The Centers for Medicare & Medicaid Services (CMS) has issued interpretive guidance for the Interim Final Rule – Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination, along with enforcement deadlines. There are separate appendices of interpretive guidelines for each provider type.
Due to a is preliminarily injunction in the following twenty-five states: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia, and Wyoming. Medicare- and Medicaid-certified providers and suppliers in those states are not required to comply with the Interim Final Rule, and surveyors will not investigate compliance with the rule in facilities located in those states, pending future developments in the litigation.
CMS is staggering enforcement of the requirements for mandatory staff vaccinations into two phasers and providing some flexibility for compliance as follows.
Phase I Implementation date is January 27, 2022
- Policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient contact are vaccinated for COVID-19, including all required components of the policies and procedures specified below (e.g., related to tracking staff vaccinations, documenting medical and religious exemptions,etc.); and
- 100% of staff have received at least one dose of COVID-19 vaccine or have a pending request for, or have been granted a qualifying exemption, or are identified as having a temporary delay as recommended by the CDC, the facility is compliant under the rule; or
- Less than 100% of all staff have received at least one dose of COVID-19 vaccine, or have a pending request for, or have been granted a qualifying exemption, or are identified as having a temporary delay as recommended by the CDC, the facility is non-compliant under the rule. The facility will receive notice of their non-compliance with the 100% standard. A facility that is above 80% and has a plan to achieve a 100% staff vaccination rate within 60 days would not be subject to an enforcement action. Facilities that do not meet these parameters could be subject to additional enforcement actions depending on the severity of the deficiency and the type of facility (e.g., plans of correction, termination).
Phase II Implementation date is By February 28, 2022
- Policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or resident contact are vaccinated for COVID-19, including all required components of the policies and procedures specified below (e.g., related to tracking staff vaccinations, documenting medical and religious exemptions, etc.); and
- 100% of staff have received the necessary doses to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multiple vaccine series) or have been granted a qualifying exemption, or are identified as having a temporary delay as recommended by the CDC, the facility is compliant under the rule; or
- Less than 100% of all staff have received at least one dose of a single-dose vaccine, or all doses of a multiple vaccine series, or have been granted a qualifying exemption, or are identified as having a temporary delay as recommended by the CDC, the facility is non-compliant under the rule. The facility will receive notice of their non-compliance with the 100% standard. A facility that is above 90% and has a plan to achieve a 100% staff vaccination rate within 30 days would not be subject to an enforcement action. Facilities that do not meet these parameters could be subject to additional enforcement actions depending on the severity of the deficiency and the type of facility
Within 90 days and thereafter following issuance of the memorandum, facilities failing to maintain compliance with the 100% standard may be subject to enforcement action.
CMS also updated its Current Emergencies Page with corresponding FAQs and infographics. These items can be found under the “Clinical and Technical Guidance for All Health Care Providers” using the following link: https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page
Of note, within the CMS FAQs, is a question that addresses the alignment with Occupational Safety and Health Administration (OSHA) Emergency Temporary Standard (ETS). Since OSHA has officially withdrawn their Healthcare ETS, except for the recordkeeping and reporting requirements, Medicare certified providers will need to evaluate the applicability and compliance requirements with the OSHA vaccine and testing ETS and the CMS vaccine mandate rule.
Q: Which rule is a given health care facility expected to follow – the CMS Omnibus Staff Vaccination Rule, the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, or the OSHA COVID-19 vaccination and testing Emergency Temporary Standard?
A: Updated as of December 28, 2021: If a Medicare- or Medicaid-certified provider or supplier falls under the requirements of CMS’s Omnibus Staff Vaccination Rule, it should look to those requirements first. Health care facilities are generally subject to new federal vaccination requirements based on primacy.
If facilities participate in and are certified under the Medicare or Medicaid programs and are regulated by the CMS health and safety standards known as the Conditions of Participation (CoPs), Conditions for Coverage (CfCs), and Requirements for Participation, then they are expected to abide by the requirements established in the CMS Omnibus Staff Vaccination Rule.
Please refer to the litigation update at the beginning of this document for a list of states where the rule is enjoined and does not apply.
There are situations where the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors or the OSHA COVID-19 Vaccination and Testing Emergency Temporary Standard may also apply to staff who are not subject to the vaccination requirements outlined in the CMS Omnibus Staff Vaccination Rule.
If facilities are not subject to the requirements of the IFC, then the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors or OSHA COVID-19 Vaccination and Testing Temporary Standard apply.
Facilities should review the inclusion criterion for these regulations and comply with all applicable requirements.
All federal entities, including CMS, OSHA, and others, are working closely together to enforce the requirements to ensure maximum coverage of staff across settings with minimal duplication of enforcement efforts.