About Covid-19
FDA calls meeting of its advisers to discuss Covid vaccine boosters: “The US Food and Drug Administration said Wednesday it has called a meeting of its vaccine advisers for September 17 to discuss booster doses of coronavirus vaccine.
That's three days before the September 20 target date to start offering booster doses announced by the White House last month.”
In three related articles:
WHO presses world leaders to hold off on Covid vaccine booster shots through September: “The World Health Organization asked world leaders again to hold off on giving Covid-19 booster shots so poorer nations can vaccinate more of their populations with first doses.”
EU health body says no urgent need for vaccine boosters:”The European Centre for Disease Prevention and Control (ECDC) said on Wednesday there was no urgent need for booster doses of COVID-19 vaccines for the fully vaccinated, citing data on the effectiveness of shots.
The comments follow a similar statement from the European Medicines Agency last month that more data was needed on the duration of protection after full inoculation to recommend using booster shots.”
Israel’s COVID-19 boosters are preventing infections, new studies suggest: “A report for the country’s Ministry of Health, posted Friday, showed a third dose reduced recipients’ risk of testing positive for SARS-CoV-2 by more than 10-fold 2 weeks later. And in a preprint posted yesterday, researchers used data from a health maintenance organization (HMO) to calculate that a third dose roughly halves a person’s chances of testing positive for the virus starting 1 week after the shot and further reduces it after the second week.”
Tens of billions of dollars in pandemic aid for hospitals and nursing homes not distributed: “As many hospitals bulge again with covid-19 patients, a wide swath of the health-care industry is exasperated that federal health officials have not made available any more of the aid since President Biden took office. About $44 billion from a Provider Relief Fund created last year remains unspent, along with $8.5 billion Congress allotted in March for medical care in rural areas…
Federal health officials declined to discuss reasons for the delay, but HHS said in a statement: ‘We continue to work expeditiously to get these funds out the door and will be announcing another distribution of funds soon. Plans are being finalized.’”
Axios-Ipsos poll: Vaccine hesitancy may be crumbling: “The 20% who say they're either not very likely (6%) or not at all likely (14%) comprise a new low in the survey, and down from a combined 34% in March and 23% two weeks ago.” See the survey for other findings.
Risk factors and disease profile of post-vaccination SARS-CoV-2 infection in UK users of the COVID Symptom Study app: a prospective, community-based, nested, case-control study: “Vaccination (compared with no vaccination) was associated with reduced odds of hospitalisation or having more than five symptoms in the first week of illness following the first or second dose, and long-duration (≥28 days) symptoms following the second dose. Almost all symptoms were reported less frequently in infected vaccinated individuals than in infected unvaccinated individuals, and vaccinated participants were more likely to be completely asymptomatic, especially if they were 60 years or older.”
WHO opens pandemic intelligence hub to look out for future crises: “A World Health Organization ‘pandemic intelligence hub’ launched by the UN agency’s director general, Tedros Adhanom Ghebreyesus, and Germany’s Angela Merkel in Berlin on Wednesday will try to help governments identify future pandemics at an earlier stage and improve monitoring of new variant strains of Covid-19.
The hub, which will host scientists and policymakers from around the globe on a project-by-project basis, is designed to make it easier for governments to compare notes on emerging infectious diseases and pull in additional relevant information on travel patterns, trade routes or human-animal interactions in agriculture.”
About pharma
FDA Regains Rulemaking Authority in Reversal of Trump-Era Move: “The Food and Drug Administration once again has the authority to issue its own regulations under a notice issued Wednesday that reverses a Trump-era change.
Former Health and Human Services Secretary Alex Azar issued a memo in September 2020, requiring that all rules coming out of the department’s agencies and offices would need to be signed by the secretary.”
Antibiotics increase the risk of colon cancer: “There is a clear link between taking antibiotics and an increased risk of developing colon cancer within the next five to ten years. This has been confirmed by researchers at Umeå University, Sweden, after a study of 40,000 cancer cases. The impact of antibiotics on the intestinal microbiome is thought to lie behind the increased risk of cancer.”
Another reason for judicious use of antibiotics.
About healthcare equipment/devices
Baxter to pay $10.5 billion in cash for Hillrom: “Baxter International and Hillrom said today that they have a deal in which Baxter has agreed to acquire Hillrom for $156 a share in cash, ‘for a total equity value of approximately $10.5 billion and a total enterprise value of approximately $12.4 billion, including the assumption of debt.’”
Tracking Your Premarket Submission’s Progress (Progress Tracker): New at the FDA: “The FDA built a secure, web-based tracker that displays the Center for Devices and Radiological Health’s (CDRH) progress in reviewing traditional 510(k) submissions.”
About health insurance
Medicare trustees project hospital fund to run out in 2026, same deadline as year before: “Medicare’s insurance trust fund that pays hospitals is expected to run out of money in 2026, the same projection as last year, according to a new report from Medicare’s board of trustees.
The report, released Tuesday, found Medicare spent $925.8 billion in 2020 and served 62.6 million people. It found that the COVID-19 pandemic had a major impact on the short-term financing for the program, but the financial status overall of the fund hasn’t significantly changed.”
FAH calls for Congress to delay $36B in Medicare cuts set to go into effect in October: “A key hospital group wants to ensure a 4% cut to Medicare spending doesn’t go into effect as facilities are still struggling with the financial impact of the pandemic.
The Federation of American Hospitals (FAH) is asking Congress to include a delay to the 4% cut as part of a government funding package that must be passed before current funding expires Sept. 30.”
Laboratory Owner Pleads Guilty to $73 Million Medicare Kickback Scheme: “A Florida man pleaded guilty yesterday in the Southern District of Florida for his role in a $73 million conspiracy to defraud Medicare by paying kickbacks to a telemedicine company to arrange for doctors to authorize medically unnecessary genetic testing. The scheme exploited temporary amendments to telehealth restrictions enacted during the COVID-19 pandemic that were intended to ensure access to care for Medicare beneficiaries.”
UnitedHealth Group To Expand Obamacare To Seven New States In 2022: “UnitedHealthcare is poised to capitalize by growing in even more markets for next year, filing for approval from state regulators to participate on insurance exchanges to offer coverage in Alabama, Florida, Georgia, Illinois, Louisiana, Michigan and Texas.”
About healthcare IT
FBI warns healthcare systems of Hive ransomware following Memorial Health System attack: “The cybersecurity division of the FBI is warning organizations of Hive ransomware, citing indicators of compromise and recent incidents. The ransomware is actively targeting healthcare systems.
The warning follows an attack by the same group on Memorial Health System in mid-August. While the healthcare system said employee and patient personal and financial information was not compromised, the attack shut its computer systems down on Aug. 15.
Hive ransomware was first observed in June 2021 and exhibits file encryption capabilities and terminates backup and file copying processes to carry out its attacks, the FBI said.”
Cyberattacks against outpatient, specialty clinics on the rise as data breaches double from 2018: “Healthcare breaches have nearly doubled since 2018 and continued to climb through the first half of 2021, according to a report by Critical Insight, a Seattle-based healthcare-focused cybersecurity firm…
The report shows that there were 43 breaches of hospitals and 74 breaches of outpatient, specialty clinics in the first half of 2021. “
Apple plans to add blood pressure monitoring, thermometer to smartwatch: report: “Apple is working on new health-related features for its smartwatch, including a tool for blood pressure measurement and a thermometer to help with fertility planning…
The company is expected to release its seventh version of the Apple Watch in the coming weeks, but most of its more ambitious health-related improvements aren’t expected before 2022.”
About hospitals and health systems
67 financial benchmarks for health system executives: Useful benchmarks from bond rating services.