On May 11, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released an interim final rule with comment period that establishes new COVID-19 vaccine immunization requirements for residents and staff.[1] The rule is scheduled to go into effect on May 21, 2021. Specifically, CMS added new regulatory requirements at §483.80(d)(3)(i)-(vii) (F887) for long-term care (“LTC”) facilities to develop policies and procedures to educate residents or resident representatives and staff regarding the benefits and risks and potential side effects associated with the COVID-19 vaccine and offer the vaccine unless it is medically contraindicated or the resident or staff member has already been immunized. The facility must also maintain appropriate documentation to reflect that the facility provided the required COVID-19 vaccine education, and whether the resident and staff member received the vaccine.
CMS also added a new regulatory requirement at 483.80(g)(1)(viii)-(ix) (F884) for LTC facilities to report, on a weekly basis, through NHSN’s LTCF COVID-19 Module the following: (a) COVID-19 vaccine status of residents and staff, including the total numbers of residents and staff, (b) the numbers of residents and staff vaccinated, (c) the numbers of each dose of COVID-19 vaccine received, (d) any COVID-19 vaccination adverse events; and (e) therapeutics administered to residents for treatment of COVID-19.
The new requirements for educating and offering COVID-19 vaccination to residents and staff provide that in situations where COVID-19 vaccination requires multiple doses, that the resident or resident representative and staff are also provided with education regarding the benefits and potential side effects of the vaccine and current information regarding those additional doses, including any changes in the benefits, risks or potential side effects associated with the COVID-19 vaccine, before requesting consent for administration of any additional doses. The new requirements also provide that the resident, resident representative or staff member has the opportunity to accept or refuse a COVID-19 vaccine and to change their decision about vaccination at any time.
With respect to documentation, the new requirements provide that the resident’s medical record must include documentation that indicates, at a minimum:
- that the resident or resident representative was provided education regarding the benefits and potential side effects of the COVID-19 vaccine; and
- each dose of COVID-19 vaccine administered to the resident; or
- if the resident did not receive the COVID-19 vaccine due to medical contraindications or refusal.
The facility must maintain documentation related to staff COVID-19 vaccination that includes, at a minimum, the following:
- that staff were educated on the benefits and potential side effects of the COVID-19 vaccine
- staff were offered the COVID-19 vaccine or information on obtaining COVID-19 vaccine; and
- the COVID-19 vaccine status of staff and related information as indicated by NHSN.
With respect to the new COVID-19 vaccination reporting requirements added under F884, CMS notes that facilities must begin including vaccination and therapeutic data reporting in facility NHSN submissions by 11:59p.m. Sunday, June 13, 2021. Facilities must submit the data through the NHSN reporting system at least once every seven days to be compliant with the new reporting requirements. CMS has indicated that it will begin reviewing for compliance with the new vaccination reporting requirements effective Monday, June 14, 2021.
Failure to meet the reporting requirements under F884, which now includes the new vaccination reporting requirements, will result in a single deficiency at F884 for that reporting week and the imposition of a civil money penalty (“CMP”) starting at $1,000 for the first occurrence of a failure to report. For each subsequent week that the facility fails to submit the required COVID-19 data, the noncompliance will result in an additional CMP imposed at an amount increased by $500 and added to the previously imposed CMP amount for each subsequent occurrence (e.g., $1,000 for first occurrence of noncompliance; $1,500 for second occurrence of noncompliance, etc.).
Nursing home providers will need to ensure compliance with the new requirements related to educating and offering COVID-19 vaccination to residents and staff and the new requirements related to COVID-19 vaccination reporting to avoid potential deficiencies and sanctions.
If you have any questions regarding CMS’ COVID-19 vaccine immunization requirements for residents and staff, or would like assistance in developing the required policies and procedures to achieve compliance with these requirements, please do not hesitate to contact Tanya Daniels Harris (tharris@ldylaw.com). Thank you, and stay well.