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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations
than the risk of death among infected persons age 40 to 49 years. Yet the average years of remaining life among younger persons at these ages is far greater than among older persons at higher ages. Age, however, is not anywhere near a perfect indicator of risk since, for example, health care workers and those with immune system disorders face elevated risks from exposure. Sorting out all these factors to reach either a qualitative or quantitative estimate of net benefits from any particular policy is extremely complex and is one reason why vaccination priorities have differed among the states and over time.
All these data and estimation limitations apply to even the short-term impacts of this rule, and major uncertainties remain as to the future course of the pandemic, including but not limited to vaccine effectiveness in preventing disease transmission from those vaccinated, and the long-term effectiveness of vaccination.
E. Other Effects 1. Sources of Payment We anticipate that virtually all of the costs of this rule will be reimbursed from funds already appropriated under the CARES Act and the American Rescue Plan Act of 2021. For example, the amounts provided in the Provider Relief Fund is $7.4 billion, many times more than the relatively small costs of this rule. As previously discussed, if there are treatment cost savings to hospitals and other care providers as a result of the vaccinations that will be made due to this rule, the treatment cost savings would in turn result in savings to payers. It is likely that half or more of these savings would primarily accrue to Medicare given the elderly or disability status of most clients and Medicares role as primary payer, but there would also be substantial savings to Medicaid, private insurance paid by employers and employees, and private out-of-pocket payers including residents.
2. Regulatory Flexibility Act The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. Under the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Individuals and states are not included in the definition of a small entity. For purposes of the RFA, we estimate that many LTC facilities and most ICFsIID
are small entities as that term is used in
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the RFA because they are either nonprofit organizations or meet the SBA
definition of a small business having revenues of less than $8.0 million to $41.5 million in any 1 year. HHS uses an increase in costs or decrease in revenues of more than 3 to 5 percent as its measure of significant economic impact. The HHS standard for substantial number is 5 percent or more of those that will be significantly impacted, but never fewer than 20.
The average annual cost of a nursing home stay is about $271.98 per day or about $100,000 per year.99 As estimated previously, the average annual cost of this rule is about $24.70 per resident or staff person in the first year. This cost does not approach the 3 percent threshold. For ICFsIID, one estimate of average annual costs per client is $140,000, also a level at which this rule does not approach the 3 percent threshold.100 Moreover, since most or all of these costs will be reimbursed through the CARES Act or other COVID19 funding sources, the financial strain on these facilities should be negligible and the likely net effect positive. Considering the cost savings from treating seriously ill residents, the financial impact is likely to be positive. Therefore, the Department has determined that this interim final rule will not have a significant economic impact on a substantial number of small entities and that a final RIA is not required. Finally, this IFC was not preceded by a general notice of proposed rulemaking and the RFA requirement for a final regulatory flexibility analysis does not apply to final rules not preceded by a proposed rule.
3. Small Rural Hospitals Section 1102b of the Social Security Act requires us to prepare a RIA if a proposed rule may have a significant impact on the operations of a substantial number of small rural hospitals. For purposes of this requirement, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100
beds. Because this rule has no direct effects on any hospitals, the Department has determined that this interim final rule will not have a significant impact on the operations of a substantial 99 See Marcum Accountants & Advisors, A Five Year Nursing Home Statistical Analysis 2014 to 2018, at https www.marcumllp.com/wp-content/
uploads/marcum-five-year-nursing-homestatistical-analysis-2014-2018.pdf.
100 See In-Home and Residential Long-Term Supports and Services for Persons with Intellectual or Developmental Disabilities: Status and Trends 2017, op cit, page 77.

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number of small rural hospitals. This interim final rule is also exempt because that provision of law only applies to final rules for which a proposed rule was published.
4. Unfunded Mandates Reform Act Section 202 of the Unfunded Mandates Reform Act of 1995 UMRA
requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates will impose spending costs on state, local, or tribal governments, or by the private sector, require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2021, that threshold is approximately $158
million. This rule does contain mandates on private sector entities, and we estimate the resulting amount to be about the same as this threshold in the first year. This IFC was not preceded by a notice of proposed rulemaking, and therefore the requirements of UMRA do not apply. The information in this RIA
and the preamble as a whole would, however, meet the requirements of UMRA.
5. Federalism Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule and subsequent final rule that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications.
Nothing in this rule will have a substantial direct effect on state or local governments, preempt state laws, or otherwise have federalism implications.
F. Alternatives Considered As discussed earlier in the preamble, a major substantive alternative that we considered was to require vaccination activities education and offering for all persons who may provide paid or unpaid services, such as visiting specialists or volunteers, who are not on the regular payroll on a weekly or more frequent basis. That is, individuals who work in the facility infrequently. We also considered including visitors, such as family members. All these categories present major problems for compliance, enforcement, and record-keeping, as well as a multitude of complexities related to visit frequency, resident exposure, and vaccination management.
Furthermore, the efficacy of such a policy would be difficult to establish.
For example, vaccinating a one-time visitor on the day of their visit would not improve resident safety because the vaccine is not instantly effective upon administration. There are also ethical
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