Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash

The FEHBlog should rename Monday’s column COVID-19 Vaccine Good News because for the fourth Monday in a row that news leads the FEHBlog.

Healthcare Dive reports that “Moderna on Monday released new study results showing the [messenger RNA based] coronavirus vaccine it developed with U.S. government scientists to be 94.1% effective at preventing COVID-19 in a large clinical trial, data the company will use to request emergency approval” from the Food and Drug Administration.

According to Moderna’s announcement

[P]rimary analysis was based on 196 cases [of COVID-19 within the test group of 30,000 individuals, half of whom received the vaccine and the other half of whom received a placebo]. 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 [vaccine] group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.

Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).

The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.

Healthcare Dive adds that

Moderna said it will submit on Monday [today] an application for emergency use authorization in the U.S. and for conditional marketing approval in Europe. The FDA will convene a panel of independent advisers to publicly review Moderna’s application, likely on Dec. 17. * * *

An authorization for either vaccine [Pfizer – BioNTech or Moderna] would kick off a mass immunization campaign in the U.S. But supplies of each shot will be extremely limited for months. Moderna expects to have just 20 million doses available in the U.S. this year, and between 500 million to 1 billion in 2021. [Two doses protect one person. The Wall Street Journal notes that Pfizer and BioNTech said they would deliver about 25 million doses by year’s end, potentially enough for about 12.5 million people in the U.S.]

A Centers for Disease Control and Prevention advisory committee will meet on Tuesday to vote on how vaccine doses will allocated. Healthcare workers on the front lines of the pandemic will likely be vaccinated first.

The Wall Street Journal expands on this last point:

Expected to be first in line: health workers treating coronavirus patients and in something of a surprise, nursing-home residents.

The Advisory Committee on Immunization Practices, the outside medical experts advising the U.S. Centers for Disease Control and Prevention, will vote on who should get the first doses, after discussing plans for distributing the shots and monitoring for potential side effects.

In other news

  • The FEHBlog overlooked the CDC’s Antibiotic Awareness Week which was held from November 18 – 24. Better late than never right. This is an important public health cause and the link provides useful resources.
  • The FEHBlog noticed a Health Payer Intelligence article about a health plan that “has reduced out-of-pocket healthcare spending by collectively giving members millions of dollars in rewards through their My Health Pays program.” The FEHBlog did a little investigative work and he discovered that the health plan in question participates in the ACA marketplace. It is crazy that individual health plans have no limits on wellness reward uses while group health plans generally must limit their wellness rewards to reimbursing medical services and supplies or Medicare premiums. Congress should level the playing field.

Midweek Update

Health Payer Intelligence discusses a Kaiser Family Foundation survey on deferred healthcare due to the COVID-19 emergency. “Almost 50 percent of American adults deferred care themselves or have a household member who deferred care due to the coronavirus, but more than two-thirds of those who deferred (32 percent of the total adult population) plan to get care in the next couple of months” Wow. Bear in mind that this backlog developed over the past three months. The FEHBlog therefore expects that providers will have the capacity to provide all of this deferred care quickly. But no doubt they will try to do so safely.

Speaking of patient safety, the Choosing Wisely program explains a successful program to improve patient care while reducing costs.

Choosing Wisely serves as the foundational underpinning for all of our discussions with clinicians regarding how we can deliver the highest value care to our patients,” said Alistair Aaronson, MD, MHA, FACP, who joined St. Jude (part of Providence St. Joseph Health System) in 2017 as its Executive Medical Director for Operations and High-Value Care.

Under Dr. Aaronson’s leadership, the 320-bed hospital launched a series of “bite-size projects” to reduce overutilization. Clinicians would pick a topic where there was anecdotal evidence of overutilization and then select a Choosing Wisely recommendation related to that topic. They would then compare their practice patterns against the recommendation; if the results were not positive, they would develop a project to address the overuse.

That’s a sensible solution that can be applied to other nagging problems that face us.

The FEHBlog took note of this Wall Street Journal article on progress being made in the convalescent plasma program to treat COVID-19. The article explains how proponents of this treatment are recruiting COVID-19 survivors to donate plasma in order produce the treatment.

Finding qualified plasma is more complicated than it might seem. Potential donors must meet the requirements of all blood donors, such as weight, age, and underlying health. Some don’t show up for their appointments; others find they are unable to give a sufficient amount.

“These are all challenges we have to recognize along the way in getting a donation from someone to an actual product,” said Dr. Pampee Young, chief medical officer of biomedical services at the American Red Cross. “We are building the plane as we fly it.”

The Red Cross has collected plasma from 4,000 recovered Covid-19 donors to date through its website RedCrossBlood.org/plasma4covid, according to a spokeswoman. She said the organization supports the efforts of the coalition but didn’t join it. “At this time, the Red Cross is fortunate to be able to meet the needs of our hospital partners,” she said. “We also have the capacity to ramp up our supply if necessary.”

[Moreover,] for-profit companies in the coalition [such as Microsoft] also continue to look for donors on their own through digital advertising and other online outreach, according to industry experts.

Surprisingly, one dose of the treatment may require donations from more than one survivor. The developers are fine tuning this issue now as studies continue.

UPI reports that “Workplace wellness programs designed to encourage employees to engage in activities and monitor their health might have negligible benefits, according to a study published Tuesday by JAMA Internal Medicine.”

[The researchers] compared healthcare outcomes and attitudes among [3,300] employees enrolled in the [generous wellness program] to those of 1,584 staff members not included in the initiative. [The study was conducted over a two year period.]

Overall, they found that participants in the wellness program were 5 percent more likely to have a regular primary care physician and more likely to have a positive attitude about their own health, compared to employees who did not participate in wellness-related initiatives.

The FEHBlog cannot understand why increased adoption of primary care physicians did not produce

significant effects on participants’ height, weight, waist circumference, body mass index, blood pressure, cholesterol or blood-sugar levels.

In addition, the risk for high blood pressure, diabetes or obesity was roughly the same for participants and non-participants after one and two years, researchers said.

Similarly, there were no differences between the two groups in terms of doctors’ office visits, hospital visits or emergency department visits.

That is one sobering study.

In other news, OPM today posted a “Fact Sheet: The Use of Flexible Work Schedules in Response to Coronavirus Disease 2019 (COVID-19)” and Govexec.com reports that the Postal Service like many other businesses is struggling with the COVID-19 emergency. But to their credit the mail continues to be delivered.

Weekend update

OPM directs us to the National & Community Service website for ideas on how to celebrate tomorrow’s Martin Luther King Jr. holiday. The FEHBlog believes that our country is indebted to Dr. King for his bold, essential leadership.

The House of Representatives has a district work period this week, while the Senate will be holding a trial on the House’s impeachment of the President.

Last Friday, the Centers for Disease Control announced updates to its vaping restriction recommendations in light of the subsiding vaping-related lung injury known as EVALI crisis. The FEHBlog appreciates the caution that the CDC has shown in handling this crisis.

Fierce Healthcare recently announced its Fierce 15 of 2019.

Big and small, high-tech and not, we’re honoring this collection of companies across the U.S. that are trying to change the world by changing the healthcare industry. 

The FEHBlog is not familiar with any of these companies but in time?

Healthcare Dive helpfully summarizes five key trends fo providers and payers. The FEHBlog is familiar with all of these.

Kaiser Health News discuss the latest hot item in wellness programs — helping employees sleep.