Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare
CMS posted QSO-23-02-ALL … Revised Guidance for Staff Vaccination Requirements the afternoon of Wednesday, October 26, 2022. This is a 163-page Memorandum. Be sure to watch for the red ink – there’s a lot of it.
CMS is replacing QSO memoranda 22-07-ALL Revised, 22-09-ALL Revised, and 22-11-ALL Revised and is revising the interpretive guidance for all provider types found in Attachments A through N. The revisions address frequency of review of the Staff Vaccination requirements, as well as Immediate Jeopardy, Condition-level and actual harm determinations to ensure that deficiency citations recognize good faith efforts by providers/suppliers.
Medicare and Medicaid-certified facilities are expected to comply with all applicable regulatory requirements, and CMS has a variety of established enforcement remedies. For nursing homes, home health agencies, and hospice (beginning in 2022), this includes civil monetary penalties, denial of payments, and—as a final measure—termination of participation from the Medicare and Medicaid programs. The sole enforcement remedy for noncompliance for hospitals and certain other acute and continuing care providers is termination; however, CMS’s primary goal is to bring health care facilities into compliance. Termination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance.
CMS expects all providers’ and suppliers’ staff to have received the appropriate number of doses of the primary vaccine series unless exempted as required by law, or delayed as recommended by CDC. Facility staff vaccination rates under 100% constitute noncompliance under the rule. Noncompliance does not necessarily lead to termination, and facilities will generally be given opportunities to return to compliance. For example, a facility that is noncompliant and has implemented a plan to achieve compliance would not be subject to an enforcement action.
While Federal, State agencies (SAs), Accrediting Organization (AOs), and CMS-contracted surveyors may expand any survey to include staff vaccination requirement compliance review, SAs and AOs will only be expected to perform compliance reviews of the staff vaccination requirements as part of initial certification, standard recertification or reaccreditation surveys, and in response to specific complaint allegations related to the staff vaccination requirements. Surveyors may modify the staff vaccination compliance review if the provider/supplier was determined to be in substantial compliance with this requirement within the previous six weeks. Additional information and expectations for compliance can be found at the provider-specific guidance attached to this memorandum.
Guidance specific to provider types and certified suppliers is provided in the following attachments. The provider-specific guidance has been updated, and revised for assigning severity at Immediate Jeopardy, Harm, and Condition levels to align with QSO-22-17-ALL. State Survey Agencies should reach out to their CMS Location if they are considering citing vaccine requirements at immediate jeopardy, condition or actual harm levels.
- Attachment A: LTC Facilities (nursing homes) … begins on page 4
- Attachment B: ASC … begins on page 12
- Attachment C: Hospice … begins on page 24
- Attachment D: Hospitals … begins on page 36
- Attachment E: PRTF … begins on page 48
- Attachment F: ICF/IID … begins on page 60
- Attachment G: Home Health Agencies … begins on page 72
- Attachment H: CORF … begins on page 84
- Attachment I: CAH … begins on page 96
- Attachment J: OPT … begins on page 107
- Attachment K: CMHC … begins on page 118
- Attachment L: HIT … begins on page 129
- Attachment M: RHC/FQHC … begins on page 141
- Attachment N: ESRD Facilities … begins on page 153
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