Biden-Harris Administration Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Workers at health care facilities that participate in Medicare and Medicaid programs. The anticipated Interim Final Rule was issued by Centers for Medicare & Medicaid Services (CMS) today. CMS also provided FAQs that address many questions related to the Interim Final Rule, which can be found here: www.cms.gov/files/document/cms-omnibus-staff-vax-requirements-2021.docx. The following is a brief summary of the regulatory language and CMS FAQs:
WHO DOES THE REGULATION APPLY TO?
- Hospitals
- Long Term Care facilities
- Ambulatory Surgical Centers
- Hospices
- Home Health Agencies
- Programs of All-Inclusive Care for the Elderly
- Psychiatric Residential Treatment Facilities
- Intermediate Care Facilities for Individuals with Intellectual Disabilities
- Comprehensive Outpatient Rehabilitation Facilities
- Critical Access Hospitals
- Clinics (rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services)
- Community Mental Health Centers
- Home Infusion Therapy suppliers
- Rural Health Clinics/Federally Qualified Health Centers
- End-Stage Renal Disease Facilities
Notably, physician clinics are not regulated by CMS and, therefore, not included in the Interim Final Rule.
TIMING
Q: What is the deadline to have eligible staff vaccinated?
A: There are two deadlines – December 5, 2021 and January 4, 2022. See chart on page 58 of the Interim Final Rule.
- Phase 1 – 30 days after interim rule publication (Dec 5) – all staff have received first dose or requested and/or been granted a lawful exemption, prior to staff providing any care, etc.
- Phase 2 – 60 days after publication – staff fully vaccinated (final dose by the effective date), except for those who have been granted exemptions from COVID-19 vaccination.
- Staff who have completed a primary vaccination series by the final date are considered to have met these requirements even if they have not yet completed a 14-day waiting period for full vaccination.
Note: For purposes of this rule, documented receipt of additional or booster doses is not needed for staff who have completed a COVID-19 primary vaccination series.
TESTING
Q: Is there an alternative to vaccination, such as testing?
A: No. At this time, CMS is not allowing for daily or weekly testing of unvaccinated individuals as an alternative to vaccination.
- CMS expects continued compliance with its September 2020 regulation for LTC facilities to test facility residents and staff for COVID-19. (FAQs page 6)
EXEMPTIONS AND ACCOMODATIONS
CMS requires facilities to allow for exemptions to staff with recognized medical conditions for which vaccines are contraindicated (as a reasonable accommodation under the ADA) or religious beliefs, observances, or practices (established under Title VII of the Civil Rights Act of 1964.
Providers and suppliers should establish exceptions as part of its policies and procedures and in alignment with Federal law.
- Exemptions must be documented, but CMS allows providers to establish their own process for staff to request an exemption.
- For medical exemptions, the staff member must provide documentation confirming recognized clinical contraindications to vaccination that is signed and dated by a licensed practitioner, specifying which of the authorized COVID-19 vaccines are clinically contraindicated and the recognized clinical reasons, and a statement by the practitioner recommending the staff member be exempted from the facility’s COVID-19 vaccination requirements. Clinical contraindications should be based on the CDC’s informational document Summary Document for Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States, accessed at https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinicalconsiderations.pdf.
- For religious exemptions, CMS suggests reviewing the EEOC’s Compliance Manual on Religious Discrimination and refers providers to this template:
- Staff that have previously had COVID-19 or who show they have COVID antibodies are not exempt. However, the regulation does address staff for whom COVID-19 vaccination must be temporarily delayed (i.e., recent exposure), as recommended by the CDC.
- Regarding accommodations, the regulation requires that facilities develop a process for implementing additional precautions for any staff who are not vaccinated. CMS “encourages facilities to review the Equal Employment Opportunity Commission’s website for additional information that may warrant accommodations. In granting such exemptions or accommodations, employers must ensure that they minimize the risk of transmission of COVID-19 to at-risk individuals[.]” See FAQs page 8.
POLICIES
Facilities must also have appropriate policies and procedures developed and implemented that will ensure compliance with the regulation and establish and implement a process by which staff may request an exemption based on an applicable Federal law.
ENFORCEMENT – Enforcement will occur via state survey agencies.
Q: What type of enforcement will be implemented?
A: If a provider or supplier does not meet the requirements, it will be cited by a surveyor as being non-compliant and have an opportunity to return to compliance before additional actions occur. State survey agencies will assess during standard recertification surveys and on all complaint surveys. You should anticipate surveyors will review the policy and procedure, 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, along with interviews and observations, will be used to determine compliance.
For nursing homes, home health agencies, and hospice, enforcement remedies will include CMPs, denial of payment, and even termination as a final measure. The remedy for non-compliance among hospitals and certain other acute and continuing care providers is termination. However, CMS has stated its goal is to bring facilities into compliance and termination would only generally occur after providing a facility with an opportunity to make corrections and come into compliance.
REGARDING ALIGNMENT WITH OSHA – see FAQ on page 10.
The interim final rule can be found here: https://public-inspection.federalregister.gov/2021-23831.pdf
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