About Covid-19
Pfizer, BioNTech ask FDA to authorize coronavirus vaccine for children 5 to 11: ”U.S. pharmaceutical firm Pfizer and its German partner, BioNTech, have asked the Food and Drug Administration to authorize their coronavirus vaccine for emergency use for children 5 to 11 years old, the companies announced Thursday.
An estimated 28 million children in the United States would be eligible for the shots if regulators give the green light — a process expected to take several weeks. The coronavirus vaccine would be the first available in this country for children younger than 12 years old.”
Covid-19 booster shots have outpaced the US rate of new vaccinations. And the millions still unvaccinated could trigger 'future waves,' expert warns: “An average of 384,963 booster vaccine doses are being given daily, while roughly 281,303 people are getting their first dose every day and about 292,927 people are becoming fully vaccinated each day, according to Wednesday's CDC data.”
3 Ways to Make Sure That Your N95 Isn't Counterfeit: Among the recommendations: “Check the labeling on your N95 respirator.
The following is printed on every NIOSH-approved respirator: the word ‘NIOSH’ in visible in block letters along with the Testing and Certification (TC) approval number and a model number. This information must be on the respirator itself and not just on the packaging.”
Clotting linked to AstraZeneca vaccine could relate to specific blood group, suggests study: “Researchers in the UK say they have identified the first genetic link which could make people vaccinated with AstraZeneca's COVID-19 vaccine Vaxzevria more predisposed to cerebral venous thrombosis (CVT), reported The Telegraph…
When adjusting for other factors, people with an AB blood type had a 5.6 times increased risk of CVT, the researchers said.
Blood groups A and B both had almost a three times increased risk of CVT compared to blood group O, according to the news source.”
About the public’s health
Federal judge blocks enforcement of Texas abortion ban; state will appeal: “U.S. District Judge Robert L. Pitman granted the Biden administration’s request to temporarily halt the law, clearing a path to restore access to abortion in the nation’s second-most populous state.”
But the Texas attorney general’s office quickly notified the court of its intent to appeal.CDC director warns the U.S. is at risk of a severe flu season this year: The “U.S. population may now have reduced immunity against influenza after seasonal flu cases reached an all-time low last year when large parts of the nation were shut down, Walensky told reporters during a White House press briefing.”
Characterizing the Chemical Landscape in Commercial E-Cigarette Liquids and Aerosols by Liquid Chromatography–High-Resolution Mass Spectrometry: Vaping is more dangerous than we thought. “Previous studies have focused on measuring known toxicants, particularly those present in traditional cigarettes, while fewer have investigated unknown compounds and transformation products formed during the vaping process…
Six potentially hazardous additives and contaminants, including the industrial chemical tributylphosphine oxide and the stimulant caffeine, were identified and quantified in the e-cig liquids and aerosols analyzed.”
A Hyde fight threatens Democrats' Medicaid ambitions: The Hyde Amendment bars using federal funds for abortions in most circumstances. Today’s The Health 202 in the Washington Post provides a great explanation of what is happening with that provision in current law making.
About healthcare IT
Medtronic releases urgent recall for insulin pump vulnerable to hackers: “Medtronic said hackers could potentially deliver or block doses of insulin, which poses a danger for the wearer, according to an October news release.”
CHIME names 2021 'Most Wired' hospitals: “The College of Healthcare Information Management Executives has recognized 107 hospitals as achieving Level 9 status in its 2021 Healthcare's Most Wired program.”
VR can help underserved patients, but reimbursement challenges stymie broader adoption, study finds: “Studies have shown that VR can be an effective treatment for opioid-sparing pain management, but the majority of these studies were conducted among primarily White, relatively advantaged populations and in well-resourced settings, according to a research team from AppliedVR and S.O.L.V.E. Health Tech, a health equity incubation partner embedded within the University of California, San Francisco (UCSF)…
However, significant barriers exist to expand access to less-served and more diverse patient populations, according to the team's research published in the Journal of Medical Internet Research.
Healthcare providers, including users and non-users of VR, identified a lack of reimbursement for the technology as one of the biggest barriers for adoption…”
About hospitals and health systems
HCA shrinks Georgia footprint, sells 5 hospitals for $1.6B: “Though HCA's footprint in Georgia is smaller after selling the five facilities for a combined $1.58 billion, the company still operates five hospitals in the state. The system added a hospital in the southeast part of the state in May when it acquired Meadows Regional Hospital in Vidalia.”
Top 10 most trusted health system brands: “Johns Hopkins Medicine had the most trusted health system brand in the U.S., according to research released by branding agency Monigle.
In partnership with the American Hospital Association and Society for Health Care Strategy and Market Development, Monigle surveyed 30,138 respondents who were the healthcare decision-makers for their household.”
The whole report is interesting and worth downloading.
M&A Quarterly Activity Report: Q3 2021: “A total of 7 transactions involving 20 hospitals were announced in Q3. Total transacted revenue for the quarter was $5.2 billion; combined with Q1 and Q2, total transacted revenue for 2021 is now at $22.4 billion. Average seller size by revenue year-to-date was $659 million, more than double the average of $329 million over the past six years (2015–2020). Of note, the total revenue transacted year-to-date is nearly on par with that of years past, despite only half (or even less) of the total transaction volume. We believe that the trend of high average seller size will continue into Q4 as larger health systems look to partner to overcome adverse effects from the COVID-19 pandemic and seek strategic combinations that broaden their reach.”
In a related article: Chamber of Commerce, AHA press Congress to stay away from merger framework: “The U.S. Chamber of Commerce and the American Hospital Association (AHA) led a major effort to convince Congress to not change how the federal government scrutinizes mergers.
The letter (PDF), also signed by biotech and technology groups, urges Congress to provide more resources to federal agencies for antitrust enforcement rather than make any changes to the legal and regulatory framework for evaluating deals. The letter, dated Tuesday, comes as the Federal Trade Commission (FTC) has ramped up its scrutiny of hospital mergers over concerns they increase prices and decrease quality.”
Upcoding continues to drive cost recovery, according to industry executives: “According to the Market Surveillance and Transparency Committee of the Massachusetts Health Policy Commission, hospitals coded for about 2 out of 5 patients with the highest severity levels – the third and fourth severity levels – in 2020, up from about one in four patients in 2013….there was no corresponding increase in chronic disease prevalence, age or life expectancy to explain this increase, data from the Center for Health Information and Analysis show.
‘We ran a series of analyzes to see if there were any population-wide factors that could explain the rise in risk scores, but in fact they are not,’ – David Auerbach, senior director of research and spending at Massachusetts Health. The Policy Commission said Wednesday at its market surveillance meeting, noting that an aging population explains only about 0.5% of the 11.7% increase in risk assessment from 2013 to 2018. There have been no changes in life expectancy or the overall burden of chronic disease, it added.”
About health insurance
'Surprise Bill' Arbitrators Should Not Send Surprise Bills: Regulators: “Certified independent dispute resolution entities are supposed to arbitrate disputes between health insurers and health care providers over out-of-network emergency care bills and certain other out-of-network bills.
Some states already have comparable versions of the No Surprises Act arbitration system in place.
Federal officials believe typical arbitrators participating in the state No Surprises systems are charging $300 to $600 per arbitration.”
Specifically, the document says: “The certified IDR [Independent Dispute Resolution] entity may not charge a fee that is beyond the upper or lower limits for fees set forth in annual guidance published by the Departments as approved fixed fees, unless the IDR entity or certified IDR entity requests and can provide justification for the higher or lower fee, and the Departments provide written approval for the certified IDR entity to charge a fee beyond the upper or lower limits for fees set forth in guidance.”
The final amounts set may drive the amounts over which payers or providers choose to formally mediate.
Insurers, employers say New York prior authorization suspension will up healthcare costs: In a followup to a previously-reported post:
”New York insurers and employers are bracing for the impacts of Gov. Kathy Hochul's sweeping measures to address hospital staffing shortages by waiving prior authorizations, among other requirements.
Lev Ginsburg, senior director of government affairs for The Business Council of New York State, told the Niagara Gazette that he anticipates the lack of a ‘check and balance’ provided by prior authorizations will drive up state healthcare costs.”
About pharma
FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs: “Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug. The FDA is continuing our efforts to help preserve access to compounded drugs for patients who have a medical need for them…
We are proposing a two-part compliance policy. The policy describes circumstances under which the agency generally does not intend to take action against a hospital or health system pharmacy, that is not an outsourcing facility, that compounds and distributes a drug without first receiving a valid prescription or order for an individual patient. These circumstances include that compounded drugs be administered only to patients within the hospital or health system and the drugs are used or discarded within 24 hours of leaving the pharmacy.”