CMS issues updated guidance for certified facilities on COVID-19 vaccine requirement as public health emergency continues
The Center for Medicare & Medicaid Services (CMS) and The Joint Commission (TJC) have published guidance on survey procedures and enforcement of the COVID-19 vaccine requirement for hospitals and health care facilities after the U.S. Supreme Court lifted injunctions from lower courts that halted enforcement in 25 states impacted by lawsuits.
Both CMS and TJC indicate that enforcement will soon be part of regularly scheduled surveys or complaint surveys.
According to the most recent CMS guidance and specific information for enforcement at hospitals, “[s]urveyors will begin surveying for compliance 30 days after the issuance of the QSO-22-09-ALL memorandum, through a full survey for recertification or reaccreditation, federal initial surveys, or a complaint survey. Surveyors will be guided to focus on the vaccination status and hospital policies to address vaccination for staff that regularly work in the hospital (e.g., weekly), using a phased-in approach as described.”
The memorandum from the CMS Quality, Safety and Oversight Group was published on January 14, 2022, and includes a note that the information applies to all states not covered under the earlier QSO-22-07-ALL memo issued December 28, 2021, except for Texas, which has a separate legal challenge.
Dust off and update your policies to show any changes are approved before your next survey now that CMS, TJC and other accrediting organizations will be surveying and assessing compliance with CMS Conditions of Participation for health care workers to be fully vaccinated against COVID-19. (42 CFR §482.42 Conditions of Participation: Infection prevention and control and antibiotic stewardship programs. (g) Standard: COVID-19 vaccination of hospital staff.)
Required documents for surveyors:
- All policies and processes regarding health care staff vaccinations.
- Reports for overall vaccination rates of staff (excluding staff with exemptions).
- Tracking lists of all staff, including positions/titles and vaccination status.
- Sample selection of current documentation including vaccinated, unvaccinated and exempted staff.
Policies should clearly state processes for securely recording and tracking COVID-19 vaccination status of all staff (including booster doses) as well as processes for securely documenting and tracking staff requests for an exemption from COVID-19 vaccination requirements based on an applicable federal law.
CMS has said hospitals and other health care providers covered under the interim final rule have 30 days after the publication of applicable guidance to show that all staff have either had at least one (1) dose of the vaccine or been approved for a religious or medical exemption. Providers then have another 30 days to show that staff are fully vaccinated or have an approved exemption.
Facilities should be able to show progress on vaccine compliance and that staff exemption requests are being acted upon efficiently as deadlines for compliance quickly approach.
- For states not impacted by the U.S. Supreme Court decision, the previously announced compliance dates of January 28, 2022, and February 27, 2022, remain in effect.
- New dates for compliance applicable to Ohio and the other states where the rule was previously enjoined from going into effect is February 14, 2022, for policies and procedures ensuring facility staff are vaccinated to be in effect and for staff to receive the first dose of the vaccine with March 15, 2022, for staff to complete the vaccine series.
While nursing homes, home health agencies and hospice (beginning in 2022) first face civil monetary penalties, CMS has stated it will follow current enforcement procedures based on level of deficiency cited during surveys indicating any providers not in substantial compliance could be subject to denial of payments and as a final measure termination of participation from the Medicare and Medicaid programs.
Extension of PHE
The COVID-19 pandemic was first declared a national public health emergency (PHE) effective January 31, 2020, and the U.S. Secretary of Health and Human Services has extended such declaration for another 90 days, effective January 16, 2022. This will be the eighth extension with this renewal marking entry into the third year of the pandemic.
The PHE, among other things, allows for certain waivers of regulatory requirements to allow hospitals and other health care providers to meet continuing demands of patient surges and shortages of staffing and/or supplies. The list of emergency blanket 1135 waivers allowed under the PHE was last updated in November 2021.
CMS and accrediting organizations have said that patient safety regulations waived under the 1135 blanket will not be enforced until the national PHE is lifted and that hospitals will get up to 60 days notice in order to come back into compliance as time may be needed to conduct maintenance, find supplies/parts, make repairs and arrange for the required inspections to meet the CMS Conditions of Participation.