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Delta variant ignites new mask debate

Posted on by • Posted in Asymptomatic Transmission, Centers for Disease Control & Prevention (CDC), Coronavirus, Coronavirus Delta Variant, Coronavirus Mutation, Infection Control, Infection Control Plan, Infectious Virus, National Strategy, Pandemic, Personal Protective Equipment (PPE), Public Health, Public Opinion, Public Perception, Public Safety, Social Distancing, Vaccine, Vaccine Distribution, Vaccine Efficacy, Vaccine Hesitancy Rate, Vaccine Safety, Vaccine Skepticism, Vaccine Supply • Leave a comment

Delta variant ignites new mask debate

Delta variant ignites new mask debate | TheHill

Health officials are grappling with how to prevent potential COVID-19 outbreaks from the delta variant that is spreading rapidly across the U.S.

Concern over the highly transmissible delta strain prompted Los Angeles County this week to recommend that all people wear masks indoors, even if they’re vaccinated. The World Health Organization (WHO) has also encouraged fully vaccinated people to continue using masks.

But the Centers for Disease Control and Prevention (CDC) has not signaled any plans to revise its mask guidance, with Biden administration officials and some experts say that fully vaccinated Americans are safe from all existing COVID-19 variants.

“If you have been vaccinated, the message we’re conveying is you’re safe,” White House press secretary Jen Psaki said Wednesday. “Vaccines are effective, and that is something we want to be very clear with the public about.”

Still, the move by officials in Los Angeles County raises the prospect that mask recommendations and even mandates could make a return to certain parts of the country.

The CDC projected the delta variant made up more than a quarter of cases in the U.S. in the most recent two-week period, ending June 19 — a jump from 10 percent the previous two weeks.

Los Angeles County issued a statement Monday saying it “strongly recommends” all people wear masks in indoor settings where they don’t know everyone’s vaccination status.

Barbara Ferrer, director of the county’s Department of Public Health, told The Hill that officials want to take time to get more people vaccinated as research is conducted on delta variant transmission from the fully vaccinated.

“While we’re doing that work with building confidence, we’re going to go ahead and offer as much protection as possible for everyone,” she said.

Leana Wen, an emergency physician and public health professor at George Washington University, praised the county’s decision as the “right move,” saying she hopes other jurisdictions follow suit to protect both vaccinated and unvaccinated residents.

“People who are fully vaccinated are still at risk, albeit a low risk, from those who are unvaccinated,” Wen said.

“Fully vaccinated people can be around others who are fully vaccinated without any limitations,” she added. “However, if they’re going to be around unvaccinated people or vaccination status is not being checked, then those could be high-risk settings” where masks should be worn.

For now, Los Angeles County is an outlier as cities and states continue to loosen mask requirements. Washington’s King County, home to Seattle, and Pennsylvania were the latest jurisdictions to end their mandates, taking that step this week.

CDC Director Rochelle Walensky told NBC’s “Today” on Wednesday that the agency’s guidance that fully vaccinated people don’t need masks in most settings has not changed. She said the WHO has given conflicting instructions, saying the international organization is focused on the global community, which has a lower vaccination rate than the U.S.

“We have always said that local policymakers need to make policies for their local environment,” Walensky said. “But those masking policies are not to protect the vaccinated, they’re to protect the unvaccinated.”

So far, the delta strain has not led to any changes in masking policies at the White House or the Capitol.

The White House does not require masks if a person is vaccinated, although the administration is not checking to see whether all maskless people have gotten their COVID-19 shots.

In recent weeks, the House has ended its universal mask requirement, and few people in the Capitol continue to wear them. The overwhelming majority of lawmakers in both parties have shed masks and freely gather in large groups on the House floor.

The Senate, which never had a mask requirement since nearly all senators voluntarily wore facial coverings when it was recommended, has also relaxed its pandemic restrictions.

But the delta variant threat is influencing other activities in the House. Speaker Nancy Pelosi (D-Calif.) announced this week that proxy voting would be extended through Aug. 17, and House Majority Leader Steny Hoyer (D-Md.) said that was due to the global spread of the delta variant.

“As we know, there are some countries in the world that are seeing a virulent resurgence of this new variant of the COVID-19. Israel is a perfect example of that,” Hoyer told reporters, referring to Israel reimposing its indoor mask mandate despite having one of the world’s highest vaccination rates. “But even in Israel, where they have the vaccine available, they’re seeing a resurgence.”

“So, the Speaker correctly, along with the medical advice that she’s gotten, determined that there was still justification for staying on guard,” Hoyer said.

Recent studies have found that COVID-19 vaccines are effective against the strain. Both doses of Pfizer-BioNTech were found to be 88 percent effective against symptomatic disease.

There is “less data” on how Johnson & Johnson performs, Walensky said Wednesday, but “right now we have no information to suggest that you need a second shot after J&J, even with the delta variant.”

Jen Kates, senior vice president and director of global health & HIV policy at the Kaiser Family Foundation, said research shows the CDC guidance “still stands,” although she acknowledged the agency needs to be prepared to adjust.

Kates expressed concern that the resurgence of the mask debate could affect the vaccination effort, noting the variant is spreading mostly among unvaccinated people.

“The worst outcome, I think, is that people choose not to get vaccinated because they think the vaccines aren’t as effective against variants,” she said.

As most Americans have gotten vaccinated, COVID-19 cases, hospitalizations and deaths have declined significantly. But the U.S. is expected to fall short of President Biden’s goal to have 70 percent of adults receiving at least one vaccine dose by the Fourth of July.

The White House still plans to move forward with Independence Day festivities. The administration sent 1,000 invitations for people to gather at 1600 Pennsylvania Ave. on Sunday, with vaccinated people allowed to go without masks. All guests were instructed to get tested one to three days before arriving.

“We certainly feel comfortable and confident moving forward with our event here at the White House and individuals having barbecues in their backgrounds this week to celebrate the Fourth of July,” Psaki said on Wednesday.

CRISPR Shows Promise in Gene-Editing Therapy During Clinical Trial

Posted on by • Posted in Biotech, Clinical Research, Clinical Trials, CRISPRs, Gene Editing, Gene Therapy, Investigational Therapy • Leave a comment
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CRISPR-Cas9 Gene Therapy Shows Promise in Angelman Mouse Model

Scientists at UCL National Amyloidosis Centre at the Royal Free Hospital, London are hoping their gene editing therapy using CRISPR will be a breakthrough for patients suffering from hereditary transthyretin (ATTR) amyloidosis. In a phase 1 clinical trial, the first six patients have shown positive interim results for gene-editing treatment.

The CRISPR breakthrough comes in treating transthyretin amyloidosis, a mutation in the transthyretin (TTR) gene. Those with this mutation produce an abnormal protein, which gradually builds up in the heart and nerves. Symptoms can include numbness in the hands and feet, loss of control of the bowel and bladder, and loss of mobility.

Hereditary transthyretin amyloidosis gets progressively worse and is fatal. Up until this point, most of the treatment options available to patients have included management of the symptoms and prevention of progression.

Those taking part in the trial have received a molecule knows as CRISPR/Cas9 via one-off infusion. The purpose of this is to deactivate the incorrect gene within the liver cell.

“With the gene no longer active in the liver, it is expected that the patient will only produce negligible levels of the harmful transthyretin protein,” UCL stated in a press release. 

Scientists saw in the first six patients a reduced production of the harmful transthyretin protein by up to 96 percent, 28 days after the treatment. Additionally, there were no serious adverse effects witnessed. This data was published in the New England Journal of Medicine.

“As the trial progresses, patients will be given higher doses of the gene editing therapy with the hope that will drive the levels of toxic protein even lower,” UCL explained. 

CRISPR/Cas9, a Nobel Prize-winning technology, has been used to edit cells outside the body in the past. However, UCL is presenting the first clinical data which CRISPR/Cas9 is being used as medicine itself for a potential therapy.

“This is wonderful news for patients with this condition. If this trial continues to be successful, the treatment may permit patients who are diagnosed early in the course of the disease to lead completely normal lives without the need for ongoing therapy,” Professor Julian Gillmore, the trial lead, of the UCL National Amyloidosis Centre, part of the UCL Centre for Amyloidosis and Acute Phase Proteins said in a press release.

“Until very recently, the majority of treatments we have been able to offer patients with this condition have had limited success. If this trial continues to go well, it will mean we can offer real hope and the prospect of meaningful clinical improvement to patients who suffer from this condition,” Gillmore continued.

The global trial includes patients from the Royal Free London and a hospital located in Auckland, New Zealand. The investigational therapy, designated NTLA-2001, is being developed by Intellia Therapeutics; a biotechnology company based in the United States.

 This could be a big step forward in using CRISPR as gene therapy. Typically, the therapy is injected into the site of illness. However, this newest approach injects CRISPR directly into the bloodstream, which could revolutionize how clinicians treat certain illnesses.

California hospital beats suit over ER fee nondisclosure

Posted on by • Posted in District Court, District Court of Appeals, Emergency Care, Health System, Hospital, Hospital Industry, Lawsuit, Price Transparency, Rev Cycle Management, Revenue Cycle, Surprise Bills • Leave a comment
https://www.beckershospitalreview.com/legal-regulatory-issues/california-hospital-beats-suit-over-er-fee-nondisclosure.html?origin=CFOE&utm_source=CFOE&utm_medium=email&utm_content=newsletter&oly_enc_id=2893H2397267F7G
California moves end surprise ER bills after Vox's reporting - Vox

A California hospital was properly dismissed from a lawsuit alleging it violated state consumer protection laws by failing to disclose emergency room visit fees before treatment, a state appellate court ruled June 29. 

Joshua Yebba filed the lawsuit against AHMC Anaheim (Calif.) Regional Medical Center, alleging the hospital violated California’s Unfair Competition Law and Consumer Legal Remedies Act when it did not disclose a separate fee for an emergency room visit before treating him. Mr. Yebba claimed he would have gone to a different ER if he knew about the fee. He sued on behalf of himself and others who allegedly were charged the separate ER fee without knowing about it. 

The lawsuit centered on whether the hospital had a duty to disclose the ER fee to patients before treating them and whether the hospital violated the consumer protection laws by not disclosing them. 

The hospital argued that it fulfilled any duty to disclose the fee because it has a written or electronic copy of its chargemaster available. However, Mr. Yebba contended that Anaheim Regional had a duty to tell him personally while checking in or to at least post a sign about the fees in the ER. 

A lower court dismissed the case against the hospital on the grounds that Anaheim Regional had no duty to disclose the separate ER fee to Mr. Yebba before treating him and that the allegations didn’t violate the consumer protection acts.

The California Court of Appeals 4th District affirmed the dismissal, saying that California lawmakers have determined what pricing information hospitals must disclose to patients and when, and a court decision increasing the requirements “upsets the legislative balance between the consumers’ right to information and the hospitals’ burden of providing it.”

Read the full court opinion here. 

‘It’d be catastrophic’: Dallas-area hospitals could lose $1.1B annually without Medicaid waiver, healthcare group warns

Posted on by • Posted in Health Policy, Health System, Hospital, Hospital Industry, Medicaid, Medicaid Expansion, Medicaid Section 1115 Waiver • Leave a comment
https://www.beckershospitalreview.com/finance/it-d-be-catastrophic-dallas-area-hospitals-could-lose-1-1b-annually-without-medicaid-waiver-healthcare-group-warns.html?origin=CFOE&utm_source=CFOE&utm_medium=email&utm_content=newsletter&oly_enc_id=2893H2397267F7G
Original map. Location of hospitals in Dallas, TX. Source: North... | Download Scientific Diagram

Hospitals in the Dallas-Fort Worth region could collectively lose $1.1 billion in funding each year without a Medicaid waiver extension, a healthcare group warned, according to CBS Local.

The group, Texas Essential Healthcare Partnerships, represents 72 hospitals in the Dallas-Fort Worth region, including those operated by Dallas-based Tenet Healthcare and Houston-based Baylor Scott & White Health. 

In April, CMS rescinded approval for a Section 1115 waiver to extend reimbursement to Texas hospitals for uncompensated care through September 2030. President Joe Biden’s CMS said that under the previous administration, CMS and Texas failed to adhere to public comment period requirements in the approval process, so it should be rescinded.  

Don Lee, Texas Essential Healthcare Partnerships, told CBS he’s concerned about CMS’ decision to rescind the waiver next year and that hospitals could begin feeling the effects in just three months. 

“There’s about $330 million of very important mental healthcare funding for mental healthcare services for the poor that will be lost starting in September of this year,” Mr. Lee told CBS Local. 

Texas plans to resubmit its application to extend the 1115 waiver soon, according to the report. However, if the new application is not approved, Mr. Lee said that some hospitals in the North Texas region may be forced to close. 

“We believe it’d be catastrophic, not just for the hospitals, but for all Texans,” Mr. Lee told CBS Local. 

‘I only see the potential for massive financial loss’: Former Spectrum CFO doubts value of Beaumont merger

Posted on by • Posted in Board, Divestitures, Health System, Hospital, Hospital Industry, Margin Improvement, Market Consolidation, Market Power, Mergers & Acquisitions, Strategic Alignment, Strategy • Leave a comment
https://www.beckershospitalreview.com/finance/i-only-see-the-potential-for-massive-financial-loss-former-spectrum-cfo-doubts-value-of-beaumont-merger.html?origin=CFOE&utm_source=CFOE&utm_medium=email&utm_content=newsletter&oly_enc_id=2893H2397267F7G
I only see the potential for massive financial loss': Former Spectrum CFO doubts value of Beaumont merger

Michael Freed, the former CFO of Spectrum Health, said he was “stunned” when he heard that the Grand Rapids, Mich.-based system plans to pursue a merger with Southfield, Mich.-based Beaumont Health, for myriad reasons. 

In a June 24 open letter to Spectrum’s board of directors, Mr. Freed said during his tenure they discussed possible mergers routinely and that a Spectrum-Beaumont combination “brought nothing new with it” and wouldn’t enhance value. 

“The markets didn’t overlap, so there were no significant administrative savings opportunities. The ability of each hospital to grow wasn’t enhanced by adding the other to the ‘system,'” Mr. Freed wrote. “In short, I never saw how such a merger could improve health, enhance value or make care more affordable. I still don’t.”

Mr. Freed was Spectrum’s CFO from May 1995 to December 2013. During his tenure, he helped oversee the formation of Spectrum and a substantive period of growth for the Michigan system. Mr. Freed also served as CEO of Spectrum’s health plan, Priority Health, from May 2012 until he retired in January 2016.

In his letter, Mr. Freed outlined several reasons he was “stunned” by the pursuit of the merger that would create a health system with 22 hospitals, 305 outpatient centers and about $13 billion in operating revenue.

Mr. Freed wrote that the merger with Beaumont, which is based in Southfield, Mich., may not be in the best interest of West Michigan. He said the combination of the two systems raises questions about whether governance truly will remain in the region and with Spectrum, if financial transparency will continue and if Spectrum will continue to honor the consent decree it signed in 1997 establishing a set of operational guidelines. 

If the merger moves forward, “debt can be placed on the books of West Michigan while investments EARNED IN West Michigan could be spent in SE Michigan … and vice versa,” Mr. Freed wrote. “If this entity should someday merge with other out-of-state entities, West Michigan could find itself investing in healthcare in other states as well, rather than in its own health.”

Mr. Freed raised concerns over the agreement between Spectrum and Beaumont to create a 16-person board of directors, seven of whom would come from Spectrum and seven from Beaumont. The CEO would come from Spectrum, and one new board member will be appointed. 

“While this structure looks to favor Spectrum Health initially, it would only take the hiring of a board member more favorable to Beaumont Health and the replacement of the CEO (in favor of Beaumont Health) for Spectrum Health to find itself outvoted 9 to 7 on key issues,” Mr. Freed said.

Additionally, Mr. Freed noted that the merger has the potential for massive financial losses to West Michigan. In particular, Mr. Freed said losses would stem from the financial assets of Spectrum and Priority Health no longer residing in West Michigan. 

“I’ll admit, I don’t see any value in this merger,” Mr. Freed wrote. “I only see the potential for massive financial loss, both historically and an undetermined amount going forward, to the region that produced all of Spectrum Health.” 

Mr. Freed urged the Spectrum board to take a few steps before moving forward with the merger, including selling or divesting Priority Health. 

“When you sign the documents that will permanently change this region, your signature will forever hold you accountable for the repercussions,” Mr. Freed wrote. “Please sign carefully.” 

Spectrum Health told MiBiz it remains committed to the commitments in the 1997 consent agreement and that it “remains enthusiastic” about the merger.

“Spectrum Health is fully committed to fulfilling its consent decree obligations and will continue to uphold its tenets,” the health system said. “We remain confident that creating a new system not only meets our current obligations to our local communities but will also improve the health of individuals in West Michigan and throughout the state.”

Access the full letter here.