California moves to toughen state’s nursing home oversight

 California lawmakers on Monday moved to strengthen the state’s oversight of nursing homes, barring anyone from operating a skilled nursing facility without a license.

Democratic Assemblyman Al Muratsuchi said his bill would give the California Department of Public Health stronger authority to block unqualified and unethical owners by shutting down what he said is an increasing number of for-profit nursing home chains operating unlicensed nursing homes.

“This bill seeks to fix a broken state licensing system,” Muratsuchi said.

The problem has only been exacerbated by the pandemic, endangering thousands of those who are elderly or disabled, said Democratic Assemblyman Jim Wood.

“Part of what we’re trying to do is protect some of the most vulnerable people in our society,” Wood said. “We’ve seen too many perish in nursing homes during COVID. We’re seeing another wave of it now. They’re a fragile population.”

The Assembly passed the bill on a 47-12 vote, sending it to the Senate.

Muratsuchi cited two chains that he said are collectively running several dozen homes without appropriate state licensing.

Many of their licensing applications were denied years ago due to poor conditions, he said, yet they’ve been allowed to keep operating while buying more nursing homes during the pandemic.

His bill would set licensing standards and bar the use of management agreements that critics say the corporations have used to circumvent state licensure requirements. Violators could be hit with civil penalties of $10,000.

“The state’s failure to screen out unfit operators is like a welcome sign to bad actors,” said California Advocates for Nursing Home Reform, which backed the bill as part of a package of reform legislation in the last year.

It said owners’ decisions on staffing, administration and care “have life and death consequences for nursing home residents in the best of times, and never more so than during the pandemic.”

A 2018 state audit also faulted the state’s poor oversight.

The California Association of Health Facilities, which represents most of the state’s nursing homes, opposed the bill without further amendments, but agreed that the process needs reform.

It blamed California for having “the most unworkable and lengthy licensure process in the nation.” However, it said, “nursing facilities did not create this backwards process. It has been perpetuated by the state – and it needs to end.”

The bill goes too far, it said, with “stringent disqualifications criteria (that) would eliminate most if not all potential applicants.”

https://apnews.com/article/business-health-california-nursing-homes-7a747abdadefb55ef345a3ed636634b4

NY mask mandate to remain in place during appeal

 New York’s mask mandate will remain in effect while the state appeals a ruling from a lower court judge overturning it, an appellate panel of judges ruled Monday.

The ruling from the four-judge panel followed an appeals court judge’s decision last week temporarily restoring it the day after the initial ruling overturning it.

The state’s health commissioner had reinstated the mask mandate in mid-December over a surge in coronavirus cases, requiring masks in schools, health care facilities, homeless shelters, jails, public transportation, and in any indoor public area where vaccination wasn’t required for entry.

It was initially put in place for a least a month; it has now been extended to Feb. 10.

A group of parents sued over the mandate, and in the initial ruling against it, a judge said the governor and the health department didn’t have the authority to reinstate it.

In the decision from the appeals panel, the judges said the mandate would be in place until the state’s appeal of the lower court ruling was decided, and said the state had until March 2 to file.

https://apnews.com/article/coronavirus-pandemic-health-new-york-nyc-state-wire-98dd566f7605a7f13a9a065945f0d69c

Universal health care bill fails to pass in California

 A bill that would have created the nation’s only government-funded universal health care system died in the California Assembly on Monday as Democrats could not gather enough support to bring it for a vote ahead of a legislative deadline.

The bill had to pass by midnight on Monday to have a chance at becoming law this year. Democrats needed 41 votes for that to happen, a threshold that did not seem impossible given that they control 56 of the 80 seats in the state Assembly and universal health care has long been a priority for the party.

But intense lobbying from business groups put pressure on more moderate Democrats, who face tough reelection campaigns this year in newly-redrawn districts. Plus, Democrats were missing four lawmakers from their caucus — including three of their more liberal members — who had resigned recently to take other jobs.

“Especially with four democratic vacancies in the Assembly, the votes were not there today, but we will not give up,” Assemblymember Ash Kalra, a Democrat from San Jose and the bill’s author, said in a news release.

Kalra’s decision not to bring the bill up for a vote incensed his allies in the California Nurses Association, who have been pushing for this bill for years — including campaigning heavily for Democratic Gov. Gavin Newsom’s 2018 election. While Kalra had authored the bill and gotten it out of two legislative committees to reach the Assembly floor, the Nurses Association said in a statement they were “outraged that Kalra chose to just give up on patients across the state.”

Progressives have dreamed about a universal health care system in the U.S. for decades. Health care is so expensive, they say, in part because the nation’s health care system is paid for by multiple parties, including patients, insurance companies, employers and the government. Instead, they say the U.S. health care system should have a single payer — the government — that would keep prices under control and make health care available to all.

But while other nations have adopted such systems, it’s been impossible to establish in the United States. Vermont enacted the nation’s first such system in 2011, but later abandoned it because it would have cost too much.

In California, voters overwhelmingly rejected a universal health care system in a 1994 ballot initiative. Former Republican Gov. Arnold Schwarzenegger twice vetoed similar legislation in the 2000s. And a 2017 proposal stalled in the state Assembly.

The biggest hurdle is cost. A study of a 2017 proposal for universal health care in California estimated it would cost $331 billion, which is about $356 billion today when adjusted for inflation. Meanwhile, California is expected to account for about $517 billion in health care spending this year, with the largest chunk coming from employers and households, according to an analysis by a commission established by Gov. Gavin Newsom to study universal health care.

For comparison, California’s entire state operating budget — which pays for things like schools, courts, roads and bridges and other important services — is about $262 billion this year.

To pay for the plan, Democrats had introduced a separate bill that would impose hefty new income taxes on businesses and individuals, which fueled much of the opposition to the plan.

“Today’s vote in the Assembly was a vote to protect their constituents from higher taxes and chaos in our health care system,” said Ned Wigglesworth, spokesperson for Protect California Health Care, a coalition of health care providers opposed to the bill.

Supporters say consumers are already paying exorbitant amounts for health care, saying a single-payer system would save money by eliminating deductibles, copays and expensive monthly insurance premiums.

Both bills are now likely dead for the year. But Kalra appeared to indicate he would try again next year, saying “this is only a pause for the single-payer movement.”

He’ll have to navigate a new Legislature next year following the midterm elections that will see lots of turnover in the state Assembly because of term limits. Assembly Speaker Anthony Rendon, a Democrat from the Los Angeles area who will be termed out in 2024, said he was “deeply disappointed” Kalra did not call the bill for a vote on Monday.

“I support single-payer and fully intended to vote yes on this bill,” Rendon said. “With time, we will have better and more successful legislation to bring us closer to this goal. I expect more and more of my colleagues to sign on, so we can make California a health care justice leader.”

Republicans, meanwhile, seemed to welcome Democrats’ persistence.

“The fact that a proposal for a government takeover of our state’s entire health care system even made it this far shows just how out of touch the Democratic party is from the needs of everyday Californians,” Assembly Republican Leader Marie Waldron said.

https://apnews.com/article/business-health-california-legislature-state-legislature-88d57ed5845b47c54e7c0e397ab7de13

All-out effort to keep Biden COVID-free; no ‘normal’ yet

 When President Joe Biden met with U.S. governors at the White House on Monday, he was the only one given a glass of water — lest anyone else remove their mask to take a drink.

The president was seated more than 10 feet from everyone, including Vice President Kamala Harris and members of his Cabinet.

A White House staffer who was wearing a surgical mask when Biden entered the room was quickly handed an N95 version.

These are just some of the extraordinary efforts on the part of the White House to keep the president from getting COVID-19, even though he’s gotten both of his regular vaccinations and his booster.

It’s no surprise that unusual steps are taken to protect any president. But the strict precautions could also threaten to undercut the Biden administration’s own efforts to tell Americans — especially those who are vaccinated and boosted — that they can get on with something closer to their normal lives in the face of the omicron wave.

And it’s emblematic of the messaging challenges surrounding the administration’s approach to COVID-19 as the virus becomes endemic, familiar and somewhat controlled but still menacing, with hard-to-follow guidelines often unevenly implemented.

For months, Biden aides have fretted that the people who are most protected against COVID-19 remain the most cautious, a dynamic they view as a drag on the nation’s economic and psychological recovery.

When the highly transmissible omicron variant hit, Biden said it was a “cause for concern, not cause for panic.”

In recent weeks, his aides and science advisers have highlighted study after study showing the strong protection offered by the COVID vaccines against the variant and reassuring vaccinated people they can go about their daily lives. At a Jan. 19 press conference, Biden declared: “We have the tools — vaccines, boosters, masks, tests, pills — to save lives and keep businesses and schools open” and rejected the notion that still-widespread restrictions reflect a “’new normal.”

“It will get better,” he promised.

Since even before Biden was elected, his aides have gone all-out to protect the now-79-year-old president from potential infection. He spent much of the 2020 campaign season holding remote events from a studio in the basement of his home, venturing out for travel in a bubble of frequently tested aides subject to an array of restrictions.

That caution continued well after he was fully vaccinated and living at the White House. The president has held up his administration’s fidelity to Centers for Disease Control and Prevention guidelines as a virtue, after they were regularly flouted by former President Donald Trump, who became seriously ill after contracting the virus.

As the nation’s virus response and vaccination campaign has become increasingly politicized, White House officials have expressed both political and policy concerns over a possible Biden infection. Though the vaccines are highly effective, a breakthrough case could erode public confidence in the shots and be used as a political cudgel against a president who was elected to bring an end to the pandemic.

Biden himself has at times taken a more relaxed approach to restrictions.

When the CDC last May surprised the White House by easing its guidelines on indoor mask-wearing by fully vaccinated individuals, Biden sought to publicly model the policy for the rest of the nation. He was meeting with vaccinated Republican lawmakers when the change was announced and led the group in removing their masks.

But that CDC guidance proved to be premature and was reversed over the summer, because vaccinated people could still transmit the virus, potentially endangering the tens of millions of Americans who are still unvaccinated.

When the delta strain surged last fall, the White House strengthened its testing protocols for everyone close to Biden — restrictions that had been lessened once aides were fully vaccinated and case counts began to fall nationally. In-person meetings were once again curtailed. Aides began increasing the distance between Biden and even vaccinated-and-tested individuals as a precaution, reminiscent of his earliest days in office.

In early January, as the nation’s capital led the country in per capita COVID-19 cases, White House press secretary Jen Psaki highlighted the “very strict precautions” taken to keep Biden and Harris safe, including mandatory mask-wearing and daily testing for those coming in contact with them.

She also said the White House had taken to limiting gatherings “to under 30 people.” But there were nearly 40 participants named by the administration — as well as two dozen members of the press — at Biden’s Monday meeting with the governors.

Psaki said the administration takes extra precautions any time the president removes his mask to speak to a group. She noted that the nation continues to set records in reported cases and hospital admissions.

“The president’s view is that right now we still need to keep our heads down and stay at it to fight what is still surging in parts of the country,” she said. “But we do have the tools to get to a point where it does not disrupt our daily lives.”

Biden, aides say, has relished opportunities outside the White House when he can engage in the sort of political glad-handing that has been suppressed by the pandemic. And in public, he’s chafed at some of the precautions, saying that the first thing he aims to do differently in his second year in the White House is “I’m going to get out of this place more often.”

He’s hardly alone in his impatience.

On Monday, seated across a large gap from Biden in the East Room, Arkansas Gov. Asa Hutchinson, the chair of the governors’ association, appealed for the government to more clearly define a pathway out of the pandemic.

“We need the CDC to help us to have the right standards to end this pandemic and move to more endemic status,” he said. “We want to go from today to more normal.”

The night before, the president and first lady Jill Biden did attend the black-tie National Governors Association dinner at Mount Vernon. Biden spoke, but he didn’t stay for dinner.

https://apnews.com/article/coronavirus-pandemic-joe-biden-health-pandemics-kamala-harris-648f64eafd0b4f58e05f75e236b65e00

US urges Pfizer to apply for under-5 COVID shots

  U.S. regulators are urging drugmaker Pfizer to apply for emergency authorization for a two-dose regimen of its COVID-19 vaccine for children 6 months to 5 years old while awaiting data on a three-dose course, aiming to clear the way for the shots as soon as late February, a person familiar with the matter told The Associated Press Monday.

The company’s application was expected to be submitted as soon as Tuesday.

Early Pfizer data has shown the vaccine — which is administered to younger kids at one-tenth the strength of the adult shot — is safe and produces an immune response. But last year Pfizer announced the two-dose shot proved to be less effective at preventing COVID-19 in kids ages 2-5, and regulators encouraged the company to add a third dose to the study on the belief that another dose would boost the vaccine’s effectiveness much like booster doses do in adults.

Now, the Food and Drug Administration is pushing the company to submit its application based on the two-dose data for potential approval in February, and then to return for additional authorization once it has the data from the third dose study, which is expected in March, the person familiar with the matter said. The two-step authorization process could mean that young children could be vaccinated more than a month earlier than previous estimates, assuming the FDA and the Centers for Disease Control and Prevention greenlight the shots.

The person spoke on the condition of anonymity to discuss sensitive regulatory issues. The person said the decreased effectiveness of the two-dose vaccine was not unexpected given the emergence of the highly transmissible omicron variant of COVID-19. Allowing young kids to be vaccinated with a two-dose shot earlier would ultimately accelerate when they could get the expected stronger protection from a third dose.

That would be welcome news for parents of young children, the last remaining age group without approval of COVID-19 shots.

Young children are far less likely than adults to develop serious complications or to die from COVID-19, but incidences of illness among the age group have risen amid the nationwide spike in cases from the omicron variant. Most cases and deaths occur among older people, especially those who are unvaccinated.

Speeding the authorization of pediatric vaccines against COVID-19 has been a priority for more than a year of the Biden administration, which believes them critical to reopening and keeping open schools and day care centers — and for freeing up parents occupied by childcare responsibilities to return to the workforce.

Vaccines for kids ages 5-12 were approved by U.S. regulators in November, though uptake of shots has been slower than U.S. officials hoped.

Pfizer’s primary series is administered three weeks apart. The third dose for young kids is being studied for administration at least two months after the second dose.

https://apnews.com/article/coronavirus-pandemic-business-health-0ec7437a181ddbade75dea90884a6b8f

ImmunityBio: Promising Study Results for Strategy to Reduce HIV Viral Load

 

• Data from the Phase 1 "HIV Cure" Study as published in Nature Medicine showed that Anktiva (N-803) stimulates latent HIV replication in CD4+ cells (the kick) and increases immune cell activation (the kill)

• Activated CD4, CD8, and NK immune cells are necessary for finding and killing HIV-infected cells

• No treatment-related serious adverse events were reported

• Multiple Phase 1 and 2 trials with Anktiva in patients with HIV are ongoing

• The need for this therapeutic approach is significant: Globally there are an estimated 38 million people living with HIV; in the US, with 1.2 million people living with HIV, the average annual cost of antiretrovirals is $36,000, while nearly $2 billion is spent on those therapies in developing countries

https://finance.yahoo.com/news/immunitybio-announces-promising-clinical-study-001600024.html

MaxCyte, Intima Bioscience to Advance Tumor Infiltrating Lymphocytes Programs

 MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT, MXCN), a leading provider of enabling platform technologies for ex-vivo cell engineering, today announces the signing of a strategic platform license (SPL) with Intima Bioscience, Inc., a clinical stage biotechnology company developing genetically engineered cell therapies for solid tumor cancer. Intima joins a group of 15 other leading cell therapy companies who have partnered with MaxCyte.

Under the terms of the agreement, Intima obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related milestone payments.

Intima is currently running a Phase 1/2 clinical study (NCT04426669) of its lead checkpoint cell therapy candidate, which targets the immune checkpoint CISH in patients with gastrointestinal and colon cancers.

https://finance.yahoo.com/news/maxcyte-signs-strategic-platform-license-070000857.html