Today's News and Commentary

JAMA editor-in-chief stepping down amid fallout of 'No physician is racist' controversy: “Howard Bauchner, M.D., has held the role for almost a decade but was placed on administrative leave in late March roughly a month after the medical journal released a controversial podcast featuring then-Deputy Editor Ed Livingston, M.D., and Mitchell Katz, M.D., deputy editor for JAMA Internal Medicine and CEO of NYC Health + Hospitals.
The episode kicked off a discussion on structural racism by questioning its existence in healthcare. It was promoted with a tweet that read: ‘No physician is racist, so how can there be structural racism in healthcare?’”
“I remain profoundly disappointed in myself for the lapses that led to the publishing of the tweet and podcast,” Dr. Bauchner said in a statement. “Although I did not write or even see the tweet, or create the podcast, as editor in chief, I am ultimately responsible for them.”
The AMA issued this statement: AMA announces transition in JAMA editorial leadership

Johnson & Johnson to pay $2.1bn in talc cancer case after Supreme Court rejection: “Johnson & Johnson must pay $2.1bn in damages to women who blamed their ovarian cancer on asbestos in the drugmaker’s baby powder, after the US Supreme Court refused to review the case. The judgment was the largest against the company, which has battled a wave of litigation and lost several cases as thousands of people claimed the products led to cancer. The appeal that was denied on Tuesday related to a case filed in Missouri in 2018 involving 22 women.”

About hospitals and health systems

A couple financial reports from large systems.
Banner Health joins recovering nonprofits with $63M operating income, $3B total revenue: “That increase in revenue was, however, paired with a rise in costs. The system reported a year-over-year increase from $2.4 billion to almost $3 billion, nearly half of which was attributed to higher salaries and benefits payouts…
To date, Banner said it has received about $465 million in CARES Act funding. It also received $654 million in Medicare Advance and Accelerated Payments, which will be recouped over 12 to 18 months beginning in April.”
Cleveland Clinic posts $61M profit in Q1 thanks to strong patient service revenue: “But the system still is facing higher expenses for supplies and salaries for workers, which have shot up for hospitals across the country throughout the pandemic. Cleveland Clinic spent $1.5 billion on salaries and benefits for the first quarter compared with $1.48 billion for the same period last year. Costs for supplies also increased to $297 million, slightly above the $269 million it paid in the first quarter of 2020…
Another bright spot is an increase in patient volumes. Total surgical cases for Cleveland Clinic increased 6.5% for the first quarter compared to the first quarter of 2020. Inpatient admissions also increased by 1.1% for the quarter.”

About Covid-19

For the first time in over a year, the US records a daily average of fewer than 20,000 new Covid-19 cases: The headline is the story.

Covid-19 Prevention Measures Are Keeping Childhood Diseases Like Chickenpox at Bay: “The disinfecting and hand-washing that became common during the Covid-19 pandemic have also served as powerful tools against a host of childhood ailments such as chickenpox, stomach viruses and strep throat, recent data suggest.”

Moderna applies for full F.D.A. approval for its Covid vaccine.: “Moderna on Tuesday became the latest pharmaceutical company to apply to the U.S. Food and Drug Administration for full approval for its Covid-19 vaccine for use in people 18 and older. F.D.A. approval would allow the company to market the shot directly to consumers, and could also help raise public confidence in the vaccine.
Full approval could also make it easier for schools, employers, government agencies and the U.S. military, which has encountered resistance to coronavirus vaccines, to mandate vaccinations.”

Israel reports link between rare cases of heart inflammation and COVID-19 vaccination: “The COVID-19 vaccine made by Pfizer and BioNTech appears to put young men at elevated risk of developing a heart muscle inflammation called myocarditis, researchers in Israel say. In a report submitted today to the Israeli Ministry of Health, they conclude that between one in 3000 and one in 6000 men ages 16 to 24 who received the vaccine developed the rare condition. But most cases were mild and resolved within a few weeks, which is typical for myocarditis.”

U.S. begins study testing mix-and-match Covid vaccine booster shots: “The NIH said it started a trial looking at what happens when an adult who is fully vaccinated with one type of Covid vaccine, like Pfizer’s, is boosted with a different shot about three to four months later.
The trial will include about 150 adults who have been fully vaccinated with the Johnson & Johnson, Moderna or Pfizer Covid vaccines, according to the agency.
Federal health officials said people who have not yet received an authorized vaccine are also eligible to enroll in the trial in a separate group.”

Cancer patients show good COVID immune response to vaccine, infection: This article explains the data behind the headline. For more detail, see the JAMA Oncology editorial commenting on the research.

19 Vaccination and Nonpharmaceutical Interventions [NPIs] With Infections, Hospitalizations, and Mortality: “A decision analytical model of North Carolina found that removing NPIs [such as face masks] while vaccines were distributed resulted in substantial increases in infections, hospitalizations, and deaths. Furthermore, as NPIs were removed, higher vaccination coverage with less efficacious vaccines contributed to a larger reduction in risk of infection compared with more efficacious vaccines at lower coverage.”

Coronavirus: West Virginia gives residents chance to win guns with a Covid-19 shot: No comment needed.

WHO grants emergency listing to Sinovac's coronavirus vaccine: “The World Health Organization (WHO) on Tuesday issued an emergency-use listing for Sinovac's inactivated COVID-19 vaccine CoronaVac in adults aged 18 and over, the second such authorisation it has granted to a Chinese company, and the seventh listing overall. Sinopharm became the first non-Western COVID-19 vaccine developer to be endorsed by the UN agency after its inoculation BBIBP-CorV won WHO backing last month.”

Protection Because of Prior SARS-CoV-2 Infection: As research is looking into the longevity of protection from Covid-19 due to natural infection or vaccination, there are some caveats to findings. Read this short editorial from JAMA Internal Medicine for a good explanation of these interpretation qualifications.

On a roll, Moderna taps Thermo Fisher for fill-finish duties and Lonza for booster shot manufacturing: The headline is the story.

About health insurance

Industry Voices—Delay in codifying 'reasonable and necessary' undermines healthcare enforcement: “In a rule issued in the waning days of the last administration, the Centers for Medicare & Medicaid Services sought to codify for the first time a definition of “reasonable and necessary” for purposes of determining whether an item or service is eligible for Medicare reimbursement.
That codification, embedded in the Medicare Coverage of Innovative Technology rule, appears required by the logic of the Supreme Court’s decision in Azar v. Allina Health Services. However, CMS recently prevented this regulation from going into effect, leaving the definition of “reasonable and necessary” to continue residing solely in sub-regulatory guidance.
The failure to codify a definition, in violation of the Medicare Act as interpreted by Allina, gives new ammunition to defendants in healthcare enforcement actions, including False Claims Act matters, that rely on the sub-regulatory definition of ‘reasonable and necessary.’”

Major rulings including Obamacare loom for U.S. Supreme Court: A reminder that the Court has still not decided on the validity of the ACA.

PAHCF [The Partnership for America’s Health Care Future] Medicare Expansion, Suggests Extending ACA Policies: “‘Not only would opening up seniors’ Medicare to younger Americans mainly absorb those who are already covered or have access to coverage, research shows the unaffordable costs would be passed on to taxpayers and could hasten the Medicare program’s bankruptcy, all while threatening patients’ access to quality care,’ Lauren Crawford Shaver, executive director of the PAHCF, said in the statement.”

CenterWell Senior Primary Care Extends its Value-Based Care to People with Original Medicare: In the past, offering Medicare beneficiaries additional benefits for a reduced or no cost was considered an illegal inducement. Then CMS allowed Medicare Advantage plans to offer extended services (transportation, meals, etc.) without legal consequences. Now, under a CMS Direct Contracting Model, Humana-owned CenterWell Senior Primary Care is able to offer those same extra benefits. “Under this new Direct Contracting Model, CenterWell’s reimbursement will be dependent on the quality of care it provides; CenterWell will share financial responsibility for patients’ medical costs with CMS.”

U.S. Consumers Often Lack Literacy In Healthcare Finances: Not a new finding; but what is newsworthy is that this problem still exists. For example: “Two-thirds of Americans can’t correctly define concepts such as healthcare insurance premiums, co-payments and deductibles. And, a majority of Americans isn’t familiar with basic elements of the Affordable Care Act (ACA), such as when the open enrollment period is, if there is a tax penalty for foregoing coverage, and whether health plans must enroll those with pre-existing conditions.”

Access to Care, Cost of Care, and Satisfaction With Care Among Adults With Private and Public Health Insurance in the US: “In this survey study of 149 290 individuals residing in 17 states and the District of Columbia, individuals with employer-sponsored and individually purchased private insurance were more likely to report poor access to health care, higher costs of care, and less satisfaction with care compared with individuals covered by publicly sponsored insurance programs.”

About the public’s health

China reports human case of H10N3 bird flu, a possible first: “A man in eastern China has contracted what might be the world’s first human case of the H10N3 strain of bird flu, but the risk of large-scale spread is low, the government said Tuesday.” Where have we heard that?

A pandemic anniversary: 40 years of HIV/AIDS: This Lancet article is a reminder that the first CDC article on what we now recognize as HIV/AIDS was published 40 years ago this month.

Best and Worst States for Elderly Healthcare: At the top are Minnesota and North Dakota. At the bottom are Georgia (50) and Oklahoma (51).

The Fastest-Growing U.S. States Have the Worst Health Care: “The fastest-growing states in terms of population over the last decade, including Texas, Florida, and Georgia, consistently rank last when it comes to health and health care. This is because these states have large numbers of uninsured adults, high levels of premature death from treatable conditions, less investment in public health, too many people with mental illness unable to get the care they need, and residents facing mounting insurance costs that make health care less affordable than in many other parts of the country, according to the Commonwealth Fund.”

About healthcare technology

Rapid Response Revival Defibrillator Gains CE Mark: “The small, portable defibrillator is designed so that “someone with no medical training can use it quickly in a high-stress situation,” the company said, adding that the product will be priced at one-tenth of the cost of a traditional AED.” The key point is the price, which will allow more widespread availability.

Illumina hits yet another legal snag as clock ticks on $8B deal for Grail: “Illumina's multibillion-dollar deal for cancer blood test developer Grail was already under an antitrust microscope in the U.S. and Europe. Now, the watchdogs have raised a new threat.
A federal court allowed U.S. regulators to potentially postpone their action to block the deal, pending legal outcomes across the pond—all while the deal runs up against a deadline set to expire before the end of this year.”

About healthcare IT

New Device That Connects To Computer, Combined With Telehealth Visit, Can Help Parents Get To Bottom Of Children’s Ear Pain: I wonder if the inventors ever examined a squirming, crying child?

1 in 4 hospitals can't send patients' EHR data to third parties, ONC finds: “While 90 percent of hospitals have the certified EHR technology patients need to view, download and transmit their health information electronically, only 3 out of every 4 hospitals have enabled the tech function, according to a June ONC data brief.” The number is actually worse: 90 percent of hospitals have the certified EHR technology X .75 (3 out of every 4 hospitals have enabled the tech function) = 67.5% can perform the function.

Brain-computer interface allowing 'locked-in' ALS patients to communicate earns European approval: “The dream of a device converting nonverbal amyotrophic lateral sclerosis (ALS) patients’ brainwaves into speech could finally become a reality now that a neural signal processing platform designed to do just that has received regulatory clearance in Europe.
The NeuroKey platform was developed by the Wyss Center for Bio and Neuroengineering, a nonprofit research institute in Switzerland.”

About pharma

Sanofi looks to take Mylan to court, again, over EpiPen antitrust allegations: “Sanofi is requesting a new trial to argue that Mylan blocked competition to its EpiPen competitor Auvi-Q, leveraging price hikes and steep rebates to maintain a U.S. epinephrine ‘monopoly.’ The move comes after a Kansas District Court in December ruled in Mylan’s favor.”