About Covid-19
This Lab Charges $380 for a Covid Test. Is That What Congress Had in Mind?: “At the drugstore, a rapid Covid test usually costs less than $20.
Across the country, over a dozen testing sites owned by the start-up company GS Labs regularly bill $380.
There’s a reason they can. When Congress tried to ensure that Americans wouldn’t have to pay for coronavirus testing, it required insurers to pay certain laboratories whatever “cash price” they listed online for the tests, with no limit on what that might be.
GS Labs’s high prices and growing presence — it has performed a half-million rapid tests since the pandemic’s start, and still runs thousands daily — show how the government’s longstanding reluctance to play a role in health prices has hampered its attempt to protect consumers.”
Although people have a choice of tests, the “free” Covid-19 testing program makes them care less about which one they they get.
In a matter of days, Pfizer CEO says they'll be ready to ask for approval of a Covid-19 vaccine for kids: “Pfizer/BioNTech plans to ask for authorization of a Covid-19 vaccine for some children under 12 soon, bringing the US one step closer to offering protection to a population that has grown particularly vulnerable as the fall season gets underway.
’It is a question of days, not weeks,’ Pfizer Chairman and CEO Albert Bourla told ABC News Sunday about when the company will submit data on children ages 5 to 11 to the FDA for consideration.”
New potential factor contributing to severity of COVID-19 identified: “CD47 is a so-called 'do not eat me' signal to the immune system's defences that protect cells from being destroyed. Virus-induced CD47 on the surface of infected cells is likely to protect them from immune system recognition, enabling the production of larger amounts of virus, resulting in more severe disease.
Well-known risk factors for severe COVID-19 such as older age and diabetes are associated with higher CD47 levels. High CD47 levels also contribute to high blood pressure, which is a large risk factor for COVID-19 complications such as heart attack, stroke, and kidney disease.
The data suggest that age and virus-induced high CD47 levels contribute to severe COVID-19 by preventing an effective immune response and increasing disease-associated tissue and organ damage.”
U.S. schools with mask requirements are seeing fewer outbreaks, the C.D.C. finds.: “One study, conducted in Arizona, where children returned to school in July, found that schools that did not require staff and students to wear masks were 3.5 times as likely to have a virus outbreak as schools that required universal masking.
A second study looked at infections among all children in 520 different counties across the United States, and found that once the public school year started, pediatric cases increased at a far higher rate in counties where schools did not require masks.”
Science is still unlikely to change the minds of masking opponents who see mandates as a personal rights infringement issue.
Sharp increase in employers favoring vaccine mandate: “More than half of U.S. employers, 54%, already have a COVID-19 vaccine mandate or are strongly considering one, according to a recent survey by McGriff, a subsidiary of Truist Insurance Holdings Inc.
The broker said Friday that the survey taken earlier this month shows that more employers were already leaning toward a mandate, whereas in a previous survey in January, only 3% of employers told McGriff they were planning on a vaccine mandate.
The Instant Insights COVID-19 vaccine mandate survey conducted by the McGriff Employee Benefits Division showed that 11% of the 315 employers surveyed had already implemented, or were in the process of implementing, a vaccine mandate.”
In a related story: U.S. court upholds hospital employee COVID-19 vaccine rule in test case: A federal judge on Friday ruled that a Cincinnati, Ohio-area healthcare provider could require its employees get vaccinated against COVID-19 or risk losing their job, in what appears to be the first ruling of its kind for a private employer in the United States.
The employees of St. Elizabeth Healthcare failed to establish that their individual liberties were being violated by the vaccine requirement of the hospital operator, which has the right to set employment terms, said U.S. District Judge David Bunning in Covington, Kentucky.”
Federal judge delays vaccine mandate for NYC teachers: “New York City schools have been temporarily blocked from enforcing a vaccine mandate for its teachers and other workers by a federal appeals judge just days before it was to take effect.
Workers in the nation’s largest school system were to be required to show vaccination proof starting Monday. But late Friday, a judge for the 2nd U.S. Circuit Court of Appeals granted a temporary injunction sought by a group of teachers pending review by a three-judge panel, which will take up the motion Wednesday.
Department of Education spokesperson Danielle Filson said officials were seeking a speedy resolution in court.”
WHO Adds REGEN-COV to List of Recommended COVID-19 Treatments: “The World Health Organization (WHO) has added Regeneron’s COVID-19 antibody cocktail, REGEN-COV (casirivimab/imdevimab), to its list of recommended treatments in updated clinical guidelines.
The world body also announced that it is in negotiations with Roche, which is distributing the cocktail through a deal with Regeneron. The WHO also highlighted the ‘high cost and low availability of the combination therapy’ as a barrier to access and said it is in discussions with Regeneron to donate REGEN-COV treatment courses.”
Transdermal vaccination via 3D-printed microneedles induces potent humoral and cellular immunity: “Microneedle patches designed to precisely deliver cargos into the intradermal space, rich in immune cells, provide a noninvasive and self-applicable vaccination approach, eliminating the need for hypodermic needles and trained medical personnel for vaccine administration. Here, we show that advanced 3D printing methods allow for the manufacturing of polymeric microneedles of controlled geometries (difficult to manufacture using traditional methods) designed to enhance vaccine component coating. Using model vaccine components, we demonstrated that 3D-printed microneedle delivery resulted in enhanced cargo retention in the skin, activation of immune cells, and more potent humoral and cellular immune responses as compared with traditional vaccination routes.”
About healthcare IT
FBI warns of Conti ransomware after 400 attacks: 5 things to know: “The FBI and Cybersecurity and Infrastructure Security Agency are warning of the increased use of Conti ransomware after more than 400 attacks on American and international organizations were reported….
During most Conti ransomware attacks, hackers steal files, encrypt servers and demand a ransom payment, according to a news release. Conti actors usually gain access to the network through spear phishing campaigns, stolen desktop credentials, phone calls and fake software promoted on search engines.
Amazon launches $40M health equity accelerator: “Amazon Web Services is committing $40 million over three years to its new global program to support equity in health outcomes…
Through the program, organizations can apply to receive Amazon Web Services credits and expertise to create products and services aiming to improve health outcomes for marginalized populations. This year's deadline for applications is Nov. 15.”
About pharma
Court Rules Takeda is Liable to Abbvie for Lupron Depot Damages: “Takeda has been unable to supply the drug — which is indicated to treat endometriosis, uterine fibroids, premature puberty and prostate cancer — to AbbVie Endocrine, an AbbVie subsidiary, since an FDA inspection of its plant in Hikari, Japan, in 2019 turned up problems.”
Judge Says FDA Must Rework Oversight of Compounding Pharmacies: “Judge Christopher Cooper of the U.S. District Court for the District of Columbia ruled last week that the agency violated procedure in producing the ‘standard Memorandum of Understanding,’ which establishes an agreement between individual state pharmacy boards and the FDA.
Congress required the FDA to develop this document in 1997 when it passed Section 503A of the federal Food, Drug and Cosmetic Act (FDCA), but it wasn’t finalized until last October.
Seven compounding pharmacies sued to challenge the final document, and Cooper has found in their favor to the extent that the FDA must now ‘either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis.’”
Biogen used charity giving to illegally boost multiple sclerosis drug sales, Humana lawsuit says: “For years, federal prosecutors have gone after drug companies for allegedly using charity contributions as a way to boost sales. Biogen was among the pharma players to ink a federal settlement, but, now, insurance giant Humana is targeting the company’s charity giving with a new lawsuit.
In a suit filed in Massachusetts Friday, Humana says Biogen sought to boost sales for multiple sclerosis drugs Tysabri, Avonex and Tecfidera by ‘seeding’ patients with free sample drugs then ‘sweeping’ them onto Medicare and other government insurance programs through its charity giving.”
About health insurance
Aetna hit with class-action lawsuit alleging discriminatory policies for mental health treatment: “The complaint, which was filed this week in U.S. District Court in the Central District of California, alleges that Aetna illegally denied claims for mental health residential treatment services.
In 2019, the plaintiff, who has an Aetna insurance plan through his employer, Fox Entertainment Group, enrolled his 16-year-old son who has autism spectrum disorder in a mental health residential treatment center located in Utah, according to the complaint.
Aetna denied the plaintiff's claim for reimbursement for his son's treatment at the residential facility.
According to Aetna's letter to the plaintiff, as cited in the complaint, the insurer said it was denying coverage because the facility is not accredited by an agency such as The Joint Commission, the Committee on Accreditation of Rehabilitation Facilities, the American Osteopathic Association's Healthcare Facilities Accreditation Program or the Council on Accreditation.
Aetna also said the mental health residential treatment center is not covered under the terms of the plan because a behavioral provider is not actively on duty 24 hours per day for 7 days a week and the patient is not treated by a psychiatrist at least once per week but on an as-needed basis.”
Details about provisions for treatment in an accredited facility were not provided in the article.