About the public’s health
FDA clears nation's first COVID-19 vaccine: On Friday, this story was the most important one of the past week. And today: First vaccine administered in the United States: “Coronavirus vaccines were given to Americans for the first time on Monday, beginning with Sandra Lindsay, a critical care nurse at New York’s Long Island Jewish Medical Center.”
New coronavirus variant identified in England, health secretary says: “‘Britain has identified a new variant of the novel coronavirus, Health Secretary Matt Hancock said Monday, noting that it ‘may be associated with the faster spread in the south of England.’
Officials have linked more than 1,000 cases to the variant, according to an initial analysis, and ‘numbers are increasing rapidly,’ Hancock said.
’I must stress at this point that there is currently nothing to suggest that this variant is more likely to cause serious disease, and the latest clinical advice is that it’s highly unlikely that this mutation would fail to respond to a vaccine,’ he said.”
HHS rolls $250M ad campaign with Fauci, science focus front and center: “The ‘Tell Me More digital video campaign kicks off the delayed and then restarted Department of Health and Human Services (HHS) effort initially bid-out in September. In the opening video, Fauci reassures that with science and public health tools the pandemic will end, while additional videos dive into details of the science of the virus and vaccine development.”
This strategy may work in some population segments, but research has shown that no matter how well the science is explained, it will not convince some people of the vaccine’s necessity. Campaigns need to take into account the unique cultural experiences of certain groups when crafting the messages.
Getting Covid Vaccines to People Will Cost States Billions They Don’t Have: ”The federal government is providing the vaccine, along with syringes, needles, face masks and shields. But state leaders say they must hire medical workers, provide community outreach and education, set up vaccination clinics and ensure storage capacity for vaccines. Some states are also concerned about having enough supplies, such as gloves and gowns, to protect health-care workers as well as people getting vaccinated.”
New Zealand lifts all Covid restrictions, declaring the nation virus-free: The headline speaks for itself. Always good to be reminded about how success can be achieved.
Australia Scraps COVID-19 Vaccine Supply Deal With CSL: “The Australian government has scrapped a supply deal with CSL for 51 million doses of its COVID-19 vaccine co-developed with the University of Queensland, after trial participants falsely tested positive for HIV.”
A good example why vaccines need extensive testing. However, what if this vaccine were the only one that was proven to be effective?
About pharma
AstraZeneca to buy Alexion for $39 billion as part of immunology push: “AstraZeneca indicated that upon closing of the transaction, which is scheduled to complete in the third quarter of next year, it will form a dedicated rare disease unit to be headquartered in Boston, Massachusetts. The UK drugmaker noted that the unit will be led by members of Alexion's current senior management team.
The price of the purchase represents a premium of around 45% to Alexion's closing share price on December 11.”
Hospitals and Pharmacists File Lawsuit Over Drug Companies’ Refusals of 340B Discounts: “Five national hospital organizations and an organization of hospital pharmacists representing participants in the 340B drug pricing program filed a federal lawsuit today against the U.S. Department of Health and Human Services (HHS) over the department’s failure to enforce program requirements and halt drug company actions that undermine the program. The groups are joined in the lawsuit by three 340B hospitals serving patient communities in need that have been harmed by the companies’ refusals to provide discounts on prescription drugs dispensed at community-based pharmacies, as required by the 340B program.”
The top 10 R&D programs laid to rest in 2020: Throughout the year many articles are written about promising new drug therapies. Here is a list of the top ten that did not make it. And at the successful end of the process: Recommendations for 15 new drugs lead decisions from CHMP's [European Medicines Agency's Committee for Medicinal Products for Human Use] meeting
About health insurance
Health insurers balk at last-minute deal in Congress on surprise medical bills: “The Democratic and Republican leaders of three House committees and one Senate committee said this weekend they agreed on an approach [this link has a chart with the important provisions of this proposal] to resolving surprise medical bills, opening the door to include it in the government funding package Congress is trying to finalize this week…
Under the measure, an independent arbiter would settle disagreements between providers and insurers over how much to pay for surprise medical bills. Insurers and patient groups, who argue this would favor doctors, had instead wanted payments tied to median in-network rates, in what’s known as a ‘benchmarking’ approach.”
If this legislation passes, it could be the first step to a de facto regionally based, uniform fee schedule.
About hospitals and health systems
Moody's - 2021 outlook for US not-for-profit and public healthcare sector remains negative on constrained revenue, rising costs: Among the report’s findings:
“Median operating cash flow will drop 10%-15% in 2021 from Moody's annualized third-quarter 2020 estimate
Softer demand for certain services due to coronavirus fears will continue until pandemic ends”
Fall 2020 Leapfrog Hospital Safety Grade: This link provides access to hospitals across the country and how they fared with respect to multiple quality criteria. For a “big picture,” see: Where are the 29 Leapfrog straight-'A' hospitals? and Where are the 16 Leapfrog 'F' hospitals?”
About medical devices
TGA Releases New Regulations on Personalized Medical Devices: “Australia’s Therapeutic Goods Administration (TGA) has released new regulatory requirements for personalized medical devices that will become effective Feb. 25, 2021.
The TGA said that increasing use of 3D printing for medical applications is raising questions about the adequacy of the current medical device regulatory framework to mitigate the risks to patients.”
Here is the original proposal the TGA published last year. It could serve as a template for the way we handle this issue in the U.S.
About healthcare IT
Microsoft rolls out COVID-19 vaccine management platform as nationwide distribution gets: underway: “The tech giant is working with business partners including Accenture, Avanade, EY, and Mazik Global to deploy vaccine management solutions that enable registration capabilities for patients and providers, phased scheduling for vaccinations, streamlined reporting, and management dashboarding with analytics and forecasting…”
Assessment of Electronic Health Record Use Between US and Non-US Health Systems: “In this cross-sectional study of the EHR metadata of 371 health systems in the US and abroad, US clinicians vs non-US clinicians were found to spend more time per day actively using the EHR, receive more system-generated messages, write a higher proportion of automatically generated note text, and spend more time using the EHR after hours.
Findings from this study suggest that US clinicians compared with non-US clinicians had a higher EHR burden, which could be alleviated by minimizing EHR uncertainties and consolidating documentation requirements.”