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CMS Issues New Guidance for Hospitals Regarding Mass Vaccinations

Additional Guidance is now available from the Centers for Medicare and Medicaid Services (CMS) regarding updated guidance about mass vaccination events either on campus or to support events off campus.

Here are details regarding the CMS website and the new blanket waiver as well as FAQ’s regarding the most updated guidance:

Blanket waiver:

CMS is modifying the following regulations: Conditions of Participation (CoP) for COVID-19 Vaccinations.  Under the authority afforded by Section 1135 of the Social Security Act, for the duration of the Public Health Emergency, CMS is modifying the following regulation:

§ 482.23 Condition of participation: Nursing services. 12 (c) Standard: Preparation and administration of drugs. (3) With the exception of influenza and pneumococcal vaccines, which may be administered per physician-approved hospital policy after an assessment of contraindications, orders for drugs and biologicals must be documented and signed by a practitioner who is authorized to write orders in accordance with State law and hospital policy, and who is responsible for the care of the patient.

To allow for hospital and community administration of COVID-19 vaccines, the following highlighted language is being incorporated into this regulation for the duration of the PHE:

§ 482.23 Condition of participation: Nursing services. (c) Standard: Preparation and administration of drugs. (3) With the exception of influenza, pneumococcal, and COVID-19 vaccines (either currently approved by the FDA or authorized under an FDA Emergency Use Authorization), which may be administered per physician-approved hospital policy after an assessment of contraindications, orders for drugs and biologicals must be documented and signed by a practitioner who is authorized to write orders in accordance with State law and hospital policy, and who is responsible for the care of the patient.

Question: Under the CMS hospital Conditions of Participation (CoPs),1 does a hospital need an order from a physician (or other clinician practitioner acting in accordance with his or her state scope-of-practice requirements) to administer one of the available COVID-19 vaccines to an individual who is requesting COVID-19 immunization?

Answer: CMS, under the waiver authority provided in section 1135 of the Social Security Act (42 U.S.C. 1320b-5), is modifying the requirements at 42 CFR 482.23(c)(3) to allow a hospital to administer any COVID-19 vaccine, authorized under an FDA Emergency Use Authorization without an individual clinician order. This modification to the CoP requirement is equivalent to the individual order exception currently provided at 42 CFR 482.23(c)(3) for influenza and pneumococcal vaccination orders and their administration. Under the section 1135 waiver authority, COVID-19 vaccines will now be included in this regulatory exception for the duration of the Public Health Emergency (PHE). This will allow hospitals to administer COVID-19 vaccines to patients and other individuals requesting immunization in a manner similar to their previous influenza and/or pneumococcal events. Hospitals must adhere to any state law or administrative requirements regarding the administration of vaccinations. We recognize the pressing need to ensure broad access to available COVID-19 vaccines and the essential role hospitals fill in serving their communities. This includes hospitals hosting, either on campus or offsite, mass immunization events that are easily accessible for those members of the community requesting immunization. These events (similar to annual influenza immunization programs) are typically governed by state law and practice. CMS policy allows participating hospitals (including critical access hospitals and other Medicare enrolled provider and supplier types) to serve as “mass immunizers” of the COVID-19 vaccines without any additional enrollment (https://www.cms.gov/medicare/covid19/enrollment-administering-covid-19-vaccine-shots). CMS recommends that a hospital planning to provide this essential service to its community follow all state laws and administrative requirements, in addition to the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices guidelines for safe vaccine administration (https://www.cdc.gov/vaccines/covid-19/index.html).

1 Please note that this discussion of the Medicare hospital CoP order requirements, which apply to all Medicare participating hospitals and all hospital patients, and which is contained in the FAQ here, clarifies CMS enforcement of those specific hospital CoP requirements only. However, the requirements for payment under Medicare, particularly those related to hospital patient orders, and which apply to hospital services provided to Medicare beneficiaries only, may differ from the CoPs in both their composition and application.

For published FAQ which can be used for anyone inquiring about this information click here.

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