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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
collect and maintain the information using information technology IT
systems that are designed to meet all of the security standards protocols established under Federal law or by HHS relevant to such information.18
The claims-level data elements that HHS proposes to require plans and issuers to submit to support HHSs publication of the comprehensive public report, but that are not explicitly listed in section 9823 of the Code, section 723
of ERISA, and section 2799A8 of the PHS Act, include: The date of service;
billing NPI and Current Procedural Terminology CPT/Healthcare Common Procedure Coding System HCPCS
codes information; and certain information about each air ambulance transport such as the loaded miles and whether the transport was an interfacility transport. These data elements, specifically the NPI and the date of service, would enable the Secretaries of HHS and Transportation to combine and validate the information collected from plans and issuers and the information collected from providers of air ambulance services.
Similarly, to enable the Secretaries of HHS and Transportation to analyze and summarize the data in an appropriate and meaningful manner in a comprehensive public report, HHS also proposes that the claims-level data elements include the market type of the plan or coverage associated with the air ambulance services. For fully-insured coverage, this would include the individual, small group, and large group markets, as defined in section 2791e of the PHS Act. For self-insured group health plans, this would include identification of the plan sponsor as a small employer or large employer, as defined in section 2791e of the PHS
Act, with reasonable estimates allowed when the exact information on the size of the employer is not available. Under this proposal, FEHB plans would also be separately identified.
Further, to satisfy the requirements for the comprehensive public report described in section 106c of the No Surprises Act, including the required assessments of the frequency of patient balance billing and claims appeals made by air ambulance providers, HHS
18 HHSs enterprise-wide information security and privacy program was launched in FY 2003, to help protect HHS against potential IT threats and vulnerabilities. The program ensures compliance with Federal mandates and legislation, including the Federal Information Security Management Act and the Presidents Management Agenda. The HHS
Cybersecurity Program plays an important role in protecting HHSs ability to provide mission-critical operations. In addition, the HHS Cybersecurity Program is the cornerstone of the HHS IT Strategic Plan.

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proposes that the claims-level data elements include certain claim adjudication information including whether the claim was paid, partially paid, denied, or appealed, and the reason for the denial and the outcome of the appeal, if applicable, as well as certain claim payment information including submitted charges, amounts paid by the payor, and cost-sharing amount.
In order to streamline the provision of the required disclosures and to avoid unnecessary duplication of reporting with respect to group health insurance coverage, the Departments propose that, to the extent coverage under a plan consists of group health insurance coverage, the plan satisfies the reporting requirements if the plan requires the issuer offering the coverage to provide the information pursuant to a written agreement between the plan and the issuer. For example, if a plan and an issuer enter into a written agreement under which the issuer agrees to report the information required under proposed 45 CFR 149.230, and the issuer fails to submit a complete or timely report, then the issuer, but not the plan, would have violated these reporting requirements. However, if a plan has knowledge that the required report has not been submitted, the Departments would encourage the plan to work with the issuer to correct the noncompliance as soon as practicable or notify the applicable agency enforcing this requirement.
The Departments also highlight that nothing prevents a self-insured group health plan from contracting with another party, such as a third-party administrator TPA, to report the required information, including, to the extent permitted under other Federal or state laws, entering into a written agreement for the other party to indemnify the plan in the event the other party fails to submit a complete or timely report. However, the plan would be required to monitor the other party to ensure that the entity is submitting the required information as it is ultimately the responsibility of the selfinsured group health plan to report the information required under proposed 45
CFR 149.230. The proposed information collection instrument is designed in a manner that would enable a TPA that submits information on behalf of multiple self-insured group health plans to submit a single submission that includes the required data elements for all such plans.
Excepted benefits are exempt from requirements in chapter 100 of the Code, part 7 of ERISA, and Part A and
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Part D of Title XXVII of the PHS Act.19 20
Short-term, limited-duration insurance is excluded from the definition of individual health insurance coverage and is exempt from the new requirements established in section 2799A8 of the PHS Act. Therefore, short-term, limited-duration insurance as defined in 26 CFR 54.98012, 29
CFR 2590.7012, and 45 CFR 144.103
and coverage that consists solely of excepted benefits as described in section 9832 of the Code, section 733 of ERISA, and section 2791 of the PHS
Act would not be subject to the reporting requirements set forth in 45
CFR 149.230 in these proposed rules.
Individual coverage health reimbursement arrangements and other account-based plans, as described in 26
CFR 54.98152711d6i, 29 CFR
2590.7152711d6i, and 45 CFR
147.126d6i, make reimbursements subject to a maximum fixed dollar amount for a period, such that the benefit design of these coverage options makes concepts related to the reporting of data related to air ambulance services inapplicable. Therefore, under these proposed rules, the reporting requirements also would not apply to individual coverage health reimbursement arrangements and other account-based plans, consistent with the existing applicability provisions in 45
CFR 149.20 with respect to other No Surprises Act requirements in 45 CFR
part 149.
Section 9823 of the Code, section 723
of ERISA, and section 2799A8 of the PHS Act and other provisions of the No Surprises Act that are applicable to group health plans and health insurance issuers offering group or individual health insurance coverage apply to grandfathered health plans. Section 1251 of the Affordable Care Act provides that grandfathered health plans are not subject to certain provisions of the Code, ERISA, and the PHS Act, as added by the Affordable Care Act, for as long as they maintain their status as grandfathered health plans. For example, grandfathered health plans are subject neither to the requirement to cover certain preventive services without cost sharing under section 2713
of the PHS Act, nor to the annual limitation on cost sharing set forth 19 See section 9831 of the Code, section 732 of ERISA, and section 2722 of the PHS Act.
20 The CAA amended the PHS Act statutory exemption for these products to include the new requirements established under the new Part D of the PHS Act. See section 102a3B of the No Surprises Act, which made conforming amendments to add the phrase and Part D to section 2722b, c1, c2 and c3 of the PHS
Act.

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