CMS Clarifies Vaccine Mandate Survey Guidance

With all states now past the Phase 2 deadline established by the Centers for Medicare and Medicaid Services (“CMS”) with respect to the vaccine mandate for staff of Medicare and Medicaid certified health facilities, the agency updated its guidance to surveyors to clarify some aspects of the survey process and citations to be issued for violations.

QSO-22-09-ALL, originally issued on January 14, 2022, and revised on April 5, 2022 (the “Memorandum”), makes the following clarifications for skilled nursing/nursing facilities with respect to conducting staff vaccination compliance reviews and citing violations:

Life Safety Code-Only Complaints or Follow-Up Surveys

In the case of Life Safety Code-only complaints or follow-up surveys, CMS clarified that surveying for compliance with staff vaccination requirements is not required but stops short of prohibiting surveyors from conducting such reviews. Further, the memo permits surveyors to modify the staff vaccination compliance review if the provider was determined to be in substantial compliance with this requirement within the previous six weeks. The memo, however, does not specify how surveyors may modify the compliance review and it does not require them to do so. In addition, because it is so narrow and applies only to Life Safety Code-only complaints or follow-up surveys where the provider has had a compliance review in the past six weeks, it is likely to be utilized sparingly.

Definition of “Temporarily Delayed Vaccination”

CMS is narrowing the criteria for a temporarily delayed vaccination. Under the original definition, a “temporarily delayed vaccination” is one that must be “temporarily postponed, as recommended by 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.” The Memorandum redefines it as a vaccination that must be “temporarily deferred, as recommended by CDC, due to clinical considerations, including known COVID-19 infection until recovery from the acute illness (if symptoms were present) and criteria to discontinue isolation have been met.” The redefinition has the effect of shortening the period of the temporary delay.

Unvaccinated Staff

The Memorandum clarifies that facility staff who have been suspended or are on extended leave do not count as unvaccinated staff for purposes of compliance with the vaccine mandate.

Contract Staff

In the Memorandum, CMS clarifies that the failure of the facility to obtain evidence of the vaccination status of contract staff will result in a citation at F888.

Good-Faith Effort

CMS provides an example of how a provider’s “good-faith effort” to achieve full vaccination of its staff can reduce the scope and severity of a citation for failure to meet the 100% requirement. As specified in the original version of the Memorandum, surveyors and CMS may lower the scope and severity of a citation and/or enforcement action if, inter alia, “the facility provides evidence that they have taken aggressive steps to have all staff vaccinated, such as advertising for new staff, hosting vaccine clinics, etc.” The revised Memorandum provides an example whereby a D-level citation may be reduced to an A-level violation in the case of a facility having a staff vaccination of 90% or more and no outbreak among residents in the previous four  weeks. Again, however, given that the application of the good-faith effort reduction is permissive, it remains to be seen how many providers will be affected by it.

The revised Memorandum did not address booster shots for staff despite numerous statements by CMS that the agency expects staff to be “up to date” with their vaccination status. The omission is somewhat perplexing as the Attachment pertaining to other providers, such as hospice, home health, and ambulatory surgical centers, references such an expectation.