HEALTH CARE BRIEFING: Top Court Backs Health Worker Vaccine Rule

A divided Supreme Court left in force New York’s requirement that health-care workers be vaccinated against Covid-19, refusing to order exemptions for 20 providers who say they object to the shot on religious grounds.

The rebuff, which came with no explanation, follows a similar rejection in a Maine case in October. Justices Neil Gorsuch, Clarence Thomas, and Samuel Alito dissented, with Gorsuch criticizing New York Gov. Kathy Hochul (D) for comments she made defending the lack of a religious exemption. Hochul three months ago said people with religious objections to vaccine rules “aren’t listening to God and what God wants.”

The orders come amid a cultural and political firestorm over Covid-19 vaccine requirements. Republican-led states including Florida are moving to fine companies unless they let workers opt out, pushing back against President Joe Biden’s plan to require private employers to make sure workers are vaccinated or face federal occupational safety penalties. A federal appeals court has put the Biden rules on hold, and that issue is likely to reach the Supreme Court soon as well.

New York is among a handful of states that mandate vaccinations for health-care workers without allowing any religion-based exemption. New York’s mandate, issued Aug. 26 by the Department of Health, requires health-care workers to be vaccinated if they are in close contact with patients, residents or other workers. The rule exempts people who have a medical reason for not getting vaccinated.

Two groups of doctors, nurses and other providers contend the mandate violates their constitutional rights. They say they are Christians opposed to the three available vaccines because they have links to cell lines derived from aborted fetuses. They told the court they either have already lost their jobs or will soon lose them. Read more from Greg Stohr.

Benefits of Vaccine Rule Outweigh Costs, U.S. Tells Court: Opponents of the Biden administration’s emergency Covid-19 shot-or-test rule ignored its benefits when they argued against dissolving a court order blocking a measure that may save an average of 77 lives per day, government lawyers said in a brief. The administration told the U.S. Court of Appeals for the Sixth Circuit that the regulation will help employers by reducing the frequency of infections in the workplace in exchange for “modest” costs to its implementation. The Fifth Circuit ignored all of the standard’s benefits in pausing the rule, the U.S. said. Robert Iafolla has more.

MORE ON THE PANDEMIC:

• In the American Northeast, officials are trying every tactic to curtail a winter surge that has emergency rooms overflowing and infection rates soaring. Admissions of patients with Covid-19 rose 14.4% across the nation in the week ending on Dec. 9, according to the Department of Health and Human Services. That rate was more than double—33.5%—in New England. The delta variant is still the predominant strain in the U.S., but officials are preparing for more cases due to omicron. Read more from Carey Goldberg and Nic Querolo.
• Omicron dented the protection afforded by two doses of Pfizer’s and AstraZeneca’s vaccines as feared, researchers found, increasing the risk of infection. Blood samples collected from people vaccinated with either shot and tested against the new variant showed a significant drop in neutralizing antibodies, a proxy for protection, especially compared to the delta variant, Oxford University researchers said yesterday, echoing other studies that emphasized the need for boosters. Suzi Ring has more.
• Federal nutrition assistance and agricultural infrastructure top the list of solutions that would help feed Native Americans, many of whom struggled to keep meals on the table during the coronavirus pandemic, a new survey finds. Almost half of Native American and Alaska Native survey respondents suffered food insecurity as Covid-19 outbreaks ravaged the U.S., the Native American Agriculture Fund, the Food Research & Action Center, and the University of Arkansas’ Indigenous Food and Agriculture Initiative reported today. Read more from Megan U. Boyanton.

More Headlines:

• Omicron Severity Seen Masked by Prior 72% Case Rate in S. Africa
• Ivermectin Treatment Demand for Dad Turned Down by Court
• Frequent Flyer Loses Fight Against TSA’s Airplane Mask Mandate

Happening on the Hill

Hearings on the Hill:

• FDA Nominee Hearing: The Senate Health, Education, Labor, and Pensions Committee meets for a hearing today on the nomination of Robert Califf to be commissioner of the Food and Drug Administration. Six other former FDA chiefs yesterday sent committee leaders a joint letter endorsing Califf, saying he “has the experience to be effective from day one.” Find it here. Celine Castronuovo and Alex Ruoff preview what to watch.
• Global Vaccinations: The House Select Subcommittee on the Coronavirus Crisis scheduled a hearing today on accelerating Covid-19 vaccinations globally.

Wyden Wants Premium Hike Cap for Alzheimer’s Drug: Senate Finance Chairman Ron Wyden (D-Ore.) called on the Biden administration to restrict increases in Medicare Part B premiums tied to a new Alzheimer’s drug, according to a statement. “Medicare beneficiaries cannot afford to be saddled with a record increase in monthly premium costs,” Wyden said in a letter to HHS Secretary Xavier Becerra yesterday. “Especially when those premium costs are being driven up by uncertain expectations of sky high Medicare costs for an outrageously expensive drug like Aduhelm.” Norah Mulinda has more.

• “Aduhelm’s high price tag only underscores the urgent need to pass the Build Back Better Act, which will lower costs, and ensure seniors are able to access the prescription drugs they need to live full and healthy lives,” Leslie Dach, chair of the advocacy group Protect Our Care, which tends to align with Democrats, said in a statement applauding Wyden’s letter.

What Else to Know Today

Medical Trial Diversity Ignored by FDA in Fee Plan, Groups Say: Medical advocacy groups are insisting that stronger commitments to improving clinical trial diversity be included in the next user fee deal between the FDA and drugmakers, which will establish industry’s top priorities for the next five years.

An updated proposal implementing the fees companies pay to help get their cutting edge drugs to market wouldn’t hold them accountable for broadening the pool of patients who enroll in studies, the groups say. The disproportionate Covid-19 case and death rates among Americans of color underscore the need to make sure clinical trials reflect the actual population affected by a particular disease or condition under scrutiny, they say. Many drugmakers, however, say the user fee deal is the wrong avenue to address the issue. Read more from Celine Castronuovo.

SCOTUS Turns Away J&J Over Cancer Suits: The Supreme Court turned away a Johnson & Johnson appeal that sought to create a broad shield from lawsuits accusing the company of failing to warn consumers that its iconic baby powder could cause cancer. The justices, without comment, left intact a Mississippi Supreme Court ruling that let the state use its consumer protection laws to sue the company. J&J argued the case was precluded by the Food and Drug Administration’s 2014 move not to require cancer warnings on talcum-powder products. Read more from Greg Stohr and Jef Feeley.

• Meanwhile, the court signaled interest in Bayer’s bid to stop thousands of claims that its top-selling Roundup weedkiller causes cancer, asking Biden’s White House for advice on whether to hear the company’s appeal in a potentially multibillion-dollar case. Bayer is challenging a $25 million award to Edwin Hardeman, a California man who says decades of exposure to Roundup caused his non-Hodgkin’s lymphoma. Read more from Greg Stohr.
• The court also turned away a fight between Impax Laboratories and the Federal Trade Commission over whether a deal with name brand rival Endo to delay the market entry of Impax’s opioid drug was anticompetitive. The justices’ denial of the case marks a missed opportunity to review the FTC’s ability to restrict pay-for-delay deals, which industry observers say may hinder competition and lead to higher drug prices. Ian Lopez has more.

Biden Aims to Slash ‘Time Tax’ for Aid: Biden signed an executive order yesterday that seeks to reduce bureaucratic hurdles for Americans seeking government benefits and services. The order—targeting 36 federal services across a slew of U.S. agencies and departments—calls for a portal for recipients of Medicare to identify ways to save money on drugs and health care, among a number of of other measures. Justin Sink has more.

State-Made Paid Leave Evolves: Ensuring low-income workers can access paid time off for family and medical needs has become an increasingly high priority for state-run paid leave programs, including one in Connecticut that’s set to start paying benefits Jan. 1. The movement among the most recent paid leave adopters—including Colorado, the District of Columbia, Oregon, and Washington state—also helped shape the policy details of a nationwide paid leave proposal that passed the U.S. House last month but faces major hurdles in the Senate. Read more from Chris Marr.

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