Today, the U.S. Supreme Court issued its opinion by a 5-4 vote with Justices Clarence Thomas, Samuel Alito, Neil Gorsuch and Amy Coney Barrett dissenting regarding the Department of Health and Human Services Interim Final Rule requiring vaccination of all healthcare staff at covered facilities-- unless exempt for medical or religious reasons (the "CMS Vaccine Mandate").  The Court found that the CMS Vaccine Mandate does not exceed the authority of the Secretary of Health and Human Services ("HHS") and stayed the previous orders entered by two District Courts which had prevented the enforcement of the CMS Vaccine Mandate in 25 states. 

The Court noted that "COVID-19 is a highly contagious, dangerous, and especially for Medicare and Medicaid patients-deadly disease." In upholding the CMS Vaccine Mandate, the Court noted that the Secretary determined that the "vaccine mandate will substantially reduce the likelihood that healthcare workers will contract the virus and transmit it to their patients." It reasoned that a core mission of HHS is to ensure that the healthcare providers who care for Medicare and Medicaid patients protect their health and safety. As such, the Vaccine Mandate is consistent with the authority provided by Congress to establish detailed conditions for facilities to comply with to be eligible to receive federal funding. These requirements have long included requirements to prevent the transmission of communicable diseases and infections. The Secretary based the rule on, among other things, data that in many facilities more than 35% of staff remained unvaccinated and that the COVID-19 virus can spread rapidly among unvaccinated healthcare staff and from them to patients who are often elderly, disabled, or in poor health. In fact, the Court cited from the oral argument during which counsel for the state of Missouri conceded that the Secretary had the authority in the interest of infection control to require hospital employees to wear gloves, sterilized instruments and wash their hands in a certain way. Similarly, healthcare workers are already required to be vaccinated for a litany of diseases. 

The Court's decision allows the Centers for Medicare & Medicaid Services ("CMS") to withhold Medicare funds from provider organizations that do not implement a vaccination requirement for their workforce. The Vaccine Mandate covers about 17 million healthcare workers.

What does this mean for employers covered by the CMS rule?  We have previously described the CMS Vaccine Mandate in a Legal Alert here.  On December 29, 2021, CMS published additional guidance describing enforcement action thresholds for non-compliance.  Compliance surveys as part of initial certification, standard recertification or reaccreditation, and complaint surveys will begin on January 27, 2022.  Healthcare employers covered by the CMS rule should immediately comply with the CMS Vaccine Mandate, bearing in mind the following enforcement thresholds:

  • On or before January 27, 2022:
    • A facility will be considered compliant if it demonstrates that 1) policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient/resident contact are vaccinated for COVID-19; and 2) 100% of staff have received at least one dose of COVID-19 vaccine, or have a pending request for, or have been granted a qualifying exemption, or have been identified as having a temporary delay as recommended by the CDC.
    • If less than 100% of all staff have received at least one dose of COVID-19 vaccine (or have a pending request for, or have been granted a qualifying exemption, or have been identified as having a temporary delay as recommended by the CDC), the facility is non-compliant and will receive a notice of non-compliance.
    • A facility that is above 80% and has a plan to achieve a 100% staff vaccination rate within 60 days would not be subject to additional enforcement action.
    • Facilities with a staff vaccination rate less than 80% may be subject to additional enforcement action depending on the severity of the deficiency and the type of facility.
  • On or before February 28, 2022:
    • A facility will be considered compliant if it demonstrates that 1) policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient or resident contact, are vaccinated for COVID-19; and 2) 100% of staff have received the necessary doses to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multiple-dose vaccine series), or have been granted a qualifying exemption, or have been identified as having a temporary delay as recommended by the CDC.
    • If less than 100% of all staff have received at least one dose of a single-dose vaccine, or all doses of a multiple-dose vaccine series (or have been granted a qualifying exemption, or identified as having a temporary delay as recommended by the CDC), the facility is non-compliant and will receive a notice of non-compliance.
    • A facility that is above 90% and has a plan to achieve a 100% staff vaccination rate within 30 days would not be subject to additional enforcement action.
    • Facilities with a staff vaccination rate less than 90% may be subject to additional enforcement action depending on the severity of the deficiency and the type of facility.
  • Beginning March 28, 2022:
    • Facilities that do not maintain compliance with the 100% standard may be subject to enforcement action.

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