CMS Issues Guidance Regarding Compliance With Health Care Staff Vaccination Requirements

The Centers for Medicare and Medicaid Services (CMS) has issued regulations and guidance regarding the requirement that health care staff be fully vaccinated for COVID-19.  (The US Supreme Court recently affirmed CMS’ authority to mandate the vaccination of health care personnel.)

This regulation and guidance document sets forth the requirements that ASCs must meet to ensure compliance with the rule and, importantly, the instructions that Medicare surveyors will adhere to in conducting Medicare surveys.   It is imperative that ophthalmic ASCs carefully review this complete document in order to facilitate compliance with the rules and mitigate the likelihood of sanctions for violations thereto.  

The following are some highlights of the document:

General Policy

All ASCs are required to achieve a 100 percent vaccination rate for their staff through the development of a policy to address vaccinations applicable to all staff who provide any care, treatment, or other services for the ASC and/or its patients.  

Surveying for Compliance

Surveys will be conducted through a full survey for recertification or reaccreditation, federal initial surveys, or a complaint survey.  It is not anticipated that partial surveys will be conducted on an ad hoc or random basis simply to address the COVID-19 vaccination requirements, except with respect to a complaint filed with the surveying agency. Compliance deadlines vary depending upon the state in which your facility is located. (Details can be reviewed at pages 4-6.)

Policies and Procedures

ASCs must have a process for ensuring that all staff, as defined in the regulation, have received at least one dose of the vaccine prior to providing services within the facility.  The policy must also ensure that those staff who are not yet fully vaccinated, or who have been granted an exemption, e.g., religious or medical, adhere to additional precautions that mitigate the spread of COVID-19. These actions might include, among other practices:  reassignment of staff to non-patient areas or telework; physical distancing measures; at least weekly testing for exempted staff; use of NIOSH-approved N95 or equivalent or higher-level respirator regardless of whether they are providing direct patient care.

ASCs must track and securely document staff members’ vaccination status, exemptions, and temporary vaccination delays.

Vaccination Exemptions

Facilities must have a process by which staff may request an exemption from COVID-19 vaccination and track and secure documentation of information provided by applicants, the facility’s determination of the request, and any accommodations including mitigation practices, that are granted.  Requests for religious exemptions must be documented and evaluated in accordance with each ASC’s policies and procedures.  (EEOC guidelines for evaluating and responding to such requests can be reviewed in Section L).  Note that surveyors will determine whether the ASC has an effective process for staff to request a religious exemption; however, the surveyor will NOT evaluate the details of the request for a religious exemption, not the rationale for the ASC’s acceptance or denial of the request.  

Survey Process and Levels of Deficiency

Compliance will be assessed through observation, interview, and record review as part of the survey process.  (Details with respect to how surveyors will be evaluating vaccination policies and procedures are available at pages 9-14.)

The guidance includes information regarding the level of deficiency that would be assigned for not meeting certain vaccination percentage rates.  Note that these percentages apply against the total staff that are required to be vaccinated, a number which does not include those staff members with valid medical or religious exemptions.  

Physician Offices/Clinics

The federal vaccination requirements do not apply to physician offices (unless they are part of a larger system). However, CMS has indicated that physicians with admitting privileges at facilities subject to the mandate would also need to comply with the vaccination requirements.

As noted above, it is very important that ophthalmic ASCs carefully review these materials to get a complete picture of what will be required under the COVID-19 health care personnel vaccine mandate.  

Should you have any questions, contact your survey agency or OOSS Washington Counsel, Michael Romansky, at mromansky@ooss.org.