About Covid-19
Federal judge overrules Texas ban on mask mandates in schools: “A federal judge ruled Wednesday that Texas Gov. Greg Abbott’s (R) ban on mask mandates in schools violates the Americans With Disabilities Act, a decision that could have national implications as several other states are embroiled in legal battles over face covering requirements for children…
Disability Rights Texas, an advocacy group, challenged the Republican governor’s ban in August, arguing that it discriminates against students with disabilities — many of whom have health conditions that put them at greater risk for severe illness or death — by forcing them to risk exposure to the coronavirus or stay home from school.”
While Texas state officials are trying to prevent disease-controlling measures: Unvaccinated 20 times more likely to die from COVID-19: Texas study: “A Texas government study found that unvaccinated people were 20 times more likely to die of COVID-19 than the fully vaccinated throughout most of September, providing further evidence backing the vaccines.
The research, published by the Texas Department of State Health Services on Monday, determined that 81.3 percent of COVID-19-related deaths between Sept. 4 and Oct. 1 occurred among unvaccinated people. In comparison, 5 percent of these fatalities occurred among the partially vaccinated, and 13.7 percent involved fully vaccinated patients.
In that time period, unvaccinated individuals in their 40s were 55 times more likely to die from COVID-19 than others who were the same age and fully vaccinated. Among those aged 75 and older, the unvaccinated were 12 times more likely to die.”
States challenge Biden’s vaccine mandate for health workers: “The lawsuit filed in a federal court in Missouri contends that the vaccine requirement threatens the jobs of millions of health care workers and could “exacerbate an alarming shortage” in health care fields, particularly in rural areas where some health workers have been hesitant to get the shots…
Joining the lawsuit were the attorneys general of Alaska, Arkansas, Iowa, Kansas, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming. All are Republicans except for Democratic Attorney General Tom Miller of Iowa, whose state is led by Republican Gov. Kim Reynolds.”
Home virus tests recalled over false positives reach 2 million kits.: “The Australian company Ellume has expanded a recall of its at-home coronavirus test because of concerns about a ‘higher-than-acceptable’ rate of false positives, the U.S. Food and Drug Administration said on Tuesday.
The recall now includes roughly two million of the 3.5 million test kits that Ellume had shipped to the United States by last month, a substantial increase from the company’s earlier estimate that about 427,000 of those kits were potentially faulty.
It is not clear how many false positives the affected tests have yielded. The issue, which the company had previously traced to a problem with one of the raw materials used in its test kits, does not affect the reliability of negative results.”
About health insurance
2021 Employer Health Benefits Survey: This annual KFF study is the best single source of information on employer-sponsored insurance. While there are many valuable details in the chapters, the overall message in the press today is: “In 2021, the average annual premiums for employer-sponsored health insurance are $7,739 for single coverage and $22,221 for family coverage. The average single and family premiums increased 4% over the past year. During this period, workers’ wages increased 5% and inflation increased 1.9%.
The average premium for family coverage has increased 22% over the last five years and 47% over the last ten years.”
TransUnion Healthcare: 2021 Sees 55% Rise in Financial Assistance Transactions: “The number of financial assistance transactions processed by TransUnion Healthcare increased 55% between September 2020 and September 2021. A new analysis from TransUnion Healthcare (NYSE: TRU) released at the HFMA Annual Conference indicates hospitals are more proactively working with patients to understand their financial needs and provide them appropriate options…
While the increased number of financial assistance transactions was likely exacerbated by the economic downturn caused by the pandemic… other factors, like hospital billing practices also played a role.”
About pharma
Current and Resolved Drug Shortages and Discontinuations Reported to FDA: The total list has 156 entries, many of which are highly-used drugs, e.g., cefazolin, cefotaxime, dexamethasone, digoxin, dobutamine, and epinephrine. Those medications are just the A through E entries!
Doctor Who Distributed Unapproved Cancer Treatment Drug Convicted of More Than Two Dozen Felony Charges: “A physician has been found guilty of 26 felony charges for fraudulently distributing an unapproved cancer treatment over a six-year period, charging up to $2,000 per bottle, the Justice Department announced today.
Benedict Liao, 81, a.k.a. ‘Wada Masao,’ and ‘Masao A. Wada,’ of Fullerton, was found guilty on Tuesday afternoon of seven counts of wire fraud, 11 counts of selling a misbranded drug and eight counts of selling an unapproved new drug…
From July 2012 through June 2014, Liao sold and distributed Allesgen at a price generally set at $2,000 per bottle, plus shipping, to customers in various states and in foreign countries, because of which he received at least approximately $850,000 in revenue. From approximately July 2014 through January 2018, Liao continued to sell and distribute additional bottles of Allesgen to customers in various states and in foreign countries, as a result of which he received additional revenue totaling approximately $765,000.”
How was he able to sell this substance for 6 years?
Vizient Calls on Industry Stakeholders to Join Alliance to End Drug Shortages: “Vizient, Inc….announced the formation of a new alliance to end drug shortages in the U.S. The End Drug Shortages Alliance will provide a forum for key stakeholders across the industry to take strategic aim at one of the health care industry’s most pressing and enduring issues.
Vizient, which connects more than half the nation's health care organizations to pharmaceutical suppliers through its contracting services, monitors more than $80 billion in pharmaceutical spend across all classes for trade. In 2019, a Vizient member survey revealed that managing drug shortages costs U.S. hospitals more than $359 million annually in labor alone.”
FDA Issues Nearly 50 Product-Specific Guidances for Generics Producer: ““The guidances provide product-specific recommendations on, among other things, the design of bioequivalence studies to support abbreviated new drug applications” (ANDAs), said the agency in a Federal Register notice published Tuesday.
Of the new and updated draft PSGs released, 13 guidances pertain to complex generic products, covering products with a complex active ingredient, formulation, route of delivery or dosage form. And more PSGs on complex generics are expected soon. On its website, the agency lists a further 69 complex generics set to receive draft guidances.”
About hospitals and health systems
100 of the largest hospitals and health systems in America | 2021: FYI
About healthcare quality
Addressing health care disparities by improving quality and safety: A new policy statement from the Joint Commission. Accreditation requirements are listed on page 7.
About healthcare devices
A decade retrospective of medical robotics research from 2010 to 2020: An excellent review of the topic.
A useful overview of the conclusions (with references left in the text): “Although the field cannot yet point to comprehensive clinical trials that show that robotic surgical procedures provide improved procedural outcomes for patients (70) or reduced procedure cost compared with nonrobotic surgery (71), a number of patient benefits have been demonstrated. These include shorter hospital stays, faster recuperation, fewer reoperations, and reduced blood transfusions (71). For surgeons, robots provide improved ergonomics, leading to reductions in neck and back pain (72) as well as hand and wrist numbness (73) with less physical and mental stress compared with direct hand-controlled procedures (74). These factors increase a surgeon’s quality of life and could potentially lengthen their career. Studies have also shown that robotics can markedly reduce radiation exposure to both the surgeon and the patient (75).”