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OMB Control No: 1210-0144	ICR Reference No: 202503-1210-004
Status: Active	Previous ICR Reference No: 202501-1210-005
Agency/Subagency: DOL/EBSA	Agency Tracking No:
Title: Affordable Care Act Internal Claims and Appeals and External Review Procedures for ERISA Plans
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/01/2025
	Date Received in OIRA: 04/30/2025
Terms of Clearance: Prior to next the extension or revision of this package, the agency will consider changes to improve accessibility (e.g., through increasing the use of plain language) and make it easier for participants and beneficiaries to appeal claim denials.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2028	36 Months From Approved	07/31/2025
Responses	187,601	0	390,574
Time Burden (Hours)	18,370	0	19,047
Cost Burden (Dollars)	613,741	0	602,026

Abstract: The Patient Protection and Affordable Care Act, Public Law 111-148, (the Affordable Care Act or the Act) was enacted on March 23, 2010. As part of the Act, Congress added Public Health Service Act (the PHS Act) section 2719, which provides rules relating to internal claims and appeals and external review processes. The Department of Labor, Internal Revenue Service, and the Health and Human Services Department (the Departments) issued final regulations (80 FR 72191) that set forth rules implementing PHS Act section 2719 for internal claims and appeals and external review processes. With respect to internal claims and appeals processes for group health coverage, PHS Act section 2719 and paragraph (b)(2)(i) of the final regulations provide that group health plans and health insurance issuers offering group health insurance coverage must comply with the internal claims and appeals processes set forth in 29 CFR 2560.503-1 (the DOL claims procedure regulation) and update such processes in accordance with standards established by the Secretary of Labor in paragraph (b)(2)(ii) of the regulations. The DOL claims procedure regulation requires plans to provide every claimant who is denied a claim with a written or electronic notice that contains the specific reasons for denial, a reference to the relevant plan provisions on which the denial is based, a description of any additional information necessary to perfect the claim, and a description of steps to be taken if the participant or beneficiary wishes to appeal the denial. The regulation also requires that any adverse decision upon review be in writing (including electronic means) and include specific reasons for the decision, as well as references to relevant plan provisions. Paragraph (b)(2)(ii)(C) of the final regulations adds a requirement that non-grandfathered ERISA-covered group health plans provide to the claimant, free of charge, any new or additional evidence considered relied upon, or generated by the plan or issuer in connection with the claim. In addition, the PHS Act section 2719 and the final regulations provide that group health plans and issuers offering group health insurance coverage must comply either with a State external review process or a Federal review process. The regulations provide a basis for determining when plans and issuers must comply with an applicable State external review process and when they must comply with the Federal external review process. The No Surprises Act extends the balance billing protection related to external reviews to grandfathered plans. The definitions of group health plan and health insurance issuer that are cited in section 110 of the No Surprises Act include both grandfathered and non-grandfathered plans and coverage. Accordingly, the practical effect of section 110 of the No Surprises Act is that grandfathered health plans must provide external review for adverse benefit determinations involving benefits subject to these surprise billing protections. The claims procedure regulation imposes information collection requirements as part of the reasonable procedures that an employee benefit plan must establish regarding the handling of a benefit claim. These requirements include third-party notice and disclosure requirements that the plan must satisfy by providing information to participants and beneficiaries of the plan.

Authorizing Statute(s): PL: Pub.L. 116 - 260 No Surprises Act Name of Law: Consolidated Appropriations Act, 2021
PL: Pub.L. 111 - 148 2719 Name of Law: The Patient Protection and Affordable Care Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 56416	07/09/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 17982	04/30/2025
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	187,601	390,574	-202,973
Annual Time Burden (Hours)	18,370	19,047	-677
Annual Cost Burden (Dollars)	613,741	602,026	11,715

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Adjustments to the burden estimates result from updated estimates on the number of ERISA-covered plans and policyholders and increases in wage rates and postage rates, as well as a change to how the number of plans is calculated. These changes result in 713,149 fewer respondents, a decrease of 202,973 responses, a decline of the hour burden by 677 hours, and increase of the cost burden by $11,715 compared with the prior submission.

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: James Butikofer 202 693-8434 Butikofer.James@dol.gov

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