Today's News and Commentary

About Covid-19

Renewal of Determination That A Public Health Emergency Exists: “As a result of the continued consequences of the Coronavirus Disease 2019 (COVID-19) pandemic, on this date and after consultation with public health officials as necessary, I, Xavier Becerra, Secretary of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, do hereby renew, effective October 18, 2021, the January 31, 2020, determination by former Secretary Alex M. Azar II, that he previously renewed on April 21, 2020, July 23, 2020, October 2, 2020, and January 7, 2021, and that I renewed on April 15, 2021 and July 19, 2021, that a public health emergency exists and has existed since January 27, 2020, nationwide.”
The renewal extends the state of emergency for at least another 90 days.

F.D.A. to Allow ‘Mix and Match’ Approach for Covid Booster Shots: “The Food and Drug Administration is planning to allow Americans to receive a different Covid-19 vaccine as a booster from the one they initially received, a move that could reduce the appeal of the Johnson & Johnson vaccine and provide flexibility to doctors and other vaccinators.
The government would not recommend one shot over another, and it might note that using the same vaccine as a booster when possible is preferable, people familiar with the agency’s planning said. But vaccine providers could use their discretion to offer a different brand, a freedom that state health officials have been requesting for weeks.”

Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-bind, randomised, placebo-controlled, phase 3 trial: “Interferon beta-1a plus remdesivir was not superior to remdesivir alone in hospitalised patients with COVID-19 pneumonia. Patients who required high-flow oxygen at baseline had worse outcomes after treatment with interferon beta-1a compared with those given placebo.” This study highlights the benefits of treatments for Covid-19 under specific clinical conditions.

Pfizer, Moderna will rake in a combined $93 billion next year on COVID-19 vaccine sales: report: “The messenger RNA shot producers are projected to break the bank next year, generating combined sales of $93.2 billion, nearly twice the amount they are expected to rake in this year, says Airfinity. The health data analytics group puts total market sales for COVID-19 vaccines in 2022 at $124 billion, according to data seen by The Financial Times.”

Assessment of Out-of-Pocket Spending for COVID-19 Hospitalizations in the US in 2020: “In this cross-sectional study of 4075 COVID-19 hospitalizations in 2020, 71.2% of privately insured patients and 49.1% of Medicare Advantage patients had cost sharing for any hospitalization-related service, including those billed by clinicians; 4.6% of privately insured and 1.3% of Medicare Advantage had cost sharing for facility services billed by hospitals, with mean out-of-pocket spending of $3840 and $1536, respectively…
The findings suggest that out-of-pocket spending for COVID-19 hospitalizations may be substantial if insurers allow cost-sharing waivers to expire.”

Pfizer vaccine 93% effective at preventing hospitalizations in 12-18 year olds, CDC says: “Pfizer's COVID-19 vaccine was 93 percent effective at preventing hospitalizations from the virus in children ages 12 to 18 in a real-world study conducted by the CDC, the agency said Oct. 19.”

About health insurance

‘An Arm and a Leg’: Hello? We Spend 12 Million Hours a Week on the Phone With Insurers: An interesting podcast with the message in the headline. Dan Weissmann is a great interviewer.

UnitedHealth launches employer virtual primary care service: “UnitedHealthcare is expanding its telehealth offerings for employers with a new virtual primary care service that offers access to doctors with low or no co-pays for routine visits on their phones or via computer…
UnitedHealth is partnering with telehealth provider Amwell, which will provide the platform for virtual care as well as the clinical services through its medical group. The virtual primary care program will initially be available for employers in 11 states including Colorado, Texas and Maryland, as well as Washington, DC.”

Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated Approval: “Between 2017 and 2019, Medicare Parts B and D cumulatively spent at least $569 million on the 10 cancer drug indications with a confirmed lack of OS [overall survival] benefit after AA[accelerated approval]. Approximately $224 million of this spending was for indications that were either voluntarily withdrawn by the manufacturers or recommended by the ODAC for withdrawal. These results suggest that spending on the remaining 4 AA indications may continue to increase unless the FDA revokes these indications.”

AMERICAN CUSTOMER SATISFACTION INDEX:Insurance and Health Care Study 2020-2021: Start with pages 4-6. Note that Hospitals are two points lower than the US Postal Service.

About healthcare IT

Third-party health apps are vulnerable to hacks, report finds: A reminder: “Third-party health apps that pull patient data from electronic health record systems are vulnerable to hacks, according to a new report. The electronic health records themselves, which are housed at health centers and subject to the federal privacy law HIPAA, are well protected. But as soon as a patient gives permission for their data to leave the health record and head toward a third-party app — like programs that track people’s medications, for example — it’s easy for hackers to access. 
Hospitals and health care systems are a major target for hackers, and attacks have only escalated over the past few years. Patient health data is some of the most valuable information to hackers: each record can be worth hundreds of dollars on the dark web, in part because they can’t be changed easily and it’s harder to detect when the data is used fraudulently. Credit card numbers, on the other hand, can easily be changed and are only worth a few dollars.”

Finances Stymie Patient Data Sharing, Interoperability at FQHCs: “Federally qualified health centers (FQHCs) and other safety-net providers face interoperability challenges that limit their patient data sharing capabilities, according to a new whitepaper published by CareAdvisors…
The majority of safety net providers, including community hospitals, FQHCs, and community health clinics, have been excluded from patient data sharingopportunities due to a lack of resources for investment in EHR systems such as Epic and Cerner that interoperate with other providers.”

Man gets 7-year prison sentence for 2014 UPMC database hack: The article highlights the potentially severe penalties for hacking: “A Michigan man was sentenced to seven years in prison for his role in the hacking and theft of data belonging to more than 65,000 UPMC employees, the Justice Department said Oct. 18. 
Justin Sean Johnson, 30, of Detroit, was charged in June 2020 and sentenced Oct. 15, 2021, to 60 months' incarceration for conspiracy to defraud the U.S. and 24 months for aggravated identity theft for hacking into the Pittsburgh-based health system's human resource server databases in 2013 and 2014…”

About healthcare devices

Hearing aids without a prescription or an exam? The FDA takes big step toward making that happen.: “More than four years after Congress ordered the agency to allow over-the-counter hearing aids, it took the first step Tuesday to broaden access to more accessible and affordable devices for millions of patients with mild to moderate hearing loss. The agency’s proposal would create a new category of over-the-counter hearing aids and supersede state-level regulations that require patients to go through physicians or audiologists to get prescriptions and fittings for them.”

About the public’s health

US flu cases up 23 percent from 2020: “The U.S. has seen 23 percent more flu cases this year compared to last year’s influenza season, though flu activity is still below normal pre-pandemic years, according to data collected by the Walgreens Flu Index.
According to the flu index, which includes data through the week ending on Oct. 9, Nevada leads the U.S. in the number of flu cases reported this year, followed by Mississippi and Texas.”

About healthcare providers

Grand Rounds Health and Doctor On Demand Rebrand as Included Health: “-Grand Rounds Health and Doctor On Demand… announced their combined integrated virtual care and navigation company will be called Included Health.”