For employers, covering COVID-19 shots and other vaccinations is now a lot more complicated.
Officials at the U.S. Food and Drug Administration took vaccinations off the auto-pilot list Wednesday, by withdrawing emergency use rules for COVID vaccinations like Novavax’s Nuvaxovid vaccine and tightening access rules for other COVID vaccinations.
A team at the Pandemic Mitigation Collaborative says wastewater testing shows a new wave of U.S. cases began in July, that people in the United States are still suffering about 3.6 million new COVID infections per week, and that COVID is still causing more than 1,300 excess deaths per week, or about 1 excess death per 3,000 new cases.
But FDA officials said that they believe that the COVID emergency period is over and that the current, lower level of COVID risk no longer justifies encouraging healthy people under age 65 to get vaccinated.
“Those vaccines are available for all patients who choose them after consulting with their doctors,” according to a comment that Robert F. Kennedy Jr., the secretary of the U.S. Department of Health and Human Services, posted on X. com. HHS is the parent department of the FDA and the U.S. Centers for Disease Control and Prevention as well as the manager of the Medicare, Medicaid and Affordable Care Act public exchange programs.
Kennedy’s comment on X.com appears to imply that working-age people with health problems, such as obesity, might be able to get COVID vaccine shots without a prescription, but that other working-age people might need a prescription to get a COVID shot.
Kennedy is trying to oust Susan Monarez, the CDC director, because of her opposition to proposed HHS vaccination policy changes, according to press reports.
The Advisory Committee on Immunization Practices, the team that helps the CDC and HHS decide which vaccines should be covered by employer-sponsored health plans and other major medical plans as “free” preventive services, is set to meet to discuss the coverage rules for COVID vaccines and other vaccines in September.
The backdrop: Traditionally, U.S. vaccination programs have had strong, bipartisan support.
When the Senate Health, Education, Labor and Pensions Committee held a hearing in January on Kennedy’s nomination to be HHS secretary, Republicans joined with Democrats to tell him how strongly they support maintaining active U.S. vaccination programs.
America’s Health Insurance Plans, the Blue Cross Blue Shield Association and other health coverage provider groups wrote to HHS in September 2023 to support the idea of continuing to offer COVID vaccines to plan participants without imposing co-payments or other cost-sharing requirements on the participants.
Kennedy, however, has had a long career as a leader of the Children’s Defense Fund, a critic of U.S. vaccination programs. The fund argues that evidence for the efficacy of some vaccines is poor and that the risks posed by some vaccines may outweigh the benefits.
The employer perspective: Kathryn Bakich, senior vice president for health compliance at Segal, is an attorney who helps employers set up and run health benefits programs.
“Employers really want to use preventive medicine tools to assure that their employees can be as healthy as possible,” Bakich said in an email. “Vaccines are a part of that preventive strategy. Vaccines cost less than treatment, they prevent diseases, and help increase immunity generally. So employers want to provide cost-effective coverage for vaccines.”
Employers see plan participants having ready access to vaccines through pharmacies and worksite clinics as a good way to keep employees healthy, Bakich said.
The main concern right now is uncertainty about the coverage rules for COVID vaccines, she said.
“Today,” Bakich said, “it is becoming impossible to determine what the FDA has approved, what the CDC has approved, and whether that will be changing.”
Employers are also worried about the possibility that vaccine coverage rule uncertainty will start to affect the rules for vaccines other than COVID vaccines, Bakich said.