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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
limited-duration coverage. The proposed reporting requirements would also provide HHS with data for such coverage similar to those collected by the DOL on the compensation provided by issuers of group health insurance coverage.
The proposed requirements in 45 CFR
149.230 and 149.460 of these proposed rules are related to the air ambulance data reporting requirements as set forth in section 106a of the No Surprises Act for providers of air ambulance services and section 106b of the No Surprises Act, which added parallel provisions at section 9823 of the Code, section 723 of ERISA, and section 2799A8 of the PHS
Act, requiring plans and issuers offering group or individual health insurance coverage to submit claims data related to air ambulance services. The data collection would support the production of the comprehensive report on air ambulance services required under section 106c of the No Surprises Act and would enable the identification and analysis of unfair and deceptive practices and unfair methods of competition as noted in section 106f of the No Surprises Act. These proposed rules would also implement certain provisions that would allow HHS to enforce the No Surprises Act to protect individuals from surprise medical bills for emergency services, air ambulance services furnished by nonparticipating providers, and non-emergency services furnished by nonparticipating providers at participating facilities in certain circumstances.
The proposed revisions to 45 CFR part 150, including the proposed inclusion of a new subpart E, would accomplish three objectives: i Implementing section 2799B4 of the PHS Act, which subjects providers and facilities, including providers of air ambulance services, to CMS enforcement and oversight in certain circumstances; ii updating the existing regulations to ensure they align with industry standards and current CMS practices;
and iii implementing section 106e of the No Surprises Act, which states that a provider of air ambulance services that fails to submit all information required under section 106a2 of the No Surprises Act shall be subject to a civil money penalty of not more than $10,000. The proposed revisions and these new rules are necessary to enable CMS to carry out this statutory mandate and enforce the provisions of the PHS
Act and the No Surprises Act against providers and facilities, including providers of air ambulance services.
They also serve to strengthen CMSs authority and oversight of issuer and non-Federal governmental plan
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compliance with applicable PHS Act requirements.
B. Overall Impact The Departments have examined the impacts of these proposed rules as required by Executive Order 12866 on Regulatory Planning and Review September 30, 1993, Executive Order 13563 on Improving Regulation and Regulatory Review January 18, 2011, the Regulatory Flexibility Act RFA
September 19, 1980, Pub. L. 96354, section 202 of the Unfunded Mandates Reform Act of 1995 March 22, 1995, Pub. L. 1044, Executive Order 13132
on Federalism August 4, 1999, and the Congressional Review Act 5 U.S.C.
8042.
Executive Orders 12866 and 13563
direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety effects, distributive impacts, and equity. Executive Order 13563
emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. A
regulatory impact analysis RIA must be prepared for rules with economically significant effects $100 million or more in any 1 year.
Section 3f of Executive Order 12866
defines a significant regulatory action as an action that is likely to result in a rule: 1 Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities also referred to as economically significant; 2 creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; 3
materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or 4
raising novel legal or policy issues arising out of legal mandates, the Presidents priorities, or the principles set forth in the Executive order. An RIA
must be prepared for major rules with economically significant effects $100
million or more in any 1 year, and a significant regulatory action is subject to review by OMB. This rule is not likely to have economic impacts of $100
million or more in at least 1 year, and therefore is not expected to be economically significant under
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Executive Order 12866. OMB has determined, however, that the actions are significant within the meaning of section 3f4 of the Executive order.
Therefore, the Departments have provided an assessment of the potential benefits and costs associated with this rule. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by OMB.
The proposed provisions related to disclosure and reporting of direct and indirect agent and broker compensation related to enrollments in individual health insurance coverage and shortterm, limited-duration insurance would help provide transparency to consumers wishing to apply for such coverage. The data submitted to HHS by issuers of such coverage would enable HHS to determine the compensation paid to agents and brokers, the structures being used to determine agent and broker compensation, and potentially determine if compensation is being used to intentionally steer individuals toward plans with less comprehensive benefits.
The provisions related to air ambulance data reporting in these proposed rules would provide complete, uniform, nationwide information on air ambulance services that is currently not available. The information collected from providers of air ambulance services would be used to satisfy the requirements for the comprehensive public report described in section 106c of the No Surprises Act and to allow the Secretary of Transportation to determine whether a provider of air ambulance services has engaged in unfair and deceptive practices or unfair methods of competition. The data collected from plans and issuers regarding air ambulance services would enable HHS
and the Department of Transportation to combine and validate the information collected from plans, issuers, and providers of air ambulance services and would provide additional information to support the production of the report described in section 106c of the No Surprises Act. Inclusion of discrete, yet de-identified, air ambulance data from each FEHB carrier will allow for transparency and data validation with respect to air ambulance services provided to FEHB covered individuals, for purposes of ensuring a comprehensive report to Congress, and to further support the implementation of 5 U.S.C. 8902p which specifically ends surprise air ambulance bills in the FEHB
Program.
In addition, the enforcement provisions in these proposed rules would establish the process by which CMS would investigate complaints and enforce the PHS Act requirements
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