-vbc-platform