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This interim final rule with comment period revises the infection control requirements that most Medicare- and Medicaid-participating providers and suppliers must meet to participate in the Medicare and Medicaid programs.  These changes are necessary to protect the health and safety of residents, clients, patients, and staff and reflect lessons learned as result of the COVID-19 public health emergency.  The revisions to the infection control requirements establish COVID-19 vaccination requirements for staff at the included Medicare- and Medicaid-participating providers and suppliers.

Statement of Need:

The rule establishes COVID-19 vaccination requirements for staff at the included Medicare-and Medicaid-participating providers and suppliers.  These changes are necessary to protect the health and safety of residents, clients, patients, and staff. 

Summary of the Legal Basis:

CMS has broad statutory authority to establish health and safety regulations, which includes authority to establish health and safety standards for Medicare and Medicaid certified facilities.  We believe requiring staff vaccinations for COVID-19 is critical to safeguarding the health and safety of all individuals seeking health care in Medicare and Medicaid certified facilities.  Sections 1102 and 1871 of the Social Security Act (the Act) grant the Secretary of Health and Human Services authority to make and publish such rules and regulations, not inconsistent with the Act, as may be necessary to the efficient administration of the functions with which the Secretary is charged under this Act.

Alternatives:

In developing the policies contained in this rule, we considered numerous alternatives to the final provisions including limiting vaccination requirements to direct care employees, additional requirements, and different implementation time frames.  These alternatives are discussed in further detail in the rule.

Anticipated Costs and Benefits:

We estimate costs associated with this rulemaking including those costs associated with information collection requirements, additional recordkeeping, and costs associated with vaccination.  We anticipate benefits of the rule to include reduction in the transmission of infections and decreases in hospitalizations and mortality.

Risks:

Although there is some uncertainty about the effects of this rule on health care staffing, we believe that the wide application of these requirements will reduce the likelihood of individual workers seeking new employment in order to avoid vaccination.