On November 4, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released the text of its long-awaited Interim Final Rule (“IFR”) entitled “Omnibus COVID-19 Healthcare Staff Vaccination.” On the same date, the Occupational Safety and Health Administration (“OSHA”) released the text of its IFR entitled “COVID-19 Vaccination and Testing ETS”. Both regulations contain official 60-day comment periods, both will be officially published in the Federal Register on November 5, 2021, and both will become immediately effective upon publication.
Links to the CMS regulation and FAQS can be found here:
1. CMS Interim Final Rule – Federal Register :: Public Inspection: Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination
2. CMS Omnibus COVID 19 Health Care Staff Vaccination Interim Final – Rule – FAQ – CMS Omnibus Staff Vax Requirements – External FAQ (508 Compliant)
Links to the OSHA ETS and FAQS can be found here:
3. OSHA COVID 19 Vaccination Testing; Emergency Temporary Standard – Federal Register :: Public Inspection: COVID-19 Vaccination and Testing; Emergency Temporary Standard
4. OSHA ETS FAQ – COVID-19 Vaccination and Testing ETS – Frequently Asked Questions | Occupational Safety and Health Administration (osha.gov)
While we are in the process of thoroughly reviewing and evaluating both regulations prior to their official publication, here is what we know so far:
- The CMS regulation applies to all Medicare and Medicaid-certified providers and supplier types that are regulated under the Medicare Conditions of Participation (MCoPs), Conditions for Coverage (CfC) or other requirements. These providers, including hospitals, nursing homes, hospices and home health agencies, are required to have a process and policy in place ensuring that all applicable staff are vaccinated against COVID-19.
- The CMS vaccination requirement applies to all eligible staff working at a provider that participates in the Medicare and/or Medicaid programs, regardless of clinical responsibility or patient contact. It also applies to offsite workers.
- The CMS regulation does not apply to Personal Care/Assisted Living Facilities, Group Homes and other similar settings which are not Medicare/Medicaid certified providers. However, the OSHA ETS may apply to these entities if they employ 100+ employees. Additionally, DHS or another state regulatory agency may impose requirements for these providers regarding the vaccination of staff.
- The CMS regulation provides two vaccination deadlines:
- All staff must have received the first dose of a 2-dose COVID-19 vaccine or a 1-dose COVID-19 vaccine by December 5, 2021.
- All staff must be fully vaccinated (two weeks or more since completing a primary vaccination series for COVID-19) by January 4, 2022.
- Staff who are not vaccinated within the above timeframes are prohibited from providing care and services to the provider’s patients/residents.
- The CMS regulation requires providers to allow exemptions to staff with recognized medical conditions for which vaccines are contra-indicated or religious beliefs, observances or practices that prohibit the vaccine. Providers have the flexibility to establish their own processes for both seeking a religious or medical exemption, as well as determining whether or not such an exemption is appropriate. Providers are admonished to follow all applicable guidance provided by the Equal Employment Opportunity Commission (“EEOC”) in determining exemptions.
- CMS expects its regulation to be enforced via state survey agency compliance reviews. State survey agencies will assess provider compliance during either standard recertification surveys or during complaint surveys.
- Onsite surveyors will be checking to ensure that a provider has met three basic requirements: 1) a provider must have a policy or plan in place to vaccinate all eligible staff, 2) a provider must have a policy or plan in place to provide exemptions and accommodations for staff who are eligible, and 3) a provider must have a process or plan in place to track and document staff vaccinations.
- CMS will utilize a variety of enforcement remedies to ensure compliance with the mandate, including CMPs, denial of payments, and possible termination from the Medicare/Medicaid program.
- The OSHA ETS applies only to employers (of 100+ employees) and facilities that are not subject to the more specific OSHA Health Care ETS issued in June of 2021. Health care providers must continue to follow the OSHA Health Care ETS unless and until it is rescinded.
- The OSHA ETS requires covered employers to implement a mandatory COVID-19 vaccination policy OR a weekly COVID testing option.
We will continue to review and evaluate these regulations upon publication and will continue to provide guidance to our client in the future.
As always, please do not hesitate to contact us with any questions you may have regarding the mandate or the policies to be developed in response.
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