Today's News and Commentary

About Covid-19

Most Americans say they should be vaccinated before the U.S. donates Covid-19 shots elsewhere: “Three-quarters of Americans believe the U.S. government should start donating Covid-19 vaccines to other countries, but only after every person in the U.S. who wants a vaccine has received one, according to a new survey from STAT and The Harris Poll.
At the same time, just over half of Americans said they agree with the idea that the Biden administration should immediately start donating vaccines to other countries in order to achieve global herd immunity, which reflects growing concern that the coronavirus cannot be contained until most of the world is vaccinated…
Not surprisingly, there are diverging views among different slices of those polled. More members of Gen Z and millennials — 59% and 65%, respectively — than middle-aged or older Americans believe the U.S. government should start to immediately donate Covid-19 vaccines to other countries. And 63% of Democrats support immediate donations, compared with just 43% of Republicans.”

The US is vaccinating millions of Americans daily. But here's why Covid-19 cases and hospitalizations are up: “In the past seven days, the US reported an average of more than 67,100 new Covid-19 infections daily, according to Johns Hopkins University data. That's slightly below where the average was a week prior, but it's still 25% above where it was nearly a month ago.
And about 44,000 Covid-19 patients were in US hospitals as of Sunday, the most recent day that data was available, according to the US Department of Health and Human Services. That number has generally been inching up since late March, when it dipped to around 37,900.
Experts say there are several reasons for the rise in these numbers, including dangerous coronavirus variants -- such as the more contagious B.1.1.7 strain that has helped fuel another surge in Michigan. Pandemic fatigue and more Americans moving around have also likely contributed to the rise.”

FDA unlocks pooled COVID-19 screening for previously authorized tests: “The FDA is making it easier for the makers of authorized COVID-19 tests to have multiple samples tested at once—allowing more people to be screened more regularly while using fewer resources.
This pooled testing approach has been previously green-lit by the agency for individual companies since last summer; the strategy only checks single samples when the larger batch returns a positive result.
Now, the FDA will begin issuing amendments to a potentially broad number of its past authorizations for certain molecular diagnostics—including those for people who are showing no symptoms, and only require a simple swab of the front of the nose, compared to the deeper nasopharyngeal swabs common during the early phases of the pandemic.”

The US spat over the vaccine IP waiver: A really good summary of the issue of sharing IP for the
Covid-19 vaccines.

GOP Reps Introduce Bill To Get Vaccines To Citizens First: “The same day that adults in all 50 states became eligible for the COVID-19 vaccine, Republican legislators introduced a bill on Monday to prioritize U.S. citizens and green card holders for the shot over everyone else in the country.
U.S. Reps. Fred Keller and Mike Kelly, R-Pa., and Rep. Nancy Mace, R-S.C., said that the Saving Hypodermic injections and Offering vaccines to Taxpayers Swiftly, or SHOTS, Act would instruct the U.S. Department of Homeland Security to ‘ensure that American citizens and lawful permanent residents are given priority to receive the COVID-19 vaccine over those visiting or who have entered the United States illegally.’”
The legislators obviously missed the memo that everyone needs to be immunized if “American citizens and lawful permanent residents” are to be safe.

House Democrats launch investigation into J&J contractor Emergent: “House Democrats have launched an investigation into Emergent BioSolutions, the embattled contract manufacturer of Johnson & Johnson's coronavirus vaccines, to find out if the company used its relationship with a key Trump administration official to secure federal contracts.
In a letter sent to the company's CEO and its executive chairman, Democrats on the Oversight Committee and the Select Subcommittee on the Coronavirus Crisis said they were concerned Emergent won contracts ‘despite a track record of increasing prices without justification and failing to meet contract requirements.’”

About health insurance

Anthem raises outlook as it posts $1.7B in Q1 profit:”Profits were up 9.3% from the first quarter of 2020, according to the insurer's financial release, when the company brought in $1.5 billion.
Revenues were $32.4 billion for the quarter, which fell short of expectations from Zacks Investment Research. Revenue was also up 9.3% year over year, Anthem said, from $29.6 billion in the first quarter of 2020.”
The expectations in this sector were for profits to decline as Covid-19-postponed care surged back.

Aetna bringing CVS-centric plan to new markets with eye on further expansion: “Aetna first unveiled its Connected Plan last year, and now it's bringing the design to new markets with its sights on even further expansion.
The Aetna Connected Plan with CVS Health centers the capabilities of the insurer's parent company, including its retail pharmacies, MinuteClinics and HealthHUB stores. After launching in the Kansas City market, the plan is now coming to Southern California and St. Louis.
Aetna is aiming to offer the plan in 15 markets by the end of the year…”

Texas’ Obamacare Medicaid Provider Fee Case Headed to SCOTUS: “Texas and five other states will be asking the U.S. Supreme Court to hear their objections to an Obamacare program that cost them nearly $500 million in ‘health insurer premium’ fees imposed on Medicaid managed care companies.
The U.S. Court of Appeals for the Fifth Circuit agreed to halt the issuance of a mandate confirming the states’ liability for the tax until Sept. 6 or the states’ filing of a petition for review by the nation’s top court, whichever occurs first.
The Affordable Care Act’s Section 9010 taxes health insurers on the premiums they charge states for Medicaid managed care...”

2019 Medicare Current Beneficiary Survey Early Look: This report was just released (despite the date on the headline): Highlights:
77% of Medicare beneficiaries report good, very good, or excellent health.
48% of Medicare beneficiaries report having one or more disabiities.
The vast majority of Medicare beneficiaries are satisfied with health care quality, ease of access, and cost (see Table 4)

Mass. Eye And Ear Agrees To Pay $2.7M To Resolve Fraud Complaint: “A Boston hospital that specializes in eye, ear, nose and throat ailments has agreed to pay $2.7 million to resolve federal fraud allegations, Acting U.S. Attorney for Massachusetts Nathaniel Mendell announced Tuesday.
Prosecutors say Massachusetts Eye and Ear improperly billed government health care programs for certain office visits, defrauding the country of more than a million dollars.”

Oscar Health launches tech platform business +Oscar: “Oscar's health plans are built on the technology infrastructure, and it has entered into a number of partnerships with others in the industry, including Cigna and Cleveland Clinic, that harness that tech stack to enhance the member experience and simplify administrative tasks.
Through +Oscar, provider-sponsored health plans and regional insurers can operate at a similar level of efficiency to larger payers despite the smaller scale, Oscar Health said.”

Cigna accuses Connecticut physician practice of price gouging: “A Connecticut physician practice suing Cigna over COVID-19 payments exploited a national health emergency and overcharged insurers for diagnostic tests, Cigna claimed in recent court filings.
The price gouging claims come amid a legal battle between Cigna and Murphy Medical Associates, an internal and preventive medical practice in Southwestern Connecticut. In an amended complaint filed March 24, Murphy Medical accused Cigna of failing to provide coverage for COVID-19 testing and related services.”

Assessment of Potentially Preventable Hospital Readmissions After Major Surgery and Association With Public vs Private Health Insurance and Comorbidities: “This cohort study using a weighted sample of 1 937 354 patients found that 18% of readmissions within 90 days of hospital discharge were for a potentially preventable cause. Public insurance, compared with private insurance, was associated with an increased risk of potentially preventable readmission….
This study suggests that improved access to ambulatory care in the postoperative period, particularly for high-risk patients, may be associated with a substantial reduction in postoperative readmissions after major surgery.”

About healthcare IT

Global investment in telehealth, artificial intelligence hits a new high in Q1 2021: “Telehealth investment hit an all-time high of $4.2 billion in just 139 deals in the first quarter, almost doubling the $2.2 billion raised in the same quarter a year ago, according to CB Insights.
That's the highest global funding for telehealth during one quarter on record, according to the company's first-quarter 2021 report. Funding also was up 18% from the $3.6 billion raised in the fourth quarter of 2020.”

The telehealth services Blue Cross Blue Shield is making permanent: “While Blue Cross Blue Shield has not made a companywide announcement on where telehealth stands after the pandemic, its subsidiaries have been individually sharing where they are in their plans.”
The article has brief statements on what 7 Blues Plans are doing.

The association between perceived electronic health record usability and professional burnout among US nurses: “The mean nurse-rated EHR SUS [System Usability Scale: 0-100] score was 57.6 (SD 16.3). A score of 57.6 is in the bottom 24% of scores across previous studies and categorized with a grade of ‘F.’ On multivariable analysis adjusting for age, gender, race, ethnicity, relationship status, children, highest nursing-related degree, mean hours worked per week, years of nursing experience, advanced certification, and practice setting, nurse-rated EHR usability was associated with burnout with each 1 point more favorable SUS score and associated with a 2% lower odds of burnout (OR 0.98; 95% CI, 0.97–0.99; P < .001)…[In other words,] EHR usability and the odds of burnout were strongly associated with a dose-response relationship.”
See hospitals and health systems below for a nursing shortage article.

About pharma

Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics: “This study found that older adults and Black patients were underrepresented in postmarketing studies of novel cancer therapeutics to a similar degree that they were underrepresented in premarketing studies. These findings suggest that postmarketing studies are not associated with improvements to gaps in demographic representation present at the time of FDA approval.”

J&J's sales of prescription drugs up 9.6% in Q1, topping forecasts:
—Prescription drug sales: $12.2 billion (forecasts of $12.1 billion), up 9.6%
—Overall revenue: $22.3 billion (forecasts of $22 billion), up 7.9%
—Profit: $6.2 billion, up 6.9%
”The company noted that sales growth of prescription drugs was driven by Darzalex, Erleada, Imbruvica, Invega Sustenna/Xeplion/Invega Trinza/Trevicta, Stelara and Tremfya, partially offset by declines for Remicade and Zytiga due to biosimilar and generic competition.
Johnson & Johnson noted that its COVID-19 vaccine Ad26.COV2.S generated sales of $100 million in the first quarter, despite its use being paused in the US and rollout delayed in Europe due to concerns over blood clots.”

FDA loses ‘drug or device’ argument again: “A federal appeals court has ruled that the FDA must regulate a barium sulfate product ingested before imaging as a device rather than a drug. The decision counts as a win for Genus Medical Technologies (St. Louis), maker of the Vanilla SilQ line of contrast agents used to image structures or fluids within the body.
Genus has manufactured Vanilla SilQ since 2015 and sought regulation for it as a device because the opacity of its barium sulfate component enables healthcare providers to visualize the gastrointestinal tract. Barium sulfate is an inert metal salt that does not chemically interact with human cells or tissue, as a drug does…
Genus estimated the cost of seeking clearance to market its product as a device at $60,000, whereas seeking approval to market it as a drug could exceed $500,000, plus a continuing annual cost of more than $186,000, according to the court order dismissing the FDA’s motion for summary judgment…
[T]he appeals court agreed with a lower court in ruling that the FDCA [Food Drug and Cosmetic Act] ‘unambiguously forecloses the FDA’s interpretation,’ granting summary judgment in Genus’s favor and vacating the FDA decision to classify Genus’s products as drugs. ‘We agree with the district court that the text, statutory structure and legislative history of the Act make plain that the Congress did not grant the FDA such sweeping discretion,’ circuit judge Karen L. Henderson wrote for the court.”
Since some products can be classified as a device or drug at the FDA’s discretion, this decision is significant in the boundaries it puts on such discretion.

About hospitals and health systems

Hospital executives report high nursing vacancies, greater reliance on costly travel nurses: “Thirty-six percent of hospital executives say they anticipate more than 25 openings this year compared to 17% in 2020, while 21% anticipated more than 50 opens and 11% predicted more than 100 open positions, according to a survey conducted by Avant Healthcare Professionals
Seventy percent of the respondents reported losing anywhere from 5% to 30% of their staff as a direct result of COVID-19.New graduates and internal recruitment are the primary strategies these organizations will employ to address those vacancies, although many fewer respondents said they were focusing on that second option in 2021 compared to the year prior (45% versus 70%).”

Tenet posts $97M in profit in Q1 due to higher acuity patients: “Hospital chain Tenet Healthcare posted $97 million in profit in the first quarter of the year, up slightly from the $94 million it earned the same period in 2020 before the COVID-19 pandemic took hold.
Overall, Tenet Wednesday reported $3.9 billion in revenue for the hospital segment, up by nearly 3% from the $3.8 billion in the first quarter of 2020. Patient service revenue was also $3.6 billion in the first quarter compared with $3.5 billion in the first quarter of 2020.
‘The increase in revenues was primarily due to higher patient acuity and commercial payer mix, which more than offset lower patient volumes as a result of COVID,’ Tenet said…”