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Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Rules and Regulations
In this rule, HHS finalizes revised 2022 user fee rates, which will impact issuer rate setting. HHS believes that health insurance issuers and group health plans would be classified under the North American Industry Classification System code 524114
Direct Health and Medical Insurance Carriers. According to SBA size standards, entities with average annual receipts of $41.5 million or less would be considered small entities for these North American Industry Classification System codes. Issuers could possibly be classified in 621491 HMO Medical Centers and, if this is the case, the SBA
size standard would be $35 million or less.225 HHS believes that few, if any, insurance issuers underwriting comprehensive health insurance policies in contrast, for example, to travel insurance policies or dental discount policies fall below these size thresholds. Based on data from MLR
annual report 226 submissions for the 2019 MLR reporting year, approximately 77 out of 479 issuers of health insurance coverage nationwide had total premium revenue of $41.5 million or less. This estimate may overstate the actual number of small health insurance issuers that may be affected, since over 67 percent of these small companies belong to larger holding groups, and many, if not all, of these small companies are likely to have non-health lines of business that will result in their revenues exceeding $41.5 million. The user fee rates finalized in this rule are lower than the 2021 benefit year user fee rates by 0.25 percent, and these new rates are higher than the previously finalized 2022 benefit year user fee rates by 0.5 percent. Therefore, these user fee rates will only impact premium revenue for these issuers by approximately 0.25
percent, since no issuer has effectuated payments under the previously finalized user fee rates, and this impact is below HHSs 3 to 5 percent significance threshold stated earlier.
In this final rule, HHS also codifies a new monthly special enrollment period for certain APTC-eligible individuals.
Because this special enrollment period has the potential to introduce new adverse selection risk into the individual market, HHS sought comment in the RIA on the impact on premiums of this policy in Exchanges where it is implemented. HHS estimates that this policy could result in an increase in premiums of 0.5 to 2 percent when the enhanced APTC provisions of 225 https www.sba.gov/document/support-tablesize-standards.
226 Available at https www.cms.gov/CCIIO/
Resources/Data-Resources/mlr.html.

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the ARP are in effect, and this impact is below HHSs 3 to 5 percent significance threshold stated earlier in this preamble.
In addition, the other provisions in this rule will either reduce costs or have no cost impact. Therefore, HHS does not expect the provisions of this rule to affect a substantial number of small entities. HHS does not believe that this threshold will be reached by the requirements in this final rule.
Therefore, the Secretary of HHS has determined that this final rule will not have a significant economic impact on a substantial number of small entities.
In addition, section 1102b of the Act requires HHS to prepare a regulatory impact analysis in certain cases if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604
of the RFA. For purposes of section 1102b of the Act, HHS defines a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100
beds. While this rule is not subject to section 1102 of the Act, HHS has determined that this final rule would not affect small rural hospitals, as the policies finalized in this rule impact consumer assisters, Exchanges, states, issuers, and consumers, but do not directly pertain to providers or facilities.
Therefore, the Secretary of HHS has determined that this rule will not have a significant impact on the operations of a substantial number of small rural hospitals.
F. Unfunded Mandates Reform Act UMRA
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 require spending in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2021, that threshold is approximately $158 million. Although HHS has not been able to quantify all costs, HHS
expects the combined impact on state, local, or Tribal governments and the private sector to be below the threshold.
G. 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.
In HHSs view, while this final rule does not impose substantial direct requirement costs on state and local
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governments, this regulation has federalism implications due to potential direct effects on the distribution of power and responsibilities among the state and Federal governments relating to determining standards relating to health insurance that is offered in the individual and small group markets.
In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have federalism implications or limit the policy making discretion of the states, HHS has engaged in efforts to consult with and work cooperatively with affected states, including participating in conference calls with and attending conferences of the NAIC, and consulting with state insurance officials on an individual basis.
While developing this rule, HHS
attempted to balance the states interests in regulating health insurance issuers with the need to ensure market stability.
By doing so, HHS complied with the requirements of E.O. 13132.
Because states have flexibility in designing their Exchange and Exchangerelated programs, state decisions will ultimately influence both administrative expenses and overall premiums. States are not required to establish an Exchange. For states that elected previously to operate an Exchange, those states had the opportunity to use funds under Exchange Planning and Establishment Grants to fund the development of data. Accordingly, some of the initial cost of creating programs was funded by Exchange Planning and Establishment Grants. After establishment, Exchanges must be financially self-sustaining, with revenue sources at the discretion of the state. A
user fee is assessed on issuers under all existing Exchange models, including State Exchanges where the user fee is assessed by the state, SBEFPs, and the FFEs. HHS solicited comment on the proposed user fee rate of 2.75 percent of monthly premiums for issuers in FFEs and 2.25 percent of monthly premiums for issuers in SBEFPs.
H. Congressional Review Act This final rule is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 5
U.S.C. 801, et seq., which specifies that before a rule can take effect, the Federal agency promulgating the rule shall submit to each House of the Congress and to the Comptroller General a report containing a copy of the rule along with other specified information, and has been transmitted to the Congress and the Comptroller for review. This final rule is a major rule as that term is
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