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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules The proposed changes to 45 CFR part 144 would make technical and conforming amendments regarding the purpose of part 150.
The proposed changes to 45 CFR part 148 would set forth requirements for health insurance issuers offering individual health insurance coverage or short-term, limited-duration insurance to disclose to policyholders information regarding direct and indirect compensation provided by the issuer to an agent or broker associated with enrolling individuals in such coverage.
The proposed amendments to 45 CFR
part 148 also set forth proposed requirements related to the annual reports that health insurance issuers offering individual health insurance coverage or short-term, limited-duration insurance would be required to submit to HHS regarding the direct and indirect compensation paid to agents and brokers. In addition, these proposed rules would make technical and conforming amendments regarding the basis, purpose, and scope of 45 CFR part 148.
The proposed changes to 45 CFR part 149 would require plans, issuers, and providers of air ambulance services to submit to HHS certain data regarding air ambulance services. Proposed rules under 26 CFR 54.98231 and 29 CFR
2590.723 would provide that group health plans and health insurance issuers offering group health insurance coverage that satisfy the requirements under 45 CFR part 149 that implement section 2799A8 of the PHS Act would be treated as satisfying the parallel requirements under section 9823 of the Code and section 723 of ERISA. The proposed change to 5 CFR part 890
would require FEHB carriers to comply with the requirements of 45 CFR
149.230 with respect to an FEHB plan in the same manner as such provisions apply to a group health plan or health insurance issuer offering group or individual health insurance coverage.
OPM would coordinate with HHS to receive FEHB air ambulance services data.
The proposed changes to 45 CFR part 150 would make procedural changes to the process HHS utilizes to investigate possible violations of the PHS Act, including proposed amendments to clarify the process to investigate complaints and potential violations of the PHS Act and to impose civil money penalties against non-Federal governmental plans and issuers of group or individual health insurance coverage.
The proposed changes would also set forth the process for imposing civil money penalties on providers and facilities, including providers of air
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ambulance services, for failure to comply with 45 CFR part 149 and failure to provide data required in section 106a of the No Surprises Act.
II. Provisions of the Proposed Rules on Reporting Requirements Regarding Air Ambulance ServicesDepartments of HHS, Labor, and the Treasury A. In General These proposed rules propose requirements related to data collection from providers of air ambulance services, as required by section 106a of the No Surprises Act, and from plans and issuers offering group or individual health insurance coverage, as required by section 9823 of the Code, section 723
of ERISA, and section 2799A8 of the PHS Act, as added by section 106b of the No Surprises Act.
These proposed rules also include an HHS-only proposed rule that sets forth civil money penalties specified in section 106e of the No Surprises Act that would apply to providers of air ambulance services for failure to submit data as required under section 106a of the No Surprises Act.5
Air ambulance services frequently result in surprise medical bills due to individuals inabilities to select an innetwork provider of air ambulance services when faced with an urgent medical situation. Because of low network participation rates by providers of air ambulance services, individuals are also unable to avoid potential higher cost sharing and balance billing by outof-network providers. A 2019 study by the Government Accountability Office GAO analyzed data from 2017 and found that 69 percent of air ambulance transports of privately-insured patients were out-of-network.6
When individuals are unable to avoid providers or providers of air ambulance services that are not in their plans network, it raises health care costs and exposes individuals to financial risk.7
The ability to balance bill is often used as leverage by providers to obtain higher in-network payments, which results in 5 Section 106b of the No Surprises Act amends part D of Title XXVII of the PHS Act by adding new section 2799A8. As such, the enforcement provisions under PHS Act section 2723 and 45 CFR
part 150 extend to PHS Act section 2799A8 air ambulance data reporting requirements on issuers and non-Federal governmental group health plans.
Section 106a of the No Surprises Act is codified in the United States Code as a note to PHS Act section 2799A8.
6 Air Ambulance: Available Data Show PrivatelyInsured Patients Are at Financial Risk. GAO19
292 March 2019.
7 Cooper Z et al., Out-of-Network Billing and Negotiated Payments for Hospital-Based Physicians, Health Affairs 39, No. 1, 2020. doi: 10.1377/
hlthaff.2019.00507.

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higher premiums, higher cost sharing for consumers, and overall increased health care expenditures.8 Studies have shown that surprise medical bills can be substantial, including with respect to air ambulance services. The GAO found that for privately-insured patients, the median price charged by providers of air ambulance services was about $36,400
for a rotary-wing transport and $40,600
for a fixed-wing transport in 2017.9 In an earlier study,10 the GAO noted that there is no national data on balance billing and the extent to which providers of air ambulance services have contracts with health insurance companies. Some states have attempted to collect data on balance billing. The GAO study stated that a Michigan state review of 19 cases of balance billing for air ambulance services between 2013
and 2016 showed an average balance bill of $31,000. Data on cases investigated and closed by the Maryland Insurance Administration between January 2014 and April 2018 showed that the amount of balance bills for air ambulance services ranged from $12,300
to $52,000.
Although some states have enacted laws to regulate the billing practices of providers of air ambulance services, many of these efforts have been unsuccessful due to a preemption provision in the Airline Deregulation Act of 1978 ADA. The ADA states, in relevant part, . . . a State, political subdivision of a State, or political authority of at least two States may not enact or enforce a law, regulation, or other provision having the force and effect of law related to a price, route, or service of an air carrier that may provide air transportation under this subpart. 11
Assuming that a provider of air ambulance services is an air carrier covered by this provision, as is typical,12 the provision preempts state 8 See, Cooper, Z. et al, Surprise! Out-Of-Network Billing For Emergency Care in the United States, NBER Working Paper 23623, 20173623; Duffy, E. et al., Policies to Address Surprise Billing Can Affect Health Insurance Premiums. The American Journal of Managed Care 26.9 2020: 401404; and Brown E.C.F., et al., The Unfinished Business of Air Ambulance Bills, Health Affairs Blog March 26, 2021, DOI: 10.1377/hblog20210323.911379, available at https www.healthaffairs.org/do/
10.1377/hblog20210323.911379/full/.
9 Air Ambulance: Available Data Show PrivatelyInsured Patients Are at Financial Risk. GAO19
292 March, 2019.
10 Air Ambulance: Data Collection and Transparency Needed to Enhance DOT Oversight.
GAO17637 July 27, 2017.
11 49 U.S.C. 41713b.
12 A provider of air ambulance services is a covered air carrier if it has economic authority from the Department of Transportation to provide interstate air transportation. Most providers of air ambulance services have such authority under the
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