HEALTH CARE BRIEFING: Top Court Leaves Vaccine Onus on Companies

States and businesses will have to decide for themselves whether American workers should be required to get coronavirus shots, after President Joe Biden’s flagship vaccination mandate was gutted by the U.S. Supreme Court.

The court yesterday blocked Biden’s workplace health rule that would have required companies with 100 or more employees to either mandate Covid-19 vaccination or weekly testing. A separate rule to require vaccination for federal contractors had earlier stalled amid legal fights.

Taken together, the high court’s decisions exempt millions of workers from measures Biden announced in the fall as vaccinations slowed and the delta variant fueled a new spike in cases. Despite ample supplies of shots, the U.S. badly trails other industrialized nations at inoculations, with less than 63% of the population fully vaccinated, according to the Bloomberg Vaccine Tracker.

The U.S. vaccination campaign has suffered from political divisions, with polls showing Republicans far less willing to get shots than Democrats. Multiple Republican political leaders have fought vaccine mandates and some have baselessly questioned the safety and efficacy of shots, undermining Biden’s effort to curb the pandemic.

The employer mandate “was the single most effective policy for getting people vaccinated,” said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. Judges have generally made clear that businesses are free to require vaccines for their employees, and Biden urged businesses and states to impose their own mandates.

As of now, the U.S. is left with two remaining mandates. One requires vaccination for roughly 10 million health-care workers at Medicare- and Medicaid-participating hospitals and in other health-care settings, upheld by the court yesterday. The other rule requires shots for most federal workers. The court’s verdict on health-care workers is a win for the administration. The rule will save lives both of workers and patients, Biden said: “We will enforce it.” Read more from Josh Wingrove.

The decision signals trouble for OSHA’s other infectious disease rulemakings. The high court decision doesn’t halt OSHA’s other Covid-19 curbing efforts, including the issuance of workplace hazard citations under that general duty clause, which has been a bulwark of its enforcement efforts thus far.

Brent Clark, a partner with Seyfarth Shaw in Chicago and co-chair of the firm’s Workplace Safety and Environmental Group, said he was pleased that the court’s majority opinion upheld OSHA’s ability to regulate occupational hazards while rejecting the emergency standard as a public health measure. “It seemed like OSHA was trying to address a public health issue through an occupational health standard,” Clark said. Read more from Bruce Rolfsen.

Businesses threatened by omicron’s spread might be forced to implement a vaccine mandate anyway to protect the workers they have and keep factories open.

While many companies have already imposed their own vaccine requirements, about 1 in 3 employers planned to do so only if the OSHA rule took effect. Those companies now face a decision, one that might be forced upon them by surging Covid-19 infection rates that have sent absenteeism soaring at plants, hospitals and other workplaces.

“With this new variant, employers who were on the fence before about doing a mandate will have to look at whether testing or vaccination will be necessary just to continue operating,” said Rachel Conn, an employment and OSHA partner at law firm Nixon Peabody. “It may be about just keeping the facility open at this point.” Read more from Matthew Boyle.

Meanwhile, health-care facilities must once again work toward complying with a Biden administration vaccine mandate, attorneys who advise hospitals and other medical providers said in the wake of the Supreme Court’s decision to allow that requirement to move forward.

Health-care providers should be “full speed ahead” in their efforts to comply with the requirement, said Frank Morris Jr., a member of Epstein Becker & Green.

But providers may have a short time frame to take action. The deadline for workers at facilities in states unaffected by the lower court injunctions to get their first dose of a Covid-19 vaccine is Jan. 27, according to the CMS. The agency has not said whether it will offer an alternative deadline for the states involved in the litigation that reached the high court. Read more from Allie Reed.

Happening on the Hill

Future of Trump-Era Medicare Program Spurs Fight: A growing number of Democrats in Congress are pushing the Biden administration to end a little-known Medicare program they say undermines health care for seniors. The effort, backed by dozens of House Democrats, is part of the fight to reshape Medicare between groups that seek to give traditional public coverage to every American, and industry groups that want more flexibility in how they treat patients.

“This is an assault on traditional Medicare,” said Ed Weisbart, chair of the Missouri chapter of Physicians for a National Health Program. His group supports creation of a single-payer health system in the U.S. Weisbart and his group have been lobbying lawmakers and federal officials to end the program that allows Medicare providers to get paid lump sums to treat patients instead of billing for each service provided. The experiment was started under the Trump administration and continues under Biden. Read more from Alex Ruoff.

FDA Pick Advances to Full Senate: Robert Califf is a step closer to becoming the new head of the Food and Drug Administration after a Senate panel yesterday advanced his nomination. The Senate Health, Education, Labor and Pensions Committee voted 13-8 to support Califf, who previously led the agency in the final year of the Obama administration. The vote came after a hearing in which he got bipartisan support from panel members, despite some opposition over his drug industry ties. Sens. Bernie Sanders (I-Vt.) and Maggie Hassan (D-N.H.) joined most Republicans in voting no. Celine Castronuovo has more.

• Sen. Edward Markey (D-Mass.) will also oppose Califf’s nomination, saying he is not the leader agency needs to effectively regulate addictive opioids. Markey said he met with Califf to discuss how the FDA could better work to tackle addiction issues but got no commitment to “decisive and comprehensive action necessary to ensure reforms that the FDA, under his leadership, would implement on opioid regulation.” Find the statement from Markey here.

Lawmakers Say Ease Blood Donor Regulations: Democrats in Congress want the Biden administration to permit men who had sex with another man to donate blood without any deferrals. Over 20 Democratic senators sent a letter to federal health officials yesterday calling for an update to FDA blood donation guidelines amid shortages of blood reported by the Red Cross. Separately, House Oversight Chair Carolyn Maloney (D-N.Y.) asked the FDA to rethink the three-month deferral for donating blood by men who have had sex with another man. Read more from Alex Ruoff.

The Coronavirus Pandemic

Government Services Bog Down on Federal Sick Days: Passengers at the Phoenix airport had to be funneled into consolidated checkpoints because so many security agents called in sick. In a San Jose, California, courtroom, a federal judge postponed the highly anticipated fraud trial of Theranos Inc.’s former president because jurors can’t be brought in to fill out questionnaires. And at supermarkets from coast to coast consumers could soon be paying even more for ground beef as meat-packing plants and slaughterhouses have slowed production because of a lack of government inspectors.

Across the country, the coronavirus surge that is claiming record numbers of victims is disrupting a federal civilian workforce of 2 million. That has delayed the processing of tax returns, drug approvals and even foreign travel by diplomats as workers call in sick, quarantine or stay home to care for ill family members. Read more from Ari Natter.

Biden to Double At-Home Test Order, Provide Masks: Biden said his administration will double its order of rapid Covid-19 tests to send to Americans, while also distributing “high quality” masks to help fight the omicron variant. The plan to buy another 500 million at-home tests comes as the U.S. is facing a shortage, creating long lines at testing centers and a scarcity of rapid at-home tests in stores. At the same time, prices for masks offering the highest protection are rising. Health researchers recommend N95 and KN95 masks. As omicron surged, people have flocked to buy them, boosting their prices. Read more from Josh Wingrove, Courtney Rozen, and Justin Sink.

Hospital Admissions Show Omicron’s Spread to West: The Covid-19 burden on U.S. health-care facilities is spreading from the Northeast to parts of the West Coast, as well as rural states across the nation. The seven-day average of hospital admissions with confirmed Covid-19 is up 76% in Alaska, 59% in Idaho and 53% in Arkansas over the last week, according to Department of Health and Human Services data. Oregon and California round out the worst five states by momentum with admissions up 52% and 51% respectively, while the Northeast is flashing signs that cases will fall in days. Read more from Jonathan Levin.

• Covid-19 cases among U.S. nursing-home workers rose nearly tenfold in recent weeks as omicron raced through senior-care facilities. A record 57,000 nursing-home workers tested positive during the week that ended Jan. 9, data from the CDC show, up from about 6,000 the week ending Dec. 19. Cases are also spiking among nursing-home residents. Around 32,000 residents tested positive last week, close to the previous peak in late 2020. Read more from John Tozzi.

Virus Loses Most Infection Capacity After 20 Minutes: SARS-CoV-2 loses most of its ability to infect shortly after being exhaled and is less likely to be contagious at longer distances, an analysis from the University of Bristol’s Aerosol Research Centre shows. Researchers found the virus loses 90% of its contagion capacity 20 minutes after being airborne and that most of the loss occurs in the first five minutes of it reaching the air, according to the study. With some nations opening debate about an endemic phase of the pandemic, insights into how the virus travels will help guide their approach. Irina Anghel has more.

• Related: Omicron Less Severe Even for Unvaccinated, Study Says

More Headlines:

• U.S. Truckers Must Get Shots or Be Denied Entry, Canada Rules
• U.S. Nurses Are Striking in Protest of Covid Working Conditions
• N.Y.C. Mayor to Weigh ‘Temporary’ Remote Option for Schools
• Sewage Data Show Omicron Wave May Have Peaked in Boston
• Hundreds of Millions of Vaccines Risk Going Into Trash: Report
• Astra Touts New Data Showing Covid Shot Effective as Booster
• Africa Needs a Sixfold Rise in Weekly Shots in Arms, WHO Says

What Else to Know Today

Biogen Preps Fight for More Alzheimer’s Drug Coverage: Biogen executives vowed to fight to reverse Medicare’s preliminary decision to sharply restrict coverage of the company’s Alzheimer’s drug, while saying more cost cuts and strategic measures are possible if the move stands. The drugmaker is urging patients and physicians to show their disapproval with the plans to restrict reimbursement for Aduhelm to patients in randomized trials. Potentially only a small fraction of patients would be able to access the drug under the rule, CEO Michel Vounatsos said, Robert Langreth and Angelica Peebles report.

Nursing Homes, Home Health Marked for Medicare Cuts in 2023: A federal advisory commission will recommend to Congress that traditional Medicare lower payments by 5% to nursing homes, home health agencies, and inpatient rehabilitation facilities in 2023. After assessing payment adequacy, the Medicare Payment Advisory Commission found that the three provider groups were receiving sufficient reimbursement for the services they provide. MedPAC provides lawmakers with analysis and policy advice on the taxpayer-funded Medicare program. Read more from Tony Pugh.

More Headlines:

• Sarepta Gets Agency Look at Dystrophy Treatment Patents

Editor’s Note: Bloomberg Government’s Health Care Briefing will not publish on the Monday, Jan. 17 Martin Luther King Jr. Day federal holiday. We’ll return Tuesday, Jan. 18.

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