FDA authorizes second coronavirus booster shot for people 50 and older: “The Food and Drug Administration on Tuesday authorized a second booster shot of the Pfizer-BioNTech and Moderna coronavirus vaccines for people 50 and older, a decision intended to help shore up protection against severe illness.
The shots, which can be given at least four months after a first booster dose, are not a permanent solution to the pandemic…
The second booster is expected to become available immediately after the Centers for Disease Control and Prevention reaches a decision on who should get it.”
About Covid-19
If you got J&J vaccine, consider two mRNA booster shots, CDC data suggest: “The nearly 17 million Americans who received the one-shot Johnson & Johnson coronavirus vaccine are less protected against serious illness and hospitalizations than those who got the Pfizer-BioNTech and Moderna shots, according to federal data released Tuesday.
The latest data suggest Johnson & Johnson recipients should get a booster with one of the messenger RNA vaccines, if they haven’t already done so — and even consider a second messenger RNA booster for the greatest protection. The data come from a Centers for Disease Control and Prevention report that analyzed the results of mix-and-match vaccine-and-booster combinations during a four-month period when the highly transmissible omicron variant was dominant.”
COVID-19 tracker: Cost watchdog ICER endorses Pfizer, Merck antiviral pricing: “After reviewing the cost and efficacy of treatments from GlaxoSmithKline, Merck and Pfizer, the Institute for Clinical and Economic Review concluded that the meds "have prices reasonably aligned with patient benefits." In a statement, ICER president Steven Pearson said data show the medicines are ‘able to reduce hospitalizations among patients with mild-to moderate COVID-19 who are at high risk of progression to severe disease.’”
And in a related post: Special Assessment of Outpatient Treatments for COVID-19: “In this revised Evidence Report, ICER is presenting a full evaluation of clinical and economic outcomes of four treatments for mild-to-moderate COVID-19 among outpatients at high risk of progression to severe disease: sotrovimab, molnupiravir, PaxlovidTM, and fluvoxamine.”
Shifting Support for Some, But Not All, Covid Mandates: From a Monmouth University poll: “More than 3 in 4 Americans (77%) endorse the C.D.C. relaxing its face mask and social distancing recommendations in areas with low Covid rates. Just 34% of the public supports instituting or reinstituting face mask and social distancing guidelines in their state at the current time, which is down significantly from 52% in January. At the same time, support for requiring people to show proof of vaccination in order to work in an office or around people has held steady – 44% now and 43% in January. A majority of Democrats continue to back vaccine (69%) and mask (60%) mandates, while at the same time saying they support the C.D.C. relaxing its Covid guidance (67%).”
Read the entire article for results of extensive questioning.
About health insurance
CMS Office of the Actuary Releases 2021-2030 Projections of National Health Expenditures: This CMS posting further explains yesterday’s lead from Health Affairs.
Optum and LHC Group to Combine, Advancing Abilities to Extend Value-Based Care into Patients’ Homes: “Optum, a diversified health services company, and LHC Group…, a national patient-focused provider of high-quality in-home health care services, have agreed to combine to further strengthen their shared ability to advance value-based care, especially in the comfort of a patient’s own home. The agreement calls for the acquisition of LHC Group’s outstanding common stock for $170 per share [more than $5.5 Billion].
The combination of LHC Group with Optum Health, which works with over 100 health plans, unites two organizations dedicated to providing compassionate and comprehensive care to patients and their families. LHC Group’s history of high-quality home and community-based care matched with Optum’s extensive value-based care experience and resources will accelerate the combined companies’ ability to deliver integrated care, improving outcomes and patient experiences.”
Comment: A further vertical diversification for UnitedHealth Group through its Optum subsidiary.
Impact of the American Rescue Plan Act [ARPA] on State-Based Health Insurance Marketplaces [SBMs]: Increased Affordability and Access for Consumers: “ARPA enhanced the amount of tax credits available to marketplace consumers and extended eligibility for premium tax credits to more middle-income Americans (individuals making over $54,360 per year or over $111,000 for a family of four). Currently, these provisions are set to expire on December 31, 2022…
SBMs estimate most of their enrollees will lose financial support if the enhanced subsidies are not extended. SBMs estimate that consumers’ average spending on premiums may increase by 15-70%.v Connecticut, Minnesota, and New York estimate consumers will spend over $1,300 per year in additional premium costs.”
About hospitals and healthcare systems
Feds restore billions in halted payments to Texas hospitals, but the fight over uninsured care continues: “Federal health officials…restored $7 million a day in funding to Texas hospitals after stopping it six months ago over concerns about how the state pays for health care for uninsured Texans.
Until last September, Texas had tapped this funding, which comes through what is known as the 1115 Medicaid waiver, to reimburse hospitals for patients who use Medicaid…
But Texas had come up with its own mechanism known as the Local Provider Participation Funds, in which private hospitals set up taxing districts and sent that money through local and state governments to the U.S. Centers for Medicare and Medicaid Services.
However, after it was discovered some hospitals profited from the Medicaid payments and covered the tax for other hospitals, CMS halted the payments in September while it argued with the state over whether that LPPF system is allowed.
Whether the system violates the rules of the state’s 10-year 1115 funding agreement with CMS remains an open question.”
Comment: This funding dispute is not just a Texas issue. The method that state used to get Medicaid funds has been disputed for many years.
About pharma
Inflation caused ‘unprecedented’ drops in net pharmaceutical prices, analysis finds: “Amid ongoing turmoil over the cost of prescription medicines, a new analysis finds that brand-name drugmakers increased their wholesale prices by 4.4% in the last quarter of 2021, up slightly from 3.8% a year earlier. But when accounting for inflation, wholesale prices fell by 2.3%.
At the same time, net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — dropped by 0.7%. But after considering inflation, net prices actually fell 5.4%.”
HHS is investigating how consumers are marketed accelerated approval drugs: “Not surprisingly, most pharma companies don’t call attention to the fact that the drug has received this fast track when advertising to the consumer…
According to the submission from the HHS about the new study:
‘A content analysis of DTC websites for accelerated approval products found that 21 percent of the disclosures used language directly from the approved physician labeling, 79 percent of the disclosures used at least some medical language, but 27 percent of the websites did not include any disclosure that the products attained approval through this pathway... The same analysis found that 84 percent of accelerated approval disclosures on DTC websites mentioned the approval basis, 68 percent mentioned unknown outcomes, and 47 percent mentioned confirmatory trials.’”
Association of Glucagon-Like Peptide-1 Receptor Agonist Use With Risk of Gallbladder and Biliary Diseases: “This systematic review and meta-analysis of RCTs found that use of GLP-1 RAs was associated with increased risk of gallbladder or biliary diseases, especially when used at higher doses, for longer durations, and for weight loss.”
About the public’s health
Biden proposes $81.7 billion in spending to prepare for future pandemics: “About $15 billion in funding for vaccines, tests and treatments was stripped out of the government funding bill earlier this month and is stalled amid disputes about how to pay for it, with lawmakers seeking new ways to offset the funds.
The president’s budget calls for $40 billion for the development and manufacturing of vaccines, treatments and tests aimed at future threats.
Another $28 billion would go to the Centers for Disease Control and Prevention for surveillance, lab capacity and the public health workforce.
The National Institutes of Health would get $12.1 billion for research on vaccines and other measures, while the Food and Drug Administration would get $1.6 billion for its labs and information technology.”
Association of Habitual Alcohol Intake With Risk of Cardiovascular Disease: “Findings In this cohort study of 371 463 individuals, genetic evidence supported a nonlinear, consistently risk-increasing association between all amounts of alcohol consumption and both hypertension and coronary artery disease, with modest increases in risk with light alcohol intake and exponentially greater risk increases at higher levels of consumption.
Meaning In this study, alcohol consumption at all levels was associated with increased risk of cardiovascular disease, but clinical and public health guidance around habitual alcohol use should account for the considerable differences in cardiovascular risk across different levels of alcohol consumption, even those within current guideline-recommended limits.”
Dangerous PFAS Chemicals Are in Your Food Packaging: From Consumer Reports: “CR found 'forever chemicals' in bowls, bags, plates, and wrappers, even from some companies that say they've phased them out…
These per- and polyfluoroalkyl substances (PFAS), known as ‘forever chemicals,’ can be found not only in nonstick pans and waterproof gear but also in the grease-resistant packaging that holds your food from takeout chains and supermarkets. Packaging made with PFAS often resembles paper or cardboard—a seemingly virtuous alternative to plastic—but salad dressing and fry oil do not leak through…
CR tested multiple samples of 118 products and calculated average organic fluorine levels for each. Overall, CR detected that element in more than half the food packaging tested. Almost a third—37 products—had organic fluorine levels above 20 ppm, and 22 were above 100 ppm.
Among the 24 retailers we looked at, nearly half had at least one product above that level, and most had one or more above 20 ppm [a commonly accepted cutoff for toxicity].”
See the end of the article for fast food brand products and PFAS content.
FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs: “U.S. Food and Drug Administration announced it is requesting a total budget of $8.4 billion as part of the President’s fiscal year (FY) 2023 budget – a nearly 34% ($2.1 billion) increase over the agency’s FY 2022 appropriated funding level for investments in critical public health modernization, core food safety and medical product safety programs and other vital public health infrastructure. The request includes $3.7 billion in budget authority – including an increase of $356 million, and $3 billion in user fees – an increase of $153 million. The request also includes $1.6 billion in mandatory funding to support the FDA’s ability to prepare for future pandemics.”
About healthcare IT
Secret World of Pro-Russia Hacking Group Exposed in Leak: This article is a detailed account of how Russian-based Trickbot Group was planning to install ransomeware in 400 US hospitals during the height of the Covid-19 pandemic in 2020. Fortunately US cyber security experts and Homeland Security thwarted the effort. A Ukrainian researcher provided details of the operation.
About healthcare personnel
Find the Best Medical Schools: From US News. The first link is for research rankings, but you should look at other rankings by specialty and focus (like primary care and rural health). You can also check rankings of nursing masters programs and a variety of “allied health” offerings.
About health technology
Producing faster CAR-T cell therapy inside the body with a spongelike implant: “The researchers developed the all-in-one implant, called Multifunctional Alginate Scaffolds for T cell Engineering and Release (MASTER), to take the cumbersome CAR-T cell manufacturing steps from outside the body to the inside.
In a proof-of-concept study in a lymphoma mouse model, the researchers isolated and implanted patient-derived T cells with the MASTER platform on the same day to generate CAR-T cells inside the animals’ bodies. Compared with conventional CAR-T cells, CAR-T cells made with MASTER showed improved anticancer potency, the team reported in a study published in Nature Biotechnology.”