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FDA Authorizes First Oral Antiviral for Treatment of COVID-19

Comagine Health

The Food and Drug Administration  issued an emergency-use authorization Dec. 22 for the first oral antiviral treatment for mild to moderate COVID-19 in adults and children over 12.

Pfizer's Paxlovid will be available by prescription only and should be initiated as soon as possible after the diagnosis of COVID-19 and within five days of symptom onset, according to a press release from the FDA. The pill is designed for those who are high risk for progression to severe COVID-19, including hospitalization or death.

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.  

Paxlovid is not a substitute for vaccination in those for whom COVID-19 vaccination and a booster dose are recommended, the FDA states. 



From Littler Mendelson P.C.

On Friday evening [December 17,2021], the U.S. Court of Appeals for the Sixth Circuit dissolved the Fifth Circuit’s stay of OSHA’s “vaccine or test” requirement for private employers. Following the Court’s order, OSHA quickly announced that employers will now have until:

  • January 10 to develop compliant policies
  • February 9 to begin testing programs

More detail and analysis of the OSHA ETS litigation can be found in our recently published ASAP.

However, within hours of the Sixth Circuit’s decision, a broad coalition of 26 trade groups filed the first of several emergency appeal applications to the U.S. Supreme Court requesting a stay pending Supreme Court review. The U.S. Supreme Court has asked for responses by December 30, 2021.

In the interim, and if you have 100 or more employees, we recommend that you put plans in place to come into compliance with any OSHA ETS requirements that apply to your business by the newly established deadlines. OSHA intends to begin enforcement efforts unless and until the ETS is enjoined again or ultimately declared unlawful – decisions that we will not get until sometime in 2022.


Court Stay on OSHA Emergency Temporary Standard Dissolved

Late Friday evening, it was announced that the U.S. Court of Appeals for the Sixth Circuit dissolved the Fifth Circuit's stay on the OSHA Emergency Temporary Standard (ETS). OSHA can now implement and enforce the COVID-19 Vaccine and Testing ETS for employers with at least 100 employees - at least until another court intervenes.

OSHA has updated its website stating that it will not issue citations for non-compliance with any requirements of the ETS before January 10, 2022, and will not issue citations for non-compliance with the standard’s testing requirements before February 9, as long as an employer is exercising reasonable, good faith efforts to come into compliance with the standard. OSHA further stated that it will work with the regulated community to provide compliance assistance.



MACS Will Provide Mailing to Hospice Regarding the VBID Model


On December 16, 2021, CMS issued Change Request 12524, which directs the Medicare Administrative Contractors (MACs) to provide a direct mailing to hospice providers regarding the Hospice Benefit Component, Value Based Insurance Design (VBID) Model and participating Medicare Advantage Organizations. The mailing will raise general awareness of the hospice benefit component and provide education on participation and billing for Medicare Advantage enrollees that receive services in affected areas. 


Talks between Manchin and Biden at standstill as Build Back Better likely stalled until next year

By Clare ForanManu Raju and Phil Mattingly, CNN

Updated 8:23 PM ET, Wed December 15, 2021

(CNN)Senate Democrats are expected to punt consideration of the cornerstone element of President Joe Biden's agenda into next year after private conversations between Biden and the key Democratic holdout made clear the bill would not have the votes to pass this month.

Critical talks between Biden and West Virginia Democrat Joe Manchin, the Senate's most important swing vote, over how to pass a $1.75 trillion economic and climate package remain far from any resolution on a series of issues, according to multiple sources with knowledge of the discussions.

The impasse, even as talks are expected to continue, marks the clearest sign yet that Democrats will be forced to delay a Senate vote until at least 2022 despite an effort by leadership to approve the bill before Christmas.

A source briefed on the conversations tells CNN that talks between Manchin and Biden over the bill, known as Build Back Better, are "very far apart." Given the state of the talks between the influential moderate senator and the President, sources familiar with the matter say Senate Majority Leader Chuck Schumer is very likely to punt the bill into 2022.

One of the most pivotal issues holding up progress is the child tax credit, a major Democratic Party priority that delivers aid to families and is key to the Biden administration's effort to reduce child poverty. Manchin wants to cut the expanded child tax credit from the bill, with a source telling CNN that he wants to "zero it out."

There are many reasons that Senate Democrats are not ready to vote to pass the Build Back Better legislation in addition to the holdup with Manchin. The legislative text is not yet finalized, a parliamentary review of the bill to ensure Democrats can pass it on a party-line vote is not complete and other policy issues have yet to be resolved, including how to deal with a controversial state and local tax deduction. Enter your email to sign up for CNN’s “What Matters” Newsletter.

But cutting the child tax credit is a nonstarter for Biden, sources note, and that's been the central issue of disagreement, though there are several others outstanding, in the discussions between the two over the last few days.

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