CMS Releases Interim Final Rule for Health Care Staff Vaccination
CMS Interim Final Rule Federal Register and FAQs On Thursday, November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule (IFR) regarding COVID-19 vaccination requirements for employees of Medicare and Medicaid-certified facilities.
What health care providers does this affect?
- Ambulatory Surgical Centers (ASCs) (§ 416.51)
- Hospices (§ 418.60)
- Psychiatric residential treatment facilities (PRTFs) (§ 441.151)
- Programs of All-Inclusive Care for the Elderly (PACE) (§ 460.74)
- Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities) (§ 482.42)
- Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes (§ 483.80)
- Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) (§ 483.430)
- Home Health Agencies (HHAs) (§ 484.70)
- Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§§ 485.58 and 485.70)
- Critical Access Hospitals (CAHs) (§ 485.640)
- Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services (§ 485.725)
- Community Mental Health Centers (CMHCs) (§ 485.904)
- Home Infusion Therapy (HIT) suppliers (§ 486.525)
- Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) (§ 491.8)
- End-Stage Renal Disease (ESRD) Facilities (§ 494.30)
Please note that this IFR ONLY applies to Medicare and Medicaid-certified facilities and does not apply to care settings such as Assisted Living Facilities and Group Homes.
Who does this apply to?
The rule applies to employees regardless of whether their positions are clinical or non-clinical, and includes employees, students, trainees, and volunteers. It also includes individuals who provide treatment or other services for the facility under contract or other arrangements. CMS recognizes that many infrequent services and tasks are performed in facilities are conducted by “one off” vendors, and providers are not required to ensure the vaccination of individuals who infrequently provide ad-hoc non-health care services (such delivery and repair personnel).
The rule does not apply to staff who exclusively provide telehealth or telemedicine services outside of the facility or staff who provide support services outside of the facility who do not have any direct contact with residents and other staff.
Religious and medical exemptions
The regulation provides for exemptions based on recognized medical conditions or religious beliefs, observances, or practices. Facilities must develop a process or plan for permitting exemptions in alignment with federal law. Accommodations granted by facilities must ensure that the risk of transmission of COVID-19 to at-risk individuals is minimized. Accommodations may include testing, source control, physical distancing, or job reassignment.
CMS believes that exemptions could be appropriate in certain limited circumstances, but no exemption should be provided to any staff for whom it is not legally required (under the ADA or Title VII of the Civil Rights Act of 1964) or who requests an exemption solely to evade vaccination. CMS stated surveyors will be directed to ask for facilities’ policies and procedures on vaccine exemptions.
Providers are required to track and document the vaccination status of each staff member. Examples of acceptable forms of proof of vaccination include:
- CDC COVID-19 vaccination record card (or a legible photo of the card)
- Documentation of vaccination from a health care provider or electronic health record, or
- State immunization information system record
Covered providers are required to develop and implement policies and procedures regarding vaccine requirements and ensure all eligible staff get at least one dose of a vaccine series prior to providing care or any other services by December 5th, 2021. Providers must ensure staff complete the vaccination series by January 4th, 2022.
Staff who have completed a primary vaccination series by Jan. 4, 2022 are considered to have met these requirements, even if they have not yet completed the 14-day waiting period required for full vaccination. This does not apply to staff who have been granted exemptions from the COVID-19 vaccine based on medical or religious reasons. The rule does not include a testing requirement or test-out option for unvaccinated staff.
What to include in your policy
A provider’s policy and procedure must include the following:
- A process for ensuring all staff have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services. (Except for staff who have pending requests for, or who have been granted, exemptions to vaccination requirements, or whom vaccination must be temporarily delayed per CDC clinical guidance.)
- A process for ensuring that all staff are fully vaccinated for COVID-19. (Except for staff who have pending requests for, or who have been granted, exemptions to vaccination requirements, or whom vaccination must be temporarily delayed per CDC clinical guidance.)
- Implementation of additional precautions intended to mitigate the transmission and spread of COVID-19 for all staff who are not fully vaccinated due to religious or medical exemptions. (i.e. testing, physical distancing, source control, or job reassignment).
- A process for tracking and documenting vaccination status of all staff and any staff who have obtained booster doses as recommended by the CDC.
- A process by which staff may request an exemption from the COVID-19 vaccination requirements based on an applicable Federal law.
- A process for tracking documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff COVID-19 vaccination requirements.
- A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner. Documentation must contain:
A. Information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications.
B. A statement by the practitioner recommending that the staff member be exempted from the facility’s COVID-19 vaccination requirements based on the recognized clinical contraindications.
- A process for ensuring the tracking and documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed as recommended by the CDC due to clinical precautions and considerations (i.e. individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment).
- Contingency plans for staff who are not fully vaccinated for COVID-19:
A. Staff who will not be able to provide care, treatment, or other services for the provider or its patients until they have at least received a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID19 vaccine (Example- vaccinated agency staff to fill in).
B. Address the safe provision of services by individuals who have requested an exemption from vaccination while their request is being considered and by those staff for whom vaccination must be temporarily delayed, as recommended by CDC clinical guidelines.
Enforcement of Health Care Staff Vaccination
CMS expects state survey agencies to conduct onsite compliance reviews of these requirements via standard recertification surveys and all complaint surveys. Surveyors will be looking to determine if a facility has:
- A process or plan for vaccinating all eligible staff
- A process or plan for providing exemptions and accommodations for those who are exempt
- A process or plan for tracking and documenting staff vaccinations
While onsite, surveyors will review the facility’s COVID-19 vaccination policies and procedures, the number of resident and staff COVID-19 cases over the last 4 weeks, and a list of all staff and their vaccination status. This information, in addition to interviews and observations, will be used to determine the compliance of the provider or supplier with these requirements.
If a provider does not meet the requirements, they will be cited as being non-compliant and have an opportunity to return to compliance before additional actions occur. Additional actions due to non-compliance includes civil monetary penalties, denial of payment, and even termination from the Medicare and Medicaid program as a final measure.
Comments on the Interim Final Rule are being accepted until January 4th and can be submitted to http://www.regulations.gov.
In conjunction with the CMS rule, OSHA also issued its new Emergency Temporary Standard which includes vaccination, testing, and masking requirements for employers with 100 or more employees. OSHA’s new rule will not apply to workplaces covered by the COVID-19 Healthcare ETS while it is in effect or the federal contractor vaccination requirement.
See M3’s overview of the OSHA ETS for vaccination, testing and face coverings.