CMS Reverses Position and Will Begin Enforcement of Health Care Staff Vaccine Requirement

Reversing its prior position, CMS announced on December 28, 2021, that it would begin enforcement of the COVID-19 vaccine requirement, established by the interim final rule, published November 05, 2021, in 25 states and the District of Columbia[1] in a phased approach beginning January 27, 2022. With the announcement CMS issued guidance for surveyors regarding enforcement in S&C Memo QSO 22-07-ALL (“Memo”), describing how CMS will enforce the rule and how facilities that are non-compliant may avoid enforcement action if meeting certain threshold criteria during periods up to 90 days after issuance of the Memo as follows:

By January 27, 2022 (30 days after issuance of the Memo)

If a facility does not meet the 100% compliance rule, but policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient or resident contact, are vaccinated for COVID-19, then:

1. The facility will be considered compliant if 100% of staff:
   1. have received at least one dose of COVID-19 vaccine, or
   2. have a pending request for or have been granted a qualifying exemption, or
   3. have been identified as having a temporary delay as recommended by the CDC.
2. A facility that is not compliant would receive notice of their non-compliance with the 100% standard; however, the facility would not be subject to additional enforcement action, if:
   1. the facility is above 80% compliance, and
   2. has a plan to achieve a 100% staff vaccination rate within 60 days.

By February 26, 2022 (60 days after issuance of the Memo)

If a facility does not meet the 100% compliance rule, but policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient or resident contact, are vaccinated for COVID-19, then:

1. The facility will be considered compliant if 100% of staff:
   1. have 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), or
   2. have been granted a qualifying exemption, or
   3. have been identified as having a temporary delay as recommended by the CDC.

Note the differences in the 60 day period (as opposed to the 30 day period): (a) the vaccine doses must be complete and (b) exemptions must be granted (not just pending).

2. A facility that is not compliant would receive notice of their non-compliance with the 100% standard; however, the facility would not be subject to additional enforcement action, if:
   1. the facility is above 90% compliance, and
   2. has a plan to achieve a 100% staff vaccination rate within 30 days.

After March 28, 2022 (90 days after issuance of the Memo)

All facilities must be 100% compliant and facilities failing to maintain compliance with the 100% standard may be subject to enforcement action.

The Memo instructs that federal, state, Accreditation Organization, and CMS-contracted surveyors will begin surveying for compliance with the requirements as part of initial certification, standard recertification or reaccreditation, and complaint surveys 30 days following the issuance of this memorandum – that is beginning on January 27, 2022. Under CMS’s survey authority (nursing homes, home health agencies, and hospice), enforcement can include civil monetary penalties, denial of payments, and—as a final measure—termination of participation from the Medicare and Medicaid programs. The Memo notes that the sole enforcement remedy for non-compliance for hospitals and certain other acute and continuing care providers is termination, but that “CMS’s primary goal is to bring health care facilities into compliance” and that “[t]ermination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance.”

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[1] The states where enforcement will begin are: 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. Pending review by the Supreme Court of challenge to the rule, surveyors will not enforce the requirements in 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, Texas, Utah, West Virginia, and Wyoming.