Aligning with OSHA’s newly released Emergency Temporary Standard that requires vaccination programs for employers, the Centers for Medicare & Medicaid Services (CMS) issued their own specific rules regarding vaccination effective November 5, 2021. As mentioned in President Biden’s White House COVID-19 Plan back in September, this rule outlines specific vaccine requirements for most health care settings as a Condition of Participation in Medicare and Medicaid programs. This will include hospitals, ambulatory surgery centers, home health agencies and long-term care facilities (with the exception of assist living facilities or group homes).

The primary requirements of this rule are as follows:


Healthcare providers must establish a process or policy to ensure staff, except for those individuals who are granted an exemption, are fully vaccinated over two phases:

Phase 1 – By December 5, 2021, staff at all healthcare facilities where the regulation applies must have received their first dose of a 2-shot series or a single dose of a 1-shot vaccine. This must be completed before staff can provide any care, treatment or other services for the facility and/or its patients.
Phase 2 – By January 4, 2022, staff must have completed the entire vaccination series.
This includes all staff, regardless of clinical responsibility or patient care.
An exemption is made for individuals who provide services 100% remotely (teleworkers) and have no direct contact with patients and other staff, however, if they come into the facility at all, they are then included in the staff vaccination requirement.
Documentation must be tracked and securely maintained for each staff member. Acceptable forms of proof include the CDC COVID-19 vaccination record (or legible photo of the card), documentation of vaccination from a healthcare provider or electronic health record, or state immunization information system record.


Healthcare providers must establish a process for staff to request an exemption for recognized medical conditions or religious beliefs, observances or practices. The requests must be documented and evaluated. If the exemption is for a medical condition, the documentation must confirm recognized clinical contraindications and must be signed and dated by a licensed practitioner other than the individual requesting the exemption.

Staff who have previously had COVID-19 are not exempt from the requirement.
If a staff member meets the exemption requirement and remains unvaccinated, a process must be developed to address accommodations and to implement additional precautions to mitigate transmission and spread of COVID-19.

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While many healthcare facilities have already started implementing similar programs, this new rule puts a clear deadline on having it in place. CMS has stated that they expect state survey agencies to conduct compliance reviews for this rule through their standard recertification surveys or based on any complaint surveys. If you have any questions specific to your organization, please reach out to your Assurance Healthcare Safety Advocate.

ABOUT THE AUTHOR


Lauren Gizzi

Lauren Gizzi is the Vice President of Safety at Assurance with more than ten years of industry experience. An expert in safety programming and risk management, she works closely with our clients and Safety Advocates to establish effective safety programs that achieve measurable results. Lauren attended Roosevelt University and has received the following designations: Associate in Risk Management (ARM), Associate in Claims (AIC), Construction Risk and Insurance Specialist (CRIS) and Associate in General Insurance (AINS).