About Covid-19
XBB.1.5's transmissibility, severity: 4 Qs answered “Maria Van Kerkhove, PhD, the WHO's COVID-19 technical lead…called it the ‘most transmissible subvariant that has been detected yet,’ due to mutations that allow it to adhere to the cell and replicate easily. Experts believe it has a growth advantage over its relative, XBB, which was already hailed as the most transmissible…
There's been no indication XBB.1.5. causes more severe disease than other omicron strains, though it's not completely certain yet…
It's not certain how well omicron boosters neutralize XBB.1.5, though more data is expected soon…”
Fla. surgeon general used ‘flawed’ vaccine science, faculty peers say “Joseph A. Ladapo, a professor of medicine at the University of Florida and the state’s surgeon general, relied upon a flawed analysis and may have violated university research integrity rules when he issued guidance last fall discouraging young men from receiving common coronavirus vaccines, according to a report from a medical school faculty task force.” The report ends with this statement: “In summary, the committee has concerns that Dr. Ladapo may have violated Sections 3.B.3 of the UF faculty policy on research integrity and has referred the matter to the University of Florida Research Integrity Officer (RIO).”
About health insurance/insurers
States Get New Pathway to Tackle Social Needs in Medicaid “States will be able to introduce initiatives addressing health-related social needs into their Medicaid managed care plans under guidance issued Wednesday by the Biden administration.
They will be able to offer alternative benefits that tackle social needs such as housing and food insecurity in an effort to help Medicaid enrollees maintain their coverage and improve their health outcomes.
The Centers for Medicare & Medicaid Services said it will allow managed care plans to pay for alternative benefits in lieu of more traditional services offered by state plans.”
Humana laying off over 1,100 associates, shuttering all SeniorBridge locations “Humana is laying off at least 1,162 employees in two states following the decision to close all its SeniorBridge home care facilities nationwide.
The payer closed 16 facilities at the end of 2022, and said it plans to close its remaining seven locations in New York by March 5…
Humana purchased SeniorBridge in 2012 to manage chronic and home care services for predominantly seniors.”
BLUE CROSS BLUE SHIELD COMPANIES FORM SYNERGIE MEDICATION COLLECTIVE, A NEW VENTURE TO RADICALLY IMPROVE AFFORDABILITY AND ACCESS TO COSTLY MEDICATIONS FOR MILLIONS OF AMERICANS “Announced today, Synergie Medication Collective is a new medication contracting organization founded by a group of Blue Cross and Blue Shield affiliated companies to serve both Blues and select independent health plans. Synergie is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans. These high-cost treatments include multi-million-dollar gene therapies and infusible cancer drugs and represent a substantial portion of overall drug spend, with significant growth in future spend anticipated.
Synergie aims to significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders. With a core philosophy that prioritizes partnership and transparency, Synergie aims to play a key role in ensuring affordable access to treatment for millions of people.”
About pharma
Justice Dept.: Despite bans, abortion pills may be mailed to any state “The Justice Department has issued a legal opinion that the U.S. Postal Service may deliver abortion pills to people in states that have banned or sharply restricted the procedure, saying that federal law allows the mailing of the pills because the sender cannot know for sure whether the recipient would use them illegally…
The U.S. Postal Service had asked the Justice Department to say whether it would be legally allowed to deliver pills that could be used for abortion in a state where the procedure is outlawed. The response was a resounding yes.The Justice Department’s opinion — which was quickly condemned by antiabortion groups — does not change any state or federal laws. It hinges on the department’s interpretation of Section 1461 of the Comstock Act, a law originally passed in 1873 that governs how the Postal Service handles the delivery of contraception and items considered ‘obscene.’”
WALGREENS BOOTS ALLIANCE REPORTS FISCAL 2023 FIRST QUARTER RESULTS “First quarter financial highlights
First quarter loss per share* was $4.31 compared to earnings per share (EPS*) of $4.13 in the year-ago quarter reflecting a $6.5 billion pre-tax charge recognized in connection with the previously announced opioid litigation settlement frameworks and certain other opioid-related matters
Adjusted EPS decreased 30.8 percent to $1.16, down 29.9 percent on a constant currency basis against strong growth of 53.1 percent in the year-ago quarter reflecting higher COVID-19 vaccine volumes
First quarter sales decreased 1.5 percent year-over-year, to $33.4 billion, up 1.1 percent on a constant currency basis; excluding the negative impact from AllianceRx Walgreens of 485 basis points and the positive contributions from U.S. Healthcare M&A of 280 basis points, sales growth was 3.2 percent on a constant currency basis
Invested $3.5 billion in debt and equity to support VillageMD's acquisition of Summit Health, which closed January 3, 2023, accelerating U.S. Healthcare segment sales and path to profitability
Sold 19.2 million shares of AmerisourceBergen common stock in November and December, with after-tax cash proceeds of $3 billion
About the public’s health
FDA accepts filing for AstraZeneca, Sanofi's RSV preventative nirsevimab “AstraZeneca and Sanofi said Thursday that the FDA accepted a filing seeking approval of nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. The agency's target action date for the application is in the third quarter of 2023, although the companies noted that the regulator has committed to expedite its review.
Nirsevimab recently gained clearance in the EU, where it is marketed under the brand name Beyfortus, for the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season. The approval by the European Commission was the first regulatory authorisation for the single-dose, long-acting antibody.”
Misdiagnosis Meets Overdiagnosis in the ER This Letter to the Editor responds to an article in The Wall Street Journal that claimed the study on diagnostic ER errors used faulty statistics. You should read it, as well as the referenced study.
About healthcare IT
Trends in Ransomware Attacks on US Hospitals, Clinics, and Other Health Care Delivery Organizations, 2016-2021 “In this cohort study of 374 ransomware attacks, the annual number of ransomware attacks on health care delivery organizations more than doubled from 2016 to 2021, exposing the personal health information of nearly 42 million patients. During the study period, ransomware attacks exposed larger quantities of personal health information and grew more likely to affect large organizations with multiple facilities.”
Comment: Why have healthcare security measures not improved as much as other parts of IT systems? Their failures are the reason we cannot have unique patient identifiers.
About healthcare personnel
U.S. Moves to Bar Noncompete Agreements in Labor Contracts “In a far-reaching move that could raise wages and increase competition among businesses, the Federal Trade Commission on Thursday unveiled a rule that would block companies from limiting their employees’ ability to work for a rival.
The proposed rule would ban provisions of labor contracts known as noncompete agreements, which prevent workers from leaving for a competitor or starting a competing business for months or years after their employment, often within a certain geographic area. The agreements have applied to workers as varied as sandwich makers, hair stylists, doctors and software engineers.”
We will need to see what the final rule looks like, but it could have a profound impact on healthcare professionals. For example, professionals need to be compensated for signing a non-compete agreement. If that arrangement can no longer exist, will payments drop? Or will employers need to start offering retention bonuses in lieu of non-compete clauses?
About health technology
GE HealthCare rises 8% in market debut, eyes small deals “ GE HealthCare Technologies Inc's shares rose as much as 8.4% in their Nasdaq debut on Wednesday and its chief executive said the company was looking to do small acquisitions to boost its cardiology and oncology operations in the long term.
The company, which was spun off from conglomerate GE had opened 3% lower in its first day of trading and closed up 8% at $60.49.”
FDA Grants Breakthrough Device Designation to OverC Multi-Cancer Detection Blood Test “The FDA has granted a breakthrough device designation to the OverC Multi-Cancer Detection Blood Test (MCDBT) for the early detection of cancers including esophageal, liver, lung, ovarian, and pancreatic in adults aged to 50 to 75 years with average risk.
In findings from the THUNDER case-control study, OverC™ MCDBT demonstrated a 69.1% rate of sensitivity and 98.9% rate of specificity. In data from 308 patients with surgery-resectable lung cancer and 261 age- and sex-matched non-cancer controls published in 2021, the assay detected 52% to 81% of patients at disease stages IA to III with a specificity rate of 96% (95% CI, 93%-98%).
In a subgroup analysis of 115 participants, the assay identified nearly twice as many patients with cancer as those detected by ultradeep mutation sequencing analysis. The specificity rate was 100% (95% CI, 91%-100%).
Investigators will further validate the assay in prospective interventional studies in an asymptomatic population.”