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Our Take: New COVID-19 mandates could require millions more to be vaccinated by Jan. 4 unless lawsuits prevail

Nov 08, 2021

CMS issued an interim emergency regulation Thursday requiring eligible staff at all health care facilities that participate in Medicare and Medicaid programs to be fully vaccinated against COVID-19 by Jan. 4.

CMS said its requirements would apply to approximately 76,000 providers and cover more than 17 million health care workers. Providers that must comply with the requirements range from hospitals, health systems, and clinics to home health agencies, long-term care facilities, dialysis centers, and community mental health centers.

Exemptions will be available for medical or religious reasons.

The Labor Department’s Occupational Safety and Health Administration (OSHA), also issued an emergency temporary standard (ETS) on Thursday requiring employers with 100 or more workers to develop, implement, and enforce a mandatory COVID-19 vaccination policy. Companies can adopt an alternative policy that gives employees the option of getting vaccinated or undergoing regular testing (at least weekly) and wearing a face covering while indoors.

The Labor Department said the ETS will cover two-thirds of the country’s private-sector workforce. In the 26 states that have state plans with OSHA, it will also cover public-sector workers employed by state and local governments.

Approximately 31 million unvaccinated workers would be affected by the OSHA mandate. According to The Associated Press, OSHA estimated that the mandate would save the lives of more than 6,500 workers and prevent more than 250,000 hospitalizations in the next six months.

Employers must comply with most of the ETS requirement within 30 days (by Dec. 5) and with the testing requirements within 60 days (by Jan. 4). Companies that fail to comply could face penalties of almost $14,000 per violation.

The ETS requires employers to provide paid time off for workers to get vaccinated, as well as paid leave to recover from side effects. It does not require employers to pay for COVID-19 testing.

President Joe Biden issued a statement Thursday in which he said, “Vaccination is the single best pathway out of this pandemic.” He added that while he would have “much preferred that requirements not become necessary, too many people remain unvaccinated for us to get out of this pandemic for good.”

He noted that vaccine requirements help send people back to work. They also “make our economy more resilient in the face of COVID and keep our businesses open,” he said.

Also on Thursday, the Biden administration delayed its vaccine mandate for federal contractors — which was supposed to take effect on Dec. 8 — to align with the newer mandates taking effect on Jan. 4.

Our Take: As expected, it didn’t take long for the legal pushback to begin.

President Biden announced in early September that he would take additional steps to help end the pandemic, giving critics of the planned mandates ample time to prepare their strategies.

On Thursday, the attorneys general of Kentucky, Ohio, and Tennessee filed a lawsuit to keep the mandate for federal contractors from going into effect. Florida had already filed a lawsuit against that mandate the week before.

Then on Friday, the attorneys general in 11 other states, led by Missouri’s attorney general, Eric Schmitt, and joined by private and nonprofit groups, filed a lawsuit in the U.S. Court of Appeals for the Eighth Circuit to block the OSHA mandate.

On Saturday, the Fifth Circuit Court of Appeals, which is based in New Orleans, granted an emergency stay of the OSHA mandate.

The stay was in response to a joint petition filed by the states of Texas, Louisiana, Mississippi, South Carolina, and Utah, along with a number of businesses and religious and advocacy groups.

The court said the plaintiffs had raised “grave statutory and constitutional issues,” the AP reported, noting that the federal government is required to provide an expedited reply to the motion for a permanent injunction on Monday and a petitioners’ reply on Tuesday.

According to the AP, at least 27 states have filed lawsuits challenging the mandates.

Marty Walsh, secretary of the Labor Department, said the administration is ready for the barrage of legal challenges to the OSHA mandate.

“We’re confident about the rule put together, and I think it’s unfortunate that this rule has been out for about eight hours now and people already are suing on it,” Walsh said Thursday on NPR’s All Things Considered. “This is about protecting workers in the workplace. This is about protecting Americans. This is about increasing our number of people in this country that are vaccinated.”

This fight is sure to go several rounds. If the Fifth Circuit Court grants a permanent injunction, then OSHA could take the case to the Supreme Court. We’ll keep you posted.

What else you need to know
Pfizer’s investigational oral COVID-19 drug reduced the risk of hospitalization or death by 89%, according to an interim analysis of data from the Phase II/III study called EPIC-HR, the company said in a press release. The trial’s investigators are evaluating Paxlovid, which is a combination of a drug referred to as PF-07321332 and a low dose of ritonavir, in patients at high risk of progressing to severe illness. Among the participants who were treated within three days of symptom onset, 0.8% of those treated with Paxlovid (3 out of 389) were hospitalized through day 28, whereas 7.0% of those who received placebo were hospitalized or died (27 out of 385 were hospitalized, with seven subsequent deaths). Pfizer said it is stopping enrollment in clinical trials of Paxlovid and will submit available data to the FDA along with a request for emergency use authorization.

More than 35,000 Kaiser Permanente workers could go on strike later this month. That includes as many as 28,400 in Southern California and nearly 3,400 in Oregon and southwest Washington who could begin an open-ended strike on Nov. 15, with another 8,000 poised to strike in five states soon thereafter. In contract negotiations, Kaiser Permanente proposed a two-tier wage system whereby wages for future hires would be reduced by as much as 39%. The health system subsequently lowered the cut to 15%, but workers say the health system is already inadequately staffed and they fear the two-tier wage system would exacerbate the problem by making it harder to recruit new workers and retain existing staff. Unions representing the workers submitted the requisite 10-day notices last week and said the workers would strike unless negotiations improve.

Merck withdrew and refiled notification of its $11.5 billion bid to buy Acceleron Pharma to give the Federal Trade Commission additional time to review the proposed deal. The move gives the FTC an extra 15 days for review and extends the expiration of Merck’s tender offer from Nov. 10 to Nov. 18. Meanwhile, several of Acceleron’s investors have opposed Merck’s offer on the grounds that it undervalues Acceleron. Merck has its eye on sotatercept, an investigational drug in Acceleron’s pipeline that is in Phase III testing as a treatment for pulmonary arterial hypertension. Sotatercept is part of a licensing agreement between Acceleron and Bristol Myers Squibb. BMS is Acceleron’s largest shareholder, with an 11.5% stake it acquired through its buyout of Celgene. If Merck’s bid to acquire Acceleron is approved, the company still expects to close the transaction by the end of the year.

Roche will buy back Novartis’ voting stake in the company for $20.7 billion. Novartis said in a press statement that it has agreed to sell 53.3 million bearer shares of Roche common stock, representing an approximate 33% voting stake, to Roche for $388.99 per share. In 2001, Novartis paid $2.8 billion (32 million shares at $87 per share) for a 20% stake in Roche. Over the ensuing two years, Novartis added to its stake in Roche “for a total consideration of approximately USD $5 billion.” Novartis CEO Vas Narasimhan said, “After more than 20 years as a shareholder of Roche, we concluded that now is the right time to monetize our investment.” The transaction is subject to approval by Roche’s shareholders. Once it has been completed, Roche said it intends to cancel the repurchased shares.

Aetna will launch a new network to cover gene therapies for rare diseases. The insurer’s Gene-based, Cellular and Other Innovative Therapies network will launch on Jan. 1 and will initially cover three gene therapies: Spark Therapeutics’ Luxturna for inherited retinal dystrophy and two treatments for spinal muscular atrophy — Biogen’s Spinraza and Novartis Gene Therapies’ Zolgensma. The national network will be included as a standard medical benefit in all of Aetna’s fully insured plans and will be available to self-insured plans as well, according to a CVS Health press release. The network will also offer a financial protection program for CVS Caremark clients and Aetna plan sponsors who do not have traditional stop-loss insurance.

Walmart Health hired Ochsner Health System’s Dr. David Carmouche to serve as the retailer’s senior vice president of omnichannel care solutions. Currently, Dr. Carmouche is the executive vice president of value-based care and network operations at Ochsner, where he oversees the New Orleans-based health system’s primary care, urgent care, and occupational health businesses. In his new role, which he will assume on Nov. 29, he will lead Walmart’s ongoing expansion into retail health care — not only through additional primary care clinics at Walmart stores but also through telemedicine, home health services and other offerings.

What we’re reading
Why A Universal COVID-19 Vaccine Mandate Is Ethical Today. Health Affairs, 11.3.21

Leaders: Stop Confusing Correlation with Causation. Harvard Business Review, 11.5.21

What else we’re reading
Flow: The Psychology of Optimal Experience, by Mihaly Csikszentmihalyi.

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