HEALTH CARE BRIEFING: Biden Adviser Says Mandate on Legal Ground

President Joe Biden’s requirement for employees at companies with more than 100 workers to get Covid-19 vaccinations or regular testing is on solid legal ground, presidential adviser Cedric Richmond said, Tony Czuczka reports.

“We’re very confident we’re on statutory and legal grounds,” Richmond said yesterday on CBS’s “Face the Nation.”

A federal appeals court in New Orleans temporarily halted the mandate’s nationwide rollout on Friday and gave the Biden administration until today to respond. Republican state attorney-generals and companies have been challenging the U.S. Occupational Safety and Health Administration’s rule, which sets a Jan. 4 deadline.

“The purpose of the OSHA rule is that we keep employees safe in the workplace,” Richmond said. “So when you go to work you want to make sure that you’re safe, and we see that mandate vaccines work.”

The administration is “fully prepared to defend this standard in court,” Solicitor of Labor Seema Nanda, the U.S. Labor Department’s top legal officer, said Saturday.

Earlier: Appeals Court Halts Rollout of Biden’s Company Vaccine Rule

• Alabama employers face new limits on their ability to fire workers who refuse a mandated vaccine, under legislation Gov. Kay Ivey (R) signed Friday as part of a broader GOP pushback against federal workplace mandates. The Alabama legislation, SB 9, requires employers that mandate Covid-19 vaccines to give workers the opportunity to request an exemption and bars employers from firing anyone who makes that request. Read more from Chris Marr.
• OSHA’s new emergency temporary standard doesn’t require employers to pay testing fees or compensate workers for the time spent being tested, but other federal, state, and local laws may require it and business-side attorneys want clarity on what they should do. “What OSHA has actually done is not take a position. They said we’re not going to independently require employers to pay for tests, however employers might have to under pre-existing law,” said Devjani Mishra in New York, leader of Littler Mendelson P.C.’s Covid-19 task force. Read more from Bruce Rolfsen.
• The largest trade group for the trucking industry interprets the administration’s vaccine and testing rule as exempting most of its drivers even without specific language in the mandate. The sector had been heavily lobbying for a carve-out for truckers before the administration’s announcement Thursday of an emergency temporary standard requiring vaccinations or weekly testing for workers of larger employers by Jan. 4. Read more from Lillianna Byington and Ryan Beene.

The Coronavirus Pandemic

Child Vaccine Demand Underscores Divisions: After months of home schooling and school quarantines, children are getting their Covid-19 vaccines. Early indications are that the rollout is mirroring what grownups have just experienced—the children’s vaccine is in high demand in urban coastal areas, met with deep skepticism in many segments of society, and is difficult to find in rural areas off the beaten track. The result could be that areas with high vaccination rates already will get even more inoculated and protected while others remain vulnerable.

The Centers for Disease Control and Prevention said last week that the coronavirus is among the top 10 leading causes of death among children 5 to 11 in the last year. Even so, less than a third of parents said they’re eager to get their kids 5 to 11 vaccinated, while another third said they’ll wait and see how the vaccine is working, a Kaiser Family Foundation poll says. The final third said they will definitely not get the vaccine for their kids. Read more from Anna Edney.

Pfizer Results Open Door to New Chapter for Treatments: The world needs an easy-to-take Covid-19 treatment. Pfizer’s and Merck’s Covid-19 pills might be just that. But questions remain over how well they will work in the real world, how safe they are and whether they will need to be taken in drug cocktails rather than alone. Pfizer’s pill results were hailed as remarkable Friday, the drug reduced the risk of hospitalization or death by 89% in patients. It follows a successful Covid pill trial from rival Merck in October and both drugmakers are now working to get regulatory authorization.

That’s left even the most skeptical doctors and scientists cheering the moment as a feat for drug development—and a potential turning point in the pandemic. “Just stunning,” Ashish Jha, dean of the Brown University School of Public Health, tweeted about the results. He said that the “implications of effective therapeutics for ending the pandemic are very, very large.” But successful development of the pills, drugs known as antivirals, wasn’t a given. Read more from Emma Court and Fiona Rutherford.

• Pfizer is aiming to submit data from its Covid-19 pill to federal regulators by Thanksgiving on Nov. 25, potentially clearing the way for an emergency-use authorization, according to CEO Albert Bourla. Speaking in an interview on Bloomberg TV, he said the drugmaker was preparing to submit the data to the Food and Drug Administration. In the meantime, the CEO called on countries around the world to secure supply agreements. Read more from Riley Griffin.

Moderna Struggles With Vial-Filling: More than 10 months after U.S. regulators first authorized its shot, Moderna is finding that inventing a Covid-19 vaccine was actually a relatively straightforward task compared with what would come next: ramping up vial-filling operations on multiple continents and distributing the vaccine to countries across the world in the midst of a pandemic. The company announced it would be able to supply just 700 million to 800 million doses this year, down from its prior projection of up to 1 billion doses—not due to production, but logistics. Robert Langreth and Angelica LaVito have more.

More Headlines:

• FDA Clears Vaccine-Substance Batches From Emergent Factory
• U.S. Flights Re-Open, Handing British Airways $1 Billion Lifeline
• Aide Close to Biden Suspected of Covid-19 Case Tests Negative
• U.N. Summit’s Covid Honor System Puts Infection Rate at 0.1%

On Lawmakers’ Radars

Infrastructure Bill Passed, Drug Prices Wait: The House on Friday passed a bipartisan $550 billion infrastructure package in decades, but action will have to wait on a more than $1.75 trillion tax and spending package that makes up much of the rest of Biden’s domestic agenda. The social spending package, which is set to include provisions that would allow Medicare to negotiate some drug prices, will have to wait until House lawmakers return the week of Nov. 15. House Majority Leader Steny Hoyer said the legislation would be passed before the Nov. 25 Thanksgiving holiday. In a statement, House moderates who opposed moving forward on Friday said they would allow for a vote no later than the week of Nov. 15, Erik Wasson, Billy House, Laura Davison and Jarrell Dillard report.

Mending Trust on Tap for Next FDA Head: A new permanent commissioner at the Food and Drug Administration will need to bring more clarity to the government’s pandemic response and restore trust to a federal agency that remains without a Senate-confirmed leader nearly a year into the Biden administration, policy analysts and former FDA officials say. Biden has only weeks left to name a replacement for acting Commissioner Janet Woodcock, who was ruled out for the job amid opposition on Capitol Hill. Installing a permanent head is seen as necessary to bring a steady presence during the pandemic.

“It’s hard to have a vision and goals that you want to achieve as an acting commissioner,” former FDA Deputy Chief of Staff Kalah Auchincloss said. A Senate-confirmed commissioner is likelier “to have a thought about what direction the ship should go in and potentially change directions.” Read more from Celine Castronuovo.

Lawmakers Say Surprise Billing Rule Not Written Correctly: Reps. Brad Wenstrup (R-Ohio) and Tom Suozzi (D-N.Y.) led 150 lawmakers in urging secretaries of the Health and Human Services, Treasury, and Labor departments to rewrite a surprise billing interim final rule to more accurately reflect the No Surprises Act. The rule “could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care,” the lawmakers said. That’s “the exact opposite of the goal of the law,” they said. Read their letter here.

What Else to Know

SCOTUS to Weigh Dispute Over Kidney Care Coverage: The Supreme Court will review the scope of federal laws governing how employee health benefit plans must treat people with end-stage kidney disease. The dispute stems from a suit a dialysis provider brought against an Ohio hospital’s health plan for treating all dialysis providers as “out-of-network” and reimbursing them at the lowest level rate. Due to a lack of in-network dialysis providers, DaVita argues Marietta Memorial Hospital’s employee health plan incentivizes patients to switch to Medicare to avoid paying more for life-sustaining care. Read more from Lydia Wheeler.

• The bench will also take a look at cases from a pair of doctors convicted of running pill mills. The question the justices agreed to take up is whether Xiulu Ruan’s and Shakeel Kahn’s convictions can stand without a trial court considering their good faith defense over whether they “reasonably believed” or “subjectively intended” their prescriptions were within the course of professional practice. Read more from Kimberly Strawbridge Robinson.

J&J Renews Fight to Halt Baby Powder Suits: Johnson & Johnson is seeking to revive its strategy for resolving tens of thousands of lawsuits alleging its baby powder caused ovarian cancer and other health problems in women. The company ended a two-day trial in Charlotte, N.C., on Friday to decide whether to temporarily pause 38,000 lawsuits aimed at J&J and about 250 retailers and insurance companies. The judge said he would announce his ruling next week when J&J’s bankrupt unit returns to court. Halting the suits is a key part of J&J’s strategy. Read more from Steven Church.

Sirona Strategies Names New Senior Director: The health care consulting firm Sirona Strategies today plans to announce that Alison Armstrong, who spent 14 years with the insurer Anthem, will join the company as senior director, Alex Ruoff reports. Armstrong will register to lobby for the firm and help run two coalitions, Moving Health Home and Data Coalition for Health Equity.

More Headlines:

• Punitive Damages Ruled Out in Hospital-Plan Payment Spats
• U.S. Rebuffs Owing $43 Million Tax Refund to Express Scripts
• Pot Stocks Surge After Report on Republican Legalization Bill
• iRhythm Hit by Second Subpoena Over FDA Communications
• Humira, Enbrel Rivals Would Bring Billions in Patient Savings

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com