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OMB Control No: 0938-1401	ICR Reference No: 202506-0938-006
Status: Active	Previous ICR Reference No: 202203-0938-004
Agency/Subagency: HHS/CMS	Agency Tracking No: CCIIO
Title: Requirements Related to Surprise Billing: Qualifying Payment Amount, Notice and Consent, Disclosure on Patient Protections Against Balance Billing, and State Law Opt-in (CMS-10780)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR: Yes
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/22/2025
	Date Received in OIRA: 06/09/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2028	36 Months From Approved
Responses	58,676,716	0	0
Time Burden (Hours)	4,886,380	0	0
Cost Burden (Dollars)	0	0	0

Abstract: On December 27, 2020, the Consolidated Appropriations Act, 2021 (Pub. L. 116-260), which included the No Surprises Act, was signed into law. The No Surprises Act provides federal protections against surprise billing and limits out-of-network cost sharing under many of the circumstances in which surprise medical bills arise most frequently. The 2021 interim final regulations “Requirements Related to Surprise Billing; Part I” (2021 interim final regulations) issued by the Departments of Health and Humans Services, the Department of Labor, the Department of Treasury, and the Office of Personnel Management, implement provisions of the No Surprises Act that apply to group health plans, health insurance issuers offering group or individual health insurance coverage, and carriers in the Federal Employees Health Benefits (FEHB) Program that provide protections against balance billing and out-of-network cost sharing with respect to emergency services, non-emergency services furnished by nonparticipating providers at certain participating health care facilities, and air ambulance services furnished by nonparticipating providers of air ambulance services. The 2021 interim final regulations prohibit nonparticipating providers, emergency facilities, and providers of air ambulance services from balance billing participants, beneficiaries, and enrollees in certain situations unless they satisfy certain notice and consent requirements. The No Surprises Act and the 2021 interim final regulations require group health plans and issuers of health insurance coverage to provide information about qualifying payment amounts to nonparticipating providers and facilities and to provide disclosures on patient protections against balance billing to participants, beneficiaries and enrollees. Self-insured plans opting in to State law are required to provide a disclosure to participants. Certain nonparticipating providers and nonparticipating emergency facilities may are provide participants, beneficiaries, and enrollees with notice and obtain their consent to waive balance billing protections, provided certain requirements are met. In addition, certain providers and facilities are required to provide disclosures on patient protections against balance billing to participants, beneficiaries and enrollees.

Authorizing Statute(s): PL: Pub.L. 116 - 260 Title I of Division BB Name of Law: Consolidated Appropriations Act, 2021

Citations for New Statutory Requirements: PL: Pub.L. 116 - 260 Title I of Division BB Name of Law: Consolidated Appropriations Act, 2021

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 99871	12/11/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 20166	05/12/2025
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Change Due to Potential Violation of the PRA
Annual Number of Responses	58,676,716	58,676,716
Annual Time Burden (Hours)	4,886,380	4,886,380
Annual Cost Burden (Dollars)	0	0

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:

Annual Cost to Federal Government: $594,000

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: Jamaa Hill 301 492-4190

Common Form ICR: Yes
Description/Changes for Common Form Usage:

Approved RCFs using this ICR

Agency/Sub Agency	RCF ID	RCF Title	RCF Status	IC Title

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