Regulatory Reminder

Here are some Regulatory updates related to COVID-19 vaccinations and education and reporting. From the Interim Final Rule released yesterday to the SNF FY 2022 Proposed Rule, CNS requirements related to COVID-19 vaccination administration and reporting are serious business.

Interim Final Rule: (Medicare and Medicaid Programs; COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff)

Late yesterday, CMS posted an interim final rule related to COVID-19 vaccination education and reporting requirements for Skilled Nursing Facilities. They also issues a memo QSO-21-19-NH. In these documents CMS has laid out new policy regarding these issues and iterates potential F-tag citations and Civil Monetary Penalties, or CMPs, associated with non-compliance.

In Summary

CMS added the following new requirements

  • LTC facilities must develop policies and procedures to educate residents or resident representatives and staff regarding the benefits 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.
  • Additionally, the facility must 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.
  • LTC facilities must report COVID-19 vaccine status of residents and staff, each dose of vaccine received, COVID-19 vaccination adverse events, and therapeutics administered to residents for treatment of COVID-19 and this data must be reported to CDC’s NHSN system.
  • CMS intends to post the new information collected on the CMS COVID-19 Nursing Home Data website.

Noncompliance related to the new requirements for educating and offering COVID-19 vaccination to residents and staff will be cited at F-tag 887 (COVID-19 Immunization), and noncompliance related to COVID-19 vaccination reporting will be cited at F-tag 884 (Reporting – National Healthcare Safety Network (NHSN)).

To determine compliance, surveyors will request a facility point of contact to provide information on how residents and staff are educated about and offered the COVID-19 vaccine, including samples of educational materials. Surveyors will also request a list of residents and staff and their COVID-19 vaccination status from which they will select a sample of residents and staff to review records and conduct interviews to confirm they were educated on and offered the COVID-19 vaccine in accordance with the new requirements.

Facilities must continue submitting their COVID-19 data to NHSN at least weekly, but no later than Sunday at 11:59 p.m., each week. Facilities must begin including vaccination and therapeutic data reporting in facility NHSN submissions by 11:59 p.m. Sunday, June 13, 2021. To be compliant with the new reporting requirements, facilities must submit the data through the NHSN reporting system at least once every seven days. Facilities may choose to submit multiple times a week..

CMS will begin reviewing for compliance with the new vaccination reporting requirements Monday, June 14, 2021. Facilities identified as not meeting the all reporting requirements, including the new vaccination reporting requirements, will receive a deficiency citation at F884 on the CMS 2567, Statement of Deficiencies, at a scope and severity level of F (no actual harm with a potential for more than minimal harm that is not an Immediate Jeopardy [IJ] and that is widespread).

Failure to meet reporting requirements will also result in a 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 report, 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.

SNF FY 2022 Proposed Rule Quality Reporting Program (QRP) Update

As you may know, in the FY 2022 SNF PPS proposed rule, CMS has also proposed proposing the adoption of the COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) SNF QRP Measure beginning with the FY 2023 SNF QRP. 

In Summary

This measure would require SNFs to report on COVID-19 HCP vaccination in order to assess whether SNFs are taking steps to limit the spread of COVID-19 among their HCP, reduce the risk of transmission within their facilities and help sustain the ability of SNFs to continue serving their communities throughout the COVID-19 PHE and beyond.

Under this proposal, SNFs would report the vaccination data, for QRP reporting requirements, through the Centers for Disease Control and Prevention National Healthcare Safety Network beginning October 1, 2021 (clearly the Interim Final takes precedence with reporting required by June 13 to avoid survey penalties and CMPs).

CMS is proposing to publicly report the COVID-19 Vaccination Coverage among Healthcare Personnel measure beginning with the October 2022 Care Compare refresh or as soon as technically feasible using data collected for Q4 2021 (October 1, 2021 through December 31, 2021).  If finalized as proposed, a SNF’s HCP COVID-19 vaccination coverage rate would be displayed based on one quarter of data. Provider preview reports would be distributed in July 2022.  

Thereafter, HCP COVID-19 vaccination coverage rates would be displayed based on one quarter of data updated quarterly. Subsequent to this, one additional quarter of data would be added to the measure calculation during each advancing refresh, until the point four full quarters of data is reached. Thereafter, the measure would be reported using four rolling quarters of data.

Note also that CMS has indicated that this reporting requirement will also be subject to the SNFs QRP Annual Payment Update requirements and non-reporting could affect a2% reduction to a facility’s annual market basket update.

Take heed. CMS is serious about compliance in these areas. Be sure to download QSO-21-19-NH to be sure your facility will be in compliance with these new regulatory requirements.