CMS COVID-19 Vaccination Mandate & Methodology for Compliance

Jump to:
Vaccine Mandate Basics
Components of Compliance
Impacts of Non-Compliance
Creating Policies and Procedures

In November 2021, the Centers for Medicare & Medicaid Services (CMS) issued a rule requiring employees of healthcare facilities that participate in Medicare and Medicaid to be fully vaccinated with the COVID-19 vaccine by January 2, 2022. Some states challenged the legality of the rule, and two federal courts blocked the rule from taking effect. Upon appeal, the U.S. Supreme Court on January 13, 2022, overturned the lower courts’ decisions and allowed the CMS COVID-19 vaccination mandate to take effect.

Vaccine Mandate Basics

CMS has provided an infographic, guidance for specific types of facilities, and a document with frequently asked questions. To summarize:

• The mandate applies to Medicare- and Medicaid-certified providers and facilities regulated by CoPs, CfCs, or Requirements.
• The rule applies to current and new staff members who provide treatment, care, or services to patients or a facility. This includes providers, employees, students, and volunteers – whether onsite or offsite. It does not apply to those who provide only telemedicine services.
• There are two implementation phases. Phase 1 mandates that those covered must receive a first dose or single dose within 30 days of the rule’s effective date. Phase 2 mandates that those covered must receive a second dose of a series within 60 days of the rule’s effective date.
• The Phase 1 and Phase 2 effective dates vary by state, but the latest deadlines were February 22 for Phase 1 and March 21 for Phase 2.
• CMS defines “fully vaccinated” as two weeks after an individual has completed a primary vaccination series, such as two doses of Pfizer or Moderna, or one dose of Johnson & Johnson. However, those who have received the shots are considered vaccinated even if they haven’t completed the 14-day waiting period following the shot.
• The mandate does not apply to those who are granted exemption or those whom the Centers for Disease Control recommends that the vaccination be delayed.

Components of Compliance

COVID-19 vaccine compliance will be examined as part of the survey conducted by CMS or your hospital’s accreditation body. As part of the survey, the examiners will:

• Evaluate your facility’s COVID-19 prevention program, which includes reviewing records, and conducting staff interviews.
• Examine a roster of those to whom the rule applies that indicates their vaccination status.
• Review the policy regarding exempt employees, documentation of exempt employees, and education programs for those employees.
• Review the facility’s COVID-19 policies and procedures.
• Examine medical exemptions to verify that they are signed and dated by a physician or advanced practice practitioner.
• Observe patient care to determine adherence to infection control and prevention standards of practice.
• Review policies and procedures regarding COVID-19 isolation, screening, and testing, as well as compliance with masking protocol.
• Review environmental services procedures.

Impacts of Non-Compliance

There can be serious consequences for facilities found not to be in compliance. Compliance is defined as:

Phase 1: Policies and procedures have been developed and implemented AND 100% of staff have received at least one dose, unless they have been granted exemption or have delayed the vaccine per CDC recommendation.

If a facility is non-compliant, they will receive a notice, but if the facility has more than an 80% vaccination rate and has a plan to achieve a 100% vaccination rate, no further enforcement action will be taken.

Phase 2: Policies and procedures have been developed and implemented for all staff AND 100% of staff have received all doses of a vaccine, unless they have been granted exemption or have delayed the vaccine per CDC recommendation.

If a facility is non-compliant, they will receive a notice, but if the facility has more than an 90% vaccination rate and has a plan to achieve a 100% vaccination rate, no further enforcement action will be taken.

Ninety days after a state’s Phase 2 date, a facility can be subject to enforcement action if it doesn’t maintain compliance with the 100% vaccination rate standard. The ultimate penalty is termination from CMS.

Creating Policies and Procedures

According to CMS, a hospital’s policies and procedures must include:

• A process for ensuring all staff covered by the rule (and who don’t have exemptions) have received at least a single-dose COVID-19 vaccine or the first dose of a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the hospital and/or its patients.
• A process for ensuring that all staff covered by the rule (and who don’t have exemptions) are fully vaccinated for COVID-19.
• A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19.
• A process for tracking and securely documenting the COVID-19 vaccination status of all covered by the rule.
• A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses.
• A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based upon federal law.
• A process for tracking and securely documenting information provided by those staff who have requested, and for whom the hospital 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, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable state and local laws. Further, that the documentation contains: all 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; and a statement by the authenticating practitioner recommending that the staff member be exempted from the hospital’s COVID-19 vaccination requirements for staff based on the recognized clinical contraindications.
• A process for ensuring the tracking and secure 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, including, but not limited to, 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.

As MSPs, we can take leadership roles in bringing our hospitals into compliance with the CMS COVID-19 vaccination mandate. In the process, we are helping to ensure patient safety and protecting our organizations’ revenue streams.