Today's News and Commentary

About Covid-19

F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month: “President Biden said last week that he expected a fully approved vaccine in early fall. But the F.D.A.’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had ‘taken an all-hands-on-deck approach’ to the work.”

Covid Live Updates: W.H.O. Calls for Moratorium on Covid Vaccine Boosters: “The World Health Organization called on Wednesday for a moratorium on coronavirus vaccine booster shots until the end of September to help all countries vaccinate at least 10 percent of their populations, appealing to the world’s wealthiest nations to address dramatic disparities in global vaccination rates.”

Who Can Make You Get a Covid Vaccine?: A really good review of the topic and what is currently being done.

Biden tells Florida, Texas leaders: Help on COVID-19 or 'get out of the way': Further information from the White House press conference reported here yesterday: “U.S. President Joe Biden on Tuesday urged Republican leaders in Florida and Texas - home to roughly a third of all new U.S. COVID-19 cases - to follow public health guidelines on the pandemic or ‘get out of the way’ as the country struggles to contain the rapid spread of the disease's Delta variant…
Florida Governor Ron DeSantis has opposed strict COVID-19 restrictions. On Friday, he issued an order blocking mask mandates in the state's schools. Texas Governor Greg Abbott issued an order last spring that would impose fines for mask mandates.”

Korea confirms first two cases of delta plus: “Delta plus is a sub-lineage of delta with an extra mutation in the spike protein called K417N -- the same mutation found in beta and gamma, variants of concern first spotted in South Africa and Brazil, respectively. South Africa stopped using AstraZeneca’s vaccine in February after a study showed it did not work well against the beta variant.”

After Nearly 9 Million Pfizer Shots for U.S. Teens, Serious Side Effects Rare: CDC: “As of July 16, close to 9 million teens, aged 12 to 17, had received the Pfizer-BioNTech vaccine — the only one okayed for that age group. Among roughly 9,240 reported side effects, 91% were minor, such as soreness near the vaccination site. 
But 9% were serious, with 4% developing a heart problem known as myocarditis…”

About healthcare quality

Mirror, Mirror 2021: Reflecting Poorly: Health Care in the U.S. Compared to Other High-Income Countries: From the Commonwealth Fund:

  • Key Findings: The top-performing countries overall are Norway, the Netherlands, and Australia. The United States ranks last overall, despite spending far more of its gross domestic product on health care. The U.S. ranks last on access to care, administrative efficiency, equity, and health care outcomes, but second on measures of care process.

  • Conclusion: Four features distinguish top performing countries from the United States: 1) they provide for universal coverage and remove cost barriers; 2) they invest in primary care systems to ensure that high-value services are equitably available in all communities to all people; 3) they reduce administrative burdens that divert time, efforts, and spending from health improvement efforts; and 4) they invest in social services, especially for children and working-age adults.”

Differences in Cancer Care Expenditures and Utilization for Surgery by Hospital Type Among Patients With Private Insurance: A good example of the need to analyze methodology before assessing usefulness of a study’s findings.
“In this cross-sectional study, surgery at NCI centers vs community hospitals was associated with higher insurer spending for a surgical episode without differences in care utilization [length of stay, ED use, or hospital readmission within 90 days of discharge] patients with private insurance undergoing cancer surgery.” However…
”while every attempt was made to adjust for differences in case mix, our claims-based analysis did not allow for complete adjustment of clinical factors such as stage at diagnosis, surgical complexity, and pathologic status, which limited our ability to judge surgical quality.”
Further, longterm outcomes were not assessed.

Association Between the Physician Quality Score in the Merit-Based Incentive Payment System and Hospital Performance in Hospital Compare in the First Year of the Program: “Are higher scores on the Merit-Based Incentive Payment System (MIPS) for physicians associated with hospital-level patient outcomes?…
The MIPS quality score was not associated with the hospital composite rate of postoperative complications.”
Read the article for more information, the results for all surgical specialties are not straightforwardly uniform.

Majority of nursing homes missing broad safety, quality inspections due to the pandemic: “While the standard surveys, which check for quality and federal compliance, are required at least every 15 months, 71% of Centers for Medicare & Medicaid Services-certified nursing homes nationally had gone at least 16 months without one as of May 2021, according to a report from the Office of Inspector General.
Though it kept in place more narrow surveys such as infection control and targeted complaint investigations, CMS had suspended standard surveys due to the COVID-19 pandemic in March 2020. However, despite announcing in August 2020 that states should resume the surveys, resources allowing, the backlog grew from 8% in June of 2020 to 71%, the OIG’s latest examination of CMS administrative data found.”

About healthcare IT

FDA clears Abbott’s iPhone app for FreeStyle Libre 2: A reminder that such devices need FDA approval.

Envisioning a world of big, AI-ready—and free—healthcare data, a top medical school leads by example: “The academic medical institution that maintains the world’s best-stocked library of curated, patient-deidentified and AI-ready data is going 100% open source with its digital riches. 
Stanford Health announced…it already has nine available datasets containing more than 1 million useable assets—specifically annotated medical images—and is likely to hit 2 million within the next year.
As part of the expansion, the Center for Artificial Intelligence in Medicine and Imaging (AIMI) at Stanford University School of Medicine is partnering with Microsoft’s AI for Health program.”

About the public’s health

Effect of Graphic Warning Labels [GWL] on Cigarette Packs on US Smokers’ Cognitions and Smoking Behavior After 3 Months: “Although there was a significant increase in cognitions about quitting in the GWL group, there was no evidence of increased quitting or reduced consumption, and this was biochemically validated at the postintervention visit.”

About pharma

Amgen vows to fight after IRS demands $3.6B in back taxes—and a bigger bill could be on the way: “Amgen’s tax revelation came amid a mixed quarter for the drugmaker, which raked in $6.5 billion during the period. While that was a 5% increase compared with last year, the COVID-19 recovery has been gradual and will likely hit sales for the rest of the year, Amgen forecasted.”

About healthcare devices

Philips faces 2nd Class I recall in a month, this time for high-flow therapy ventilators: “At the core of the issue is a safety mechanism in the ventilators that caps the oxygen flow delivered to a patient and issues a low-priority alarm when the system reaches a default maximum pressure limit. A blockage to the flow of oxygen could raise the pressure, therefore triggering the safety cutoff and preventing the device from reaching the necessary level of oxygen flow.”

About health insurance

Aetna, CVS to enter ACA marketplace in 8 states: “The first Aetna CVS Health hybrid-branded product will be available in Arizona, Florida, Georgia, Missouri, Nevada, North Carolina, Virginia and Texas, according to a series of Aug. 4 news releases, and confirmed by a CVS spokesperson.”

CVS Health sees profit dip to $2.8B in Q2: “While profits are down slightly compared to the second quarter of 2020, the company is still on par for the first half of the year, bringing in $5 billion in profit. It also reported $5 billion in profit for the first half of 2020.”

Nationwide out-of-pocket spending jumped 10% in 2021. Expect that growth to continue through 2026: “Consumer out-of-pocket spending on healthcare is set to hit an estimated $491.6 billion, or about $1,650 per person, in the U.S., according to a recent report.
The number is a roughly 10% increase over last year’s total and is expected to maintain a continual annual growth rate of 9.9% for the next five years…”

About hospitals and health systems

Hospitals with higher credit ratings weathered greater margin deterioration, Fitch says: “In contrast, hospitals with ‘BBB’ ratings below investment grade categories saw incremental improvements in operating margins. 
Fitch said hospitals with lower ratings likely saw some improvement for several reasons, including that many took immediate expense reduction efforts and recognized stimulus funding quickly. Fitch also said the smaller sample size may have contributed.”

CMS' final inpatient payment rule for 2022: 7 things to know: A good summary of the rule.

MUSC wraps up purchase of 3 South Carolina hospitals from LifePoint Health: The headline is the story.