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Health Care Workforce COVID-19 Vaccination Mandate: Start Your Engines!

Health & Life Sciences Sarah E. Coyne, Jon R. Kammerzelt, Rachel L. Dykema

All eligible health care staff from all health care facilities that are regulated by Medicare or Medicaid (which means practically everyone) must receive their first COVID-19 vaccine dose by DECEMBER 6, 2021 and their second dose (unless they received Johnson & Johnson (J&J) as their first dose) by JANUARY 4, 2022. These health care facilities must have a policy in place mandating all of this, which means the policy needs to happen QUICKLY per an emergency interim final rule released by the Centers for Medicare and Medicaid (CMS). Also, while there will still be religious and health care exemptions, everyone else must get vaccinated and unlike non-health care employers, there is no testing alternative. Health care workers are being held to a higher standard. All of this was articulated in a rule released November 4, 2021 and formally published in the Federal Register on November 5, 2021 (and became effective as of that date). There are some helpful CMS FAQs that address a number of the confusing issues. The Occupational Safety and Health Administration (OSHA) released a rule at the same time governing private employers that does not apply to those regulated by the CMS rule, but those affected by the June OSHA emergency rule relating to COVID-19 are still regulated under that rule as well. Litigation has been launched against the simultaneous OSHA rule, but the CMS rule is effective now.

Below are some of the most important takeaways from the mandatory requirements:

  • The rule applies to all health care facilities certified by Medicare and Medicaid, including hospitals, critical access hospitals, rural health clinics, federally qualified health centers, long term care facilities, ambulatory surgery centers, community mental health centers, comprehensive outpatient rehabilitation facilities, end-stage renal disease facilities, home health agencies, home infusion therapy suppliers, hospices, intermediate care facilities for individuals with intellectual disabilities, clinics, rehabilitation agencies and public health agencies as providers of outpatient physical therapy and speech language pathology services, psychiatric residential treatment facilities, and programs for all-inclusive care for the elderly.
  • The required policy must mandate vaccination on the above schedule, meaning that the policy should be in place well before December 6, 2021 when the first dose (of Moderna or Pfizer) or only dose (of J&J) must occur for each member of the facility’s workforce.
  • This rule does not mandate booster vaccines for fully vaccinated individuals.
  • The rule applies to all workers who interact in any way with patients or other staff – meaning non-clinical folks too – administrators, housekeeping, food service, patient transport staff, etc.
  • The rule applies to Board members.
  • The rule applies to current staff and new staff.
  • The rule applies to contracted staff (e.g. contracted clinicians, portable x-ray suppliers, mental health professionals, and social workers).
  • This rule applies to students, trainees, volunteers, and all other unpaid workforce members who interact with patients or other staff.
  • The rule applies to most vendors (except those that interact with the health care facility staff or patients only infrequently).
  • The rule applies to anyone with clinical privileges or on the medical staff too – not just employees.
  • There is a tiny sliver of the workforce that is excepted from the policy, which is those who work 100% remotely and never interact with patients or staff.
  • All eligible staff (i.e., almost everyone) must be “fully vaccinated” two weeks after January 4, 2022 unless a religious or health care exemption applies.
  • This law controls over contrary State laws.
  • There is no testing alternative to vaccination.
  • For those staff who meet a religious or health care exemption, the health care facility must implement safeguards to mitigate the risk of transmission.
  • While physician offices are not subject to CMS Conditions of Participation, those physicians who are on the medical staff of regulated hospitals are subject to the rule.
  • There is no exception for those who have tested positive for COVID-19 antibodies.

The policy must include:

  • A process to ensure that applicable staff are fully vaccinated;
  • Implementation of appropriate precautions to mitigate transmission of COVID-19 for those not yet fully vaccinated or subject to a religious or health care exemption;
  • A plan for how vaccination status will be tracked including boosters and necessary delays (e.g. if the person is sick and thus cannot be vaccinated by the deadline) etc.; and
  • A plan for how the facility will track those who are exempt and provider’s signed explanations for health care exemption.

CMS will enforce this rule in the usual way – through surveys, with statements of deficiencies, and potential penalties. CMS retained the right to impose the most severe penalty if warranted – termination of Medicare and Medicaid participation privileges. Consequences range from a 23 day termination track for immediate jeopardy to simple requirements to come into compliance, based on severity. Surveyors will receive specific training in surveying for compliance with the vaccine mandate.

If you are seeking assistance with implementing the required policy on this extremely short timeline or if you have any further questions, please contact your local Quarles & Brady attorney, or:

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