Fauci plans to step down in December after half a century in government “Anthony S. Fauci, the nation’s preeminent infectious-disease expert who achieved unprecedented fame while enduring withering political attacks as the face of the coronavirus pandemic response under two presidents, plans to step down in December after more than a half-century of public service, he announced Monday.
Fauci, 81, has led the National Institute of Allergy and Infectious Diseases since 1984. He joined the parent agency, the National Institutes of Health, in 1968 as a 27-year-old doctor who had just finished medical residency and was quickly identified as a rising star…
Fauci emphasized that he is not exiting the public square. He said he hopes to teach, lecture, write — perhaps a book, along with essays and other types of writing — and use his experience to inspire and teach a younger generation of scientists.”
About Covid-19
Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine “Pfizer Inc. and BioNTech SE today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine to address the continued evolution of SARS-CoV-2. Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.”
Creating a Roadmap for the End of the COVID-19 Public Health Emergency “CMS has developed a roadmap for the eventual end of the Medicare PHE waivers and flexibilities, and is sharing information on what health care facilities and providers can do to prepare for future events. Similar to the guidance CMS has made available to states, CMS is releasing fact sheets that will help the health care sector transition to operations once the PHE ends, whenever that may occur….
The fact sheets we are releasing… summarize the current status of Medicare Blanket waivers and flexibilities by provider type as well as flexibilities applicable to the Medicaid community.”
Everyone over 12 expected to be eligible for new boosters, White House official says The headline is the story.
FDA authorizes Novavax Covid-19 vaccine for emergency use in ages 12-17 The headline is the story.
About health insurance/Costs
REQUIREMENTS RELATED TO SURPRISE BILLING: FINAL RULES Fact Sheet from the Department of Labor
An early look at what is driving health costs in 2023 ACA markets “We find that insurers in this market are proposing to raise premiums by more than in recent years. The median proposed premium increase is 10% across these 72 insurers. The main contributor to premium growth is health cost trend, which reflects rising prices paid to providers and pharmaceutical companies as well as a rebound in utilization. While our analysis focuses on the ACA markets, the main premium drivers we identified (prices and utilization) are systemic and not specific to the ACA markets.”
Aon: U.S. Employer Health Care Costs Projected to Increase 6.5 Percent Next Year “Average costs for U.S. employers that pay for their employees' health care will increase 6.5 percent to more than $13,800 per employee in 2023, according to Aon…
This projection is more than double the 3 percent increase to health care budgets which employers experienced from 2021 to 2022; but is significantly below the 9.1 inflation figure reported through the Consumer Price Index…
Medical claims were suppressed for most employers during the first year of the COVID-19 pandemic, during which time much care was postponed or skipped during quarantines. Employers have seen the medical claims experience return to more typical levels of growth and anticipate inflationary cost pressures in the coming year.”
CMS Releases Proposed Rule to Improve Medicaid & CHIP Quality Reporting Across States “This rule proposes requirements for mandatory annual state reporting of three different quality measure sets:
the Core Set of Children’s Health Care Quality Measures for Medicaid and CHIP;
the behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid; and
the Core Sets of Health Home Quality Measures for Medicaid.
These Core Sets are designed to measure the overall national quality of care for beneficiaries, monitor performance at the state level, and improve the quality of health care.”
About hospitals and healthcare systems
Failed Medicaid expansion negotiations reveal N.C. hospitals' might The expansion had bipartisan support, but the state hospital association successfully quashed the effort because in contained a provision pulling back on the certificate of need (CON)law; in other words, it could have increased competition for hospitals.
For an update of CON laws, see: Certificate of Need (CON) State Laws
About pharma
Pharma ad spending up just 1% this year as the slow move away from TV into digital continues For “the first six months of 2022, the pharma industry spent $5.5 billion on all ads for its products, most of which was on its drug products.
While that’s a huge figure, it actually represents a slow drop in growth from previous years, with only a slight 1% lift during January to June 2022 versus the same time last year.
Ad spend for prescription drugs, which accounts for 88% of pharma category dollars ($4.8 billion), in fact fell 2% year on year. On the other hand, ad expenses for over-the-counter medicines and remedies jumped 23% during the same period.“
FDA accepts Astellas menopause drug NDA “Tokyo-based Astellas Pharma announced this week that the U.S. FDA has accepted its New Drug Application for fezolinetant, an investigational new drug for the treatment of menopause-associated symptoms such as hot flashes or night sweats.
The indicated PDUFA date is February 22, 2023, as Astellas is also employing a priority review voucher. The NDA acceptance hinged on three phase 3 trials which enrolled 2,800 women from across the U.S., Canada and Europe. The trials evaluated the efficacy and safety of the drug for the treatment of moderate to severe vasomotor symptoms (VMS) caused by menopause or sex-related hormone disorders.”
However, this March: Astellas' menopause drug suffers rare setback as failed Asian trial blots previously pristine record “Astellas’ $550 million bet on menopause drug fezolinetant has hit unexpected turbulence. After acing a pair of phase 3 clinical trials and racing to regulators, Astellas has reported the failure of fezolinetant to beat placebo in a late-stage study of patients in Asia.”
This case highlights the vagaries of the FDA approval process.
About the public’s health
The global burden of cancer attributable to risk factors, 2010–19: a systematic analysis for the Global Burden of Disease Study 2019 “The leading risk factors at the most detailed level globally for risk-attributable cancer deaths and DALYs in 2019 for both sexes combined were smoking, followed by alcohol use and high BMI. Risk-attributable cancer burden varied by world region and Socio-demographic Index (SDI), with smoking, unsafe sex, and alcohol use being the three leading risk factors for risk-attributable cancer DALYs in low SDI locations in 2019, whereas DALYs in high SDI locations mirrored the top three global risk factor rankings.”
Low-temperature mineralization of perfluorocarboxylic acids “Per- and polyfluoroalkyl substances (PFAS) are persistent, bioaccumulative pollutants found in water resources at concentrations harmful to human health. Whereas current PFAS destruction strategies use nonselective destruction mechanisms, we found that perfluoroalkyl carboxylic acids (PFCAs) could be mineralized through a sodium hydroxide–mediated defluorination pathway. PFCA decarboxylation in polar aprotic solvents produced reactive perfluoroalkyl ion intermediates that degraded to fluoride ions (78 to ~100%) within 24 hours.”
A potentially low-cost, effective means to address this important solution problem.
WHO says monkeypox vaccine ‘not a silver bullet’ as breakthrough cases reported “There is limited data on the efficacy of the vaccine, and what is available has been drawn from animal studies. The main study used to indicate efficacy dates back to the 1980s and looked at a different type of smallpox vaccine — potentially more powerful than the safer vaccines that have since been developed. That study showed 85 percent protection against monkeypox.”
High-Contact Object and Surface Contamination in a Household of Persons with Monkeypox VirusInfection — Utah, June 2022 “Monkeypox virus DNA was detected from many objects and surfaces sampled indicating that some level of contamination occurred in the household environment. However, the inability to detect viable virus suggests that virus viability might have decayed over time or through chemical or environmental inactivation. Although both patients were symptomatic and isolated in their home for >3 weeks, their cleaning and disinfection practices during this period might have limited the level of contamination within the household. These data are limited, and additional studies are needed to assess the presence and degree of surface contamination and investigate the potential for indirect transmission of Monkeypox virus in household environments.”
About healthcare IT
NIH ANNOUNCES 4 TELEHEALTH RESEARCH CENTERS OF EXCELLENCE FOR CANCER CARE “The National Institutes of Health's National Cancer Institute (NCI) has designated four health systems as national centers for excellence for their work in using telehealth to improve cancer treatment and care management. The four programs will split $23 million over the next five years to establish the NCI's Telehealth Research Centers of Excellence (TRACE) initiative, which is being supported by the Cancer Moonshot, launched in 2016 and restarted earlier this year by President Joe Biden.”
In 2019, less than one in five primary care physicians electronically exchanged (i.e., sent or received) health information with PHAs.
Nearly half of primary care physicians reported electronically searching or querying for vaccination or immunization history from sources outside their health care organization.
Most physicians electronically recorded social and behavioral determinants of health data.
Physicians who engaged in interoperability were more likely to electronically: exchange information with PHAs; search for vaccination information; and record social and behavioral determinants of health data.
Certified health IT use is associated with higher rates of electronic public health reporting and electronic recording of social and behavioral determinants of health data.
Public health reporting and recording capabilities varied by EHR developer market share…
In 2019, about one in ten (12%) office-based physicians nationally electronically exchanged patient health information with PHAs, including the Centers for Disease Control and Prevention (CDC), state or local public health authorities..
Electronic exchange capabilities were higher among primary care physicians (18%) compared to physicians nationally, ranging from 12% of general/family practice primary care physicians to 24% of internal medicine and 26% of pediatric primary care physicians.
Overall, about a quarter of physicians nationally did not know whether their practice electronically exchanged patient health information with PHAs.”
More than 80 health systems hit by cybersecurity breaches in August FYI
About healthcare personnel
CommonSpirit readies launch of nation’s largest nursing residency program According to CEO Wright Lassiter: “ We’re creating this inner nationwide staffing company to create a platform whereby nurses can work in 21 states with out having to depart the employer, with out having to lose seniority, with out being outdoors the profit and mission halo of the group.”
About health technology
Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy Read the FDA notice about this Class 1 recall.
And in a related article: Medical Device Recalls Hit Two-Year Record in Q2 “Medical device recalls reached their highest level in two years during the second quarter of 2022 with 268 events, a 34 percent increase from the 200 recalls in the first quarter…”