About Covid-19
Pfizer says its COVID-19 vaccine is 100% effective in children ages 12-15: “In a placebo-controlled trial of 2,260 adolescents, none of the participants who received the real vaccine developed COVID-19, the companies said.
Eighteen adolescents who received placebo, or fake, doses became infected with the virus, they said.”
The numbers are still small but consistent with the robust immune responses in younger persons.
Coronavirus: Nations call for independent probe into virus origin: “A group of 14 countries including the US, UK, Japan, Canada and Australia issued a joint statement on Tuesday that expressed “shared concerns” over the World Health Organization’s study on the origins of the coronavirus outbreak and called for an independent probe
The countries voiced concerns that the ‘international expert study on the source of the Sars-Cov-2 virus was significantly delayed and lacked access to complete, original data and samples.’”
WHO site visitors insist their Chinese hosts were transparent and forthcoming, but other nations are not convinced.
Johnson & Johnson COVID- 19 Vaccine Manufacturing Error Affects 15 Million Doses:”Amanufacturing error at a plant involved in COVID-19 vaccine production affected 15 million doses worth of an ingredient for Johnson & Johnson’s vaccine, according to two sources familiar with the matter, but the company downplayed the situation and said it met its most recent vaccine delivery target…
“This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process, J&J said.”
CDC director says data 'suggests that vaccinated people do not carry the virus': “CDC director Rochelle Walensky said data suggests fully vaccinated people don't carry COVID-19.” However, Two-thirds of epidemiologists warn mutations could render current COVID vaccines ineffective in a year or less
Justice Department Takes Action Against COVID-19 Fraud-Historic level of enforcement action during national health emergency continues: “As of [Friday], the Department of Justice has publicly charged 474 defendants with criminal offenses based on fraud schemes connected to the COVID-19 pandemic. These cases involve attempts to obtain over $569 million from the U.S. government and unsuspecting individuals through fraud and have been brought in 56 federal districts around the country. These cases reflect a degree of reach, coordination, and expertise that is critical for enforcement efforts against COVID-19 related fraud to have a meaningful impact and is also emblematic of the Justice Department’s response to criminal wrongdoing.”
Each new crisis creates new opportunities to commit fraud.
Humanigen's COVID-19 phase 3 hits goal, sending stock soaring: “A phase 3 clinical trial of Humanigen’s lenzilumab in hospitalized COVID-19 patients has met its primary endpoint. Humanigen plans to use the data to seek emergency use authorization from the FDA.
Lenzilumab targets GM-CSF, a cytokine associated with negative outcomes in COVID-19 patients. By neutralizing the cytokine, drug developers including Humanigen and GlaxoSmithKline have predicted that they may be able to counter life-threatening complications that arise when the immune system reacts particularly strongly to the virus.”
COVID-19's fourth wave is hitting the US hard: “The United States has reported an average of 65,000 new cases in the last seven days, according to data from the Centers for Disease Control and Prevention (CDC), up about 10,000 cases per day since the most recent nadir two weeks ago.
Those figures are well below the January apex of the third wave of infections, when a quarter-million people a day were testing positive for the virus.”
Covid Vaccine Hesitancy Drops Among All Americans, New Survey Shows: “A new poll of attitudes toward covid vaccinations shows Americans are growing more enthusiastic about being vaccinated, with the most positive change in the past month occurring among Black Americans.
About 55% of Black adults said they had been vaccinated or plan to be soon, up 14 percentage points from February, according to a poll released Tuesday by KFF. The rate now approaches that of Hispanics, at 61%, and whites at 64%. (Asian Americans were not polled in sufficient numbers to compare their responses with other racial and ethnic groups.)
But the poll found that 13% of respondents overall said they will ‘definitely not’ be vaccinated, signaling that significant hurdles remain in the nation’s vaccination campaign. (KHN is the editorially independent newsroom of KFF, an endowed nonprofit organization providing national information on health issues.)
Among all groups, Republicans and white evangelical Christians were the most likely to say they will not get vaccinated, with almost 30% of each group saying they will ‘definitely not’ get a shot.”
T cells induced by COVID-19 infection respond to new virus variants -U.S. study: “‘Our data, as well as the results from other groups, shows that the T cell response to COVID-19 in individuals infected with the initial viral variants appears to fully recognize the major new variants identified in the UK, South Africa and Brazil,” said Andrew Redd of the NIAID and Johns Hopkins University School of Medicine who led the study.”
Germany suspends use of AstraZeneca’s Covid shot for the under-60s, dealing another blow to drugmaker: “Germany has suspended use of the coronavirus vaccine created by AstraZeneca and the University of Oxford in the under-60s, due to renewed concerns over reports of blood clots.” And in a related story: Amid rollout imbroglio, AstraZeneca's COVID vaccine has at least one fresh start: A new brand name: “AstraZeneca’s COVID-19 vaccine has an official name, Vaxzevria, now approved in Europe. But is a new name enough to hurdle its rollout communication glitches and now wavering vaccine confidence?”
Digital papers, please? New York becomes first state to roll out IBM's digital COVID-19 vaccine passport: IBM and New York state launched the Excelsior Pass. “Built on the tech giant’s Digital Health Pass platform, it combines a smartphone wallet app for individual use and a scanner app for businesses. The official launch comes after two pilot programs and a beta test proved its efficacy.”
Debates about HIPAA compliance fall on the side of this types of proof card does not violates theses laws.
White House weighs temporarily lifting intellectual property shield on Covid-19 vaccines: “The White House is weighing whether to suspend intellectual property protections for Covid-19 vaccines and treatments, in response to pressure from developing nations and subsequent support from progressive lawmakers, according to three sources familiar with the matter.
A temporary suspension of intellectual property protections would apply to all medical technologies to treat or prevent Covid-19. South Africa and India made a formal request to the World Trade Organization to waive the protections until the pandemic is over, but the issue was tabled without a resolution.”
Mentioned in previous blogs, the concept is called a “compulsory license” or “walk in” rights.
About health insurance
CMS to pause Medicare payments until Congress passes sequester fix next month: “The Biden administration is temporarily holding Medicare claims with service dates on or after April 1 to ensure providers aren't impacted by a 2% cut to payments set to go back into effect on that date…
The agency also notified Medicare Advantage and Part D plans that ‘CMS will resume standard sequestration reductions beginning with April 2021 payment for Medicare Advantage organizations and Prat D sponsors.’”
Epic, Humana ramp up partnership to focus on streamlining prior authorizations: “In this next phase of the collaboration, EHR vendor Epic and Humana will connect their software to manage prior authorizations electronically and make Humana member information available to providers at the point of care, the companies said.”
It is amazing that something so needed took so long to be recognized and developed.
As Medicare Advantage Enrollment Booms, Healthcare Entities Need to Plan Around Key Trends: Chartis’ 2021 Medicare Advantage Competitive Enrollment Report. Among the findings:
“Medicare Advantage grew 9.6 percent this year, while enrollment in Original Medicare fell 2.6 percent, pushing Medicare Advantage penetration to 42 percent[up from 32% five years ago],
For-profit plan growth continues to outpace Blue and non-profit plans. For-profit plans now account for 71 percent of all enrollees, up from 69 percent last year.
Among for-profit plans, UnitedHealthcare and Centene saw the greatest gains, adding 1.6 million lives between the two, and pushing their combined share up 4 points.”
The article also ranks top MA plans based on enrollment (United is #1)
Medicare Advantage beneficiaries save more money on out-of-pocket costs than Medicare fee-for-service: This research shows why the popularity of these plans continues to grow. “Beneficiaries in MA reported out-of-pocket and premium spending of $3,354 a year in 2018, compared with $4,994 in fee-for-service, the analysis added. That was a $42 increase since 2017.”
Here are the payment models the Biden administration has pulled for review or delayed: A good review of this topic.
DOJ taking a closer look at Optum-Change deal amid antitrust concerns: “The Department of Justice (DOJ) is digging further into UnitedHealth Group's planned $13 billion acquisition of Change Healthcare…The deal was first announced in January, with UnitedHealth saying it would purchase the revenue management company for $7.84 billion in cash and $5 billion in debt. The healthcare giant intends to fold it into its Optum subsidiary.”
About healthcare IT
Digital health's top 10 money raisers in 2021—so far: FYI
Why experts say the information blocking ban will be game changing for patients: “Starting next week, a new regulation goes into effect that will give patients easier access to their digital health records through their smartphones.”
Assessment of Diagnosis and Triage in Validated Case Vignettes Among Nonphysicians Before and After Internet Search: “Results of this study suggest that, contrary to concerns of its harmfulness, an internet search was associated with modest improvements in diagnosis but had no association with triage.”
About pharma
Pumped by a big year for its flu shots, Sanofi lays out €600M for new vaccine manufacturing plant: “The French drugmaker plans to splash out €600 million to build a new flu vaccine factory in Toronto to increase supply of its Fluzone High-Dose vaccine. The plant will turn out the vaccine, which contains four times more antigen than standard-dose vaccines, for Canada, the U.S. and Europe.”
In the current and post-Covid-19 eras, vaccines are recognized as valuable (and profitable) products.
Characteristics of Copayment Offsets for Prescription Drugs in the United States: Offsets are “coupons, vouchers, and other types of copayment… that reduce patients’ out-of-pocket drug spending...
In this analysis of patient-level pharmacy claims from 2017 to 2019, approximately half of all offsets involved pharmacy-PBM contractual arrangements, and half were offered by manufacturers. All offsets were associated with a significant reduction in patients’ out-of-pocket costs, were highly concentrated among a few drugs, and were generally not more generous among individuals in counties with lower income or larger Black or uninsured populations.”
The top 20 pharma companies by 2020 revenue: FYI
Novartis Can Provide CAR-T Therapy for Free, OIG Says: “HHS’ Office of Inspector General (OIG) said Novartis is free to pay for low-income patients to receive its pricey CAR-T therapy Kymriah (tisagenlecleucel), and those payments will not be considered illegal.
OIG told Novartis that while payments for the $475,000 one-time gene therapy could in theory compel doctors or treatment centers to use the treatment or influence patients to choose it, patients are able to get the drug at many different healthcare centers so they would be unlikely to accept the payment simply to get the drug at one specific place or from one specific doctor.”
The issue here is illegal inducement.
About the public’s health
Births: Final Data for 2019: Yes, this data is the latest published and has a wealth of information.
”A total of 3,747,540 births were registered in the United States in 2019, down 1% from 2018. The general fertility rate declined from 2018 to 58.3 births per 1,000 women aged 15–44 in 2019. The birth rate for females aged 15–19 fell 4% between 2018 and 2019. Birth rates declined for women aged 20–34 and increased for women aged 35–44 for 2018–2019. The total fertility rate declined to 1,706.0 births per 1,000 women in 2019. Birth rates declined for both married and unmarried women from 2018 to 2019.”
Declines in Prevalence of Human Papillomavirus Vaccine-Type Infection Among Females after Introduction of Vaccine — United States, 2003–2018: Latest report on this subject form the CDC. “Nationally representative data through 2018 indicate that HPV vaccine-type prevalence continues to decline among females aged 14–19 (88%) and 20–24 (81%) years compared with before vaccination. The findings also show evidence of indirect protection of unvaccinated females through herd effects in these age groups.”
2021's Most & Least Stressed States: Topping the list of most stressed is Nevada. Least stressed is South Dakota. Check the rankings for further states.
Secondhand Smoke Is Sending Kids to the ER: “Compared to other kids, those exposed to secondhand smoke were more likely to have had an urgent care visit over a one-year period, and to incur higher costs for such visits. They also were nearly twice as likely to be admitted to the hospital.”
Do we need yet another reason to ban smoking?
Black Patients Are More Likely Than White Patients to Be in Hospitals with Worse Patient Safety Conditions: “Black patients experienced higher rates of adverse patient safety events on 6 of 11 patient safety measures, including 5 of 7 surgery-related patient safety measures. For 9 of 11 patient safety indicators, including 6 of 7 surgery-related patient safety indicators, Black patients were significantly less likely to be admitted into hospitals classified as “high quality” (i.e., hospitals best at minimizing patient safety risks based on the median value of each patient safety indicator). These findings suggest that current policies aimed at reducing adverse patient safety events have been ineffective in addressing inequities in the quality of inpatient care. “
The question now is why black patients need to go to those hospitals. Obviously, proximity is a major factor. This research would make a great discussion topic to root out the “why’s” and offer solutions.
About healthcare professionals