Key Questions About the New COVID-19 Vaccination Requirement for Health Care Provider Staff

On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) published regulations that establish the first ever federal vaccination requirements for health care provider staff. Drawing on its authority to establish patient health and safety standards, CMS is requiring health care providers that participate in the Medicare and/or Medicaid programs to ensure that their staff are fully vaccinated against COVID-19. The new rule applies to staff who provide any care, treatment, or other services for providers or patients, including contractors and volunteers.

CMS says it is now requiring health care staff to be vaccinated because its earlier efforts to simply encourage vaccination have been “insufficient” to protect patient health and safety. CMS cites data showing that COVID-19 cases in nursing homes surged with the rise of the Delta variant. The nursing home staff vaccination rate is nearly 73 % nationally as of October 2021, with substantial variation by region. CMS concluded that standard federal requirements across provider types are needed because the existing “patchwork” of state and employer requirements has not been enough to bring the pandemic under control in health care settings. CMS notes that the vaccines are safe and highly effective at preventing severe illness and death, and unvaccinated staff can strain the health care system by transmitting COVID-19 to patients and having to miss work if they are recovering from COVID-19 or quarantining after exposure.

The new rule applies to Medicare and Medicaid providers that are directly regulated by CMS and therefore does not reach all Medicaid providers, such as certain home and community-based services (HCBS) providers. The rule applies to nursing homes, hospitals, outpatient rehab facilities, federally qualified health centers, rural health centers, and home health agencies, among other provider types. Residents and staff of other HCBS providers, such as group homes, assisted living facilities, and day habilitation programs, face increased risk of serious illness or death from COVID-19, similar to nursing homes. But, because states (and not CMS) license and regulate these providers, CMS has not required them to comply with the new rule. States or individual providers could adopt staff vaccination mandates, and providers may be subject to other rules such as the Occupational Safety and Health Administration requirement for large employers (which has been put on hold by the courts) or state or local requirements.

The new rule raises many important issues to watch:

  • Will providers have enough lead time to implement the new rule? Staff must have received their first vaccine dose by December 6, 2021, and must be fully vaccinated by January 4, 2022, or have been granted an exemption (based on disability or sincere religious belief) or temporary delay (based on CDC clinical guidelines). Decisions about whether to grant exemptions will be made by providers. The rule does not require staff to receive booster shots, though providers must track staff who have received a CDC-recommended booster. Providers also must implement “additional precautions” to mitigate COVID-19 transmission and adopt contingency plans to address staff who are not fully vaccinated.
  • How will the new rule affect health care staffing levels? An October 2021 KFF tracking poll found that 1 in 5 adults continue to say that they definitely will not get the COVID-19 vaccine or will do so only if required. When asked what they would do if their employer required the COVID-19 vaccine without an option for regular testing, 72% of unvaccinated workers (9% of all adults) say they would leave their jobs. The same poll found that just 5% of unvaccinated adults said they have left a job because an employer required them to get vaccinated. CMS acknowledges that some staff may leave their jobs because they do not want to receive the vaccine. It remains to be seen whether the new rule will exacerbate existing staffing shortages or whether these effects may vary by region. CMS cites examples of vaccine mandates adopted by health systems in Texas and Detroit and a long-term care parent corporation with 250 facilities as well as the New York state health care worker mandate, all of which resulted in high rates of compliance and few employee resignations.
  • Will efforts to monitor and enforce the new rule be sufficient? CMS says that provider compliance with the new rule will be part of the existing oversight process through which state or federal inspectors review all Medicare and Medicaid program requirements. CMS envisions that inspectors will review facility policies and records and conduct staff interviews to verify vaccination status. CMS will provide guidance about oversight as well as penalties for noncompliance, which could include civil monetary penalties, denial of payment for new long-term care facility admissions, or termination of Medicare and/or Medicaid program participation.
  • How long will the new rule be in place? CMS will determine whether to make the new rule permanent based on public comments (due January 4, 2022) and the future course of the pandemic. The new rule is not tied to the duration of the COVID-19 public health emergency (PHE), and CMS expects that it will “remain relevant for some time beyond” the PHE end. Medicare interim final rules expire after three years unless they are finalized. In the near term, the new rule already has been challenged in a lawsuit filed by 10 state attorneys general in Missouri federal district court, which could delay or prevent implementation of the rule.

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