With legal scholars saying President Biden is within the law in mandating COVID-19 vaccines for all healthcare workers, the Centers for Medicare & Medicaid Services (CMS) is moving quickly to enforce the requirement and will issue interim regulation in October.

Biden announced the vaccination requirements on Sept. 9, 2021, expanding on his idea of leveraging CMS reimbursements to require all healthcare workers to be immunized against the pandemic virus.

“Already, I’ve announced we’ll be requiring vaccinations for all nursing home workers who treat patients on Medicare and Medicaid, because I have that federal authority,” Biden said. “I’m using that same authority to expand that to cover those who work in hospitals, home healthcare facilities, or other medical facilities — a total of 17 million healthcare workers. If you’re seeking care at a health facility, you should be able to know that the people treating you are vaccinated. Simple. Straightforward. Period.”

Citing the highly transmissible Delta variant and continuing nursing home outbreaks, President Biden ordered to the Department of Health and Human Services (HHS) to mandate COVID-19 vaccinations for long-term care staff on Aug. 18, 2021. As a result, the CMS was already moving to make nursing homes require that all workers be fully vaccinated or risk losing federal funding. After Biden’s announcement of the expanded mandates in healthcare, the CMS followed suit, saying that in collaboration with the Centers for Disease Control and Prevention (CDC), “emergency regulations requiring vaccinations for nursing home workers will be expanded to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs.”1

The CMS is developing an Interim Final Rule, including a comment period, which is expected to be issued in October.

“Facilities across the country should make efforts now to get healthcare staff vaccinated to make sure they are in compliance when the rule takes effect,” the CMS stated. “Nursing homes with an overall staff vaccination rate of 75% or lower experience higher rates of preventable COVID infection. In CMS’s review of available data, the agency is seeing lower staff vaccination rates among hospital and end-stage renal disease facilities. To combat this issue, CMS is using its authority to establish vaccine requirements for all [participating] providers and suppliers.”

Given the public health situation, using the reimbursement powers of CMS to affect and enforce healthcare policy should hold up in court, says Lawrence Gostin, JD, a law professor at Georgetown University in Washington, DC. More specifically, the president has the power to use government agencies to enforce vaccine mandates in healthcare and places of work, he added.

“I think he is on strong legal ground there,” he says. “The federal government can set conditions on the receipt of Medicare and Medicaid funding, as long as they are reasonable. These mandates are evidence-based and logical because healthcare settings [are treating] some of most vulnerable people in the country. Healthcare workers and establishments have the strongest ethical duty to protect their patients. So that is on firm legal ground.”

In another mandate that could see legal challenges, Biden ordered the Department of Labor to develop an emergency rule to require all employers with 100 or more workers — an estimated 80 million workers — to ensure their workforces are fully vaccinated or that people can show a negative test at least once a week.

“I think there will be challenges, but again the President is on strong legal footing,” Gostin says. “He is acting under the Occupational Health and Safety Act, which allows the President to set standards for workplace health and safety. The threat of an infectious disease in the workplace — with a highly infectious variant that could cause hospitalization or death — is at least as hazardous as a workplace injury. We are currently in a public health emergency.”

Another view is that the vaccine mandate for businesses could be legally challenged because the Occupational Safety and Health Administration will use an Emergency Temporary Standard, which must meet a threshold of “grave danger” to those being protected, noted Walter Olson, a senior fellow at the Cato Institute, in an opinion piece published recently.

“That is a vague and open-ended standard, but even so, it opens up one set of possible challenges,” he said in the commentary. “Is a test-or-vax mandate that applies even to employees who work from home, or who have already contracted the virus and recovered, truly needed to protect other workers from ‘grave danger?’”2

Gostin clarified that a President does not have the power to simply mandate vaccination for all citizens. There has been some misinformation to the contrary citing the 1905 U.S. Supreme Court ruling in the case of Jacobsen v. Massachusetts, which allowed a smallpox vaccination mandate.

“That’s a common and malicious assumption that people make,” he says. “It is the states and cities that have that power, not the federal government. That 1905 case involved the powers — in that particular case — of the city of Cambridge, MA.”

Booster Shot Blurred

That being said, the Biden administration still has some powers it can deploy for vaccines, including requiring them for air travel bound to federal oversight.

The federal response is a mix of public health and political consequences, as Biden holds back some actions and pushes forward on others. For example, he again urged sports and entertainment venues to require proof of vaccination or a negative test for entry. Even if these venues tried to enforce such measures, the CDC cards being used currently to show vaccination status are woefully short of a true national vaccination registry system that cannot be easily gamed, Gostin says. The Biden administration has resisted creating such a system, which could be branded as government intrusion by political opponents. They appear to be trying to strike a balance that must constantly be recalibrated, and the President seemed to concede the administration got out ahead of federal agencies previously when announcing COVID-19 booster shots would begin Sept. 20. 

Neither the Food and Drug Administration (FDA) nor the CDC had formally recommended the booster shot as that date approached. Healthcare workers are expected to be a top priority for the third dose of messenger ribonucleic acid (mRNA) vaccine, but beyond that there was considerable confusion about the timing and target groups. President Biden did not mention a date when the booster shots will begin and emphasized that nothing will go forward without a green light from the FDA and CDC.

“The decision of which booster shots to give, when to start them, and who will give them will be left completely to the scientists at the FDA and the CDC,” he said in his address on vaccine mandates.

The original booster plan was to give at least one dose of an mRNA vaccine to those vaccinated at least eight months prior, the HHS announced in August when the Sept. 20 rollout date was announced. “At that time, the individuals who were fully vaccinated earliest, including many healthcare providers, nursing home residents, and other seniors, will likely be eligible for a booster,” the HHS statement said.3

The CDC’s Advisory Committee on Immunization Practices (ACIP) recently discussed the booster issue at an August 30 meeting, but did not make any formal recommendations or cast any votes, explains William Schaffner, MD, a liaison member of ACIP as medical director for the National Foundation for Infectious Diseases.

“There has certainly been a lot of confusion, but the FDA has not issued an Emergency Use Authorization (EUA) that would permit the boosters to be given,” he says. “The companies have to submit data supporting that. Because boosters are not yet authorized, ACIP has not yet issued any recommendations. That said, the last meeting was clearly moving in the direction of looking — at the very least — at those people who were first vaccinated who are highly vulnerable, like nursing home residents and healthcare providers. There was mention of older adults after that, but they haven’t gone very far down this road.” 

The FDA’s Vaccines and Related Biological Products Advisory Committee has called a meeting for Sept. 17, 2021, when presumably the booster EUA would be issued if the data are good and the decision is made to move forward rapidly to meet the sense of urgency of the Biden administration. Given similar situation situations in the past, ACIP could then call an emergency meeting and recommend the booster if the data are convincing enough to the panel and already have passed FDA muster.

Driven by Delta

The CDC reported previously in an in-house briefing that the SARS-COV-2 Delta variant has an R-naught — the number of susceptible people who will be infected by one case — of between five and eight. The makes it as transmissible as chickenpox, and more transmissible than Middle East respiratory syndrome, severe acute respiratory syndrome, Ebola, seasonal flu, the 1918 pandemic flu, and the common cold.4,5

Given this threat and reports of waning immunity over time, the American Nurses Association (ANA) and other medical groups already have urged members to get the booster when it is available.

“We realize the only way we are going to get this Delta strain under control is if we all get vaccinated,” says ANA President Ernest Grant, PhD, RN, FAAN. “That is evidence-based science. And now science is pointing to the fact that we need this booster.”

Although only 58% of nurses in a recent ANA survey supported mandating the vaccine, the ANA already has signed off on a statement supporting the requirement and expects compliance.6,7 According to findings of the survey, the majority of nurses (90%) said they are immunized against COVID-19 or plan to get vaccinated, and say they are comfortable recommending COVID-19 vaccines.

“The safety of the public is at stake. Nurses are expected, from an ethical and professional standpoint, to model the safe behavior that we are expecting the public to do,” Grant says. “People who are unvaccinated are like a drunk driver out there. We are trying to minimize the risk of the Delta variant.”

Rather than simply a third shot that will wane in eight months, the booster should have a multiplier effect on the immune system, said Anthony Fauci, MD, director of the National Institute of Health’s National Center for Allergy and Infectious Diseases. “The booster mRNA immunization increases antibody titers by at least tenfold,” he said at an Aug. 18, 2021, White House briefing. “You get a dramatic increase in antibody titers when you do a third immunization dose.”

Part of this effect is the result of immunizing immune-competent people who already have had two shots, such as healthcare workers. An EUA for boosters in those who are immunocompromised — and thus may have lacked a full immune response to the prior two shots — already has been approved by the FDA and recommended by the CDC. Boosting immune-competent people could imprint longer-lasting immunity, reinvigorating B cells and T cells in the immune system while greatly increasing neutralizing antibodies.

“Part of the biology of boosting is that it really gives you a faster antibody response, and one that is higher than the initial series provided,” Schaffner says. “There are data to support that it will provide long-term protection.”

This effect also could lessen transmission from vaccinated people, which was reported in the Provincetown, MA, COVID-19 outbreak.8

“We hope with a higher serum antibody level, you would get more antibody at the surface of mucous membranes, thus preventing the initial infection, making it less likely that a person who is vaccinated could be a transmitter of the infection,” he says.

The booster will be the same mRNA vaccine people were inoculated with originally. In another complicating factor, the Pfizer vaccine has been fully approved for FDA licensure but the Moderna shot remained in EUA status as this report was filed. Another question is whether the booster shot will be mandated for those who fall under the new Biden administration requirements. That remained unclear but could reasonably be expected if the third shot is thought necessary to overcome waning immunity in those already vaccinated.

Presumably, the vaccinated population would not make much of an issue of receiving a booster, but the unvaccinated are falling further behind. A leader on COVID-19 vaccinations, Israel already is giving the booster shots and discussing whether a fourth shot may be necessary.9 The COVID-19 Delta variant continues to spread in the country, but the cases generally are mild, prompting the observation that, “Israel hasn’t defeated the virus, but it has probably redefined what success against the virus looks like.”10

REFERENCES

  1. Centers for Medicare & Medicaid Services. Biden-Harris administration to expand vaccination requirements for health care settings. Published Sept. 9, 2021. https://www.cms.gov/newsroom/press-releases/biden-harris-administration-expand-vaccination-requirements-health-care-settings
  2. Olson W. Where does Biden get the authority to mandate vaccination? Reason. Published Sept. 10, 2021. https://reason.com/2021/09/10/where-does-biden-get-the-authority-to-mandate-vaccination/
  3. U.S. Department of Health and Human Services. Joint statement from HHS public health and medical experts on COVID-19 booster shots. Published Aug. 18, 2021. https://www.hhs.gov/about/news/2021/08/18/joint-statement-hhs-public-health-and-medical-experts-covid-19-booster-shots.html
  4. McMorrow M. Improving communications around vaccine breakthrough and vaccine effectiveness. The Washington Post. Published July 29, 2021. https://context-cdn.washingtonpost.com/notes/prod/default/documents/8a726408-07bd-46bd-a945-3af0ae2f3c37/note/57c98604-3b54-44f0-8b44-b148d8f75165.
  5. Centers for Disease Control and Prevention. Delta variant: What we know about the science. Updated Aug. 26, 2021. https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html#:~:text=%E2%80%A2%20The%20Delta%20variant%20is,contagious%20as%20previous%20variants
  6. American Nurses Association. New survey data: Nurses recommend COVID-19 vaccines and support mandates and boosters if recommended. Published Aug 18, 2021. https://www.nursingworld.org/news/news-releases/2021/ew-survey-data--nurses-recommend-covid-19-vaccines/
  7. American Nurses Association. ANA supports mandated COVID-19 vaccinations for nurses and all health care professionals. Published July 26, 2021. https://www.nursingworld.org/news/news-releases/2021/ana-supports-mandated-covid-19-vaccinations-for-nurses-and-all-health-care-professionals/?fbclid=IwAR3EHyo7vt7z5Eer0UwV0RbCmzmeCv8cW4zfAJwRn1FP9ETrSpF4nVcVPM
  8. Brown CM, Vostok J, Johnson H, et al. Outbreak of SARS-CoV-2 infections, including COVID-19 vaccine breakthrough infections, associated with large public gatherings — Barnstable County, Massachusetts, July 2021. MMWR Morb Mortal Wkly Rep 2021;70:1059-1062.
  9. Lawati AA. Middle East newsletter: Israel considers fourth coronavirus shot. Bloomberg. Published Sept. 12, 2021. https://www.bloomberg.com/news/newsletters/2021-09-12/middle-east-newsletter-israel-considers-fourth-coronavirus-shot
  10. Chafets Z. Israel’s rising COVID cases aren’t so scary this time. The Washington Post. Published Sept. 7, 2021. https://www.washingtonpost.com/business/israels-rising-covid-cases-arent-so-scary-this-time/2021/09/07/49c6f886-0fbe-11ec-baca-86b144fc8a2d_story.html