Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Delta variant front, AHIP informs us

Today, the Food and Drug Administration (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted to unanimously (19-0) endorse a booster dose for the Moderna COVID-19 vaccine for persons:

  • 65 years of age and older;
  • 18 through 64 years of age at high risk of severe COVID-19; and
  • 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

The Moderna booster dose is 50 micrograms – half the dosage of each of the first two doses in the series.  Individuals who are immunocompromised will receive the larger dose as was administered for earlier doses, as the third dose is considered part of the original series rather than a booster. * * *

The VRBPAC will convene again tomorrow to discuss recommendations for booster doses of the Johnson & Johnson vaccine and NIH will present data on heterologous use of booster doses following primary series of the three currently authorized or approved vaccines.

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommending the Moderna and Johnson & Johnson vaccine boosters on October 20-21

Yesterday, the Equal Employment Opportunity Commission updated its COVID 19 vaccine incentive and mandate FAQ guidance for employers. The EEOC enforces the Title VII, the Americans with Disabilities Act and the Genetic Information Non-Discrimination Act among other measures. No surprises, as far as the FEHBlog can tell. Search for 10/13/2021 to find the new FAQs.

In related news, Politico reports that “President Joe Biden is likely to nominate former Food and Drug Administration Commissioner Robert Califf to return to the top role at the sweeping regulatory agency, according to four people with knowledge of the situation. * * * Califf previously served as commissioner for nearly a year in Obama’s second administration after an overwhelming vote in his favor. The White House has not finalized its decision, and the people with knowledge cautioned the situation could still change. But nine months into its search for a permanent FDA chief, Califf is now viewed as the leading candidate for the job.

In healthcare business news —

Healthcare Dive tells us that

  • UnitedHealth Group expects its planned $13 billion acquisition of data analytics firm Change Healthcare that’s been held up by DOJ review to close “in the first part of 2022,” COO Dirk McMahon told investors on a Thursday morning call.
  • The news is likely to anger hospital groups, which have raised concerns — some direct to regulators — that the deal could lower health IT competition and give its payer arm UnitedHealthcare an unfair advantage in contract negotiations.
  • The news comes as the diversified healthcare [company] beat Wall Street expectations on both earnings and revenue in the third quarter, with a topline of $72.3 billion, up 11% year over year, due to double-digit percentage growth in both UnitedHealthcare and health services business Optum. Profit was $4.2 billion, up 29% compared to the third quarter last year. As a result, Minnetonka, Minnesota-based UnitedHealth bumped its full-year guidance.

The Wall Street Journal reports that

Walgreens Boots Alliance Inc. will pay $5.2 billion to acquire a controlling stake in primary-care network VillageMD as the pharmacy chain seeks to remodel itself as a healthcare provider.

VillageMD operates more than 200 clinics where it has acquired or hired its own physicians and medical staff. Walgreens said the investment will enable it to open doctors’ offices at 600 or more of its drugstore locations by 2025, and a further 400 by 2027.

The drugstore company already owns a stake in VillageMD after agreeing last summer to pay $1 billion in equity and debt over the three years in exchange for a 30% stake in the Chicago-based startup. Under the deal announced Thursday, Walgreens will hold a 63% stake in VillageMD.

The deal is the first major strategic move under Walgreens Chief Executive Rosalind Brewer, who came to the company from Starbucks in January.

Also Thursday, Walgreens said it would acquire a majority stake in CareCentrix Inc., a Hartford, Conn.-based home health benefits manager. Walgreens said it derives 85% of its revenue from some 35 million customers who have chronic conditions such as diabetes or heart disease.

Finally, STAT News reports that

Five months ago, weight loss company Noom announced $540 million in funding, dwarfing its previous investments. With locked-down users flocking to its app, revenues in 2020 had surged to $400 million, and the company made an ambitious pitch: It would spend the money to expand its behavioral change approach to other conditions, including diabetes, hypertension, and sleep.

Now, Noom is taking its first big step toward becoming a diversified digital health company with Noom Mood, a smartphone wellness app targeted toward people with daily stress and anxiety. Like the company’s weight loss program, Mood — which the company first rolled out as a beta program last year — primarily draws on concepts from cognitive behavioral therapy. “It was kind of a no-brainer,” said Andreas Michaelides, Noom’s chief of psychology. “These concepts are really what we consider to be the gold standard with psychology.”