About Covid-19
Children as young as 6 months can now receive an updated Covid-19 vaccine “The US Food and Drug Administration on Thursday authorized updated Covid-19 vaccines from Moderna and Pfizer/BioNTech for use in children from ages 6 months through 5 years.
The bivalent vaccines target the original strain as well as the BA.4/5 Omicron strains. Bivalent vaccines were previously authorized as a booster for people age 5 and older.”
Vaccine hesitancy prospectively predicts nocebo side-effects following COVID-19 vaccination “Results show that a quantifiable and meaningful portion of COVID-19 vaccine side-effects is predicted by vaccine hesitancy, demonstrating that side-effects comprise a psychosomatic nocebo component in vaccinated individuals. The data reveal distinct risk levels for future side-effects, suggesting the need to tailor public health messaging.”
New Receptor “Decoy” Drug Neutralizes COVID-19 Virus and Its Variants “Scientists at Dana-Farber Cancer Institute have developed a drug that potently neutralizes SARS-CoV-2, the COVID-19 coronavirus, and is equally effective against the Omicron variant and every other tested variant. The drug is designed in such a way that natural selection to maintain infectiousness of the virus should also maintain the drug’s activity against future variants.
The investigational drug, described in a report published today in Science Advances, is not an antibody, but a related molecule known as an ACE2 receptor decoy. Unlike antibodies, the ACE2 decoy is far more difficult for the SARS-CoV-2 virus to evade because mutations in the virus that would enable it to avoid the drug would also reduce the virus’s ability to infect cells. The Dana-Farber scientists found a way to make this type of drug neutralize coronaviruses more potently in animals infected with COVID-19 and to make it safe to give to patients.”
Federal judge declines 14 states' challenge to CMS vaccine mandate “A federal judge in Louisiana on Dec. 2 declined a case brought by 14 states challenging the Biden administration's rule that requires COVID-19 vaccination for eligible staff at healthcare facilities participating in Medicare and Medicaid programs.”
About health insurance/insurers
UnitedHealth's LHC Group acquisition delayed until 2023 “Previously expected to close by the end of 2022, United Health Group's acquisition of home-health firm LHC Group will now likely be finalized in the first quarter of 2023, according to an LHC filing with the Securities and Exchange Commission.
The agreement was extended until March 28, according to the filing. UnitedHealth and LHC also certified to the FTC their substantial compliance with a June 10 request for additional information and documentation regarding the proposed acquisition.”
Value-Based Payment As A Tool To Address Excess US Health Spending An excellent review.
A couple takeaways: More Than Half Of Health Care Payments Are Still Based On Fee-For-Service
Savings Attributable To ACOs Range From Just Under 1 Percent To Just Over 6 Percent
About pharma
RCTs with prognostic digital twins overcome the limitations of external control arms Digital twins are being used for a variety of purposes, including expedited drug development. This article is a good review of what it is and how it is being used.
About the public’s health
FDA expected to decide on Pfizer RSV vaccine for older adults by May 2023 “KEY POINTS:
Pfizer, in a statement Wednesday, said the FDA has accepted its RSV vaccine candidate for review under an expedited process that reduces the approval process by four months.
The FDA is expected to make a final decision on whether to approve the vaccine by May 2023.
Between 60,000 and 120,000 older adults are hospitalized with RSV every year and 6,000 to 10,000 older adults die from the virus.
There currently is no vaccine.”
About healthcare IT
Amazon shuts down support for Alexa HIPAA-compliant programs for hospitals, payers “Amazon will no longer support HIPAA compliance on its Alexa devices after launching a program three years ago for some hospitals and payers.
In April 2019, Amazon paved the way for Alexa to be used in healthcare when it announced its Amazon Alexa HIPAA-compliant skills kit for developers. The announcement paved the way for developers to build voice skills that can securely transmit private patient health information.”
Survey of Telehealth Use by Commercial Insurance Enrollees Highlights: 40% of respondents with commercial insurance used telehealth to access health services in the past year. 60% are satisfied with the care they received via telehealth.”
Obviously, convenience was the leading benefit users cites.
Digital Therapeutics Alliance and Curebase release publication setting the stage for a fit-for-purpose evidence standard for digital therapeutics (DTx) “The Digital Therapeutics Alliance (DTA), a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare, in collaboration with DTA Resource Partner, Curebase, a company committed to democratizing access to clinical studies, today released a publication to provide a fit-for-purpose evidence standard for DTx product regulatory, reimbursement, and clinical acceptance.
The publication, “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard”, outlines foundational principles specific to the DTx category of medicine and baseline expectations for healthcare decision makers (HCDMs) related to the types, quality, and timing of clinical trials necessary to evaluate and implement DTx therapies in real-world settings.”
A new coalition aims to close AI’s credibility gap in medicine with testing and oversight “The group, billing itself as the Coalition for Health AI, called for the creation of independent testing bodies and a national registry of clinical algorithms to allow physicians and patients to assess their suitability and performance, and root out bias that so often skews their results…
Like the many documents of its kind, the coalition’s blueprint is merely a proclamation — a set of principles and recommendations that are eloquently articulated but easily ignored. The group is hoping that its broad membership will help stir a national conversation and concrete steps to start governing the use of AI in medicine. Its blueprint was built with input from Microsoft and Google, MITRE Corp, universities such as Stanford, Duke and Johns Hopkins, and government agencies including the Office of the National Coordinator for Health Information Technology, the Food and Drug Administration, National Institutes of Health, and the Centers for Medicare & Medicaid Services.”
Augmented Reality and Virtual Reality in Medical Devices A great review of the subject from the FDA.