About Covid-19
Evusheld Likely Not Effective Against Omicron, FDA Says “The FDA has updated its fact sheet for healthcare providers for the use of AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) which is authorized for emergency use for treatment of COVID-19 infections.
The agency warned that the injectable treatment might not be able to neutralize certain SARS-CoV-2 viral variants and that Evusheld might not be effective at preventing COVID-19 caused by the variants.”
Merck Covid antiviral pill did not cut hospitalisation risk, study finds “Results from a UK pivotal trial showed that Merck & Co.'s COVID-19 antiviral pill Lagevrio (molnupiravir) failed to lower the risk of hospitalisation and death among adults at higher risk from the disease, reported Financial Times.”
APIC urges members to disregard new CDC masking guidelines “The recent relaxation of masking guidelines for healthcare professionals by the Centers for Disease Control and Prevention (CDC) seems a bit premature to one professional organization.
In fact, infection preventionists should disregard the CDC’s updated recommendation and maintain mandatory masking requirements for healthcare workers who come into contact with patients, states the Association for Professionals in Infection Control and Epidemiology (APIC) in a press release.”
Newsom signs bill to police California doctors on COVID-19 misinformation “California doctors will be subject to discipline and possible suspension of their licenses to practice for spreading misinformation about the COVID-19 pandemic to patients, following Gov. Gavin Newsom’s signature of one of the most controversial pieces of pandemic legislation lawmakers sent to his desk.
AB 2098 by Assemblyman Evan Low, D-Campbell, was co-sponsored by the California Medical Association to tamp down COVID-19 misinformation, often spread through social media, promoting untested or ineffective treatments and cures and questioning the effectiveness of face masks and vaccines.”
CDC ends daily reporting of COVID case and death data, in shift to weekly updates “After more than two years of publishing data on COVID-19 cases and deaths on a daily basis, the Centers for Disease Control and Prevention announced Thursday it would shift to weekly updates to its nationwide tracking of the virus.”
About health insurance/insurers
Readmission Reduction as a Hospital Quality MeasureTime to Move on to More Pressing Concerns? A good, thoughtful review of the topic.
Elevance Health faces Medicare Advantage fraud suit “Elevance Health is facing a federal lawsuit alleging the insurer received more than $100 million in overpayments from CMS after a judge declined to dismiss the suit, the Indianapolis Business Journal reported Oct. 5.”
Comparison of Health Care Utilization by Medicare Advantage and Traditional Medicare Beneficiaries With Complex Care Needs “Question Do rates of health care utilization for beneficiaries with complex care needs differ between traditional Medicare and Medicare Advantage (MA)?
Findings In this cross-sectional study of 1 844 326 Medicare beneficiaries, those enrolled in MA had lower rates of hospital stays, emergency department visits, and 30-day readmissions. The largest relative differences were observed for hospital stays, which ranged from −9.3% to −11.9% across different cohorts of beneficiaries with complex care needs.”
About hospitals and healthcare systems
CommonSpirit Health seeks to raise $1.5B from bond issues “CommonSpirit Health has issued a pair of bonds as it aims to raise $1.5 billion to cover past and future expenses.
Chicago-based CommonSpirit will use the proceeds to refinance prior debt, reimburse prior capital expenditures and fund general corporate purposes…”
About pharma
FDA Awards $1.3 Million Grant to Biologics & Biosimilars Collective Intelligence Consortium “The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) announced… that it has received a major grant from the Food & Drug Administration (FDA) in support of biosimilars research. The award provides $1.3 million over two years for a new BBCIC study focused on increasing the efficiency of biosimilar drug development and review.
The study—entitled "Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data to Produce Real-World Evidence"—reflects BBCIC's longstanding commitment to evaluating the safety and effectiveness of biologics, including biosimilars, through the generation of reliable, real- world data (RWD) and evidence (RWE).”
Mark Cuban Cost Plus Drug Company announces first health plan partner, Capital Blue Cross “Beginning this month, the Pennsylvania-based plan and Mark Cuban's drug company (MCCPDC) will begin to let members and community organizations know about their collaboration and how they can access low-cost drugs, according to a press release. In 2023, Capital Blue Cross members will be able to use their insurance cards at the company's online pharmacy.”
Novo Nordisk ready to submit once-weekly insulin to FDA after scoring final phase 3 win “Icodec demonstrated non-inferiority in reducing hemoglobin A1c, a measure of blood sugar, in patients with type 2 diabetes at week 52 when compared with once-daily basal insulin analogs. Specifically, participants who received Icodec saw an HbA1c reduction of 1.68% points, compared with 1.31% for patients who received once-daily basal insulins.”
HHS: Specialty drug costs up more than $300 billion since 2016 “Key takeaways:
--HHS released two reports that showed the U.S. health care system spent about $603 billion on prescription drugs in 2021.
--The cost of specialty drugs has continued to grow, increasing 43% since 2016 and representing 50% of total drug spending in 2021.
--HHS said the reports highlight the potential benefits of the Inflation Reduction Act. If the legislation had been in place from July 2021 to July 2022, at least 1,200 drugs may have been subjected to a provision that now requires manufacturers to pay Medicare rebates if they implement a price increase that is higher than drug inflation.”
US considers first over-the-counter birth control pill “Two US Food and Drug Administration advisory committees will in November consider an application by HRA Pharma, a subsidiary of Perrigo Company, to sell a previously prescription-only oral contraceptive pill over the counter. It is the first such application to be considered by the agency, which is also in talks with another company, Cadence Health, over its plan to sell contraceptive pills in the same manner.”
About the public’s health
Smoking Costs U.S. Economy Almost $900 Billion a Year “Smoking isn't only costly in terms of health risks, it also cost the U.S. economy $891 billion in 2020.
That was almost 10 times the cigarette industry's $92 billion revenue, according to the authors of a new American Cancer Society study.”
2022 National Survey: Attitudes about Influenza and Pneumococcal Disease, and the Impacts of COVID-19 “The National Foundation for Infectious Diseases (NFID) commissioned an annual survey to better understand beliefs about influenza (flu) and pneumococcal disease, as well as attitudes and practices around vaccination, including the impacts of the COVID-19 pandemic…”
Some highlights:
--"69% agree that annual flu vaccination is the best preventive measure against flu-related deaths and hospitalizations but only 49% plan to get a flu vaccine during the 2022-2023 flu season
--Of concern, about 1 in 5 (22%) who are at higher risk2 for flu-related complications said they were not planning to get vaccinated this season”
Guide to Evidence for Health-Related Social Needs Interventions: 2022 Update “This updated evidence guide is intended for users of the Return on Investment (ROI) Calculator for Partnerships to Address the Social Determinants of Health, sponsored by the Commonwealth Fund. It summarizes our most recent assessment of the evidence available for the calculator to establish a business case for sustainable financial arrangements between health care and community-based organizations serving adults with complex health and social needs.”
This monograph is an excellent resource evidence-based SDOH interventions.
About healthcare IT
Google Cloud introduces digital suite for medical imaging “Google Cloud is rolling out a set of tools specifically for digital imaging, designed to make diagnostic data more accessible and interoperable.
The company’s Medical Imaging Suite will also serve as a gateway for the development and implementation of artificial intelligence programs for quickly parsing patient scans and potentially finding hidden details.”
Call it data liberation day: Patients can now access all their health records digitally “Under federal rules taking effect Thursday, health care organizations must give patients unfettered access to their full health records in digital format. No more long delays. No more fax machines. No more exorbitant charges for printed pages.”
About health technology
Natera’s Blood Test for Ovarian Cancer Relapse Shows Promise in Study “Natera’s Signatera circulating tumor DNA (ctDNA) test outperformed the cancer antigen CA 125 test by one month and radiological imaging by 10 months in identifying patients with the highest risk of recurrence of epithelial ovarian cancer (EOC), researchers reported in the journal Gynecologic Oncology.”