Thursday Miscellany

David Ermer–Congress, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

From the Capitol Hill front, Roll Call reports that

President Joe Biden and Democratic leaders reluctantly acknowledged Thursday that the Senate would soon recess for the year without passing their sprawling $2.2 trillion social safety net and climate spending bill or voting rights legislation. 

From the Omicron front, Bloomberg tells us that

President Joe Biden warned that unvaccinated Americans face “a winter of severe illness and death” as he urged initial doses and booster shots amid a surge of coronavirus cases and the emergence of the omicron variant.

David Leonhardt writing in his New York Times Morning column adds that “about 15 percent of American adults remain unvaccinated.”

From the COVID vaccine front, AHIP informs us that

Today, the CDC’s Advisory Committee on Immunization Practices (ACIP) convened to discuss the recent developments and safety considerations for the Janssen/Johnson & Johnson COVID-19 vaccine. 

ACIP voted unanimously to amend their recommendation: mRNA COVID-19 vaccines are preferred over the Janssen COVID-19 vaccine for the prevention of COVID-19 for those 18 years of age and older. 

Deliberations within the committee stressed the importance of updating the Clinical Considerations and educational materials regarding the vaccine to ensure that anyone who chooses to receive the Janssen adenovirus-based vaccine is informed of the potential risks.  

Earlier this week, the FDA updated its Emergency Use Authorization Fact Sheet to indicate that the Janssen vaccine is contraindicated for individuals with a history of thrombosis with thrombocytopenia syndrome (TTS).  This was based on new information showing that cases of TTS have been reported in both males and females, and that approximately 15% of TTS cases have been fatal.

Following the discussion, the Committee reviewed a presentation on safety data regarding the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years old.  Very few adverse events or severe systemic reactions were reported, with most incidents including pain, fever, fatigue, headache, and/or myalgia, and most beginning one or two days following the second dose with symptoms alleviating within a few days.  To date, there have been two deaths in children who received the vaccine, each with children who have complicated medical histories, both of which are still under investigation.

Finally, CDC presented current data about the Omicron variant.  This variant appears to be more transmissible than earlier variants, but more data is needed to know if it causes more severe illness.  Vaccines are expected to protect against severe illness, hospitalizations, and death, with booster vaccines showing increased protection than the two-dose series.  It is unclear how prior infection impacts neutralization.  CDC is continuing to monitor real-world evidence across all populations to inform further action.

Also from the omicron front, Healthcare Dive reports that

— FDA has identified three COVID-19 molecular tests that are not able to detect the omicron variant and warned that the diagnostics from Applied DNA Sciences, Meridian Bioscience and Tide Laboratories will return false negative results.

— The agency on Wednesday updated its list of tests impacted by virus mutations. While FDA continues to gather additional information and work with the three manufacturers to address these issues, it recommended the diagnostics not be used by clinical laboratory staff and healthcare providers.

— Makers of both polymerase chain reaction and rapid antigen tests have said their tests can detect omicron. Siemens Healthineers is the latest company to claim its testing portfolio is unaffected by the variant. However, Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, told test developers Wednesday during a virtual town hall that the agency continues to receive “a lot of inquiries” about omicron and its potential impact on diagnostics and will continue to focus efforts on evaluating molecular and antigen tests.

The Wall Street Journal adds that

Pfizer Inc. and BioNTech SE  say they have asked U.S. regulators to fully approve their Covid-19 vaccine for adolescents ages 12 to 15. The vaccine was fully approved by the U.S. Food and Drug Administration in August for people 16 years and older. 

From the COVID vaccine mandate front, we have two court decisions:

  • The Society for Human Resources Management explains that “On Dec. 15, the 5th U.S. Circuit Court of Appeals lifted a district court’s order that had blocked the Biden administration’s COVID-19 vaccination directive for health care workers nationwide. But the requirement remains blocked in 24 states.” The 24 states are composed of 14 State plaintiffs in the 5th Circuit case and 10 State plaintiffs in the first PI. The Congressional Research Service recently wrote a report on nationwide injunctions.
  • The government contractor mandate nationwide preliminary injunction (“PI”) followed the same course as the healthcare workers preliminary injunction — a PI issued for three states followed by a court in another state issuing a nationwide injunction. Perhaps the 11th U.S. Circuit Court of Appeals which is hearing the government’s appeal of the government contractor mandate PI (Case No. 21-14269), will follow the 5th Circuit’s lead.
  • The National Law Review reports that

[Also on Dec. 15] The [U.S. Court of Appeals for the] Sixth Circuit denied en banc review in the OSHA vaccine mandate cases.  The vote was a close one, with eight judges voting in favor of initial hearing en banc.  But that’s not enough under the circuit’s rules, which require a majority of the 16 active judges to vote for en banc treatment.  As a result, the current panel reviewing the case will decide whether to continue the stay issued by the Fifth Circuit, which may end up being the most consequential decision in the case until it comes before the Supreme Court.

From the miscellany department —

  • GoodRx brings us up to date on Alzheimer’s Disease research.
  • “The HEALTH CARE TRANSFORMATION TASK FORCE (HCTTF or Task Force), a group of leading health care payers, providers, purchasers and patient organizations, today announced that its provider and payer members reported having 61 percent of their business in value-based payment arrangements at the end of 2020. Value-based care and payment arrangements focus on lowering costs and improving the quality of care to drive overall population health. The new report shows significant progress towards the goal and has increased twofold from the group’s first report of 30 percent in value-based arrangements in 2015.”

Roughly 40% of U.S. healthcare payments were tied to alternative payment models (APMs) last year, with Medicare Advantage claims representing the largest amount, a new survey found.

The survey, published Wednesday by the Health Care Payment Learning & Action Network, showed that more work needs to be done as most healthcare payments were still tied to a fee-for-service model.

“The survey shows we have made limited progress in moving away from fee for service between 2019 and 2020,” said Mark McClellan, M.D., Ph.D., director of Duke University’s Margolis Center for Health Policy and co-chair of the LAN CEO forum, during the LAN Summit Wednesday. “Most payments are still in fee-for-service, especially outside of Medicare.”

  • If you are bit confused by these findings, APMs are a type of value based pricing arrangement. Health Affairs offered a useful article on the various value based payment models earlier his year.