Tuesday Tidbits

Photo by Patrick Fore on Unsplash

More good news on the COVID-19 vaccine front:

  • Becker’s Health IT reports that “Healthcare workers in Indiana who tried signing up for the first round of COVID-19 vaccinations Dec. 14 overwhelmed the state’s enrollment website, resulting in down time, according to Indianapolis NBC affiliate WTHR.” Why is this good news? Because now that the COVID-19 vaccine is a reality, people will want the jab as the call it in Britain. That’s human nature.
  • The Wall Street Journal reports that “The Food and Drug Administration [“FDA’] said Tuesday that the Covid-19 vaccine developed by Moderna Inc. was “highly effective,” setting the stage for an emergency authorization later this week that would add a second vaccine to the arsenal against the pandemic.” Here’s a link to the Moderna briefing document for Thursday’s meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee.

A friend of the FEHBlog pointed out the following encouraging FDA announcement

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” 

The announcement today of the first fully at-home OTC COVID-19 diagnostic test follows last month’s authorization of the first prescription COVID-19 test for home use and last week’s announcement of the first non-prescription test system, in which a lab processes the self-collected sample. The FDA has authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing. The Ellume COVID-19 Home Test is the first COVID-19 test that can be used completely at home without a prescription. 

On the omnibus / COVID-19 relief bill front, the Wall Street Journal reports

The top four congressional leaders discussed a coronavirus relief package and sweeping spending bill on Tuesday and planned to return for another meeting in the evening, as lawmakers raced to reach an agreement before critical support programs expire at year’s end.

House Speaker Nancy Pelosi (D., Calif.), Senate Majority Leader Mitch McConnell (R., Ky.), Senate Minority Leader Chuck Schumer (D., N.Y.) and House Minority Leader Kevin McCarthy (R., Calif.) first conferred in the afternoon, with the meeting of both parties’ leaders a signal that they could be ready to make the difficult decisions needed to cut a deal. 

The group will meet again late Tuesday. 

“We’re continuing to work. I think there’s progress. We’ll get back together,” Mr. McCarthy said following the afternoon meeting.

Treasury Secretary Steven Mnuchin, who spoke to Mrs. Pelosi earlier Tuesday for more than an hour, also joined the first meeting by phone. 

The legislative text must be released tomorrow if Congress want to stick with the current December 18 deadline for action.

A friend of the FEHBlog pointed out the Office of Management and Budget’s Office of Information and Regulatory Affairs has issued its Fall 2020 Unified Agenda of “Regulatory and Deregulatory Actions. Here’s a link to the OPM agenda. The FEHBlog noticed a FEHBP centralized enrollment proposed rule and a final FEHBAR rule involving the Truth in Negotiations Act threshold change which the FEHBlog called to OPM’s attention.

In other healthcare news

  • Health Payer Intelligence offers “Five Pivotal Payer Industry Trends To Watch in 2021.”
  • Healthcare Finance News reports that various healthcare trade associations have asked a federal district court in Maryland to preliminarily enjoin implementation of the Trump Administration’s Medicare Part B international drug price index pilot scheduled for January 1, 2021. The motion was filed on December 10 and the government filed its opposition today.
  • A friend of the FEHBlog pointed out this NIH press release on the state of bad teenager habits.

Findings released today from the most recent Monitoring the Future (MTF) survey of substance use behaviors and related attitudes among teens in the United States indicate that levels of nicotine and marijuana vaping did not increase from 2019 to early 2020, although they remain high. The annual MTF survey is conducted by the University of Michigan’s Institute for Social Research, Ann Arbor, and is funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

In the four years since the survey began including questions on nicotine and marijuana vaping, use of these substances among teens have increased to markedly high levels From 2017 to 2019, the percentage of teenagers who said they vaped nicotine in the past 12 months roughly doubled for eighth graders from 7.5% to 16.5%, for 10th graders from 15.8% to 30.7%, and for 12th graders from 18.8% to 35.3%. In 2020, the rates held steady at a respective 16.6%, 30.7%, and 34.5%. However, somewhat encouragingly, daily, or near daily (20 occasions in the past 30 days), nicotine vaping declined among 10th and 12th graders from 2019 to 2020, by close to half — from 6.8% to 3.6% in 10th grade and from 11.6% to 5.3% in 12th grade.