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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
meet the proposed reporting requirements, HHS estimates a total one-time burden of 30,000 hours, with an equivalent cost of $3,074,760.
Once the process for collecting and formatting the required data is established, HHS assumes that the resources required to submit the required information to HHS for the 2022 and 2023 plan years to be submitted by March 31, 2023 and March 30, 2024, respectively would be limited. HHS estimates that each provider of air ambulance services would require a computer and systems information manager 4 hours at an hourly rate of $155.52 to oversee the compilation of the data, a computer
programmer 4 hours at an hourly rate of $91.96 to extract the required data and provide it in the required reporting format, a business operations specialist 8 hours at an hourly rate of $81.06 to review the data reports, and an administrative secretary 4 hours at an hourly rate of $38.86 to assist in the assembly of documents and submit them to HHS. HHS estimates that each provider of air ambulance services would incur an annual burden of 20
hours, with an equivalent cost of $1,794.
For all providers of air ambulance services, HHS estimates an annual burden of 1,500 hours, with an equivalent cost of $134,538 in 2023 and 2024.

The total one-time burden and costs, to be incurred in 2022, for all providers of air ambulance services to make the appropriate IT and system changes would be approximately 30,000 hours and a total cost of approximately $3,074,760. Providers of air ambulance services would also incur an annual burden and cost to submit the data to HHS, for 2023 and 2024, of 1,500 hours and $134,538. CMS is seeking an OMB
control number and approval for the proposed information collection OMB
control number: 0938NEW Reporting Requirements Regarding Air Ambulance Services CMS10785.

TABLE 6PROPOSED ONE-TIME AND ANNUAL BURDEN AND COSTS RELATED TO AIR AMBULANCE DATA REPORTING
REQUIREMENTS FOR PROVIDERS OF AIR AMBULANCE SERVICES
Estimated number of respondents
Year
Number of responses
Burden per response hours
Total annual burden hours
Total cost
2022
2023
2024

75
75
75

75
75
75

400
20
20

30,000
1,500
1,500

$3,074,760
134,538
134,538

Three-Year Average

75

75

147

11,000

1,114,612

F. ICRs Regarding CMS Enforcement of Group and Individual Insurance Market and Provider and Facility Requirements 45 CFR 150.303, 150.311, 150.313, 150.509, 150.517, and 150.525
The process by which CMS
investigates allegations of noncompliance against issuers and nonFederal governmental plans is detailed in 45 CFR 150.301 through 150.347.
Sections 2799A1a2Aii and 2726a of the PHS Act, as amended by the CAA, require CMS to conduct certain targeted audits. Therefore, HHS
proposed amendments to 45 CFR
150.303c to authorize random and targeted investigation and market conduct examinations.
Section 2723b of the PHS Act, as amended by the CAA, authorizes the Secretary of HHS to impose civil money penalties as a means of enforcing the individual and group insurance market requirements contained in Part A and Part D of Title XXVII of the PHS Act with respect to health insurance issuers when a state does not have authority to enforce or fails to substantially enforce these provisions and with respect to group health plans that are non-Federal governmental plans in all states. Section 2799B4 of the PHS Act, as added by section 104 of the No Surprises Act, adopts a similar framework for CMSs enforcement authority over providers
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and facilities, including providers of air ambulance services, in states that do not have authority or otherwise fail to substantially enforce the requirements of Part E of Title XXVII of the PHS Act, as added by the CAA. In addition, section 106e of the No Surprises Act authorizes HHS to impose civil money penalties on providers of air ambulance services for failure to submit to the Secretaries of HHS and Transportation information related to air ambulance services required under section 106a of the No Surprises Act.
CMS would take enforcement action upon receiving information that an issuer, non-Federal governmental plan, provider, facility, or provider of air ambulance services may be violating a provision of the PHS Act. Sources of information may include: i Complaints; ii reports from plans or issuers, providers or facilities, state insurance departments, state health departments, medical boards, the NAIC, and any other Federal or state agencies;
and iii any other information that indicates potential noncompliance with PHS Act requirements for example, review of a providers or issuers public website. Upon receiving information regarding a potential violation where CMS is responsible for enforcement, or upon being selected for a targeted or random investigation or market conduct examination, CMS would undertake
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either an investigation or a market conduct examination.
When CMS becomes aware of a potential violation, CMS would commence an investigation by issuing a notice to the responsible entity detailing the potential violation. Such notice would give the responsible entity an opportunity to respond, and state that it may be subject to a civil money penalty or corrective action. HHS proposes that the responsible entity could respond within the allotted time frame as communicated in the written notice to the responsible entity, request an extension, or default and be subject to the civil money penalty or corrective action. CMS also may subject a provider of air ambulance services to a civil money penalty if such provider fails to submit data required in section 106a of the No Surprises Act.
HHS believes this collection is exempt from the PRA under 5 CFR
1320.4a2, which provides an exemption from PRA when information is gathered during the conduct of a civil action to which the United States or any official or agency thereof is a party, or during the conduct of an administrative action, investigation, or audit involving an agency against specific individuals or entities.
G. Summary of Annual Burden Estimates for Proposed Requirements
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