Note: This article has been revised to include information on the Group 2 states and Texas as of January 25, 2022.
Nursing homes face possible citations, civil monetary penalties, denial of payments and—as a final measure—termination of participation from the Medicare and Medicaid programs by the Centers for Medicare & Medicaid Services (“CMS”) as they embark on complying with the new CMS COVID-19 vaccine requirements for their staff.
On December 28, 2021, the Quality, Safety & Oversight Group at CMS issued a memorandum entitled “Guidance for the Interim Final Rule – Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination” (“Group 1 QSO Memo”) that unpacks the new CMS COVID-19 vaccine requirements compliance elements for the health care providers and creates survey guidelines for assessing provider compliance and penalizing providers that fail those requirements. The Group 1 QSO Memo specifically applies to the following states: California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Tennessee, Vermont, Virginia, Washington and Wisconsin.
On January 14, 2022, the Quality, Safety & Oversight Group at CMS issued a memorandum entitled “Guidance for the Interim Final Rule – Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination” (“Group 2 QSO Memo”) that unpacks the new CMS COVID-19 vaccine requirements compliance elements for the health care providers and creates survey guidelines for assessing provider compliance and penalizing providers that fail those requirements. The Group 2 QSO Memo specifically applies to the following 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, Utah, West Virginia and Wyoming.
On January 20, 2022, the Quality, Safety & Oversight Group at CMS issued a memorandum entitled “Guidance for the Interim Final Rule – Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination” (“Texas QSO Memo”) that unpacks the new CMS COVID-19 vaccine requirements compliance elements for the health care providers and creates survey guidelines for assessing provider compliance and penalizing providers that fail those requirements. The Texas QSO Memo specifically applies to Texas.
The Group 1 QSO Memo, Group 2 QSO Memo and Texas QSO Memo (“the QSO Memos”) describe the compliance assessment process that applies to all covered provider types and contains provider-specific details for each type in a group of attachments, one for each provider type.
Background
On November 5, 2021, CMS published an Interim Final Rule with comment period (86 FR 61555), entitled “Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination,” revising the infection control requirements that most Medicare and Medicaid certified providers and suppliers must meet to participate in the Medicare and Medicaid programs.
Phased Approach of Compliance
CMS expects the staff of providers and suppliers to have received the appropriate number of vaccine doses by timeframes detailed in the QSO Memo unless exempted as required by law, or delayed as recommended by CDC. The timeframes are based on the issuance date of each of the QSO Memos, which was December 28, 2021 for the Group 1 QSO Memo, January 14, 2022 for the Group 2 QSO Memo and January 20, 2022 for the Texas QSO Memo. Facility staff vaccination rates under 100% constitute noncompliance under the rule. The key dates and enforcement action thresholds are as follows:
- Phase 1
Within 30 days after issuance of each QSO Memo, (January 27, 2022 for the Group 1 QSO Memo, February 14, 2022 for the Group 2 QSO Memo and February 21, 2022 for the Texas QSO Memo), a facility will be in compliance if it demonstrates all of the following:
a) The facility has policies and procedures in place to ensure that all facility staff, regardless of clinical responsibility or patient or resident contact are vaccinated for COVID-19; and
b) 100% of staff have either (1) received at least one dose of COVID-19 vaccine, (2) a pending request for a qualifying exemption, (3) been granted qualifying exemption, or (4) are identified as having a temporary delay as recommended by the CDC due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, or individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment in the last 90 days.
If less than 100% of all staff have either (1) received at least one dose of COVID-19 vaccine, (2) a pending request for a qualifying exemption, (3) been granted qualifying exemption, or (4) are identified as having a temporary delay as recommended by the CDC, the facility is non-compliant.
Planning for compliance is important and can save a facility from enforcement actions. In non‑compliant cases, the facility will receive notice of their non-compliance with the 100%
standard. However, a facility that is above 80% and has a plan to achieve a 100% staff vaccination rate within 60 days would not be subject to additional enforcement action. Facilities that do not meet these parameters could be subject to additional enforcement actions depending on the severity of the deficiency and the type of facility, which could include plans of correction, civil monetary penalties, denial of payment or termination.
- Phase 2
Within 60 days after issuance of each of the QSO Memos, (February 28, 2022 for the Group 1 QSO Memo, March 15, 2022 for the Group 2 QSO Memo and March 21, 2022 for the Texas QSO Memo), a facility will be in compliance if it demonstrates all of the following:
a) The facility has policies and procedures in place to ensure that all facility staff, regardless of clinical responsibility or patient or resident contact are vaccinated for COVID-19; and
b) 100% of staff have either: (1) received the necessary doses to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multiple-dose vaccine series), (2) been granted a qualifying exemption, or (3) are identified as having a temporary delay as recommended by the CDC.
If less than 100% of all staff have either: (1) received the necessary doses to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multiple-dose vaccine series), (2) been granted a qualifying exemption, or (3) are identified as having a temporary delay as recommended by the CDC, the facility will be considered non-compliant.
Again, planning for compliance is important and can save a facility from enforcement actions. In non-compliant cases, the facility will receive notice of their non-compliance with the 100%
standard. However, a facility that is above 90% and has a plan to achieve a 100% staff vaccination rate within 30 days would not be subject to additional enforcement action. Facilities that do not meet these parameters could be subject to additional enforcement actions depending on the severity of the deficiency and the type of facility.
- Phase 3
By 90 days after the date of each of the QSO Memos (March 28, 2022 for the Group 1 QSO Memo, April 14, 2022 for the Group 2 QSO Memo and April 20, 2022 for the Texas QSO Memo) , facilities failing to maintain compliance with the 100% standard may be subject to enforcement action.
Surveys Start
Federal, state, Accreditation Organization and CMS-contracted surveyors will begin surveying for compliance with these requirements as part of initial certification, standard recertification or reaccreditation, and complaint surveys on January 27, 2022, 30 days after the date of the Group 1 QSO Memo for the Group 1 States.
Federal, state, Accreditation Organization and CMS-contracted surveyors will begin surveying for compliance with these requirements as part of initial certification, standard recertification or reaccreditation, and complaint surveys on February 14, 2022, 30 days after the date of the Group 2 QSO Memo for the Group 2 States.
Federal, state, Accreditation Organization and CMS-contracted surveyors will begin surveying for compliance with these requirements as part of initial certification, standard recertification or reaccreditation, and complaint surveys on February 22, 2022, 30 days after the date of the Texas QSO Memo for Texas.
CMS directs that surveyors focus on staff that regularly work in the facility (e.g., weekly).
Survey Guidance for Skilled Nursing Facilities – New F Tag 888
The QSO Memo includes multiple attachments, each focused on a specific provider type. Attachment A focuses on skilled nursing providers (“Attachment A”). Attachment A introduces a new citation tag for skilled nursing providers, F Tag 888, regarding infection control under CFR §483.80(i).
- Staff Definition
For purposes of the vaccine requirement, Attachment A defines “staff” as individuals who provide any care, treatment or other services for the facility and/or its residents, including employees; licensed practitioners; adult students, trainees and volunteers; and individuals who provide care, treatment or other services for the facility and/or the residents, under contract or by other arrangements. This definition also includes individuals under contract or by arrangement with the facility, including hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals, licensed practitioners, adult students, trainees or volunteers.
Staff does not include anyone who provides only telemedicine services or support services outside of the facility and who does not have any direct contact with residents. In addition, nursing homes are not required to ensure the vaccination of individuals who very infrequently provide ad hoc non-health care services (such as annual elevator inspection), or services that are performed exclusively off-site.
- Policies and Procedures
The facility’s policies and procedures must ensure that all facility staff, regardless of clinical responsibility or patient or resident contact are vaccinated for COVID-19 and address each of the components specified in CFR §483.80(i).
- Tracking and Tracking Tools
Attachment A emphasizes that a facility must track and securely document:
- Each staff member’s vaccination status (including the specific vaccine received, dates of each dose received or the date of the next scheduled dose for a multi-dose vaccine);
- Any staff member who has obtained any booster doses (including the specific vaccine booster received and the date of the administration of the booster);
- Staff who have been granted an exemption from vaccination (including the type of exemption and supporting documentation);
- Requirements by the facility; and
- Staff for whom COVID-19 vaccination must be temporarily delayed. For temporary delays, facilities should track when the identified staff can safely resume their vaccination.
Facilities have the flexibility to use tracking tools of their choice. Facilities must be ready to provide evidence of this tracking to the surveyor for review. The tracking tool should identify each staff’s role, assigned work area and how they interact with residents. The tracking tool must include staff who are contractors, volunteers or students.
- Exemptions
Facilities must have a process by which staff may request exemption from COVID-19 vaccination based on applicable federal law. Attachment A describes that the process should clearly identify how an exemption is requested, and to whom the request must be made. Additionally, facilities must have a process for collecting and evaluating such requests, including the tracking and secure documentation of information provided by those staff who have requested the exemption, the facility’s determination of the request and any accommodations that are granted.
Attachment A emphasizes that surveyors will not evaluate the details of a request for a religious exemption, nor the rationale for the facility’s acceptance or denial of the request. Rather, surveyors will review to ensure the facility has an effective process for staff to request a religious exemption for a sincerely held religious belief.
- Contingency Plans
Facilities are required to have plans for staff who are not fully vaccinated. Attachment A details that contingency plans should include actions that the facility would take when staff have indicated that they will not get vaccinated and do not qualify for an exemption. Contingency plans should also address staff who are not fully vaccinated due to an exemption or temporary delay in vaccination, such as through the additional precautions required at CFR §483.80(i)(3)(iii).
Facilities should prioritize contingency plans for those staff that have not obtained any doses of any vaccine over staff that have received a single dose of a multi-dose vaccine. The plans should also indicate the actions the facility will take if the deadline is not met, such as actively seeking replacement staff through advertising or obtaining temporary vaccinated staff until permanent vaccinated replacements can be found.
Survey Process – Key Elements
- Recent Information Request
To determine compliance with §483.80(i), surveyors will request the facility’s COVID-19 vaccination policies and procedures, the number of resident and staff COVID-19 cases over the last 4 weeks and a list of all staff and their vaccination status.
- Offsite Data Review and Preparations
Surveyors should verify facility reporting of vaccine data to CDC’s National Healthcare Safety Network (“NHSN”) as a part of offsite preparation prior to going onsite for any initial, certification or complaint survey. This will help them determine if there are inaccuracies in the facility’s vaccine NHSN reporting or with the facility’s process for tracking and securely documenting the COVID-19 vaccination status for all staff [per §483.80(i)(3)(iv)]. The percent of staff vaccinated as reported through NHSN and as identified through the onsite survey should be reasonably consistent, although the numbers may not be exactly the same. For example, there is a time lag between when facilities submit data to NHSN and when the data is posted publicly.
- Scope and Severity
Facility staff vaccination rates under 100% constitute non-compliance under the rule. The level of severity will be cited based on the level of harm, or likelihood of harm for residents. For example, facilities with a high percentage of unvaccinated staff, several COVID-19 infections and gaps in their policy and procedures, represent a higher risk of harm to residents. Therefore, these facilities would be cited at a higher level of severity than facilities with few unvaccinated staff, no COVID-19 infections and compliant policy and procedures.
Next Actions
- Skilled nursing facilities should promptly select a tracking tool and populate the required data that surveyors will request.
- Facilities should ensure their policies and procedures accurately reflect the process for requesting a vaccination exemption.
- Facilities should also explore and detail their contingency plan through policy and procedures.
- Facilities should not lose track of the reporting, testing and education requirements introduced in regulations earlier in the public health emergency.
If you have questions or would like additional information about this topic, please contact:
- Sean Fahey at (317) 977-1472 or sfahey@wp.hallrender.com;
- Brian Jent at (317) 977-1402 or bjent@wp.hallrender.com;
- Todd Selby at (317) 977-1440 or tselby@wp.hallrender.com; or
- Your regular Hall Render attorney.
More information about Hall Render’s Post-Acute and Long-Term Care services can be found here.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer an individual’s questions that may constitute legal advice.
