Nurse

0938-AU75 202110 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0938 Centers for Medicare & Medicaid Services CMS 0900 Department of Health and Human Services HHS Omnibus COVID-19 Health Care Staff Vaccination (CMS-3415)

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.

]]> Economically Significant First Time Published in The Unified Agenda Final Rule Stage Yes No Section 610 Review 42 CFR 483 42 U.S.C. 1395hh 42 U.S.C. 1302 Yes

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.

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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.

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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.

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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.

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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.

]]> Interim Final Rule 11/05/2021 86 FR 61555 Interim Final Rule Effective 11/05/2021 Interim Final Rule Comment Period End 01/04/2022 Yes Businesses Governmental Jurisdictions Organizations Federal Local State Yes Yes No Kim Roche Nurse 0938 Centers for Medicare & Medicaid Services CMS 410 786-3524 kim.roche@cms.hhs.gov Center for Clinical Standards and Quality, MS: C2-21-16, 7500 Security Boulevard, Baltimore MD 21244