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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules In determining the disclosure and data reporting requirements for agent and broker compensation in these proposed rules, HHS considered requiring disclosure of intermediary payments to consumers for example, payments made through general line agencies or marketing organizations prior to finalizing enrollment. That level of detail was determined to be impractical and would not have enough positive impact on the consumer to justify the cost to implement. HHS also considered requiring the disclosure of actual amounts of compensation an agent or broker would receive. That, too, was rejected as being impossible to calculate ahead of time, as well as being potentially overly burdensome on the sales process. Furthermore, HHS
considered requiring signed documentation from the consumer stating disclosure had occurred. This was not pursued, given concerns regarding burden.
In determining the data reporting requirements for air ambulance services contained in these proposed rules, the Departments considered available alternative regulatory proposals. Given the statutory requirements of section 106 of the No Surprises Act, these alternatives were limited to reducing the number of data reporting elements required. However, collecting data in a more aggregated format would not support many of the analyses required in the statute for the comprehensive report on air ambulance services required under section 106c. Section 106c of the No Surprises Act requires, among other analyses, assessments of amounts paid by issuers for furnishing air ambulance services, amounts paid out-of-pocket by consumers, any changes in the amounts paid over time and as an assessment of any evidence of gaps in rural access to air ambulance services. The absence of detailed transport-level data would limit the Secretaries of HHS and Transportation ability to conduct these analyses.
E. Regulatory Flexibility Act The RFA 5 USC 601, et seq., requires agencies to prepare an initial regulatory flexibility analysis to describe the impact of these proposed rules on small entities, unless the head of the agency can certify that the rule will not have a significant economic impact on a substantial number of small entities.
The RFA generally defines a small entity as: 1 A proprietary firm meeting the size standards of the Small Business Administration SBA, 2 a not-for-profit organization that is not dominant in its field, or 3 a small government jurisdiction with a
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population of less than 50,000. States and individuals are not included in the definition of small entity. HHS uses a change in revenues of more than 3 to 5
percent as its measure of significant economic impact on a substantial number of small entities.
The provisions in these proposed rules would affect health insurance issuers, group health plans, TPAs on behalf of self-insured group health plans, and issuers of short-term, limited-duration insurance. Health insurance issuers and group health plans would be classified under the North American Industry Classification System NAICS code 524114 Direct Health and Medical Insurance Carriers.
According to SBA size standards, entities with average annual receipts of $41.5 million or less are considered small entities for this 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.60 The Departments expect that few, if any, insurance companies 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 medical loss ratio MLR annual report 61
submissions for the 2019 MLR reporting year, approximately 77 out of 473
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 companies 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 Departments are of the view that the same assumptions also apply to TPAs that would be affected by these proposed rules.
Providers of air ambulance services would be classified under NAICS code 621910 Ambulance Services, with a size standard of $16.5 million or less.
Based on a 2020 USC-Brookings Schaeffer report on air ambulance services,62 by 2017, large private equity firms controlled roughly two-thirds of the air ambulance market. The 60 https www.sba.gov/document/support--tablesize-standards.
61 Available at https www.cms.gov/CCIIO/
Resources/Data-Resources/mlr.html.
62 Adler, L., Hannick, K., and Lee, S. High Air Ambulance Charges Concentrated in Private EquityOwned Carriers. USC-Brookings Schaffer Initiative for Health Policy. October 13, 2020.

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Departments lack data on the number of small entities in the air ambulance market. As discussed earlier in the Collection of Information Requirements section, a provider of air ambulance services would incur a cost of approximately $41,000 in 2022 and annual costs of $1,794 in 2023 and 2024
to submit the required information to HHS. The Departments seek comment on whether any providers of air ambulance services may be considered small entities including entities with annual revenue under $16.5 million or independent not-for-profit entities not dominant in the industry and whether these costs would result in an impact of more than 3 to 5 percent of revenues for those small entities.
Agents and brokers would be classified under NAICS code 524210
Insurance Agencies and Brokerages, with a size standard of $8 million or less. The proposed requirement to provide agent or broker compensation disclosure to individuals prior to enrollment would affect an estimated 55,541 agents and brokers, many of whom are likely to be employed by small entities. As discussed earlier in the HHS Collection of Information Requirements section, an agent or broker would incur a cost of approximately $33 to comply with the proposed requirement. This is unlikely to cause a change in revenue of more than 3 to 5 percent for agents and brokers.
As discussed earlier in the Regulatory Impact Analysis, the proposed provisions related to enforcement in these proposed rules regarding enforcement of section 2799B4 of the PHS Act would also affect approximately 2,400 providers including providers of air ambulance services and facilities annually, some of which might be small entities. A
provider or facility subject to investigation would incur a cost of approximately $354. This is unlikely to cause a change in revenue of more than 3 to 5 percent for providers and facilities.
Therefore, the Departments do not anticipate that the proposed provisions in these proposed rules would have a significant effect on a substantial number of small entities. The Departments seek comment on this analysis.
In addition, section 1102b of the SSA requires the Departments to prepare a regulatory impact analysis if a rule under Title XVIII, Title XIX, or part B of Title 42 of the SSA may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to
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