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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
laws that would limit the amount of payment that the provider of air ambulance services would otherwise be entitled to receive.13 Even within states that have enacted protections against surprise billing, state insurance regulations typically apply only to health insurance coverage, as ERISA
generally preempts state laws that would otherwise regulate self-insured group health plans sponsored by private employers.14 Finally, states are limited in their ability to address surprise bills that involve an out-of-state provider, including an out-of-state provider of air ambulance services.
As states, the Federal Government, oversight agencies, and advocacy groups have examined the issue of air ambulance services and balance billing, it has become clear that there is a lack of comprehensive, national data on air ambulance costs, transports, and contractual arrangements between providers of air ambulance services and plans and issuers. In its 2017 report, the GAO recommended that the Federal Government assess available data to determine what additional information would be needed to address future concerns regarding unfair or deceptive practices.15 In addition, section 418 of the FAA Reauthorization Act of 2018
directed the Secretary of Transportation, in consultation with HHS, to form an Advisory Committee on Air Ambulance and Patient Billing Advisory Committee. In January 2021, the Advisory Committees subcommittee on the Prevention of Balance Billing recommended to the full Advisory Committee the collection of data to a improve understanding of the air ambulance industry by policymakers, b increase transparency of market conditions impacting air ambulance services, and c indirectly improve contract negotiation between payors and air ambulance providers and suppliers. 16
provisions of 14 CFR part 298. See, for example, Scarlett v. Air Methods Corp., 922 F.3d 1053 10th Cir. 2019; Air Evac EMS v. Cheatham, 910 F.3d 751
4th Cir. 2018.
13 See, for example, Guardian Flight LLC v.
Godfread, 991 F.3d 916, 921 8th Cir. 2021
holding that ADA preempted state law prohibiting out-of-network providers of air ambulance services from balance billing and requiring them to accept amounts paid by insurers; Bailey v. Rocky Mountain Holdings, LLC, 889 F.3d 1259, 126972
11th Cir. 2018 holding that ADA preempted state law that prohibited providers of air ambulance services from collecting more than amount specified in fee schedule.
14 In addition, FEHB contract terms preempt state law in accordance with 5 U.S.C. 8902m1.
15 See Air Ambulance: Data Collection and Transparency Needed to Enhance DOT Oversight.
GAO17637 July 27, 2017.
16 Air Ambulance and Patient Billing Advisory Committees Subcommittee on Prevention of
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Section 106 of the No Surprises Act takes important steps to increase transparency regarding air ambulance services. Specifically, section 106a of the No Surprises Act requires providers of air ambulance services to submit certain data to the Secretaries of HHS
and Transportation. Section 106b of the No Surprises Act requires plans and issuers to submit certain data on air ambulance services to the Secretaries of HHS, DOL, and the Treasury, through section 9823 of the Code, section 723 of ERISA and section 2799A8 of the PHS
Act. Section 106d of the No Surprises Act requires HHS, in consultation with the Secretary of Transportation, to specify through notice and comment rulemaking, the form and manner in which the reports described under section 106a of the No Surprises Act regarding reporting by providers of air ambulance services and section 9823 of the Code, section 723 of ERISA, and section 2799A8 of the PHS Act regarding reporting by plans and issuers must be submitted to such Secretaries. Therefore, in these proposed rules, HHS proposes amendments to 45 CFR part 149 that specify the form and manner of these reports. In addition, the Department of the Treasury and DOL propose to add 26
CFR 54.98231 and 29 CFR 2590.723 to specify that group health plans and health insurance issuers offering group health insurance coverage would satisfy the requirements under section 9823 of the Code and section 723 of ERISA, respectively, by submitting a report to HHS that satisfies the requirements of 45 CFR 149.230. In the interest of burden reduction and efficiency, the Departments propose that the required information reporting by group health plans and health insurance issuers offering group and individual health insurance coverage, together with the required information reporting by FEHB
carriers,17 would be satisfied through reporting to HHS.
B. Basis and Scope 45 CFR 149.10
HHS proposes to amend 45 CFR
149.10a to add a reference to section 106a of the No Surprises Act, which Balance Billing, A Report on the Prevention of Balance Billing, January 2021, DOTOST2018
02060026_attachment_1. At its second full committee meeting in May 2021, the Advisory Committee recommended the collection of eight specific data elements from providers of air ambulance services. See section I.A of the preamble. The Committees final report containing this recommendation had yet to be produced at the time this rulemaking was published.
17 OPM proposes to authorize and require FEHB
carriers to submit air ambulance data to HHS. OPM
will coordinate with HHS to receive FEHB air ambulance services data.

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requires data reporting by providers of air ambulance services, to the basis of part 149.
C. Applicability 45 CFR 149.20
HHS proposes to amend 45 CFR
149.20 to include a reference to the new subpart C, which under these proposed rules would include data submission requirements for plans and issuers. See section II.F. of the preamble for discussion of the applicability of the proposed rules regarding data submission requirements for providers of air ambulance services.
D. Definitions 45 CFR 149.30
HHS proposes to amend 45 CFR
149.30 by adding definitions relevant to data submission requirements for providers of air ambulance services and plans and issuers. The Departments propose to define an air ambulance base as a site from which a provider of air ambulance services operates to provide air ambulance services. The Departments propose to define a National Provider Identifier NPI by referencing the definition in 45 CFR
162.406. The Departments seek comment on these proposed definitions.
E. Reporting Requirements for Plans and Issuers Regarding Air Ambulance Services 45 CFR 149.230
HHS proposes to amend part 149 by adding 45 CFR 149.230 to subpart C to describe the data reporting requirements for plans and issuers. Proposed 45 CFR
149.230a includes general requirements, the timing and form of the data submission, and the reporting requirements in circumstances when a transfer of business occurs.
As discussed in sections I.A and II.A
of the preamble, section 106b of the No Surprises Act added parallel provisions at section 9823 of the Code, section 723
of ERISA, and section 2799A8 of the PHS Act requiring plans and issuers to submit information regarding air ambulance services jointly to the Departments. Section 106d of the No Surprises Act directs HHS, in consultation with the Secretary of Transportation, to undertake notice and comment rulemaking to specify the form and manner in which plans and issuers must submit this information.
Therefore, in these proposed rules, HHS
proposes amendments to 45 CFR part 149 that specify the form and manner for the reports required in section 9823
of the Code, section 723 of ERISA, and section 2799A8 of the PHS Act, as enacted in section 106b of the No Surprises Act. In the interest of burden reduction and efficiency, the Department of the Treasury and DOL

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