The Centers for Medicare & Medicaid Services (CMS) on Dec. 29 issued guidance regarding the Interim Final Rule (IFR) regarding Covid-19 vaccination requirements for healthcare staff that the agency published in early November.
In the Dec, 29 memo, CMS specified that this guidance does not apply to the following states that are still subject to preliminary injunctions that federal courts issued to block implementation of the IFR in those 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.
The new CMS guidance delineates the following deadlines and clarifications for requirements that most Medicare- and Medicaid-certified providers must meet in all other states:
Within 30 days after issuance of the guidance, healthcare facilities must:
- Have policies and procedures developed and implemented to ensure all facility staff are vaccinated; and
- 100% of staff have received at least one dose of Covid-19 vaccine, or have requested an exemption due to a disability or sincerely held religious beliefs, or must wait to receive the vaccine as the Centers for Disease Control and Prevention (CDC) recommends.
- Facilities that fail to meet this requirement will receive notice of non-compliance, but those that are above 80% and have a plan to achieve 100% staff vaccination within 60 days will not be subject to additional enforcement action.
Within 60 days after the guidance has been issued, healthcare facilities must:
- Have policies and procedures developed and implemented to ensure all facility staff are vaccinated; and
- 100% of staff have received completed vaccine series or been granted an exemption due to a disability, or sincerely held religious beliefs, or must wait to receive the vaccine as the CDC recommends.
- Facilities that fail to meet this requirement will receive notice of their non-compliance, but those that are above 90% and have a plan to achieve 100% staff vaccination within 30 days will not be subject to additional enforcement action.
Within 90 days of issuance of the guidance, facilities failing to maintain compliance with the 100% standard may be subject to enforcement action.
CMS also issued specific guidance for each healthcare facility type subject to the IFR, including hospitals and psychiatric residential treatment facilities (PRTFs). The guidance for hospitals and PRTFs appears to be the same. These more specific guidance documents note that “the requirements described above do not include the 14-day waiting period as identified by CDC for full vaccination. Rather, these requirements are considered met with the completed vaccine series (i.e., one dose of a single dose vaccine, or final dose of a multi-dose vaccine series).”
This guidance specifies that hospitals and PRTFs “must have a process for ensuring all staff have received at least a single-dose, or the first dose of a multi-dose Covid-19 vaccine series prior to providing any care, treatment, or other services for the facility and/or its patients.”
Hospitals and PRTFs “must also ensure those staff who are not yet fully vaccinated . . . adhere to additional precautions that are intended to mitigate the spread of Covid-19.” The guidance suggests a variety of actions or job modifications a facility can implement, including reassigning staff to remote work, mandatory routine Covid-19 testing in accordance with Occupational Safety and Health Administration (OSHA) and CDC guidelines, and requiring staff to wear N95 or higher-level respirators. CMS suggests similar actions for unvaccinated staff who are exempt from the vaccination requirements.
The guidance for hospitals and PRTFs clarifies that “[s]taff who exclusively provide telehealth or telemedicine services outside of the hospital setting” and “[s]taff who provide support services for the hospital that are preformed exclusively outside of the hospital setting” are exempt from the vaccination requirements. The guidance also notes, however, “that these individuals may be subject to other federal requirements for Covid-19 vaccination.”
In addition, the guidance notes that hospitals and PRTFs are not required to ensure that “one-off” vendors, volunteers, and professionals that provide infrequent, ad hoc, non-healthcare services (such as annual elevator inspections) are vaccinated.
Hospitals and PRTFs must track and securely document the following information:
- Each staff member’s (including contractors, volunteers, and students) vaccination status including specific vaccine, date of each dose, and date of next scheduled dose as well as each staff’s role, assigned work area, and how they interact with patients;
- Staff who have obtained any booster doses (including specific vaccine and date);
- Staff granted an exemption (including type of exemption and supporting documentation including documentation signed and dated by a licensed practitioner for medical exemptions);
- Staff for whom vaccination must be temporarily delayed (including date when staff can safely be vaccinated); and
- Staff who telework full-time.
The CMS guidance also recommends that hospitals and PRTFs refer to the following CDC informational document when assessing requests for medical exemptions: Summary Document for Interim Clinical Considerations for Use of Covid-19 Vaccines Currently Authorized in the United States.
Regarding religious exemptions, the CMS guidance directs hospitals and PRTFs to the Equal Employment Opportunity Commission Compliance Manual on Religious Discrimination for information on evaluating and responding to such requests.
The guidance also discusses contingency plans that hospitals and PRTFs must have in place for staff who do not comply with these vaccination requirements, including those who qualify for an exemption. These plans can include actively seeking replacement staff or temporary vaccinated staff until permanent vaccinated replacements can be hired.
Surveyors will begin evaluating for compliance 30 days after this guidance was issued during full surveys for recertification or reaccreditation, federal initial surveys, or complaint surveys.
This guidance includes detailed instructions for surveyors, including levels of deficiency that may be assigned based on levels of staff vaccination and other factors including whether policies and procedures regarding staff Covid-19 vaccination have been developed and implemented by a facility. In addition, the guidance specifies that surveyors may lower a citation level and/or enforcement action if they identify that prior to the survey that:
- A hospital or PRTF “has no or has limited access to vaccine, and the hospital [or PRTF] has documented attempts to obtain vaccine access (e.g., contact with health departments and pharmacies)”; or
- A hospital or PRTF “provides evidence that they have taken aggressive steps to have all staff vaccinated, such as advertising for new staff, hosting vaccine clinics, etc.”
