About Covid-19
Nearly 15 million deaths related to covid-19, WHO estimates “The coronavirus pandemic led to nearly 15 million excess deathsworldwide, according to a new estimate by the World Health Organization, including people who died from covid-19 and others who died from indirect causes such as health care shortages as the virus surged and overwhelmed hospitals. The WHO defines excess deaths as ‘the difference between the number of deaths that have occurred and the number that would be expected in the absence of the pandemic based on data from earlier years.’
Most of the excess deaths during the first two years of the pandemic were concentrated in Southeast Asia, Europe, and the Americas, the WHO said in a news release. More than two-thirds occurred in just 10 countries.”
And in a related article: Covid's toll in the U.S. reaches a once unfathomable number: 1 million deaths “The U.S. on Wednesday surpassed 1 million Covid-19 deaths, according to data compiled by NBC News — a once unthinkable scale of loss even for the country with the world's highest recorded toll from the virus.
The number — equivalent to the population of San Jose, California, the 10th largest city in the U.S. — was reached at stunning speed: 27 months after the country confirmed its first case of the virus.”
Vaccines Effective Against New Omicron Subvariants, WHO Chief Says “‘It’s too soon to know whether these new sub-variants can cause more severe disease than other omicron sub-variants, but early data suggest vaccination remains protective against severe disease and death,’ Tedros Adhanom Ghebreyesus, said at a media briefing in Geneva Wednesday.”
And in a related article: Moderna targets autumn release for Omicron vaccine
COVID-19 Vaccination—Becoming Part of the New Normal From leaders at the FDA:
”…it is time to accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal. It will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses such as influenza. And it likely will require similar annual consideration for vaccine composition updates in consultation with the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC)….
By summer, decisions will need to be made for the 2022-2023 season about who should be eligible for vaccination with additional boosters and regarding vaccine composition. Administering additional COVID-19 vaccine doses to appropriate individuals this fall around the time of the usual influenza vaccine campaign has the potential to protect susceptible individuals against hospitalization and death, and therefore will be a topic for FDA consideration”
1 in 5 Parents of Children Under 5 Intend to Get Them a COVID-19 Vaccine Right Away Once Eligible; Most Say Approval Delays Have Not Shaken Their Confidence in Vaccine’s Safety and Effectiveness From a KFF survey: “About a fifth (18%) of parents with children under age 5 say they intend to get their child vaccinated ‘right away’ once federal regulators authorize its use for their child’s age group… Another 38% say they would want to ‘wait and see’ how it works for other young children before getting their child vaccinated…
significant shares of these parents are reluctant, with 27% saying they will ‘definitely not’ get their child vaccinated and 11% saying they would do so ‘only if required’ for school or daycare.”
Also: “As COVID-19 cases have begun to rise nationally in recent weeks, a little more than a third (35%) of adults think there is a new wave of COVID-19 infections hitting the country. Most say either that there is not a new wave (50%) or that they aren’t sure if there is (14%).”
FDA rebukes Pfizer CEO's suggestion to take more Paxlovid if COVID-19 symptoms return “The FDA rebuked Pfizer CEO Albert Bourla’s proposed solution to reports that some patients experienced a relapse of COVID-19 symptoms after treatment with the company's antiviral Paxlovid.”
The Impact of COVID-19 on the Rural Health Care Landscape “Before the COVID-19 pandemic began, hospital closures were increasing in rural communities across the nation: 116 rural hospitals closed between 2010 and 2019. Over the past two years, federal relief has helped stabilize facilities, and the pace of closures slowed. However, this assistance was temporary, and rural hospitals continue to struggle financially and to recruit and retain nurses and other health care employees…
[For example] out of 2,176 rural hospitals, 441 face three or more concurrent financial risk factors, putting them at risk of service reduction or closure…
[Recommendations:] TO PROVIDE IMMEDIATE STABILIZATION, CONGRESS OR THE SECRETARY OF HHS SHOULD:
Provide full relief to rural hospitals from Medicare sequestration pay- ment reductions until two years after the Public Health Emergency (PHE) ends.
Increase reimbursement for Medicare CAH [Critical Access Hospital]
services by 3% starting in FY2023.
Re-establish the CAH “necessary provider” designation process.
Allow additional flexibility in CAH eligibility criteria.
Update the Medicare base payment rate for SCHs [Sole Community Hospitals]
and MDHs [Medicare Dependent Hospitals]
to ensure that reimbursement reflects current costs.
Make available capital infrastructure grants or loans that rural hospitals can use to modify services lines or improve structural or patient safety.”
Evaluation of Trends in Alcohol Use Disorder [AUD] –Related Mortality in the US Before and During the COVID-19 Pandemic “In this cross-sectional study, we used data from 2012 to 2019 to project 2020 and 2021 mortality rates and found that AUD-related mortality rates increased among all ages and sexes during the pandemic. Younger persons, particularly those aged 25 to 44 years, had the steepest upward trend. The small proportion of COVID-19–related deaths suggests that excess deaths were more likely attributable to indirect effects of the pandemic such as stay-at-home policies and reduced medical and social resources for patients with AUD.”
About health insurance
Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, 2021 Highlights from the National Center for Health Statistics, National Health Interview Survey, 2021:
In 2021, among people of all ages, 9.2% were uninsured, 39.5% had public coverage, and 60.4% had private coverage at the time of interview…
Adults aged 18–64 were the most likely to be uninsured (13.5%),f ollowed by children aged 0–17 years (4.1%) and adults aged 65 and over (0.6%).
Adults aged 65 and over were the most likely to have public coverage (96.1%), followed by children aged 0–17 years (44.3%) and adults aged 18–64 (21.7%).
HHS' surprise-billing appeal on hold “HHS requested a hold on its appeal of a Texas federal court ruling that voided part of the arbitration process outlined under the No Surprises Act.
HHS filed an appeal on the decision April 22 but later asked the court to hold its appeal until it releases the final surprise billing rule this summer. The court granted the hold to pause the legal challenge on May 3.
Centene to sell Magellan, Pantherx pharmacy businesses for $2.8B “Centene has signed a definitive agreement to sell Magellan Rx and Pantherx Rare in two separate deals for a total of $2.8 billion.
Centene intends to use the proceeds to repurchase stock and the balance to reduce debt, according to a May 5 press release.
Magellan Rx focuses on specialty drug management, Medicaid administration and pharmacy benefits management. It will be sold to Eagan, Minn.-based Prime Therapeutics…
Pantherx is a specialty and rare drug pharmacy in Pittsburgh that Centene purchased in December 2020. The company is being sold to a group: the Vistria Group, General Atlantic, and Nautic Partners. The sale is subject to federal regulatory approvals and is expected to close in the next two to four months.”
Cigna launching provider consult service for oncology care “The program, backed by the capabilities of the insurer's Evernorth subsidiary, allows community oncologists to connect with cancer subspecialty experts at centers designated by the National Cancer Institute (NCI). These connections will allow patients to benefit from the latest innovations in cancer care while also keeping their care close to home, Cigna said.
In a pilot, community oncologists had their treatment plans reviewed by experts at PinnacleHealth. In 40% of cases reviewed, patients were recommended alternative tests or treatment based on new advancements in research.”
About hospitals and healthcare systems
Banner invests in Atlas Health Partners, plans to double ASC footprint “Phoenix-based Banner Health has invested in Atlas Healthcare Partners, a group that develops and manages ambulatory surgery centers with health systems and physicians.
Atlas and Banner entered a joint venture in 2018 to build and operate a network of ASCs in Arizona, Colorado and Wyoming, according to a May 3 news release.
In the last three years, the venture grew the system's ASC footprint from eight to 26, increased volume by 155 percent and revenue by 475 percent.
By the end of 2025, the Banner Atlas joint venture anticipates doubling in size and owning and operating more than 50 ASCs.”
Supply-Chain Snags Create Shortages Of Lifesaving Medical Supplies In U.S. “The U.S. healthcare system is facing supply shortages that dwarf the problems experienced in the early days of the Covid-19 pandemic, when needed personal protective equipment, like masks and gowns, was nearly impossible to come by. Back then, shortages might have been more urgent, but today’s problems include a much wider array of equipment. They can be traced to component scarcities, backlogged ports, transportation glitches and lockdowns in China to combat the spread of Covid-19…
The list of scarce items is long. It includes latex and vinyl examination gloves, surgical gowns, laboratory reagents, specimen-collection testing supplies, saline-flush syringes and dialysis-related products, according to the U.S. Food and Drug Administration.”
CONTRACT PHARMACY RESTRICTIONS REPRESENT GROWING THREAT TO 340B HOSPITALS AND PATIENTS Highlights:
—”The estimated annualized impact of the restrictions on 340B hospitals has more than doubled since the end of 2021 to a median of $2.2 million for DSH/RRC/SCHs and $448,000 for CAHs.
—More than three-quarters of hospitals report they likely will need to make cuts to programs and services if these restrictions become permanent.”
About pharma
Moderna Revenue Triples on Soaring Covid-19 Vaccine Sales “The biotechnology company’s revenue topped $6 billion in the period ended March 31, beating analyst expectations and rising from $1.94 billion a year earlier, driven almost entirely by sales of its messenger RNA-based vaccine, branded as Spikevax.”
Walgreens to pay $683M to settle Florida opioid suit “Walgreens has agreed to pay Florida $683 million to resolve all claims related to the ‘distribution and dispensing of prescription opioid medications.’
The suit alleged Walgreens dispensed more than 4.3 billion total opioid pills in Florida from May 2006 to June 2021 and that more than half of them showed indicators of fraud or addiction that the company should have noticed and addressed…”
Johnson & Johnson sues benefits company for allegedly overusing drug cost assistance program “Drug manufacturer Johnson & Johnson has filed a lawsuit against drug benefit company SaveOnSP for allegedly taking advantage of a J&J program that covers out-of-pocket costs for patients who use some of the more expensive prescription drugs…
In the civil lawsuit filed in federal court in New Jersey, J&J said it overpaid in copay assistance by at least $100 million due to the services provided by SaveOnSP. This, said J&J, is due to contract interference and deceptive trade practices by the company.”
About the public’s health
2022 National Survey on LGBTQ Youth Mental Health Among the findings that indicate an urgent need for mental health interventions in this group:
—45% of LGBTQ youth seriously considered suicide in the past year
—14% of LGBTQ youth attempted suicide in the past year
—73% of LGBTQ youth reported experiencing symptoms of anxiety
—58% of LGBTQ youth reported experiencing symptoms of depression
Subsequent primary cancer risk among five-year survivors of adolescent and young adult [AYA] cancers “AYA cancer survivors are almost twice as likely to die from a new primary cancer as the general population, highlighting the need for primary care clinicians to prioritize cancer prevention and targeted surveillance strategies in these individuals.”
Tobacco manufacturers agree to point-of-sale warning settlement “The Big Three U.S. tobacco manufacturers and the federal government have reached a settlement on “corrective statements” addressing the health risks of smoking and secondhand smoke to be displayed in retail outlets.
The settlement covers point-of-sale displays of tobacco products, including the placement and the number of corrective-statement signs.
The settlement could represent the next phase of rolling out corrective statements ordered by a federal judge in 2006.”
See the article for specifics of the agreement.
Sex and Race Differences in the Evaluation and Treatment of Young Adults Presenting to the Emergency Department With Chest Pain “Women and people of color with CP waited longer to be seen by physicians, independent of clinical features. Women were independently less likely to be admitted when presenting with CP. These differences could impact downstream treatment and outcomes.”
About healthcare IT
Review of the Department of Health and Human Services' Compliance with the Federal Information Security Modernization Act of 2014 for Fiscal Year 2021 From the HHS OIG: “The Federal Information Security Modernization Act of 2014 (FISMA) requires Inspectors General to perform an annual independent evaluation of their agency's information security programs and practices to determine the effectiveness of those programs and practices. HHS OIG engaged Ernst & Young LLP (EY) to conduct this audit…
Overall, through the evaluation of FISMA metrics, it was determined that the HHS' information security program was 'Not Effective'. This determination was made based on HHS not meeting the 'Managed and Measurable' maturity level for the Identify, Protect, Detect, and Recover function areas as required by DHS guidance and the FY 2021 Inspector General FISMA Reporting Metrics. However, HHS continues to implement changes to strengthen the maturity of its enterprise-wide cybersecurity program.”
The report has some recommendations for improvement.
CDC Tracked Millions of Phones to See If Americans Followed COVID Lockdown Orders “The Centers for Disease Control and Prevention (CDC) bought access to location data harvested from tens of millions of phones in the United States to perform analysis of compliance with curfews, track patterns of people visiting K-12 schools, and specifically monitor the effectiveness of policy in the Navajo Nation, according to CDC documents obtained by Motherboard. The documents also show that although the CDC used COVID-19 as a reason to buy access to the data more quickly, it intended to use it for more-general CDC purposes.”
Mental health apps have terrible privacy protections, report finds “As a category, mental health apps have worse privacy protections for users than most other types of apps, according to a new analysis from researchers at Mozilla. Prayer apps also had poor privacy standards, the team found…
In the latest iteration of the guide, the team analyzed 32 mental health and prayer apps. Of those apps, 29 were given a “privacy not included” warning label, indicating that the team had concerns about how the app managed user data. The apps are designed for sensitive issues like mental health conditions, yet collect large amounts of personal data under vague privacy policies, the team said in the statement. Most apps also had poor security practices, letting users create accounts with weak passwords despite containing deeply personal information.
The apps with the worst practices, according to Mozilla, are Better Help, Youper, Woebot, Better Stop Suicide, Pray.com, and Talkspace.”
The 10 largest data breaches ever reported in healthcare FYI
About healthcare personnel
Affirmative Action Bans and Enrollment of Students From Underrepresented Racial and Ethnic Groups in U.S. Public Medical Schools “State affirmative action bans were associated with significant reductions in the percentage of students in U.S. public medical schools from underrepresented racial and ethnic groups.”
About health technology
FDA clears Abbott test to spot 4 STIs at once amid soaring case rates “Abbott’s assay runs on its Alinity m molecular PCR platform. Using just one swab or urine sample, it simultaneously tests for several bacteria: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium, which cause, respectively, chlamydia, gonorrhea, trichomoniasis and both urethritis and cervicitis.”
