COVID-19 Vaccine Mandate Update

In 2021 CMS first issued the COVID-19 vaccine mandate - Liles Parker

(June 20, 2023): In response to the recent public health crises, the Centers for Medicare & Medicaid Services (CMS) first implemented a vaccine mandate for healthcare providers in late 2021. This policy was an effort to safeguard the vulnerable populations served by healthcare workers. This directive required that all healthcare workers, volunteers and third-party contractors working in facilities participating in Federal health benefit plans be vaccinated against COVID-19. While supporters of the mandate viewed it as a necessary step to protect the public, others voiced concerns over personal liberty, potential workforce disruptions AND safety concerns. [1] This article provides an overview of the history surrounding the COVID-19 vaccine mandate and discusses recent changes to the existing CMS mandate.

I. Background of the COVID-19 Vaccine Mandate:

The history of the COVID-19 vaccine mandate is a complex and controversial one. There are fervent beliefs on both sides of the issue. Supporters of vaccine mandates argue that they are necessary to protect public health and prevent the spread of COVID-19. Opponents of vaccine mandates argue that they violate individual liberties and that the vaccines are not safe or effective. An overview of the relevant chronology is outlined below:

  • December 12, 2019 -- Emergence of COVID-19: Patients in Wuhan, China were identified with atypical, pneumonia symptoms that did not respond well to standard medical treatment regimens.[2]
  • January 2020 – COVID-19 Spreads Outside of China’s Borders: By the end of January 2020, the COVID-19 virus had been detected in multiple countries around the world, including the United States.[3]
  • January 31, 2020 – HHS Declares that a Public Health Emergency Exists Under the PHSA: Pursuant to §319 of the Public Health Service Act (PHSA) (42 U.S.C. §247d), the Secretary, HHS, determined that a public health emergency (PHE) exists for the United States.[4]
  • February 4, 2020 – Secretary, HHS Declared that a Public Health Emergency Exists Under the FD&C Act: Under Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Secretary of the Department of Health and Human Services (HHS) determined that there was a public health emergency that had a significant potential to affect national security or the health and security of United States citizens living abroad, and that involved the virus that causes COVID-19.[5]
  • March 11, 2020 – The World Health Organization (WHO) Weighs In: After more than 118,000 individuals had been infected with COVID-19, the WHO declared that COVID-19 was officially a pandemic. By this time, approximately 114 countries had reported COVID-19 cases and 4,291 deaths had been attributed to the virus.[6]
  • March 13, 2020 – President Donald Trump Declares a National Emergency: Citing the Constitution and Sections 201 and 301 of the National Emergencies Act (50 U.S.C. 1601 et seq.), President Trump proclaimed that the COVID-19 outbreak in the United States constituted a national emergency, beginning March 1, 2020. [7]
  • January 21, 2021 -- Emergency Use Authorization of Vaccines: The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUAs) for the Pfizer, Inc. and the ModernaTX, Inc. COVID-19 vaccines. At this time, there was no Federal mandate for healthcare workers to be vaccinated.[8]
  • Late Summer 2021 -- Private Sector Mandates: Some private healthcare organizations and hospital systems began requiring their employees to get vaccinated, setting a precedent for vaccine mandates in the healthcare sector.
  • September 9, 2021 – Federal Worker Vaccine Mandate: President Biden issued an Executive Order mandating all Federal workers, including those in healthcare sectors like the Department of Veterans Affairs, be vaccinated against COVID-19. As the Executive Order provides:

“Accordingly, building on these actions, and in light of the public health guidance regarding the most effective and necessary defenses against COVID-19, I have determined that to promote the health and safety of the Federal workforce and the efficiency of the civil service, it is necessary to require COVID-19 vaccination for all Federal employees, subject to such exceptions as required by law." (Emphasis added).[9]

  • November 5, 2021 - CMS Vaccine Mandate: CMS issued an Interim Final Rule revising the requirements that most Medicare and Medicaid certified providers, and associated suppliers must meet to participate in the Medicare and Medicaid programs. The Interim Final Rule effectively required COVID-19 vaccinations for healthcare workers at all CMS-participating facilities.[10]
  • January 13, 2022 - Final Rulings and Implementation: After numerous court battles, the CMS vaccine mandate was upheld by the Supreme Court and began to be enforced across the United States.[11] However, the Supreme Court set aside an OSHA mandate which required employees of private business with more than 100 employees to be vaccinated. [12]
  • May 11, 2023 – Termination of the National Public Health Emergency: On January 30, 2023, President Biden announced that the administration planned to end the existing public health emergency on May 11, 2023.[13]
  • June 5, 2023 – CMS Ends the COVID-19 Vaccine Mandate: Earlier this month, CMS announced the end of its vaccine mandate for Medicare and Medicaid certified providers and suppliers.[14] The new Interim Final Rule (IFR) ending this mandate goes into effect on August 4, 2023.

II. Assessment of the CMS June 5th Final Rule:

On June 5, 2023, CMS ended the COVID-19 vaccine mandate for Federally funded health care facilities. While the new rule does not officially go into effect until August 4, 2023, the termination of this requirement means that health care workers in these settings are no longer required to be vaccinated against COVID-19. While the ultimate impact of this decision is still being debated, proponents of the vaccine mandate have expressed concern that it could lead to an increased risk of COVID-19 transmission. It is worth noting that as of May 12, 2023 (the last reporting period currently available), the Centers for Disease Control and Prevention (CDC) reported that 9,455 COVID-19 related hospitalizations had been reported within the past week. In any event, there are a number of takeaways you should consider now that the CMS vaccine mandate has been lifted:

  • Despite the end of the vaccination mandate, CMS continues to encourage vaccine administration. Although the final rule removes the COVID-19 staff vaccine mandate, CMS continues to advocate for Medicare and Medicaid certified providers to encourage staff members and patients to continue receiving the COVID-19 vaccine.
  • CMS will Transition to quality metrics to encourage vaccination. To incentivize the continuance of COVID-19 vaccination efforts, the final rule requires providers to report the percentage of vaccinated patients and staff as quality metrics. This serves as an incentive to health care providers and staff, as well as long term care facilities, to administer the updated vaccine.
  • CMS will exercise enforcement discretion in implementing the IFR. Although the IFR will become effective August 4, 2023, the COVID-19 public health emergency expired May 11, 2023. Given the timing, along with the upcoming effective date for the end of the vaccination mandate, CMS has indicated it will not enforce staff vaccine requirements that may remain effective through August 4, 2023.
  • There is no explicit right to refuse vaccination included in the IFR. This may be relevant in jurisdictions where state or local governments or employers continue to impose vaccine mandates on healthcare providers, staff or suppliers.

With the end of the public health emergency, and now this latest action from CMS, it appears that healthcare providers and institutions are finally returning to a “new normal”.

III. Conclusion:

The debate over vaccine mandates is likely to continue for some time. Nevertheless, we believe that it is clear that the COVID-19 vaccine has had a significant impact on the course of the pandemic. The vaccine has helped to reduce the number of cases, hospitalizations, and deaths from COVID-19. It has also helped to keep businesses and schools open and to prevent the economy from collapsing.
If you have questions about how this regulatory update affects your business, contact the attorneys at Liles Parker for assistance.

Jennifer Papapanagiotou is an experienced health law attorney. Jennifer and the other attorneys at Liles Parker represent healthcare providers and suppliers around the country in Medicare, Medicaid and private payor disputes and transactions. Should your practice or clinic need experienced health law legal counsel, give us a call for a free consultation. We can be reached at: 1 (800) 475-1906.