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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations United States for administration through the CDC COVID19 Vaccination Program, all ICFIID clients are able to receive the vaccine without any copays or out-of-pocket costs. Currently Medicaid pays for the administration of the COVID19 vaccine to beneficiaries, and other public and private insurance providers are required to cover it as well.
Education for clients and representatives must also provide the opportunity for follow up questions, and be conducted in a manner that is reasonably understood by the clients and representatives. Information should be made available in accessible formats as appropriate for a facilitys population. That is, educational materials and delivery must meet relevant standards in Section 504 of the Rehabilitation Act, which may include making such material available in large print, Braille, and American Sign Language, and using close captioning, audio descriptions, and plain language for people with vision, hearing, cognitive, and learning disabilities.
3. ICFIID Voluntary Reporting While there would be great value in collecting more data about COVID19
incidence and vaccinations in ICFsIID, we are not mandating such data submission at this time. Currently there are only approximately 80 ICFsIID
participating in the NHSN or any other formal reporting program, although there are opportunities for ICFsIID to enroll. Requiring all ICFsIID to report to NHSN would create a new field of administrative burden for ICFsIID, potentially requiring new equipment, administrative staff, and training.
Further, reporting through NHSN would require time, likely several weeks to months, for the facilities not yet participating in NHSN to complete enrollment with CDC and appropriately train those staff who would be responsible for data submission, effectively making compliance within the effective date of this IFC nearly impossible. Based on the information we have received from stakeholders, we do not believe that ICFsIID are administering therapeutics at this time.
We encourage voluntary reporting as facilities are able to do so.
C. Enforcement Enforcement of the provisions of this IFC for LTC facilities will be similar to those requirements addressing influenza and pneumococcal vaccinations. We will impose civil money penalties if we determine that the facility has failed to
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report vaccination data.59 Education and vaccine administration must be reflected in facility policies and procedures, as well as in staff and resident records. In addition, NHSN
reporting of vaccine and therapeutics must be reflected in facility policies and procedures, with evidence of data submission. For ICFsIID, education and administration of the vaccine must be reflected in facility policies and procedures, as well as in staff and client records. Updated guidance and information on reporting and enforcement of these new requirements will be issued when this IFC is published.
We specify at 483.80d3i and 483.460a4i that COVID19 vaccines must be offered when available. If a facility does not have access to the vaccine, we expect the facility to provide, upon request, evidence that efforts have been made to make the vaccine available to its residents or clients, and staff. For example, documentation of communications with the facility medical director, the local health department, or listing of vaccination sites may be used to show efforts to make the vaccine available to residents, clients, and staff. Similar to influenza vaccines, if there is a manufacturing delay, we ask the facility to provide sufficient evidence of such.
The infection prevention and control plan is designed to allow for documentation of vaccine efforts. While Pharmacy Partnership clinics are currently the most common avenue for delivering COVID19 vaccines to LTC
facilities, we expect all facilities to be prepared to participate in other distribution programs possibly through local health departments or traditional pharmacies as the vaccine continues to become more widely available at a multiplicity of sites.
If an individual resident, client, or staff member requests vaccination against COVID19, but missed earlier opportunities for any reason including recent residency or employment, changing health status, overcoming vaccine hesitancy, or any other reason, we expect facility records to show efforts made to acquire a vaccination opportunity for that individual.
Although we are not establishing formal timeframes within which vaccination must be arranged for new residents, clients, or staff, we expect LTC facilities and ICFsIID to support vaccination for 59 Social Security Act. Section 1819h2Bii.
Accessed at https www.ssa.gov/OP_Home/ssact/
title18/1819.htm; and Social Security Act. Section 1919h2Aii. Accessed at https www.ssa.gov/
OP_Home/ssact/title19/1919.htm. Both accessed on April 28, 2021.

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these individuals as quickly as practicable. Further, we expect personnel records for facility staff and health records for residents and clients to reflect appropriate administration of any multi-dose vaccine series, including efforts to acquire subsequent doses as necessary.
III. Waiver of Proposed Rulemaking We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule before the provisions of the rule are finalized, either as proposed or as amended in response to public comments, and take effect, in accordance with the Administrative Procedure Act APA Pub. L. 79404, 5 U.S.C. 553, and, where applicable, section 1871 of the Act. Specifically, 5
U.S.C. 553 requires the agency to publish a notice of the proposed rule in the Federal Register that includes a reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subjects and issues involved. Further, 5 U.S.C. 553
requires the agency to give interested parties the opportunity to participate in the rulemaking through public comment before the provisions of the rule take effect. Similarly, section 1871b1 of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and a period of not less than 60 days for public comment for rulemaking carrying out the administration of the insurance programs under title XVIII of the Act.
Section 1871b2C of the Act and 5
U.S.C. 553 authorize the agency to waive these procedures, however, if the agency for good cause finds that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued. Section 553d of title 5 of the U.S. Code ordinarily requires a 30-day delay in the effective date of a final rule from the date of its publication in the Federal Register.
This 30-day delay in effective date can be waived, however, if an agency finds good cause to support an earlier effective date. Section 1871e1Bi of the Act also prohibits a substantive rule from taking effect before the end of the 30-day period beginning on the date the rule is issued or published. However, section 1871e1Bii of the Act permits a substantive rule to take effect before 30 days if the Secretary finds that a waiver of the 30-day period is necessary to comply with statutory requirements or that the 30-day delay would be contrary to the public interest.

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